Part 14. TEXAS OPTOMETRY BOARD
The Texas Optometry Board proposes amendments to §271.2 concerning requirements for license application. The amendment clarifies when college and optometry school transcripts must be submitted to the Board.
Chris Kloeris, executive director of the Texas Optometry Board, has determined that for the first five-year period the proposed amendment is in effect, there will be no fiscal implications for state and local governments as a result of enforcing or administering the rule.
Chris Kloeris also has determined that for each of the first five years the amendment is in effect, the public benefit anticipated is that applicants will have clear guidelines regarding the time period to submit required documents.
The amendments do not require the submission of additional documents. Therefore Mr. Kloeris has determined that there will be no economic costs for persons who are required to comply with the amendments, including small businesses. No disparate effect is foreseen on small or micro-businesses.
Comments on the proposal may be submitted to Chris Kloeris, Executive Director, Texas Optometry Board, 333 Guadalupe Street, Suite 2-420, Austin, Texas 78701-3942. The deadline for furnishing comments is thirty days after publication in the Texas Register.
The amendment is proposed under the Texas Optometry Act, Texas Occupations Code, §351.151, and §351.254. No other sections are affected by the amendments.
The Texas Optometry Board interprets §351.151 as authorizing the adoption of procedural and substantive rules for the regulation of the optometric profession and §351.254 as setting the educational requirements for license as an optometrist.
§271.2.Applications.
(a) - (e) (No change.)
(f)
Applications submitted by graduates of an approved
college of optometry must contain a certified copy of the optometry school
transcript. A license will not be issued until the applicant has submitted
certified
[
Certified
] copies of the transcript of record
from preoptometry and optometry colleges attended by the applicant [
shall accompany each application
], which certified transcript of record
shall show the total number of hours of attendance, the subjects studied,
the grades or marks given, and the date of graduation of the applicant.
All transcripts must be submitted to the executive director prior to the date
which is one year after successful passage of the board's jurisprudence examination;
otherwise, the applicant must reapply and take and pass the board's jurisprudence
examination.
(g) - (i) (No change.)
This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of the Secretary of State on May 31, 2007.
TRD-200702128
Chris Kloeris
Executive Director
Texas Optometry Board
Earliest possible date of adoption: July 15, 2007
For further information, please call: (512) 305-8502
The Texas Optometry Board proposes amendments to §273.8 concerning reinstatement of expired licenses and reexamination requirements for expired licenses. The amendments clarify the type of examination required for licenses that have expired, including therapeutic license requirements. For expired licenses where the optometrist is practicing in another state, the amendments require the applicant for reinstatement to obtain an official license verification from all states in which the optometrist is licensed, and clarifies that §351.501 of the Optometry Act applies to license reinstatements.
Chris Kloeris, executive director of the Texas Optometry Board, has determined that for the first five-year period the amendment is in effect, there will be no fiscal implications for state and local governments as a result of enforcing or administering the rule.
Chris Kloeris also has determined that for each of the first five years the amendment is in effect, the public benefit anticipated is that the agency will have access to records of any disciplinary action that the expired licensee may have received in the current states of licensure, which can be reviewed by the agency prior to a reinstatement of an expired license. The amendments will require persons applying to reinstate an expired license to submit one or more license verifications, depending on the number of states in which licensed, which typically cost $15 to $20. This cost will be incurred by individual applicants, and no disparate effect is foreseen on small or micro-businesses. The amendment clarifying the examination required for a new license when the license has expired, including therapeutic examination and education, does not change the examination currently used. Obtaining 16 hours of continuing education is estimated to cost $500. This cost will be incurred by individual applicants, and no disparate effect is foreseen on small or micro-businesses.
Comments on the proposal may be submitted to Chris Kloeris, Executive Director, Texas Optometry Board, 333 Guadalupe Street, Suite 2-420, Austin, Texas 78701-3942. The deadline for furnishing comments is thirty days after publication in the Texas Register.
The amendment is proposed under the Texas Optometry Act, Texas Occupations Code, §§351.151, 351.252, 351.304, 351.306, 351.308 and 351.501. No other sections are affected by the amendments.
The Texas Optometry Board interprets §351.151 as authorizing the adoption of procedural and substantive rules for the regulation of the optometric profession, §351.252 as setting the requirements for therapeutic license, §351.304 to require reexamination upon license expiration, §351.306 to allow reinstatement of an expired license if the former licensee is practicing out of state, §351.308 as setting continuing education requirements, and §351.501 as defining the conduct by applicants or licensees that allow the agency to refuse to issue a license or impose disciplinary action.
§273.8.Renewal of License.
(a) Expired license.
(1) - (3) (No change.)
(4) If a person's license has been expired for one year or
longer, the person may not renew the license but may obtain a new license
by
taking and passing the jurisprudence exam,
[
submitting
to reexamination,
]
obtaining 16 hours of board approved continuing
education,
and complying with the requirements and procedures for obtaining
an initial license.
If the person was not licensed as a therapeutic optometrist
when the license expired, the person must also complete the requirements for
therapeutic license in §§280.1 - 280.3 of this title prior to obtaining
a new license.
(5) The board, however, may renew without examination an expired license of a person who was previously licensed in Texas, is currently licensed in another state, and has been in practice for two years immediately preceding application for renewal. The person shall be required to furnish documentation of continuous practice for the two-year period, pay the renewal fee as established by subsection (a)(3) of this title, above. The person must furnish license verifications from each state in which the person is currently or previously licensed. A license renewal under this section is subject to the same requirements of §351.501 of the Act as a license applicant.
(6) - (7) (No change.)
(b) (No change.)
This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of the Secretary of State on May 31, 2007.
TRD-200702129
Chris Kloeris
Executive Director
Texas Optometry Board
Earliest possible date of adoption: July 15, 2007
For further information, please call: (512) 305-8502
Subchapter A. ALL CLASSES OF PHARMACIES
The Texas State Board of Pharmacy proposes new §291.2, concerning Definitions, §291.3, concerning Required Notifications, §291.24, concerning Pharmacy Residency Programs, and §291.27, concerning Confidentiality. The Texas State Board of Pharmacy proposes amendments to §291.6, concerning Pharmacy License Fees, §291.8, concerning Return of Prescription Drugs, §291.10, concerning Pharmacy Balance Registration/Inspection, §291.18, concerning Time Limit for Filing a Complaint, §291.19, concerning Administrative Actions as a Result of a Compliance Inspection, §291.22, concerning Petition to Establish an Additional Class of Pharmacy, and §291.23, concerning Pilot or Demonstration Research Projects for Innovative Applications in the Practice of Pharmacy. The Texas State Board of Pharmacy proposes the repeal of §291.2, concerning Change of Location and/or Name, §291.3, concerning Managing Officers, §291.4, concerning Change of Ownership, §291.7, concerning Change of Pharmacist Employment, §291.12, concerning Fire or Other Disaster, §291.13, concerning Emergency Remote Pharmacy License, §291.15, concerning Notification of Theft of Loss of a Controlled Substance or a Dangerous Drug, §291.16, concerning Definitions, §291.20, concerning Remote Pharmacy Services, §291.21, concerning Notification to Consumers, §291.25, concerning Pharmacies Compounding Non-sterile Pharmaceuticals, §291.26, concerning Pharmacies Compounding Sterile Pharmaceuticals, and §291.27, concerning Pharmacy Residency Programs. The proposed new rules, amendments, and repeals, if adopted, provide a more organized Subchapter A of Chapter 291 regarding all classes of pharmacies.
New §291.2, if adopted, provides the definitions for the subchapter previously found in §291.16 which is proposed as a repealed rule published in this edition of the Texas Register. New §291.3, if adopted, contains the required notifications for pharmacies previously found in §§291.2, 291.3, 291.4, 291.7, 291.12, 291.15 and 291.21 which are proposed as repealed rules published in this edition of the Texas Register. New §291.24, if adopted, provides the standards for pharmacy residency programs previously found in §291.27 which is proposed as a repealed rule published in this edition of the Texas Register. New §291.27, if adopted, provides the confidentiality requirements for all classes of pharmacy previously located within the rules for each class of pharmacy and clarifies that pharmacy must have written polices and procedures to prohibit the unauthorized disclosure of confidential records. The amendments to §291.6, if adopted, will raise pharmacy license fees based on increased expense. The amendments to §291.8, if adopted, will implement Senate Bill 1188 passed by the 79th Texas Legislature which made changes to the Texas Pharmacy Act, allowing for the return of certain prescription drugs in sealed unopened tamper-evident individual packaging and either individually packaged or packaged in unit-dose packaging and will allow for the return of certain unused prescription drugs for penal institutions. The amendments to §291.10, if adopted, will clarify the board's authority to inspect balances in pharmacies. The amendments to §291.18, if adopted, correct punctuation. The amendments to §291.19, if adopted, clarify inspection procedures. The amendments to §291.22, if adopted, correct grammar. The amendments to §291.23, update the reference to the Texas Pharmacy Act. The §§291.13, 291.20, 291.25, and 291.26 are proposed as new rules in new Subchapter G of Chapter 291 and are published elsewhere in this edition of the Texas Register.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for the first five-year period the amendments are in effect, there will be fiscal implications for state government as a result of enforcing or administering the proposal as follows:
Revenue Increase
FY2008 = $321,750
FY2009 = $351,000
FY2010 = $351,000
FY2011 = $351,000
FY2012 = $351,000
There are no anticipated fiscal implications for local government.
Ms. Dodson has determined that, for each year of the first five year period the proposal will be in effect, the public benefit anticipated as a result of enforcing the proposal will be assuring that the Texas State Board of Pharmacy is adequately funded to carry out its mission. The effect on large, small or micro-businesses (pharmacies) required to comply with the proposal will be an increase of $117 for an initial registration and an increase of $117 for the renewal of a registration.
The economic cost to an individual will be the same as the economic cost to a business, if the individual chooses to pay the business registration fee.
Comments on the proposed new rules, amendments and repeals may be submitted to Allison Benz, R.Ph., M.S., Director of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Austin, Texas, 78701, FAX (512) 305-8082. Comments must be received by 5:00 p.m., July 30, 2007.
22 TAC §§291.2 - 291.4, 291.7, 291.12, 291.13, 291.15, 291.16, 291.20, 291.21, 291.25 - 291.27
(Editor's note: The text of the following sections proposed for repeal will not be published. The sections may be examined in the offices of the Texas State Board of Pharmacy or in the Texas Register office, Room 245, James Earl Rudder Building, 1019 Brazos Street, Austin.)
The repeals are proposed under §551.002 and §554.051 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by the repeal: Chapters 551 - 566 and 568 - 569, Texas Occupations Code.
§291.2.Change of Location and/or Name.
§291.3.Change of Managing Officers.
§291.4.Change of Ownership.
§291.7.Change of Pharmacist Employment.
§291.12.Fire or Other Disaster.
§291.13.Emergency Remote Pharmacy License.
§291.15.Notification of Theft or Loss of a Controlled Substance or a Dangerous Drug.
§291.16.Definitions.
§291.20.Remote Pharmacy Services.
§291.21.Notification to Consumers.
§291.25.Pharmacies Compounding Non-Sterile Pharmaceuticals.
§291.26.Pharmacies Compounding Sterile Pharmaceuticals.
§291.27.Pharmacy Residency Programs.
This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of the Secretary of State on June 4, 2007.
TRD-200702221
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: July 15, 2007
For further information, please call: (512) 305-8028
22 TAC §§291.2, 291.3, 291.6, 291.8, 291.10, 291.18, 291.19, 291.22 - 291.24, 291.27
The amendments and new rules are proposed under §§551.002, 554.051, and 562.1085 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act. The Board interprets §562.1085 as authorizing the agency to adopt rules to implement the provisions of the section.
The statutes affected by the amendments and new rules: Chapters 551 - 566 and 568 - 569, Texas Occupations Code.
§291.2.Definitions.
Any term not defined in this chapter shall have the definition set out in the Act, §551.003.
§291.3.Required Notifications.
(a) Change of Location and/or Name.
(1) When a pharmacy changes location and/or name, the following is applicable.
(A) A new completed pharmacy application containing the information outlined in §291.1 of this title (relating to Pharmacy License Application), must be filed with the board within 10 days of the change of location of the pharmacy.
(B) The previously issued license must be returned to the board office.
(C) An amended license reflecting the new location and/or name of the pharmacy will be issued by the board; and
(D) A fee as specified in §291.6 of this title (relating to Pharmacy License Fees) will be charged for issuance of the amended license.
(2) Disasters, accidents, and emergencies which require the pharmacy to change location shall be immediately reported to the board.
(b) Change of Managing Officers.
(1) The owner of a pharmacy shall notify the board in writing within 10 days of a change of any managing officer of a partnership or corporation which owns a pharmacy. The written notification shall include the effective date of such change and the following information for all managing officers:
(A) name and title;
(B) home address and telephone number;
(C) date of birth; and
(D) social security number.
(2) For purposes of this subsection, managing officers are defined as the top four executive officers, including the corporate officer in charge of pharmacy operations, who are designated by the partnership or corporation to be jointly responsible for the legal operation of the pharmacy.
(c) Change of Ownership.
(1) When a pharmacy changes ownership, a new/completed pharmacy application must be filed with the board and the licensed issued to previous owner shall be returned to the board.
(2) The new application shall include the following information:
(A) the name and address of pharmacy;
(B) the type of ownership;
(C) the names, home addresses, dates of birth, phone numbers, and social security numbers of all owners; if a partnership or corporation, the name, title, home address, home phone number, date of birth, and social security number of all managing officers;
(D) the name and license number of the pharmacist-in-charge and of other pharmacists employed by the pharmacy;
(E) a copy of lease agreement or alternatively, a notarized statement signed by the lessee and lessor certifying the existence of a lease agreement, or if the location of the pharmacy is owned by the applicant, a notarized statement certifying such location ownership;
(F) a copy of the purchase contract or mutual agreement between the buyer and seller, or a notarized statement of intent to convey ownership signed by both the buyer and seller, stating the proposed date of ownership change;
(G) the signature of the pharmacist-in-charge;
(H) the notarized signature of the owner, or if the pharmacy is owned by a partnership or corporation, the notarized signature of an owner or managing officer;
(I) federal tax ID number;
(J) description of business services that will be offered;
(K) name and address of malpractice insurance carrier or statement that the business will be self-insured;
(L) the certificate of authority, if applicant is an out-of-state corporation;
(M) the articles of incorporation, if the applicant is a corporation;
(N) a current Texas Franchise Tax Certificate of Good Standing; and
(O) any other information requested on the application.
(3) Paragraph (4) of this subsection applies to all change of ownership applications for Class A (Community) pharmacies or Class C (Institutional) pharmacies owned by a management company with the following exceptions.
(A) Paragraph (4) of this subsection does not apply to a change of ownership application submitted by an entity which already owns a pharmacy licensed in Texas.
(B) Paragraph (4)(A) and (C) of this subsection do not apply to each individual owner or managing officer listed on a new pharmacy application if the individual possesses an active pharmacist license in Texas.
(4) If the pharmacy is to be licensed as a Class A (Community) Pharmacy or a Class C (Institutional) pharmacy owned by a management company, the applicant must submit copies of the following documents in addition to the information required in paragraph (2) of this subsection:
(A) the birth certificate, passport, or other document proving the date of birth of the owner, or, if the pharmacy is owned by a partnership or a closely held corporation:
(i) one of these documents for each managing officer; and
(ii) a list of all owners of the corporation;
(B) an approved credit application from a primary wholesaler or other documents showing credit worthiness as approved by the Board; and
(C) a current driver license or state issued photo ID card of each individual owner, or, if the pharmacy is owned by a partnership or a closely held corporation, a current driver license or state issued photo ID card for each managing officer.
(5) A fee as specified in §291.6 of this title will be charged for issuance of a new license.
(d) Change of Pharmacist Employment.
(1) Change of pharmacist employed in a pharmacy. When a change in pharmacist employment occurs, the pharmacist shall report such change in writing to the board within 10 days. The pharmacist-in-charge shall delete or enter the name of the pharmacist changing employment on the license of such pharmacy.
(2) Change of pharmacist-in-charge of a pharmacy.
(A) On the date of change of the pharmacist-in-charge of a Class A (community) or Class C (institutional) pharmacy, an inventory of the following shall be taken:
(i) all Schedule II controlled substances;
(ii) all dosage forms containing pentazocine (e.g., Talwin);
(iii) all dosage forms containing phentermine (e.g., Ionamin, Fastin, Adipex-P, etc.);
(iv) all dosage forms containing diazepam (e.g., Valium);
(v) all dosage forms containing phendimetrazine (e.g., Bontril, Plegine, Prelu-2, etc.);
(vi) all dosage forms containing codeine;
(vii) all dosage forms containing hydrocodone (e.g., Tussionex, Tussend, Vicodin, Hycomine, etc.);
(viii) all dosage forms containing alprazolam (e.g., Xanax);
(ix) all dosage forms containing triazolam (e.g., Halcion);
(x) all dosage forms containing butorphanol (e.g., Stadol);
(xi) all dosage forms containing nalbuphine (e.g., Nubain); and
(xii) all dosage forms containing carisoprodol (e.g., Soma).
(B) This inventory shall constitute, for the purpose of this section, the closing inventory of the departing pharmacist-in-charge and the beginning inventory of the incoming pharmacist-in-charge.
(C) If the departing and the incoming pharmacists-in-charge are unable to conduct the inventory together, a closing inventory shall be conducted by the departing pharmacist-in-charge and a new and separate beginning inventory shall be conducted by the incoming pharmacist-in-charge.
(D) The incoming pharmacist-in-charge shall be responsible for the following actions:
(i) deleting the name of the departing pharmacist-in-charge on the pharmacy license;
(ii) entering the name of the incoming pharmacist-in-charge on the pharmacy license;
(iii) notifying the board within 10 days in writing on a form provided by the board, that a change of pharmacist-in-charge has occurred. The notification shall include the following:
(I) the name and license number of the departing pharmacist-in-charge;
(II) the name and license number of the incoming pharmacist-in-charge;
(III) the date the incoming pharmacist-in-charge became the pharmacist-in-charge; and
(IV) a statement signed by the incoming pharmacist-in-charge attesting that:
(-a-) an inventory has been conducted by the departing and incoming pharmacists-in-charge; if the inventory was not taken by both pharmacists, the statement shall provide an explanation; and
(-b-) the incoming pharmacist-in-charge has read and understands the laws and rules relating to this class of pharmacy.
(e) Notification of Theft or Loss of a Controlled Substance or a Dangerous Drug.
(1) Controlled substances. For the purposes of the Act, §562.106, the theft or significant loss of any controlled substance by a pharmacy shall be reported in writing to the board immediately on discovery of such theft or loss. A pharmacy shall be in compliance with this subsection by submitting to the board a copy of the Drug Enforcement Administration (DEA) report of theft or loss of controlled substances, DEA Form 106, or by submitting a list of all controlled substances stolen or lost.
(2) Dangerous drugs. A pharmacy shall report in writing to the board immediately on discovery the theft or significant loss of any dangerous drug by submitting a list of the name and quantity of all dangerous drugs stolen or lost.
(f) Fire or Other Disaster. If a pharmacy experiences a fire or other disaster, the following requirements are applicable.
(1) Responsibilities of the pharmacist-in-charge.
(A) The pharmacist-in-charge shall be responsible for reporting the date of the fire or other disaster which may affect the strength, purity, or labeling of drugs, medications, devices, or other materials used in the diagnosis or the treatment of the injury, illness, and disease; such notification shall be immediately reported to the board, but in no event shall exceed 10 days from the date of the disaster.
(B) The pharmacist-in-charge or designated agent shall comply with the following procedures.
(i) If controlled substances, dangerous drugs, or Drug Enforcement Administration (DEA) order forms are lost or destroyed in the disaster, the pharmacy shall:
(I) notify the DEA, Department of Public Safety (DPS), and Texas State Board of Pharmacy (board) of the loss of the controlled substances or order forms. A pharmacy shall be in compliance with this section by submitting to each of these agencies a copy of the DEA's report of theft or loss of controlled substances, DEA Form-106, immediately on discovery of the loss; and
(II) notify the Texas State Board of Pharmacy in writing of the loss of the dangerous drugs by submitting a list of the dangerous drugs lost.
(ii) If the extent of the loss of controlled substances or dangerous drugs is not able to be determined, the pharmacy shall:
(I) take a new, complete inventory of all remaining drugs specified in §291.17(c) of this title (relating to Inventory Requirements);
(II) submit to DEA and DPS a statement attesting that the loss of controlled substances is indeterminable and that a new, complete inventory of all remaining controlled substances was conducted and state the date of such inventory; and
(III) submit to the board a statement attesting that the loss of controlled substances and dangerous drugs is indeterminable and that a new, complete inventory of the drugs specified in §291.17(c) of this title was conducted and state the date of such inventory.
(C) If the pharmacy changes to a new, permanent location, the pharmacist-in-charge shall comply with subsection (a) of this section.
(D) If the pharmacy moves to a temporary location, the pharmacist shall comply with subsection (a) of this section. If the pharmacy returns to the original location, the pharmacist-in-charge shall again comply with subsection (a) of this section.
(E) If the pharmacy discontinues business (ceases to operate as a pharmacy), the pharmacist-in-charge shall comply with §291.5 of this title (relating to Closed Pharmacies).
(F) The pharmacist-in-charge shall maintain copies of all inventories, reports, or notifications required by this section for a period of two years.
(2) Drug stock.
(A) Any drug which has been exposed to excessive heat, smoke, or other conditions which may have caused deterioration shall not be dispensed.
(B) Any potentially adulterated or damaged drug shall only be sold, transferred, or otherwise distributed pursuant to the provisions of the Texas Food Drug and Cosmetics Act (Chapter 431, Health and Safety Code) administered by the Bureau of Food and Drug Safety of the Texas Department of State Health Services.
(g) Notification to Consumers.
(1) Pharmacy.
(A) Every licensed pharmacy shall provide notification to consumers of the name, mailing address, Internet site address, and telephone number of the board for the purpose of directing complaints concerning the practice of pharmacy to the board. Such notification shall be provided as follows.
(i) If the pharmacy serves walk-in customers, the pharmacy shall either:
(I) post in a prominent place that is in clear public view where prescription drugs are dispensed a sign furnished by the board which notifies the consumer that complaints concerning the practice of pharmacy may be filed with the board and list the board's name, mailing address, Internet site address, telephone number of the board, and if applicable a toll-free telephone number for filing complaints; or
(II) provide with each dispensed prescription a written notification in a type size no smaller than ten-point Times Roman which states the following: "Complaints concerning the practice of pharmacy may be filed with the Texas State Board of Pharmacy at: (list the mailing address, Internet site address, telephone number of the board, and if applicable a toll-free telephone number for filing complaints)."
(ii) If the prescription drug order is delivered to patients at their residence or other designated location, the pharmacy shall provide with each dispensed prescription a written notification in type size no smaller than ten-point Times Roman which states the following: "Complaints concerning the practice of pharmacy may be filed with the Texas State Board of Pharmacy at: (list the mailing address, Internet site address, telephone number of the board, and if applicable a toll-free telephone number for filing complaints)." If multiple prescriptions are delivered to the same location, only one such notice shall b required.
(iii) The provisions of this subsection do not apply to prescriptions for patients in facilities where drugs are administered to patients by a person required to do so by the laws of the state (i.e., nursing homes).
(B) A pharmacy that maintains a generally accessible site on the Internet that is located in Texas or sells or distributes drugs through this site to residents of this state shall post the following information on the pharmacy's initial home page and on the page where a sale of prescription drugs occurs.
(i) Information on the ownership of the pharmacy, to include at a minimum, the:
(I) owner's name or if the owner is a partnership or corporation, the partnership's or corporation's name and the name of the chief operating officer;
(II) owner's address;
(III) owner's telephone number; and
(IV) year the owner began operating pharmacies in the United States.
(ii) The Internet address and toll free telephone number that a consumer may use to:
(I) report medication/device problems to the pharmacy; and
(II) report business compliance problems.
(iii) Information about each pharmacy that dispenses prescriptions for this site, to include at a minimum, the:
(I) pharmacy's name, address, and telephone number;
(II) name of the pharmacist responsible for operation of the pharmacy;
(III) Texas pharmacy license number for the pharmacy and a link to the Internet site maintained by the Texas State Board of Pharmacy; and
(IV) the names of all other states in which the pharmacy is licensed, the license number in that state, and a link to the Internet site of the entity that regulates pharmacies in that state, if available.
(C) A pharmacy whose Internet site has been awarded a Verified Internet Pharmacy Practice Site (VIPPS) certification by the National Association of Boards of Pharmacy shall be in compliance with subparagraph (B) of this paragraph by displaying the VIPPS seal on the pharmacy internet site.
(2) Texas State Board of Pharmacy. On or before January 1, 2005, the board shall establish a pharmacy profile system as specified in §2054.2606, Government Code.
(A) The board shall make the pharmacy profiles available to the public on the agency's Internet site.
(B) A pharmacy profile shall contain at least the following information:
(i) name, address, and telephone number of the pharmacy;
(ii) pharmacy license number, licensure status, and expiration date of the license;
(iii) the class and type of the pharmacy;
(iv) ownership information for the pharmacy;
(v) names and license numbers of all pharmacists working at the pharmacy;
(vi) whether the pharmacy has had prior disciplinary action by the board;
(vii) whether the pharmacy's consumer service areas are accessible to disabled persons, as defined by law;
(viii) the type of language translating services, including translating services for persons with impairment of hearing, that the pharmacy provides for consumers; and
(ix) insurance information including whether the pharmacy participates in the state Medicaid program.
(C) The board shall gather this information on initial licensing and update the information in conjunction with the license renewal for the pharmacy.
§291.6.Pharmacy License Fees.
(a) Initial License Fee.
(1) The fee for an initial license shall be
$443
[
$329
] for a two year registration and for processing the application
and issuance of the pharmacy license as authorized by the Act §554.006.
(2) In addition, the following fees shall be collected:
(A)
$15
[
$12
] surcharge to fund a program
to aid impaired pharmacists and pharmacy students as authorized by the Act §564.051;
(B) - (C) (No change.)
(3) (No change.)
(b) (No change.)
(c) Renewal Fee.
(1) The fee for biennial renewal of a pharmacy license shall be
$443
[
$329
] for processing the application and issuance
of the pharmacy license as authorized by the Act §554.006;
(2) In addition, the following fees shall be collected:
(A)
$15
[
$12
] surcharge to fund a program
to aid impaired pharmacists and pharmacy students as authorized by the Act §564.051;
(B) - (C) (No change.)
(d) (No change.)
§291.8.Return of Prescription Drugs.
(a) (No change.)
(b) Return of prescription drugs from health care facilities.
(1) Purpose. The purpose of this subsection is to outline procedures for the return of unused drugs from a health care facility or a penal institution to a dispensing pharmacy as specified in the §562.1085 of the Occupations Code. Nothing in this section shall require a consultant pharmacist, health care facility , penal institution, or pharmacy to participate in the return of unused drugs.
(2) Definitions. The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise.
(A) - (B) (No change.)
(C) Licensed health care professional--A person licensed by the Texas Medical Board, Texas Board of Nurse Examiners, or the Texas State Board of Pharmacy.
(D) Penal institution--A place designated by law for confinement of persons arrested for, charged with, or convicted of an offense. A penal institution includes a city, county or state jail or prison.
(3) Consultant pharmacist/health care facility licensed health care professional/penal institution responsibilities. A consultant pharmacist or licensed health care professional may return to a pharmacy certain unused drugs, other than a controlled substance as defined by Chapter 481, Health and Safety Code, purchased from the pharmacy.
(A) The unused drugs must:
(i) be approved by the federal Food and Drug Administration and be:
(I)
sealed in [
the manufacturer's original
] unopened
tamper-evident packaging and either individually packaged or packaged in unit-dose
packaging;
(II) - (III) (No change.)
(IV) parenteral medications in sealed multiple-dose containers
approved by the federal Food and Drug Administration from which doses have
not been withdrawn
.
[
; and
]
(ii) not be the subject of a mandatory recall by a state or
federal agency or a voluntary recall by a drug seller or manufacturer
; and
[
.
]
(iii) have not been in the physical possession of the person for whom it was prescribed.
(B) (No change.)
(C) The consultant pharmacist /licensed health care professional shall be responsible for assuring an inventory of the drugs to be returned to a pharmacy is completed. The following information shall be included on this inventory:
(i) (No change.)
(ii) name and pharmacist license number of the consultant pharmacist or name and license number of the licensed health care professional ;
(iii) - (vii) (No change.)
(viii) signature of consultant pharmacist
.
[
;
]
(D) The health care facility /penal institution shall send a copy of the inventory specified in subparagraph (C) of this paragraph to:
(i) - (ii) (No change.)
(4) Dispensing/Receiving pharmacy responsibilities. If a pharmacy accepts the return of unused drugs from a health care facility /penal institution , the following is applicable.
(A) - (C) (No change.)
(5) (No change.)
§291.10.Pharmacy Balance Registration/Inspection.
(a) Definitions. The following words and terms, when used in
this section, shall have the following meanings, unless the context clearly
indicates otherwise. Pharmacy balance--An instrument for weighing
including
[
ingredients used in the compounding of drugs in a pharmacy. The
term pharmacy balance includes
] balances and scales.
(b) Registration.
(1) A pharmacy shall annually or biennially register each pharmacy
balance [
which may be used in the compounding of drugs
]. The fee
for the annual registration shall be $12.50 per pharmacy balance. The fee
for the biennial registration shall be $25.00 per pharmacy balance.
(2) (No change.)
(c) Inspection.
(1) (No change.)
(2) If a pharmacy balance fails the accuracy inspection, the following is applicable.
(A) The pharmacy balance may not be used [
in the compounding
of drugs
] until it is repaired by an authorized repair person.
(B) (No change.)
§291.18.Time Limit for Filing a Complaint.
For the purposes of the Act, §556.055, the board determines that
a ''reasonable time
''
[
'
] to be no less than 10 days
from the date of an inspection giving rise to a possible complaint; provided,
however, in situations presenting imminent danger to the public health and
safety, the board may obtain an injunction under the Act, §566.051, to
restrain or enjoin a person from continuing to violate the Act or rules promulgated
pursuant to the Act without waiting the 10-day period set out in this section.
§291.19.Administrative Actions as a Result of a Compliance Inspection.
As a result of a compliance inspection or compliance reinspection of a pharmacy wherein violations of the Texas Pharmacy Act, Controlled Substances Act, Dangerous Drug Act, Texas Food, Drug and Cosmetic Act, or rules adopted pursuant to such acts as observed:
(1)
an agent
[
a compliance officer
] of
the board may issue a written report of areas of non-compliance that need
improvement;
(2)
an agent
[
a compliance officer
] of
the board may issue a written warning notice listing specific violations to
which the licensee shall respond in writing to the board by the date stated
on the warning notice, indicating that the violations listed in the warning
notice have been corrected;
(3)
an agent
[
a compliance officer
] of
the board may recommend the institution of disciplinary action against a licensee
if such
agent
[
compliance officer
] determines that:
(A) - (B) (No change.)
(4)
an agent
[
a compliance officer
] of
the board, upon determination that the violations observed are of a nature
that pose an imminent peril to the public health, safety, or welfare, may
recommend to the director of compliance, the institution of action by a district
court in Travis County, Texas, to restrain or enjoin a licensee from continuing
the violation, in addition to recommending the institution of disciplinary
action against a licensee.
§291.22.Petition to Establish an Additional Class of Pharmacy.
(a) (No change.)
(b) Procedures for petitioning the board to establish an additional
class of pharmacy. A person who wishes the board to consider establishing
an additional class of pharmacy shall submit to the board a petition
that
[
for which
] contains at least the following information:
(1) - (2) (No change.)
(c) (No change.)
§291.23.Pilot or Demonstration Research Projects for Innovative Applications in the Practice of Pharmacy.
(a) Purpose. The purpose of this section is to specify the procedures to be followed in applying for approval of a pilot or demonstration research project for innovative applications in the practice of pharmacy as authorized by §554.011 of the Texas Pharmacy Act (Chapters 551- 566 and 568 - 569 , Texas Occupations Code). In reviewing projects, the board will only consider projects that expand pharmaceutical care services which contribute to positive patient outcomes. The board will not consider any project intended only to provide a competitive advantage.
(b) - (e) (No change.)
§291.24.Pharmacy Residency Programs.
For the purposes of Subchapter T, Chapter 61, Education Code, the standards for pharmacy residency programs shall be the standards required by the American Society of Health-System Pharmacists' Commission on Credentialing. The pharmacy residency programs approved by the Board shall be published periodically in the minutes of the Board.
§291.27.Confidentiality.
(a) A pharmacist shall provide adequate security of prescription drug orders, medication orders, and patient medication records to prevent indiscriminate or unauthorized access to confidential health information. If prescription drug orders, requests for refill authorization, or other confidential health information are not transmitted directly between a pharmacy and a physician but are transmitted through a data communication device, confidential health information may not be accessed or maintained by the operator of the data communication device unless specifically authorized to obtain the confidential information by this section.
(b) Confidential records are privileged and may be released only to:
(1) the patient or the patient's agent;
(2) a practitioner or another pharmacist if, in the pharmacist's professional judgement, the release is necessary to protect the patient's health and well being;
(3) the board or to a person or another state or federal agency authorized by law to receive the confidential record;
(4) a law enforcement agency engaged in investigation of a suspected violation of Chapter 481 or 483, Health and Safety Code, or the Comprehensive Drug Abuse Prevention and Control Act of 1970 (21 U.S.C. Section 801 et seq.);
(5) a person employed by a state agency that licenses a practitioner, if the person is performing the person's official duties; or
(6) an insurance carrier or other third party payor authorized by a patient to receive such information.
(c) A pharmacy shall provide written polices and procedures to prohibit the unauthorized disclosure of confidential records.
This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of the Secretary of State on June 4, 2007.
TRD-200702219
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: July 15, 2007
For further information, please call: (512) 305-8028
The Texas State Board of Pharmacy proposes amendments to §291.31 concerning Definitions, §291.32 concerning Personnel, §291.33 concerning Operational Standards, and §291.34 concerning Records. The Texas State Board of Pharmacy proposes the repeal of §291.37 concerning Centralized Prescription Dispensing and §291.38 concerning Central Prescription Drug or Medication Order Processing. The proposed amendments to §291.31, if adopted, clarify the definition for hot water, update and clarify the definitions for pharmacy technicians and pharmacy technician trainees, and clarify the definition for prescription drug. The proposed amendments to §291.32, if adopted, clarify that a pharmacist must check the data entry of a prescription, at the time of data entry when the prescription is placed "on hold" and update the rules to include pharmacy technician trainees. The proposed amendments to §291.33, if adopted, correct references to other rules in the chapter, correct the alternative labeling requirements for customized patient medication packages to conform with changes made to the alternative labeling requirements for dispensing containers, allow for the reuse of certain types of prescription containers if the patient or patient's agent has difficulty reading or understanding the prescription label, and incorporate recommendations made by the Task Force on Security in Community (Class A) Pharmacies. The proposed amendments to §291.34, if adopted, require pharmacies to provide the board or its representative with records in electronic format, if the records are maintained in an electronic format, and updates and corrects references. The §291.37 and §291.38 are proposed as new rules in new Subchapter G of Chapter 291 and are published elsewhere in this edition of the Texas Register.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for the first five-year period the proposed rule amendments are in effect, there will be no fiscal implications for state or local government as a result of enforcing or administering the rule.
Ms. Dodson has determined that, for each year of the first five-year period §291.31 will be in effect, the public benefit anticipated as a result of enforcing the proposed rule amendments will be to ensure that pharmacies have access to hot water as defined by the rule; for each year of the first five-year period §291.32 will be in effect, the public benefit anticipated as a result of enforcing the rules will be to ensure that prescriptions placed "on hold" are checked by a pharmacist; for each year of the first five-year period §291.33 will be in effect, the public benefit anticipated as a result of enforcing the rule will be to ensure the security of Class A pharmacies and to prohibit the diversion of prescription drugs from Class A pharmacies, and will be to allow pharmacies to reuse certain types of prescription containers for patients that have difficulty reading prescription labels; for each year of the first five-year period §291.34 will be in effect, the public benefit anticipated as a result of enforcing the rule will be to ensure that pharmacies provide records to the Board in the requested format. There is no fiscal impact for individuals, small or large businesses, or to other entities which are required to comply with §§291.31, 291.32, 291.34. There may be pharmacies that would be required to obtain security systems that comply with §291.33. However, it is difficult to project the exact costs due to variations in pharmacy size, settings, and types of systems available.
A public hearing to receive comments on the proposed §291.33 with regard to the security requirements will be held at 9:00 a.m. on Tuesday, August 7, 2007, at the Health Professions Council Board Room, 333 Guadalupe Street, Tower II, Room 2-225, Austin, Texas 78701. Persons planning to present comments to the Board are asked to provide a written copy of their comments prior to the hearing or bring 20 copies to the hearing. Written comments may be submitted to Allison Benz, R.Ph., M.S., Director of Professional Services, 333 Guadalupe Street, Suite 3-600, Austin, Texas, 78701, FAX: (512) 305-8082, E-mail: allison.benz@tsbp.state.tx.us. Comments must be received by 5:00 p.m., July 30, 2007.
The amendments are proposed under §551.002, and §554.051 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by the amendments: Chapters 551 - 566 and 568 - 569, Texas Occupations Code.
§291.31.Definitions.
The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.
(1) - (22) (No change.)
(23) Hot water--The temperature of water from the pharmacy's sink maintained at 120 to 140 degrees F (49 to 60 C).
(24)
[
(23)
] Medical Practice Act--The
Texas Medical Practice Act, Subtitle B, Occupations Code, as amended.
(25)
[
(24)
] Medication order--A written
order from a practitioner or a verbal order from a practitioner or his authorized
agent for administration of a drug or device.
(26)
[
(25)
] New prescription drug order--A
prescription drug order that:
(A) has not been dispensed to the patient in the same strength and dosage form by this pharmacy within the last year;
(B) is transferred from another pharmacy; and/or
(C) is a discharge prescription drug order. (Note: furlough prescription drug orders are not considered new prescription drug orders.)
(27)
[
(26)
] Original prescription--The:
(A) original written prescription drug order; or
(B) original verbal or electronic prescription drug order reduced to writing either manually or electronically by the pharmacist.
(28)
[
(27)
] Part-time pharmacist--A
pharmacist who works less than full-time.
(29)
[
(28)
] Patient counseling--Communication
by the pharmacist of information to the patient or patient's agent in order
to improve therapy by ensuring proper use of drugs and devices.
(30)
[
(29)
] Pharmaceutical care--The
provision of drug therapy and other pharmaceutical services intended to assist
in the cure or prevention of a disease, elimination or reduction of a patient's
symptoms, or arresting or slowing of a disease process.
(31)
[
(30)
] Pharmacist-in-charge--The
pharmacist designated on a pharmacy license as the pharmacist who has the
authority or responsibility for a pharmacy's compliance with laws and rules
pertaining to the practice of pharmacy.
(32)
[
(31)
] Pharmacy technician--An
individual
who is registered with the board as a pharmacy technician
and
whose responsibility in a pharmacy is to provide technical services
that do not require professional judgment regarding preparing and distributing
drugs and who works under the direct supervision of and is responsible to
a pharmacist. [
Pharmacy technician includes registered pharmacy technicians
and pharmacy technician trainees.
]
(33)
[
(32)
] Pharmacy technician trainee--
An individual who is registered with the board as a pharmacy technician trainee
and is authorized to participate in a pharmacy's technician training program.
[
A person who is not registered as a pharmacy technician by the
board and is either:
]
[(A) participating in a pharmacy's technician training program; or]
[(B) currently enrolled in a:]
[(i) pharmacy technician training program accredited by the American Society of Health-System Pharmacists; or]
[(ii) health science technology education program in a Texas high school that is accredited by the Texas Education Agency.]
(34)
[
(33)
] Physician assistant--A physician
assistant recognized by the Texas State Board of Medical Examiners as having
the specialized education and training required under Subtitle B, Chapter
157, Occupations Code, and issued an identification number by the Texas State
Board of Medical Examiners.
(35)
[
(34)
] Practitioner--
(A) a person licensed or registered to prescribe, distribute, administer, or dispense a prescription drug or device in the course of professional practice in this state, including a physician, dentist, podiatrist, or veterinarian but excluding a person licensed under this subtitle;
(B) a person licensed by another state, Canada, or the United Mexican States in a health field in which, under the law of this state, a license holder in this state may legally prescribe a dangerous drug;
(C) a person practicing in another state and licensed by another state as a physician, dentist, veterinarian, or podiatrist, who has a current federal Drug Enforcement Administration registration number and who may legally prescribe a Schedule II, III, IV, or V controlled substance, as specified under Chapter 481, Health and Safety Code, in that other state; or
(D) an advanced practice nurse or physician assistant to whom a physician has delegated the authority to carry out or sign prescription drug orders under §§157.0511, 157.052, 157.053, 157.054, 157.0541, or 157.0542 , Occupations Code.
(36)
[
(35)
] Prepackaging--The act of
repackaging and relabeling quantities of drug products from a manufacturer's
original commercial container into a prescription container for dispensing
by a pharmacist to the ultimate consumer.
(37) Prescription drug--
(A) a substance for which federal or state law requires a prescription before the substance may be legally dispensed to the public;
(B) a drug or device that under federal law is required, before being dispensed or delivered, to be labeled with the statement:
(i) "Caution: federal law prohibits dispensing without prescription" or "Rx only" or another legend that complies with federal law; or
(ii) "Caution: federal law restricts this drug to use by or on the order of a licensed veterinarian"; or
(C) a drug or device that is required by federal or state statute or regulation to be dispensed on prescription or that is restricted to use by a practitioner only.
(38)
[
(36)
] Prescription drug order--
(A) a written order from a practitioner or a verbal order from a practitioner or his authorized agent to a pharmacist for a drug or device to be dispensed; or
(B) a written order or a verbal order pursuant to Subtitle B, Chapter 157, Occupations Code.
(39)
[
(37)
] Prospective drug use review--A
review of the patient's drug therapy and prescription drug order or medication
order prior to dispensing or distributing the drug.
(40)
[
(38)
] State--One of the 50 United
States of America, a U.S. territory, or the District of Columbia.
(41)
[
(39)
] Texas Controlled Substances
Act--The Texas Controlled Substances Act, Health and Safety Code, Chapter
481, as amended.
(42)
[
(40)
] Written protocol--A physician's
order, standing medical order, standing delegation order, or other order or
protocol as defined by rule of the Texas State Board of Medical Examiners
under the Texas Medical Practice Act.
§291.32.Personnel.
(a) Pharmacist-in-charge.
(1) General.
(A) Each Class A pharmacy shall have one pharmacist-in-charge who is employed on a full-time basis, who may be the pharmacist-in-charge for only one such pharmacy; provided, however, such pharmacist-in-charge may be the pharmacist-in-charge of:
(i) more than one Class A pharmacy, if the additional Class A pharmacies are not open to provide pharmacy services simultaneously; or
(ii) up to two Class A pharmacies open simultaneously if the pharmacist-in-charge works at least 10 hours per week in each pharmacy.
(B) The pharmacist-in-charge shall comply with the provisions of §291.17 of this title (relating to Inventory Requirements).
(2) Responsibilities. The pharmacist-in-charge shall have responsibility for the practice of pharmacy at the pharmacy for which he or she is the pharmacist-in-charge. The pharmacist-in-charge may advise the owner on administrative or operational concerns. The pharmacist-in-charge shall have responsibility for, at a minimum, the following:
(A) education and training of pharmacy technicians and pharmacy technician trainees ;
(B) supervising a system to assure appropriate procurement of prescription drugs and devices and other products dispensed from the Class A pharmacy;
(C) disposal and distribution of drugs from the Class A pharmacy;
(D) storage of all materials, including drugs, chemicals, and biologicals;
(E) maintaining records of all transactions of the Class A pharmacy necessary to maintain accurate control over and accountability for all pharmaceutical materials required by applicable state and federal laws and sections;
(F) supervising a system to assure maintenance of effective controls against the theft or diversion of prescription drugs, and records for such drugs;
(G) adherence to policies and procedures regarding the maintenance of records in a data processing system such that the data processing system is in compliance with Class A (community) pharmacy requirements;
(H) legal operation of the pharmacy, including meeting all inspection and other requirements of all state and federal laws or sections governing the practice of pharmacy; and
(I) [
effective September 1, 2000,
] if the pharmacy
uses an automated pharmacy dispensing system, shall be responsible for the
following:
(i) consulting with the owner concerning and adherence to the policies and procedures for system operation, safety, security, accuracy and access, patient confidentiality, prevention of unauthorized access, and malfunction;
(ii) inspecting medications in the automated pharmacy dispensing system, at least monthly, for expiration date, misbranding, physical integrity, security, and accountability;
(iii) assigning, discontinuing, or changing personnel access to the automated pharmacy dispensing system;
(iv) ensuring that pharmacy technicians , pharmacy technician trainees, and licensed healthcare professionals performing any services in connection with an automated pharmacy dispensing system have been properly trained on the use of the system and can demonstrate comprehensive knowledge of the written policies and procedures for operation of the system; and
(v) ensuring that the automated pharmacy dispensing system is stocked accurately and an accountability record is maintained in accordance with the written policies and procedures of operation.
(b) (No change.)
(c) Pharmacists.
(1) General.
(A) The pharmacist-in-charge shall be assisted by sufficient number of additional licensed pharmacists as may be required to operate the Class A pharmacy competently, safely, and adequately to meet the needs of the patients of the pharmacy.
(B) All pharmacists shall assist the pharmacist-in-charge in meeting his or her responsibilities in ordering, dispensing, and accounting for prescription drugs.
(C) Pharmacists are solely responsible for the direct supervision of pharmacy technicians and pharmacy technician trainees and for designating and delegating duties, other than those listed in paragraph (2) of this subsection, to pharmacy technicians and pharmacy technician trainees . Each pharmacist:
(i) shall verify the accuracy of all acts, tasks, and functions performed by pharmacy technicians and pharmacy technician trainees ; and
(ii) shall be responsible for any delegated act performed by pharmacy technicians and pharmacy technician trainees under his or her supervision.
(D) Pharmacists shall directly supervise pharmacy technicians and pharmacy technician trainees who are entering prescription data into the pharmacy's data processing system by one of the following methods.
(i) Physically present supervision. A pharmacist shall be physically present to directly supervise a pharmacy technician or pharmacy technician trainee who is entering prescription data into the data processing system. Each prescription entered into the data processing system shall be verified at the time of data entry. If the pharmacist is not physically present due to a temporary absence as specified in §291.33(b)(4) of this title (relating to Operational Standards), on return the pharmacist must:
(I) conduct a drug regimen review for the prescriptions data entered during this time period as specified in §291.33(c)(2) of this title; and
(II) verify that prescription data entered during this time
period was entered accurately [
prior to delivery of the prescription
to the patient or patient's agent
].
(ii) Electronic supervision. A pharmacist may electronically supervise a pharmacy technician or pharmacy technician trainee who is entering prescription data into the data processing system provided the pharmacist:
(I) is on-site, in the pharmacy where the technician /trainee is located;
(II) has immediate access to any original document containing prescription information or other information related to the dispensing of the prescription. Such access may be through imaging technology provided the pharmacist has the ability to review the original, hardcopy documents if needed for clarification; and
(III) verifies the accuracy of the data entered information prior to the release of the information to the system for storage and/or generation of the prescription label.
(E) All pharmacists while on duty, shall be responsible for complying with all state and federal laws or rules governing the practice of pharmacy.
(F) A dispensing pharmacist shall ensure that the drug is dispensed and delivered safely, and accurately as prescribed. In addition, if multiple pharmacists participate in the dispensing process, each pharmacist shall ensure the safety and accuracy of the portion of the process the pharmacist is performing. The dispensing process shall include, but not be limited to, drug regimen review and verification of accurate prescription data entry, including data entry of prescriptions placed on hold , packaging, preparation, compounding and labeling and performance of the final check of the dispensed prescription.
(2) Duties. Duties which may only be performed by a pharmacist are as follows:
(A) receiving oral prescription drug orders and reducing these orders to writing, either manually or electronically;
(B) interpreting prescription drug orders;
(C) selection of drug products;
(D) performing the final check of the dispensed prescription before delivery to the patient to ensure that the prescription has been dispensed accurately as prescribed;
(E) communicating to the patient or patient's agent information about the prescription drug or device which in the exercise of the pharmacist's professional judgement, the pharmacist deems significant, as specified in §291.33(c) of this title;
(F) communicating to the patient or the patient's agent on his or her request information concerning any prescription drugs dispensed to the patient by the pharmacy;
(G) assuring that a reasonable effort is made to obtain, record, and maintain patient medication records;
(H) interpreting patient medication records and performing drug regimen reviews; and
(I) performing a specific act of drug therapy management for a patient delegated to a pharmacist by a written protocol from a physician licensed in this state in compliance with the Medical Practice Act.
(3) Special requirements for compounding.
(A) Non-Sterile
Preparations.
[
Pharmaceuticals.
] All pharmacists engaged in compounding non-sterile
preparations
[
pharmaceuticals
] shall meet the training requirements specified
in
§291.131
[
§291.25
] of this title (relating
to Pharmacies Compounding Non-sterile
Preparations
[
Pharmaceuticals
]).
(B) Sterile
Preparations.
[
Pharmaceuticals.
] All pharmacists engaged in compounding sterile
preparations
[
pharmaceuticals
] shall meet the training requirements specified in
§291.133
[
§291.26
] of this title (relating to Pharmacies
Compounding Sterile
Preparations
[
Pharmaceuticals
]).
(d) Pharmacy Technicians and Pharmacy Technician Trainees .
(1) General.
(A) All pharmacy technicians and pharmacy technician trainees shall meet the training requirements specified in §297.6 of this title (relating to Pharmacy Technician and Pharmacy Technician Trainee Training).
(B) Special requirements for compounding.
(i) Non-Sterile Preparations. All pharmacy technicians and pharmacy technician trainees engaged in compounding non-sterile preparations shall meet the training requirements specified in §291.131 of this title (relating to Pharmacies Compounding Non-Sterile Preparations).
(ii) Sterile Preparations. All pharmacy technicians and pharmacy technician trainees engaged in compounding sterile preparations shall meet the training requirements specified in §291.133 of this title (relating to Pharmacies Compounding Sterile Preparations).
[
(A)
On June 1, 2004, all persons
employed as pharmacy technicians shall be either registered pharmacy technicians
or pharmacy technician trainees as follows.]
[
(i)
All persons who have passed
the required pharmacy technician certification examination shall be registered
with the board under the provisions of this section.]
[
(ii)
All persons who have not
taken and passed the required pharmacy certification examination may be designated
pharmacy technician trainees, if qualified under the provisions of §297.5
of this title (relating to Pharmacy Technician Trainees).]
[
(B)
Between January 1, 2004, and
May 31, 2004, all persons employed as pharmacy technicians who are qualified
for registration by the board shall register according to the schedule designated
by the board. Between January 1, 2004 and May 31, 2004, persons who are awaiting
their scheduled time for registration and persons who have applied for registration,
but the registration has not been completed shall comply with the rules in
effect prior to January 1, 2004, relating to requirements and duties for certified
or exempt pharmacy technicians.]
[
(C)
All pharmacy technicians shall
meet the training requirements specified in §297.6 of this title (relating
to Pharmacy Technician Training).]
[
(D)
Special requirements for compounding.]
[
(i)
Non-Sterile Pharmaceuticals.
All pharmacy technicians engaged in compounding non-sterile pharmaceuticals
shall meet the training requirements specified in §291.25 of this title
(relating to Pharmacies Compounding Non-Sterile Pharmaceuticals).]
[
(ii)
Sterile Pharmaceuticals.
Pharmacy technicians may compound sterile pharmaceuticals pursuant to medication
orders provided the pharmacy technicians:]
[
(I)
have completed the training
specified in §291.26 of this title (relating to Pharmacies Compounding
Sterile Pharmaceuticals); and]
[
(II)
are supervised by a pharmacist
who has completed the training specified in §291.26 of this title, conducts
in-process and final checks, and affixes his or her initials to the label
or if batch prepared, to the appropriate quality control records. (The initials
are not required on the label if it is maintained in a permanent record of
the pharmacy).]
(2) Duties.
(A) Pharmacy technicians and pharmacy technician trainees may not perform any of the duties listed in subsection (c)(2) of this section.
(B) A pharmacist may delegate to pharmacy technicians and pharmacy technician trainees any nonjudgmental technical duty associated with the preparation and distribution of prescription drugs provided:
(i) a pharmacist verifies the accuracy of all acts, tasks, and functions performed by pharmacy technicians and pharmacy technician trainees ;
(ii) pharmacy technicians and pharmacy technician trainees are under the direct supervision of and responsible to a pharmacist; and
(iii) only pharmacy technicians and pharmacy technician trainees who have been properly trained on the use of an automated pharmacy dispensing system and can demonstrate comprehensive knowledge of the written policies and procedures for the operation of the system may be allowed access to the system; and
(C) Pharmacy technicians
and pharmacy technician trainees
may perform only nonjudgmental technical duties associated with the
preparation and distribution of prescription drugs,
as follows:
[
including but not limited to the following:
]
(i) initiating and receiving refill authorization requests;
(ii) entering prescription data into a data processing system;
(iii) taking a stock bottle from the shelf for a prescription;
(iv) preparing and packaging prescription drug orders (i.e., counting tablets/capsules, measuring liquids and placing them in the prescription container);
(v) affixing prescription labels and auxiliary labels to the
prescription container
;
[
provided the pharmacy technician:
]
[
(I)
has completed the education
and training requirements outlined in §297.6 of this title; and]
[
(II)
is registered as a pharmacy
technician within the provisions of §297.3 of this title (relating to
Registration Requirements)]
(vi) reconstituting medications;
(vii) prepackaging and labeling prepackaged drugs;
(viii) loading bulk unlabeled drugs into an automated dispensing system provided a pharmacist verifies that the system is properly loaded prior to use;
(ix) compounding non-sterile and sterile prescription drug orders; and
(x) bulk compounding.
(3) Ratio of pharmacist to pharmacy technicians and pharmacy technician trainees.
(A) Except as provided in subparagraph (B) of this paragraph, the ratio of pharmacists to pharmacy technicians and pharmacy technician trainees may be 1:3, provided at least one of the three is a pharmacy technician. The ratio of pharmacists to pharmacy technician trainees may not exceed 1:2.
(B) As specified in §568.006 of the Act, a pharmacy that primarily compounds non-sterile pharmaceuticals may have a ratio of pharmacists to pharmacy technicians/pharmacy technician trainees of 1:5 provided:
(i) the pharmacy:
(I) dispenses no more than 20 different prescription drugs; and
(II) does not produce sterile preparations including intravenous or intramuscular drugs on-site; and
(ii) the following conditions are met:
(I) at least four are pharmacy technicians and not pharmacy technician trainees; and
(II) The pharmacy has written policies and procedures regarding the supervision of pharmacy technicians and pharmacy technician trainees, including requirements that the pharmacy technicians and pharmacy technician trainees included in a 1:5 ratio may be involved only in one process at a time. For example, a technician/trainee who is compounding non-sterile preparations may not also call physicians for authorization of refills.
[
(A)
Except as provided in subparagraphs
(B) and (C) of this paragraph, the ratio of pharmacists to pharmacy technicians
may not exceed 1:2.]
[
(B)
The ratio of pharmacists to
pharmacy technicians may be 1:3, provided at least one of the three pharmacy
technicians is a registered pharmacy technician.]
[
(C)
As specified in §568.006
of the Act, a pharmacy that primarily compounds non-sterile pharmaceuticals
may have a ratio of pharmacists to pharmacy technicians of 1:5 provided:]
[
(i)
the pharmacy:]
[
(I)
dispenses no more than 20
different prescription drugs; and]
[
(II)
does not produce sterile
pharmaceuticals including intravenous or intramuscular drugs on-site; and]
[
(ii)
the following conditions are met:]
[
(I)
at least four of the pharmacy
technicians are registered pharmacy technicians; and]
[
(II)
The pharmacy has written
policies and procedures regarding the supervision of pharmacy technicians,
including requirements that the registered pharmacy technicians included in
a 1:5 ratio may be involved only in one process at a time. For example, a
technician who is compounding non-sterile pharmaceuticals may not also call
physicians for authorization of refills.]
(e) Identification of pharmacy personnel. All pharmacy personnel shall be identified as follows.
(1) Pharmacy technicians. All pharmacy technicians shall wear
an identification tag or badge
that
[
which
] bears the
person's name and identifies him or her as a [
pharmacy technician trainee,
a registered
] pharmacy technician, or a certified pharmacy technician,
if the technician maintains current certification with the Pharmacy Technician
Certification Board or any other entity providing an examination approved
by the
board.
[
Board.
]
(2) Pharmacy technician trainees. All pharmacy technician trainees shall wear an identification tag or badge that bears the person's name and identifies him or her as a pharmacy technician trainee.
(3)
[
(2)
] Pharmacist interns. All pharmacist
interns shall wear an identification tag or badge
that
[
which
] bears the person's name and identifies him or her as a pharmacist
intern.
(4)
[
(3)
] Pharmacists. All pharmacists
shall wear an identification tag or badge
that
[
which
]
bears the person's name and identifies him or her as a pharmacist.
§291.33.Operational Standards.
(a) Licensing requirements.
(1) A Class A pharmacy shall register annually or biennially with the board on a pharmacy license application provided by the board, following the procedures specified in §291.1 of this title (relating to Pharmacy License Application).
(2) A Class A pharmacy which changes ownership shall notify
the board within ten days of the change of ownership and apply for a new and
separate license as specified in
§291.3 of this title (relating
to Required Notifications).
[
§291.4 of this title (relating
to Change of Ownership).
]
(3) A Class A pharmacy which changes location and/or name shall
notify the board within ten days of the change and file for an amended license
as specified in
§291.3 of this title (relating to Required Notifications).
[
§291.2 of this title (relating to Change of Location and/or
Name).
]
(4) A Class A pharmacy owned by a partnership or corporation
which changes managing officers shall notify the board in writing of the names
of the new managing officers within ten days of the change, following the
procedures in §291.3 of this title (relating to
Required Notifications
[
Change of Managing Officers
]).
(5) - (8) (No change.)
(9) A Class A (community) pharmacy engaged in the compounding
of non-sterile pharmaceuticals shall comply with the provisions of
§291.131
[
§291.25
] of this title (relating to Pharmacies Compounding
Non-sterile
Preparations
[
Pharmaceuticals
]).
(10) A Class A (community) pharmacy engaged in the compounding
of sterile pharmaceuticals shall comply with the provisions of
§291.133
[
§291.26
] of this title (relating to Pharmacies Compounding
Sterile
Preparations
[
Pharmaceuticals
]).
(11) A Class A (Community) pharmacy engaged in the provision
of remote pharmacy services, including storage and dispensing of prescription
drugs, shall comply with the provisions of
§291.121
[
§291.20
] of this title (relating to Remote Pharmacy Services).
(12) Class A (Community) pharmacy engaged in centralized prescription
dispensing and/or prescription drug or medication order processing shall comply
with the provisions of
§291.123 of this title (relating to Centralized
Prescription Drug or Medication Order Processing) and/or §291.125 of
this title (relating to Centralized Prescription Dispensing).
[
§291.37 of this title (relating to Centralized Prescription Dispensing)
and/or §291.38 of this title (relating to Centralized Prescription Drug
or Medication Order Processing).
]
(b) Environment.
(1) General requirements.
(A) The pharmacy shall be arranged in an orderly fashion and kept clean. All required equipment shall be clean and in good operating condition.
(B) A Class A pharmacy shall have a sink with hot and cold running water within the pharmacy, exclusive of restroom facilities, available to all pharmacy personnel and maintained in a sanitary condition.
(C) A Class A pharmacy which serves the general public shall contain an area which is suitable for confidential patient counseling.
(i) Such counseling area shall:
(I) be easily accessible to both patient and pharmacists and not allow patient access to prescription drugs;
(II) be designed to maintain the confidentiality and privacy of the pharmacist/patient communication.
(ii) In determining whether the area is suitable for confidential patient counseling and designed to maintain the confidentiality and privacy of the pharmacist/patient communication, the board may consider factors such as the following:
(I) the proximity of the counseling area to the check-out or cash register area;
(II) the volume of pedestrian traffic in and around the counseling area;
(III) the presence of walls or other barriers between the counseling area and other areas of the pharmacy; and
(IV) any evidence of confidential information being overheard by persons other than the patient or patient's agent or the pharmacist or agents of the pharmacist.
(D) The pharmacy shall be properly lighted and ventilated.
(E) The temperature of the pharmacy shall be maintained within a range compatible with the proper storage of drugs; the temperature of the refrigerator shall be maintained within a range compatible with the proper storage of drugs requiring refrigeration.
(F) Animals, including birds and reptiles, shall not be kept within the pharmacy and in immediately adjacent areas under the control of the pharmacy. This provision does not apply to fish in aquariums, guide dogs accompanying disabled persons, or animals for sale to the general public in a separate area that is inspected by local health jurisdictions.
(2) Security.
(A) Each pharmacist while on duty shall be responsible for the security of the prescription department, including provisions for effective control against theft or diversion of prescription drugs, and records for such drugs.
(B) Any area of a pharmacy that contains prescription drugs shall be locked by key, combination or other mechanical or electronic means to prohibit unauthorized access when a pharmacist is not on-site except as provided in subparagraphs (C) and (D) of this paragraph and paragraph (3) of this subsection. The following is applicable:
(i) Any area of a pharmacy that contains prescription drugs constructed after September 1, 2008, shall be enclosed by walls, partitions or other means of floor-to-ceiling enclosure. Pharmacies licensed prior to September 1, 2008, shall be exempt from this provision unless the pharmacy changes its address.
(ii) Effective, September 1, 2008, the pharmacy's key, combination or other mechanical or electronic means of locking the pharmacy may not be duplicated without the authorization of the pharmacist-in-charge or owner.
(iii) Effective, September 1, 2008, at a minimum, the pharmacy must have a basic alarm system and an electronic monitoring system to track individuals entering the area of a pharmacy that contains prescription drugs.
(C) Prior to authorizing individuals to enter the pharmacy, the pharmacist-in-charge may designate persons who may enter the pharmacy to perform functions documented by the pharmacist-in-charge including access to the pharmacy by other pharmacists, pharmacy personnel and other individuals. The pharmacy must maintain written documentation of authorized individuals other than pharmacy personnel who accessed the pharmacy when a pharmacist is not on-site.
(D) Only persons designated in writing by the pharmacist-in-charge may unlock the area of a pharmacy that contains prescription drugs except in emergency situations. An additional key to the area of a pharmacy that contains prescription drugs may be maintained in a secure location outside the area of a pharmacy that contains prescription drugs for use during an emergency or as designated by the pharmacist-in-charge for entry by another pharmacist.
(E) Written policies and procedures for the pharmacy's security shall be developed and implemented by the pharmacist-in-charge and/or the owner of the pharmacy. Such polices and procedures may include quarterly audits of controlled substances commonly abused or diverted, perpetual inventories, and monthly reports from the pharmacy's wholesaler(s) of controlled substances purchased by the pharmacy.
[
(B)
The prescription department
shall be locked by key or combination so as to prevent access when a pharmacist
is not on-site. However, the pharmacist-in-charge may designate persons who
may enter the pharmacy to perform functions designated by the pharmacist-in-charge
(e.g., janitorial services).]
(3) Temporary absence of pharmacist.
(A) On-site supervision by pharmacist.
(i) If a pharmacy is staffed by only one pharmacist, the pharmacist may leave the prescription department for breaks and meal periods without closing the prescription department and removing pharmacy technicians, pharmacy technician trainees, and other pharmacy personnel from the prescription department provided the following conditions are met:
(I) at least one pharmacy technician remains in the prescription department;
(II) the pharmacist remains on-site at the licensed location of the pharmacy and is immediately available;
(III) the absence does not exceed 30 minutes at a time and a total of one hour in a 12 hour period;
(IV) the pharmacist reasonably believes that the security of the prescription department will be maintained in his or her absence. If in the professional judgment of the pharmacist, the pharmacist determines that the prescription department should close during his or her absence, then the pharmacist shall close the prescription department and remove the pharmacy technicians, pharmacy technician trainees, or other pharmacy personnel from the prescription department during his or her absence; and
(V) a notice is posted which includes the following information:
(-a-) the fact that the pharmacist is on a break and the time the pharmacist will return; and
(-b-) the fact that pharmacy technicians may begin the processing of prescription drug orders or refills brought in during the pharmacist's absence, but the prescription or refill may not be delivered to the patient or the patient's agent until the pharmacist verifies the accuracy of the prescription.
(ii) During the time a pharmacist is absent from the prescription department, only pharmacy technicians who have completed the pharmacy's training program may perform the following duties, provided a pharmacist verifies the accuracy of all acts, tasks, and functions performed by the pharmacy technicians prior to delivery of the prescription to the patient or the patient's agent:
(I) initiating and receiving refill authorization requests;
(II) entering prescription data into a data processing system;
(III) taking a stock bottle from the shelf for a prescription;
(IV) preparing and packaging prescription drug orders (i.e., counting tablets/capsules, measuring liquids and placing them in the prescription container);
(V) affixing prescription labels and auxiliary labels to the prescription container provided the pharmacy technician:
(-a-) has completed the training requirements outlined in §297.6 of this title (relating to Pharmacy Technician and Pharmacy Technician Trainee Training); and
(-b-) is registered as a pharmacy technician within the provisions of §297.3 of this title (relating to Registration Requirements); and
(VI) prepackaging and labeling prepackaged drugs.
(iii) Upon return to the prescription department, the pharmacist shall:
(I) conduct a drug regimen review as specified in subsection (c)(2) of this section; and
(II) verify the accuracy of all acts, tasks, and functions performed by the pharmacy technicians prior to delivery of the prescription to the patient or the patient's agent.
(iv) An agent of the pharmacist may deliver a previously verified prescription to the patient or his or her agent provided a record of the delivery is maintained containing the following information:
(I) date of the delivery;
(II) unique identification number of the prescription drug order;
(III) patient's name;
(IV) patient's phone number or the phone number of the person picking up the prescription; and
(V) signature of the person picking up the prescription.
(v) Any prescription delivered to a patient when a pharmacist is not in the prescription department must meet the requirements for a prescription delivered to a patient as described in subsection (c)(1)(F) of this section.
(vi) During the times a pharmacist is absent from the prescription department a pharmacist intern shall be considered a registered pharmacy technician and may perform only the duties of a registered pharmacy technician.
(vii) In pharmacies with two or more pharmacists on duty, the pharmacists shall stagger their breaks and meal periods so that the prescription department is not left without a pharmacist on duty.
(B) Pharmacist is off-site.
(i) In a prescription department staffed by only one pharmacist during a shift, an agent of the pharmacist may deliver a previously verified prescription to a patient or patient's agent during short periods of time when a pharmacist is off-site, provided the following conditions are met:
(I) no more than a total of three pharmacy technicians or pharmacy technician trainees may remain in the pharmacy; however, at least one of the individuals must be a pharmacy technician;
(II) short periods of time may not exceed two consecutive hours in a 24 hour period and on no more than two occasions in a calendar month;
(III) the pharmacist reasonably believes the security of the pharmacy will be maintained in his or her absence. If, in the professional judgment of the pharmacist, the pharmacist determines that the pharmacy should close during his or her absence, then the pharmacist shall close the pharmacy during his or her absence;
(IV) a notice is posted which includes the following information:
(-a-) the fact that the pharmacist is off-site and not present in the pharmacy;
(-b-) the fact that no new prescriptions may be prepared at the pharmacy but previously verified prescriptions may be delivered to the patient or the patient's agent; and
(-c-) the date/time when the pharmacist will return; and
(V) the pharmacy must maintain written documentation of the absences of the pharmacist(s).
(ii) During the time, a pharmacist is absent from the pharmacy and is off-site, a record of prescriptions delivered must be maintained and contain the following information:
(I) date of the delivery;
(II) unique identification number of the prescription drug order;
(III) patient's name;
(IV) patient's phone number or the phone number of the person picking up the prescription;
(V) signature of the person picking up the prescription; and
(VI) dates and times that prescription drug orders were delivered to patients or patients' agents in the absence of the pharmacist;
(iii) Any prescription delivered to a patient when a pharmacist is not on-site at the pharmacy must meet the requirements for a prescription delivered to a patient as described in subsection (c)(1)(F) of this section.
(iv) In pharmacies with two or more pharmacists working during a shift, the pharmacists shall stagger their schedules so that the pharmacy is not left without a pharmacist on duty.
[
(A)
If a pharmacy is staffed by
a single pharmacist, the pharmacist may leave the prescription department
for breaks and meal periods without closing the prescription department and
removing pharmacy technicians and other pharmacy personnel from the prescription
department provided the following conditions are met:]
[
(i)
at least one registered pharmacy
technician remains in the prescription department;]
[
(ii)
the pharmacist remains on-site
at the licensed location of the pharmacy and available for an emergency;]
[
(iii)
the absence does not exceed
30 minutes at a time and a total of one hour in a 12 hour period;]
[
(iv)
the pharmacist reasonably
believes that the security of the prescription department will be maintained
in his or her absence. If in the professional judgment of the pharmacist,
the pharmacist determines that the prescription department should close during
his or her absence, then the pharmacist shall close the prescription department
and remove the pharmacy technicians or other pharmacy personnel from the prescription
department during his or her absence; and]
[
(v)
a notice is posted which includes
the following information:]
[
(I)
the fact that pharmacist is
on a break and the time the pharmacist will return; and]
[
(II)
the fact that pharmacy technicians
may begin the processing of prescription drug orders or refills brought in
during the pharmacist absence but the prescription or refill may not be delivered
to the patient or the patient's agent until the pharmacist returns and verifies
the accuracy of the prescription.]
[
(B)
During the time a pharmacist
is absent from the prescription department, only pharmacy technicians who
have completed the pharmacy's training program may perform the following duties,
provided a pharmacist verifies the accuracy of all acts, tasks, and functions
performed by the pharmacy technicians prior to delivery of the prescription
to the patient or the patient's agent:]
[
(i)
initiating and receiving refill
authorization requests;]
[
(ii)
entering prescription data
into a data processing system;]
[
(iii)
taking a stock bottle from
the shelf for a prescription;]
[
(iv)
preparing and packaging prescription
drug orders (i.e., counting tablets/capsules, measuring liquids and placing
them in the prescription container);]
[
(v)
affixing prescription labels
and auxiliary labels to the prescription container provided the pharmacy technician:]
[
(I)
has completed the training
requirements outlined in §297.6 of this title (relating to Pharmacy Technician
Training); and]
[
(II)
is registered as a pharmacy
technician within the provisions of §297.3 of this title (relating to
Registration Requirements); and]
[
(vi)
prepackaging and labeling
prepackaged drugs.]
[
(C)
Upon return to the prescription
department, the pharmacist shall:]
[
(i)
conduct a drug regimen review
as specified in subsection (c)(2) of this section; and]
[
(ii)
verify the accuracy of all
acts, tasks, and functions performed by the pharmacy technicians prior to
delivery of the prescription to the patient or the patient's agent.]
[
(D)
An agent of the pharmacist
may deliver a prescription drug order to the patient or his or her agent provided
a record of the delivery is maintained containing the following information:]
[
(i)
date of the delivery;]
[
(ii)
unique identification number
of the prescription drug order;]
[
(iii)
patient's name;]
[
(iv)
patient's phone number or
the phone number of the person picking up the prescription; and]
[
(v)
signature of the person picking
up the prescription.]
[
(E)
Any prescription delivered
to a patient when a pharmacist is not in the prescription department must
meet the requirements for a prescription delivered to a patient as described
in subsection (c)(1)(F) of this section.]
[
(F)
During the times a pharmacist
is absent from the prescription department a pharmacist intern shall be considered
a registered pharmacy technician and may perform only the duties of a registered
pharmacy technician.]
[
(G)
In pharmacies with two or
more pharmacists on duty, the pharmacists shall stagger their breaks and meal
periods so that the prescription department is not left without a pharmacist
on duty.]
(c) Prescription dispensing and delivery.
(1) Patient counseling and provision of drug information.
(A) To optimize drug therapy, a pharmacist shall communicate to the patient or the patient's agent, information about the prescription drug or device which in the exercise of the pharmacist's professional judgment the pharmacist deems significant, such as the following:
(i) the name and description of the drug or device;
(ii) dosage form, dosage, route of administration, and duration of drug therapy;
(iii) special directions and precautions for preparation, administration, and use by the patient;
(iv) common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur;
(v) techniques for self monitoring of drug therapy;
(vi) proper storage;
(vii) refill information; and
(viii) action to be taken in the event of a missed dose.
(B) Such communication:
(i) shall be provided with each new prescription drug order;
(ii) shall be provided for any prescription drug order dispensed by the pharmacy on the request of the patient or patient's agent;
(iii) shall be communicated orally in person unless the patient or patient's agent is not at the pharmacy or a specific communication barrier prohibits such oral communication; and
(iv) shall be reinforced with written information. The following is applicable concerning this written information.
(I) Written information designed for the consumer such as the USP DI patient information leaflets shall be provided.
(II) When a compounded product is dispensed, information shall be provided for the major active ingredient(s), if available.
(III) For new drug entities, if no written information is initially available, the pharmacist is not required to provide information until such information is available, provided:
(-a-) the pharmacist informs the patient or the patient's agent that the product is a new drug entity and written information is not available;
(-b-) the pharmacist documents the fact that no written information was provided; and
(-c-) if the prescription is refilled after written information is available, such information is provided to the patient or patient's agent.
(C) Only a pharmacist may verbally provide drug information to a patient or patient's agent and answer questions concerning prescription drugs. Non-pharmacist personnel may not ask questions of a patient or patient's agent which are intended to screen and/or limit interaction with the pharmacist.
(D) Nothing in this subparagraph shall be construed as requiring a pharmacist to provide consultation when a patient or patient's agent refuses such consultation. The pharmacist shall document such refusal for consultation.
(E) In addition to the requirements of subparagraphs (A) - (D) of this paragraph, if a prescription drug order is delivered to the patient at the pharmacy, the following is applicable.
(i) So that a patient will have access to information concerning
his or her prescription, a prescription may not be delivered to a patient
unless a pharmacist is in the pharmacy, except as provided in subsection (b)(3)
of this section. [
or clause (ii) of this subparagraph.
]
[
(ii)
An agent of the pharmacist
may deliver a prescription drug order to the patient or his or her agent during
short periods of time when a pharmacist is absent from the pharmacy, provided
the short periods of time do not exceed two hours in a 24 hour period, and
provided a record of the delivery is maintained containing the following information:]
[
(I)
date of the delivery;]
[
(II)
unique identification number of the prescription drug order;]
[
(III)
patient's name;]
[
(IV)
patient's phone number or
the phone number of the person picking up the prescription; and]
[
(V)
signature of the person picking up the prescription.]
(ii)
[
(iii)
] Any prescription delivered
to a patient when a pharmacist is not in the pharmacy must meet the requirements
described in subparagraph (F) of this paragraph.
(iii)
[
(iv)
] A Class A pharmacy shall
make available for use by the public a current or updated edition of the United
States Pharmacopeia Dispensing Information, Volume II (Advice to the Patient),
or another source of such information designed for the consumer.
(F) In addition to the requirements of subparagraphs (A) - (D) of this paragraph, if a prescription drug order is delivered to the patient or his or her agent at the patient's residence or other designated location, the following is applicable.
(i) The information specified in subparagraph (A) of this paragraph shall be delivered with the dispensed prescription in writing.
(ii) If prescriptions are routinely delivered outside the area covered by the pharmacy's local telephone service, the pharmacy shall provide a toll-free telephone line which is answered during normal business hours to enable communication between the patient and a pharmacist.
(iii) The pharmacist shall place on the prescription container or on a separate sheet delivered with the prescription container in both English and Spanish the local and if applicable, toll-free telephone number of the pharmacy and the statement: "Written information about this prescription has been provided for you. Please read this information before you take the medication. If you have questions concerning this prescription, a pharmacist is available during normal business hours to answer these questions at (insert the pharmacy's local and toll-free telephone numbers)."
(iv) The pharmacy shall maintain and use adequate storage or shipment containers and use shipping processes to ensure drug stability and potency. Such shipping processes shall include the use of appropriate packaging material and/or devices to ensure that the drug is maintained at an appropriate temperature range to maintain the integrity of the medication throughout the delivery process.
(v) The pharmacy shall use a delivery system which is designed to assure that the drugs are delivered to the appropriate patient.
(G) Except as specified in subparagraph (B) of this paragraph, in the best interest of the public health and to optimize drug therapy, upon delivery of a refill prescription, a pharmacist shall ensure that the patient or patient's agent is offered information about the refilled prescription. Either a pharmacist or other pharmacy personnel shall inform the patient or patient's agent that a pharmacist is available to discuss the patient's prescription and provide information.
(H) A pharmacy shall post a sign no smaller than 8.5 inches by 11 inches in clear public view at all locations in the pharmacy where a patient may pick up prescriptions. The sign shall contain the following statement in a font that is easily readable: "Do you have questions about your prescription? Ask the pharmacist." Such notification shall be in both English and Spanish.
(I) The provisions of this paragraph do not apply to patients in facilities where drugs are administered to patients by a person required to do so by the laws of the state (i.e., nursing homes).
(2) - (5) (No change.)
(6) Prescription containers.
(A) A drug dispensed pursuant to a prescription drug order shall be dispensed in a child-resistant container unless:
(i) the patient or the practitioner requests the prescription not be dispensed in a child-resistant container; or
(ii) the product is exempted from requirements of the Poison Prevention Packaging Act of 1970.
(B) A drug dispensed pursuant to a prescription drug order shall be dispensed in an appropriate container as specified on the manufacturer's container.
(C) Prescription containers or closures shall not be re-used. However, if a patient or patient's agent has difficulty reading or understanding a prescription label, a prescription container may be reused provided:
(i) the container is designed to provide audio-recorded information about the proper use of the prescription medication;
(ii) the container is reused for the same patient;
(iii) the container is cleaned; and
(iv) a new safety closure is used each time the prescription container is reused.
(7) - (8) (No change.)
(d) - (g) (No change.)
(h) Customized patient medication packages.
(1) - (2) (No change.)
(3) Label.
(A) The patient med-pak shall bear a label stating:
(i) the name of the patient;
(ii) the unique identification number for the patient med-pak itself and a separate unique identification number for each of the prescription drug orders for each of the drug products contained therein;
(iii) the name, strength, physical description or identification, and total quantity of each drug product contained therein;
(iv) the directions for use and cautionary statements, if any, contained in the prescription drug order for each drug product contained therein;
(v) if applicable, a warning of the potential harmful effect of combining any form of alcoholic beverage with any drug product contained therein;
(vi) any storage instructions or cautionary statements required by the official compendia;
(vii) the name of the prescriber of each drug product;
(viii) the date of preparation of the patient med-pak and the beyond-use date assigned to the patient med-pak (which such beyond-use date shall not be later than 60 days from the date of preparation);
(ix) the name, address, and telephone number of the pharmacy;
(x) the initials or an identification code of the dispensing pharmacist; and
(xi) any other information, statements, or warnings required for any of the drug products contained therein.
(B) If the patient med-pak allows for the removal or separation of the intact containers therefrom, each individual container shall bear a label identifying each of the drug product contained therein.
(C) The dispensing container is not required to bear the label specified in subparagraph (A) of this paragraph if:
(i) the drug is prescribed for administration to an ultimate user who is institutionalized in a licensed health care institution (e.g., nursing home, hospice, hospital);
(ii) no more than a 34-day supply or 100 dosage units, whichever is less, is dispensed at one time;
(iii) the drug is not in the possession of the ultimate user prior to administration;
(iv) the pharmacist-in-charge has determined that the institution:
(I) maintains medication administration records which include adequate directions for use for the drug(s) prescribed;
(II) maintains records of ordering, receipt, and administration of the drug(s); and
(III) provides for appropriate safeguards for the control and storage of the drug(s); and
(v)
the dispensing container bears a label that
[
the system employed by the pharmacy in dispensing the prescription drug order
] adequately:
(I) identifies the:
(-a-) pharmacy by name and address;
(-b-) unique identification number of the prescription;
(-c-) name and strength of each drug product dispensed;
(-d-) name of the patient;
(-e-) name of the prescribing practitioner of each drug product and if applicable, the name of the advanced practice nurse or physician assistant who signed the prescription drug order ; and
(II) for each drug product sets forth the directions for use and cautionary statements, if any , contained on the prescription drug order or required by law.
(4) - (7) (No change.)
§291.34.Records.
(a) Maintenance of records.
(1) Every inventory or other record required to be kept under the provisions of §291.31 of this title (relating to Definitions), §291.32 of this title (relating to Personnel), §291.33 of this title (relating to Operational Standards), §291.34 of this title (relating to Records), and §291.35 of this title (relating to Official Prescription Requirements), contained in Community Pharmacy (Class A) shall be:
(A) kept by the pharmacy and be available, for at least two years from the date of such inventory or record, for inspecting and copying by the board or its representative and to other authorized local, state, or federal law enforcement agencies; and
(B) supplied by the pharmacy within 72 hours, if requested by an authorized agent of the Texas State Board of Pharmacy. If the pharmacy maintains the records in an electronic format, the requested records must be provided in an electronic format if specifically requested by the board or its representative. Failure to provide the records set out in this section, either on site or within 72 hours, constitutes prima facie evidence of failure to keep and maintain records in violation of the Act.
(2) - (4) (No change.)
(b) Prescriptions.
(1) - (6) (No change.)
(7) Refills.
(A) Refills may be dispensed only in accordance with the prescriber's authorization as indicated on the original prescription drug order.
(B) If there are no refill instructions on the original prescription drug order (which shall be interpreted as no refills authorized) or if all refills authorized on the original prescription drug order have been dispensed, authorization from the prescribing practitioner shall be obtained prior to dispensing any refills.
(C) Refills of prescription drug orders for dangerous drugs or nonprescription drugs.
(i) Prescription drug orders for dangerous drugs or nonprescription drugs may not be refilled after one year from the date of issuance of the original prescription drug order.
(ii) If one year has expired from the date of issuance of an original prescription drug order for a dangerous drug or nonprescription drug, authorization shall be obtained from the prescribing practitioner prior to dispensing any additional quantities of the drug.
(D) Refills of prescription drug orders for Schedules III - V controlled substances.
(i) Prescription drug orders for Schedules III - V controlled substances may not be refilled more than five times or after six months from the date of issuance of the original prescription drug order, whichever occurs first.
(ii) If a prescription drug order for a Schedule III, IV, or V controlled substance has been refilled a total of five times or if six months have expired from the date of issuance of the original prescription drug order, whichever occurs first, a new and separate prescription drug order shall be obtained from the prescribing practitioner prior to dispensing any additional quantities of controlled substances.
(E) A pharmacist may exercise his professional judgment in refilling a prescription drug order for a drug, other than a controlled substance listed in Schedule II, without the authorization of the prescribing practitioner, provided:
(i) failure to refill the prescription might result in an interruption of a therapeutic regimen or create patient suffering;
(ii) either:
(I) a natural or manmade disaster has occurred which prohibits the pharmacist from being able to contact the practitioner; or
(II) the pharmacist is unable to contact the practitioner after a reasonable effort;
(iii) the quantity of prescription drug dispensed does not exceed a 72-hour supply;
(iv) the pharmacist informs the patient or the patient's agent at the time of dispensing that the refill is being provided without such authorization and that authorization of the practitioner is required for future refills;
(v) the pharmacist informs the practitioner of the emergency refill at the earliest reasonable time;
(vi) the pharmacist maintains a record of the emergency refill containing the information required to be maintained on a prescription as specified in this subsection;
(vii) the pharmacist affixes a label to the dispensing container
as specified in
§291.33(c)(7)
[
§291.33(c)(6)
]
of this title; and
(viii) if the prescription was initially filled at another pharmacy, the pharmacist may exercise his professional judgment in refilling the prescription provided:
(I) the patient has the prescription container, label, receipt or other documentation from the other pharmacy which contains the essential information;
(II) after a reasonable effort, the pharmacist is unable to contact the other pharmacy to transfer the remaining prescription refills or there are no refills remaining on the prescription;
(III) the pharmacist, in his professional judgment, determines that such a request for an emergency refill is appropriate and meets the requirements of clauses (i) and (ii) of this subparagraph; and
(IV) the pharmacist complies with the requirements of clauses (iii) - (v) of this subparagraph.
(c) (No change.)
(d) Prescription drug order records maintained in a manual system.
(1) - (5) (No change.)
(6) Effective January 1, 2009, each time a modification, change,
or manipulation is made to a record of dispensing, documentation of such change
shall be recorded on the back of the prescription or on another appropriate,
uniformly maintained, readily retrievable record, such
as
[
a
]medication records. The documentation of any modification, change,
or manipulation to a record of dispensing shall include the identification
of the individual responsible for the alteration.
(e) Prescription drug order records maintained in a data processing system.
(1) - (3) (No change.)
(4) Transfer of prescription drug order information. For the purpose of refill or initial dispensing, the transfer of original prescription drug order information is permissible between pharmacies, subject to the following requirements.
(A) The transfer of original prescription drug order information for controlled substances listed in Schedule III, IV, or V is permissible between pharmacies on a one-time basis only. However, pharmacies electronically sharing a real-time, on-line database may transfer up to the maximum refills permitted by law and the prescriber's authorization.
(B) The transfer of original prescription drug order information for dangerous drugs is permissible between pharmacies without limitation up to the number of originally authorized refills.
(C) The transfer is communicated directly between pharmacists and/or pharmacist interns orally by telephone or via facsimile or as authorized in paragraph (5) of this subsection. A transfer completed as authorized in paragraph (5) of this subsection may be initiated by a pharmacy technician or pharmacy technician trainee acting under the direct supervision of a pharmacist.
(D) Both the original and the transferred prescription drug orders are maintained for a period of two years from the date of last refill.
(E) The pharmacist or pharmacist intern transferring the prescription drug order information shall:
(i) write the word "void" on the face of the invalidated prescription drug order; and
(ii) record on the reverse of the invalidated prescription drug order the following information:
(I) the name, address, and if a controlled substance, the DEA registration number of the pharmacy to which such prescription is transferred;
(II) the name of the pharmacist or pharmacist intern receiving the prescription drug order information;
(III) the name of the pharmacist or pharmacist intern transferring the prescription drug order information; and
(IV) the date of the transfer.
(F) The pharmacist or pharmacist intern receiving the transferred prescription drug order information shall:
(i) write the word "transfer" on the face of the transferred prescription drug order; and
(ii) record on the transferred prescription drug order the following information:
(I) original date of issuance and date of dispensing or receipt, if different from date of issuance;
(II) original prescription number and the number of refills authorized on the original prescription drug order;
(III) number of valid refills remaining and the date of last refill, if applicable;
(IV) name, address, and if a controlled substance, the DEA registration number of the pharmacy from which such prescription drug order information is transferred; and
(V) name of the pharmacist or pharmacist intern transferring the prescription drug order information.
(G) Prescription drug orders may not be transferred by non-electronic means during periods of downtime except on consultation with and authorization by a prescribing practitioner; provided however, during downtime, a hard copy of a prescription drug order may be made available for informational purposes only, to the patient, a pharmacist or pharmacist intern, and the prescription may be read to a pharmacist or pharmacist intern by telephone.
(H) The original prescription drug order shall be invalidated in the data processing system for purposes of filling or refilling, but shall be maintained in the data processing system for refill history purposes.
(I) If the data processing system has the capacity to store all the information required in subparagraphs (E) and (F) of this paragraph, the pharmacist is not required to record this information on the original or transferred prescription drug order.
(J) The data processing system shall have a mechanism to prohibit the transfer or refilling of controlled substance prescription drug orders which have been previously transferred.
(5) Electronic transfer of prescription drug order information between pharmacies. Pharmacies electronically accessing the same prescription drug order records may electronically transfer prescription information if the following requirements are met.
(A) The original prescription is voided and the following information is documented in the records of the transferring pharmacy:
(i) the name, address, and if a controlled substance, the DEA registration number of the pharmacy to which such prescription is transferred;
(ii) the name of the pharmacist or pharmacist intern receiving the prescription drug order information; and
(iii) the date of the transfer.
(B) Pharmacies not owned by the same person may electronically access the same prescription drug order records, provided the owner or chief executive officer of each pharmacy signs an agreement allowing access to such prescription drug order records.
(C) An electronic transfer between pharmacies may be initiated by a pharmacy technician or pharmacy technician trainee acting under the direct supervision of a pharmacist.
(6) (No change.)
(f) - (j) (No change.)
[
(k)
Confidentiality.]
[
(1)
A pharmacist shall provide
adequate security of prescription drug orders, and patient medication records
to prevent indiscriminate or unauthorized access to confidential health information.
If prescription drug orders, requests for refill authorization, or other confidential
health information are not transmitted directly between a pharmacy and a physician
but are transmitted through a data communication device, confidential health
information may not be accessed or maintained by the operator of the data
communication device unless specifically authorized to obtain the confidential
information by this subsection.]
[
(2)
Confidential records are privileged and may be released only to:]
[
(A)
the patient or the patient's agent;]
[
(B)
a practitioner or another
pharmacist if, in the pharmacist's professional judgement, the release is
necessary to protect the patient's health and well being;]
[
(C)
the board or to a person or
another state or federal agency authorized by law to receive the confidential
record;]
[
(D)
a law enforcement agency engaged
in investigation of a suspected violation of Chapter 481 or 483, Health and
Safety Code, or the Comprehensive Drug Abuse Prevention and Control Act of
1970 (21 U.S.C. Section 801 et seq.);]
[
(E)
a person employed by a state
agency that licenses a practitioner, if the person is performing the person's
official duties; or]
[
(F)
an insurance carrier or other
third party payor authorized by a patient to receive such information.]
This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of the Secretary of State on June 4, 2007.
TRD-200702212
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: July 15, 2007
For further information, please call: (512) 305-8028
(Editor's note: The text of the following sections proposed for repeal will not be published. The sections may be examined in the offices of the Texas State Board of Pharmacy or in the Texas Register office, Room 245, James Earl Rudder Building, 1019 Brazos Street, Austin.)
The repeals are proposed under §551.002 and §554.051 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by the repeal: Chapters 551 - 566 and 568 - 569, Texas Occupations Code.
§291.37.Centralized Prescription Dispensing.
§291.38.Central Prescription Drug or Medication Order Processing.
This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of the Secretary of State on June 4, 2007.
TRD-200702213
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: July 15, 2007
For further information, please call: (512) 305-8028
The Texas State Board of Pharmacy proposes amendments to §291.72 concerning Definitions, §291.73 concerning Personnel, §291.74 concerning Operational Standards, §291.75 concerning Records, and §291.76 concerning Pharmacies Located in a Freestanding Ambulatory Surgical Center. The proposed amendments to §291.72, if adopted, clarify the definition for hot water and update and clarify the definitions for pharmacy technicians and pharmacy technician trainees. The proposed amendments to §291.73, if adopted, update the rules to include pharmacy technician trainees and clarify the responsibilities of owners of Class C pharmacies. The proposed amendments to §291.74, if adopted, will allow Class C pharmacies to distribute repackaged drugs to other Class C pharmacies under common ownership in accordance with SB 492 passed by the 79th Texas Legislature, Regular Session. The proposed amendments to §291.75, if adopted, require pharmacies to provide the board or its representative with records in electronic format, if the records are maintained in an electronic format, and update and correct references. The proposed amendments to §291.76, if adopted, update and clarify the definitions for pharmacy technicians and pharmacy technician trainees and clarify the responsibilities of owners of pharmacies located in ambulatory surgical centers.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for the first five-year period the rule is in effect, there will be no fiscal implications for state or local government as a result of enforcing or administering the rule.
Ms. Dodson has determined that, for each year of the first five-year period the rule will be in effect, the public benefit anticipated as a result of enforcing the rule will be to ensure that the rules are up to date and clear and the public benefit anticipated as a result of enforcing §291.74 will be to ensure that drugs prepackaged and distributed by a Class C pharmacy to another Class C pharmacy under common ownership are handled in a manner to ensure the health and safety of the public. There is no fiscal impact for individuals, small or large businesses or to other entities which are required to comply with this section.
Comments on the proposed amendments may be submitted to Allison Benz, R.Ph., M.S., Director of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Austin, Texas, 78701, FAX (512) 305-8082. Comments must be received by 5 pm, July 30, 2007.
The amendments are proposed under §551.002 and §554.051 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by the amendments: Chapters 551 - 566 and 568 - 569, Texas Occupations Code.
§291.72.Definitions.
The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise.
(1) - (24) (No change.)
(25) Hot water--The temperature of water from the pharmacy's sink maintained at 120 to 140 degrees F (49 to 60 C).
(26)
[
(25)
] Inpatient--A person who
is duly admitted to the licensed hospital, or other hospital or facility maintained
or operated by the state, or who is receiving long term care services or Medicare
extended care services in a swing bed on the hospital premise or an adjacent,
readily accessible facility which is under the authority of the hospital's
governing body. For the purposes of this definition, the term "long term care
services" means those services received in a skilled nursing facility which
is a distinct part of the hospital and the distinct part is not licensed separately
or formally approved as a nursing home by the state, even though it is designated
or certified as a skilled nursing facility. An inpatient includes a person
confined in any correctional institution operated by the state of Texas.
(27)
[
(26)
] Institutional pharmacy--Area
or areas in a facility where drugs are stored, bulk compounded, delivered,
compounded, dispensed, and distributed to other areas or departments of the
facility, or dispensed to an ultimate user or his or her agent.
(28)
[
(27)
] Investigational new drug--New
drug intended for investigational use by experts qualified to evaluate the
safety and effectiveness of the drug as authorized by the Food and Drug Administration.
(29)
[
(28)
] Medical Practice Act--The
Texas Medical Practice Act, Subtitle B, Occupations Code, as amended.
(30)
[
(29)
] Medication order--A written
order from a practitioner or a verbal order from a practitioner or his authorized
agent for administration of a drug or device.
(31)
[
(30)
] Part-time pharmacist--A
pharmacist either employed or under contract, who routinely works less than
full-time.
(32)
[
(31)
] Perpetual inventory--An
inventory which documents all receipts and distributions of a drug product,
such that an accurate, current balance of the amount of the drug product present
in the pharmacy is indicated.
(33)
[
(32)
] Pharmaceutical care--The
provision of drug therapy and other pharmaceutical services intended to assist
in the cure or prevention of a disease, elimination or reduction of a patient's
symptoms, or arresting or slowing of a disease process.
(34)
[
(33)
] Pharmacist-in-charge--Pharmacist
designated on a pharmacy license as the pharmacist who has the authority or
responsibility for a pharmacy's compliance with laws and rules pertaining
to the practice of pharmacy.
(35)
[
(34)
] Pharmacy and therapeutics
function--Committee of the medical staff in the facility which assists in
the formulation of broad professional policies regarding the evaluation, selection,
distribution, handling, use, and administration, and all other matters relating
to the use of drugs and devices in the facility.
(36)
[
(35)
] Pharmacy technician--An
individual
who is registered with the board as a pharmacy technician
and
whose responsibility in a pharmacy is to provide technical services
that do not require professional judgment regarding preparing and distributing
drugs and who works under the direct supervision of and is responsible to
a pharmacist. [
Pharmacy technician includes registered pharmacy technicians
and pharmacy technician trainees.
]
(37)
[
(36)
] Pharmacy technician trainee--
An individual who is registered with the board as a pharmacy technician trainee
and is authorized to participate in a pharmacy's technician training program.
[
(A)
not registered as a pharmacy
technician by the board, and either:]
[
(B)
participating in a pharmacy's
technician training program; or]
[
(C)
currently enrolled in a:]
[
(i)
pharmacy technician training program accredited
by the American Society of Health-System Pharmacists; or]
[
(ii)
health science technology education program
in a Texas high school that is accredited by the Texas Education Agency.]
(38)
[
(37)
] Pre-packaging--The act of
re-packaging and re-labeling quantities of drug products from a manufacturer's
original container into unit-dose packaging or a multiple dose container for
distribution within the facility.
(39)
[
(38)
] Prescription drug--
(A) A substance for which federal or state law requires a prescription before it may be legally dispensed to the public;
(B) A drug or device that under federal law is required, prior to being dispensed or delivered, to be labeled with either of the following statements:
(i) Caution: federal law prohibits dispensing without prescription or "Rx only" or another legend that complies with federal law; or
(ii) Caution: federal law restricts this drug to use by or on order of a licensed veterinarian; or
(C) A drug or device that is required by any applicable federal or state law or regulation to be dispensed on prescription only or is restricted to use by a practitioner only.
(40)
[
(39)
] Prescription drug order--
(A) a written order from a practitioner or a verbal order from a practitioner or his authorized agent to a pharmacist for a drug or device to be dispensed; or
(B) a written order or a verbal order pursuant to Subtitle B, Chapter 157, Occupations Code.
(41)
[
(40)
] Quality assurance--The set
of activities used to assure that the process used in the preparation of sterile
drug products lead to products that meet predetermined standards of quality.
(42)
[
(41)
] Quality control--The set
of testing activities used to determine that the ingredients, components (e.g.,
containers), and final sterile pharmaceuticals prepared meet predetermined
requirements with respect to identity, purity, non-pyrogenicity, and sterility.
(43)
[
(42)
] Sample--A prescription drug
which is not intended to be sold and is intended to promote the sale of the
drug.
(44)
[
(43)
] Texas Controlled Substances
Act--The Texas Controlled Substances Act, the Health and Safety Code, Chapter
481, as amended.
(45)
[
(44)
] Unit-dose packaging--The
ordered amount of drug in a dosage form ready for administration to a particular
patient, by the prescribed route at the prescribed time, and properly labeled
with name, strength, and expiration date of the drug.
(46)
[
(45)
] Unusable drugs--Drugs or
devices that are unusable for reasons, such as they are adulterated, misbranded,
expired, defective, or recalled.
(47)
[
(46)
] Written protocol--A physician's
order, standing medical order, standing delegation order, or other order or
protocol as defined by rule of the Texas State Board of Medical Examiners
under the Texas Medical Practice Act Subtitle B, Chapter 157, Occupations
Code.
§291.73.Personnel.
(a) (No change.)
(b) Pharmacist-in-charge.
(1) General.
(A) Each institutional pharmacy in a facility with 101 beds or more shall have one full-time pharmacist-in-charge, who may be pharmacist-in-charge for only one such pharmacy.
(B) Each institutional pharmacy in a facility with 100 beds or less shall have one pharmacist-in-charge who is employed or under contract, at least on a consulting or part-time basis, but may be employed on a full-time basis, if desired, and who may be pharmacist-in-charge for no more than three facilities or 150 beds.
(C) A pharmacist-in-charge may be in charge of one facility with 101 beds or more and one facility with 100 beds or less provided the total number of beds does not exceed 150 beds.
(D) The pharmacist-in-charge shall be assisted by additional
pharmacists
, pharmacy technicians and pharmacy technician trainees
[
and pharmacy technicians
] commensurate with the scope of services provided.
(E) If the pharmacist-in-charge is employed on a part-time or consulting basis, a written agreement shall exist between the facility and the pharmacist, and a copy of the written agreement shall be made available to the board upon request.
(2) Responsibilities. The pharmacist-in-charge shall have the responsibility for, at a minimum, the following:
(A) providing the appropriate level of pharmaceutical care services to patients of the facility;
(B) ensuring that drugs and/or devices are prepared for distribution safely, and accurately as prescribed;
(C) providing written guidelines and approval of the procedure
to assure that all pharmaceutical requirements are met when any part of preparing,
sterilizing, and labeling of sterile
preparations
[
pharmaceuticals
] is not performed under direct pharmacy supervision;
(D) participating in the development of a formulary for the facility, subject to approval of the appropriate committee of the facility;
(E) developing a system to assure that drugs to be administered to inpatients are distributed pursuant to an original or direct copy of the practitioner's medication order;
(F) developing a system for the filling and labeling of all containers from which drugs are to be distributed or dispensed;
(G) assuring that the pharmacy maintains and makes available a sufficient inventory of antidotes and other emergency drugs as well as current antidote information, telephone numbers of regional poison control center and other emergency assistance organizations, and such other materials and information as may be deemed necessary by the appropriate committee of the facility;
(H) maintaining records of all transactions of the institutional pharmacy as may be required by applicable law, state and federal, and as may be necessary to maintain accurate control over and accountability for all pharmaceutical materials including pharmaceuticals, components used in the compounding of pharmaceuticals, and drug delivery devices;
(I) participating in those aspects of the facility's patient care evaluation program which relate to pharmaceutical utilization and effectiveness;
(J) participating in teaching and/or research programs in the facility;
(K) implementing the policies and decisions of the appropriate committee(s) relating to pharmaceutical services of the facility;
(L) providing effective and efficient messenger or delivery service to connect the institutional pharmacy with appropriate areas of the facility on a regular basis throughout the normal workday of the facility;
(M) developing a system for the labeling, storage, and distribution of investigational new drugs, including maintenance of information in the pharmacy and nursing station where such drugs are being administered, concerning the dosage form, route of administration, strength, actions, uses, side effects, adverse effects, interactions and symptoms of toxicity of investigational new drugs;
(N) assuring that records in a data processing system are maintained such that the data processing system is in compliance with Class C (Institutional) pharmacy requirements;
(O) assuring that a reasonable effort is made to obtain, record, and maintain patient medication records;
(P) assuring the legal operation of the pharmacy, including meeting all inspection and other requirements of all state and federal laws or rules governing the practice of pharmacy; and
(Q) if the pharmacy uses an automated medication supply system, shall be responsible for the following:
(i) reviewing and approving all policies and procedures for system operation, safety, security, accuracy and access, patient confidentiality, prevention of unauthorized access, and malfunction;
(ii) inspecting medications in the automated medication supply system, at least monthly, for expiration date, misbranding, physical integrity, security, and accountability;
(iii) assigning, discontinuing, or changing personnel access to the automated medication supply system;
(iv) ensuring that pharmacy technicians , pharmacy technician trainees, and licensed healthcare professionals performing any services in connection with an automated medication supply system have been properly trained on the use of the system and can demonstrate comprehensive knowledge of the written policies and procedures for operation of the system; and
(v) ensuring that the automated medication supply system is stocked accurately and an accountability record is maintained in accordance with the written policies and procedures of operation.
(c) (No change.)
(d) Pharmacists.
(1) General.
(A) The pharmacist-in-charge shall be assisted by a sufficient number of additional licensed pharmacists as may be required to operate the institutional pharmacy competently, safely, and adequately to meet the needs of the patients of the facility.
(B) All pharmacists shall assist the pharmacist-in-charge in meeting the responsibilities as outlined in subsection (b)(2) of this section and in ordering, administering, and accounting for pharmaceutical materials.
(C) All pharmacists shall be responsible for any delegated act performed by pharmacy technicians or pharmacy technician trainees under his or her supervision.
(D) All pharmacists while on duty, shall be responsible for complying with all state and federal laws or rules governing the practice of pharmacy.
(E) A distributing pharmacist shall ensure that the drug is prepared for distribution safely, and accurately as prescribed. In addition, if multiple pharmacists participate in the preparation of medication orders for distribution, each pharmacist shall ensure the safety and accuracy of the portion of the process the pharmacist is performing. The preparation and distribution process for medication orders shall include, but not be limited to, drug regimen review, and verification of accurate medication order data entry, preparation, and distribution, and performance of the final check of the prepared medication.
(2) Duties. Duties of the pharmacist-in-charge and all other pharmacists shall include, but need not be limited to the following:
(A) providing those acts or services necessary to provide pharmaceutical care;
(B) receiving, interpreting, and evaluating prescription drug orders, and reducing verbal medication orders to writing either manually or electronically;
(C) participating in drug and/or device selection as authorized by law, drug and/or device supplier selection, drug administration, drug regimen review, or drug or drug-related research;
(D) performing a specific act of drug therapy management for a patient delegated to a pharmacist by a written protocol from a physician licensed in this state in compliance with the Medical Practice Act Subtitle B, Chapter 157, Occupations Code;
(E) accepting the responsibility for:
(i) distributing drugs and devices pursuant to medication orders;
(ii) compounding and labeling of drugs and devices;
(iii) proper and safe storage of drugs and devices; and
(iv) maintaining proper records for drugs and devices.
(3) Special requirements for compounding.
(A) Non-Sterile
Preparations.
[
Pharmaceuticals.
] All pharmacists engaged in compounding non-sterile
preparations
[
pharmaceuticals
] shall meet the training requirements specified
in
§291.131
[
§291.25
] of this title (relating to Pharmacies Compounding Non-sterile
Preparations
[
Pharmaceuticals
]).
(B) Sterile
Preparations
[
Pharmaceuticals
].
All pharmacists engaged in compounding
sterile preparations
[
non-sterile pharmaceuticals
] shall meet the training requirements specified
in
§291.133
[
§291.26
] of this title (relating
to Pharmacies Compounding Sterile
Preparations
[
Pharmaceuticals
]).
(e) Pharmacy technicians and pharmacy technician trainees .
(1) General. All pharmacy technicians and pharmacy technician trainees shall meet the training requirements specified in §297.6 of this title (relating to Pharmacy Technician and Pharmacy Technician Trainee Training).
[
(A)
On June 1, 2004, all persons
employed as pharmacy technicians must be either registered pharmacy technicians
or pharmacy technician trainees as follows.]
[
(i)
All persons who have passed the required pharmacy
technician certification examination must be registered with the board under
the provisions of this section.]
[
(ii)
All persons who have not taken and passed
the required pharmacy certification examination shall be designated pharmacy
technician trainees under the provisions of §297.5 of this title (relating
to Pharmacy Technician Trainees).]
[
(B)
Between January 1, 2004, and
May 31, 2004, all persons employed as pharmacy technicians who are qualified
for registration by the board shall register according to the schedule designated
by the board. Between January 1, 2004 and May 31, 2004, persons who are awaiting
their scheduled time for registration and persons who have applied for registration,
but the registration has not been completed shall comply with the rules in
effect prior to January 1, 2004, relating to requirements and duties for certified
or exempt pharmacy technicians.]
[
(C)
All pharmacy technicians shall
meet the training requirements specified in §297.6 of this title (relating
to Pharmacy Technician Training).]
(2) Duties. Duties may include, but need not be limited to, the following functions under the direct supervision of and responsible to a pharmacist:
(A) pre-packing and labeling unit and multiple dose packages, provided a pharmacist supervises and conducts in-process and final checks and affixes his or her signature (first initial and last name or full signature) or electronic signature to the appropriate quality control records;
(B) preparing, packaging, compounding, or labeling prescription drugs pursuant to medication orders, provided a pharmacist supervises and checks the preparation;
(C) bulk compounding or batch preparation provided a pharmacist supervises and conducts in-process and final checks and affixes his or her initials to the appropriate quality control records;
(D) distributing routine orders for stock supplies to patient care areas;
(E) entering medication order and drug distribution information into a data processing system, provided judgmental decisions are not required and a pharmacist checks the accuracy of the information entered into the system prior to releasing the order or in compliance with the absence of pharmacist requirements contained in §291.74(e) of this title (relating to Operational Standards);
(F) loading bulk unlabeled drugs into an automated compounding or counting device provided a pharmacist supervises, verifies that the system was properly loaded prior to use, and affixes his or her signature (first initial and last name or full signature) or electronic signature to the appropriate quality control records; and
(G) may be allowed access to automated medication supply systems after proper training on the use of the automated medication supply system and demonstration of comprehensive knowledge of the written policies and procedures for its operation.
(H) compounding sterile
preparations
[
pharmaceuticals
] pursuant to medication orders provided the pharmacy technicians
or pharmacy technician trainees:
(i) have completed the training specified in
§291.133
[
§291.26
] of this title (relating to Pharmacies Compounding
Sterile
Preparations
[
pharmaceuticals
]; and
(ii) are supervised by a pharmacist who has completed the training
specified in
§291.133
[
§291.26
] of this title
and who conducts in-process and final checks, and affixes his or her initials
to the label or if batch prepared, to the appropriate quality control records.
(The initials are not required on the label if it is maintained in a permanent
record of the pharmacy.)
(3) Special requirements for compounding.
(A) Non-Sterile
Preparations
[
Pharmaceuticals
]. All pharmacy technicians
and pharmacy technician trainees
engaged
in compounding non-sterile
preparations
[
pharmaceuticals
]
shall meet the training requirements specified in
§291.131
[
§291.25
] of this title.
(B) Sterile
Preparations
[
Pharmaceuticals
].
Pharmacy technicians
and pharmacy technician trainees engaged in compounding
sterile preparations shall meet the training requirements specified in §291.133
of this title.
[
may compound sterile pharmaceuticals pursuant to
medication orders provided the pharmacy technicians:
]
[(i) have completed the training specified subsection §291.26 of this title; and]
[(ii) are supervised by a pharmacist who has completed the training specified in §291.26 of this title and who conducts in-process and final checks, and affixes his or her initials to the label or if batch prepared, to the appropriate quality control records. (The initials are not required on the label if it is maintained in a permanent record of the pharmacy).]
(4) Procedures.
(A) pharmacy technicians and pharmacy technician trainees shall handle medication orders in accordance with standard, written procedures and guidelines.
(B) pharmacy technicians and pharmacy technician trainees shall handle prescription drug orders in the same manner as those working in a Class A pharmacy.
(f) Owner. The owner of a Class C pharmacy shall have responsibility for all administrative and operational functions of the pharmacy. The pharmacist-in-charge may advise the owner on administrative and operational concerns. The owner shall have responsibility for, at a minimum, the following, and if the owner is not a Texas licensed pharmacist, the owner shall consult with the pharmacist-in-charge or another Texas licensed pharmacist:
(1) establishment of policies for procurement of prescription drugs and devices and other products dispensed from the Class C pharmacy;
(2) establishment and maintenance of effective controls against the theft or diversion of prescription drugs;
(3) if the pharmacy uses an automated pharmacy dispensing system, reviewing and approving all policies and procedures for system operation, safety, security, accuracy and access, patient confidentiality, prevention of unauthorized access, and malfunction;
(4) providing the pharmacy with the necessary equipment and resources commensurate with its level and type of practice; and
(5) establishment of policies and procedures regarding maintenance, storage, and retrieval of records in a data processing system such that the system is in compliance with state and federal requirements.
(g)
[
(f)
] Identification of pharmacy
personnel. All pharmacy personnel shall
be identified as follows.
[
wear an identification tag or badge which bears the person's name and identifies
him or her by title or function as follows:
]
(1) Pharmacy technicians. All pharmacy technicians shall wear
an identification tag or badge
that
[
which
] bears the
person's name and identifies him or her as a [
pharmacy technician trainee,
a registered
] pharmacy technician, or a certified pharmacy technician,
if the technician maintains current certification with the Pharmacy Technician
Certification Board or any other entity providing an examination approved
by the
board.
[
Board.
]
(2) Pharmacy technician trainees. All pharmacy technician trainees shall wear an identification tag or badge that bears the person's name and identifies him or her as a pharmacy technician trainee.
(3)
[
(2)
] Pharmacist interns. All pharmacist
interns shall wear an identification tag or badge
that
[
which
] bears the person's name and identifies him or her as a pharmacist intern.
(4)
[
(3)
] Pharmacists. All pharmacists
shall wear an identification tag or badge
that
[
which
]
bears the person's name and identifies him or her as a pharmacist.
§291.74.Operational Standards.
(a) Licensing requirements.
(1) - (2) (No change.)
(3) A Class C pharmacy which changes ownership shall notify
the board within 10 days of the change of ownership and apply for a new and
separate license as specified in
§291.3 of this title (relating
to Required Notifications).
[
§291.4 of this title (relating to Change of Ownership).
]
(4) A Class C pharmacy which changes location and/or name shall
notify the board within 10 days of the change and file for an amended license
as specified in
§291.3 of this title (relating to Required Notifications).
[
§291.2 if this title (relating to Change of Location and/or
Name).
]
(5) A Class C pharmacy owned by a partnership or corporation
which changes managing officers shall notify the board in writing of the names
of the new managing officers within 10 days of the change following the procedures
in
§291.3 of this title (relating to Required Notifications).
[
§291.3 of this title (relating to Change of Managing Officers).
]
(6) - (9) (No change.)
(10) A Class C (Institutional) pharmacy engaged in non-sterile
compounding of drug products for inpatients of the hospital shall comply with
the provisions of
§291.131 of this title (relating to Pharmacies
Compounding Non-sterile Preparations);
[
§291.25 of this title
(relating to Pharmacies Compounding Non-Sterile Pharmaceuticals);
]
(11) A Class C (Institutional) pharmacy engaged in the compounding
of sterile pharmaceuticals shall comply with the provisions of
§291.133
of this title (relating to Pharmacies Compounding Sterile Preparations).
[
§291.26 of this title (relating to Pharmacies Compounding Sterile Pharmaceuticals).
]
(12) A Class C (Institutional) pharmacy engaged in the provision
of remote pharmacy services, including storage and dispensing of prescription
drugs, shall comply with the provisions of
§291.121
[
§291.20
] of this title (relating to Remote Pharmacy Services).
(13) A Class C (Institutional) pharmacy engaged in centralized
prescription dispensing and/or prescription drug or medication order processing
shall comply with the provisions of
§291.123 of this title (relating
to Centralized Prescription Drug or Medication Order Processing) and/or §291.125
of this title (relating to Centralized Prescription Dispensing).
[
§291.37 of this title (relating to Centralized Prescription Dispensing)
and/or §291.38 of this title (relating to Centralized Prescription Drug
or Medication Order Processing).
]
(b) - (e) (No change.)
(f) Drugs.
(1) - (2) (No change.)
(3) Prepackaging of drugs.
(A) Distribution within a facility.
(i) Drugs may be prepackaged in quantities suitable for internal distribution by a pharmacist or by pharmacy technicians or pharmacy technician trainees under the direction and direct supervision of a pharmacist.
(ii) The label of a prepackaged unit shall indicate:
(I) brand name and strength of the drug; or if no brand name, then the generic name, strength, and name of the manufacturer or distributor;
(II) facility's unique lot number;
(III) expiration date based on currently available literature; and
(IV) quantity of the drug, if the quantity is greater than one.
(iii) Records of prepackaging shall be maintained to show:
(I) name of the drug, strength, and dosage form;
(II) facility's unique lot number;
(III) manufacturer or distributor;
(IV) manufacturer's lot number;
(V) expiration date;
(VI) quantity per prepackaged unit;
(VII) number of prepackaged units;
(VIII) date packaged;
(IX) name, initials, or electronic signature of the prepacker; and
(X) name, initials, or electronic signature of the responsible pharmacist.
(iv) Stock packages, prepackaged units, and control records shall be quarantined together until checked/released by the pharmacist.
(B) Distribution to other Class C (Institutional) pharmacies under common ownership.
(i) Drugs may be prepackaged in quantities suitable for distribution to other Class C (Institutional) pharmacies under common ownership by a pharmacist or by pharmacy technicians or pharmacy technician trainees under the direction and direct supervision of a pharmacist.
(ii) The label of a prepackaged unit shall indicate:
(I) brand name and strength of the drug; or if no brand name, then the generic name, strength, and name of the manufacturer or distributor;
(II) facility's unique lot number;
(III) expiration date based on currently available literature;
(IV) quantity of the drug, if the quantity is greater than one; and
(V) name of the facility responsible for pre-packaging the drug.
(iii) Records of pre-packaging shall be maintained to show:
(I) name of the drug, strength, and dosage form;
(II) facility's unique lot number;
(III) manufacturer or distributor;
(IV) manufacturer's lot number;
(V) expiration date;
(VI) quantity per prepackaged unit;
(VII) number of prepackaged units;
(VIII) date packaged;
(IX) name, initials, or electronic signature of the prepacker;
(X) name, initials, or electronic signature of the responsible pharmacist; and
(XI) name of the facility receiving the pre-packaged drug.
(iv) Stock packages, prepackaged units, and control records shall be quarantined together until checked/released by the pharmacist.
(v) The pharmacy shall have written procedure for the recall of any drug prepackaged for another Class C Pharmacy under common ownership. The recall procedures shall require:
(I) notification to the pharmacy to which the prepackaged drug was distributed;
(II) quarantine of the product if there is a suspicion of harm to a patient;
(III) a mandatory recall if there is confirmed or probable harm to a patient; and
(IV) notification to the board if a mandatory recall is instituted.
[
(A)
Drugs may be pre-packaged
in quantities suitable for internal distribution only by a pharmacist or by
supportive personnel under the direction and direct supervision of a pharmacist.]
[
(B)
The label of a pre-packaged unit shall indicate:]
[
(i)
brand name and strength of the drug; or if
no brand name, then the generic name, strength, and name of the manufacturer
or distributor;]
[
(ii)
facility's unique lot number;]
[
(iii)
expiration date based on currently available literature; and]
[
(iv)
quantity of the drug, if the quantity is greater than one.]
[
(C)
Records of pre-packaging shall be maintained to show:]
[
(i)
name of the drug, strength, and dosage form;]
[
(ii)
facility's unique lot number;]
[
(iii)
manufacturer or distributor;]
[
(iv)
manufacturer's lot number;]
[
(v)
expiration date;]
[
(vi)
quantity per prepackaged unit;]
[
(vii)
number of prepackaged units;]
[
(viii)
date packaged;]
[
(ix)
name, initials, or electronic signature of the prepacker; and]
[
(x)
name, initials, or electronic signature of the responsible pharmacist.]
[
(D)
Stock packages, repackaged
units, and control records shall be quarantined together until checked/released
by the pharmacist.]
(4) - (5) (No change.)
(g) - (i) (No change.)
(j) Automated devices and systems.
(1) (No change.)
(2) Automated medication supply systems.
(A) - (B) (No change.)
(C) Policies and procedures of operation.
(i) When an automated medication supply system is used to store or distribute medications for administration pursuant to medication orders, it shall be operated according to written policies and procedures of operation. The policies and procedures of operation shall establish requirements for operation of the automated medication supply system and shall describe policies and procedures that:
(I) include a description of the policies and procedures of operation;
(II) provide for a pharmacist's review and approval of each original or new medication order filled through the use of the automated medication supply system:
(-a-) before the order is filled when a pharmacist is on duty except for an emergency order;
(-b-) retrospectively within 72 hours in a facility with a full-time pharmacist when a pharmacist is not on duty at the time the order is made; or
(-c-) retrospectively within 7 days in a facility with a part-time or consultant pharmacist when a pharmacist is not on duty at the time the order is made;
(III) provide for access to the automated medication supply
system for stocking and retrieval of medications which is limited to licensed
healthcare professionals
, pharmacy technicians, or pharmacy technician
trainees
[
or pharmacy technicians
] acting under the supervision of a pharmacist;
(IV) provide that a pharmacist is responsible for the accuracy of the restocking of the system. The actual restocking may be performed by a pharmacy technician or pharmacy technician trainee ;
(V) provide for an accountability record to be maintained which documents all transactions relative to stocking and removing medications from the automated medication supply system;
(VI) require a prospective or retrospective drug regimen review is conducted as specified in subsection (g) of this section; and
(VII) establish and make provisions for documentation of a preventative maintenance program for the automated medication supply system.
(ii) A pharmacy which uses an automated medication supply system to fill medication orders shall, at least annually, review its written policies and procedures, revise them if necessary, and document the review.
(D) (No change.)
(3) (No change.)
(4) Automated checking device.
(A) For the purpose of this subsection, an automated checking device is a fully automated device which confirms, after a drug is prepared for distribution but prior to delivery to the patient, that the correct drug and strength has been labeled with the correct label for the correct patient.
(B) The final check of a drug prepared pursuant to a medication order shall be considered accomplished using an automated checking device provided:
(i) a check of the final product is conducted by a pharmacist prior to delivery to the patient or the following checks are performed by a pharmacist:
(I) the prepackaged drug used to fill the order is checked by a pharmacist who verifies that the drug is labeled and packaged accurately; and
(II) a pharmacist checks the accuracy of each original or new medication order.
(ii) the medication order is prepared, labeled, and made ready for delivery to the patient in compliance with Class C (Institutional) Pharmacy rules; and
(iii) prior to delivery to the patient:
(I) the automated checking device confirms that the correct drug and strength has been labeled with the correct label for the correct patient; and
(II) a pharmacist performs all other duties required to ensure that the medication order has been prepared safely and accurately as prescribed.
(C) If the final check is accomplished as specified in subparagraph (B) of this paragraph, the following additional requirements must be met.
(i) The pharmacy has conducted initial testing of the automated checking device and has a continuous quality assurance program which documents that the automated checking device accurately confirms that the correct drug and strength has been labeled with the correct label for the correct patient.
(ii) The pharmacy documents and maintains:
(I) the name(s), initials, or identification code(s) of each pharmacist responsible for the checks outlined in subparagraph (B)(I) of this paragraph; and
(II) the name(s), initials, or identification code(s) and specific
activity(ies) of each pharmacist
, pharmacy technician, or pharmacy technician
trainee
[
or pharmacy technician
] who performs any other portion
of the medication order preparation process.
(iii) The pharmacy establishes mechanisms and procedures to test the accuracy of the automated checking device at least monthly.
§291.75.Records.
(a) Maintenance of records.
(1) Every inventory or other record required to be kept under the provisions of §291.71 of this title (relating to Purpose), §291.72 of this title (relating to Definitions), §291.73 of this title (relating to Personnel), §291.74 of this title (relating to Operational Standards), and this section contained in Institutional Pharmacy (Class C) shall be:
(A) kept by the institutional pharmacy and be available, for at least two years from the date of such inventory or record, for inspecting and copying by the board or its representative, and to other authorized local, state, or federal law enforcement agencies; and
(B) supplied by the pharmacy within 72 hours, if requested by an authorized agent of the Texas State Board of Pharmacy. If the pharmacy maintains the records in an electronic format, the requested records must be provided in an electronic format if specifically requested by the board or its representative. Failure to provide the records set out in this subsection, either on site or within 72 hours, constitutes prima facie evidence of failure to keep and maintain records in violation of the Act.
(2) - (4) (No change.)
(b) - (f) (No change.)
[
(g)
Confidentiality.
[
(1)
A pharmacist shall provide adequate security
of prescription drug orders, medication orders, and patient medication records
to prevent indiscriminate or unauthorized access to confidential health information.]
[
(2)
Confidential records are privileged and may be released only to]
[
(A)
the patient or the patient's agent;]
[
(B)
a practitioner or another pharmacist if, in
the pharmacist's professional judgement, the release is necessary to protect
the patient's health and well being;]
[
(C)
the board or to a person or another state or
federal agency authorized by law to receive the confidential record;]
[
(D)
a law enforcement agency engaged in investigation
of a suspected violation of Chapter 481 or 483, Health and Safety Code, or
the Comprehensive Drug Abuse Prevention and Control Act of 1970 (21 U.S.C.
Section 801 et seq.);]
[(E)
a person employed by a state agency that licenses
a practitioner, if the person is performing the person's official duties;
or]
[
(F)
an insurance carrier or other third party payor
authorized by a patient to receive such information.]
§291.76.Class C Pharmacies Located in a Freestanding Ambulatory Surgical Center.
(a)
Purpose. The purpose of this section is to provide standards
in the conduct, practice activities, and operation of a pharmacy located in
a freestanding ambulatory surgical center that is licensed by the
Texas Department of State Health Services
[
Texas Department of Health
]. Class C pharmacies located in a freestanding ambulatory surgical
center shall comply with this section, in lieu of §§291.71 - 291.75
of this title (relating to Purpose; Definitions; Personnel; Operational Standards;
and Records).
(b) Definitions. The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise.
(1) - (22) (No change.)
(23) Pharmacy technician-- An individual
who is registered
with the board as a pharmacy technician and
whose responsibility in
a pharmacy is to provide technical services that do not require professional
judgment regarding preparing and distributing drugs and who works under the
direct supervision of and is responsible to a pharmacist. [
Pharmacy technician
includes registered pharmacy technicians and pharmacy technician trainees.
]
(24) Pharmacy technician trainee--
An individual who is
registered with the board as a pharmacy technician trainee and is authorized
to participate in a pharmacy's technician training program.
[
A
person who is:
]
[
(A)
not registered as a pharmacy
technician by the board, and either:]
[
(B)
participating in a pharmacy's
technician training program; or]
[
(C)
currently enrolled in a:]
[
(i)
pharmacy technician training program accredited
by the American Society of Health-System Pharmacists; or]
[
(ii)
health science technology education program
in a Texas high school that is accredited by the Texas Education Agency.]
(25) (No change.)
(c) Personnel.
(1) - (2) (No change.)
(3) Pharmacists.
(A) General.
(i) The pharmacist-in-charge shall be assisted by a sufficient number of additional licensed pharmacists as may be required to operate the ASC pharmacy competently, safely, and adequately to meet the needs of the patients of the facility.
(ii) All pharmacists shall assist the pharmacist-in-charge in meeting the responsibilities as outlined in paragraph (1)(B) of this subsection and in ordering, administering, and accounting for pharmaceutical materials.
(iii) All pharmacists shall be responsible for any delegated act performed by pharmacy technicians under his or her supervision.
(iv) All pharmacists while on duty shall be responsible for complying with all state and federal laws or rules governing the practice of pharmacy.
(B) Duties. Duties of the pharmacist-in-charge and all other pharmacists shall include, but need not be limited to, the following:
(i) receiving and interpreting prescription drug orders and oral medication orders and reducing these orders to writing either manually or electronically;
(ii) selection of prescription drugs and/or devices and/or suppliers; and
(iii) interpreting patient profiles.
(C) Special requirements for compounding.
(i) Non-Sterile
Preparations
[
Pharmaceuticals
]. All pharmacists engaged in compounding non-sterile
preparations
[
pharmaceuticals
] shall meet the training requirements specified
in
§291.131
[
§291.25
] of this title (relating
to Pharmacies Compounding Non-Sterile
Preparations
[
Pharmaceuticals
]).
(ii) Sterile
Preparations
[
Pharmaceuticals
]. All pharmacists engaged in compounding non-sterile
preparations
[
pharmaceuticals
] shall meet the training requirements specified
in
§291.133
[
§291.26
] of this title (relating to Pharmacies Compounding Sterile
Preparations
[
Pharmaceuticals
]).
(4) Pharmacy technicians and pharmacy technician trainees .
(A) General. All pharmacy technicians and pharmacy technician trainees shall meet the training requirements specified in §297.6 of this title (relating to Pharmacy Technician and Pharmacy Technician Trainee Training).
[
(A)
General]
[
(i)
On June 1, 2004, all persons employed as pharmacy
technicians must be either registered pharmacy technicians or pharmacy technician
trainees as follows.]
[
(I)
All persons who have passed the required pharmacy
technician certification examination must be registered with the board under
the provisions this section.]
[
(II)
All persons who have not taken and passed
the required pharmacy certification examination shall be designated pharmacy
technician trainees under the provisions of §297.5 of this title (relating
to Pharmacy Technician Trainees).]
[
(ii)
Between January 1, 2004, and May 31, 2004,
all persons employed as pharmacy technicians who are qualified for registration
by the board shall register according to the schedule designated by the board.
Between January 1, 2004 and May 31, 2004, persons who are awaiting their scheduled
time for registration and persons who have applied for registration, but the
registration has not been completed shall comply with the rules in effect
prior to January 1, 2004, relating to requirements and duties for certified
or exempt pharmacy technicians.]
[
(iii)
All pharmacy technicians shall meet the training
requirements specified in §297.6 of this title (relating to Pharmacy
Technician Training).]
(B) Duties. Duties may include, but need not be limited to, the following functions, under the direct supervision of a pharmacist:
(i) prepacking and labeling unit and multiple dose packages, provided a pharmacist supervises and conducts in-process and final checks and affixes his or her signature or electronic signature to the appropriate quality control records;
(ii) preparing, packaging, compounding, or labeling prescription drugs pursuant to medication orders, provided a pharmacist supervises and checks the preparation;
(iii) compounding sterile
preparations
[
pharmaceuticals
] pursuant to medication orders
;
[
provided the pharmacy technicians:
]
[(I) have completed the training specified in §291.26 of this title (relating to Pharmacies Compounding Sterile Pharmaceuticals); and]
[(II) are supervised by a pharmacist who has completed the sterile products training specified in §291.26 of this title, conducts in-process and final checks, and affixes his or her initials to the label or if batch prepared, to the appropriate quality control records. (The initials are not required on the label if it is maintained in a permanent record of the pharmacy.)]
(iv) bulk compounding, provided a pharmacist supervises and conducts in-process and final checks and affixes his or her initials to the appropriate quality control records;
(v) distributing routine orders for stock supplies to patient care areas;
(vi) entering medication order and drug distribution information into a data processing system, provided judgmental decisions are not required and a pharmacist checks the accuracy of the information entered into the system prior to releasing the order or in compliance with the absence of pharmacist requirements contained in subsection (d)(6)(E) and (F) of this section;
(vii) maintaining inventories of drug supplies;
(viii) maintaining pharmacy records; and
(ix) loading bulk unlabeled drugs into an automated drug dispensing system provided a pharmacist supervises, verifies that the system was properly loaded prior to use, and affixes his or her signature or electronic signature to the appropriate quality control records.
(C) Procedures.
(i) Pharmacy technicians and pharmacy technician trainees shall handle medication orders in accordance with standard written procedures and guidelines.
(ii) Pharmacy technicians and pharmacy technician trainees shall handle prescription drug orders in the same manner as pharmacy technicians working in a Class A pharmacy.
(D) Special requirements for compounding.
(i) Non-Sterile
Preparations
[
Pharmaceuticals
]. All pharmacy technicians
and pharmacy technician trainees
engaged in compounding non-sterile
preparations
[
pharmaceuticals
]
shall meet the training requirements specified in
§291.131
[
§291.25
] of this title.
(ii) Sterile
Preparations
[
Pharmaceuticals
]. All pharmacy technicians and pharmacy technician trainees engaged
in compounding non-sterile preparations shall meet the training requirements
specified in §291.131 of this title. [
Pharmacy technicians may compound
sterile pharmaceuticals pursuant to medication orders provided the pharmacy
technicians:
]
[(I) have completed the training specified in §291.26 of this title; and]
[(II) are supervised by a pharmacist who has completed the training specified in §291.26 of this title and who conducts in-process and final checks, and affixes his or her initials to the label or if batch prepared, to the appropriate quality control records. (The initials are not required on the label if it is maintained in a permanent record of the pharmacy).]
(5) Owner. The owner of an ASC pharmacy shall have responsibility for all administrative and operational functions of the pharmacy. The pharmacist-in-charge may advise the owner on administrative and operational concerns. The owner shall have responsibility for, at a minimum, the following, and if the owner is not a Texas licensed pharmacist, the owner shall consult with the pharmacist-in-charge or another Texas licensed pharmacist:
(A) establishment of policies for procurement of prescription drugs and devices and other products dispensed from the ASC pharmacy;
(B) establishment and maintenance of effective controls against the theft or diversion of prescription drugs;
(C) if the pharmacy uses an automated pharmacy dispensing system, reviewing and approving all policies and procedures for system operation, safety, security, accuracy and access, patient confidentiality, prevention of unauthorized access, and malfunction;
(D) providing the pharmacy with the necessary equipment and resources commensurate with its level and type of practice; and
(E) establishment of policies and procedures regarding maintenance, storage, and retrieval of records in a data processing system such that the system is in compliance with state and federal requirements.
(6)
[
(5)
] Identification of pharmacy
personnel. All pharmacy personnel shall
be identified as follows:
[
wear an identification tag or badge which bears the person's name and identifies
him or her by title or function as follows:
]
(A)
Pharmacy technicians. All pharmacy technicians shall wear
an identification tag or badge
that
[
which
] bears the
person's name and identifies him or her as a pharmacy technician trainee a
registered pharmacy technician, or a certified pharmacy technician, if the
technician maintains current certification with the Pharmacy Technician Certification
Board or any other entity providing an examination approved by the
board
[
Board
].
(B) Pharmacy technician trainees. All pharmacy technician trainees shall wear an identification tag or badge that bears the person's name and identifies him or her as a pharmacy technician trainee.
(C)
[
(B)
] Pharmacist interns. All pharmacist
interns shall wear an identification tag or badge
that
[
which
] bears the person's name and identifies him or her as a pharmacist
intern.
(D)
[
(C)
] Pharmacists. All pharmacists
shall wear an identification tag or badge
that
[
which
]
bears the person's name and identifies him or her as a pharmacist.
(d) Operational standards.
(1) Licensing requirements.
(A) An ASC pharmacy shall register annually with the board on a pharmacy license application provided by the board, following the procedures specified in §291.1 of this title (relating to Pharmacy License Application).
(B) If the ASC pharmacy is owned or operated by a pharmacy management or consulting firm, the following conditions apply.
(i) The pharmacy license application shall list the pharmacy management or consulting firm as the owner or operator.
(ii) The pharmacy management or consulting firm shall obtain DEA and DPS controlled substances registrations that are issued in the name of the firm, unless the following occur:
(I) the pharmacy management or consulting firm and the facility cosign a contractual pharmacy service agreement which assigns overall responsibility for controlled substances to the facility; and
(II) such pharmacy management or consulting firm maintains dual responsibility for the controlled substances.
(C) An ASC pharmacy which changes ownership shall notify the
board within 10 days of the change of ownership and apply for a new and separate
license as specified in
§291.3 of this title (relating to Required
Notifications).
[
§291.4 of this title (relating to Change
of Ownership).
]
(D) An ASC pharmacy which changes location and/or name shall
notify the board of the change within 10 days and file for an amended license
as specified in
§291.3 of this title (relating to Required Notifications).
[
§291.2 of this title (relating to Change of Location and/or
Name).
]
(E) An ASC pharmacy owned by a partnership or corporation which
changes managing officers shall notify the board in writing of the names of
the new managing officers within 10 days of the change, following the procedures
in §291.3 of this title (relating to
Required Notifications
[
Change of Managing Officers
]).
(F) An ASC pharmacy shall notify the board in writing within 10 days of closing, following the procedures in §291.5 of this title (relating to Closed Pharmacies).
(G) A fee as specified in §291.6 of this title (relating to Pharmacy License Fees) will be charged for issuance and renewal of a license and the issuance of an amended license.
(H) A separate license is required for each principal place of business and only one pharmacy license may be issued to a specific location.
(I) An ASC pharmacy, licensed under the Act, §560.051(a)(3), concerning institutional pharmacy (Class C), which also operates another type of pharmacy which would otherwise be required to be licensed under the Act, §560.051(a)(1), concerning community pharmacy (Class A), or the Act, §560.051(a)(2), concerning nuclear pharmacy (Class B), is not required to secure a license for the other type of pharmacy; provided, however, such license is required to comply with the provisions of §291.31 of this title (relating to Definitions), §291.32 of this title (relating to Personnel), §291.33 of this title (relating to Operational Standards), §291.34 of this title (relating to Records), and §291.35 of this title (relating to Official Prescription Records), or §291.51 of this title (relating to Purpose), §291.52 of this title (relating to Definitions), §291.53 of this title (relating to Personnel), §291.54 of this title (relating to Operational Standards), and §291.55 of this title (relating to Records), contained in Nuclear Pharmacy (Class B), to the extent such sections are applicable to the operation of the pharmacy.
(J) An ASC pharmacy engaged in non-sterile compounding of drug
products for inpatients of the hospital shall comply with the provisions of
§291.131
[
§291.25
] of this title (relating to Pharmacies
Compounding Non-Sterile
Preparations
[
Pharmaceuticals
]).
(K) An ASC pharmacy engaged in the compounding of sterile pharmaceuticals
shall comply with the provisions of
§291.133
[
§291.26
] of this title (relating to Pharmacies Compounding Sterile
Preparations
[
Pharmaceuticals
]).
(L) An ASC pharmacy engaged in the provision of remote pharmacy
services, including storage and dispensing of prescription drugs, shall comply
with the provisions of
§291.121
[
§291.20
]
of this title (relating to Remote Pharmacy Services).
(M) An ASC pharmacy engaged in centralized prescription dispensing
and/or prescription drug or medication order processing shall comply with
the provisions of
§291.123 of this title (relating to Centralized
Prescription Drug or Medication Order Processing) and/or §291.125 of
this title (relating to Centralized Prescription Dispensing).
[
§291.37 of this title (relating to Centralized Prescription Dispensing)
and/or §291.38 of this title (relating to Centralized Prescription Drug
or Medication Order Processing).
]
(2) - (3) (No change.)
(4) Library. A reference library shall be maintained which includes the following in hard-copy or electronic format:
(A) current copies of the following:
(i) Texas Pharmacy Act and rules;
(ii) Texas Dangerous Drug Act and rules;
(iii) Texas Controlled Substances Act and rules;
(iv) Federal Controlled Substances Act and rules or official publication describing the requirements of the Federal Controlled Substances Act and rules;
(B) at least one current or updated reference from each of the following categories:
(i) Drug interactions. A reference text on drug interactions, such as Drug Interaction Facts. A separate reference is not required if other references maintained by the pharmacy contain drug interaction information including information needed to determine severity or significance of the interaction and appropriate recommendations or actions to be taken;
(ii) General information. A general information reference text, such as:
(I) Facts and Comparisons with current supplements;
(II) United States Pharmacopeia Dispensing Information Volume I (Drug Information for the Healthcare Provider);
(III) AHFS Drug Information with current supplements;
(IV) Remington's Pharmaceutical Sciences; or
(V) Clinical Pharmacology;
(C) a current or updated reference on injectable drug products, such as Handbook of Injectable Drugs;
(D) basic antidote information and the telephone number of the nearest regional poison control center.
(E) if the pharmacy compounds sterile
preparations
[
pharmaceuticals
], specialty references appropriate for the scope of
services provided by the pharmacy, e.g., if the pharmacy prepares cytotoxic
drugs, a reference text on the preparation of cytotoxic drugs, such as Procedures
for Handling Cytotoxic Drugs.
(F) metric-apothecary weight and measure conversion charts.
(5) Drugs.
(A) Procurement, preparation, and storage.
(i) The pharmacist-in-charge shall have the responsibility for the procurement and storage of drugs, but may receive input from other appropriate staff of the facility, relative to such responsibility.
(ii) The pharmacist-in-charge shall have the responsibility for determining specifications of all drugs procured by the facility.
(iii) ASC pharmacies may not sell, purchase, trade, or possess prescription drug samples, unless the pharmacy meets all of the following conditions:
(I) the pharmacy is owned by a charitable organization described in the Internal Revenue Code of 1986, or by a city, state or county government;
(II) the pharmacy is a part of a health care entity which provides health care primarily to indigent or low income patients at no or reduced cost;
(III) the samples are for dispensing or provision at no charge to patients of such health care entity; and
(IV) the samples are possessed in compliance with the federal Prescription Drug Marketing Act of 1986.
(iv)
[
(iii)
] All drugs shall be stored
at the proper temperatures, as defined by the following terms.
(I) Room temperature--temperature maintained between 15 degrees Celsius (59 degrees Fahrenheit) and 30 degrees Celsius (86 degrees Fahrenheit).
(II) Cool--temperature between 8 degrees Celsius (46 degrees
Fahrenheit) and 15 degrees Celsius (59 degrees Fahrenheit)
. An article
for which storage in a cool place is directed may, alternatively, be stored
in a refrigerator unless otherwise specified on the labeling.
[
which may, alternatively, be stored in a refrigerator unless otherwise specified
on the labeling.
]
(III) Refrigerate--temperature that is thermostatically maintained between 2 degrees Celsius (36 degrees Fahrenheit) and 8 degrees Celsius (46 degrees Fahrenheit).
(IV) Freeze--temperature that is thermostatically maintained
between
minus
[
-
] 20 degrees Celsius (
minus
[
-
] 4 degrees Fahrenheit) and
minus
[
-
] 10 degrees
Celsius (14 degrees Fahrenheit).
(v)
[
(iv)
] Any drug bearing an expiration
date may not be dispensed or distributed beyond the expiration date of the
drug.
(vi)
[
(v)
] Outdated drugs shall be removed
from dispensing stock and shall be quarantined together until such drugs are
disposed of.
(B) Formulary.
(i) A formulary may be developed by an appropriate committee of the ambulatory surgical center.
(ii) The pharmacist-in-charge or consultant pharmacist shall be a full voting member of any committee which involves pharmaceutical services.
(C) Prepackaging of drugs and loading of bulk unlabeled drugs into automated drug dispensing system.
(i) Prepackaging of drugs.
(I) Drugs may be prepackaged in quantities suitable for internal distribution only by a pharmacist or by pharmacy technicians or pharmacy technician trainees under the direction and direct supervision of a pharmacist.
(II) The label of a prepackaged unit shall indicate:
(-a-) brand name and strength of the drug; or if no brand name, then the generic name, strength, and name of the manufacturer or distributor;
(-b-) facility's lot number;
(-c-) expiration date; and
(-d-) quantity of the drug, if quantity is greater than one.
(III) Records of prepackaging shall be maintained to show:
(-a-) the name of the drug, strength, and dosage form;
(-b-) facility's lot number;
(-c-) manufacturer or distributor;
(-d-) manufacturer's lot number;
(-e-) expiration date;
(-f-) quantity per prepackaged unit;
(-g-) number of prepackaged units;
(-h-) date packaged;
(-i-) name, initials, or electronic signature of the prepacker; and
(-j-) signature or electronic signature of the responsible pharmacist.
(IV) Stock packages, repackaged units, and control records shall be quarantined together until checked/released by the pharmacist.
(ii) Loading bulk unlabeled drugs into automated drug dispensing systems.
(I) Automated drug dispensing systems may be loaded with bulk unlabeled drugs only by a pharmacist or by pharmacy technicians or pharmacy technician trainees under the direction and direct supervision of a pharmacist.
(II) The label of an automated drug dispensing system container shall indicate the brand name and strength of the drug; or if no brand name, then the generic name, strength, and name of the manufacturer or distributor.
(III) Records of loading bulk unlabeled drugs into an automated drug dispensing system shall be maintained to show:
(-a-) name of the drug, strength, and dosage form;
(-b-) manufacturer or distributor;
(-c-) manufacturer's lot number;
(-d-) expiration date;
(-e-) date of loading;
(-f-) name, initials, or electronic signature of the person loading the automated drug dispensing system; and
(-g-) signature or electronic signature of the responsible pharmacist.
(IV) The automated drug dispensing system shall not be used until a pharmacist verifies that the system is properly loaded and affixes his or her signature or electronic signature to the record specified in subclause (III) of this clause.
(6) Medication orders.
(A) Drugs may be administered to patients in ASCs only on the order of a practitioner. No change in the order for drugs may be made without the approval of a practitioner.
(B) Drugs may be distributed only pursuant to the original or a direct copy of the practitioner's medication order.
(C) Pharmacy technicians and pharmacy technician trainees may not receive oral medication orders.
(D) ASC pharmacies shall be exempt from the labeling provisions and patient notification requirements of §562.006 and §562.009 of the Act, as respects drugs distributed pursuant to medication orders.
(E) In ASCs with a full-time pharmacist, if a practitioner orders a drug for administration to a bona fide patient of the facility when the pharmacy is closed, the following is applicable.
(i) Prescription drugs and devices only in sufficient quantities for immediate therapeutic needs of a patient may be removed from the ASC pharmacy.
(ii) Only a designated licensed nurse or practitioner may remove such drugs and devices.
(iii) A record shall be made at the time of withdrawal by the authorized person removing the drugs and devices. The record shall contain the following information:
(I) name of the patient;
(II) name of device or drug, strength, and dosage form;
(III) dose prescribed;
(IV) quantity taken;
(V) time and date; and
(VI) signature or electronic signature of person making withdrawal.
(iv) The original or direct copy of the medication order may substitute for such record, provided the medication order meets all the requirements of clause (iii) of this subparagraph.
(v) The pharmacist shall verify the withdrawal as soon as practical, but in no event more than 72 hours from the time of such withdrawal.
(F) In ASCs with a part-time or consultant pharmacist, if a practitioner orders a drug for administration to a bona fide patient of the ASC when the pharmacist is not on duty, or when the pharmacy is closed, the following is applicable.
(i) Prescription drugs and devices only in sufficient quantities for therapeutic needs may be removed from the ASC pharmacy.
(ii) Only a designated licensed nurse or practitioner may remove such drugs and devices.
(iii) A record shall be made at the time of withdrawal by the authorized person removing the drugs and devices; the record shall meet the same requirements as specified in subparagraph (E)(iii) of this paragraph.
(iv) The pharmacist shall verify each distribution after a reasonable interval, but in no event may such interval exceed seven days.
(7) - (9) (No change.)
(e) Records.
(1) Maintenance of records.
(A) Every inventory or other record required to be kept under the provisions of §291.76 of this title (relating to Institutional Pharmacy (Class C)) shall be:
(i) kept by the pharmacy and be available, for at least two years from the date of such inventory or record, for inspecting and copying by the board or its representative, and other authorized local, state, or federal law enforcement agencies; and
(ii) supplied by the pharmacy within 72 hours, if requested by an authorized agent of the Texas State Board of Pharmacy. If the pharmacy maintains the records in an electronic format, the requested records must be provided in an electronic format if specifically requested by the board or its representative. Failure to provide the records set out in this subsection, either on site or within 72 hours, constitutes prima facie evidence of failure to keep and maintain records in violation of the Act.
(B) Records of controlled substances listed in Schedules I and II shall be maintained separately from all other records of the pharmacy.
(C) Records of controlled substances listed in Schedules III - V shall be maintained separately or readily retrievable from all other records of the pharmacy. For purposes of this subsection, readily retrievable means that the controlled substances shall be asterisked, red-lined, or in some other manner readily identifiable apart from all other items appearing on the record.
(D) Records, except when specifically required to be maintained in original or hard-copy form, may be maintained in an alternative data retention system, such as a data processing or direct imaging system, e.g., microfilm or microfiche, provided:
(i) the records in the alternative data retention system contain all of the information required on the manual record; and
(ii) the alternative data retention system is capable of producing a hard copy of the record upon the request of the board, its representative, or other authorized local, state, or federal law enforcement or regulatory agencies.
(2) - (6) (No change.)
[
(7)
Confidentiality.]
[
(A)
A pharmacist shall provide adequate security
of prescription drug orders, medication orders, and patient medication records
to prevent indiscriminate or unauthorized access to confidential health information.]
[
(B)
Confidential records are privileged and may be released only to:]
[
(i)
the patient or the patient's agent;]
[
(ii)
a practitioner or another pharmacist if, in
the pharmacist's professional judgement, the release is necessary to protect
the patient's health and well being;]
[
(iii)
the board or to a person or another state
or federal agency authorized by law to receive the confidential record;]
[
(iv)
a law enforcement agency engaged in investigation
of a suspected violation of Chapter 481 or 483, Health and Safety Code, or
the Comprehensive Drug Abuse Prevention and Control Act of 1970 (21 U.S.C.
Section 801 et seq.);]
[
(v)
a person employed by a state agency that licenses
a practitioner, if the person is performing the person's official duties;
or]
[
(vi)
an insurance carrier or other third party
payor authorized by a patient to receive such information.]
This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of the Secretary of State on June 4, 2007.
TRD-200702214
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: July 15, 2007
For further information, please call: (512) 305-8028
The Texas State Board of Pharmacy proposes amendments to §291.92 concerning Personnel. The proposed amendments to §291.92, if adopted, clarify the responsibilities of owners of Class D pharmacies.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for the first five-year period the rule is in effect, there will be no fiscal implications for state or local government as a result of enforcing or administering the rule.
Ms. Dodson has determined that, for each year of the first five-year period the rule will be in effect, the public benefit anticipated as a result of enforcing the rule will be to clarify that owners are also responsible for the operation of a Class D pharmacy. There is no fiscal impact for individuals, small or large businesses or to other entities which are required to comply with this section.
Comments on the proposed amendments may be submitted to Allison Benz, R.Ph., M.S., Director of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Austin, Texas, 78701, FAX (512) 305-8082. Comments must be received by 5 pm, July 30, 2007.
The amendments are proposed under §551.002, and §554.051 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by the amendments: Chapters 551 - 566 and 568 - 569, Texas Occupations Code.
§291.92.Personnel.
(a) - (d) (No change.)
(e) Owner. The owner of Class D pharmacy shall have responsibility for all administrative and operational functions of the pharmacy. The pharmacist-in-charge may advise the owner on administrative and operational concerns. The owner shall have responsibility for, at a minimum, the following, and if the owner is not a Texas licensed pharmacist, the owner shall consult with the pharmacist-in-charge or another Texas licensed pharmacist:
(1) establishment of policies for procurement of prescription drugs and devices and other products provided or dispensed from the Class D pharmacy;
(2) establishment and maintenance of effective controls against the theft or diversion of prescription drugs;
(3) providing the pharmacy with the necessary equipment and resources commensurate with its level and type of practice; and
(4) establishment of policies and procedures regarding maintenance, storage, and retrieval of records in a data processing system such that the system is in compliance with state and federal requirements.
This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of the Secretary of State on June 4, 2007.
TRD-200702215
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: July 15, 2007
For further information, please call: (512) 305-8028
The Texas State Board of Pharmacy proposes amendments to §291.104, concerning Operational Standards and §291.105, concerning Records. The proposed amendments to §291.104 update references to other rules in this chapter and the proposed amendments to §291.105, if adopted, require pharmacies to provide the board or its representative with records in electronic format, if the records are maintained in an electronic format.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for the first five-year period the amendments are in effect, there will be no fiscal implications for state or local government as a result of enforcing or administering the amended sections.
Ms. Dodson has determined that, for each year of the first five-year period the amendments will be in effect, the public benefit anticipated as a result of enforcing the amended sections will be to ensure that the rules are up to date and clear in order to protect the public safety. There is no fiscal impact for individuals, small or large businesses or to other entities which are required to comply with the amended sections.
Comments on the proposed amendments may be submitted to Allison Benz, R.Ph., M.S., Director of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Austin, Texas 78701, FAX (512) 305-8082. Comments must be received by 5:00 p.m., July 30, 2007.
The amendments are proposed under §551.002 and §554.051 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by the amendments: Chapters 551 - 566 and 568 - 569, Texas Occupations Code.
§291.104.Operational Standards.
(a) Licensing requirements.
(1) - (3) (No change.)
(4) A Class E pharmacy which changes ownership shall notify
the board within ten days of the change of ownership and apply for a new and
separate license as specified in
§291.3 of this title (relating
to Required Notifications)
[
§291.4 of this title (relating
to Change of Ownership)].
(5) A Class E pharmacy which changes location and/or name shall
notify the board within ten days of the change and file for an amended license
as specified in
§291.3 of this title (relating to Required Notifications)
[
§291.2 of this title (relating to Change of Location and/or
Name)
].
(6) A Class E pharmacy owned by a partnership or corporation
which changes managing officers shall notify the board in writing of the names
of the new managing officers within ten days of the change, following the
procedures in §291.3 of this title (relating to
Required Notifications
[
Change of Managing Officers
]).
(7) - (10) (No change.)
(11) A Class E pharmacy engaged in the centralized dispensing
of prescription drug or medication orders shall comply with the provisions
of
§291.125
[
§291.37
] of this title (relating
to Centralized Prescription Dispensing).
(12) A Class E pharmacy engaged in central processing of prescription
drug or medication orders shall comply with the provisions of
§291.123
[
§291.38
] of this title (relating to Central Prescription
or Medication Order Processing).
(13) A Class E (Non-Resident) pharmacy engaged in the compounding
of non-sterile
preparations
[
pharmaceuticals
] shall
comply with the provisions of
§291.131
[
§291.25
] of this title (relating to Pharmacies Compounding Non-Sterile
Preparations
[
Pharmaceuticals
]).
(14) A Class E (Non-Resident) pharmacy engaged in the compounding
of sterile
preparations
[
pharmaceuticals
] shall comply with the provisions of
§291.133
[
§291.26
]
of this title (relating to Pharmacies Compounding Sterile
Preparations
[
Pharmaceuticals
]).
(b) - (d) (No change.)
(e) Transfer of Prescription Drug Order Information. Unless
compliance would violate the pharmacy or drug laws or rules in the state in
which the pharmacy is located, a pharmacist in a Class E pharmacy may not
refuse to transfer prescriptions to another pharmacy
that
[
who
] is making the transfer request on behalf of the patient.
(f) (No change.)
§291.105.Records.
(a) Maintenance of records.
(1) Every record required to be kept under this section shall be:
(A) kept by the pharmacy and be available, for at least two years from the date of such record, for inspecting and copying by the board or its representative, and other authorized local, state, or federal law enforcement agencies; and
(B) supplied by the pharmacy within 72 hours, if requested by an authorized agent of the Texas State Board of Pharmacy. If the pharmacy maintains the records in an electronic format, the requested records must be provided in an electronic format if specifically requested by the board or its representative. Failure to provide the records set out in this section, either on site or within 72 hours, constitutes prima facie evidence of failure to keep and maintain records in violation of the Act.
(2) (No change.)
(b) (No change.)
[(c) Confidentiality.]
[(1) A Class E pharmacy shall provide adequate security of prescription drug order and patient medication records to prevent indiscriminate or unauthorized access to confidential health information. If prescription drug orders, requests for refill authorization, or other confidential health information are not transmitted directly between a pharmacy and a physician but are transmitted through a data communication device, confidential health information may not be accessed or maintained by the operator of the data communication device other than for legal purposes under federal and state law.]
[(2) Confidential records are privileged and may be released only to:]
[(A) the patient or the patient's agent;]
[(B) practitioners and other pharmacists if, in the pharmacist's professional judgment, the release is necessary to protect the patient's health and well-being;]
[(C) the board or to a person or another state or federal agency authorized by law to receive the confidential record;]
[(D) a law enforcement agency engaged in investigation of a suspected violation Chapter 481 or 483, Health and Safety Code, or the Comprehensive Drug Abuse Prevention and Control Act of 1970 (21 U.S.C. Section 801 et seq.);]
[(E) a person employed by a state agency that licenses a practitioner, if the person is performing the person's official duties; or]
[(F) an insurance carrier or third party payer authorized by a patient to receive such information.]
This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of the Secretary of State on June 4, 2007.
TRD-200702216
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: July 15, 2007
For further information, please call: (512) 305-8028
22 TAC §§291.120, 291.121, 291.123, 291.125, 291.127, 291.129, 291.131, 291.133
The Texas State Board of Pharmacy proposes new §291.120, concerning General, §291.121, concerning Remote Pharmacy Services, §291.123, concerning Central Prescription Drug or Medication Order Processing, §291.125, concerning Centralized Prescription Dispensing, §291.127, concerning Emergency Remote Pharmacy License, §291.129, concerning Satellite Pharmacy, §291.131, concerning Pharmacies Compounding Non-sterile Preparations, and §291.33, concerning Pharmacies Compounding Sterile Preparations.
New §291.120, if adopted, provides the purpose of the new subchapter. New §291.121, if adopted, contains the requirements for remote pharmacy services previously found in §291.20 which is proposed as a repealed rule published in this edition of the Texas Register. New §291.123, if adopted, provides the requirements for Central Prescription Drug Order or Medication Order Processing previously found in §291.38 which is proposed as a repealed rule published elsewhere in this edition of the Texas Register. New §291.125, if adopted, provides the requirements for Centralized Prescription Dispensing previously found in §291.37 which is proposed as a repealed rule published elsewhere in this edition of the Texas Register. New §291.127, if adopted, provides the requirements for Emergency Remote Pharmacy License previously found in §291.13 which is proposed as a repealed rule published elsewhere in this edition of the Texas Register. New §§291.121, 291.123, 291.125, and 291.127 are being moved from other sections in Chapter 291 to better organize the subchapters, contain formatting and grammar corrections, and require pharmacies to provide the board or its representative with records in electronic format, if the records are maintained in an electronic format.
New §291.129, if adopted, provides new rules for a new class of pharmacy regarding the provision of pharmacy services by a satellite pharmacy owned by a Class A or Class C pharmacy, in a location that is not at the same location as a Class A or Class C pharmacy. New §291.131, if adopted, will outline operating standards for pharmacies that compound non-sterile preparations, implement the recommendations of the TSBP appointed Task Force on Compounding (Task Force), and incorporate many of the provisions included in the United States Pharmacopeia (USP) General Chapter 795 (Pharmaceutical Compounding ( Non-sterile Preparations) in accordance with S.B. 492 passed during the 79th Regular Session of the Texas Legislature regarding compounding. New §291.133, if adopted, will outline operating standards for pharmacies that compound sterile preparations, implement the recommendations of the TSBP appointed Task Force on Compounding (Task Force), and incorporate provisions included in the United States Pharmacopeia (USP) General Chapter 797 (Pharmaceutical Compounding ( Sterile Preparations) in accordance with S.B. 492 passed during the 79th Regular Session of the Texas Legislature regarding compounding.
The TSBP established the Task Force in September 2005. The Task Force was composed of representatives from the pharmacy community appointed by the three major pharmacy associations in Texas and pharmacists primarily involved in compounding. The Task Force was established to review the current standards of practice for pharmacy compounding and was charged with: (1) reviewing current federal and state requirements for pharmacy compounding; (2) reviewing S.B. 492 passed by the 79th Texas Legislature with regard to pharmacy compounding; and (3) making recommendations to the Board of Pharmacy regarding standards for pharmacy compounding in Texas that provide necessary compounded medications while protecting the health, safety, and welfare of the public. The Task Force met three times and presented its recommendations to the Board at the October 31, 2006 meeting. The Task Force recommended incorporating many of the proposed revisions to USP General Chapter 797 (Pharmaceutical Compounding - Sterile Preparations) into the rules. In November 2006, the Board voted to propose the rules recommended by the Task Force. The proposed rules were published in the December 16, 2006, issue of the Texas Register. A public hearing was held on February 13, 2007. At the February Board meeting, the Board voted to withdraw the proposed rules based on comments received and directed staff to reconvene the Task Force. The Board directed staff to draft rules that only incorporated current USP 797 requirements. After reviewing the revised draft of rules at the May 2007 meeting, the Board voted to publish the draft rules as proposed rules. In accordance with S.B. 492, the Task Force recommended changes to the rules to allow (1) pharmacies to compound preparations for "office use" by a practitioner or for use by veterinarians as specified in §563.054 of the Texas Pharmacy Act; (2) Class A pharmacies to compound preparations for a Class C pharmacy; and (3) Class C pharmacies to compound preparations to other Class C pharmacies under common ownership.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for the first five-year period the rule is in effect, there will be no fiscal implications for state government as a result of enforcing or administering the rule. There are no anticipated fiscal implications for local government.
Ms. Dodson has determined that, for each year of the first five-year period the rule will be in effect, the public benefit anticipated as a result of enforcing the rule will be the establishment of rules for the operation of satellite pharmacies and the establishment of standards for the safe compounding of non-sterile and sterile preparations by pharmacies. Ms. Dodson has also determined that, for each year of the first five-year period the rule will be in effect, an economic cost may exist for entities/persons required to comply with the rule as described below.
There might be an adverse economic effect on micro, small, and large businesses or to other entities/persons who are required to comply with the rules for pharmacies compounding sterile preparations. Based on the significant variances in pharmacies' physical structure and layout, it is difficult for TSBP to determine the actual cost to businesses required to comply with this rule. These costs would involve bringing the sterile compounding area of pharmacies into compliance with the new provisions of the rules and in establishing media fill test procedures. TSBP cannot precisely determine the number of pharmacies affected because TSBP records do not provide information about the details of the pharmacies' compounding operations. In addition, TSBP is unable to reduce these costs because to do so would compromise the purposes of this rule which is intended to protect the health and safety of the public. In order to comply with the library requirements, pharmacies compounding sterile preparations that do not already maintain a copy of the USP would incur a minimum cost of $690. In order to comply with the library requirements, pharmacies compounding non-sterile preparations that do not already maintain a copy of USP Chapter 795 would incur a minimum cost of $225.00.
Examples of new requirements under the rules are: (1) low- and medium-risk preparations must be prepared in a designated room for compounding; (2) when preparing high-risk preparations, the primary engineering control must be located in a buffer room that provides a physical separation, through the use of walls, doors and pass through and has a minimum differential positive pressure of 0.02 to 0.05 inches water column; (3) the pharmacy must establish medial fill test procedures for low, medium and high-risk preparations; and (4) the pharmacy must establish a quality control and quality assurance program that meets the requirements of Chapter 797 of the USP. The actual dollar amount for bringing the pharmacy into compliance may vary greatly between pharmacies and could range from one hundred to several tens of thousand dollars. The majority of pharmacies have less than 100 employees, such that the cost per employee would result in an amount between one dollar per employee to several thousand dollars.
A public hearing to receive comments on the proposed §291.131 and §291.133 will be held at 9:00 a.m. on Tuesday, August 7, 2007, at the Health Professions Council Board Room, 333 Guadalupe Street, Tower II, Room 2-225, Austin, Texas 78701. Persons planning to present comments to the Board are asked to provide a written copy of their comments prior to the hearing or bring 20 copies to the hearing. Written comments may be submitted to Allison Benz, R.Ph., M.S., Director of Professional Services, 333 Guadalupe Street, Suite 3-600, Austin, Texas, 78701, FAX: (512) 305-8082, E-mail: allison.benz@tsbp.state.tx.us. Comments must be received by 5:00 p.m., July 30, 2007.
The new rules are proposed under §§551.002, 551.003, 554.001, 554.051, 560.053 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §551.003(9) as authorizing the agency to adopt rules concerning the compounding of prescriptions. The Board interprets §551.003(33) as authorizing the agency to adopt rules concerning the practice of pharmacy. The Board interprets §554.001(a) as authorizing the agency to adopt rules to administer and enforce the Act and rules adopted under the Act as well as enforce other laws relating to the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act. The Board interprets §554.051(b) as authorizing the agency to adopt rules concerning the operation of a licensed pharmacy located in this state applicable to a pharmacy licensed by the board that is located in another state, if the board determines the rule is necessary to protect the health and welfare of the citizens of this state. The Board interprets §560.053 as authorizing the agency to adopt rules establishing additional pharmacy classifications.
The statutes affected: Chapters 551 - 566 and 568 - 569, Texas Occupations Code.
§291.120.General.
(a) Purpose. This subchapter applies to all classes of pharmacies except as otherwise noted.
(b) Definitions.
(1) The Texas Pharmacy Act or Act--Subtitle J, other than Chapter 567, Occupations Code, as amended.
(2) Board--The Texas State Board of Pharmacy.
§291.121.Remote Pharmacy Services.
(a) Remote pharmacy services using automated pharmacy systems.
(1) Purpose. The purpose of this section is to provide standards for the provision of pharmacy services by a Class A or Class C pharmacy in a facility that is not at the same location as the Class A or Class C pharmacy through an automated pharmacy system as outlined in §562.109 of the Texas Pharmacy Act.
(2) Definitions. The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise. All other words and terms shall have the meanings defined in the Act.
(A) Automated pharmacy system--A mechanical system that dispenses prescription drugs and maintains related transaction information.
(B) Remote site--A facility not located at the same location as a Class A or Class C pharmacy, at which remote pharmacy services are provided using an automated pharmacy dispensing system.
(C) Prepackaging--The act of repackaging and relabeling quantities of drug products from a manufacturer's original commercial container, or quantities of unit dosed drugs, into another cartridge or container for dispensing by a pharmacist using an automated pharmacy system.
(D) Provider pharmacy--The community pharmacy (Class A) or the institutional pharmacy (Class C) providing remote pharmacy services.
(E) Remote pharmacy service--The provision of pharmacy services, including the storage and dispensing of prescription drugs, in remote sites.
(F) Unit dose--An amount of a drug packaged in a dosage form ready for administration to a particular patient, by the prescribed route at the prescribed time, and properly labeled with name, strength, and expiration date of the drug.
(3) General requirements.
(A) A provider pharmacy may provide remote pharmacy services using an automated pharmacy system to a jail or prison operated by or for the State of Texas, a jail or prison operated by local government or a healthcare facility regulated under Chapter 142, 242, 247, or 252, Health and Safety Code, provided drugs are administered by a licensed healthcare professional working in the jail, prison, or healthcare facility.
(B) A provider pharmacy may only provide remote pharmacy services using an automated pharmacy system to inpatients of the remote site.
(C) A provider pharmacy may provide remote pharmacy services at more than one remote site.
(D) Before providing remote pharmacy services, the automated pharmacy system at the remote site must be tested by the provider pharmacy and found to dispense accurately. The provider pharmacy shall make the results of such testing available to the board upon request.
(E) A provider pharmacy which is licensed as an institutional (Class C) pharmacy is required to comply with the provisions of §§291.31 - 291.34 of this title (relating to Definitions, Personnel, Operational Standards, and Records for Class A (Community) Pharmacies) and this section.
(F) The pharmacist-in-charge of the provider pharmacy is responsible for all pharmacy operations involving the automated pharmacy system located at the remote site including supervision of the automated pharmacy system and compliance with this section.
(G) A pharmacist from the provider pharmacy shall be accessible at all times to respond to patient's or other health professionals' questions and needs pertaining to drugs dispensed through the use of the automated pharmacy system. Such access may be through a 24 hour pager service or telephone which is answered 24 hours a day.
(4) Operational standards.
(A) Application for permission to provide pharmacy services using an automated pharmacy system.
(i) A Class A or Class C Pharmacy shall make application to the board to provide remote pharmacy services using an automated pharmacy system. The application shall contain an affidavit with the notarized signatures of the pharmacist-in-charge, and the medical director or the person responsible for the on-site operation of the facility (e.g., administrator, chief operating officer, owner, chief executive officer), and include the following:
(I) the name, address, and license number of the provider pharmacy;
(II) name and address of the facility where the remote pharmacy services will be provided;
(III) a statement indicating that the provider pharmacy and the facility have entered into a written contract or agreement which outlines the services to be provided and the responsibilities and accountabilities of each party in fulfilling the terms of the contract or agreement in compliance with federal and state laws and regulations; and
(IV) documentation that the automated pharmacy system is located where medications are administered by license healthcare professionals and is:
(-a-) a facility regulated under Chapter 142, 242, 247, or 252, Health and Safety Code; or
(-b-) a jail or prison, operated by the State of Texas or local government.
(ii) Such application shall be resubmitted every two years in conjunction with the application for renewal of the provider pharmacy's license. The renewal petition shall contain the documentation required in clause (i) of this subparagraph except the notarized signature of the medical director or the person responsible for the on-site operation of the facility (e.g., administrator, chief operating officer, owner, chief executive officer) is not required.
(iii) Upon approval of the application, the provider pharmacy will be sent a certificate which must be displayed at the remote site.
(B) Notification requirements.
(i) A provider pharmacy shall notify the board in writing within ten days of a change of location, discontinuance of service, or closure of:
(I) a remote site where an automated pharmacy system is operated by the pharmacy; or
(II) a remote pharmacy service at a remote site.
(ii) A provider pharmacy shall comply with appropriate federal and state controlled substance registrations for each remote site if controlled substances are maintained within an automated pharmacy system at the facility.
(C) Environment/Security.
(i) A provider pharmacy shall only store drugs at a remote site within an automated pharmacy system which is locked by key, combination or other mechanical or electronic means so as to prohibit access by unauthorized personnel.
(ii) An automated pharmacy system shall be under the continuous supervision of a provider pharmacy pharmacist. To qualify as continuous supervision, the pharmacist is not required to be physically present at the site of the automated pharmacy system if the system is supervised electronically by a pharmacist.
(iii) Automated pharmacy systems shall have adequate security and procedures to:
(I) comply with federal and state laws and regulations; and
(II) maintain patient confidentiality.
(iv) Access to the automated pharmacy system shall be limited to pharmacists or personnel who:
(I) are designated in writing by the pharmacist-in-charge; and
(II) have completed documented training concerning their duties associated with the automated pharmacy system.
(v) Drugs shall be stored in compliance with the provisions of §291.33(f) of this title including the requirements for temperature, proper storage containers, and handling of outdated drugs.
(D) Prescription dispensing and delivery.
(i) Drugs shall only be dispensed at a remote site through an automated pharmacy system after receipt of an original prescription drug order by a pharmacist at the provider pharmacy in a manner authorized by §291.34(b) of this title.
(ii) A pharmacist at the provider pharmacy shall control all operations of the automated pharmacy system and approve the release of the initial dose of a prescription drug order. Subsequent doses from an approved prescription drug order may be removed from the automated medication system after this initial approval. Any change made in the prescription drug order shall require a new approval by a pharmacist to release the drug.
(iii) A pharmacist at the provider pharmacy shall conduct a drug regimen review as specified in §291.33(c) of this title prior to releasing a prescription drug order to the automated pharmacy system.
(iv) Drugs dispensed by the provider pharmacy through an automated pharmacy system shall comply with the labeling or labeling alternatives specified in §291.33(c) of this title.
(v) An automated pharmacy system used to meet the emergency medication needs for residents of a remote site must comply with the requirements for emergency medication kits in subsection (b) of this section.
(E) Drugs.
(i) Drugs for use in an automated pharmacy system shall be packaged in the original manufacturer's container or be prepackaged in the provider pharmacy and labeled in compliance with the board's prepackaging requirements for the class of pharmacy.
(ii) Drugs dispensed from the automated pharmacy system may be returned to the pharmacy for reuse provided the drugs are in sealed, tamper evident packaging which has not been opened.
(F) Stocking an automated pharmacy system.
(i) Stocking of drugs in an automated pharmacy system shall be completed by a pharmacist, pharmacy technician, or pharmacy technician trainee under the direct supervision of a pharmacist, except as provided in clause (ii) of this subparagraph.
(ii) If the automated pharmacy system uses removable cartridges or containers to hold drugs, the prepackaging of the cartridges or containers shall occur at the provider pharmacy unless provided by an FDA approved repackager. The prepackaged cartridges or containers may be sent to the remote site to be loaded into the machine by personnel designated by the pharmacist-in-charge provided:
(I) a pharmacist verifies the cartridge or container has been properly filled and labeled;
(II) the individual cartridges or containers are transported to the remote site in a secure, tamper-evident container; and
(III) the automated pharmacy system uses bar-coding, microchip, or other technologies to ensure that the containers are accurately loaded in the automated pharmacy system.
(iii) All drugs to be stocked in the automated pharmacy system shall be delivered to the remote site by the provider pharmacy.
(G) Quality assurance program. A pharmacy that provides pharmacy services through an automated pharmacy system at a remote site shall operate according to a written program for quality assurance of the automated pharmacy system which:
(i) requires continuous supervision of the automated pharmacy system; and
(ii) establishes mechanisms and procedures to routinely test the accuracy of the automated pharmacy system at a minimum of every six months and whenever any upgrade or change is made to the system and documents each such activity.
(H) Policies and procedures of operation.
(i) A pharmacy that provides pharmacy services through an automated pharmacy system at a remote site shall operate according to written policies and procedures. The policy and procedure manual shall include, but not be limited to, the following:
(I) a current list of the name and address of the pharmacist-in-charge and personnel designated by the pharmacist-in-charge to have access to the drugs stored in the automated pharmacy system;
(II) duties which may only be performed by a pharmacist;
(III) a copy of the portion of the written contract or agreement between the pharmacy and the facility which outlines the services to be provided and the responsibilities and accountabilities of each party relating to the operation of the automated pharmacy system in fulfilling the terms of the contract in compliance with federal and state laws and regulations;
(IV) date of last review/revision of the policy and procedure manual; and
(V) policies and procedures for:
(-a-) security;
(-b-) operation of the automated pharmacy system;
(-c-) preventative maintenance of the automated pharmacy system;
(-d-) sanitation;
(-e-) storage of drugs;
(-f-) dispensing;
(-g-) supervision;
(-h-) drug procurement;
(-i-) receiving of drugs;
(-j-) delivery of drugs; and
(-k-) recordkeeping.
(ii) A pharmacy that provides pharmacy services through an automated pharmacy system at a remote site shall, at least annually, review its written policies and procedures, revise them if necessary, and document the review.
(iii) A pharmacy providing remote pharmacy services using an automated pharmacy system shall maintain a written plan for recovery from an event which interrupts the ability of the automated pharmacy system to dispense prescription drugs. The written plan for recovery shall include:
(I) planning and preparation for maintaining pharmacy services when an automated pharmacy system is experiencing downtime;
(II) procedures for response when an automated pharmacy system is experiencing downtime; and
(III) procedures for the maintenance and testing of the written plan for recovery.
(5) Records.
(A) Maintenance of records.
(i) Every record required under this section must be:
(I) kept by the provider pharmacy and be available, for at least two years for inspecting and copying by the board or its representative and to other authorized local, state, or federal law enforcement agencies; and
(II) supplied by the provider pharmacy within 72 hours, if requested by an authorized agent of the Texas State Board of Pharmacy. If the pharmacy maintains the records in an electronic format, the requested records must be provided in an electronic format if specifically requested by the board or its representative. Failure to provide the records set out in this section, either on site or within 72 hours, constitutes prima facie evidence of failure to keep and maintain records in violation of the Act.
(ii) The provider pharmacy shall maintain original prescription drug orders for drugs dispensed from an automated pharmacy system in compliance with §291.34(b) of this title.
(iii) if prescription drug records are maintained in a data processing system, the system shall have a workable (electronic) data retention system which can produce a separate audit trail of drug usage by the provider pharmacy and each remote site for the preceding two years as specified in §291.34(e) of this title.
(B) Prescriptions. Prescription drug orders shall meet the requirements of §291.34(b) of this title.
(C) Records of dispensing. Dispensing records for a prescription drug order shall be maintained by the provider pharmacy in the manner required by §291.34(d) or (e) of this title.
(D) Transaction information.
(i) The automated pharmacy system shall electronically record all transactions involving drugs stored in, removed, or dispensed from the system.
(ii) Records of dispensing from an automated pharmacy system for a patient shall be maintained by the providing pharmacy and include the:
(I) identity of the system accessed;
(II) identification of the individual accessing the system;
(III) date of transaction;
(IV) name, strength, dosage form, and quantity of drug accessed; and
(V) name of the patient for whom the drug was accessed.
(iii) Records of stocking or removal from an automated pharmacy system shall be maintained by the pharmacy and include the:
(I) date;
(II) name, strength, dosage form, and quantity of drug stocked or removed;
(III) name, initials, or identification code of the person stocking or removing drugs from the system;
(IV) name, initials, or identification code of the pharmacist who checks and verifies that the system has been accurately filled;
(E) Patient medication records. Patient medication records shall be created and maintained by the provider pharmacy in the manner required by §291.34(c) of this title.
(F) Inventory.
(i) A provider pharmacy shall:
(I) keep a record of all drugs sent to and returned from a remote site separate from the records of the provider pharmacy and from any other remote site's records; and
(II) keep a perpetual inventory of controlled substances and other drugs required to be inventoried under §291.17 of this title (relating to Inventory Requirements for All Classes of Pharmacies), that are received and dispensed or distributed from each remote site.
(ii) As specified in §291.17 of this title, a provider pharmacy shall conduct an inventory at each remote site. The following is applicable to this inventory.
(I) The inventory of each remote site and the provider pharmacy shall be taken on the same day.
(II) The inventory of each remote site shall be included with, but listed separately from, the drugs of other remote sites and separately from the drugs of the provider pharmacy.
(b) Remote pharmacy services using emergency medication kits.
(1) Purpose. The purpose of this section is to provide standards for the provision of pharmacy services by a Class A or Class C pharmacy in a facility that is not at the same location as the Class A or Class C pharmacy through an emergency medication kit as outlined in §562.108 of the Texas Pharmacy Act.
(2) Definitions. The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise. All other words and terms shall have the meanings defined in the Act or §291.31 of this title.
(A) Automated pharmacy system--A mechanical system that dispenses prescription drugs and maintains related transaction information.
(B) Emergency medication kits--Controlled substances and dangerous drugs maintained by a community pharmacy (Class A), an institutional pharmacy (Class C) at an institution licensed under Chapter 242 or 252, Health and Safety Code, a non-resident (Class E) pharmacy located not more than 20 miles from an institution licensed under Chapter 242 or 252, Health and Safety Code, or a United States Department of Veterans Affairs pharmacy or another federally operated pharmacy at an institution that is licensed under Chapter 242, Health and Safety Code, and is a veterans home, as defined by Section 164.002, Natural Resources Code, to meet the emergency medication needs of a resident at that institution.
(C) Remote site--A facility not located at the same location as a Class A, Class C, Class E pharmacy or a United States Department of Affairs pharmacy or another federally operated pharmacy, at which remote pharmacy services are provided using an emergency medication kit.
(D) Prepackaging--The act of repackaging and relabeling quantities of drug products from a manufacturer's original commercial container, or quantities of unit dosed drugs, into another cartridge or container for dispensing by a pharmacist using an emergency medication kit.
(E) Provider pharmacy--The community pharmacy (Class A), the institutional pharmacy (Class C), the non-resident (Class E) pharmacy located not more than 20 miles from an institution licensed under Chapter 242 or 252, Health and Safety Code, or the United States Department of Veterans Affairs pharmacy or another federally operated pharmacy providing remote pharmacy services.
(F) Remote pharmacy service--The provision of pharmacy services, including the storage and dispensing of prescription drugs, in remote sites.
(3) General requirements.
(A) A provider pharmacy may provide remote pharmacy services using an emergency medication kit to an institution regulated under Chapter 242, or 252, Health and Safety Code.
(B) A provider pharmacy may provide remote pharmacy services at more than one remote site.
(C) A provider pharmacy shall not place an emergency medication kit in a remote site which already has a kit from another provider pharmacy.
(D) A provider pharmacy which is licensed as an institutional (Class C) or a non-resident (Class E) pharmacy is required to comply with the provisions of §§291.31 - 291.34 of this title and this section.
(E) The pharmacist-in-charge of the provider pharmacy is responsible for all pharmacy operations involving the emergency medication kit located at the remote site including supervision of the emergency medication kit and compliance with this section.
(4) Operational standards.
(A) Application for permission to provide pharmacy services using an emergency medication kit.
(i) A Class A, Class C, or Class E Pharmacy shall make application to the board to provide remote pharmacy services using an emergency medication kit. The application shall contain an affidavit with the notarized signatures of the pharmacist-in-charge, and the medical director or the person responsible for the on-site operation of the facility (e.g., administrator, owner, chief executive officer, chief operating officer), and include the following:
(I) the name, address, and license number of the provider pharmacy;
(II) name and address of the healthcare facility where the remote pharmacy services will be provided;
(III) a statement indicating that the provider pharmacy and the healthcare facility have entered into a written contract or agreement which outlines the services to be provided and the responsibilities and accountabilities of each party in fulfilling the terms of the contract or agreement in compliance with federal and state laws and regulations;
(IV) documentation that the emergency medication kit is located in a facility regulated under Chapter 242, or 252, Health and Safety Code; and
(V) documentation that the emergency kit is located in a facility that is not more than 20 miles from the Class E pharmacy providing the emergency kit.
(ii) Such application shall be resubmitted every two years in conjunction with the application for renewal of the provider pharmacy's license. The renewal petition shall contain the documentation required in clause (i) of this subparagraph except the notarized signature of the medical director or the person responsible for the on-site operation of the facility (e.g., administrator, owner, chief executive officer, chief operating officer) is not required.
(iii) Upon approval of the application, the provider pharmacy will be sent a certificate which must be displayed at the remote site.
(B) Notification requirements.
(i) A provider pharmacy shall notify the board in writing within ten days of a change of location, discontinuance of service, or closure of:
(I) a remote site where an emergency medication kit is operated by the pharmacy; or
(II) a remote pharmacy service at a remote site.
(ii) A provider pharmacy shall comply with appropriate federal and state controlled substance registrations for each remote site if controlled substances are maintained within an emergency medication kit at the facility.
(C) Environment/Security.
(i) Emergency medication kits shall have adequate security and procedures to:
(I) prohibit unauthorized access;
(II) comply with federal and state laws and regulations; and
(III) maintain patient confidentiality.
(ii) Access to the emergency medication kit shall be limited to pharmacists and licensed healthcare personnel employed by the facility.
(iii) Drugs shall be stored in compliance with the provisions of §291.33(f) of this title including the requirements for temperature, proper storage containers, and handling outdated drugs.
(D) Prescription dispensing and delivery.
(i) Drugs in the emergency medication kit shall be accessed for administration to meet the emergency medication needs of a resident of the remote site pursuant to an order from a practitioner. The prescription drug order for the drugs used from the emergency medication kit shall be forwarded to the provider pharmacy in a manner authorized by §291.34(b) of this title.
(ii) The remote site shall notify the provider pharmacy of each entry into an emergency medication kit. Such notification shall meet the requirements of paragraph (5)(D)(ii) of this subsection.
(E) Drugs.
(i) The contents of an emergency medication kit:
(I) may consist of dangerous drugs and controlled substances; and
(II) shall be determined by the consultant pharmacist, pharmacist-in-charge of the provider pharmacy, medical director, and the director of nurses and limited to those drugs necessary to meet the resident's emergency medication needs. For the purpose of this subsection, this shall mean a situation in which a drug cannot be supplied by a pharmacy within a reasonable time period.
(ii) When deciding on the drugs to be placed in the emergency medication kit, the consultant pharmacist, pharmacist-in-charge of the provider pharmacy, medical director, and the director of nurses must determine, select, and record a prudent number of drugs for potential emergency incidents based on:
(I) clinical criteria applicable to each facility's demographics;
(II) the facility's census; and
(III) the facility's healthcare environment.
(iii) A current list of the drugs stored in each remote site's emergency medication kit shall be maintained by the provider pharmacy and a copy kept with the emergency medication kit.
(iv) An automated pharmacy system may be used as an emergency medication kit provided the system limits emergency access to only those drugs approved for the emergency medication kit.
(v) Drugs for use in an emergency medication kit shall be packaged in the original manufacturer's container or prepackaged in the provider pharmacy and labeled in compliance with the board's prepackaging requirements for the class of pharmacy.
(F) Stocking emergency medication kits.
(i) Stocking of drugs in an emergency medication kit shall be completed at the provider pharmacy or remote site by a pharmacist, pharmacy technician, or pharmacy technician trainee under the direct supervision of a pharmacist, except as provided in clause (ii) of this subparagraph.
(ii) If the emergency medication kit is an automated pharmacy system which uses removable cartridges or containers to hold drugs, the prepackaging of the cartridges or containers shall occur at the provider pharmacy unless provided by and FDA approved repackager. The prepackaged cartridges or containers may be sent to the remote site to be loaded into the machine by personnel designated by the pharmacist-in-charge provided:
(I) a pharmacist verifies the cartridge or container has been properly filled and labeled;
(II) the individual cartridges or containers are transported to the remote site in a secure, tamper-evident container; and
(III) the automated pharmacy system uses bar-coding, microchip, or other technologies to ensure that the containers are accurately loaded in the automated pharmacy system.
(iii) All drugs to be stocked in the emergency medication kit shall be delivered to the remote site by the provider pharmacy.
(G) Policies and procedures of operation.
(i) A provider pharmacy that provides pharmacy services through an emergency medication kit at a remote site shall operate according to written policies and procedures. The policy and procedure manual shall include, but not be limited to, the following:
(I) duties which may only be performed by a pharmacist;
(II) a copy of the written contract or agreement between the pharmacy and the facility which outlines the services to be provided and the responsibilities and accountabilities of each party in fulfilling the terms of the contract in compliance with federal and state laws and regulations;
(III) date of last review/revision of the policy and procedure manual; and
(IV) policies and procedures for:
(-a-) security;
(-b-) operation of the emergency medication kit;
(-c-) preventative maintenance of the automated pharmacy system if the emergency medication kit is an automated pharmacy system;
(-d-) sanitation;
(-e-) storage of drugs;
(-f-) dispensing;
(-g-) supervision;
(-h-) drug procurement;
(-i-) receiving of drugs;
(-j-) delivery of drugs; and
(-k-) recordkeeping.
(ii) A pharmacy that provides pharmacy services through an emergency medication kit at a remote site shall, at least annually, review its written policies and procedures, revise them if necessary, and document the review.
(iii) A pharmacy providing remote pharmacy services using an emergency medication kit which is an automated pharmacy system shall maintain a written plan for recovery from an event which interrupts the ability of the automated pharmacy system to provide emergency medications. The written plan for recovery shall include:
(I) planning and preparation for maintaining pharmacy services when an automated pharmacy system is experiencing downtime;
(II) procedures for response when an automated pharmacy system is experiencing downtime; and
(III) procedures for the maintenance and testing of the written plan for recovery.
(5) Records.
(A) Maintenance of records.
(i) Every record required under this section must be:
(I) kept by the provider pharmacy and be available, for at least two years for inspecting and copying by the board or its representative and to other authorized local, state, or federal law enforcement agencies; and
(II) supplied by the provider pharmacy within 72 hours, if requested by an authorized agent of the Texas State Board of Pharmacy. If the pharmacy maintains the records in an electronic format, the requested records must be provided in an electronic format if specifically requested by the board or its representative. Failure to provide the records set out in this section, either on site or within 72 hours, constitutes prima facie evidence of failure to keep and maintain records in violation of the Act.
(ii) The provider pharmacy shall maintain original prescription drug orders for drugs dispensed from an emergency medication kit in compliance with §291.34(b) of this title.
(B) Prescriptions. Prescription drug orders shall meet the requirements of §291.34(b) of this title.
(C) Records of dispensing. Dispensing records for a prescription drug order shall be maintained by the provider pharmacy in the manner required by §291.34(d) or (e) of this title.
(D) Transaction information.
(i) A prescription drug order shall be maintained by the provider pharmacy as the record of removal of a drug from an emergency medication kit for administration to a patient.
(ii) The remote site shall notify the provider pharmacy electronically or in writing of each entry into an emergency medication kit. Such notification may be included on the prescription drug order or a separate document and shall include the name, strength, and quantity of the drug removed, the time of removal, and the name of the person removing the drug.
(iii) A separate record of stocking, removal, or dispensing for administration from an emergency medication kit shall be maintained by the pharmacy and include the:
(I) date;
(II) name, strength, dosage form, and quantity of drug stocked, removed, or dispensed for administration;
(III) name, initials, or identification code of the person stocking, removing, or dispensing for administration, drugs from the system;
(IV) name, initials, or identification code of the pharmacist who checks and verifies that the system has been accurately filled; and
(V) unique prescription number assigned to the prescription drug order when the drug is administered to the patient.
(E) Inventory.
(i) A provider pharmacy shall:
(I) keep a record of all drugs sent to and returned from a remote site separate from the records of the provider pharmacy and from any other remote site's records; and
(II) keep a perpetual inventory of controlled substances and other drugs required to be inventoried under §291.17 of this title, that are received and dispensed or distributed from each remote site.
(ii) As specified in §291.17 of this title, a provider pharmacy shall conduct an inventory at each remote site. The following is applicable to this inventory.
(I) The inventory of each remote site and the provider pharmacy shall be taken on the same day.
(II) The inventory of each remote site shall be included with, but listed separately from, the drugs of other remote sites and separately from the drugs of the provider pharmacy.
(c) Remote pharmacy services using telepharmacy systems.
(1) Purpose. The purpose of this section is to provide standards for the provision of pharmacy services by a Class A or Class C pharmacy in a healthcare facility that is not at the same location as a Class A or Class C pharmacy through a telepharmacy system as outlined in §562.110 of the Texas Pharmacy Act.
(2) Definitions. The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise. All other words and terms shall have the meanings defined in the Act or §291.31 of this title.
(A) Prepackaging--The act of repackaging and relabeling quantities of drug products from a manufacturer's original commercial container into a prescription container for dispensing by a pharmacist to the ultimate consumer.
(B) Provider pharmacy--The community pharmacy (Class A) or the institutional pharmacy (Class C) providing remote pharmacy services.
(C) Remote site--a facility not located at the same location as a Class A or Class C pharmacy, at which remote pharmacy services are provided using a telepharmacy dispensing system.
(D) Remote pharmacy service--The provision of pharmacy services, including the storage and dispensing of prescription drugs, drug regimen review, and patient counseling, at a remote site.
(E) Still image capture--A specific image captured electronically from a video or other image capture device.
(F) Store and forward--A video or still image record which is saved electronically for future review.
(G) Telepharmacy system--A system that monitors the dispensing of prescription drugs and provides for related drug use review and patient counseling services by an electronic method which shall include the use of the following types of technology:
(i) audio and video;
(ii) still image capture; and
(iii) store and forward.
(H) Unit-of-use--A sufficient quantity of a drug for one normal course of therapy as determined by the pharmacist-in-charge and the prescribing practitioner(s) at the healthcare facility.
(3) General requirements.
(A) A provider pharmacy may provide remote pharmacy services using a telepharmacy system to:
(i) a rural health clinic regulated under 42 U.S.C. Section 1395x(aa), as amended;
(ii) a health center as defined by 42 U.S.C. Section 254b, as amended; or
(iii) healthcare facility located in a medically underserved area as defined by state or federal law.
(B) A provider pharmacy may not provide remote pharmacy services if a Class A (Community) or Class C (Institutional) pharmacy that dispenses prescription drug orders to out-patients is located in the same community. For the purposes of this subsection a community is defined as:
(i) the census tract in which the remote site is located, if the remote site is located in a Metropolitan Statistical Area (MSA) as defined by the United States Census Bureau in the most recent U.S. Census; or
(ii) within 10 miles of the remote site, if the remote site is not located in a MSA.
(C) The provider pharmacy shall have sufficient pharmacists on duty such that each pharmacist may supervise no more than three remote sites that are simultaneously open to provide services. An exception to the supervision limit may be granted by the board in situations where the provider has documented a need for a pharmacist to supervise additional remote sites and has demonstrated that appropriate safeguards are in place to assure proper supervision of each remote site.
(D) Before providing remote pharmacy service, the telepharmacy system at the off-site facility must be tested by the provider pharmacy and found to operate properly. The provider pharmacy shall make the results of such testing available to the board upon request.
(E) A provider pharmacy which is licensed as an institutional (Class C) pharmacy is required to comply with the provisions of §§291.31 - 291.34 of this title and this section.
(F) The pharmacist-in-charge of the provider pharmacy is responsible for all operations at the remote site including supervision of the telepharmacy system and compliance with this section.
(4) Operational standards.
(A) Application to provide pharmacy services using a telepharmacy system.
(i) A Class A or class C Pharmacy shall make application to the board to provide remote pharmacy services using a telepharmacy system. The application shall contain an affidavit with the notarized signatures of pharmacist-in-charge, and the medical director or the person responsible for the on-site operation of the facility (e.g., administrator, owner, chief executive officer, chief operating officer), and include the following:
(I) the name, address, and license number of the provider pharmacy;
(II) name and address of the healthcare facility where the remote pharmacy services will be provided;
(III) a statement indicating that the provider pharmacy and the healthcare facility have entered into a written contract or agreement which outlines the services to be provided and the responsibilities and accountabilities of each party in fulfilling the terms of the contract or agreement in compliance with federal and state laws and regulations;
(IV) documentation that the healthcare facility is:
(-a-) a rural health clinic regulated under 42 U.S.C. Section 1395x(aa), as amended;
(-b-) a health center as defined by 42 U.S.C. Section 254b, as amended; or
(-c-) located in a medically underserved area as defined by state or federal law; and
(V) documentation that a Class A (Community) or Class C (Institutional) Pharmacy that dispenses prescriptions drug orders to out-patients is not located within the community, as defined in paragraph (3)(B) of this subsection, where the remote site is located.
(ii) Such application shall be resubmitted every two years in conjunction with the renewal of the provider pharmacy's license. The renewal application shall contain the documentation required in clause (i) of this subparagraph except the notarized signature of the medical director or the person responsible for the on-site operation of the facility (e.g., administrator, owner, chief executive officer, chief operating officer) is not required.
(iii) On approval of the application, the provider pharmacy will be sent a registration certificate, which must be displayed at the remote site.
(B) Notification requirements.
(i) A provider pharmacy shall notify the board in writing within ten days of a change of location, discontinuance of service, or closure of:
(I) a remote site where a telepharmacy system is operated by the pharmacy; or
(II) a remote pharmacy service at a remote site.
(ii) A provider pharmacy shall comply with appropriate federal and state controlled substance registrations for each remote site, if controlled substances are maintained.
(C) Environment/Security.
(i) A remote site shall be under the continuous supervision of a provider pharmacy pharmacist at all times the site is open to provide pharmacy services. To qualify as continuous supervision, the pharmacist is not required to be physically present at the remote site and shall supervise electronically through the use of the following types of technology:
(I) audio and video;
(II) still image capture; and
(III) store and forward.
(ii) Drugs shall be stored in compliance with the provisions of §291.33(f) of this title including the requirements for temperature, proper containers, and handling of outdated drugs.
(iii) Drugs for use in the telepharmacy system shall be stored in an area that is:
(I) separate from any other drugs used by the healthcare facility; and
(II) locked by key, combination or other mechanical or electronic means, so as to prohibit access by unauthorized personnel.
(iv) Access to the area where drugs are stored at the remote site and operation of the telepharmacy system shall be limited to pharmacists employed by the provider pharmacy or personnel who:
(I) are licensed healthcare providers pharmacy technicians or pharmacy technician trainees;
(II) are designated in writing by the pharmacist-in-charge; and
(III) have completed documented training concerning their duties associated with the telepharmacy pharmacy system.
(v) Remote sites shall have adequate security and procedures to:
(I) comply with federal and state laws and regulations; and
(II) maintain patient confidentiality.
(vi) The provider pharmacy shall have procedures that specify that drugs may only be delivered to the remote site by the provider pharmacy and shall:
(I) be shipped in a sealed container with a list of drugs delivered;
(II) signed for on receipt by an employee of the healthcare facility;
(III) be quarantined in a locked area, if personnel designated to receive the drugs by the pharmacist-in-charge is not available; and
(IV) be checked by personnel designated by the pharmacist-in-charge to verify that drugs sent by the provider pharmacy were actually received. The designated person who checks the order shall document the verification by signing and dating the list of drugs delivered.
(D) Prescription dispensing and delivery.
(i) Drugs shall only be dispensed at the remote site through a telepharmacy system after receipt of an original prescription drug order by a pharmacist at the provider pharmacy in the manner authorized by §291.34(b) of this title.
(ii) Drugs may be dispensed by the provider pharmacy through a telepharmacy system at a remote site only in unit-of-use containers that are:
(I) prepackaged in suitable containers at the provider pharmacy and appropriately labeled as specified in §291.33(c)(4) of this title; or
(II) in original manufacturer's containers.
(iii) The following duties shall be performed only by a pharmacist at the provider pharmacy:
(I) receiving an oral prescription drug order;
(II) interpret the prescription drug order;
(III) verify the accuracy of prescription data entry;
(IV) select the drug product;
(V) interpret the patient's medication record and conduct a drug regimen review as specified in clause (iv) of this subparagraph;
(VI) authorize the telepharmacy system to print a prescription label at the remote site as specified in clause (v) of this subparagraph;
(VII) perform the final check of the dispensed prescription as specified in clause (vi) of this subparagraph to ensure that the prescription drug order has been dispensed accurately as prescribed;
(VIII) counsel the patient as specified clause (vii) of this subparagraph.
(iv) A pharmacist at the provider pharmacy shall conduct a drug regimen review as specified in §291.33(c) of this title prior to delivery of the dispensed prescription to the patient or patient's agent.
(v) The dispensed prescription shall be labeled at the remote site with the information specified in §291.33(c) of this title except that:
(I) the label shall contain both the name, address, and phone number of the provider pharmacy and the name and address of the remote site; and
(II) the unique identification number of the prescription on the label shall in some manner identify the remote site which dispensed the prescription using a telepharmacy system.
(vi) A pharmacist at the provider pharmacy shall perform the final check of the dispensed prescription before delivery to the patient to ensure that the prescription has been dispensed accurately as prescribed. This final check shall be accomplished through a visual check using electronic methods.
(vii) A pharmacist at the provider pharmacy shall counsel the patient or patient's agent as specified in §291.33(c) of this title. This counseling may be performed using electronic methods. Non-pharmacist personnel may not ask questions of a patient or patient's agent which are intended to screen and/or limit interaction with the pharmacist.
(viii) If the remote site has direct access to the provider pharmacy's data processing system, only a pharmacist, pharmacy technician, or pharmacy technician trainee may enter prescription information into the data processing system. The original prescription shall be sent to the provider pharmacy and a pharmacist shall verify the accuracy of the data entry.
(ix) Drugs which require reconstitution through the addition of a specified amount of water may be dispensed by the remote site only if a pharmacy technician, pharmacy technician trainee, or licensed healthcare provider reconstitutes the product.
(E) Quality assurance program. A pharmacy that provides pharmacy services through a telepharmacy system at a remote site shall operate according to a written program for quality assurance of the telepharmacy system which:
(i) requires continuous supervision of the telepharmacy system at all times the site is open to provide pharmacy services; and
(ii) establishes mechanisms and procedures to routinely test the operation of the telepharmacy system at a minimum of every six months and whenever any upgrade or change is made to the system and documents each such activity.
(F) Policies and procedures.
(i) A pharmacy that provides pharmacy services through a telepharmacy system at a remote site shall operate according to written policies and procedures. The policy and procedure manual shall include, but not be limited to, the following:
(I) a current list of the name and address of the pharmacist-in-charge and personnel designated by the pharmacist-in-charge to have:
(-a-) have access to the area where drugs are stored at the remote site; and
(-b-) operate the telepharmacy system;
(II) duties which may only be performed by a pharmacist;
(III) a copy of the written contact or agreement between the provider pharmacy and the healthcare facility which outlines the services to be provided and the responsibilities and accountabilities of each party in fulfilling the terms of the contract or agreement in compliance with federal and state laws and regulations;
(IV) date of last review/revision of policy and procedure manual; and
(V) policies and procedures for:
(-a-) security;
(-b-) operation of the telepharmacy system;
(-c-) sanitation;
(-d-) storage of drugs;
(-e-) dispensing;
(-f-) supervision;
(-g-) drug and/or device procurement;
(-h-) receiving of drugs and/or devices;
(-i-) delivery of drugs and/or devices; and
(-j-) recordkeeping.
(ii) A pharmacy that provides pharmacy services through a telepharmacy system at a remote site shall, at least annually, review its written policies and procedures, revise them if necessary, and document the review.
(iii) A pharmacy providing remote pharmacy services through a telepharmacy system shall maintain a written plan for recovery from an event which interrupts the ability of a pharmacist to electronically supervise the telepharmacy system and the dispensing of prescription drugs at the remote site. The written plan for recovery shall include:
(I) a statement that prescription drugs shall not be dispensed at the remote site, if a pharmacists is not able to electronically supervise the telepharmacy system and the dispensing of prescription drugs;
(II) procedures for response when a telepharmacy system is experiencing downtime; and
(III) procedures for the maintenance and testing of the written plan for recovery.
(5) Records.
(A) Maintenance of records.
(i) Every record required under this section must be:
(I) kept by the provider pharmacy and be available, for at least two years for inspecting and copying by the board or its representative and to other authorized local, state, or federal law enforcement agencies; and
(II) supplied by the provider pharmacy within 72 hours, if requested by an authorized agent of the Texas State Board of Pharmacy. If the pharmacy maintains the records in an electronic format, the requested records must be provided in an electronic format if specifically requested by the board or its representative. Failure to provide the records set out in this section, either on site or within 72 hours, constitutes prima facie evidence of failure to keep and maintain records in violation of the Act.
(ii) The provider pharmacy shall maintain original prescription drug orders for medications dispensed from a remote site using a telepharmacy system in the manner required by §291.34(b) of this title.
(iii) If prescription drug records are maintained in a data processing system, the system shall have a workable (electronic) data retention system which can produce a separate audit trail of drug usage by the provider pharmacy and by each remote site for the preceding two years as specified in §291.34(e) of this title.
(B) Prescriptions. Prescription drug orders shall meet the requirements of §291.34(b) of this title.
(C) Patient medication records. Patient medication records shall be created and maintained at the provider pharmacy in the manner required by §291.34(c) of this title.
(D) Inventory.
(i) A provider pharmacy shall:
(I) keep a record of all drugs sent to and returned from a remote site separate from the records of the provider pharmacy and from any other remote site's records;
(II) keep a perpetual inventory of controlled substances and other drugs required to be inventoried under §291.17 of this title, that are received and dispensed or distributed from each remote site.
(ii) As specified in §291.17 of this title. A provider pharmacy shall conduct an inventory at each remote site. The following is applicable to this inventory.
(I) The inventory of each remote site and the provider pharmacy shall be taken on the same day.
(II) The inventory of each remote site shall be included with, but listed separately from, the drugs of other remote sites and separately from the drugs at the provider pharmacy.
§291.123.Central Prescription Drug or Medication Order Processing.
(a) Purpose.
(1) The purpose of this section is to provide standards for centralized prescription drug or medication order processing by a Class A (Community), Class C (Institutional), or Class E (Non-Resident) pharmacy.
(2) Any facility established for the purpose of processing prescription drug or medication drug orders shall be licensed as a Class A, Class C, or Class E pharmacy under the Act. However, nothing in this subsection shall prohibit an individual pharmacist employee who is licensed in Texas from remotely accessing the pharmacy's electronic data base from outside the pharmacy in order to process prescription or medication drug orders, provided the pharmacy establishes controls to protect the privacy and security of confidential records.
(b) Definitions. The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise. Any term not defined in this section shall have the definition set out in the Act. Centralized prescription drug or medication order processing--the processing of a prescription drug or medication orders by a Class A, Class C, or Class E pharmacy on behalf of another pharmacy, a health care provider, or a payor. Centralized prescription drug or medication order processing does not include the dispensing of a prescription drug order but includes any of the following:
(1) receiving, interpreting, or clarifying prescription drug or medication drug orders;
(2) data entering and transferring of prescription drug or medication order information;
(3) performing drug regimen review;
(4) obtaining refill and substitution authorizations;
(5) interpreting clinical data for prior authorization for dispensing;
(6) performing therapeutic interventions; and
(7) providing drug information concerning a patient's prescription.
(c) Operational Standards.
(1) General requirements.
(A) A Class A, Class C, or Class E Pharmacy may outsource prescription drug or medication order processing to another Class A, Class C, or Class E pharmacy provided the pharmacies:
(i) have:
(I) the same owner; or
(II) entered into a written contract or agreement which outlines the services to be provided and the responsibilities and accountabilities of each pharmacy in compliance with federal and state laws and regulations; and
(ii) share a common electronic file or have appropriate technology to allow access to sufficient information necessary or required to process a non-dispensing function.
(B) A pharmacy that performs centralized prescription drug or medication order processing shall comply with the provisions applicable to the class of pharmacy contained in either §§291.31 - 291.35 of this title (relating to Definitions, Personnel, Operational Standards, Records, and Official Prescription Requirements in Class A (Community) Pharmacies), or §§291.72 - 291.75 of this title (relating to Definitions, Personnel, Operational Standards, and Records in a Class C (Institutional) Pharmacy), or §§291.102 - 291.105 of this title (relating to Definitions, Personnel, Operational Standards, and Records in a Class E (Non-Resident) Pharmacy) to the extent applicable for the specific processing activity and this section including:
(i) duties which must be performed by a pharmacist; and
(ii) supervision requirements for pharmacy technicians and pharmacy technician trainees.
(2) Notifications to patients.
(A) A pharmacy that outsources prescription drug or medication order processing to another pharmacy shall prior to outsourcing their prescription:
(i) notify patients that prescription processing may be outsourced to another pharmacy; and
(ii) give the name of that pharmacy; or if the pharmacy is part of a network of pharmacies under common ownership and any of the network pharmacies may process the prescription, the patient shall be notified of this fact. Such notification may be provided through a one-time written notice to the patient or through use of a sign in the pharmacy.
(B) The provisions of this paragraph do not apply to patients in facilities where drugs are administered to patients by a person required to do so by the laws of the state (i.e., hospitals or nursing homes).
(3) Policy and Procedures. A policy and procedure manual as it relates to central processing shall be maintained at all pharmacies involved in central processing and be available for inspection. Each pharmacy is required to maintain only those portions of the policy and procedure manual that relate to that pharmacy's operations. The manual shall:
(A) outline the responsibilities of each of the pharmacies;
(B) include a list of the name, address, telephone numbers, and all license/registration numbers of the pharmacies involved in centralized prescription drug or medication order processing; and
(C) include policies and procedures for:
(i) protecting the confidentiality and integrity of patient information;
(ii) maintenance of appropriate records to identify the name(s), initials, or identification code(s) and specific activity(ies) of each pharmacist or pharmacy technician who performed any processing;
(iii) complying with federal and state laws and regulations;
(iv) operating a continuous quality improvement program for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, and resolve identified problems; and
(v) annually reviewing the written policies and procedures and documenting such review.
(d) Records. All pharmacies shall maintain appropriate records which identify, by prescription drug or medication order, the name(s), initials, or identification code(s) of each pharmacist, pharmacy technician, or pharmacy technician trainee who performs a processing function for a prescription drug or medication order. Such records may be maintained:
(1) separately by each pharmacy and pharmacist; or
(2) in a common electronic file as long as the records are maintained in such a manner that the data processing system can produce a printout which lists the functions performed by each pharmacy and pharmacist.
§291.125.Centralized Prescription Dispensing.
(a) Purpose. The purpose of this section is to provide standards for centralized prescription dispensing by a Class A (Community), Class C (Institutional) pharmacy, or Class E (Non-Resident) Pharmacy.
(b) Definitions. The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise. Any term not defined in this section shall have the definition set out in the Act. Centralized prescription dispensing--the dispensing or refilling of a prescription drug order by a Class A (Community), Class C (Institutional), or Class E (Non-Resident) pharmacy at the request of another Class A (Community), or Class C (Institutional) and the return of the dispensed prescriptions to the requesting pharmacy for delivery to the patient or patient's agent, or at the request of the requesting pharmacy, direct delivery to the patient.
(c) Operational standards.
(1) General requirements.
(A) A Class A (Community) or Class C (Institutional) pharmacy may outsource prescription drug order dispensing to another Class A (Community), Class C (Institutional), or Class E (Non-Resident) pharmacy provided the pharmacies:
(i) have:
(I) the same owner; or
(II) entered into a written contract or agreement which outlines the services to be provided and the responsibilities and accountabilities of each pharmacy in compliance with federal and state laws and regulations; and
(ii) share a common electronic file or have appropriate technology to allow access to sufficient information necessary or required to dispense or process a prescription drug order.
(B) The pharmacist-in-charge of the dispensing pharmacy shall ensure that:
(i) the pharmacy maintains and uses adequate storage or shipment containers and shipping processes to ensure drug stability and potency. Such shipping processes shall include the use of appropriate packaging material and/or devices to ensure that the drug is maintained at an appropriate temperature range to maintain the integrity of the medication throughout the delivery process; and
(ii) the dispensed prescriptions are shipped in containers which are sealed in a manner as to show evidence of opening or tampering.
(C) A Class A (Community) or Class C (Institutional) dispensing pharmacy shall comply with the provisions of §§291.31 - 291.35 of this title (relating to Definitions, Personnel, Operational Standards, Records, and Official Prescription Requirements in Class A (Community) Pharmacies) and this section.
(D) A Class E (Non-Resident) dispensing pharmacy shall comply with §§291.101 - 291.105 of this title (relating to Purpose, Definitions, Personnel, Operational Standards, and Records in Class E (Non-Resident) Pharmacies) and this section.
(E) Pharmacies dispensing compounded non-sterile or sterile preparations shall comply with the provisions of §291.131 of this title (relating to Pharmacies Compounding Non-Sterile Preparations) and §291.133 of this title (relating to Pharmacies Compounding Sterile Preparations).
(2) Notifications to patients.
(A) A pharmacy that outsources prescription dispensing to another pharmacy shall:
(i) prior to outsourcing the prescription:
(I) notify patients that their prescription may be outsourced to another pharmacy; and
(II) give the name of that pharmacy or if the pharmacy is part of a network of pharmacies under common ownership and any of the network pharmacies may dispense the prescription, the patient shall be notified of this fact. Such notification may be provided through a one-time written notice to the patient or through use of a sign in the pharmacy; and
(ii) if the prescription is delivered directly to the patient by the dispensing pharmacy and not returned to the requesting pharmacy, place on the prescription container or on a separate sheet delivered with the prescription container, in both English and Spanish, the local, and if applicable, the toll-free telephone number of the pharmacy and the statement: "Written information about this prescription has been provided for you. Please read this information before you take the medication. If you have questions concerning this prescription, a pharmacist is available during normal business hours to answer these questions at (insert the pharmacy's local and toll-free telephone numbers)."
(B) The provisions of this paragraph do not apply to patients in facilities where drugs are administered to patients by a person required to do so by the laws of the state (i.e., hospitals or nursing homes).
(3) Prescription Labeling. The dispensing pharmacy shall:
(A) place on the prescription label, the name and address or name and pharmacy license number of the pharmacy dispensing the prescription and the name and address of the pharmacy which receives the dispensed prescription;
(B) indicate in some manner which pharmacy dispensed the prescription (e.g., "Filled by ABC Pharmacy for XYZ Pharmacy"); and
(C) comply with all other labeling requirements in §291.33 of this title.
(4) Policies and Procedures. A policy and procedure manual as it relates to centralized dispensing shall be maintained at both pharmacies and be available for inspection. Each pharmacy is required to maintain only those portions of the policy and procedure manual that relate to that pharmacy's operations. The manual shall:
(A) outline the responsibilities of each of the pharmacies;
(B) include a list of the name, address, telephone numbers, and all license/registration numbers of the pharmacies involved in centralized prescription dispensing; and
(C) include policies and procedures for:
(i) notifying patients that their prescription may be outsourced to another pharmacy for centralized prescription dispensing and providing the name of that pharmacy;
(ii) protecting the confidentiality and integrity of patient information;
(iii) dispensing prescription drug orders when the filled order is not received or the patient comes in before the order is received;
(iv) complying with federal and state laws and regulations;
(v) operating a continuous quality improvement program for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, and resolve identified problems; and
(vi) annually reviewing the written policies and procedures and documenting such review.
(d) Records.
(1) Records may be maintained in an alternative data retention system, such as a data processing system or direct imaging system provided:
(A) the records maintained in the alternative system contain all of the information required on the manual record; and
(B) the data processing system is capable of producing a hard copy of the record upon the request of the board, its representative, or other authorized local, state, or federal law enforcement or regulatory agencies.
(2) Each pharmacy shall comply with all the laws and rules relating to the maintenance of records and be able to produce an audit trail showing all prescriptions dispensed by the pharmacy.
(3) The requesting pharmacy shall maintain records which indicate the date:
(A) the request for dispensing was transmitted to the dispensing pharmacy; and
(B) the dispensed prescription was received by the requesting pharmacy, including the method of delivery (e.g., private, common, or contract carrier) and the name of the person accepting delivery.
(4) The dispensing pharmacy shall maintain records which indicate:
(A) the date the prescription was shipped to the requesting pharmacy;
(B) the name and address where the prescription was shipped; and
(C) the method of delivery (e.g., private, common, or contract carrier).
§291.127.Emergency Remote Pharmacy License.
(a) Definitions. The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise. All other words and terms shall have the meanings defined in the Act.
(1) Emergency remote pharmacy--A pharmacy not located at the same Texas location as a home pharmacy at which pharmacy services are provided during an emergency situation.
(2) Emergency situation--An emergency caused by a natural or manmade disaster or any other exceptional situation that causes an extraordinary demand for pharmacy services.
(3) Home pharmacy--A currently licensed Class A (Community), Class C (Institutional), or Class D (Clinic) pharmacy that is providing emergency pharmacy services through an emergency remote pharmacy.
(b) Emergency remote pharmacy license. In an emergency situation, the board may grant a holder of a Class A (Community), Class C (Institutional), or Class D (Clinic) pharmacy license, the authority to operate a pharmacy and provide pharmacy services at an alternate location. The following is applicable for the emergency remote pharmacy.
(1) The emergency remote pharmacy will not be issued a separate pharmacy license, but shall operate under the license of the home pharmacy. To qualify for an emergency remote pharmacy license, the applicant must submit an application including the following information:
(A) license number, name, address, and phone number of the home pharmacy;
(B) name, address, and phone number of the emergency remote pharmacy;
(C) name and Texas pharmacist license number of the pharmacist-in-charge of the home pharmacy and of the pharmacist-in-charge of the emergency remote pharmacy; and
(D) any other information required by the board.
(2) The board will notify the home pharmacy of the approval of an emergency remote pharmacy license.
(3) The emergency remote pharmacy license shall be valid for a period as determined by the board not to exceed six months. The executive director of the board, in his/her discretion, may renew the remote license for an additional six months, if the emergency situation still exists and the holder of the license shows good cause for emergency remote pharmacy to continue operation.
(4) The emergency remote pharmacy shall have a written contract or agreement with the home pharmacy which outlines the services to be provided and the responsibilities and accountabilities of the remote and home pharmacy in fulfilling the terms of the contract or agreement in compliance with federal and state laws and regulations.
(5) The home pharmacy shall designate a pharmacist to serve as the pharmacist-in-charge of the emergency remote pharmacy.
(6) The emergency remote pharmacy shall comply with the rules for the class of pharmacy under which the home pharmacy is licensed. A Class A pharmacy shall comply with the rules under Subchapter B of this chapter titled Community Pharmacy (Class A). A Class C pharmacy shall comply with the rules under Subchapter D of this chapter titled Institutional Pharmacy (Class C). A Class D pharmacy shall comply with the rules under Subchapter E of this chapter titled Clinic Pharmacy (Class D).
(7) The records of services provided at the emergency remote pharmacy shall be:
(A) kept by the home pharmacy and be available, for at least two years from the date of provision of the service, for inspecting and copying by the board or its representative and to other authorized local, state, or federal law enforcement agencies; and
(B) supplied by the pharmacy within 72 hours, if requested by an authorized agent of the Texas State Board of Pharmacy. If the pharmacy maintains the records in an electronic format, the requested records must be provided in an electronic format if specifically requested by the board or its representative. Failure to provide the records set out in this section, either on site or within 72 hours, constitutes prima facie evidence of failure to keep and maintain records in violation of the Act.
§291.129.Satellite Pharmacy.
(a) Purpose. The purpose of this section is to create a new class of pharmacy for the provision of pharmacy services by a Class A or Class C pharmacy in a location that is not at the same location as a Class A or Class C pharmacy through a satellite pharmacy and to provide standards for the operation of this class of pharmacy established under §560.053 of the Texas Pharmacy Act.
(b) Definitions. The following words and terms, when used in the section, shall have the following meanings, unless the context clearly indicates otherwise. All other words and terms shall have the meanings defined in the Act or §291.31 of this title.
(1) Provider pharmacy--The Class A or Class C pharmacy providing satellite pharmacy services.
(2) Satellite pharmacy--A facility not located at the same location as a Class A or Class C pharmacy at which satellite pharmacy services are provided.
(3) Satellite pharmacy services--The provision of pharmacy services, including the storage and delivery of prescription drugs, in an alternate location.
(c) General requirements.
(1) A Class A or Class C provider pharmacy may establish a satellite pharmacy in a location that is not at the same location as a Class A or Class C pharmacy.
(2) The pharmacist-in-charge of the provider pharmacy is responsible for all pharmacy operations involving the satellite pharmacy including supervision of satellite pharmacy personnel and compliance with this section.
(3) A satellite pharmacy may not store bulk drugs and may only store prescription medications that have been previously verified and dispensed by the provider pharmacy.
(4) A Class C pharmacy that is a provider pharmacy dispensing outpatient prescriptions for a satellite pharmacy shall comply with the provisions of §§291.31 - 291.34 of this title (relating to Definitions, Personnel, Operational Standards, and Records for Class A (Community) pharmacies) and this section.
(5) The provider pharmacy and the satellite pharmacy must have:
(A) the same owner; and
(B) share a common electronic file or have appropriate technology to allow access to sufficient information necessary or required to process a non-dispensing function.
(d) Personnel.
(1) All individuals working at the satellite pharmacy shall be employees of the provider pharmacy and must report their employment to the board as such.
(2) A satellite pharmacy shall have sufficient pharmacists on duty to operate the satellite pharmacy competently, safely, and adequately to meet the needs of the patients of the pharmacy.
(3) Pharmacists are solely responsible for the direct supervision of pharmacy technicians and pharmacy technician trainees and for designating and delegating duties, other than those listed in paragraph (7) of this subsection, to pharmacy technicians and pharmacy technician trainees. Each pharmacist:
(A) shall verify the accuracy of all acts, tasks, and functions performed by pharmacy technicians and pharmacy technician trainees; and
(B) shall be responsible for any delegated act performed by pharmacy technicians and pharmacy technician trainees under his or her supervision.
(4) A pharmacist shall be physically present to directly supervise a pharmacy technician or pharmacy technician trainee who is entering prescription data into the data processing system. Each prescription entered into the data processing system shall be verified at the time of data entry.
(5) All pharmacists while on duty, shall be responsible for complying with all state and federal laws or rules governing the practice of pharmacy.
(6) A pharmacist shall ensure that the drug is dispensed and delivered safely and accurately as prescribed. A pharmacist shall ensure the safety and accuracy of the portion of the process the pharmacist is performing.
(7) Duties, in a satellite pharmacy, that may only be performed by a pharmacist are as follows:
(A) receiving oral prescription drug orders and reducing these orders to writing, either manually or electronically;
(B) interpreting or clarifying prescription drug orders;
(C) communicating to the patient or patient's agent information about the prescription drug or device which in the exercise of the pharmacist's professional judgment, the pharmacist deems significant, as specified in §291.33(c) of this title;
(D) communicating to the patient or the patient's agent on his or her request information concerning any prescription drugs dispensed to the patient by the pharmacy;
(E) assuring that a reasonable effort is made to obtain, record, and maintain patient medication records;
(F) interpreting patient medication records and performing drug regimen reviews; and
(G) performing a specific act of drug therapy management for a patient delegated to a pharmacist by a written protocol from a physician licensed in this state in compliance with the Medical Practice Act.
(8) Pharmacy technicians and pharmacy technician trainees may not perform any of the duties listed in paragraph (7) of this subsection. However, a pharmacist may delegate to pharmacy technicians and pharmacy technician trainees any nonjudgmental technical duty associated with the preparation and distribution of prescription drugs provided:
(A) a pharmacist verifies the accuracy of all acts, tasks, and functions performed by pharmacy technicians and pharmacy technician trainees; and
(B) pharmacy technicians and pharmacy technician trainees are under the direct supervision of and responsible to a pharmacist.
(9) Pharmacy technicians and pharmacy technician trainees, in a satellite pharmacy, may perform only nonjudgmental technical duties associated with the preparation and distribution of prescription drugs as follows:
(A) initiating and receiving refill authorization requests;
(B) entering prescription data into a data processing system; and
(C) reconstituting medications.
(10) In a satellite pharmacy, the ratio of pharmacists to pharmacy technicians/pharmacy technician trainees may be 1:3, provided at least one of the three is a pharmacy technician and not a pharmacy technician trainee.
(11) All satellite pharmacy personnel shall wear identification tags or badges that bears the person's name and identifies him or her as a pharmacist, pharmacist intern, pharmacy technician, or pharmacy technician trainee.
(e) Operational requirements.
(1) Application for permission to provide satellite pharmacy services.
(A) A Class A or Class C pharmacy shall make application to the board to provide satellite pharmacy services. The application shall contain an affidavit with the notarized signatures of the pharmacist-in-charge and the person responsible for the on-site operation of the facility where the satellite pharmacy will be located and include the following:
(i) the name, address, and license number of the provider pharmacy;
(ii) the name and address of the facility where the satellite pharmacy will be located;
(iii) anticipated date of opening and hours of operation; and
(iv) copy of the lease agreement or alternatively, a notarized statement signed by the lessee and lessor certifying the existence of a lease.
(B) Such application shall be resubmitted every two years in conjunction with the application for renewal of the provider pharmacy's license. The renewal petition shall contain the documentation required in subparagraph (A) of this paragraph except the notarized signature of the person responsible for the on-site operation of the facility where the satellite pharmacy will be located.
(C) Upon approval of the application, the provider pharmacy will be sent a certificate which must be displayed at the satellite pharmacy.
(2) Notification requirements.
(A) A provider pharmacy shall notify the board in writing within ten days of a change of location, discontinuance of service, or closure of a satellite pharmacy that is operated by the pharmacy.
(B) A provider pharmacy shall comply with appropriate federal and state controlled substance registrations for each satellite pharmacy if controlled substances are maintained at the satellite pharmacy.
(3) Environment.
(A) The satellite pharmacy shall be arranged in an orderly fashion and kept clean. All required equipment shall be clean and in good operating condition.
(B) A satellite pharmacy shall contain an area which is suitable for confidential patient counseling.
(i) Such counseling area shall:
(I) be easily accessible to both patient and pharmacists and not allow patient access to prescription drugs;
(II) be designed to maintain the confidentiality and privacy of the pharmacist/patient communication.
(ii) In determining whether the area is suitable for confidential patient counseling and designed to maintain the confidentiality and privacy of the pharmacist/patient communication, the board may consider factors such as the following:
(I) the proximity of the counseling area to the check-out or cash register area;
(II) the volume of pedestrian traffic in and around the counseling area;
(III) the presence of walls or other barriers between the counseling area and other areas of the pharmacy; and
(IV) any evidence of confidential information being overheard by persons other than the patient or patient's agent or the pharmacist or agents of the pharmacist.
(C) The satellite pharmacy shall be properly lighted and ventilated.
(D) The temperature of the satellite pharmacy shall be maintained within a range compatible with the proper storage of drugs in compliance with the provisions of §291.33(f) of this title including the requirements for temperature. The temperature of the refrigerator shall be maintained within a range compatible with the proper storage of drugs requiring refrigeration.
(E) Animals, including birds and reptiles, shall not be kept within the pharmacy and in immediately adjacent areas under the control of the pharmacy. This provision does not apply to fish in aquariums, guide dogs accompanying disabled persons, or animals for sale to the general public in a separate area that is inspected by local health jurisdictions.
(4) Security.
(A) A satellite pharmacy shall be under the continuous, physically present supervision of a pharmacist at all times the satellite pharmacy is open to provide pharmacy services.
(B) The satellite pharmacy shall be enclosed by walls, partitions or other means of floor-to-ceiling enclosure. In addition, to the security requirements outlined in §291.33(b)(2) of this title, satellite pharmacies shall have adequate security and procedures to
(i) prohibit unauthorized access;
(ii) comply with federal and state regulations; and
(iii) maintain patient confidentiality.
(C) Access to the satellite pharmacy shall be limited to pharmacists, pharmacy technicians, and pharmacy technician trainees employed by the provider pharmacy and who are designated in writing by the pharmacist-in-charge.
(D) The provider pharmacy shall have procedures that specify that prescriptions may only be delivered to the satellite pharmacy by the provider pharmacy and shall:
(i) be delivered in a sealed container with a list of the prescriptions delivered;
(ii) signed for on receipt by the pharmacist at the satellite pharmacy;
(iii) be checked by personnel designated by the pharmacist-in-charge to verify that the prescriptions sent by the provider pharmacy were actually received. The designated person who checks the order shall document the verification by signing and dating the list of prescriptions delivered.
(5) Prescription dispensing and delivery. A satellite pharmacy shall comply with the requirements outlines in §291.33(c) of this title with regard to prescription dispensing and delivery.
(6) Equipment and supplies. A satellite pharmacy shall have the following equipment and supplies:
(A) typewriter or comparable equipment;
(B) refrigerator, if storing drugs requiring refrigeration;
(C) metric-apothecary weight and measure conversion charts.
(7) Library. A reference library shall be maintained by the satellite pharmacy that includes the following in hard-copy or electronic format:
(A) current copies of the following:
(i) Texas Pharmacy Act and rules;
(ii) Texas Dangerous Drug Act and rules;
(iii) Texas Controlled Substances Act and rules; and
(iv) Federal Controlled Substances Act and rules (or official publication describing the requirements of the Federal Controlled Substances Act and rules);
(B) at least one current or updated reference from each of the following categories:
(i) patient information:
(I) United States Pharmacopeia Dispensing Information, Volume II (Advice to the Patient); or
(II) a reference text or information leaflets which provide patient information;
(ii) drug interactions: a reference text on drug interactions, such as Drug Interaction Facts. A separate reference is not required if other references maintained by the pharmacy contain drug interaction information including information needed to determine severity or significance of the interaction and appropriate recommendations or actions to be taken;
(iii) a general information reference text, such as:
(I) Facts and Comparisons with current supplements;
(II) United States Pharmacopeia Dispensing Information Volume I (Drug Information for the Healthcare Provider);
(III) Clinical Pharmacology;
(IV) American Hospital Formulary Service with current supplements; or
(V) Remington's Pharmaceutical Sciences; and
(C) basic antidote information and the telephone number of the nearest Regional Poison Control Center.
(f) Records.
(1) Maintenance of records.
(A) Every record required to be kept and §291.34 of this title and under this section shall be;
(i) kept by the provider pharmacy and be available, for at least two years from the date of such inventory or record, for inspecting and copying by the board or its representative and to other authorized local, state, or federal law enforcement agencies; and
(ii) supplied by the provider pharmacy within 72 hours, if requested by an authorized agent of the Texas State Board of Pharmacy. If the pharmacy maintains the records in an electronic format, the requested records must be provided in an electronic format if specifically requested by the board or its representative. Failure to provide the records set out in this section, either on site or within 72 hours, constitutes prima facie evidence of failure to keep and maintain records in violation of the Act.
(B) Records, except when specifically required to be maintained in original or hard-copy form, may be maintained in an alternative data retention system, such as a data processing system or direct imaging system provided:
(i) the records maintained in the alternative system contain all of the information required on the manual record; and
(ii) the data processing system is capable of producing a hard copy of the record upon the request of the board, its representative, or other authorized local, state, or federal law enforcement or regulatory agencies.
(C) Prescription drug orders shall be maintained by the provider pharmacy in the manner required by §291.34(d) or (e) of this title.
(2) Prescriptions.
(A) Prescription drug orders shall meet the requirements of §291.34(b) of this title.
(B) The provider pharmacy must maintain appropriate records to identify the name(s), initials, or identification code(s) and specific activity(ies) of each pharmacist, pharmacy technician, or pharmacy technician trainee who performed any processing at the satellite pharmacy.
(C) A provider pharmacy shall keep a record of all prescriptions sent and returned between the pharmacies separate from the records of the provider pharmacy and from any other satellite pharmacy's records.
(D) A satellite pharmacy shall keep a record of all prescriptions received and returned between the pharmacies.
§291.131.Pharmacies Compounding Non-Sterile Preparations.
(a) Purpose. Pharmacies compounding non-sterile preparations, prepackaging pharmaceutical products and distributing those products shall comply with all requirements for their specific license classification and this section. The purpose of this section is to provide standards for the:
(1) compounding of non-sterile preparations pursuant to a prescription or medication order for a patient from a practitioner in Class A (Community), Class C (Institutional), and Class E (Non-resident) pharmacies;
(2) compounding, dispensing, and delivery of a reasonable quantity of a compounded non-sterile preparation in a Class A (Community), Class C (Institutional) , and Class E (Non-resident) pharmacies to a practitioner's office for office use by the practitioner;
(3) compounding and distribution of compounded non-sterile preparations by a Class A (Community) pharmacy for a Class C (Institutional) pharmacy; and
(4) compounding of non-sterile preparations by a Class C (Institutional) pharmacy and the distribution of the compounded preparations to other Class C (Institutional) pharmacies under common ownership.
(b) Definitions. In addition to the definitions for specific license classifications, the following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise.
(1) Beyond-use date--The date or time after which the compounded non-sterile preparation shall not be stored or transported or begin to be administered to a patient. The beyond-use date is determined from the date or time when the preparation was compounded.
(2) Component--Any ingredient intended for use in the compounding of a drug preparation, including those that may not appear in such preparation.
(3) Compounding--The preparation, mixing, assembling, packaging, or labeling of a drug or device:
(A) as the result of a practitioner's prescription drug or medication order, based on the practitioner-patient-pharmacist relationship in the course of professional practice;
(B) for administration to a patient by a practitioner as the result of a practitioner's initiative based on the practitioner-patient-pharmacist relationship in the course of professional practice;
(C) in anticipation of prescription drug or medication orders based on routine, regularly observed prescribing patterns; or
(D) for or as an incident to research, teaching, or chemical analysis and not for sale or dispensing, except as allowed under Section 562.154 or Chapter 563 of the Occupations Code.
(4) Hot water--The temperature of water from the pharmacy's sink maintained at 120 to 140 degrees F (49 to 60 C).
(5) Reasonable quantity--An amount of a compounded drug that:
(A) does not exceed the amount a practitioner anticipates may be used in the practitioner's office or facility before the beyond use date of the drug;
(B) is reasonable considering the intended use of the compounded drug and the nature of the practitioner's practice; and
(C) for any practitioner and all practitioners as a whole, is not greater than an amount the pharmacy is capable of compounding in compliance with pharmaceutical standards for identity, strength, quality, and purity of the compounded drug that are consistent with United States Pharmacopoeia guidelines and accreditation practices.
(6) SOPs--Standard operating procedures.
(7) USP/NF--The current edition of the United States Pharmacopeia/National Formulary.
(c) Personnel.
(1) Pharmacist-in-charge. In addition to the responsibilities for the specific class of pharmacy, the pharmacist-in-charge shall have the responsibility for, at a minimum, the following concerning non-sterile compounding:
(A) determining that all personnel involved in non-sterile compounding possess the education, training, and proficiency necessary to properly and safely perform compounding duties undertaken or supervised;
(B) determining that all personnel involved in non-sterile compounding obtain continuing education appropriate for the type of compounding done by the personnel;
(C) assuring that the equipment used in compounding is properly maintained;
(D) maintaining an appropriate environment in areas where non-sterile compounding occurs; and
(E) assuring that effective quality control procedures are developed and followed.
(2) Pharmacists. Special requirements for non-sterile compounding.
(A) All pharmacists engaged in compounding shall:
(i) possess the education, training, and proficiency necessary to properly and safely perform compounding duties undertaken or supervised; and
(ii) obtain continuing education appropriate for the type of compounding done by the pharmacist.
(B) A pharmacist shall inspect and approve all components, drug product containers, closures, labeling, and any other materials involved in the compounding process.
(C) A pharmacist shall review all compounding records for accuracy and conduct in-process and final checks to ensure that errors have not occurred in the compounding process.
(D) A pharmacist is responsible for the proper maintenance, cleanliness, and use of all equipment used in the compounding process.
(3) Pharmacy technicians and pharmacy technician trainees. All pharmacy technicians and pharmacy technician trainees engaged in non-sterile compounding shall:
(A) possess the education, training, and proficiency necessary to properly and safely perform compounding duties undertaken;
(B) obtain continuing education appropriate for the type of compounding done by the pharmacy technician or pharmacy technician trainee; and
(C) perform compounding duties under the direct supervision of and responsible to a pharmacist.
(4) Training.
(A) All training activities shall be documented and covered by appropriate SOPs as outlined in subsection (d)(8)(A) of this section.
(B) All personnel involved in non-sterile compounding shall be well trained and must participate in continuing relevant training programs.
(d) Operational Standards.
(1) General requirements.
(A) Non-sterile drug preparations may be compounded in licensed pharmacies:
(i) upon presentation of a practitioner's prescription drug or medication order based on a valid pharmacist/patient/prescriber relationship;
(ii) in anticipation of future prescription drug or medication orders based on routine, regularly observed prescribing patterns; or
(iii) in reasonable quantities for office use by a practitioner and for use by a veterinarian.
(B) Non-sterile compounding in anticipation of future prescription drug or medication orders must be based upon a history of receiving valid prescriptions issued within an established pharmacist/patient/prescriber relationship, provided that in the pharmacist's professional judgment the quantity prepared is stable for the anticipated shelf time.
(i) The pharmacist's professional judgment shall be based on the criteria used to determine a beyond-use date outlined in paragraph (5)(C) of this subsection.
(ii) Documentation of the criteria used to determine the stability for the anticipated shelf time must be maintained and be available for inspection.
(iii) Any preparation compounded in anticipation of future prescription drug or medication orders shall be labeled. Such label shall contain:
(I) name and strength of the compounded preparation or list of the active ingredients and strengths;
(II) facility's lot number;
(III) beyond-use date as determined by the pharmacist using appropriate documented criteria as outlined in paragraph (5)(C) of this subsection; and
(IV) quantity or amount in the container.
(C) Commercially available products may be compounded for dispensing to individual patients provided the following conditions are met:
(i) the commercial product is not reasonably available from normal distribution channels in a timely manner to meet patient's needs;
(ii) the pharmacy maintains documentation that the product is not reasonably available due to a drug shortage or unavailability from the manufacturer; and
(iii) the prescribing practitioner has requested that the drug be compounded as described in subparagraph (D) of this paragraph.
(D) A pharmacy may not compound preparations that are essentially copies of commercially available products (e.g., the preparation is dispensed in a strength that is only slightly different from a commercially available product) unless the prescribing practitioner specifically orders the strength or dosage form and specifies why the patient needs the particular strength or dosage form of the preparation. The prescribing practitioner shall provide documentation of a patient specific medical need and the preparation produces a clinically significant therapeutic response (e.g. the physician requests an alternate product due to hypersensitivity to excipients or preservative in the FDA-approved product, or the physician requests an effective alternate dosage form) or if the drug product is not commercially available. The unavailability of such drug product must be documented prior to compounding. The methodology for documenting unavailability includes maintaining a copy of the wholesaler's notification showing back-ordered, discontinued, or out-of-stock items. This documentation must be available in hard-copy or electronic format for inspection by the Board.
(E) A pharmacy may enter into an agreement to compound and dispense prescription/medication orders for another pharmacy provided the pharmacy complies with the provisions of §291.125 of this title (relating to Centralized Prescription Dispensing).
(F) Compounding pharmacies/pharmacists may advertise and promote the fact that they provide non-sterile prescription compounding services, which may include specific drug products and classes of drugs.
(G) A pharmacy may not compound veterinary preparations for use in food producing animals except in accordance with federal guidelines.
(2) Library. In addition to the library requirements of the pharmacy's specific license classification, a pharmacy shall maintain a current copy, in hard-copy or electronic format, of Chapter 795 of the USP/NF concerning Pharmacy Compounding Non-Sterile Preparations.
(3) Environment.
(A) Pharmacies regularly engaging in compounding shall have a designated and adequate area for the safe and orderly compounding of non-sterile preparations, including the placement of equipment and materials. Pharmacies involved in occasional compounding shall prepare an area prior to each compounding activity which is adequate for safe and orderly compounding.
(B) Only personnel authorized by the responsible pharmacist shall be in the immediate vicinity of a drug compounding operation.
(C) A sink with hot and cold running water, exclusive of rest room facilities, shall be accessible to the compounding areas and be maintained in a sanitary condition. Supplies necessary for adequate washing shall be accessible in the immediate area of the sink and include:
(i) soap or detergent; and
(ii) air-driers or single-use towels.
(D) If drug products which require special precautions to prevent contamination, such as penicillin, are involved in a compounding operation, appropriate measures, including dedication of equipment for such operations or the meticulous cleaning of contaminated equipment prior to its use for the preparation of other drug products, must be used in order to prevent cross-contamination.
(4) Equipment and Supplies. The pharmacy shall:
(A) have a Class A prescription balance, or analytical balance and weights which shall be properly maintained and subject to periodic inspection by the Texas State Board of Pharmacy; and
(B) have equipment and utensils necessary for the proper compounding of prescription drug or medication orders. Such equipment and utensils used in the compounding process shall be:
(i) of appropriate design and capacity, and be operated within designed operational limits;
(ii) of suitable composition so that surfaces that contact components, in-process material, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the desired result;
(iii) cleaned and sanitized immediately prior and after to each use; and
(iv) routinely inspected, calibrated (if necessary), or checked to ensure proper performance.
(5) Labeling. In addition to the labeling requirements of the pharmacy's specific license classification, the label dispensed or distributed pursuant to a prescription drug or medication order shall contain the following.
(A) The generic name(s) or the official name(s) of the principal active ingredient(s) of the compounded preparation.
(B) A statement that the preparation has been compounded by the pharmacy. (An auxiliary label may be used on the container to meet this requirement).
(C) A beyond-use date after which the compounded preparation should not be used. The beyond-use date shall be determined as outlined in Chapter 795 of the USP/NF concerning Pharmacy Compounding Non-Sterile Preparations including the following:
(i) The pharmacist shall consider:
(I) physical and chemical properties of active ingredients;
(II) use of preservatives and/or stabilizing agents;
(III) dosage form;
(IV) storage containers and conditions; and
(V) scientific, laboratory, or reference data from a peer reviewed source and retained in the pharmacy. The reference data should follow the same preparation instructions for combining raw materials and packaged in a container with similar properties.
(ii) In the absence of stability information applicable for a specific drug or preparation, the following maximum beyond-use dates are to be used when the compounded preparation is packaged in tight, light-resistant containers and stored at controlled room temperatures.
(I) Nonaqueous liquids and solid formulations (Where the manufactured drug product is the source of active ingredient): 25% of the time remaining until the product's expiration date or 6 months, whichever is earlier.
(II) Water-containing formulations (Prepared from ingredients in solid form): Not later than 14 days when refrigerated between 2 - 8 degrees Celsius (36 - 46 degrees Fahrenheit).
(III) All other formulations: Intended duration of therapy or 30 days, whichever is earlier.
(iii) Beyond-use date limits may be exceeded when supported by valid scientific stability information for the specific compounded preparation.
(6) Written drug information. Written information about the compounded preparation or its major active ingredient(s) shall be given to the patient at the time of dispensing. A statement which indicates that the preparation was compounded by the pharmacy must be included in this written information. If there is no written information available, the patient should be advised that the drug has been compounded and how to contact a pharmacist, and if appropriate the prescriber, concerning the drug.
(7) Drugs, components, and materials used in non-sterile compounding.
(A) Drugs used in non-sterile compounding shall be a USP/NF grade substances manufactured in an FDA-registered facility.
(B) If USP/NF grade substances are not available, or when food, cosmetics, or other substances are, or must be used, the substance shall be of a chemical grade in one of the following categories:
(i) Chemically Pure (CP);
(ii) Analytical Reagent (AR); or
(iii) American Chemical Society (ACS); or
(iv) Food Chemical Codex; or
(C) If a drug, component or material is not purchased from a FDA-registered facility, the pharmacist shall establish purity and stability by obtaining a Certificate of Analysis from the supplier and the pharmacist shall compare the monograph of drugs in a similar class to the Certificate of Analysis.
(D) A manufactured drug product may be a source of active ingredient. Only manufactured drugs from containers labeled with a batch control number and a future expiration date are acceptable as a potential source of active ingredients. When compounding with manufactured drug products, the pharmacist must consider all ingredients present in the drug product relative to the intended use of the compounded preparation.
(E) All components shall be stored in properly labeled containers in a clean, dry area, under proper temperatures.
(F) Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the compounded drug product beyond the desired result.
(G) Components, drug product containers, and closures shall be rotated so that the oldest stock is used first.
(H) Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the compounded drug product.
(I) A pharmacy may not compound a preparation that contains ingredients appearing on a federal Food and Drug Administration list of drug products withdrawn or removed from the market for safety reasons.
(8) Compounding process.
(A) All significant procedures performed in the compounding area shall be covered by written SOPs designed to ensure accountability, accuracy, quality, safety, and uniformity in the compounding process. At a minimum, SOPs shall be developed for:
(i) the facility;
(ii) equipment;
(iii) personnel;
(iv) preparation evaluation;
(v) quality assurance;
(vi) preparation recall;
(vii) packaging; and
(viii) storage of compounded preparations.
(B) Any compounded preparation with an official monograph in the USP/NF shall be compounded, labeled, and packaged in conformity with the USP/NF monograph for the drug.
(C) Any person with an apparent illness or open lesion that may adversely affect the safety or quality of a drug product being compounded shall be excluded from direct contact with components, drug product containers, closures, any materials involved in the compounding process, and drug products until the condition is corrected.
(D) Personnel engaged in the compounding of drug preparations shall wear clean clothing appropriate to the operation being performed. Protective apparel, such as coats/jackets, aprons, hair nets, gowns, hand or arm coverings, or masks shall be worn as necessary to protect personnel from chemical exposure and drug preparations from contamination.
(E) At each step of the compounding process, the pharmacist shall ensure that components used in compounding are accurately weighed, measured, or subdivided as appropriate to conform to the formula being prepared.
(9) Quality Assurance.
(A) Initial formula validation. Prior to routine compounding of a non-sterile preparation, a pharmacy shall conduct an evaluation that shows that the pharmacy is capable of compounding a product that contains the stated amount of active ingredient(s).
(B) Finished preparation checks. The prescription drug and medication orders, written compounding procedure, preparation records, and expended materials used to make compounded non-sterile preparations shall be inspected for accuracy of correct identities and amounts of ingredients, packaging, labeling, and expected physical appearance before the non-sterile preparations are dispensed.
(10) Quality Control.
(A) The pharmacy shall follow established quality control procedures to monitor the quality of compounded drug preparations for uniformity and consistency such as capsule weight variations, adequacy of mixing, clarity, or pH of solutions. When developing these procedures, pharmacy personnel shall consider the provisions of Chapter 795, concerning Pharmacy Compounding Non-Sterile Preparations, Chapter 1075, concerning Good Compounding Practices, and Chapter 1160, concerning Pharmaceutical Calculations in Prescription Compounding contained in the current USP/NF. Such procedures shall be documented and be available for inspection.
(B) Compounding procedures that are routinely performed, including batch compounding, shall be completed and verified according to written procedures. The act of verification of a compounding procedure involves checking to ensure that calculations, weighing and measuring, order of mixing, and compounding techniques were appropriate and accurately performed.
(C) Unless otherwise indicated or appropriate, compounded preparations are to be prepared to ensure that each preparation shall contain not less than 90.0 percent and not more than 110.0 percent of the theoretically calculated and labeled quantity of active ingredient per unit weight or volume and not less than 90.0 percent and not more than 110.0 percent of the theoretically calculated weight or volume per unit of the preparation.
(e) Records.
(1) Maintenance of records. Every record required by this section shall be:
(A) kept by the pharmacy and be available, for at least two years for inspecting and copying by the board or its representative and to other authorized local, state, or federal law enforcement agencies; and
(B) supplied by the pharmacy within 72 hours, if requested by an authorized agent of the Texas State Board of Pharmacy. If the pharmacy maintains the records in an electronic format, the requested records must be provided in an electronic format. Failure to provide the records set out in this section, either on site or within 72 hours, constitutes prima facie evidence of failure to keep and maintain records in violation of the Act.
(2) Compounding records.
(A) Compounding pursuant to patient specific prescription drug or medication orders. Compounding records for all compounded preparations shall be maintained by the pharmacy electronically or manually as part of the prescription drug or medication order, formula record, formula book, or compounding log and shall include:
(i) the date of preparation;
(ii) a complete formula, including methodology and necessary equipment which includes the brand name(s) of the raw materials, or if no brand name, the generic name(s) and name(s) of the manufacturer(s) of the raw materials and the quantities of each;
(iii) signature or initials of the pharmacist or pharmacy technician or pharmacy technician trainee performing the compounding;
(iv) signature or initials of the pharmacist responsible for supervising pharmacy technicians or pharmacy technician trainees and conducting in-process and final checks of compounded preparations if pharmacy technicians or pharmacy technician trainees perform the compounding function;
(v) the quantity in units of finished preparations or amount of raw materials;
(vi) the container used and the number of units prepared;
(vii) a reference to the location of the following documentation which may be maintained with other records, such as quality control records:
(I) the criteria used to determine the beyond-use date; and
(II) documentation of performance of quality control procedures. Documentation of the performance of quality control procedures is not required if the compounding process is done pursuant to a patient specific order and involves the mixing of two or more commercially available oral liquids or commercially available preparations when the final product is intended for external use.
(B) Compounding records when batch compounding or compounding in anticipation of future prescription drug or medication orders.
(i) Master work sheet. A master work sheet shall be developed and approved by a pharmacist for preparations prepared in batch. Once approved, a duplicate of the master work sheet shall be used as the preparation work sheet from which each batch is prepared and on which all documentation for that batch occurs. The master work sheet shall contain at a minimum:
(I) the formula;
(II) the components;
(III) the compounding directions;
(IV) a sample label;
(V) evaluation and testing requirements;
(VI) specific equipment used during preparation; and
(VII) storage requirements.
(ii) Preparation work sheet. The preparation work sheet for each batch of preparations shall document the following:
(I) identity of all solutions and ingredients and their corresponding amounts, concentrations, or volumes;
(II) lot number or each component;
(III) component manufacturer/distributor or suitable identifying number;
(IV) container specifications;
(V) unique lot or control number assigned to batch;
(VI) beyond use date of batch-prepared preparations;
(VII) date of preparation;
(VIII) name, initials, or electronic signature of the person(s) involved in the preparation;
(IX) name, initials, or electronic signature of the responsible pharmacist;
(X) finished preparation evaluation and testing specifications, if applicable; and
(XI) comparison of actual yield to anticipated or theoretical yield, when appropriate.
(f) Office Use Compounding and Distribution of Compounded Preparations to Class C Pharmacies or Veterinarians in Accordance with Section 563.054 of the Act.
(1) General.
(A) A pharmacy may dispense and deliver a reasonable quantity of a compounded preparation to a practitioner for office use by the practitioner in accordance with this subsection.
(B) A Class A (Community) pharmacy is not required to register or be licensed under Chapter 431, Health and Safety Code, to distribute non-sterile compounded preparations to a Class C (Institutional) pharmacy.
(C) A Class C (Institutional) pharmacy is not required to register or be licensed under Chapter 431, Health and Safety Code, to distribute non-sterile compounded preparations that the Class C pharmacy has compounded for other Class C pharmacies under common ownership.
(D) To dispense and deliver a compounded preparation under this subsection, a pharmacy must:
(i) verify the source of the raw materials to be used in a compounded drug;
(ii) comply with applicable United States Pharmacopoeia guidelines, including the testing requirements, and the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191);
(iii) enter into a written agreement with a practitioner for the practitioner's office use of a compounded preparation;
(iv) comply with all applicable competency and accrediting standards as determined by the board; and
(v) comply with the provisions of this subsection.
(2) Written Agreement. A pharmacy that provides non-sterile compounded preparations to practitioners for office use or to another pharmacy shall enter into a written agreement with the practitioner or pharmacy. The written agreement shall:
(A) address acceptable standards of practice for a compounding pharmacy and a practitioner and receiving pharmacy that enter into the agreement including a statement that the compounded preparations may only be administered to the patient and may not be dispensed to the patient or sold to any other person or entity except as authorized by Section 563.054 of the Act;
(B) require the practitioner or receiving pharmacy to include on a patient's chart, medication order, or medication administration record the lot number and beyond-use date of a compounded preparation administered to a patient; and
(C) describe the scope of services to be performed by the pharmacy and practitioner or receiving pharmacy, including a statement of the process for:
(i) a patient to report an adverse reaction or submit a complaint; and
(ii) the pharmacy to recall batches of compounded preparations.
(3) Recordkeeping.
(A) Maintenance of Records.
(i) Records of orders and distribution of non-sterile compounded preparations to a practitioner for office use or to a Class C (Institutional) pharmacy for administration to a patient shall:
(I) be kept by the pharmacy and be available, for at least two years from the date of the record, for inspecting and copying by the board or its representative and to other authorized local, state, or federal law enforcement agencies;
(II) maintained separately from the records of products dispensed pursuant to a prescription or medication order; and
(III) supplied by the pharmacy within 72 hours, if requested by an authorized agent of the Texas State Board of Pharmacy or its representative. If the pharmacy maintains the records in an electronic format, the requested records must be provided in an electronic format. Failure to provide the records set out in this subsection, either on site or within 72 hours for whatever reason, constitutes prima facie evidence of failure to keep and maintain records.
(ii) Records may be maintained in an alternative data retention system, such as a data processing system or direct imaging system provided the data processing system is capable of producing a hard copy of the record upon the request of the board, its representative, or other authorized local, state, or federal law enforcement or regulatory agencies.
(B) Orders. The pharmacy shall maintain a record of all non-sterile compounded preparations ordered by a practitioner for office use or by a Class C pharmacy for administration to a patient. The record shall include the following information:
(i) date of the order;
(ii) name, address, and phone number of the practitioner who ordered the preparation and if applicable, the name, address and phone number of the Class C pharmacy ordering the preparation; and
(iii) name, strength, and quantity of the preparation ordered.
(C) Distributions. The pharmacy shall maintain a record of all non-sterile compounded preparations distributed pursuant to an order to a practitioner for office use or by a Class C pharmacy for administration to a patient. The record shall include the following information:
(i) date the preparation was compounded;
(ii) date the preparation was distributed;
(iii) name, strength and quantity in each container of the preparation;
(iv) pharmacy's lot number;
(v) quantity of containers shipped; and
(vi) name, address, and phone number of the practitioner or Class C pharmacy to whom the preparation is distributed.
(D) Audit Trail.
(i) The pharmacy shall store the order and distribution records of preparations for all non-sterile compounded preparations ordered by and or distributed to a practitioner for office use or by a Class C pharmacy for administration to a patient in such a manner as to be able to provide a audit trail for all orders and distributions of any of the following during a specified time period.
(I) any strength and dosage form of a preparation (by either brand or generic name or both);
(II) any ingredient;
(III) any lot number;
(IV) any practitioner;
(V) any facility; and
(VI) any pharmacy, if applicable.
(ii) The audit trail shall contain the following information:
(I) date of order and date of the distribution;
(II) practitioner's name, address, and name of the Class C pharmacy, if applicable;
(III) name, strength and quantity of the preparation in each container of the preparation;
(IV) name and quantity of each active ingredient;
(V) quantity of containers distributed; and
(VI) pharmacy's lot number.
(4) Labeling. The pharmacy shall affix a label to the preparation containing the following information:
(A) name, address, and phone number of the compounding pharmacy;
(B) the statement: "For Institutional or Office Use Only--Not for Resale"; or if the preparation is distributed to a veterinarian the statement: "Compounded Preparation";
(C) name and strength of the preparation or list of the active ingredients and strengths;
(D) pharmacy's lot number;
(E) beyond-use date as determined by the pharmacist using appropriate documented criteria;
(F) quantity or amount in the container;
(G) appropriate ancillary instructions, such as storage instructions or cautionary statements, including hazardous drug warning labels where appropriate; and
(H) device-specific instructions, where appropriate.
(g) Recall Procedures.
(1) The pharmacy shall have written procedure for the recall of any compounded non-sterile preparations provided to a patient, to a practitioner for office use, or to a pharmacy for administration. The recall procedures shall require:
(A) notification to each practitioner, facility, and/or pharmacy to which the preparation was distributed;
(B) notification to each patient to whom the preparation was dispensed;
(C) quarantine of the product if there is a suspicion of harm to a patient; and
(D) a recall if there is probable or confirmed harm to a patient.
(2) If the pharmacy identifies a suspicion of, probable, or confirmed harm to a patient, the pharmacy shall immediately notify and provide information as required by the board to the following:
(A) the Texas Department of State Health Services, Drugs and Medical Devices Group, if the preparation is distributed for office use; and
(B) the board.
(3) The board may require a pharmacy to institute a recall if there is probable or confirmed harm to a patient.
§291.133.Pharmacies Compounding Sterile Preparations.
(a) Purpose. Pharmacies compounding sterile preparations, prepackaging pharmaceutical products, and distributing those products shall comply with all requirements for their specific license classification and this section. The purpose of this section is to provide standards for the:
(1) compounding of sterile preparations pursuant to a prescription or medication order for a patient from a practitioner in Class A (Community), Class C (Institutional), and Class E (Non-resident) pharmacies;
(2) compounding, dispensing, and delivery of a reasonable quantity of a compounded sterile preparation in a Class A (Community), Class C (Institutional), and Class E (Non-resident) pharmacies to a practitioner's office for office use by the practitioner;
(3) compounding and distribution of compounded sterile preparations by a Class A (Community) pharmacy for a Class C (Institutional) pharmacy; and
(4) compounding of sterile preparations by a Class C (Institutional) pharmacy and the distribution of the compounded preparations to other Class C (Institutional) pharmacies under common ownership.
(b) Definitions. In addition to the definitions for specific license classifications, the following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise.
(1) ACPE--Accreditation Council for Pharmacy Education.
(2) Airborne particulate cleanliness class--The level of cleanliness specified by the maximum allowable number of particles per cubic meter of air as specified in the International Organization of Standardization (ISO) Classification Air Cleanliness (ISO 14644-1). For example:
(A) ISO Class 5 (formerly Class 100) is an atmospheric environment that contains less than 3,520 particles 0.5 microns in diameter per cubic meter of air (formerly stated as 100 particles 0.5 microns in diameter per cubic foot of air);
(B) ISO Class 7 (formerly Class 10,000) is an atmospheric environment that contains less than 352,000 particles 0.5 microns in diameter per cubic meter of air (formerly stated as 10,000 particles 0.5 microns in diameter per cubic foot of air); and
(C) ISO Class 8 (formerly Class 100,000) is an atmospheric environment that contains less than 3,520,000 particles 0.5 microns in diameter per cubic meter of air (formerly stated as 100,000 particles 0.5 microns in diameter per cubic foot of air).
(3) Ancillary supplies--Supplies necessary for the preparation and administration of compounded sterile preparations.
(4) Anteroom--An ISO Class 8 or better area where personnel may perform hand hygiene and garbing procedures, staging of components, order entry, labeling, and other high-particulate generating activities. It is also a transition area that:
(A) provides assurance that pressure relationships are constantly maintained so that air flows from clean to dirty areas; and
(B) reduces the need for the heating, ventilating and air conditioning (HVAC) control system to respond to large disturbances.
(5) Aseptic Processing--The technique involving procedures designed to preclude contamination of drugs, packaging, equipment, or supplies by microorganisms during preparation.
(6) Automated compounding device--An automated device that compounds, measures, and/or packages a specified quantity of individual components in a predetermined sequence for a designated sterile preparation.
(7) Batch--A specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced during a single preparation cycle.
(8) Batch preparation compounding--Compounding of multiple sterile preparation units, in a single discrete process, by the same individual(s), carried out during one limited time period. Batch preparation/compounding does not include the preparation of multiple sterile preparation units pursuant to patient specific medication orders.
(9) Beyond-use date--The date or time after which the compounded sterile preparation shall not be stored or transported or begin to be administered to a patient. The beyond-use date is determined from the date or time the preparation is compounded.
(10) Biological Safety Cabinet, Class II--A ventilated cabinet for personnel, product, and environmental protection having an open front with inward airflow for personnel protection, downward HEPA filtered laminar airflow for product protection, and HEPA filtered exhausted air for environmental protection.
(11) Buffer Area, Buffer or Core Room, Buffer or Clean Room Areas, Buffer Room Area, Buffer or Clean Area--An ISO Class 7 area where the primary engineering control area is physically located. Activities that occur in this area include the preparation and staging of components and supplies used when compounding sterile preparations.
(12) Clean room--A room in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness class. Microorganisms in the environment are monitored so that a microbial level for air, surface, and personnel gear are not exceeded for a specified cleanliness class.
(13) Component--Any ingredient intended for use in the compounding of a drug preparation, including those that may not appear in such preparation.
(14) Compounding--The preparation, mixing, assembling, packaging, or labeling of a drug or device:
(A) as the result of a practitioner's prescription drug or medication order based on the practitioner-patient-pharmacist relationship in the course of professional practice;
(B) for administration to a patient by a practitioner as the result of a practitioner's initiative based on the practitioner-patient-pharmacist relationship in the course of professional practice;
(C) in anticipation of prescription drug or medication orders based on routine, regularly observed prescribing patterns; or
(D) for or as an incident to research, teaching, or chemical analysis and not for sale or dispensing, except as allowed under Section 562.154 or Chapter 563 of the Occupations Code.
(15) Compounding Aseptic Isolator--A form of barrier isolator specifically designed for compounding pharmaceutical ingredients or preparations. It is designed to maintain an aseptic compounding environment within the isolator throughout the compounding and material transfer processes. Air exchange into the isolator from the surrounding environment shall not occur unless it has first passed through a microbial retentive filter (HEPA minimum).
(16) Critical Area--A critical area is an ISO Class 5 environment.
(17) Critical Sites--Sterile ingredients of compounded sterile preparations and locations on devices and components used to prepare, package, and transfer compounded sterile preparations that provide opportunity for exposure to contamination.
(18) Cytotoxic--A pharmaceutical that has the capability of killing living cells.
(19) Device--An instrument, apparatus, implement, machine, contrivance, implant, in-vitro reagent, or other similar or related article, including any component part or accessory, that is required under federal or state law to be ordered or prescribed by a practitioner.
(20) Disinfectant--A disinfectant is an agent that frees from infection, usually a chemical agent but sometimes a physical one, and that destroys disease-causing pathogens or other harmful microorganisms but may not kill bacterial spores. It refers to substances applied to inanimate objects.
(21) Hot water--The temperature of water from the pharmacy's sink maintained at 120 to 140 degrees F (49 to 60 C).
(22) HVAC--Heating, ventilation, and air conditioning.
(23) Immediate use--A sterile preparation that is not prepared according to USP 797 standards (i.e. outside the pharmacy and most likely not by pharmacy personnel) which shall be stored for no longer than one hour after completion of the preparation.
(24) IPA--Isopropyl alcohol (2-propanol).
(25) Media-Fill Test--A media-fill test is used to qualify aseptic technique of compounding personnel or processes and to ensure that the processes used are able to produce sterile preparation without microbial contamination. During this test, a microbiological growth medium such as Soybean--Casein Digest Medium (SCDM) is substituted for the actual drug product to simulate admixture compounding. The issues to consider in the development of a media-fill test are the following: media-fill procedures, media selection, fill volume, incubation, time and temperature, inspection of filled units, documentation, interpretation of results, and possible corrective actions required.
(26) Multiple-Dose Container--A multiple-unit container for articles or preparations intended for potential administration only and usually contains antimicrobial preservatives. The beyond-use date for an opened or entered (e.g., needle-punctured) multiple-dose container with antimicrobial preservatives is 28 days, unless otherwise specified by the manufacturer.
(27) Negative Pressure Room--A room that is at a lower pressure compared to adjacent spaces and, therefore, the net flow of air is into the room.
(28) Office use--The administration of a compounded drug to a patient by a practitioner in the practitioner's office or by the practitioner in a health care facility or treatment setting, including a hospital, ambulatory surgical center, or pharmacy in accordance with Chapter 562 of the Act, or for administration or provision by a veterinarian in accordance with Section 563.054 of the Act.
(29) Pharmacy Bulk Package--A container of a sterile preparation for potential use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for infusion or, through a sterile transfer device, for the filling of empty sterile syringes. The closure shall be penetrated only one time after constitution with a suitable sterile transfer device or dispensing set, which allows measured dispensing of the contents. The pharmacy bulk package is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area).
(30) Prepackaging--The act of repackaging and relabeling quantities of drug products from a manufacturer's original container into unit dose packaging or a multiple dose container for distribution within a facility licensed as a Class C pharmacy or to other pharmacies under common ownership for distribution within those facilities. The term as defined does not prohibit the prepackaging of drug products for use within other pharmacy classes.
(31) Preparation or Compounded Sterile Preparation--A sterile admixture compounded in a licensed pharmacy or other healthcare-related facility pursuant to the order of a licensed prescriber; the article may or may not contain sterile products.
(32) Primary Engineering Control--A device or room that provides an ISO Class 5 environment for the exposure of critical sites when compounding sterile preparations. Such devices include, but may not be limited to, laminar airflow workbenches, biological safety cabinets, and compounding aseptic isolators.
(33) Product--A product is a commercially manufactured sterile drug or nutrient that has been evaluated for safety and efficacy by the U.S. Food and Drug Administration (FDA). Products are accompanied by full prescribing information, which is commonly known as the FDA-approved manufacturer's labeling or product package insert.
(34) Positive Control--A quality assurance sample prepared to test positive for microbial growth.
(35) Positive Pressure Room--A room that is at a higher pressure compared to adjacent spaces and, therefore, the net airflow is out of the room.
(36) Quality assurance--The set of activities used to ensure that the process used in the preparation of sterile drug products lead to products that meet predetermined standards of quality.
(37) Quality control--The set of testing activities used to determine that the ingredients, components (e.g., containers), and final compounded sterile preparations prepared meet predetermined requirements with respect to identity, purity, non-pyrogenicity, and sterility.
(38) Reasonable quantity--An amount of a compounded drug that:
(A) does not exceed the amount a practitioner anticipates may be used in the practitioner's office or facility before the beyond use date of the drug;
(B) is reasonable considering the intended use of the compounded drug and the nature of the practitioner's practice; and
(C) for any practitioner and all practitioners as a whole, is not greater than an amount the pharmacy is capable of compounding in compliance with pharmaceutical standards for identity, strength, quality, and purity of the compounded drug that are consistent with United States Pharmacopoeia guidelines and accreditation practices.
(39) Single-dose container--A container intended for a single use, other than single-dose vials and single-dose large volume potential solutions. Examples of single-dose containers include pre-filled syringes, cartridges, and fusion-sealed containers without preservatives.
(40) Single-dose vial--A vial intended for a single use. Exceptions to this definition would be single dose vials routinely used to compound total potential nutrition (TPN) preparations (e.g., sodium chloride, sodium acetate, sodium phosphate, potassium chloride, potassium acetate, potassium phosphate, calcium glucontae, magnesium sulfate, multivitamin for injection, multi-trace elements, ascorbic acid, folic acid, heparin, phytonadione, l-carnitine, cysteine, selenium, injectable zinc).
(41) Single-dose large volume parenteral (LVP) solution--LVP solutions (i.e., containers of solution of at least 1000 mL) routinely used for compounding sterile TPN preparations or for batch compounding (e.g., sterile water for injection (SWFI); 5%, 10%, and 70% dextrose in SWFI; 0.9% sodium chloride; 0.45% sodium chloride; 5% dextrose/0.9% sodium chloride; 5% dextrose/0.45% sodium chloride).
(42) SOPs--Standard operating procedures.
(43) Terminal Sterilization--The application of a lethal process, e.g., steam under pressure or autoclaving, to sealed final preparation containers for the purpose of achieving a predetermined sterility assurance level of usually less than 106, i.e., or a probability of less than one in one million of a non-sterile unit.
(44) USP/NF--The current edition of the United States Pharmacopeia/National Formulary.
(c) Personnel.
(1) Pharmacist-in-charge.
(A) General. The pharmacy shall have a pharmacist-in-charge in compliance with the specific license classification of the pharmacy.
(B) Responsibilities. In addition to the responsibilities for the specific class of pharmacy, the pharmacist-in-charge shall have the responsibility for, at a minimum, the following concerning the compounding of sterile preparations:
(i) developing a system to ensure that all pharmacy personnel responsible for compounding and/or supervising the compounding of sterile preparations within the pharmacy receive appropriate education and training and competency evaluation;
(ii) determining that all pharmacists involved in compounding sterile preparations obtain continuing education appropriate for the type of compounding done by the pharmacist;
(iii) supervising a system to ensure appropriate procurement of drugs and devices and storage of all pharmaceutical materials including pharmaceuticals, components used in the compounding of sterile preparations, and drug delivery devices;
(iv) ensuring that the equipment used in compounding is properly maintained;
(v) developing a system for the disposal and distribution of drugs from the pharmacy;
(vi) developing a system for bulk compounding or batch preparation of drugs;
(vii) developing a system for the compounding, sterility assurance, quality assurance, and quality control of sterile preparations; and
(viii) if applicable, ensuring that the pharmacy has a system to dispose of hazardous waste in a manner so as not to endanger the public health.
(2) Pharmacists. Special requirements for compounding sterile preparations.
(A) All pharmacists engaged in compounding sterile preparations shall:
(i) possess the education, training, and proficiency necessary to properly and safely perform compounding duties undertaken or supervised; and
(ii) obtain continuing education appropriate for the type of compounding done by the pharmacist.
(B) A pharmacist shall inspect and approve all components, drug preparation containers, closures, labeling, and any other materials involved in the compounding process.
(C) A pharmacist shall review all compounding records for accuracy and conduct in-process and final checks to ensure that errors have not occurred in the compounding process.
(D) A pharmacist is responsible for the proper maintenance, cleanliness, and use of all equipment used in the compounding process.
(E) A pharmacist shall be accessible at all times to respond to patients' and other health professionals' questions and needs. Such access may be through a telephone or pager which is answered 24 hours a day.
(3) Pharmacy technicians and pharmacy technician trainees. Pharmacy technicians and pharmacy technician trainees may compound sterile preparations provided the pharmacy technicians and/or pharmacy technician trainees:
(A) have completed the education and training specified in paragraph (4) of this subsection; and
(B) are supervised by a pharmacist who has completed the training specified in paragraph (4) of this subsection, conducts in-process and final checks, and affixes his or her initials to the appropriate quality control records.
(4) Special education, training, and evaluation requirements for pharmacy personnel compounding or responsible for the direct supervision of pharmacy personnel compounding sterile preparations.
(A) General.
(i) All pharmacy personnel preparing sterile preparations shall receive didactic and experiential training and competency evaluation through demonstration, testing (written and practical) as outlined by the pharmacist-in-charge and described in the policy and procedure or training manual. Such training shall include instruction and experience in the following areas:
(I) aseptic technique;
(II) critical area contamination factors;
(III) environmental monitoring;
(IV) structure and engineering controls related to facilities;
(V) equipment and supplies;
(VI) sterile preparation calculations and terminology;
(VII) sterile preparation compounding documentation;
(VIII) quality assurance procedures;
(IX) aseptic preparation procedures including proper gowning and gloving technique;
(X) handling of cytotoxic and hazardous drugs, if applicable; and
(XI) general conduct in the controlled area.
(ii) The aseptic technique of each person compounding or responsible for the direct supervision of personnel compounding sterile preparations shall be observed and evaluated as satisfactory through written and practical tests, and media-fill challenge testing, and such evaluation documented.
(iii) Although media-fill tests may be incorporated into the experiential portion of a training program, media-fill tests must be conducted at each pharmacy where an individual compounds sterile preparations. No preparation intended for patient use shall be compounded by an individual until the on-site media-fill tests test indicates that the individual can competently perform aseptic procedures, except that a pharmacist may temporarily compound sterile preparations and supervise pharmacy technicians compounding sterile preparations without media-fill tests provided the pharmacist:
(I) has completed a recognized course in an accredited college of pharmacy or a course sponsored by an ACPE approved provider which provides 20 hours of instruction and experience in the areas listed in this subparagraph; and
(II) completes the on-site media-fill tests within seven days of commencing work at the pharmacy.
(iv) Media-fill tests procedures for assessing the preparation of specific types of sterile preparations shall be representative of all types of manipulations, products, risk levels, and batch sizes that personnel preparing that type of sterile preparation are likely to encounter.
(v) The pharmacist-in-charge shall ensure continuing competency of pharmacy personnel through in-service education, training, and media-fill tests to supplement initial training. Personnel competency shall be evaluated:
(I) during orientation and training prior to the regular performance of those tasks;
(II) whenever the quality assurance program yields an unacceptable result;
(III) whenever unacceptable techniques are observed; and
(IV) at least on an annual basis for low- and medium-risk level compounding, and every six months for high-risk level compounding.
(B) Pharmacists.
(i) All pharmacists who compound sterile preparations for administration to patients or supervise pharmacy technicians and pharmacy technician trainees compounding sterile preparations shall:
(I) complete through a single course, a minimum of 20 hours of instruction and experience in the areas listed in subparagraph (A) of this paragraph. Such training may be obtained through:
(-a-) completion of a structured on-the-job didactic and experiential training program at this pharmacy which provides 20 hours of instruction and experience in the areas listed in paragraph (1) of this subsection. Such training may not be transferred to another pharmacy unless the pharmacies are under common ownership and control and use a common training program; or
(-b-) completion of a recognized course in an accredited college of pharmacy or a course sponsored by an ACPE approved provider which provides 20 hours of instruction and experience in the areas listed in subparagraph (A) of this paragraph.
(II) possess knowledge about:
(-a-) aseptic processing;
(-b-) quality control and quality assurance as related to environmental, component, and finished preparation release checks and tests;
(-c-) chemical, pharmaceutical, and clinical properties of drugs;
(-d-) container, equipment, and closure system selection; and
(-e-) sterilization techniques.
(ii) The required experiential portion of the training programs specified in this subparagraph must be supervised by an individual who has already completed training as specified in subparagraph (B) or (C) of this paragraph.
(C) Pharmacy technicians and pharmacy technician trainees. In addition to specific qualifications for registration, all pharmacy technicians and pharmacy technician trainees who compound sterile preparations for administration to patients shall:
(i) have initial training obtained either through completion of:
(I) a single course, a minimum of 40 hours of instruction and experience in the areas listed in subparagraph (A) of this paragraph. Such training may be obtained through:
(-a-) completion of a structured on-the-job didactic and experiential training program at this pharmacy which provides 40 hours of instruction and experience in the areas listed in subparagraph (A) of this paragraph. Such training may not be transferred to another pharmacy unless the pharmacies are under common ownership and control and use a common training program; or
(-b-) completion of a course sponsored by an ACPE approved provider which provides 40 hours of instruction and experience in the areas listed in subparagraph (A) of this paragraph; or
(II) a training program which is accredited by the American Society of Health-System Pharmacists. Individuals enrolled in training programs accredited by the American Society of Health-System Pharmacists may compound sterile preparations in a licensed pharmacy provided:
(-a-) the compounding occurs only during times the individual is assigned to a pharmacy as a part of the experiential component of the American Society of Health-System Pharmacists training program;
(-b-) the individual is under the direct supervision of and responsible to a pharmacist who has completed training as specified in subparagraph (B) of this paragraph; and
(-c-) the supervising pharmacist conducts in-process and final checks.
(ii) acquire the required experiential portion of the training programs specified in this subparagraph under the supervision of an individual who has already completed training as specified in subparagraph (B) or (C) of this paragraph.
(D) Documentation of Training. The pharmacy shall maintain a record on each person who compounds sterile preparations. The record shall contain, at a minimum, a written record of initial and in-service training, continuing education, and the results of written and practical testing and media-fill testing of pharmacy personnel. The record shall be maintained and contain the following information:
(i) name of the person receiving the training or completing the testing or media-fill tests;
(ii) date(s) of the training, testing, or media-fill challenge testing;
(iii) general description of the topics covered in the training or testing or of the process validated;
(iv) name of the person supervising the training, testing, or media-fill challenge testing; and
(v) signature or initials of the person receiving the training or completing the testing or media-fill challenge testing and the pharmacist-in-charge or other pharmacist employed by the pharmacy and designated by the pharmacist-in-charge as responsible for training, testing, or media-fill challenge testing of personnel.
(d) Operational Standards.
(1) General Requirements.
(A) Sterile preparations may be compounded in licensed pharmacies:
(i) upon presentation of a practitioner's prescription drug or medication order based on a valid pharmacist/patient/prescriber relationship;
(ii) in anticipation of future prescription drug or medication orders based on routine, regularly observed prescribing patterns; or
(iii) in reasonable quantities for office use by a practitioner and for use by a veterinarian.
(B) Sterile compounding in anticipation of future prescription drug or medication orders must be based upon a history of receiving valid prescriptions issued within an established pharmacist/patient/prescriber relationship, provided that in the pharmacist's professional judgment the quantity prepared is stable for the anticipated shelf time.
(i) The pharmacist's professional judgment shall be based on the criteria used to determine a beyond-use date outlined in paragraph (5)(G) of this subsection.
(ii) Documentation of the criteria used to determine the stability for the anticipated shelf time must be maintained and be available for inspection.
(iii) Any preparation compounded in anticipation of future prescription drug or medication orders shall be labeled. Such label shall contain:
(I) name and strength of the compounded preparation or list of the active ingredients and strengths;
(II) facility's lot number;
(III) beyond-use date as determined by the pharmacist using appropriate documented criteria as outlined in paragraph (5)(G) of this subsection;
(IV) quantity or amount in the container;
(V) appropriate ancillary instructions, such as storage instructions or cautionary statements, including hazardous drug warning labels where appropriate; and
(VI) device-specific instructions, where appropriate.
(C) Commercially available products may be compounded for dispensing to individual patients provided the following conditions are met:
(i) the commercial product is not reasonably available from normal distribution channels in a timely manner to meet patient's needs;
(ii) the pharmacy maintains documentation that the product is not reasonably available due to a drug shortage or unavailability from the manufacturer; and
(iii) the prescribing practitioner has requested that the drug be compounded as described in subparagraph (D) of this paragraph.
(D) A pharmacy may not compound preparations that are essentially copies of commercially available products (e.g., the preparation is dispensed in a strength that is only slightly different from a commercially available product) unless the prescribing practitioner specifically orders the strength or dosage form and specifies why the patient needs the particular strength or dosage form of the preparation. The prescribing practitioner shall provide documentation of a patient specific medical need and the preparation produces a clinically significant therapeutic response (e.g. the physician requests an alternate product due to hypersensitivity to excipients or preservative in the FDA-approved product, or the physician requests an effective alternate dosage form) or if the drug product is not commercially available. The unavailability of such drug product must be documented prior to compounding. The methodology for documenting unavailability includes maintaining a copy of the wholesaler's notification showing back-ordered, discontinued, or out-of-stock items. This documentation must be available in hard-copy or electronic format for inspection by the Board.
(E) A pharmacy may enter into an agreement to compound and dispense prescription/medication orders for another pharmacy provided the pharmacy complies with the provisions of §291.125 of this title (relating to Centralized Prescription Dispensing).
(F) Compounding pharmacies/pharmacists may advertise and promote the fact that they provide sterile prescription compounding services, which may include specific drug preparations and classes of drugs.
(G) A pharmacy may not compound veterinary preparations for use in food producing animals except in accordance with federal guidelines.
(2) Microbial Contamination Risk Levels. Risk Levels for sterile compounded preparations shall be as outlined in Chapter 797, Pharmacy Compounding--Sterile Preparations of the USP/NF and as listed below.
(A) Low-risk level compounded sterile preparations.
(i) Low-Risk conditions. Low-risk level compounded sterile preparations are those compounded under all of the following conditions.
(I) The compounded sterile preparations are compounded with aseptic manipulations entirely within ISO Class 5 or better air quality using only sterile ingredients, products, components, and devices.
(II) The compounding involves only transfer, measuring, and mixing manipulations with closed or sealed packaging systems that are preformed promptly and attentively.
(III) Manipulations are limited to aseptically opening ampuls, penetrating sterile stoppers on vials with sterile needles and syringes, and transferring sterile liquids in sterile syringes to sterile administration devices and packages of other sterile products.
(IV) For a low-risk preparation, in the absence of direct sterility testing results or appropriate information sources that justify different limits, the storage periods may not exceed the following periods: before administration, 48 hours at controlled room temperature, for not more than 14 days if stored at a cold temperature, and for 45 days if stored in a frozen state at minus 20 degrees Celsius or colder). For delayed activation device systems, the storage period begins when the device is activated.
(ii) Examples of Low-Risk Compounding. Examples of low-risk compounding include the following.
(I) Single volume transfers of sterile dosage forms from ampuls, bottles, bags, and vials using sterile syringes with sterile needles, other administration devices, and other sterile containers. The solution content of ampules shall be passed through a sterile filter to remove any glass particles.
(II) Manually measuring and mixing no more than three manufactured products to compound drug admixtures.
(B) Medium-risk level compounded sterile preparations.
(i) Medium-Risk Conditions. Medium-risk level compounded sterile preparations, are those compounded aseptically under low-risk conditions and one or more of the following conditions exists.
(I) Multiple individual or small doses of sterile products are combined or pooled to prepare a compounded sterile preparation that will be administered either to multiple patients or to one patient on multiple occasions.
(II) The compounding process includes complex aseptic manipulations other than the single-volume transfer.
(III) The compounding process requires unusually long duration, such as that required to complete the dissolution or homogenous mixing (e.g., reconstitution of intravenous immunoglobulin or other intravenous protein products).
(IV) The compounded sterile preparations do not contain broad spectrum bacteriostatic substances and they are administered over several days (e.g., an externally worn infusion device).
(V) For a medium-risk preparation, in the absence of direct sterility testing results or appropriate information sources that justify different limits the beyond use dates may not exceed the following time periods: before administration, the compounded sterile preparations are properly stored and are exposed for not more than 30 hours at controlled room temperature, for not more than 7 days at a cold temperature, and for 45 days in solid frozen state at minus 20 degrees Celsius or colder.
(ii) Examples of medium-risk compounding. Examples of medium-risk compounding include the following.
(I) Compounding of total parenteral nutrition fluids using a manual or automated device during which there are multiple injections, detachments, and attachments of nutrient source products to the device or machine to deliver all nutritional components to a final sterile container.
(II) Filling of reservoirs of injection and infusion devices with multiple sterile drug products and evacuations of air from those reservoirs before the filled device is dispensed.
(III) Filling of reservoirs of injection and infusion devices with volumes of sterile drug solutions that will be administered over several days at ambient temperatures between 25 and 40 degrees Celsius (77 and 104 degrees Fahrenheit).
(IV) Transfer of volumes from multiple ampuls or vials into a single, final sterile container or product.
(C) High-risk level compounded sterile preparations.
(i) High-risk Conditions. High-risk level compounded sterile preparations are those compounded under any of the following conditions.
(I) Non-sterile ingredients, including manufactured products are incorporated or a non-sterile device is employed before terminal sterilization.
(II) Sterile ingredients, components, devices, and mixtures are exposed to air quality inferior to ISO Class 5. This includes storage in environments inferior to ISO Class 5 of opened or partially used packages of manufactured sterile products that lack antimicrobial preservatives.
(III) Non-sterile preparations are exposed no more than 6 hours before being sterilized.
(IV) It is assumed, and not verified by examination of labeling and documentation from suppliers or by direct determination, that the chemical purity and content strength of ingredients meet their original or compendial specifications in unopened or in opened packages of bulk ingredients.
(V) For a high-risk preparation, in the absence of direct sterility testing results or appropriate information sources that justify different limits, the storage periods cannot exceed the following time periods: before administration, the compounded sterile preparations are properly stored and are exposed for not more than 24 hours at controlled room temperature, for not more than 3 days at a cold temperature, and for 45 days in solid frozen state at minus 20 degrees or colder.
(VI) All non-sterile measuring, mixing, and purifying equipment is rinsed thoroughly with sterile, pyrogen-free water, and then thoroughly drained or dried immediately before use for high-risk compounding while assuring cleanliness. All high-risk compounded sterile aqueous solutions subjected to terminal sterilization are passed through a filter with a nominal porosity not larger than 1.2 micron preceding or during filling into their final containers to remove particulate matter. Sterilization of high-risk level compounded sterile preparations by filtration shall be performed entirely within an ISO Class 5 or superior air quality environment.
(ii) Examples of high-risk compounding. Examples of high-risk compounding include the following.
(I) Dissolving non-sterile bulk drug powders to make solutions, which will be terminally sterilized.
(II) Exposing the sterile ingredients and components used to prepare and package compounded sterile preparations to room air quality worse than ISO Class 5.
(III) Measuring and mixing sterile ingredients in non-sterile devices before sterilization is performed.
(IV) Assuming, without appropriate evidence or direct determination, that packages of bulk ingredients contain at least 95% by weight of their active chemical moiety and have not been contaminated or adulterated between uses.
(3) Immediate Use Compounded Sterile Preparations. For the purpose of emergency or immediate patient care, compounded sterile preparations are exempted from the requirements described in this paragraph for low-risk, medium-risk, and high-risk level compounded sterile preparations when all of the following criteria are met.
(A) Only simple aseptic measuring and transfer manipulations are performed with not more than three sterile non-hazardous commercial drug and diagnostic radiopharmaceutical drug products, including an infusion or diluent solution.
(B) Unless required for the preparation, the preparation procedure occurs continuously without delays or interruptions and does not exceed 1 hour.
(C) Administration begins not later than one hour following the completion of preparing the compounded sterile preparation.
(D) When the compounded sterile preparations is not administered by the person who prepared it, or its administration is not witnessed by the person who prepared it, the compounded sterile preparation shall bear a label listing patient identification information such as name and identification number(s), the names and amounts of all ingredients, the name or initials of the person who prepared the compounded sterile preparation, and the exact 1-hour beyond-use time and date.
(E) If administration has not begun within one hour following the completion of preparing the compounded sterile preparation, the compounded sterile preparation is promptly and safely discarded. Immediate use compounded sterile preparations shall not be stored for later use.
(F) Cytotoxic drugs shall not be prepared as immediate use compounded sterile preparations.
(4) Library. In addition to the library requirements of the pharmacy's specific license classification, a pharmacy shall maintain current or updated copies in hard-copy or electronic format of each of the following:
(A) a reference text on injectable drug preparations, such as Handbook on Injectable Drug Products;
(B) a specialty reference text appropriate for the scope of pharmacy services provided by the pharmacy, e.g., if the pharmacy prepares hazardous drugs, a reference text on the preparation of hazardous drugs; and
(C) the United States Pharmacopeia/National Formulary or the USP Pharmacist's Pharmacopeia containing USP Chapter 797, Pharmaceutical Compounding - Sterile Preparations.
(5) Environment. Compounding facilities shall be physically designed and environmentally controlled to minimize airborne contamination of critical sites.
(A) Low and Medium Risk Preparations.
(i) Effective September 1, 2008, a pharmacy that prepares low- and medium-risk preparations shall have a designated room for the compounding of sterile preparations that is constructed to minimize the opportunities for particulate and microbial contamination. The designated room shall:
(I) be clean, well lit, and of sufficient size to support sterile compounding activities;
(II) be used only for the compounding of sterile preparations;
(III) be designed such that hand sanitizing and gowning occurs outside the buffer area but is accessible without use of the hands of the compounding personnel;
(IV) have non-porous and washable floors or floor covering to enable regular disinfection;
(V) be ventilated in a manner to avoid disruption from the HVAC system and room cross-drafts;
(VI) have walls, ceilings, floors, fixtures, shelving, counters, and cabinets that are smooth, impervious, free from cracks and crevices (e.g., coved), nonshedding and resistant to damage by disinfectant agents.
(VII) have junctures of ceilings to walls coved or caulked to avoid cracks and crevices;
(VIII) have drugs and supplies stored on shelving areas above the floor to permit adequate floor cleaning;
(IX) contain only the appropriate compounding supplies and not be used for bulk storage for supplies and materials. Objects that shed particles shall not be brought into the controlled area;
(X) contain an anteroom that provides at least an ISO class 8 air quality which may contain a sink that enables hands-free use with a closed system of soap dispensing to minimize the risk of extrinsic contamination; and
(XI) contain a buffer zone or buffer room designed to maintain at least ISO Class 7 conditions. The following is applicable for the buffer area.
(-a-) There shall be some demarcation designation that delineates the anteroom or area from the buffer area.
(-b-) The buffer area shall be segregated from surrounding, unclassified spaces to reduce the risk of contaminants being blown, dragged, or otherwise introduced into the filtered unidirectional airflow environment, and this segregation should be continuously monitored.
(-c-) A buffer room that provides a physical separation, through the use of walls, doors and pass-throughs shall have a minimum differential positive pressure of 0.02 to 0.05 inches water column.
(-d-) A buffer zone that is not physically separated from the anteroom shall employ the principle of displacement airflow as defined in Chapter 797, Pharmaceutical Compounding - Sterile Preparations, of the USP/NF, with limited access to personnel.
(-e-) The buffer area shall not contain sources of water (i.e., sinks) or floor drains.
(ii) The pharmacy shall prepare sterile pharmaceuticals in a primary engineering control device, such as a laminar air flow hood, biological safety cabinet, compounding aseptic isolator which is capable of maintaining at least ISO Class 5 conditions during normal activity.
(I) The primary engineering control shall:
(-a-) be located in the buffer area or room and placed in the buffer area in a manner as to avoid conditions that could adversely affect its operation such as strong air currents from opened doors, personnel traffic, or air streams from the heating, ventilating and air condition system.
(-b-) be certified by an independent contractor according to the International Organization of Standardization (ISO) Classification of Particulate Matter in Room Air (ISO 14644-1) for operational efficiency at least every six months and when it is relocated, in accordance with the manufacturer's specifications; and
(-c-) have pre-filters inspected periodically and replaced as needed, in accordance with written policies and procedures and the manufacturer's specification, and the inspection and/or replacement date documented.
(II) The compounding aseptic isolator must be placed in an ISO Class 7 cleanroom unless the compounding aseptic isolator meets all of the following conditions.
(-a-) The isolator must provide isolation from the room and maintain ISO Class 5 during dynamic operating conditions including transferring ingredients, components, and devices into and out of the isolator and during preparation of compounded sterile preparations.
(-b-) Particle counts sampled approximately 6 to 12 inches upstream of the critical exposure site must maintain ISO Class 5 levels during compounding operations.
(-c-) The pharmacy shall maintain documentation from the manufacturer that the compounding aseptic isolator meets this standard when located in worse than ISO Class 7 environments.
(B) High-risk Preparations. In addition to the requirements in subparagraph (A) of this paragraph, when high-risk preparations are compounded, the primary engineering control shall be located in a buffer room that provides a physical separation, through the use of walls, doors and pass-throughs and has a minimum differential positive pressure of 0.02 to 0.05 inches water column.
(C) Automated compounding device. If automated compounding devices are used, the pharmacy shall have a method to calibrate and verify the accuracy of automated compounding devices used in aseptic processing and document the calibration and verification on a routine basis, based on the manufacturer's recommendations.
(D) Cytotoxic drugs. In addition to the requirements specified in subparagraphs (A) and (B) of this paragraph, if the preparation is also cytotoxic, the following is applicable.
(i) General.
(I) All personnel involved in the compounding of cytotoxic products shall wear appropriate protective apparel, such as gowns, face masks, eye protection, hair covers, shoe covers or dedicated shoes, and appropriate gloving.
(II) Appropriate safety and containment techniques for compounding cytotoxic drugs shall be used in conjunction with aseptic techniques required for preparing sterile preparations.
(III) Disposal of cytotoxic waste shall comply with all applicable local, state, and federal requirements.
(IV) Prepared doses of cytotoxic drugs must be dispensed, labeled with proper precautions inside and outside, and distributed in a manner to minimize patient contact with cytotoxic agents.
(ii) Primary engineering control device.
(I) Cytotoxic drugs must be prepared in a Class II or III biological safety cabinet or compounding aseptic isolator that is located in a ISO Class 7 room that is physically separated from other preparation areas and optimally has no less than 0.01-inch water column negative pressure to adjacent positive pressure ISO Class 7 or better, anterooms, thus providing inward airflow to contain any airborne drug.
(II) If a compounding isolator is used outside of a cleanroom, the room must maintain a minimum negative pressure of 0.01-inch water column and have a minimum of 12 air changes per hour. Note that an anteroom leading to a negative pressure room shall meet at least ISO Class 7 criteria so that air drawn into the negative pressure environment is of the same ISO Class 7 quality. A pressure indictor shall be installed that can be readily monitored for correct room pressurization.
(III) Pharmacies that prepare very low volume of cytotoxic drugs (e.g., less than five preparations per week), the use of two tiers of containment, e.g., closed--system vial-transfer device within a biological safety cabinet or compounding aseptic isolator that are located in a non-negative pressure room is acceptable.
(E) Cleaning and disinfecting the sterile compounding areas. The following cleaning and disinfecting practices and frequencies apply to direct and contiguous compounding areas, which include ISO Class 5 compounding areas for exposure of critical sites as well as buffer rooms, anterooms, and ante-areas.
(i) The pharmacist-in-charge is responsible for developing written procedures for cleaning and disinfecting the direct and contiguous compounding areas and assuring the procedures are followed.
(ii) These procedures shall be conducted prior to and after each work shift (at a minimum of every 12 hours while the pharmacy is open) and when there are spills or environmental quality breaches.
(iii) Before compounding is performed, all items are removed from the direct and contiguous compounding areas and all surfaces are cleaned of loose material and residue from spills, followed by an application of a residue-free disinfecting agent (e.g., IPA), that is left on for a time sufficient to exert its antimicrobial effect.
(iv) Work surfaces near the direct and contiguous compounding areas in the buffer or clean area are cleaned of loose material and residue from spills, followed by an application of a residue-free disinfecting agent that is left on for a time sufficient to exert its antimicrobial effect.
(v) Floors in the buffer or clean area are cleaned by mopping at least once daily when no aseptic operations are in progress preceding from the buffer or clean room area to the anteroom area.
(vi) In the anteroom area, walls, ceilings, and shelving shall be cleaned monthly.
(vii) Supplies and equipment removed from shipping cartons must be wiped with a disinfecting agent, such as IPA. However, if supplies are received in sealed pouches, the pouches may be removed as the supplies are introduced into the buffer or clean area without the need to disinfect the individual supply items. No shipping or other external cartons may be taken into the buffer or clean area.
(viii) Storage shelving, emptied of all supplies, walls, and ceilings are cleaned and disinfected at planned intervals, monthly, if not more frequently.
(F) Security requirements. The pharmacy may authorize personnel to gain access to that area of the pharmacy containing dispensed sterile preparations, in the absence of the pharmacist, for the purpose of retrieving dispensed prescriptions to deliver to patients. If the pharmacy allows such after-hours access, the area containing the dispensed sterile pharmaceuticals shall be an enclosed and lockable area separate from the area containing undispensed prescription drugs. A list of the authorized personnel having such access shall be in the pharmacy's policy and procedure manual.
(G) Storage requirements and beyond-use dating.
(i) Storage requirements. All drugs shall be stored at the proper temperature and conditions, as defined in the USP/NF. The most commonly used definitions are as follows:
(I) freezer--A place where the temperature is maintained thermostatically between minus 25 degrees and minus 10 degrees Celsius (minus 13 degrees Fahrenheit and 14 degrees Fahrenheit).
(II) cold temperature--A temperature not exceeding 8 degrees Celsius (46 degrees Fahrenheit). A refrigerator is a cold place in which the temperature maintained thermostatically between 2 degrees and 8 degrees Celsius (36 degrees and 46 degrees Fahrenheit);
(III) cool--A temperature between 8 degrees and 15 degrees Celsius (46 degrees and 59 degrees Fahrenheit). An article for which storage in a cool place is directed may, alternatively, be stored in a refrigerator unless otherwise specified on the labeling; and
(IV) controlled room temperature--A temperature maintained thermostatically between 15 degrees and 30 degrees Celsius (59 degrees and 86 degrees Fahrenheit).
(ii) Beyond-use dating.
(I) Beyond-use dates for compounded sterile preparations shall be assigned based on professional experience, which shall include careful interpretation of appropriate information sources for the same or similar formulations.
(II) Beyond-use dates for compounded sterile preparations that are prepared strictly in accordance with manufacturers' product labeling must be those specified in that labeling, or from appropriate literature sources or direct testing.
(III) Beyond-use dates for compounded sterile preparations that lack justification from either appropriate literature sources or by direct testing evidence must be assigned as described in Chapter 797, Pharmaceutical Compounding - Sterile Preparations of the USP/NF.
(6) Equipment and supplies. Pharmacies compounding sterile preparations shall have the following equipment and supplies:
(A) a calibrated system or device (i.e., thermometer) to monitor the temperature to ensure that proper storage requirements are met, if sterile pharmaceuticals are stored in the refrigerator;
(B) a calibrated system or device to monitor the temperature where bulk chemicals are stored;
(C) if applicable, a Class A prescription balance, or analytical balance and weights. Such balance shall be properly maintained and subject to periodic inspection by the Texas State Board of Pharmacy;
(D) equipment and utensils necessary for the proper compounding of sterile preparations. Such equipment and utensils used in the compounding process shall be:
(i) of appropriate design, appropriate capacity, and be operated within designed operational limits;
(ii) of suitable composition so that surfaces that contact components, in-process material, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug preparation beyond the desired result;
(iii) cleaned and sanitized immediately prior to and after each use; and
(iv) routinely inspected, calibrated (if necessary), or checked to ensure proper performance;
(E) appropriate disposal containers for used needles, syringes, etc., and if applicable, hazardous waste from the preparation of hazardous drugs and/or biohazardous waste;
(F) appropriate packaging or delivery containers to maintain proper storage conditions for sterile preparations;
(G) infusion devices, if applicable; and
(H) all necessary supplies, including:
(i) disposable needles, syringes, and other supplies for aseptic mixing;
(ii) disinfectant cleaning solutions;
(iii) hand washing agents with bactericidal action;
(iv) disposable, lint free towels or wipes;
(v) appropriate filters and filtration equipment;
(vi) cytotoxic spill kits, if applicable; and
(vii) masks, caps, coveralls or gowns with tight cuffs, shoe covers, and gloves, as applicable.
(7) Labeling.
(A) Prescription drug or medication orders. In addition to the labeling requirements for the pharmacy's specific license classification, the label dispensed or distributed pursuant to a prescription drug or medication order shall contain the following.
(i) The generic name(s) or the official name(s) of the principal active ingredient(s) of the compounded sterile preparation.
(ii) A statement that the compounded sterile preparation has been compounded by the pharmacy. (An auxiliary label may be used on the container to meet this requirement).
(iii) A beyond-use date after which the compounded sterile preparation shall not be used. The beyond-use date shall be determined as outlined in Chapter 797, Pharmacy Compounding - Sterile Preparations of the USP/NF, and paragraph (4) of this subsection.
(B) Batch. If the sterile pharmaceutical is compounded in a batch, the following shall also be included on the batch label.
(i) unique lot number assigned to the batch;
(ii) quantity;
(iii) appropriate ancillary instructions, such as storage instructions or cautionary statements, including hazardous drug warning labels where appropriate; and
(iv) device-specific instructions, where appropriate.
(C) Pharmacy bulk package. The label of a pharmacy bulk package shall:
(i) state prominently "Pharmacy Bulk Package - Not for Direct Infusion;"
(ii) contain or refer to information on proper techniques to help ensure safe use of the preparation; and
(iii) bear a statement limiting the time frame in which the container may be used once it has been entered, provided it is held under the labeled storage conditions.
(8) Written drug information. Written information about the compounded preparation or its major active ingredient(s) shall be given to the patient at the time of dispensing. A statement which indicates that the preparation was compounded by the pharmacy must be included in this written information. If there is no written information available, the patient shall be advised that the drug has been compounded and how to contact a pharmacist, and if appropriate, the prescriber, concerning the drug.
(9) Pharmaceutical Care Services. In addition to the pharmaceutical care requirements for the pharmacy's specific license classification, the following requirements must be met.
(A) Sterile preparations compounded pursuant to prescription drug orders (outpatients and long-term care facility patients).
(i) Primary provider. There shall be a designated physician primarily responsible for the patient's medical care. There shall be a clear understanding between the physician, the patient, and the pharmacy of the responsibilities of each in the areas of the delivery of care, and the monitoring of the patient. This shall be documented in the patient medication record (PMR).
(ii) Patient training. The pharmacist-in-charge shall develop policies to ensure that the patient and/or patient's caregiver receives information regarding drugs and their safe and appropriate use, including instruction when applicable, regarding:
(I) appropriate disposition of hazardous solutions and ancillary supplies;
(II) proper disposition of controlled substances in the home;
(III) self-administration of drugs, where appropriate;
(IV) emergency procedures, including how to contact an appropriate individual in the event of problems or emergencies related to drug therapy; and
(V) if the patient or patient's caregiver prepares sterile preparations in the home, the following additional information shall be provided:
(-a-) safeguards against microbial contamination, including aseptic techniques for compounding intravenous admixtures and aseptic techniques for injecting additives to premixed intravenous solutions;
(-b-) appropriate storage methods, including storage durations for sterile pharmaceuticals and expirations of self-mixed solutions;
(-c-) handling and disposition of premixed and self-mixed intravenous admixtures; and
(-d-) proper disposition of intravenous admixture compounding supplies such as syringes, vials, ampules, and intravenous solution containers.
(iii) Pharmacist-patient relationship. It is imperative that a pharmacist-patient relationship be established and maintained throughout the patient's course of therapy. This shall be documented in the patient's medication record (PMR).
(iv) Patient monitoring. The pharmacist-in-charge shall develop policies to ensure that:
(I) the patient's response to drug therapy is monitored and conveyed to the appropriate health care provider; and
(II) the first dose of any new drug therapy is administered in the presence of an individual qualified to monitor for and respond to adverse drug reactions.
(B) Sterile preparation compounded pursuant to medication orders (inpatients).
(i) Education. The pharmacist-in-charge in cooperation with appropriate multi-disciplinary staff of the facility shall develop policies to ensure that:
(I) the patient and/or patient's caregiver receives information regarding drugs and their safe and appropriate use; and
(II) healthcare providers are provided with patient specific drug information.
(ii) Patient monitoring. The pharmacist-in-charge in cooperation with appropriate multi-disciplinary staff of the facility shall develop policies to ensure that the patient's response to drug therapy is monitored and conveyed to the appropriate healthcare provider.
(10) Drugs, components, and materials used in sterile compounding.
(A) Drugs used in sterile compounding shall be a USP/NF grade substances manufactured in an FDA-registered facility.
(B) If USP/NF grade substances are not available shall be of a chemical grade in one of the following categories:
(i) Chemically Pure (CP);
(ii) Analytical Reagent (AR);
(iii) American Chemical Society (ACS); or
(iv) Food Chemical Codex.
(C) If a drug, component or material is not purchased from a FDA-registered facility, the pharmacist shall establish purity and stability by obtaining a Certificate of Analysis from the supplier and the pharmacist shall compare the monograph of drugs in a similar class to the Certificate of Analysis.
(D) All components shall:
(i) be manufactured in an FDA-registered facility; or
(ii) in the professional judgment of the pharmacist, be of high quality and obtained from acceptable and reliable alternative sources; and
(iii) stored in properly labeled containers in a clean, dry area, under proper temperatures.
(E) Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the compounded drug preparation beyond the desired result.
(F) Components, drug preparation containers, and closures shall be rotated so that the oldest stock is used first.
(G) Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the compounded drug preparation.
(H) A pharmacy may not compound a preparation that contains ingredients appearing on a federal Food and Drug Administration list of drug products withdrawn or removed from the market for safety reasons.
(11) Compounding process.
(A) Standard operating procedures (SOPs). All significant procedures performed in the compounding area shall be covered by written SOPs designed to ensure accountability, accuracy, quality, safety, and uniformity in the compounding process. At a minimum, SOPs shall be developed for:
(i) the facility;
(ii) equipment;
(iii) personnel;
(iv) preparation evaluation;
(v) quality assurance;
(vi) preparation recall;
(vii) packaging; and
(viii) storage of compounded sterile preparations.
(B) USP/NF. Any compounded formulation with an official monograph in the USP/NF shall be compounded, labeled, and packaged in conformity with the USP/NF monograph for the drug.
(C) Personnel Cleansing and Garbing.
(i) Any person with an apparent illness or open lesion that may adversely affect the safety or quality of a drug preparation being compounded shall be excluded from direct contact with components, drug preparation containers, closures, any materials involved in the compounding process, and drug products until the condition is corrected.
(ii) Before entering the clean area, compounding personnel must remove the following:
(I) personal outer garments (e.g., bandanas, coats, hats, jackets, scarves, sweaters, vests);
(II) all cosmetics, because they shed flakes and particles; and
(III) all hand, wrist, and other body jewelry.
(iii) The wearing of artificial nails or extenders is prohibited while working in the sterile compounding environment.
(iv) Personnel must don personal protective equipment and perform hand hygiene in an order that proceeds from the dirtiest to the cleanest activities as follows:
(I) Activities considered the dirtiest include donning of dedicated shoes or shoe covers, head and facial hair covers (e.g., beard covers in addition to face masks), and face mask/eye shield. Eye shields are optional unless working with irritants like germicidal disinfecting agents.
(II) After donning dedicated shoes or shoe covers, head and facial hair covers, and face masks, personnel shall perform a hand hygiene procedure by removing debris from underneath fingernails using a nail cleaner under running warm water followed by vigorous hand washing. Personnel shall begin washing arms at the hands and continue washing to elbows for at least 30 seconds with either a plain (non-antimicrobial) soap, or antimicrobial soap, and water while in the anteroom/ante-area.
(III) After completion of hand washing, personnel shall don non-shedding disposable gowns with sleeves that fit snugly around the wrists.
(IV) Gloves that form a continuous barrier with the gown shall be the last item donned before compounding begins.
(V) Gloves shall be disinfected by applying 70% IPA or appropriate disinfectant to all contact surface areas of the gloves and letting the gloves dry thoroughly. Routine application of 70% IPA shall occur throughout the compounding day and whenever nonsterile surfaces are touched.
(VI) When compounding personnel must temporarily exit the ISO Class 7 environment during a work shift, the exterior gown, if not visibly soiled, may be removed and retained in the ISO Class 8 anteroom/ante-area, to be re-donned during that same work shift only. However, shoe covers, hair and facial hair covers, face mask/eye shield, and gloves must be replaced with new ones before re-entering the ISO Class 7 clean environment along with performing proper hand hygiene.
(D) At each step of the compounding process, the pharmacist shall ensure that components used in compounding are accurately weighed, measured, or subdivided as appropriate to conform to the formula being prepared.
(12) Quality Assurance.
(A) Initial Formula Validation. Prior to routine compounding of a sterile preparation, a pharmacy shall conduct an evaluation that shows that the pharmacy is capable of compounding a product that is sterile and that contains the stated amount of active ingredient(s).
(i) Low risk preparations.
(I) Quality assurance practices include, but are not limited to the following:
(-a-) Routine disinfection and air quality testing of the direct compounding environment to minimize microbial surface contamination and maintain ISO Class 5 air quality.
(-b-) Visual confirmation that compounding personnel are properly donning and wearing appropriate items and types of protective garments and goggles.
(-c-) Review of all orders and packages of ingredients to ensure that the correct identity and amounts of ingredients were compounded.
(-d-) Visual inspection of compounded sterile preparations to ensure the absence of particulate matter in solutions, the absence of leakage from vials and bags, and the accuracy and thoroughness of labeling.
(II) Example of a Media-Fill Test Procedure. This, or an equivalent test, is performed at least annually by each person authorized to compound in a low-risk level under conditions that closely simulate the most challenging or stressful conditions encountered during compounding of low-risk level sterile produce. Once begun, this test is completed without interruption within an ISO Class 5 air quality environment. Three sets of four 5-milliliter aliquots of sterile Soybean--Casein Digest Medium are transferred with the same sterile 10-milliliter syringe and vented needle combination into separate sealed, empty, sterile 30-milliliter clear vials (i.e., four 5-milliliter aliquots into each of three 30-milliliter vials). Sterile adhesive seals are aseptically affixed to the rubber closures on the three filled vials. The vials are incubated within a range of 20 - 35 degrees Celsius for 14 days. Failure is indicated by visible turbidity in the medium on or before 14 days. The media-fill test must include a positive-control sample.
(ii) Medium risk preparations.
(I) Quality assurance procedures for medium-risk level compounded sterile preparations include all those for low-risk level compounded sterile preparations, as well as a more challenging media-fill test passed annually, or more frequently.
(II) Example of a Media-Fill Test Procedure. This, or an equivalent test, is performed at least annually under conditions that closely simulate the most challenging or stressful conditions encountered during compounding. This test is completed without interruption within an ISO Class 5 air quality environment. Six 100-milliliter aliquots of sterile Soybean--Casein Digest Medium are aseptically transferred by gravity through separate tubing sets into separate evacuated sterile containers. The six containers are then arranged as three pairs, and a sterile 10-milliliter syringe and 18-gauge needle combination is used to exchange two 5-milliliter aliquots of medium from one container to the other container in the pair. For example, after a 5-milliliter aliquot from the first container is added to the second container in the pair, the second container is agitated for 10 seconds, then a 5-milliliter aliquot is removed and returned to the first container in the pair. The first container is then agitated for 10 seconds, and the next 5-milliliter aliquot is transferred from it back to the second container in the pair. Following the two 5-milliliter aliquot exchanges in each pair of containers, a 5-milliliter aliquot of medium from each container is aseptically injected into a sealed, empty, sterile 10-milliliter clear vial, using a sterile 10-milliliter syringe and vented needle. Sterile adhesive seals are aseptically affixed to the rubber closures on the three filled vials. The vials are incubated within a range of 20 - 35 degrees Celsius for 14 days. Failure is indicated by visible turbidity in the medium on or before 14 days. The media-fill test must include a positive-control sample.
(iii) High risk preparations.
(I) Procedures for high-risk level compounded sterile preparations include all those for low-risk level compounded sterile preparations. In addition, a media-fill test that represents high-risk level compounding is performed twice a year by each person authorized to compound high-risk level compounded sterile preparations.
(II) Example of a Media-Fill Test Procedure Compounded Sterile Preparations Sterilized by Filtration. This test, or an equivalent test, is performed under conditions that closely simulate the most challenging or stressful conditions encountered when compounding high-risk level compounded sterile preparations. Note: Sterility tests for autoclaved compounded sterile preparations are not required unless they are prepared in batches of more than 25 units. This test is completed without interruption in the following sequence:
(-a-) Dissolve 3 grams of nonsterile commercially available Soybean--Casein Digest Medium in 100 milliliters of non-bacteriostatic water to make a 3% non-sterile solution.
(-b-) Draw 25 milliliters of the medium into each of three 30-milliliter sterile syringes. Transfer 5 milliliters from each syringe into separate sterile 10-milliliter vials. These vials are the positive controls to generate exponential microbial growth, which is indicated by visible turbidity upon incubation.
(-c-) Under aseptic conditions and using aseptic techniques, affix a sterile 0.2-micron porosity filter unit and a 20-gauge needle to each syringe. Inject the next 10 milliliters from each syringe into three separate 10-milliliter sterile vials. Repeat the process for three more vials. Label all vials, affix sterile adhesive seals to the closure of the nine vials, and incubate them at 20 to 35 degrees Celsius. Inspect for microbial growth over 14 days as described in Chapter 797 Pharmaceutical Compounding - Sterile Preparations, of the USP/NF.
(B) Finished preparation release checks and tests.
(i) High-risk level compounded sterile preparations. All high-risk level compounded sterile preparations that are prepared in groups of more than 25 identical individual single-dose packages (such as ampuls, bags, syringes, and vials), or in multiple dose vials for administration to multiple patients, or are exposed longer than 12 hours at 2 - 8 degrees Celsius (36 - 46 degrees Fahrenheit) and longer than six hours at warmer than 8 degrees Celsius (46 degrees Fahrenheit) before they are sterilized shall be tested to ensure they are sterile and do not contain excessive bacterial endotoxins as specified in Chapter 71, Sterility Tests of the USP/NF.
(ii) All compounded sterile preparations that are intended to be solutions must be visually examined for the presence of particulate matter and not administered or dispensed when such matter is observed.
(iii) The prescription drug and medication orders, written compounding procedure, preparation records, and expended materials used to make compounded sterile preparations at all contamination risk levels shall be inspected for accuracy of correct identities and amounts of ingredients, aseptic mixing and sterilization, packaging, labeling, and expected physical appearance before they are administered or dispensed.
(13) Quality control.
(A) Quality control procedures. The pharmacy shall follow established quality control procedures to monitor the compounding environment and quality of compounded drug preparations for conformity with the quality indicators established for the preparation. When developing these procedures, pharmacy personnel shall consider the provisions of Chapter 797, Pharmaceutical Compounding - Sterile Preparations, Chapter 1075, Good Compounding Practices, and Chapter 1160, Pharmaceutical Calculations in Prescription Compounding of the current USP/NF. Such procedures shall be documented and be available for inspection.
(B) Verification of compounding accuracy and sterility.
(i) The accuracy of identities, concentrations, amounts, and purities of ingredients in compounded sterile preparations shall be confirmed by reviewing labels on packages, observing and documenting correct measurements with approved and correctly standardized devices, and reviewing information in labeling and certificates of analysis provided by suppliers.
(ii) If the correct identify, purity, strength, and sterility of ingredients and components of compounded sterile preparations cannot be confirmed such ingredients and components shall be discarded immediately.
(iii) If individual ingredients, such as bulk drug substances, are not labeled with expiration dates, when the drug substances are stable indefinitely in their commercial packages under labeled storage conditions, such ingredients may gain or lose moisture during storage and use and shall require testing to determine the correct amount to weigh for accurate content of active chemical moieties in compounded sterile preparations.
(e) Records.
(1) Maintenance of records. Every record required under this section must be:
(A) kept by the provider pharmacy and be available, for at least two years for inspecting and copying by the board or its representative and to other authorized local, state, or federal law enforcement agencies; and
(B) supplied by the provider pharmacy within 72 hours, if requested by an authorized agent of the Texas State Board of Pharmacy. If the pharmacy maintains the records in an electronic format, the requested records must be provided in an electronic format. Failure to provide the records set out in this section, either on site or within 72 hours, constitutes prima facie evidence of failure to keep and maintain records in violation of the Act.
(2) Compounding records.
(A) Compounding pursuant to patient specific prescription drug or medication orders. Compounding records for all compounded pharmaceuticals shall be maintained by the pharmacy electronically or manually as part of the prescription drug or medication order, formula record, formula book, or compounding log and shall include:
(i) the date of preparation;
(ii) a complete formula, including methodology and necessary equipment which includes the brand name(s) of the raw materials, or if no brand name, the generic name(s) or official name and name(s) of the manufacturer(s) or distributor of the raw materials and the quantities of each;
(iii) signature or initials of the pharmacist or pharmacy technician or pharmacy technician trainee performing the compounding;
(iv) signature or initials of the pharmacist responsible for supervising pharmacy technicians or pharmacy technician trainees and conducting in-process and finals checks of compounded pharmaceuticals if pharmacy technicians or pharmacy technician trainees perform the compounding function;
(v) the quantity in units of finished products or amount of raw materials;
(vi) the container used and the number of units prepared; and
(vii) a reference to the location of the following documentation which may be maintained with other records, such as quality control records:
(I) the criteria used to determine the beyond-use date; and
(II) documentation of performance of quality control procedures.
(B) Compounding records when batch compounding or compounding in anticipation of future prescription drug or medication orders.
(i) Master work sheet. A master work sheet shall be developed and approved by a pharmacist for preparations prepared in batch. Once approved, a duplicate of the master work sheet shall be used as the preparation work sheet from which each batch is prepared and on which all documentation for that batch occurs. The master work sheet shall contain at a minimum:
(I) the formula;
(II) the components;
(III) the compounding directions;
(IV) a sample label;
(V) evaluation and testing requirements;
(VI) specific equipment used during preparation; and
(VII) storage requirements.
(ii) Preparation work sheet. The preparation work sheet for each batch of preparations shall document the following:
(I) identity of all solutions and ingredients and their corresponding amounts, concentrations, or volumes;
(II) lot number for each component;
(III) component manufacturer/distributor or suitable identifying number;
(IV) container specifications (e.g., syringe, pump cassette);
(V) unique lot or control number assigned to batch;
(VI) expiration date of batch-prepared preparations;
(VII) date of preparation;
(VIII) name, initials, or electronic signature of the person(s) involved in the preparation;
(IX) name, initials, or electronic signature of the responsible pharmacist;
(X) finished preparation evaluation and testing specifications, if applicable; and
(XI) comparison of actual yield to anticipated or theoretical yield, when appropriate.
(f) Office Use Compounding and Distribution of Compounded Preparations to Class C Pharmacies or Veterinarians in Accordance with Section 563.054 of the Act.
(1) General.
(A) A pharmacy may dispense and deliver a reasonable quantity of a compounded preparation to a practitioner for office use by the practitioner in accordance with this subsection.
(B) A Class A (Community) pharmacy is not required to register or be licensed under Chapter 431, Health and Safety Code, to distribute sterile compounded preparations to a Class C (Institutional) pharmacy.
(C) A Class C (Institutional) pharmacy is not required to register or be licensed under Chapter 431, Health and Safety Code, to distribute sterile compounded preparations that the Class C pharmacy has compounded for other Class C pharmacies under common ownership.
(D) To dispense and deliver a compounded preparation under this subsection, a pharmacy must:
(i) verify the source of the raw materials to be used in a compounded drug;
(ii) comply with applicable United States Pharmacopoeia guidelines, including the testing requirements, and the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191);
(iii) enter into a written agreement with a practitioner for the practitioner's office use of a compounded preparation;
(iv) comply with all applicable competency and accrediting standards as determined by the board; and
(v) comply with the provisions of this subsection.
(2) Written Agreement. A pharmacy that provides sterile compounded preparations to practitioners for office use or to another pharmacy shall enter into a written agreement with the practitioner or pharmacy. The written agreement shall:
(A) address acceptable standards of practice for a compounding pharmacy and a practitioner and receiving pharmacy that enter into the agreement including a statement that the compounded drugs may only be administered to the patient and may not be dispensed to the patient or sold to any other person or entity except as authorized by Section 563.054 of the Act;
(B) require the practitioner or receiving pharmacy to include on a patient's chart, medication order or medication administration record the lot number and beyond-use date of a compounded preparation administered to a patient;
(C) describe the scope of services to be performed by the pharmacy and practitioner or receiving pharmacy, including a statement of the process for:
(i) a patient to report an adverse reaction or submit a complaint; and
(ii) the pharmacy to recall batches of compounded preparations.
(3) Recordkeeping.
(A) Maintenance of Records.
(i) Records of orders and distribution of sterile compounded preparations to a practitioner for office use or to a Class C pharmacy for administration to a patient shall:
(I) be kept by the pharmacy and be available, for at least two years from the date of the record, for inspecting and copying by the board or its representative and to other authorized local, state, or federal law enforcement agencies;
(II) maintained separately from the records of products dispensed pursuant to a prescription or medication order; and
(III) supplied by the pharmacy within 72 hours, if requested by an authorized agent of the Texas State Board of Pharmacy or its representative. If the pharmacy maintains the records in an electronic format, the requested records must be provided in an electronic format. Failure to provide the records set out in this subsection, either on site or within 72 hours for whatever reason, constitutes prima facie evidence of failure to keep and maintain records.
(ii) Records may be maintained in an alternative data retention system, such as a data processing system or direct imaging system provided the data processing system is capable of producing a hard copy of the record upon the request of the board, its representative, or other authorized local, state, or federal law enforcement or regulatory agencies.
(B) Orders. The pharmacy shall maintain a record of all sterile compounded preparations ordered by a practitioner for office use or by a Class C pharmacy for administration to a patient. The record shall include the following information:
(i) date of the order;
(ii) name, address, and phone number of the practitioner who ordered the preparation and if applicable, the name, address and phone number of the Class C Pharmacy ordering the preparation; and
(iii) name, strength, and quantity of the preparation ordered.
(C) Distributions. The pharmacy shall maintain a record of all sterile compounded preparations distributed pursuant to an order to a practitioner for office use or by a Class C pharmacy for administration to a patient. The record shall include the following information:
(i) date the preparation was compounded;
(ii) date the preparation was distributed;
(iii) name, strength and quantity in each container of the preparation;
(iv) pharmacy's lot number;
(v) quantity of containers shipped; and
(vi) name, address, and phone number of the practitioner or Class C Pharmacy to whom the preparation is distributed.
(D) Audit Trail.
(i) The pharmacy shall store the order and distribution records of preparations for all sterile compounded preparations ordered by and or distributed to a practitioner for office use or by a Class C pharmacy for administration to a patient in such a manner as to be able to provide a audit trail for all orders and distributions of any of the following during a specified time period.
(I) any strength and dosage form of a preparation (by either brand or generic name or both);
(II) any ingredient;
(III) any lot number;
(IV) any practitioner;
(V) any facility; and
(VI) any pharmacy, if applicable.
(ii) The audit trail shall contain the following information:
(I) date of order and date of the distribution;
(II) practitioner's name, address, and name of the Class C pharmacy, if applicable;
(III) name, strength and quantity of the preparation in each container of the preparation;
(IV) name and quantity of each active ingredient;
(V) quantity of containers distributed; and
(VI) pharmacy's lot number;
(4) Labeling. The pharmacy shall affix a label to the preparation containing the following information:
(A) name, address, and phone number of the compounding pharmacy;
(B) the statement: "For Institutional or Office Use Only - Not for Resale"; or if the preparation is distributed to a veterinarian the statement: "Compounded Preparation";
(C) name and strength of the preparation or list of the active ingredients and strengths;
(D) pharmacy's lot number;
(E) beyond-use date as determined by the pharmacist using appropriate documented criteria;
(F) quantity or amount in the container;
(G) appropriate ancillary instructions, such as storage instructions or cautionary statements, including hazardous drug warning labels where appropriate; and
(H) device-specific instructions, where appropriate.
(g) Recall Procedures.
(1) The pharmacy shall have written procedure for the recall of any compounded sterile preparations provided to a patient, to a practitioner for office use, or to a pharmacy for administration. The recall procedures shall require:
(A) notification to each practitioner, facility, and/or pharmacy to which the preparation was distributed;
(B) notification to each patient to whom the preparation was dispensed;
(C) quarantine of the product if there is a suspicion of harm to a patient; and
(D) a recall if there is probable or confirmed harm to a patient.
(2) If the pharmacy identifies a suspicion of, probable, or confirmed harm to a patient, the pharmacy shall immediately notify and provide information as required by the board to the following:
(A) the Texas Department of State Health Services, Drugs and Medical Devices Group, if the preparation is distributed for office use; and
(B) the board.
(3) The board may require a pharmacy to institute a recall if there is probable or confirmed harm to a patient.
This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of the Secretary of State on June 4, 2007.
TRD-200702243
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: July 15, 2007
For further information, please call: (512) 305-8028
The Texas State Board of Pharmacy proposes amendments to §295.5, concerning Pharmacist License or Renewal Fees and §295.9, concerning Inactive License. The proposed amendments to §295.5, if adopted, will raise pharmacist license fees based on increased expenses. The proposed amendments to §295.9, if adopted, require pharmacists wanting to reactivate an inactive license to submit proof of completion of 30 hours of approved continuing education.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for the first five-year period the amendments are in effect, there will be fiscal implications for state government as a result of enforcing or administering the amended sections as follows:
Revenue Increase
FY2008 = $546,771
FY2009 = $596,496
FY2010 = $596,496
FY2011 = $596,496
FY2012 = $596,496
There are no anticipated fiscal implications for local government.
Ms. Dodson has determined that, for each year of the first five year period the amendments will be in effect, the public benefit anticipated as a result of enforcing the amended sections will be assuring that the Texas State Board of Pharmacy is adequately funded to carry out its mission. The effect on large, small or micro-businesses (pharmacies) will be the same as the economic cost to an individual, if the pharmacy chooses to pay the fee for the individual.
Economic cost to persons who are required to comply with the amended sections will be an increase of $51 for an initial registration and an increase of $51 for the renewal of a registration.
Comments on the proposed amendments may be submitted to Allison Benz, R.Ph., M.S., Director of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Austin, Texas 78701, FAX (512) 305-8082. Comments must be received by 5:00 p.m., July 30, 2007.
The amendments are proposed under §§551.002, 554.051, 559.101 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act. The Board interprets §559.101 as authorizing the Board to adopt rules regarding inactive licenses.
The statutes affected by the amendments: Chapters 551 - 566 and 568 - 569, Texas Occupations Code.
§295.5.Pharmacist License or Renewal Fees.
(a) (No change.)
(b) Initial License Fee.
(1) The fee for the initial license shall be
$239
[
$191
] for a two year registration and for processing the application
and issuance of the pharmacist license as authorized by the Act, §554.006.
(2) In addition, the following fees shall be collected:
(A)
$13
[
$10
] surcharge to fund a program
to aid impaired pharmacists and pharmacy students as authorized by the Act, §564.051;
(B) - (C) (No change.)
(3) (No change.)
(c) Renewal Fee.
(1) The fee for biennial renewal of a pharmacist license shall be
$239
[
$191
] for processing the application and issuance
of the pharmacist license as authorized by the Act, §554.006.
(2) In addition, the following fees shall be collected:
(A)
$13
[
$10
] surcharge to fund a program
to aid impaired pharmacists and pharmacy students as authorized by the Act, §564.051;
(B) - (C) (No change.)
(d) - (e) (No change.)
§295.9.Inactive License.
(a) - (b) (No change.)
(c) Reactivation of an inactive license.
(1) A holder of a license that is on inactive status may return the license to active status by:
(A) (No change.)
(B) providing copies of completion certificates from approved
continuing education programs as specified in §295.8(e) of this title
(relating to Continuing Education Requirements) for
30 hours
[
the number of hours that would otherwise have been required for the renewal
of the license, up to 45 hours
]. Approved continuing education earned
within two years prior to the licensee applying for the return to active status
may be applied toward the continuing education requirement
for reactivation
of the license but may not be counted toward subsequent renewal of the license
; and
(C) (No change.)
(2) If the application for reactivation of the license is made
at the time of license renewal, the applicant shall pay the license renewal
fee specified in §295.5 of this title (relating to Pharmacist License
or Renewal Fees). If the application for reactivation of the license is made
at a time other than the time of license renewal, the applicant shall pay
the fee for issuance of an amended license to practice pharmacy as specified
in §295.5
(e)
[
(d)
] of this title (relating to Pharmacist
License or Renewal Fees).
(3) In an emergency caused by a natural or manmade disaster
or any other exceptional situation that causes an extraordinary demand for
pharmacist services, the executive director of the board, in his/her discretion,
may allow pharmacists whose license has been inactive for no more than two
years to reactivate their license prior to obtaining the required continuing
education specified in paragraph
(1)(B)
[
(2)
] of this
subsection, provided the pharmacist completes the continuing education requirement
within six months of reactivation of the license. If the required continuing
education is not provided within six months, the license shall return to an
inactive status.
This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of the Secretary of State on June 4, 2007.
TRD-200702217
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: July 15, 2007
For further information, please call: (512) 305-8028
The Texas State Board of Pharmacy proposes amendments to §297.3, concerning Registration Requirements and §297.4, concerning Fees. The proposed amendments to §297.3, if adopted, will recognize the abbreviation "Ph.T.R." to be used by registered pharmacy technicians. The proposed amendments to §297.4 will raise pharmacy technician registration fees based on increased expenses.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for the first five-year period the amendments are in effect, there will be fiscal implications for state government as a result of enforcing or administering the amended sections as follows:
Revenue Increase
FY2008 = $142,208
FY2009 = $155,000
FY2010 = $155,000
FY2011 = $155,000
FY2012 = $155,000
There are no anticipated fiscal implications for local government.
Ms. Dodson has determined that, for each year of the first five year period the amendments will be in effect, the public benefit anticipated as a result of enforcing the amended sections will be assuring that the Texas State Board of Pharmacy is adequately funded to carry out its mission. The effect on large, small or micro-businesses (pharmacies) will be the same as the economic cost to an individual, if the pharmacy chooses to pay the individual fee.
Economic cost to persons who are required to comply with the amended sections will be an increase of $10 for an initial registration and an increase of $10 for the renewal of a registration.
Comments on the proposed amendments may be submitted to Allison Benz, R.Ph., M.S., Director of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Austin, Texas 78701, FAX (512) 305-8082. Comments must be received by 5:00 p.m., July 30, 2007.
The amendments are proposed under §551.002 and §554.051 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by the amendments: Chapters 551 - 566 and 568 - 569, Texas Occupations Code.
§297.3.Registration Requirements.
(a) - (d) (No change.)
(e) An individual may use the title "Registered Pharmacy Technician" or "Ph.T.R." if the individual is registered as a pharmacy technician in this state.
§297.4.Fees.
(a) (No change.)
(b) Pharmacy technician.
(1) (No change.)
(2) Initial Registration Fee.
(A) The fee for initial registration shall be
$64
[
$54
] for a two year registration and is composed of the following fees:
(i)
$56
[
$46
] for processing the application
and issuance of the pharmacy technician registration as authorized by the
Act, §568.005;
(ii) - (iii) (No change.)
(B) (No change.)
(3) Renewal Fee. The fee for biennial renewal of a pharmacy
technician registration shall be
$61
[
$51
] and is composed
of the following:
(A)
$56
[
$46
] for processing the application
and issuance of the pharmacy technician registration as authorized by the
Act, §568.005;
(B) - (C) (No change.)
(c) (No change.)
This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of the Secretary of State on June 4, 2007.
TRD-200702218
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: July 15, 2007
For further information, please call: (512) 305-8028