Part 15.
TEXAS STATE BOARD OF PHARMACY
Chapter 281.
ADMINISTRATIVE PRACTICE AND PROCEDURES
Subchapter A. GENERAL PROVISIONS
22 TAC §281.18
The Texas State Board of Pharmacy proposes new §281.18,
concerning Reporting Professional Liability Claims. The new rule, if adopted,
will implement the provisions of Senate Bill 730 (76th Legislative Session)
regarding the reporting of professional liability claims to the Texas State
Board of Pharmacy.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for
the first five-year period the rule is in effect, there will be fiscal implications
for the state as a result of enforcing or administering the rule. There are
no anticipated fiscal implications for local government. The fiscal implications
for the state are based on the cost of enforcing and/or administering the
rule by the Texas State Board of Pharmacy. Costs for the first year of the
new program will include setup costs as well as costs to administer the program.
The estimated cost to the Texas State Board of Pharmacy for the next five
years will be: FY2000--$232,175; FY2001--$160,010; FY2002--$160,010; FY2003--$160,010;
and FY2004--$160,010.
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 protection of the public by identifying licensees
who have had malpractice claims filed against them and by taking action against
the licensee when appropriate. In most cases, the malpractice insurance carrier
will be filing the report with the agency. The costs/fiscal implications to
small and large businesses or to other entities who are required to comply
with this section cannot be determined by the agency due to the variability
in the internal policies of malpractice insurance carriers. It is anticipated
that the report form will take 10 to 15 minutes to complete but could vary
greatly depending on internal policies of the insurance carrier.
Comments on the proposal may be submitted to Steve Morse, R.Ph., Director
of Compliance, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite
3-600, Box 21, Austin, Texas, 78701-3942.
The new section is proposed under §42 of the Texas Pharmacy
Act (Article 4542a-1, Texas Civil Statutes), as added in Senate Bill 730 by
the 76th Legislature, and §554.051 of the Occupations Code. The Board
interprets §42 of the Texas Pharmacy Act as authorizing the agency to
adopt rules to for reporting professional liability claims. The Board interprets §554.051
of the Occupations Code as authorizing the agency to adopt rules for the proper
administration and enforcement of the Act.
The statutes affected by this rule: Texas Civil Statutes, Article 4542a-1,
now codified as Occupations Code Subtitle J.
§281.18.Reporting Professional Liability Claims.
(a)
Reporting responsibilities.
(1)
Every insurer or other entity providing pharmacist's professional
liability insurance, pharmacy technician professional and supplemental liability
insurance, or druggist's professional liability insurance covering a pharmacist,
pharmacy technician, or pharmacy license holder in this state shall submit
to the board the information described in subsection (b) of this section at
the time prescribed.
(2)
The information shall be provided with respect to
a notice of claim letter or complaint filed against an insured in a court,
if the notice or complaint seeks damages relating to the insured's conduct
in providing or failing to provide appropriate service within the scope of
pharmaceutical care or services, and with respect to settlement of a claim
or lawsuit made on behalf of the insured.
(3)
If a pharmacist, pharmacy technician, or a pharmacy
licensed in this state does not carry or is not covered by pharmacist's professional
liability insurance, pharmacy technician professional and supplemental liability
insurance, or druggist's professional liability insurance, or if a pharmacist,
pharmacy technician, or a pharmacy licensed in this state is insured by a
non-admitted carrier or other entity providing pharmacy professional liability
insurance that does not report under this Act, the duty to report information
under subsection (b) of this section is the responsibility of the particular
pharmacist, pharmacy technician, or pharmacy license holder.
(4)
For the purposes of this section a professional liability
claim or complaint shall be defined as a cause of action against a pharmacist,
pharmacy, or pharmacy technician for conduct in providing or failing to provide
appropriate service within the scope of pharmaceutical care or services, which
proximately results in injury to or death of the patient, whether the patient's
claim or cause of action sounds in tort or contract, to include pharmacist's
interns, pharmacy residents, supervising pharmacists, on-call pharmacists,
consulting pharmacists.
(b)
Information to be reported and due dates.
(1)
Initial report. Not later than the 30th day after receipt
of the notice of claim letter or complaint by the insurer if the insurer has
the duty to report, or by the pharmacist, pharmacy technician, or a pharmacy
if the license holder has the duty to report, the following information must
be furnished to the board on a form provided by the board:
(A)
the name and address of the insurer;
(B)
the name and address of the insured and type of license
or registration held (pharmacist, pharmacy or pharmacy technician):
(C)
the insured's Texas pharmacist or pharmacy license number
or pharmacy technician registration number;
(D)
certification, if applicable;
(E)
the policy number;
(F)
name(s) of plaintiff(s);
(G)
date of injury;
(H)
county of injury;
(I)
cause of injury, e.g., dispensing error;
(J)
nature of injury;
(K)
type of action, e.g., claim only or lawsuit;
(L)
name and phone number of the person filing the report;
and
(M)
a copy of the notice of claim letter or the lawsuit filed
in court.
(2)
Follow-up report. Within 105 days after disposition
of the claim, the following information must be provided to the board on a
form provided by the board:
(A)
the name and address of the insured and type of license
or registration held (pharmacist, pharmacy or pharmacy technician):
(B)
the insured's Texas pharmacist or pharmacy license number
or pharmacy technician registration number;
(C)
name(s) of plaintiff(s);
(D)
date of disposition;
(E)
type of disposition, e.g., settlement, judgment;
(F)
amount of disposition;
(G)
whether an appeal has been taken and by which party; and
(H)
name and phone number of the person filing the report.
(3)
Definition. For the purpose of this section,
disposition of a claim shall include circumstances where a court order has
been entered, a settlement agreement has been reached, or the complaint has
been dropped or dismissed.
(c)
Report format
(1)
Separate reports are required for each defendant licensee
or registrant.
(2)
The information shall be reported on a form provided
by the board.
(3)
A court order or settlement agreement may be submitted
as an attachment to the follow-up report.
(d)
Claims not required to be reported. Examples of claims
that are not required to be reported under this section are the following:
(1)
product liability claims (i.e., where a licensee invented
a medical device which may have injured a patient but the licensee has no
personal pharmacist-patient relationship with the specific patient claiming
injury by the device);
(2)
antitrust allegations;
(3)
allegations involving improper peer review activities;
(4)
civil rights violations; or
(5)
allegations of liability for injuries occurring on
a licensee's property, but not involving a breach of duty (i.e., slip and
fall accidents).
(e)
Liability. An insurer reporting under this section, its
agents or employees, or the board or its employees or representatives are
not liable for damages in a suit brought by any person or entity for reporting
as required by this section or for any other action taken under this section.
(f)
Limit on use of information reported.
(1)
Information submitted to the board under this section and
the fact that the information has been submitted to the board may not be:
(A)
offered in evidence or used in any manner in the trial
of a suit described in this section; or
(B)
used in any manner to determine the eligibility or credentialing
of a pharmacy to participate in a health insurance plan defined by the Insurance
Code.
(2)
A report received by the board under this section
is not a complaint for which a board investigation is required except that
the board shall review the information relating to a pharmacist, pharmacy
technician, or pharmacy license holder against whom at least three professional
liability claims have been reported within a five-year period in the same
manner as if a complaint against the pharmacist, pharmacy technician, or pharmacy
license holder had been made under Chapter 555 of the Act. The board may initiate
an investigation of pharmacist, pharmacy technician, or pharmacy license holder
based on the information received under this section.
(3)
The information received under this section may be
used in any board proceedings as the board deems necessary.
(g)
Confidentiality. Information submitted under this section
is confidential, except as provided in subsection (f)(3) of this section,
and is not subject to disclosure under Chapter 552, Government Code.
(h)
Penalty. The Texas Department of Insurance may impose on
any insurer subject to this Act sanctions authorized by §§82.051-82.055
(formerly §7, Article 1.10) of the Texas Insurance Code, if the insurer
fails to report information as required by this section.
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
December 23, 1999.
TRD-9909022
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: February 6, 2000
For further information, please call: (512) 305-8028
22 TAC §281.57
The Texas State Board of Pharmacy proposes new §281.57,
concerning Disciplinary Guidelines. The new rule, if adopted, will provide
guidance and promote consistency for sanctions in contested cases.
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: (1) provide guidance and a framework of analysis
for administrative law judges in the making of recommendations in contested
licensure and disciplinary matters; (2) promote consistency in the exercise
of sound discretion by board members in the imposition of sanctions in disciplinary
matters; and (3) provide guidance for board members for the resolution of
potentially contested matters. There are no anticipated economic costs to
small or large businesses or to other entities who are required to comply
with this section as proposed.
Comments on the proposal may be submitted to Steve Morse, R.Ph., Director
of Compliance, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite
3-600, Box 21, Austin, Texas, 78701-3942.
The new section is proposed under §554.002 and §554.051
of the Texas Pharmacy Act (Subtitle J, Chapters 551-564, Occupations Code).
The Board interprets §554.002 of the Texas Pharmacy Act as authorizing
the agency to regulate the practice of pharmacy by enforcing the provisions
of the Act relating to the suspension, revocation, retirement, or restriction
of a license to practice pharmacy or to operate a pharmacy or the imposition
of an administrative penalty or reprimand on a license holder. The Board interprets §554.051
of the Texas Pharmacy Act as authorizing the agency to adopt rules for the
proper administration and enforcement of the Act.
The statutes affected by this rule: Occupations Code, Subtitle J.
§281.57.Disciplinary Guidelines.
(a)
Purpose. This section is promulgated to:
(1)
provide guidance and a framework of analysis for administrative
law judges in the making of recommendations in contested licensure and disciplinary
matters;
(2)
promote consistency in the exercise of sound discretion
by board members in the imposition of sanctions in disciplinary matters; and
(3)
provide guidance for board members for the resolution
of potentially contested matters.
(b)
Limitations. This chapter shall be construed and applied
so as to preserve board member discretion in the imposition of sanctions and
remedial measures pursuant to Chapter 566, Occupations Code. This chapter
shall be further construed and applied so as to be consistent with the Act,
and shall be limited to the extent as otherwise proscribed by statute and
board rule.
(c)
Aggravation. The following may be considered as aggravating
factors so as to merit more severe or more restrictive action by the board:
(1)
patient harm and the severity of patient harm;
(2)
economic harm to any individual or entity and the
severity of such harm;
(3)
environmental harm and severity of such harm;
(4)
increased potential for harm to the public;
(5)
attempted concealment of misconduct;
(6)
premeditated misconduct;
(7)
intentional misconduct;
(8)
motive;
(9)
prior misconduct of a similar or related nature;
(10)
disciplinary history;
(11)
prior written warnings or written admonishments from
any government agency or official regarding statutes or regulations pertaining
to the misconduct;
(12)
violation of a board order;
(13)
failure to implement remedial measures to correct
or mitigate harm from the misconduct;
(14)
lack of rehabilitative potential or likelihood for
future misconduct of a similar nature; and
(15)
relevant circumstances increasing the seriousness
of the misconduct.
(d)
Extenuation and Mitigation. The following may be considered
as extenuating and mitigating factors so as to merit less severe or less restrictive
action by the board:
(1)
absence of patient harm;
(2)
absence of economic harm to any individual or entity;
(3)
absence of environmental harm;
(4)
absence of potential harm to the public;
(5)
self-reported and voluntary admissions of misconduct;
(6)
absence of premeditation to commit misconduct;
(7)
absence of intent to commit misconduct;
(8)
motive;
(9)
absence of prior misconduct of a similar or related
nature;
(10)
absence of a disciplinary history;
(11)
implementation of remedial measures to correct or
mitigate harm from the misconduct;
(12)
rehabilitative potential;
(13)
prior community service and present value to the
community;
(14)
relevant circumstances reducing the seriousness of
the misconduct; and
(15)
relevant circumstances lessening responsibility for
the misconduct.
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
December 23, 1999.
TRD-9909023
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: February 6, 2000
For further information, please call: (512) 305-8028
Subchapter A. ALL CLASSES OF PHARMACIES
22 TAC §291.27
The Texas State Board of Pharmacy proposes new §291.27,
concerning Pharmacy Residency Programs. The new rule, if adopted, will implement
the provisions of Senate Bill 931 (76th Legislative Session) regarding recognizing
and approving pharmacy residency programs.
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 the protection of the public and increased public
confidence in the practice of pharmacy by setting standards which recognize
and approve pharmacy residency programs. Of the 32 currently operating pharmacy
residency programs identified by the agency, 28 already meet the requirements
established by this rule. Therefore, there will be minimal additional economic
costs to small and large businesses and to other entities who are required
to comply with this section.
Comments on the proposal may be submitted to Steve Morse, R.Ph., Director
of Compliance, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite
3-600, box 21, Austin, Texas, 78701-3942.
The new section is proposed under §17(a) of the Texas Pharmacy
Act (Article 4542a-1, Texas Civil Statutes), as amended by the 76th Legislature,
and §554.051 of the Occupations Code. The Board interprets §17(a)
of the Texas Pharmacy Act as authorizing the agency to specify standards for
recognizing and approving pharmacy residency programs for the purpose of Subchapter
T, Chapter 61, Education Code. The Board interprets §554.051 of the Occupations
Code as authorizing the agency to adopt rules for the proper administration
and enforcement of the Act.
The statutes affected by this rule: Texas Civil Statutes, Article 4542a-1,
now codified as Occupations Code Subtitle J.
§291.27.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.
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
December 23, 1999.
TRD-9909024
Gay Dodson, R.Ph.
Executive Director
Texas State Board of Pharmacy
Earliest possible date of adoption: February 6, 2000
For further information, please call: (512) 305-8028
22 TAC §291.29
The Texas State Board of Pharmacy proposes new §291.29,
concerning Special Exemption from Pharmacy Technician Certification Requirements.
The new rule, if adopted, will implement the provisions of Senate Bill 730
(76th Legislative Session) regarding exemptions from the requirement for pharmacy
technicians to become certified.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for
the first five-year period the rule is in effect, there will be fiscal implications
for the state as a result of enforcing or administering the rule. There are
no anticipated fiscal implications for local government. The fiscal implications
for the state are based on the cost of enforcing or administering the rule
by the Texas State Board of Pharmacy. The agency anticipates the receipt of
up to 1500 petitions the first year and 90 petitions for each of the second
through fifth years. After 5 years, the exemption process will cease. Costs
for the first year of the program will include setup costs as well as costs
to administer the program. The estimated cost to the Texas State Board of
Pharmacy for the next five years will be: FY2000--$25,380; FY2001--$803; FY2002--$803;
FY2003--$803; and FY2004--$803.
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 allow the continued use of non-certified, experienced
pharmacy technicians and to allow pharmacies in counties of less than 10,000
population to continue to use non-certified pharmacy technicians. Both exemptions
cease on January 1, 2006. The exemptions allow the affected pharmacies additional
time to get their technicians certified. The economic cost to small and large
businesses or to entities who are required to comply with this section will
largely be determined by the amount of time necessary to gather the required
information, complete the petition, and forward the petition to the agency.
It is anticipated that the time necessary to gather the information required
and to complete the petition will average approximately one hour. Assuming
that the pharmacy technician's time accounts for 3/4 of the hour and a pharmacist's
time for the remaining 1/4 hour, the agency estimates a cost of $15.13 per
petition based on salaries of $32/hr for a pharmacist and $9.50/hr for a pharmacy
technician.
Comments on the proposal may be submitted to Steve Morse, R.Ph., Director
of Compliance, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite
3-600, box 21, Austin, Texas, 78701-3942.
The new section is proposed under §20(A) of the Texas Pharmacy
Act (Article 4542a-1, Texas Civil Statutes), as added by the 76th Legislature,
and §554.051 of the Occupations Code. The Board interprets §20(A)
of the Texas Pharmacy Act as authorizing the agency to grant exemptions to
the pharmacy technician certification requirements. The Board interprets §554.051
of the Occupations Code as authorizing the agency to adopt rules for the proper
administration and enforcement of the Act.
The statutes affected by this rule: Texas Civil Statutes, Article 4542a-1,
now codified as Occupations Code Subtitle J.
§291.29.Special Exemption from Pharmacy Technician Certification Requirements
(a)
Pharmacy technicians who, on September 1, 2001, will have
been employed as a pharmacy technician in this state for at least 10 years.
(1)
Eligibility. A pharmacy technician may petition the board
for a special exemption from the certification requirements established by §20A
of the Act if the technician has been continuously employed at a pharmacy
in this state since September 1, 1991.
(2)
Petition process.
(A)
A pharmacy technician shall petition the board for the
special exemption on a form provided by the board. The petition shall contain
the following:
(i)
the name of the pharmacy technician;
(ii)
the name, address, and license number (if known) of the
pharmacies where the pharmacy technician has been employed;
(iii)
dates of employment in each pharmacy;
(iv)
a statement signed by the pharmacy technician attesting
that the information provided in the petition is true and correct; and
(v)
a statement signed by the pharmacist-in-charge of the pharmacy
attesting that the pharmacy technician has been continuously employed as a
pharmacy technician/supportive person at a pharmacy in this state since September
1, 1991.
(B)
After review of the petition and/or verification of the
employment record, the pharmacy technician shall be notified in writing of
approval or denial of the petition. If the petition is approved, the pharmacy
technician will be sent a special exemption certificate which shall be displayed
at the pharmacy named in the petition.
(3)
Limitation of exemption.
(A)
After January 1, 2001, pharmacy technicians exempted from
certification may not perform any of the duties restricted to a certified
pharmacy technician.
(B)
All exemptions from certification expire on January 1,
2006. After January 1, 2006, pharmacy technicians exempted from certification
shall cease performing the duties of a pharmacy technician until such time
as they become certified pharmacy technicians.
(b)
Pharmacy technicians working in counties with a population
of 10,000 or less.
(1)
Eligibility. A pharmacy technician may petition the board
for a special exemption from the certification requirements established by §20A
of the Act if the technician works in a county with a population of 10,000
or less.
(2)
Petition process.
(A)
A pharmacy technician shall petition the board for the
special exemption on a form provided by the board. The petition shall contain
the following:
(i)
the name of the pharmacy technician;
(ii)
the name, address, and license number of the pharmacy
where the pharmacy technician is employed;
(iii)
name of the county in which the pharmacy is located and
the most recent official population estimate for the county from the Texas
State Data Center;
(iv)
a statement signed by the pharmacy technician attesting
that the information provided in the petition is true and correct; and
(v)
a statement signed by the pharmacist-in-charge of the pharmacy
attesting that the pharmacy technician is employed as a pharmacy technician
at the pharmacy.
(B)
After review of the petition, the pharmacy technician shall
be notified in writing of approval or denial of the petition. If the petition
is approved, the pharmacy technician will be sent a special exemption certificate
which shall be displayed at the pharmacy named in the petition.
(3)
Limitation of exemption.
(A)
After January 1, 2001, pharmacy technicians exempted from
certification may not perform any of the duties restricted to a certified
pharmacy technician.
(B)
All exemptions from certification expire on January 1,
2006. After January 1, 2006, pharmacy technicians exempted from certification
shall cease performing the duties of a pharmacy technician until such time
as they become certified pharmacy technicians.
(C)
The exemption granted under this section is only applicable
for the pharmacy noted in the petition. Should the pharmacy technician cease
employment at the pharmacy or change employment the exemption is canceled
and the pharmacy technician shall comply with the certification requirements.
(D)
If the population of the county increases to a point which
exceeds a population of 10,000, the Board shall cancel the exemption. The
pharmacy technician and the pharmacist-in-charge of the pharmacy will be notified
when an exemption is canceled.
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
December 23, 1999.
TRD-9909025
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: February 6, 2000
For further information, please call: (512) 305-8028
22 TAC §§291.31-291.34, 291.36
The Texas State Board of Pharmacy proposes amendments to §291.31,
concerning Definitions, §291.32, concerning Personnel, §291.33,
concerning Operational Standards, §291.34, concerning Records, and §291.36,
concerning Class A Pharmacies Compounding Sterile Pharmaceuticals. The amendments,
if adopted, will: (1) implement the recommendations of the Task Force on Non-Resident
Pharmacies and Pharmacy Automation; and (2) make changes as a result of the
rule review of §§291.31-291.34.
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 additional
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 protect the public through the effective control
and regulation of the use of automation in pharmacies and to update and clarify
currently existing rules. The automation component of the rules permits use
of new technology which previously was restricted. Since licensees are not
mandated to use the new technology, there is no additional fiscal impact for
small or large businesses or to other entities.
The rule review component of the rules requires pharmacies to have hot
running water. Since not all pharmacies currently have hot running water,
there will be an economic cost for the small and large businesses and entities
required to comply with this section. For the very few pharmacies without
hot running water, the anticipated cost to comply could range up to several
hundred dollars depending on the water heating device selected and what is
necessary to install the device. There are no further anticipated economic
costs to small or large businesses or to other entities who are required to
comply with this section.
Comments on the proposal may be submitted to Steve Morse, R.Ph., Director
of Compliance, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite
3-600, Box 21, Austin, Texas, 78701-3942.
The amendments are proposed under §§554.002, 554.051,
and 554.005 of the Texas Pharmacy Act (Subtitle J, Chapters 551-564, Occupations
Code). The Board interprets §554.002 of the Texas Pharmacy Act as authorizing
the agency to protect the public through the effective control and regulation
of the practice of pharmacy. The Board interprets §554.051 of the Texas
Pharmacy Act as authorizing the agency to adopt rules for the proper administration
and enforcement of the Act. The Board interprets §554.005 of the Texas
Pharmacy Act as authorizing the agency to regulate the delivery or distribution
of prescription drugs as they relate to the practice of pharmacy and specify
the minimum standards for the maintenance of prescription drug records.
The statutes affected by this rule: Occupations Code, Subtitle J.
§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)
Accurately as prescribed--Dispensing, delivering, and/or
distributing a prescription drug order:
(A)-(B)
(No change.)
(C)
with correct labeling (including directions for use) as
ordered by the practitioner. Provided, however, that nothing herein shall
prohibit pharmacist substitution if substitution is conducted in strict accordance
with applicable laws and rules, including
Chapters 562 and 563
[
(2)
Act--The Texas Pharmacy Act,
Chapters 551-566,
Occupations Code,
[
(3)
(No change.)
(4)
Automated compounding or counting device
[
(5)
Automated pharmacy dispensing systems--a
mechanical system that performs operations or activities, other than compounding
or administration, relative to the storage, packaging, counting, labeling,
dispensing, and distribution of medications, and which collects, controls,
and maintains all transaction information. "Automated pharmacy dispensing
systems" does not mean "Automated compounding or counting devices" or "Automated
medication supply devices."
(6)
[
(7)
[
(A)
patient's name and address;
(B)
name, strength, and quantity of the drug to be dispensed;
(C)
directions for use;
(D)
the intended use of the drug, if appropriate;
(E)
the name, address, and telephone number of the physician;
(F)
the name, address, telephone number, and identification
number of the advanced practice nurse or physician assistant completing the
prescription drug order;
(G)
the date; and
(H)
the number of refills permitted.
(8)
[
(A)
has completed the pharmacy technician training program
of the pharmacy;
(B)
has taken and passed the National Pharmacy Technician Certification
Exam or other examination approved during an open meeting by the Board; and
(C)
maintains a current certification with the Pharmacy Technician
Certification Board or any other entity providing an examination approved
by the Board.
(9)
[
(10)
[
(A)
as the result of a practitioner's prescription drug order
or initiative based on the practitioner-patient-pharmacist relationship in
the course of professional practice;
(B)
in anticipation of prescription drug orders based on routine,
regularly observed prescribing patterns; or
(C)
for the purpose of or as an incident to research, teaching,
or chemical analysis and not for sale or dispensing.
(11)
[
(12)
[
(13)
[
(A)
"Caution: federal law prohibits dispensing without prescription";
or
(B)
"Caution: federal law restricts this drug to use by or
on the order of a licensed veterinarian."
(14)
[
(15)
[
(16)
[
(A)
a licensed nurse, physician assistant, pharmacist, or other
individual designated by a practitioner to communicate prescription drug orders
to a pharmacist;
(B)
a licensed nurse, physician assistant, or pharmacist employed
in a health care facility to whom the practitioner communicates a prescription
drug order; [
(C)
an advanced practice nurse or physician assistant authorized
by a practitioner to carry out or sign a prescription drug order for dangerous
drugs under
Chapter 157 of the Medical Practice Act (Subtitle B, Occupations
Code); or
[
(D)
a person who is a licensed
vocational nurse or has an education equivalent to or greater than that required
for a licensed vocational nurse designated by the practitioner to communicate
prescriptions for an advanced practice nurse or physician assistant authorized
by the practitioner to sign prescription drug orders under Chapter 157 of
the Medical Practice Act (Subtitle B, Occupations Code).
(17)
[
(18)
[
(19)
[
(20)
[
(21)
[
(A)
known allergies;
(B)
rational therapy-contraindications;
(C)
reasonable dose and route of administration;
(D)
reasonable directions for use;
(E)
duplication of therapy;
(F)
drug-drug interactions;
(G)
drug-food interactions;
(H)
drug-disease interactions;
(I)
adverse drug reactions; and
(J)
proper utilization, including overutilization or underutilization.
(22)
[
(23)
Electronic signature--A unique security
code or other identifier which specifically identifies the person entering
information into a data processing system. A facility which utilizes electronic
signatures must:
(A)
maintain a permanent list of the unique security codes
assigned to persons authorized to use the data processing system; and
(B)
have an ongoing security program which is capable of identifying
misuse and/or unauthorized use of electronic signatures.
(24)
[
(25)
[
(26)
[
(27)
[
(28)
[
(29)
[
(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.)
(30)
[
(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.
(31)
[
(32)
[
(33)
[
(34)
[
(35)
[
(36)
[
(A)
participating in a pharmacy's technician training program;
or
(B)
a person currently enrolled in a technician training program
accredited by the American Society of Health-System Pharmacists provided:
(i)
the person is working 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;
(ii)
the person is under the direct supervision of and responsible
to a pharmacist; and
(iii)
the supervising pharmacist conducts in-process and final
checks.
(37)
[
(38)
[
(A)
a physician, dentist, podiatrist, veterinarian, or other
person licensed or registered to prescribe, distribute, administer, or dispense
a prescription drug or device in the course of professional practice in this
state;
(B)
a person licensed by another state in a health field in
which, under Texas law, licensees in this state may legally prescribe dangerous
drugs or a person practicing in another state and licensed by another state
as a physician, dentist, veterinarian, or podiatrist, having a current Federal
Drug Enforcement Administration registration number, and who may legally prescribe
Schedule II, III, IV, or V controlled substances in such other state; or
(C)
a person licensed in the Dominion of Canada or the United
Mexican States in a health field in which, under the laws of this state, a
licensee may legally prescribe dangerous drugs;
(D)
does not include a person licensed under the Texas Pharmacy
Act.
(39)
[
(40)
[
(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)
[
(42)
State--One of the 50 United States
of America, a U.S. territory, or the District of Columbia.
(43)
[
(44)
[
§291.32.Personnel.
(a)
Pharmacist-in-charge.
(1)
General.
(A)
(No change.)
(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, at a minimum, the following:
(A)-(L)
(No change.)
(M)
maintenance of records in a data processing system such
that the data processing system is in compliance with Class A (community)
pharmacy requirements; [
(N)
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
(O)
if the pharmacy uses an automated pharmacy
dispensing 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 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 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)
Pharmacists.
(1)
(No change.)
(2)
Duties. Duties which may only be performed by a pharmacist
are as follows:
(A)-(H)
(No change.)
(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)
(No change.)
(c)
Pharmacy technicians.
(1)
(No change.)
(2)
Duties.
(A)
General.
(i)
(No change.)
(ii)
A pharmacist may delegate to pharmacy technicians any
nonjudgmental technical duty associated with the preparation and distribution
of prescription drugs provided:
(I)
a pharmacist conducts in-process and final checks; [
(II)
pharmacy technicians are under the direct supervision
of and responsible to a pharmacist
; and
(III)
only pharmacy technicians
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.
(B)
(No change.)
(3)-(5)
(No change.)
(d)
(No change.)
§291.33.Operational Standards.
(a)
Licensing requirements.
(1)
A Class[
(2)
A Class[
(3)
A Class[
(4)
A Class[
(5)
A Class[
(6)
A separate license is required for each principal
place of business and only one pharmacy license may be issued to a specific
location.
(7)
A fee as specified in §291.6 of this title (relating
to Pharmacy License Fees) will be charged for the issuance and renewal of
a license and the issuance of an amended license.
(8)
A Class[
(9)
A Class[
(b)
Environment.
(1)
General requirements.
(A)
(No change.)
[
A sink with running water
shall be available to all pharmacy personnel and maintained in a sanitary
condition.]
(B)
[
(C)
[
(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)
[
(E)
[
(F)
[
(2)-(3)
(No change.)
(c)
Prescription dispensing and delivery.
(1)
Patient counseling and provision of drug information.
(A)
(No change.)
(B)
Such communication:
(i)-(iii)
(No change.)
(iv)
[
(I)-(III)
(No change.)
(C)-(D)
(No change.)
(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)-(iii)
(No change.)
(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)-(ii)
(No change.)
(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)
(No change.)
(2)
Pharmaceutical care services.
(A)
Drug regimen review.
(i)
For the purpose of promoting therapeutic appropriateness,
a pharmacist shall at the time of dispensing a prescription drug order, review
the patient's medication record. Such review shall at a minimum identify clinically
significant:
(I)
known allergies;
(II)
rational therapy-contraindications;
(III)
reasonable dose and route of administration;
(IV)
reasonable directions for use;
(V)
duplication of therapy;
(VI)
drug-drug interactions;
(VII)
drug-food interactions;
(VIII)
drug-disease interactions;
(IX)
adverse drug reactions; and
(X)
proper utilization, including overutilization
or underutilization.
[(I)
inappropriate drug utilization;]
[(II)
therapeutic duplication;]
[(III)
drug-disease contraindications;]
[(IV)
drug-drug interactions;]
[(V)
incorrect drug dosage or duration of
drug treatment;]
[(VI)
drug-allergy interactions; and]
[(VII)
clinical abuse/misuse.]
(ii)
Upon identifying any clinically significant conditions,
situations, or items listed in clause (i) of this subparagraph, the pharmacist
shall take appropriate steps to avoid or resolve the problem including consultation
with the prescribing practitioner.
The pharmacist shall document such
occurrences if the prescription is dispensed. The documentation shall:
(I)
be maintained at the pharmacy for two
years;
(II)
contain the following information:
(-a-)
unique prescription number;
(-b-)
patient name;
(-c-)
date of the review if different from the dispensing
date;
(-d-)
the name, initials, or identification code of the
pharmacist who performed the review; and
(-e-)
steps taken to resolve the problem; and
(III)
be available in hard copy format, if
so requested by an agent of the board.
(B)
Other pharmaceutical care services which may be provided
by pharmacists include, but are not limited to, the following:
(i)
managing drug therapy as delegated by a practitioner as
allowed under the provisions of the Medical Practices Act[
(ii)
administering immunizations and vaccinations
under written protocol of a physician;
(iii)
[
(iv)
[
(v)
[
(3)
Prescription containers.
(A)
(No change.)
(B)
A drug dispensed pursuant to a prescription drug order
shall be dispensed in an appropriate container as
specified on the manufacturer's
container.
[
[(i)
If a drug is susceptible to light, the
drug shall be dispensed in a light-resistant container.]
[(ii)
If a drug is susceptible to moisture,
the drug shall be dispensed in a tight container.]
[(iii)
The container should not interact physically
or chemically with the drug product placed in it so as to alter the strength,
quality, or purity of the drug beyond the official requirements.]
(C)
(No change.)
(4)
Labeling.
(A)
At the time of delivery of the drug, the dispensing container
shall bear a label with at least the following information:
(i)-(iii)
(No change.)
(iv)
initials or an identification code of the dispensing
pharmacist;
[
(v)-(x)
(No change.)
(xi)
if the pharmacist has selected a generically equivalent
drug pursuant to the provisions of the Act,
Chapters 562 and 563
[
(xii)
the name of the advanced practice nurse or physician
assistant, if the prescription is carried out or signed by an advanced practice
nurse or physician assistant in compliance with
Subtitle B, Chapter 157,
Occupations Code;
[
(xiii)
(No change.)
(B)
(No change.)
(d)
Equipment and supplies.
(1)
Class A pharmacies dispensing prescription drug orders
shall have the following equipment and supplies:
(A)-(B)
(No change.)
(C)
adequate supply of child-resistant, light-resistant, [
(D)-(F)
(No change.)
(2)
(No change.)
[(3)
Automated dispensing or compounding
devices(s). If automated dispensing or compounded device(s) are used, the
pharmacy shall have a method to calibrate and verify the accuracy of the automated
dispensing or compounding devices and document the calibration and verification
on a routine basis.]
(e)
Library. A reference library shall be maintained which
includes the following
in hard-copy or electronic format
:
(1)
(No change.)
(2)
at least one current or updated reference from each
of the following categories:
(A)-(B)
(No change.)
(C)
a
general information
reference text, such
as
:
(i)-(iv)
(No change.)
(3)
(No change.)
(f)
(No change.)
(g)
Prepackaging of drugs [
[(1)
Prepackaging of drugs.]
(1)
[
(2)
[
(A)
[
(B)
[
(C)
[
(D)
[
(3)
[
(A)
[
(B)
[
(C)
[
(D)
[
(E)
[
(F)
[
(G)
[
(H)
[
(I)
[
(J)
[
(4)
[
[(2)
Loading bulk unlabeled drugs into
automated drug dispensing systems.]
[(A)
Automated drug dispensing systems may be loaded with bulk
unlabeled drugs only by a pharmacist or by supportive personnel under the
direction and direct supervision of a pharmacist.]
[(B)
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.]
[(C)
Records of loading bulk unlabeled drugs into an automated
drug dispensing system shall be maintained to show:]
[(i)
name of the drug, strength, and dosage form;]
[(ii)
manufacturer or distributor;]
[(iii)
manufacturer's lot number;]
[(iv)
expiration date;]
[(v)
quantity added to the automated drug dispensing system;]
[(vi)
date of loading;]
[(vii)
name or initials of the person loading the automated
drug dispensing system; and]
[(viii)
signature of the responsible pharmacist. ]
[(D)
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 to the record specified in subparagraph (C) of this paragraph.]
(h)
Customized patient medication packages.
(1)-(2)
(No change.)
(3)
Label.
(A)
The patient med-pak shall bear a label stating:
(i)-(ix)
(No change.)
(x)
the initials or an identification code of the dispensing
pharmacist;
[
(xi)
(No change.)
(B)-(C)
(No change.)
(4)-(6)
(No change.)
(7)
Recordkeeping. In addition to any individual prescription
filing requirements, a record of each patient med-pak shall be made and filed.
Each record shall contain, as a minimum:
(A)-(F)
(No change.)
(G)
the initials or an identification code of the dispensing
pharmacist.
[
(i)
(No change.)
(j)
Automated devices and systems.
(1)
Automated compounding or counting devices. If a pharmacy
uses automated compounded or counting devices:
(A)
the pharmacy shall have a method to calibrate and verify
the accuracy of the automated compounded or counting device and document the
calibration and verification on a routine basis;
(B)
the devices may be loaded with bulk or unlabeled drugs
only by a pharmacist or by supportive personnel under the direction and direct
supervision of a pharmacist;
(C)
the label of an automated compounded or counting device
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;
(D)
records of loading bulk or unlabeled drugs into an automated
compounding or counting device shall be maintained to show:
(i)
name of the drug, strength, and dosage form;
(ii)
manufacturer or distributor;
(iii)
manufacturer's lot number;
(iv)
expiration date;
(v)
quantity added to the automated compounded or counting
device;
(vi)
date of loading;
(vii)
name, initials, or electronic signature of the person
loading the
automated compounding or counting device; and
(viii)
signature or electronic signature of the responsible
pharmacist; and
(E)
the automated compounded or counting device shall not be
used until a pharmacist verifies that the system is properly loaded and affixes
his or her signature to the record specified in subparagraph (D) of this paragraph.
(2)
Automated pharmacy dispensing systems.
(A)
Authority to use automated pharmacy dispensing systems.
A pharmacy may use an automated pharmacy dispensing system to fill prescription
drug orders provided that:
(i)
the pharmacist-in-charge is responsible for the supervision
of the operation of the system;
(ii)
the automated pharmacy dispensing system has been tested
by the pharmacy and found to dispense accurately. The pharmacy shall make
the results of such testing available to the Board upon request; and
(iii)
the pharmacy will make the automated pharmacy dispensing
system available for inspection by the board for the purpose of validating
the accuracy of the system.
(B)
Quality assurance program. A pharmacy which uses an automated
pharmacy dispensing system to fill prescription drug orders shall operate
according to a written program for quality assurance of the automated pharmacy
dispensing system which:
(i)
requires continuous monitoring of the automated pharmacy
dispensing system; and
(ii)
establishes mechanisms and procedures to test the accuracy
of the automated pharmacy dispensing system at least every six months and
whenever any upgrade or change is made to the system and documents each such
activity.
(C)
Policies and procedures of operation.
(i)
When an automated pharmacy dispensing system is used to
fill prescription drug 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 pharmacy dispensing
system and shall describe policies and procedures that:
(I)
include a description of the policies and procedures of
operation;
(II)
ensure that a pharmacist reviews, approves, and is held
accountable for the transmission of each original or new prescription drug
order to the automated pharmacy dispensing system before the transmission
is made;
(III)
ensure access to the automated pharmacy dispensing system
for stocking and retrieval of medications is limited to licensed healthcare
professionals or pharmacy technicians acting under the supervision of a pharmacist;
(IV)
provide for and ensure that prior to use, a pharmacist
checks, verifies, and documents that the automated pharmacy dispensing system
has been accurately filled each time the system is stocked;
(V)
provide for an accountability record to be maintained which
documents all transactions relative to stocking and removing medications from
the automated pharmacy dispensing system;
(VI)
ensure a prospective drug regimen review is conducted
as specified in subsection (c)(2) of this section; and
(VII)
establish and make provisions for documentation of a
preventative maintenance program for the automated pharmacy dispensing system.
(ii)
A pharmacy which uses an automated pharmacy dispensing
system to fill prescription drug orders shall, at least annually, review its
written policies and procedures, revise them if necessary, and document the
review.
(D)
Recovery Plan. A pharmacy which uses an automated pharmacy
dispensing system to fill prescription drug orders shall maintain a written
plan for recovery from a disaster or any other situation which interrupts
the ability of the automated pharmacy dispensing system to provide services
necessary for the operation of the pharmacy. The written plan for recovery
shall include:
(i)
planning and preparation for maintaining pharmacy services
when an automated pharmacy dispensing system is experiencing downtime;
(ii)
procedures for response when an automated pharmacy dispensing
system is experiencing downtime;
(iii)
procedures for the maintenance and testing of the written
plan for recovery; and
(iv)
procedures for notification of the Board, each patient
of the pharmacy, and other appropriate agencies whenever an automated pharmacy
dispensing system experiences downtime for more than two days of operation
or a period of time which significantly limits the pharmacy's ability to provide
pharmacy services.
§291.34.Records.
(a)
(No change.)
(b)
Prescriptions.
(1)
(No change.)
(2)
Written prescription drug orders.
(A)
Practitioner's
[
(i)
A
practitioner
[
(ii)
The prescription drug order may not be signed by a
practitioner's
[
(B)
Required prescription drug order format.
(i)
(No change.)
(ii)
The two signature line requirement does not apply to the
following types of prescription drug orders:
(I)
prescription drug orders issued by a
practitioner
[
(II)
prescription drug orders for dangerous drugs issued by
a
practitioner
[
(III)
prescription drug orders issued by a
practitioner
[
(C)
Preprinted prescription drug order forms. No prescription
drug order form furnished to a
practitioner
[
(D)
Prescription drug orders written by
practitioners
[
(i)
Dangerous drug prescription orders. A pharmacist may dispense
a prescription drug order for dangerous drugs issued by
practitioners
[
(ii)
Controlled substance prescription drug orders.
(I)
A pharmacist may dispense prescription
drug order for controlled substances in Schedule II issued by a practitioner
in another state provided:
(-a-)
the prescription is filled in compliance with a written
plan approved by the Director of the Texas Department of Public Safety in
consultation with the Board, which provides the manner in which the dispensing
pharmacy may fill a prescription for a Schedule II controlled substance;
(-b-)
the prescription drug order is an original written
prescription issued by 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 (DEA) registration number,
and who may legally prescribe Schedule II controlled substances in such other
state; and
(-c-)
the prescription drug order is not dispensed more
than six months from the initial date of issuance and may not be refilled.
(II)
A pharmacist may dispense prescription drug
orders for controlled substances in Schedule III, IV, or V issued by a
practitioner
[
(-a-)
[
(-b-)
[
(-c-)
[
(E)
prescription drug orders written by
practitioners
[
(i)
Controlled substance prescription drug orders. A pharmacist
may not dispense a prescription drug order for a Schedule II, III, IV, or
V controlled substance issued by a
practitioner
[
(ii)
Dangerous drug prescription drug orders. A pharmacist
may dispense a dangerous drug prescription issued by a person licensed in
the Dominion of Canada or the United Mexican States as a physician, dentist,
veterinarian, or podiatrist provided:
(I)
(No change.)
(II)
if there are no refill instructions on the original written
prescription drug order (which shall be interpreted as no refills authorized)
or if all refills authorized on the original written prescription drug order
have been dispensed, a new written prescription drug order shall be obtained
from the prescribing
practitioner
[
(F)
Prescription drug orders carried out or signed by an advanced
practice nurse or physician assistant.
(i)
A pharmacist may dispense a prescription drug order for
a dangerous drug which is carried out or signed by an advanced practice nurse
or physician assistant provided:
(I)
(No change.)
(II)
the advanced practice nurse or physician assistant is
practicing in accordance with
Subtitle B, Chapter 157, Occupations Code.
[
(ii)
Each practitioner shall designate in writing the name
of each advanced practice nurse or physician assistant authorized to carry
out or sign a prescription drug order pursuant to
Subtitle B, Chapter
157, Occupations Code.
[
(G)
Prescription drug orders for Schedule II controlled substances.
No Schedule II controlled substance may be dispensed without a written prescription
drug order of a practitioner on
an official
[
(3)-(5)
(No change.)
(6)
Therapeutic Drug Interchange. A switch
to a drug providing a similar therapeutic response to the one prescribed shall
not be made without prior approval of the prescribing practitioner.
(A)
The patient shall be notified of the therapeutic drug interchange
prior to, or upon delivery, of the dispensed prescription to the patient.
Such notification shall include:
(i)
a description of the change;
(ii)
the reason for the change;
(iii)
whom to notify with questions concerning the change;
and
(iv)
instructions for return of the drug if not wanted by the
patient.
(B)
The pharmacy shall maintain documentation of patient notification
of therapeutic drug interchange which shall include:
(i)
the date of the notification;
(ii)
the method of notification;
(iii)
a description of the change; and
(iv)
the reason for the change.
(7)
[
(A)
Original prescriptions shall be maintained by the pharmacy
in numerical order and remain legible for a period of two years from the date
of filling or the date of the last refill dispensed.
(B)
If an original prescription drug order is changed, such
prescription order shall be invalid and of no further force and effect; if
additional drugs are to be dispensed, a new prescription drug order with a
new and separate number is required.
(C)
Original prescriptions shall be maintained in three separate
files as follows:
(i)
prescriptions for controlled substances listed in Schedule
II;
(ii)
prescriptions for controlled substances listed in Schedule
III-V; and
(iii)
prescriptions for dangerous drugs and nonprescription
drugs.
(D)
Original prescription records other than
prescriptions
for Schedule II controlled substances
[
(i)
the record of refills recorded on the original prescription
must also be stored in this system;
(ii)
the original prescription records must be maintained in
numerical order and separated in three files as specified in subparagraph
(C) of this paragraph; and
(iii)
the pharmacy must provide immediate access to equipment
necessary to render the records easily readable.
(8)
[
(A)
All original prescriptions shall bear:
(i)
name of the patient, or if such drug is for an animal,
the species of such animal and the name of the owner;
(ii)
address of the patient, provided, however, a prescription
for a dangerous drug is not required to bear the address of the patient if
such address is readily retrievable on another appropriate, uniformly maintained
pharmacy record, such as medication records;
(iii)
name, and if for a controlled substance, the address
and DEA registration number of the practitioner;
(iv)
name and strength of the drug prescribed;
(v)
quantity prescribed;
(vi)
directions for use;
(vii)
intended use for the drug unless the practitioner determines
the furnishing of this information is not in the best interest of the patient;
and
(viii)
date of issuance.
(B)
All original electronic prescription drug orders shall
bear:
(i)
name of the patient, if such drug is for an animal, the
species of such animal, and the name of the owner;
(ii)
address of the patient, provided, however, a prescription
for a dangerous drug is not required to bear the address of the patient if
such address is readily retrievable on another appropriate, uniformly maintained
pharmacy record, such as medication records;
(iii)
name, and if for a controlled substance, the address
and DEA registration number of the practitioner;
(iv)
name and strength of the drug prescribed;
(v)
quantity prescribed;
(vi)
directions for use;
(vii)
indications for use, unless the practitioner determines
the furnishing of this information is not in the best interest of the patient;
(viii)
date of issuance;
(ix)
a statement which indicates that the prescription has
been electronically transmitted, (e.g., Faxed to or electronically transmitted
to:);
(x)
name, address, and electronic access number of the pharmacy
to which the prescription was transmitted;
(xi)
telephone number of the prescribing practitioner;
(xii)
date the prescription drug order was electronically transmitted
to the pharmacy, if different from the date of issuance of the prescription;
and
(xiii)
if transmitted by a designated agent, the full name
of the designated agent.
(C)
All original written prescriptions for dangerous drugs
carried out or signed by an advanced practice nurse or physician assistant
in accordance with
Subtitle B, Chapter 157, Occupations Code
[
(i)
name and address of the patient;
(ii)
name, address,
and
telephone number[
(iii)
name, identification number, and original signature of
the advanced practice nurse or physician assistant;
(iv)
address and telephone number of the clinic at which the
prescription drug order was carried out or signed;
(v)
name, strength, and quantity of the dangerous drug;
(vi)
directions for use;
(vii)
indications for use, if appropriate;
(viii)
date of issuance; and
(ix)
number of refills authorized.
(D)
At the time of dispensing, a pharmacist is responsible
for the addition of the following information to the original prescription:
(i)
unique identification number of the prescription drug order;
(ii)
initials or identification code of the dispensing pharmacist;
(iii)
quantity dispensed, if different from the quantity prescribed;
(iv)
date of dispensing, if different from the date of issuance;
and
(v)
brand name or manufacturer of the drug product actually
dispensed, if the drug was prescribed by generic name or if a drug product
other than the one prescribed was dispensed pursuant to the provisions of
the Act,
Chapters 562 and 563
[
(9)
[
(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 Schedule III-V
controlled substances.
(i)
Prescription drug orders for Schedule 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)(4) of this title (relating to Operational
Standards); 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)
Patient medication records.
(1)
(No change.)
(2)
The patient medication record system shall provide
for the immediate retrieval of information for the previous 12 months which
is necessary for the dispensing pharmacist to conduct a prospective drug
regimen
[
(3)
The pharmacist-in-charge shall assure that a reasonable
effort is made to obtain and record in the patient medication record at least
the following information:
(A)-(D)
(No change.)
(E)
any known allergies, drug reactions, idiosyncrasies, and
chronic conditions or disease states of the patient and the identity of any
other drugs currently being used by the patient which may relate to prospective
drug
regimen
[
(F)-(G)
(No change.)
(4)-(5)
(No change.)
(d)
(No change.)
(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 Schedules 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)-(J)
(No change.)
(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.
[(i)
the fact that the prescription drug order
was transferred;]
[(ii)
the unique identification number of
the prescription drug order transferred;]
[(iii)
the name of the pharmacy to which it
was transferred; and]
[(iv)
the date and time of the transfer.]
[(B)
A pharmacist in the transferring pharmacy
shall review the message and document the review by signing and dating a hard
copy of the message or a log book containing the information required on the
message as soon as practical, but in no event more than 72 hours from the
time of such transfer.]
(B)
[
(6)
(No change.)
(f)-(h)
(No change.)
(i)
Permission to maintain central records. Any pharmacy that
uses a centralized recordkeeping system for invoices and financial data shall
comply with the following procedures.
(1)
Controlled substance records. Invoices and financial data
for controlled substances may be maintained at a central location provided
the following conditions are met.
(A)
Prior to the initiation of central recordkeeping, the pharmacy
submits written notification by registered or certified mail to the divisional
director of the Drug Enforcement Administration as required by Title 21, Code
of Federal Regulations,
§1304.04(a)
[
(B)-(C)
(No change.)
(2)-(4)
(No change.)
(j)
(No change.)
(k)
Confidentiality.
(1)
(No change.)
(2)
Confidential records are privileged and may be released
only to:
(A)
(No change.)
(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
[(B)
practitioners and other pharmacists when,
in the pharmacist's professional judgment, such release is necessary to protect
the patient's health and well-being;]
[(C)
other persons, the board, or other state
or federal agencies authorized by law to receive such information;]
[(D)
a law enforcement agency engaged in investigation
of suspected violations of the Controlled Substances Act or the Dangerous
Drug Act;]
[(E)
a person employed by any state agency
which licenses a practitioner as defined in the Act if such person is engaged
in the performance of the person's official duties; or ]
(F)
(No change.)
§291.36.Class A Pharmacies Compounding Sterile Pharmaceuticals.
(a)
(No change.)
(b)
Definitions. The following words and terms, when used in
this section, shall have the following meanings, unless the context clearly
indicates otherwise.
(1)-(7)
(No change.)
(8)
Automated compounding or counting device
[
(9)-(58)
(No change.)
(c)
(No change.)
(d)
Operational standards.
(1)
Licensing requirements.
(A)
A Class A pharmacy compounding sterile pharmaceuticals
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).
(B)-(I)
(No change.)
(2)
Environment.
(A)
(No change.)
(B)
Special requirements for the compounding of sterile pharmaceuticals.
When the pharmacy compounds sterile pharmaceuticals, the following is applicable.
(i)-(iii)
(No change.)
(iv)
Automated compounding or counting device
[
(v)
(No change.)
(C)
(No change.)
(3)
Prescription dispensing and delivery.
(A)
Patient counseling and provision of drug information.
(i)-(v)
(No change.)
(vi)
In addition to the requirements of clauses (i)-(iv) of
this subparagraph, 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)-(II)
(No change.)
(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 pharmacist-in-charge shall assure that:
(-a-)
the pharmacy maintain and use
adequate storage
or shipment containers and shipping processes [
(-b-)
the pharmacy
uses
[
(vii)
(No change.)
(B)-(C)
(No change.)
(4)
Pharmaceutical care services.
(A)
The following pharmaceutical care services shall be provided
by pharmacists of the pharmacy.
(i)
(No change.)
(ii)
Drug regimen review.
(I)
(No change.)
(II)
Upon identifying any clinically significant conditions,
situations, or items listed in subclause (I) of this clause, the pharmacist
shall take appropriate steps to avoid or resolve the problem including consultation
with the prescribing practitioner.
The pharmacist shall document such
occurrences if the prescription is dispensed. The documentation shall:
(-a-)
be maintained at the pharmacy for two
years;
(-b-)
contain the following information:
(-1-)
unique prescription number;
(-2-)
patient name;
(-3-)
date of the review if different from the dispensing date;
(-4-)
the name, initials, or identification code of the pharmacist
who performed the review; and
(-5-)
steps taken to resolve the problem; and
(-c-)
be available in hard copy
format, if so requested by an agent of them board.
(iii)
(No change.)
(B)
(No change.)
(5)-(7)
(No change.)
(8)
Prepackaging of drugs and loading bulk drugs into
automated compounding or counting devices
[
(A)
(No change.)
(B)
Loading bulk drugs into
automated compounding or counting
devices
[
(i)
Automated compounding or counting devices
[
(ii)
The label of an
automated compounding or counting
device
[
(iii)
Records of loading bulk drugs into an
automated
compounding or counting device
[
(I)-(IV)
(No change.)
(V)
quantity added to the
automated compounding or counting
device
[
(VI)
(No change.)
(VII)
name, initials, or electronic signature of the person
loading the
automated compounding or counting device
[
(VIII)
(No change.)
(iv)
The
automated compounding or counting device
[
(9)
Sterile pharmaceuticals.
(A)
Batch preparation.
(i)
Master work sheet. A master work sheet shall be developed
and approved by a pharmacist for each batch of sterile pharmaceuticals to
be prepared. 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)-(VI)
(No change.)
(VII)
specific equipment used during aseptic preparation (e.g.,
specific
automated compounding or counting device
[
(VIII)
(No change.)
(ii)-(iii)
(No change.)
(B)-(D)
(No change.)
(e)
Records.
(1)
(No change.)
(2)
Prescriptions.
(A)-(F)
(No change.)
(G)
Therapeutic Drug Interchange. A switch
to a drug providing a similar therapeutic response to the one prescribed shall
not be made without prior approval of the prescribing practitioner.
(i)
The patient shall be notified of the therapeutic
drug interchange prior to, or upon delivery, of the dispensed prescription
to the patient. Such notification shall include:
(I)
a description of the change;
(II)
the reason for the change;
(III)
whom to notify with questions concerning the
change; and
(IV)
instructions for return of the drug if not
wanted by the patient.
(ii)
The pharmacy shall maintain documentation of
patient notification of therapeutic drug interchange which shall include:
(I)
the date of the notification;
(II)
the method of notification;
(III)
a description of the change; and
(IV)
the reason for the change.
(H)
[
(i)
Original prescriptions shall be maintained by the pharmacy
in numerical order and remain legible for a period of two years from the date
of filling or the date of the last refill dispensed.
(ii)
If an original prescription drug order is changed, such
prescription order shall be invalid and of no further force and effect; if
additional drugs are to be dispensed, a new prescription drug order with a
new and separate number is required.
(iii)
Original prescriptions shall be maintained in one of
the following formats:
(I)
in three separate files as follows:
(-a-)
prescriptions for controlled substances listed in Schedule
II;
(-b-)
prescriptions for controlled substances listed in
Schedule III-V; and
(-c-)
prescriptions for dangerous drugs and nonprescription
drugs; or
(II)
within a patient medication record system provided that
original prescriptions for controlled substances are maintained separate from
original prescriptions for noncontrolled substances and triplicate prescriptions
for Schedule II controlled substances are maintained separate from all other
original prescriptions.
(iv)
Original prescription records other than triplicate prescriptions
may be stored on microfilm, microfiche, or other system which is capable of
producing a direct image of the original prescription record, e.g., digitalized
imaging system. If original prescription records are stored in a direct imaging
system, the following is applicable.
(I)
The record of refills recorded on the original prescription
must also be stored in this system.
(II)
The original prescription records must be maintained in
numerical order and as specified in clause (iii) of this subparagraph.
(III)
The pharmacy must provide immediate access to equipment
necessary to render the records easily readable.
(I)
[
(i)
All original prescriptions shall bear:
(I)
name of the patient;
(II)
address of the patient, provided, however, a prescription
for a dangerous drug is not required to bear the address of the patient if
such address is readily retrievable on another appropriate, uniformly maintained
pharmacy record, such as medication records;
(III)
name, and if for a controlled substance, the address
and DEA registration number of the practitioner;
(IV)
name and strength of the drug prescribed;
(V)
quantity prescribed;
(VI)
directions for use;
(VII)
intended use for the drug unless the practitioner determines
the furnishing of this information is not in the best interest of the patient;
(VIII)
date of issuance; and
(IX)
if telephoned to the pharmacist by a designated agent,
the full name of the designated agent.
(ii)
All original prescriptions for dangerous drugs carried
out by an advanced practice nurse or physician assistant in accordance with
the Medical Practice Act, §3.06(d), shall bear:
(I)
name and address of the patient;
(II)
name, address, telephone number, and original signature
of the practitioner;
(III)
name, address, telephone number, identification number,
and original signature of the advanced practice nurse or physician assistant;
(IV)
name, strength, and quantity of the dangerous drug;
(V)
directions for use;
(VI)
the intended use of the drug, if appropriate;
(VII)
date of issuance; and
(VIII)
number of refills authorized.
(iii)
All original electronic prescription drug orders shall
bear:
(I)
name of the patient;
(II)
address of the patient, provided, however, a prescription
for a dangerous drug is not required to bear the address of the patient if
such address is readily retrievable on another appropriate, uniformly maintained
pharmacy record, such as patient medication records;
(III)
name and strength of the drug prescribed;
(IV)
quantity prescribed;
(V)
directions for use;
(VI)
intended use for the drug unless the practitioner determines
the furnishing of this information is not in the best interest of the patient;
(VII)
date of issuance;
(VIII)
a statement which indicates that the prescription has
been electronically transmitted (e.g., Faxed to or electronically transmitted
to:);
(IX)
name, address, and electronic access number of the pharmacy
to which the prescription was transmitted;
(X)
telephone number of the prescribing practitioner;
(XI)
date the prescription drug order was electronically transmitted
to the pharmacy, if different from the date of issuance of the prescription;
and
(XII)
if transmitted by a designated agent, the full name of
the designated agent.
(iv)
At the time of dispensing, a pharmacist is responsible
for the addition of the following information to the original prescription:
(I)
unique identification number of the prescription drug order;
(II)
initials or identification code of the person who compounded
the sterile pharmaceutical and the pharmacist who checked and released the
product;
(III)
name, quantity, lot number, and expiration date of each
product used in compounding the sterile pharmaceutical; and
(IV)
date of dispensing, if different from the date of issuance.
(J)
[
(i)
Refills may be dispensed only in accordance with the prescriber's
authorization as indicated on the original prescription drug order. Such refills
may be indicated as authorization to refill the prescription drug order a
specified number of times or for a specified period of time period, such as
the duration of therapy.
(ii)
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.
(iii)
Refills of prescription drug orders for dangerous drugs
or nonprescription drugs shall be dispensed as follows.
(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 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.
(iv)
Refills of prescription drug orders for Schedule III-V
controlled substances shall be dispensed as follows.
(I)
Prescription drug orders for Schedule 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 comes first, a new and separate prescription drug order shall be
obtained from the prescribing practitioner prior to dispensing any additional
quantities of controlled substances.
(v)
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:
(-a-)
a natural or manmade disaster has occurred which prohibits
the pharmacist from being able to contact the practitioner; or
(-b-)
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 paragraph;
(VII)
the pharmacist affixes a label to the dispensing container
as specified in this paragraph; and
(VIII)
if the prescription was initially filled at another
pharmacy, the pharmacist may exercise his professional judgment in refilling
the prescription provided:
(-a-)
the patient has the prescription container, label, receipt
or other documentation from the other pharmacy which contains the essential
information;
(-b-)
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;
(-c-)
the pharmacist, in his professional judgment, determines
that such a request for an emergency refill is appropriate and meets the requirements
of subclauses (I) and (II) of this clause; and
(IX)
the pharmacist complies with the requirements of subclauses
(III)-(V) of this clause.
(3)-(11)
(No change.)
(f)
Triplicate prescription requirements.
The Texas State
Board of Pharmacy adopts by reference the rules promulgated by the Texas Department
of Public Safety, which are set forth in Subchapter F of 37 TAC §§13.101-13.113
concerning triplicate prescriptions.
[(1)
Definitions. The following words and
terms, when used in this subsection, shall have the following meanings, unless
the context clearly indicates otherwise.]
[(A)
Designated agent or authorized agent--An individual under
the supervision of a practitioner, designated in writing by the practitioner,
and for whom the practitioner assumes responsibility, who communicates the
practitioner's instructions to the pharmacist. The written designation of
an agent authorized to communicate prescriptions shall be maintained in the
usual place of business of the practitioner and shall be available for inspection
by investigators for the Texas State Board of Medical Examiners, the State
Board of Dental Examiners, the State Board of Veterinary Medical Examiners,
or the Department of Public Safety.]
[(B)
Emergency situation--For the purpose of authorizing an
oral prescription for a Schedule II substance, the term "emergency situation"
means those situations in which the prescribing practitioner determines that:]
[(i)
immediate administration of the controlled substance is
necessary for proper treatment of the intended ultimate user;]
[(ii)
no appropriate alternative treatment is available, including
administration of a drug which is not a controlled substance under Schedule
II; and]
[(iii)
it is not reasonably possible for the prescribing practitioner
to provide a written prescription to a pharmacist prior to the dispensing.]
[(C)
Hospital--]
[(i)
General hospital--Any establishment offering services,
facilities, and beds for use beyond 24 hours for two or more nonrelated individuals
requiring diagnosis, treatment, or care for illness, injury, deformity, abnormality,
or pregnancy, and regularly maintaining at least clinical laboratory services,
diagnostic x-ray services, treatment facilities which would include surgery
and/or obstetrical care, and other definitive medical or surgical treatment
of similar extent.]
[(ii)
Special hospital--Any establishment offering services,
facilities, and beds for use beyond 24 hours for two or more nonrelated individuals
who are regularly admitted, treated, and discharged and require services more
intensive than room, board, personal services, and general nursing care and
which has clinical laboratory facilities, diagnostic x-ray facilities, treatment
facilities, and/or other definitive medical treatment and has a medical house
staff in regular attendance, and maintains records of the clinical work performed
for each patient.]
[(iii)
Ambulatory surgical center--Approved surgical centers
licensed by the State Hospital Licensing Board and approved by Medicaid to
do day surgery when a patient is not admitted beyond a 24-hour period.]
[(D)
Institutional practitioner--]
[(i)
An individual who meets each of the following qualifications:]
[(I)
not yet licensed by the appropriate state professional
licensing board;]
[(II)
enrolled in a bona fide professional training program;]
[(III)
in a base hospital or institutional training facility
registered by the federal Drug Enforcement Administration; and]
[(IV)
authorized by the base hospital or training institution
to administer, dispense, or prescribe controlled substances.]
[(ii)
Institutional practitioner shall be limited to interns,
residents, fellows, or their equivalent.]
[(E)
Medical purpose--The utilization of controlled substances
for the purpose of relieving or curing mental or physical diseases or infirmities.]
[(F)
Possession--The actual care, custody, control, or management.]
[(G)
Prescribe--A direction or authorization, by prescription,
permitting an ultimate user lawfully to obtain controlled substances from
any person authorized by law to dispense such substances.]
[(H)
Triplicate prescription--The official Texas Department
of Public Safety prescription form utilized to administer, dispense, prescribe,
or deliver a Schedule II narcotic and/or Schedule II-N nonnarcotic controlled
substance to an ultimate user.]
[(I)
Ultimate user--A person who has lawfully obtained and
possesses a controlled substance for his own use or for the use of a member
of his household or for administering to an animal owned by him or a member
of his household.]
[(2)
Special instructions. Information
and special instruction information regarding procedures under these rules
and regulations will be furnished upon request by writing to the Triplicate
Prescription Section, Texas Department of Public Safety, P.O. Box 4087, Austin,
Texas 78773.]
[(3)
Purpose of issuing triplicate prescriptions.]
[(A)
A prescription for a controlled substance to be effective
must be issued for a legitimate medical purpose by an individual practitioner
acting in the usual course of his professional practice. The responsibility
for the proper prescribing and dispensing of controlled substances is upon
the prescribing practitioner, but a corresponding responsibility rests with
the pharmacist who fills the prescription. An order purporting to be a prescription
not issued in the usual course of professional treatment or in legitimate
and authorized research is not a prescription within the meaning and intent
of the Texas Controlled Substances Act, §481.074 and the person knowingly
filling such a purported prescription, as well as the person issuing it, may
be subject to the penalties provided for violation of the provisions of law
or rules relating to controlled substances.]
[(B)
Prescriptions for Schedule II controlled substances shall
be issued on the triplicate prescription form only and may not be refilled.]
[(4)
Emergency dispensing of Schedule
II controlled substances. No controlled substance in Schedule II may be administered,
dispensed, prescribed, or delivered without the written prescription of a
practitioner on a triplicate prescription form, except in emergency situations,
as defined as follows.]
[(A)
Schedule II controlled substances may be dispensed upon
oral or telephonically communicated prescription of a practitioner or a practitioner's
designated agent reduced promptly to writing by the pharmacy and filed by
the pharmacy. Within 72 hours after authorizing an emergency oral prescription,
the prescribing individual practitioner shall cause a written triplicate prescription,
with the "Check if Emergency" block marked and indicating the emergency quantity
prescribed to be delivered to the dispensing pharmacist. In addition to other
requirements of the CFR, Title 21, Chapter 2, Part 1306.05, the prescription
shall have written on its face "Authorization for Emergency Dispensing" and
the date of the oral order. The federal regulation will be deemed satisfied
by marking the block at the bottom of the triplicate prescription form indicating
"Check if Emergency" and filling in "Date Issued" space at top of form.]
[(B)
The written prescription may be delivered to the pharmacist
in person or by mail, but if delivered by mail, it must be postmarked within
the 72-hour period. Upon receipt, the dispensing pharmacist shall attach Copy
2 of the triplicate prescription to the oral emergency prescription which
has earlier been reduced to writing.]
[(C)
The dispensing pharmacist shall send Copy 1 of the triplicate
prescription to the Department of Public Safety within 30 days from the date
the prescription is filled. Copy 2 of the triplicate prescription, along with
the copy of the oral emergency prescription, will be retained by the pharmacy
for two years for inspection purposes. No prescription for a Schedule II controlled
substance may be refilled.]
[(5)
Partial dispensing of Schedule
II controlled substances.]
[(A)
If unable to supply the full quantity called for in a
written or emergency oral prescription for a Schedule II controlled substance,
the pharmacist may partially dispense the prescription and complete the prescription
under the following conditions.]
[(i)
The pharmacist notes the initial partial quantity dispensed
on the face of the written prescription or emergency oral prescription.]
[(ii)
The remaining portion of the prescription is dispensed
within 72 hours of the first partial dispensing. No further quantity may be
dispensed beyond 72 hours without a new prescription.]
[(iii)
If the remaining portion of the prescription is not
or cannot be dispensed within the 72-hour period, the pharmacist shall notify
the prescribing practitioner.]
[(B)
A pharmacist may dispense a prescription for a Schedule
II controlled substance in partial quantities to include individual dosage
units, for a patient in a long-term facility (LTCF) or for a patient with
a medical diagnosis documenting a terminal illness under the following conditions.]
[(i)
The pharmacist must record on the prescription whether
the patient is terminally ill or an LTCF patient. A prescription that is partially
filled and does not contain the notation terminally ill or LTCF patient shall
be deemed to have been filled in violation of the Texas Controlled Substances
Act.]
[(ii)
If there is any question about whether a patient may
be classified as having a terminal illness, the pharmacist must contact the
practitioner prior to partially filling the prescription. Both the pharmacist
and the practitioner have a corresponding responsibility to assure that the
controlled substance is for a terminally ill patient.]
[(iii)
For each partial dispensing, the dispensing pharmacist
shall record on the back of Copy 1 and Copy 2 of the prescription the:]
[(I)
date of the partial dispensing;]
[(II)
quantity dispensed;]
[(III)
remaining quantity authorized to be dispensed; and]
[(IV)
identification of the dispensing pharmacist.]
[(iv)
Prior to any subsequent partial dispensing, the pharmacist
must determine that the additional partial dispensing is necessary.]
[(v)
The total quantity of the Schedule II controlled substances
dispensed in all partial dispensings must not exceed the total quantity prescribed.]
[(vi)
Schedule II prescriptions for patients in a long-term
care facility or patients with a medical diagnosis documenting a terminal
illness shall be valid for a period not to exceed 30 days from the issue date
unless sooner terminated by discontinuance of the medication.]
[(6)
Exceptions to use of triplicate
prescriptions.]
[(A)
A medication order written for a patient who is admitted
to a hospital at the time the medication order is written and filled is not
required to be on a triplicate prescription.]
[(i)
"Medication order," as used in this subsection, will mean
a drug order issued for administration to a patient admitted to a hospital.]
[(ii)
"Admitted to a hospital," as used in this subsection,
will include the following:]
[(I)
general hospital, special hospitals, ambulatory surgical
centers, and surgical suites in dental schools;]
[(II)
hospital clinics and emergency room admittance, if the
clinic and/or emergency room is under the control, direction, and administration
as an integral part of the general or special hospital.]
[(B)
A prescription written and filled for a patient who is
admitted to a hospital at the time the prescription is written and filled
is not required to be on a triplicate prescription; however, such prescription
shall comply with the requirement of the Texas Pharmacy Act, §40(g).]
[(i)
Schedule II controlled substances may be dispensed by
a practitioner or pharmacy of the hospital to a patient who has been admitted
to a hospital and who will require an emergency quantity of controlled substances
upon release from the hospital. These Schedule II controlled substances may
only be dispensed to a patient while such patient is still admitted to and
a resident of the hospital.]
[(ii)
The amount of Schedule II controlled substances dispensed
under this paragraph may only be the amount needed for proper treatment of
the patient until access to a pharmacy other than the hospital pharmacy is
possible, but in no event may exceed a seven-day supply. However, when an
emergency supply is dispensed from the emergency room of the hospital, the
amount dispensed may not exceed a 72-hour supply.]
[(iii)
The Schedule II controlled substances dispensed under
the situations outlined in clause (ii) of this subparagraph must be in a properly
labeled container.]
[(7)
Pharmacist responsibilities.]
[(A)
Upon receipt of Copy 1 and Copy 2 of a properly completed
triplicate prescription from a practitioner, each dispensing pharmacist shall
utilize the "Pharmacy Use Only" section and record the following:]
[(i)
pharmacy name, address, area code/telephone number, and
Drug Enforcement Administration number. This information may be printed, typed,
or rubber stamped, or the pharmacist may use a label that is securely affixed
in this area;]
[(ii)
the dispensing pharmacist's signature shall be entered
in a space located directly below the pharmacy information;]
[(iii)
enter in the spaces provided the date filled and the
pharmacy prescription number;]
[(iv)
ensure that the drug prescribed and/or its substitute
is legible on Copy 1 and Copy 2 of the triplicate prescription.]
[(B)
No Schedule II prescription may be dispensed after the
end of the seventh day following the date of issuance.]
[(C)
a pharmacist may dispense a prescription that is orally
or telephonically communicated by a practitioner or his designated agent for
a Schedule II controlled substance in emergency situations, as defined by
paragraph (1)(B) of this subsection.]
[(i)
In such emergency situations the dispensing pharmacist
shall reduce promptly to writing the following:]
[(I)
name, address, and federal Drug Enforcement Administration
number of the prescribing practitioner;]
[(II)
drug prescribed, the dosage, and the instructions for
use;]
[(III)
name, address, and age of the person for whom the controlled
substance is prescribed (or if an animal, the species and owner's name and
address).]
[(ii)
The pharmacist shall file the recorded information as
set out in subparagraph (C)(i) of this paragraph in the pharmacy's Schedule
II prescription files.]
[(iii)
Within 72 hours from the time thee emergency oral or
telephonic communication was received, the practitioner must provide the dispensing
pharmacy with the triplicate prescription order corresponding to the oral
prescription order. If such triplicate prescription is not provided, the pharmacist
shall contact the Department of Public Safety and the Drug Enforcement Administration.]
[(iv)
The practitioner is required to place the date issued
on the triplicate prescription and such date shall be the date the practitioner
or his designated agent communicated the emergency oral or telephonic prescription
to the pharmacy.]
[(v)
The practitioner shall check the block at the bottom of
the triplicate prescription which indicates the prescription is an emergency
order. If the practitioner fails to check such block, the pharmacist should
do so.]
[(vi)
The pharmacist shall attach Copy 2 to the oral emergency
prescription which was reduced to writing upon receipt from the practitioner
or practitioner's designated agent.]
[(D)
Within 30 days from the date a pharmacist fills a triplicate
prescription, the pharmacy is required to mail Copy 1 of the form to the Texas
department of Public Safety, Triplicate Prescription Section, P.O. Box 4087,
Austin, Texas 78773.]
[(E)
Should a prescription be written on a triplicate prescription
by a practitioner for a controlled substance other than a Schedule II, the
pharmacist may dispense the prescription but shall mark the prescription in
such a way as to clearly indicate that the drug dispensed is not a Schedule
II controlled substance.]
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
December 23, 1999.
TRD-9909026
Gay Dodson, R.Ph.
Executive Secretary/Director
Texas State Board of Pharmacy
Earliest possible date of adoption: February 6, 2000
For further information, please call: (512) 305-8028
22 TAC §§291.101-291.105
The Texas State Board of Pharmacy proposes new §291.101,
concerning Purpose, §291.102, concerning Definitions, §291.103,
concerning Personnel, §291.104, concerning Operational Standards, and §291.105,
concerning Records. The new rules, if adopted, will implement the recommendations
of the Task Force on Non-Resident Pharmacies and Pharmacy Automation.
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 additional
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 protect the public through the effective control
and regulation of non-resident pharmacies which provide pharmacy services
to residents of Texas. These new rules primarily clarify statutory requirements
which have been in existence for several years. Therefore, the economic impact
on Class E (Non-Resident) Pharmacies is anticipated to be minimal. There are
no anticipated economic costs to other small or large businesses or to other
entities who are required to comply with this section as proposed.
Comments on the proposal may be submitted to Steve Morse, R.Ph., Director
of Compliance, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite
3-600, Box 21, Austin, Texas, 78701-3942.
The new rules are proposed under §§554.002, 554.051,
and 554.005 of the Texas Pharmacy Act (Subtitle J, Chapters 551-564, Occupations
Code). The Board interprets §554.002 of the Texas Pharmacy Act as authorizing
the agency to protect the public through the effective control and regulation
of the practice of pharmacy. The Board interprets §554.051 of the Texas
Pharmacy Act as authorizing the agency to adopt rules for the proper administration
and enforcement of the Act including adoption of rules for pharmacies located
in another state. The Board interprets §554.005 of the Texas Pharmacy
Act as authorizing the agency to regulate the delivery or distribution of
prescription drugs as they relate to the practice of pharmacy and specify
the minimum standards for the maintenance of prescription drug records.
The statutes affected by this rule: Occupations Code, Subtitle J.
§291.101.Purpose.
(a)
The purpose of these rules is to provide standards for
the operation of non-resident pharmacies (Class E) which dispense a prescription
drug or device under a prescription drug order and deliver the drug or device
to a patient in this state, by the United States mail, a common carrier, or
a delivery service.
(b)
These rules are in accordance with §554.051(a) and
(b) of the Act which permit the board to make rules concerning the operation
of licensed pharmacies in this state applicable to pharmacies licensed by
the board that are located in another state. The board has determined that
these rules are necessary to protect the health and welfare of the citizens
of this state.
(c)
Unless compliance would violate the pharmacy or drug laws
or rules in the state in which the pharmacy is located, Class E Pharmacies
are required to comply with the provisions of §291.101-291.105 of this
chapter (relating to purpose, definitions, personnel, operational standards,
and records).
§291.102.Definitions.
The following words and terms, when used in this subchapter, shall
have the following meanings, unless the context clearly indicates otherwise.
(1)
Act--The Texas Pharmacy Act, Chapters 551-566, Occupations
Code, as amended.
(2)
Accurately as prescribed--Dispensing, delivering,
and/or distributing a prescription drug order:
(A)
to the correct patient (or agent of the patient) for whom
the drug or device was prescribed;
(B)
with the correct drug in the correct strength, quantity,
and dosage form ordered by the practitioner; and
(C)
with correct labeling (including directions for use) as
ordered by the practitioner. Provided, however, that nothing herein shall
prohibit pharmacist substitution if substitution is conducted in strict accordance
with applicable laws and rules, including Subchapter A of Chapter 562 of the
Texas Pharmacy Act relating to Prescription and Substitution Requirements.
(3)
Board--The Texas State Board of Pharmacy.
(4)
Class E pharmacy license or non-resident pharmacy
license--A license issued to a pharmacy located in another state whose primary
business is to:
(A)
dispense a prescription drug or device under a prescription
drug order; and
(B)
to deliver the drug or device to a patient, including a
patient in this state, by the United States mail, common carrier, or delivery
service.
(5)
Confidential Record--Any health related record,
including a patient medication record, prescription drug order, or medication
order that:
(A)
contains information that identifies an individual; and
(B)
is maintained by a pharmacy or pharmacist.
(6)
Deliver or delivery--The actual, constructive,
or attempted transfer of a prescription drug or device or controlled substance
from one person to another, whether or not for a consideration.
(7)
Dispense--Preparing, packaging, compounding, or labeling,
in the course of professional practice, a prescription drug or device for
delivery to an ultimate user or the user's agent under a practitioner's lawful
order.
(8)
Distribute--To deliver a prescription drug or device
other than by administering or dispensing.
(9)
Generically equivalent--A drug that is "pharmaceutically
equivalent" and "therapeutically equivalent" to the drug prescribed.
(10)
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.)
(11)
Pharmaceutically equivalent--Drug products which
have identical amounts of the same active chemical ingredients in the same
dosage form and which meet the identical compendial or other applicable standards
of strength, quality, and purity according to the United States Pharmacopoeia
or other nationally recognized compendium.
(12)
Pharmacist--For the purpose of this subchapter, a
person licensed to practice pharmacy in the state where the Class E pharmacy
is located.
(13)
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 statutes and rules pertaining to the practice
of pharmacy.
(14)
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 the Act;
(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; or
(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.
(15)
Prescription drug order--An order from a practitioner
or a practitioner's designated agent to a pharmacist for a drug or device
to be dispensed.
(16)
Therapeutically equivalent--Pharmaceutically equivalent
drug products which, when administered in the same amounts, will provide the
same therapeutic effect, identical in duration and intensity.
§291.103.Personnel.
As specified in §562.101(f) of the Act (relating to Supervision
of Pharmacy), a Class E pharmacy shall be under the continuous on-site supervision
of a pharmacist and shall designate one pharmacist licensed to practice pharmacy
by the regulatory or licensing agency of the state in which the Class E pharmacy
is located to serve as the pharmacist-in-charge of the Class E pharmacy license.
§291.104.Operational Standards.
(a)
Licensing requirements.
(1)
A Class E 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) and provide the following additional information specified
in §560.052(c) of the Act (relating to Qualifications):
(A)
evidence that the applicant holds a pharmacy license, registration,
or permit issued by the state in which the pharmacy is located;
(B)
the name of the owner and pharmacist-in-charge of the pharmacy
for service of process;
(C)
evidence of the applicant's ability to provide to the board
a record of a prescription drug order dispensed by the applicant to a resident
of this state not later than 72 hours after the time the board requests the
record; and
(D)
an affidavit by the pharmacist-in-charge which states that
the pharmacist has read and understands the laws and rules relating to a Class
E pharmacy.
(2)
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 §291.4 of this title (relating
to Change of Ownership).
(3)
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 §291.2 of this title (relating to Change of Location
and/or Name).
(4)
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 Change of Managing Officers).
(5)
A Class E pharmacy shall notify the board in writing
within ten days of closing.
(6)
A separate license is required for each principal
place of business and only one pharmacy license may be issued to a specific
location.
(7)
A fee as specified in §291.6 of this title (relating
to Pharmacy License Fees) will be charged for the issuance and renewal of
a license and the issuance of an amended license.
(8)
The board may grant an exemption from the licensing
requirements of this Act on the application of a pharmacy located in a state
of the United States other than this state that restricts its dispensing of
prescription drugs or devices to residents of this state to isolated transactions.
(b)
Prescription dispensing and delivery.
(1)
General.
(A)
All prescription drugs and/or devices shall be dispensed
and delivered safely and accurately as prescribed.
(B)
The pharmacy shall maintain adequate storage or shipment
containers and use shipping processes to ensure drug stability and potency.
Such shipping processes shall include the use of packaging material and devices
to ensure that the drug is maintained at an appropriate temperature range
to maintain the integrity of the medication throughout the delivery process.
(C)
The pharmacy shall utilize a delivery system which is designed
to assure that the drugs are delivered to the appropriate patient.
(2)
Drug regimen review.
(A)
For the purpose of promoting therapeutic appropriateness,
a pharmacist shall prior to or at the time of dispensing a prescription drug
order, review the patient's medication record. Such review shall at a minimum
identify clinically significant:
(i)
inappropriate drug utilization;
(ii)
therapeutic duplication;
(iii)
drug-disease contraindications;
(iv)
drug-drug interactions;
(v)
incorrect drug dosage or duration of drug treatment;
(vi)
drug-allergy interactions; and
(vii)
clinical abuse/misuse.
(B)
Upon identifying any clinically significant conditions,
situations, or items listed in subparagraph (A) of this paragraph, the pharmacist
shall take appropriate steps to avoid or resolve the problem including consultation
with the prescribing practitioner. The pharmacist shall document such occurrences
if the prescription is dispensed. The documentation shall:
(i)
be maintained at the pharmacy for two years;
(ii)
contain the following information:
(I)
unique prescription number;
(II)
patient name;
(III)
date of the review if different from the dispensing date;
(IV)
the name, initials, or identification code of the pharmacist
who performed the review; and
(V)
steps taken to resolve the problem; and
(iii)
be available in a hard copy format, if so requested by
an agent of the board.
(3)
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,
once yearly on maintenance medications, and if the pharmacist deems appropriate,
with prescription drug order refills. (For the purposes of this clause, maintenance
medications are defined as any medication the patient has taken for one year
or longer);
(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 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 orally 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)
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.
(E)
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 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)."
(F)
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).
(G)
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.
(c)
Generic Substitution. Unless compliance would violate the
pharmacy or drug laws or rules in the state in which the pharmacy is located:
(1)
a pharmacist in a Class E pharmacy may dispense a generically
equivalent drug product if:
(A)
the generic product costs the patient less than the prescribed
drug product;
(B)
the patient does not refuse the substitution; and
(C)
the prescribing practitioner authorizes the substitution
of a generically equivalent product; or
(D)
the practitioner or practitioner's agent does not clearly
indicate that the oral or electronic prescription drug order shall be dispensed
as ordered; and
(2)
provided the pharmacist uses as a basis for the
determination of generic equivalency, the publication, Approved Drug Products
With Therapeutic Equivalence Evaluations and current supplements published
by the Federal Food and Drug Administration within the limitations stipulated
in that publication.
(d)
Therapeutic Drug Interchange. A switch to a drug providing
a similar therapeutic response to the one prescribed shall not be made without
prior approval of the prescribing practitioner.
(1)
The patient shall be notified of the therapeutic drug interchange
prior to, or upon delivery, of the dispensed prescription to the patient.
Such notification shall include:
(A)
a description of the change;
(B)
the reason for the change;
(C)
whom to notify with questions concerning the change; and
(D)
instructions for return of the drug if not wanted by the
patient.
(2)
The pharmacy shall maintain documentation of
patient notification of therapeutic drug interchange which shall include:
(A)
the date of the notification;
(B)
the method of notification;
(C)
a description of the change; and
(D)
the reason for the 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 who is making the transfer
request on behalf of the patient.
(f)
Prescriptions for Schedule II controlled substances. 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 who dispenses
a prescription for a Schedule II controlled substance issued on a Texas Official
Prescription Form shall:
(1)
mail a copy of the form to the Texas Department of Public
Safety, Electronic Prescription Section, P.O. Box 4087, Austin, Texas 78773
within 30 days of dispensing; or
(2)
electronically send the prescription information to
the Texas Department of Public Safety per their requirements for electronic
submissions within 30 days of dispensing.
§291.105.Records.
(a)
Maintenance of records.
(1)
Every record required to be kept under this section shall
be 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.
(2)
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;
(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.
(b)
Civil litigation and complaint records. A Class E pharmacy
shall keep a permanent record of:
(1)
any civil litigation commenced against the pharmacy by
a Texas resident; and
(2)
complaints that arise out of a prescription for a
Texas resident lost during delivery.
(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
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)
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. §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
December 23, 1999.
TRD-9909027
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: February 6, 2000
For further information, please call: (512) 305-8028
Subchapter B. GENERAL PROCEDURES IN A CONTESTED CASE
Chapter 291.
PHARMACIES
Subchapter B. COMMUNITY PHARMACY (CLASS A)
§40
] of the Texas Pharmacy Act.
Texas Civil Statutes, Article 4542a-1,
]
as amended.
Automated drug dispensing system
]--An automated device that
compounds,
measures, counts,
and/or
packages[
, and/or labels
]
a specified quantity of dosage units
of
[
for
] a designated
drug product.
(5)
] Board--The Texas State
Board of Pharmacy.
(6)
] Carrying out or signing
a prescription drug order--The completion of a prescription drug order presigned
by the delegating physician, or the signing of a prescription by an advanced
practice nurse or physician assistant after the person has been designated
with the Texas State Board of Medical Examiners by the delegating physician
as a person delegated to sign a prescription. The following information shall
be provided on each prescription:
(7)
] Certified Pharmacy
Technician--A pharmacy technician who:
(8)
] Component--Any ingredient
intended for use in the compounding of a drug product, including those that
may not appear in such product.
(9)
] Compounding--The preparation,
mixing, assembling, packaging, or labeling of a drug or device:
(10)
] Confidential record--Any
health-related record
that contains information that identifies an individual
and that is
maintained by a pharmacy or pharmacist, such as a patient
medication record, prescription drug order, or medication order.
(11)
] Controlled substance--A
drug, immediate precursor, or other substance listed in Schedules I-V or Penalty
Groups 1-4 of the Texas Controlled Substances Act, as amended, or a drug,
immediate precursor, or other substance included in Schedules I, II, III,
IV, or V of the Federal Comprehensive Drug Abuse Prevention and Control Act
of 1970, as amended (Public Law 91-513).
(12)
] Dangerous drug--Any
drug or device that is not included in Penalty Groups 1-4 of the Controlled
Substances Act and that is unsafe for self-medication or any drug or device
that bears or is required to bear the legend:
(13)
] Data communication
device--An electronic device that receives electronic information from one
source and transmits or routes it to another (e.g., bridge, router, switch
or gateway).
(14)
] Deliver or delivery--The
actual, constructive, or attempted transfer of a prescription drug or device
or controlled substance from one person to another, whether or not for a consideration.
(15)
] Designated agent--
or
]
the Medical Practice Act, §3.06(d)(5) or (6) (Texas
Civil Statutes, Article 4495b).
]
(16)
] Dispense--Preparing,
packaging, compounding, or labeling for delivery a prescription drug or device
in the course of professional practice to an ultimate user or his agent by
or pursuant to the lawful order of a practitioner.
(17)
] Dispensing pharmacist--The
pharmacist responsible for the final check of the dispensed prescription before
delivery to the patient.
(18)
] Distribute--The delivery
of a prescription drug or device other than by administering or dispensing.
(19)
] Downtime--Period of
time during which a data processing system is not operable.
(20)
] Drug regimen review--An
evaluation of prescription drug orders and patient medication records for:
(21)
] Electronic prescription
drug order--A prescription drug order which is transmitted by an electronic
device to the receiver (pharmacy).
(22)
] Full-time pharmacist--A
pharmacist who works in a pharmacy from 30 to 40 hours per week or, if the
pharmacy is open less than 60 hours per week, one-half of the time the pharmacy
is open.
(23)
] Hard copy--A physical
document that is readable without the use of a special device (i.e., cathode
ray tube (CRT), microfiche reader, etc.).
(24)
] Manufacturing--The production,
preparation, propagation, conversion, or processing of a drug or device, either
directly or indirectly, by extraction from substances of natural origin or
independently by means of chemical or biological synthesis and includes any
packaging or repackaging of the substances or labeling or relabeling of the
container and the promotion and marketing of such drugs or devices. Manufacturing
also includes the preparation and promotion of commercially available products
from bulk compounds for resale by pharmacies, practitioners, or other persons
but does not include compounding.
(25)
] Medical Practice Act--The
Texas Medical Practice Act,
Subtitle B, Occupations Code
[
Texas Civil Statutes, Article 4495b
], as amended.
(26)
] 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.
(27)
] New prescription drug
order--A prescription drug order that:
(28)
] Original prescription--The:
(29)
] Part-time pharmacist--A
pharmacist who works less than full-time.
(30)
] 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.
(31)
] 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.
(32)
] 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.
(33)
] Pharmacy technician--Those
individuals utilized in pharmacies whose responsibility it shall be to provide
technical services that do not require professional judgment concerned with
the preparation and distribution of drugs under the direct supervision of
and responsible to a pharmacist. Pharmacy technician includes certified pharmacy
technicians, pharmacy technicians, and pharmacy technician trainees.
(34)
] Pharmacy technician
trainee--A pharmacy technician:
(35)
] 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
[
the Medical Practice
Act, §3.06(d)
], and issued an identification number by the Texas
State Board of Medical Examiners.
(36)
] Practitioner--
(37)
] 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.
(38)
] Prescription drug order--
the Medical Practice Act, §3.06(d
5) and (6)
]
(39)
] 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)
] Texas Controlled Substances
Act--The Texas Controlled Substances Act, Health and Safety Code, Chapter
481, as amended.
(41)
] 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[
, (Texas Civil Statutes, Article
4495b)
].
and
]
(Texas Civil Statutes, Article 4495b)
].
and
]
.
] 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).
.
] 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 §291.4 of this title (relating
to Change of Ownership).
.
] 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 §291.2 of this title (relating
to Change of Location and/or Name).
.
] 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 Change of Managing
Officers).
.
] A pharmacy shall notify the
board in writing within ten days of closing, following the procedures in §291.5
of this title (relating to Closed Pharmacies).
.
] A pharmacy, licensed under the
provisions of the Act,
§560.051(a)(1),
[
§29(b)(1),
] which also operates another type of pharmacy which would otherwise
be required to be licensed under the Act,
§560.051(a)(2)
[
§29(b)(2)
], concerning Nuclear Pharmacy (Class B), is not required
to secure a license for such other type of pharmacy; provided, however, such
licensee is required to comply with the provisions of
§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.
[
§291.51 of this title (relating to Definitions), §291.52 of
this title (relating to Personnel), §291.53 of this title (relating to
Operational Standards), and §291.54 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.
]
.
] A (community) pharmacy engaged
in the compounding of sterile pharmaceuticals shall comply with the provisions
of §291.36 of this title (relating to Class A Pharmacies Compounding
Sterile Pharmaceuticals).
(B)
(C)
] A Class A pharmacy [
initially
licensed after June 1, 1989,
] 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.
(D)
]
A Class A pharmacy which
serves the general public shall contain an area which is suitable for confidential
patient counseling.
[
A Class A pharmacy initially licensed after
June 1, 1989, shall contain an area which is suitable for confidential patient
counseling and beginning January 1, 1995, all Class A pharmacies shall contain
an area which is suitable for confidential patient counseling.
]
(E)
] The pharmacy shall be properly
lighted and ventilated.
(F)
] 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.
(G)
] 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.
Beginning September 1, 1993,
] the communication
shall be reinforced with written information. The following is applicable
concerning this written information.
, such as patient
information leaflets.
]
, Texas Civil
Statutes, Article 4495b
];
(ii)
] managing patient compliance
programs;
(iii)
] providing preventative health
care services; and
(iv)
] providing case management
of patients who are being treated with high-risk or high-cost drugs, or who
are considered "high risk" due to their age, medical condition, family history,
or related concern.
follows.
name or initials of the dispensing pharmacist;
]
§40
], the statement "Substituted for Brand Prescribed" or
"Substituted for 'Brand Name'" where "Brand Name" is the actual name of the
brand name product prescribed;
the Medical Practice Act, §3.06(d);
]
and
and
] tight
, and if applicable, glass
containers;
and loading bulk unlabeled
drugs into automated drug dispensing system
].
(A)
] Drugs may be prepackaged
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 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 lot number;
(iii)
] expiration date; and
(iv)
] quantity of the drug, if the
quantity is greater than one.
(C)
] Records of prepackaging
shall be maintained to show:
(i)
] name of the drug, strength,
and dosage form;
(ii)
] facility's 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
[
name or initials
] of the prepacker; and
(x)
] signature
, 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.
the initials of the dispensing pharmacist;
]
and
the name or initials of the pharmacist who prepared
the patient med-pak.
]
Practioner's
] signature.
Written prescription drug orders shall be manually signed by the
practitioner
[
practioner
] (electronically produced or rubber stamped
signatures may not be used).
practioner
] may sign
a prescription drug order in the same manner as he would sign a check or legal
document, e.g. J.H. Smith or John H. Smith.
practioner's
] agent but may be prepared by
an agent for the signature of a
practitioner
[
practioner
].
However, the prescribing
practitioner
[
practioner
] is
responsible in case the prescription drug order does not conform in all essential
respects to the law and regulations.
practioner
] in a state other than Texas;
practioner
] in the United Mexican States
or the Dominion of Canada; and
practioners
] practicing in a federal facility provided
they are acting in the scope of their employment.
practioner
]
shall contain a preprinted order for a drug product by brand name, generic
name, or manufacturer.
practioners
] in another state.
practioners
] in a state other than Texas in the same manner
as prescription drug orders for dangerous drugs issued by
practitioners
[
practioners
] in Texas are dispensed.
practioner
] in another state provided:
(I)
] the prescription drug order
is an original written prescription issued by 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 (DEA)
registration number, and who may legally prescribe Schedule III, IV, or V
controlled substances in such other state;
(II)
] the prescription drug
order is not dispensed or refilled more than six months from the initial date
of issuance and may not be refilled more than five times; and
(III)
] if there are no refill
instructions on the original written prescription drug order (which shall
be interpreted as no refills authorized) or if all refills authorized on the
original written prescription drug order have been dispensed, a new written
prescription drug order is obtained from the prescribing
practitioner
[
practioner
] prior to dispensing any additional quantities
of controlled substances.
practioners
] in the United Mexican States or the Dominion
of Canada.
practioner
] in the Dominion of Canada or the United Mexican States.
practioner
] prior
to dispensing any additional quantities of dangerous drugs.
the Medical Practice Act, §3.06(d).
]
the Medical Practice Act, §3.06(d).
] A list of the advanced practice nurses or physician assistants designated
by the practitioner must be maintained in the practitioner's usual place of
business. On request by a pharmacist, a practitioner shall furnish the pharmacist
with a copy of the written authorization for a specific advanced practice
nurse or physician assistant.
a triplicate
] prescription form as required by the Texas Controlled Substances Act, §481.075.
(6)
] Original prescription
drug order records.
triplicate prescriptions
] may be stored on microfilm, microfiche, or other system which is capable
of producing a direct image of the original prescription record, e.g., digitalized
imaging system. If original prescription records are stored in a direct imaging
system, the following is applicable:
(7)
] Prescription
drug order information.
the Medical Practice Act, §3.06(d)
], shall bear:
,
and original signature
] of the
supervising
practitioner;
§40
].
(8)
] Refills.
use
] review at the time a prescription drug order
is presented for dispensing.
use
] review;
The data processing system shall have a mechanism to send a message
to the transferring pharmacy containing the following information:
]
(C)
] 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.
§1304(a)
],
and submits a copy of this written notification to the Texas State Board of
Pharmacy. Unless the registrant is informed by the divisional director of
the Drug Enforcement Administration that permission to keep central records
is denied, the pharmacy may maintain central records commencing 14 days after
receipt of notification by the divisional director.
Automated compounding or drug dispensing system
]--An automated
device that compounds, measures, counts,
and/or
packages[
, and/or labels
] a specified quantity of dosage units for a designated
drug product.
Automated compounding device(s)
]. If
automated compounding or counting
devices
[
automated compounding device(s)
] are used, the pharmacy
shall have a method to calibrate and verify the accuracy of
automated
compounding or counting devices
[
automated compounding devices
] used in aseptic processing and document the calibration and verification
on a routine basis.
are used
] 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
utilizes
]
a delivery system which is designed to assure that the drugs are delivered
to the appropriate patient.
automated compounding
or drug dispensing systems
].
automated compounding or drug dispensing systems
].
Automated compounding or drug dispensing systems
] may be loaded with
bulk drugs only by a pharmacist or by pharmacy technicians under the direction
and direct supervision of a pharmacist.
automated compounding or 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.
automated compounding or drug dispensing
system
] shall be maintained to show:
automated compounding or drug dispensing system
];
automated
compounding or drug dispensing system
]; and
automated compounding or 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 clause
(iii) of this subparagraph.
automated
compounding device
]); and
(G)
] Original prescription drug
order records.
(H)
] Prescription drug order information.
(I)
] Refills.
Subchapter F. NON-RESIDENT PHARMACY (CLASS E)
Chapter 309.
GENERIC SUBSTITUTION