PART 15. TEXAS STATE BOARD OF PHARMACY
CHAPTER 281. ADMINISTRATIVE PRACTICE AND PROCEDURES
SUBCHAPTER A. GENERAL PROVISIONS
The Texas State Board of Pharmacy adopts amendments to §281.7, concerning Grounds for Discipline for a Pharmacist License. These amendments are adopted without changes to the proposed text as published in the April 5, 2019, issue of the Texas Register (44 TexReg 1642) and will not be republished.
The amendments update the grounds for disciplinary action against a pharmacist license after receipt of a warning notice from the board to reflect current board policies and procedures, and correct grammatical errors.
No comments were received.
The amendments are adopted under §§551.002 and 554.051 of the Texas Pharmacy Act (Chapters 551 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by these amendments: Texas Pharmacy Act, Chapters 551 - 569, Texas Occupations Code.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on May 31, 2019.
TRD-201901604
Allison Vordenbaumen Benz, R.Ph., M.S.
Executive Director
Texas State Board of Pharmacy
Effective date: June 20, 2019
Proposal publication date: April 5, 2019
For further information, please call: (512) 305-8010
The Texas State Board of Pharmacy adopts amendments to §283.4, concerning Internship Requirements. These amendments are adopted without changes to the proposed text as published in the April 5, 2019, issue of the Texas Register (44 TexReg 1645) and will not be republished.
The amendments update the pharmacist-intern requirements to reflect the board's new procedure of issuing electronic pharmacist-intern documentation.
No comments were received.
The amendments are adopted under §551.002 and §554.051 of the Texas Pharmacy Act (Chapters 551 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by these amendments: Texas Pharmacy Act, Chapters 551 - 569, Texas Occupations Code.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on May 31, 2019.
TRD-201901605
Allison Vordenbaumen Benz, R.Ph., M.S.
Executive Director
Texas State Board of Pharmacy
Effective date: June 20, 2019
Proposal publication date: April 5, 2019
For further information, please call: (512) 305-8010
The Texas State Board of Pharmacy adopts amendments to §283.6, concerning Preceptor Requirements and Ratio of Preceptors to Pharmacist-Interns. These amendments are adopted without changes to the proposed text as published in the April 5, 2019, issue of the Texas Register (44 TexReg 1648); therefore, the rules will not be republished.
The amendments remove the requirement for pharmacist preceptors to publicly display their licenses and certificates, and correct grammatical and reference errors.
No comments were received.
The amendments are adopted under §551.002 and §554.051 of the Texas Pharmacy Act (Chapters 551- 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by these amendments: Texas Pharmacy Act, Chapters 551- 569, Texas Occupations Code.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on May 31, 2019.
TRD-201901606
Allison Vordenbaumen Benz, R.Ph., M.S.
Executive Director
Texas State Board of Pharmacy
Effective date: June 20, 2019
Proposal publication date: April 5, 2019
For further information, please call: (512) 305-8010
SUBCHAPTER A. ALL CLASSES OF PHARMACIES
The Texas State Board of Pharmacy adopts amendments to §291.17, concerning Inventory Requirements. These amendments are adopted without changes to the proposed text as published in the April 5, 2019, issue of the Texas Register (44 TexReg 1649).
The amendments clarify that the annual inventory of a Class C and Class C-S pharmacy shall include a physical count of all controlled substances located in the pharmacy and all controlled substances located in other departments of the institution.
No comments were received.
The amendments are adopted under §551.002 and §554.051 of the Texas Pharmacy Act (Chapters 551 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by these amendments: Texas Pharmacy Act, Chapters 551 - 569, Texas Occupations Code.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on May 31, 2019.
TRD-201901611
Allison Vordenbaumen Benz, R.Ph., M.S.
Executive Director
Texas State Board of Pharmacy
Effective date: June 20, 2019
Proposal publication date: April 5, 2019
For further information, please call: (512) 305-8010
The Texas State Board of Pharmacy adopts amendments to §291.32, concerning Personnel. These amendments are adopted without changes to the proposed text as published in the April 5, 2019, issue of the Texas Register (44 TexReg 1651).
The amendments allow pharmacy technicians and pharmacy technician trainees to perform data entry remotely in Class A pharmacies.
No comments were received.
The amendments are adopted under §§551.002 and 554.051 of the Texas Pharmacy Act (Chapters 551 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by these amendments: Texas Pharmacy Act, Chapters 551 - 569, Texas Occupations Code.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on May 31, 2019.
TRD-201901613
Allison Vordenbaumen Benz, R.Ph., M.S.
Executive Director
Texas State Board of Pharmacy
Effective date: June 20, 2019
Proposal publication date: April 5, 2019
For further information, please call: (512) 305-8010
The Texas State Board of Pharmacy adopts amendments to §291.34, concerning Records. These amendments are adopted without changes to the proposed text as published in the April 5, 2019, issue of the Texas Register (44 TexReg 1653) and will not be republished.
The amendments remove an outdated reference to the Department of Public Safety as one of the agencies to which reports of theft or loss of controlled substances are made, remove an outdated reference to a Schedule V nonprescription register book, and correct grammatical errors.
No comments were received.
The amendments are adopted under §551.002 and §554.051 of the Texas Pharmacy Act (Chapters 551 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by these amendments: Texas Pharmacy Act, Chapters 551 - 569, Texas Occupations Code.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on May 31, 2019.
TRD-201901615
Allison Vordenbaumen Benz, R.Ph., M.S.
Executive Director
Texas State Board of Pharmacy
Effective date: June 20, 2019
Proposal publication date: April 5, 2019
For further information, please call: (512) 305-8010
The Texas State Board of Pharmacy adopts amendments to §291.55, concerning Records. These amendments are adopted without changes to the proposed text as published in the April 5, 2019, issue of the Texas Register (44 TexReg 1654). The rule will not be republished.
The amendments remove an outdated reference to the Department of Public Safety as one of the agencies to which reports of theft or loss of controlled substances are made and correct grammatical errors.
No comments were received.
The amendments are adopted under §§551.002 and 554.051 of the Texas Pharmacy Act (Chapters 551 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by these amendments: Texas Pharmacy Act, Chapters 551 - 569, Texas Occupations Code.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on May 31, 2019.
TRD-201901616
Allison Vordenbaumen Benz, R.Ph., M.S.
Executive Director
Texas State Board of Pharmacy
Effective date: June 20, 2019
Proposal publication date: April 5, 2019
For further information, please call: (512) 305-8010
The Texas State Board of Pharmacy adopts amendments to §291.75, concerning Records. These amendments are adopted with change to the proposed text as published in the April 5, 2019, issue of the Texas Register (44 TexReg 1657). The amended rule will be republished.
The amendments remove an outdated reference to the Department of Public Safety as one of the agencies to which reports of theft or loss of controlled substances are made and correct grammatical errors.
No comments were received.
The amendments are adopted under §§551.002 and 554.051 of the Texas Pharmacy Act (Chapters 551 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by these amendments: Texas Pharmacy Act, Chapters 551 - 569, Texas Occupations Code.
§291.75.Records.
(a) Maintenance of records.
(1) Every inventory or other record required to be kept under the provisions of §291.71 of this title (relating to Purpose), §291.72 of this title (relating to Definitions), §291.73 of this title (relating to Personnel), §291.74 of this title (relating to Operational Standards), and this section contained in Institutional Pharmacy (Class C) shall be:
(A) kept by the institutional pharmacy and be available, for at least two years from the date of such inventory or record, for inspecting and copying by the board or its representative, and other authorized local, state, or federal law enforcement agencies; and
(B) supplied by the pharmacy within 72 hours, if requested by an authorized agent of the board. If the pharmacy maintains the records in an electronic format, the requested records must be provided in a mutually agreeable electronic format if specifically requested by the board or its representative. Failure to provide the records set out in this subsection, either on site or within 72 hours, constitutes prima facie evidence of failure to keep and maintain records in violation of the Act.
(2) Records of controlled substances listed in Schedules I and II shall be maintained separately from all other records of the pharmacy.
(3) Records of controlled substances listed in Schedules III - V shall be maintained separately or readily retrievable from all other records of the pharmacy. For purposes of this subsection, readily retrievable means that the controlled substances shall be asterisked, redlined, or in some other manner readily identifiable apart from all other items appearing on the record.
(4) Records, except when specifically required to be maintained in original or hard-copy form, may be maintained in an alternative data retention system, such as a data processing or direct imaging system, provided:
(A) the records in the alternative data retention system contain all of the information required on the manual record; and
(B) the alternative data retention system is capable of producing a hard copy of the record upon the request of the board, its representative, or other authorized local, state, or federal law enforcement or regulatory agencies.
(b) Outpatient records.
(1) Outpatient records shall be maintained as provided in §291.34 (relating to Records), and §291.35 (relating to Official Prescription Requirements), in chapter 291, subchapter B of this title.
(2) Outpatient prescriptions, including, but not limited to, furlough and discharge prescriptions, that are written by a practitioner must be written on a form which meets the requirements of §291.34(b)(7)(A) of this title. Medication order forms or copies thereof do not meet the requirements for outpatient forms.
(3) Controlled substances listed in Schedule II must be written on an official prescription form in accordance with the Texas Controlled Substances Act, §481.075, and rules promulgated pursuant to the Texas Controlled Substances Act, unless exempted by chapter 315 of this title (relating to Controlled Substances). Outpatient prescriptions for Schedule II controlled substances that are exempted from the official prescription requirement must be manually signed by the practitioner.
(c) Patient records.
(1) Original medication orders.
(A) Each original medication order shall bear the following information:
(i) patient name and room number or identification number;
(ii) drug name, strength, and dosage form;
(iii) directions for use;
(iv) date; and
(v) signature or electronic signature of the practitioner or that of his or her authorized agent.
(B) Original medication orders shall be maintained with the medication administration records of the patients.
(2) Patient medication records (PMR). A patient medication record shall be maintained for each patient of the facility. The PMR shall contain at a minimum the following information:
(A) Patient information:
(i) patient name and room number or identification number;
(ii) gender, and date of birth or age;
(iii) weight and height;
(iv) known drug sensitivities and allergies to drugs and/or food;
(v) primary diagnoses and chronic conditions;
(vi) primary physician; and
(vii) other drugs the patient is receiving; and
(B) Medication order information:
(i) date of distribution;
(ii) drug name, strength, and dosage form; and
(iii) directions for use.
(3) Controlled substances records. Controlled substances records shall be maintained as follows:
(A) All records for controlled substances shall be maintained in a readily retrievable manner; and
(B) Controlled substances records shall be maintained in a manner to establish receipt and distribution of all controlled substances.
(4) Schedule II controlled substances records. Records of controlled substances listed in Schedule II shall be maintained as follows:
(A) Records of controlled substances listed in Schedule II shall be maintained separately from records of controlled substances in Schedules III, IV, and V, and all other records;
(B) An institutional pharmacy shall maintain a perpetual inventory of any controlled substance listed in Schedule II; and
(C) Distribution records for controlled substances listed in Schedule II shall bear the following information:
(i) patient's name;
(ii) prescribing or attending practitioner;
(iii) name of drug, dosage form, and strength;
(iv) time and date of administration to patient and quantity administered;
(v) name, initials, or electronic signature of the individual administering the controlled substance;
(vi) returns to the pharmacy; and
(vii) waste (waste is required to be witnessed and cosigned, electronically or manually, by another individual).
(5) Floor stock records.
(A) Distribution records for Schedules II - V controlled substances floor stock shall include the following information:
(i) patient's name;
(ii) prescribing or attending practitioner;
(iii) name of controlled substance, dosage form, and strength;
(iv) time and date of administration to patient;
(v) quantity administered;
(vi) name, initials, or electronic signature of the individual administering drug;
(vii) returns to the pharmacy; and
(viii) waste (waste is required to be witnessed and cosigned, manually or electronically, by another individual).
(B) The record required by subparagraph (A) of this paragraph shall be maintained separately from patient records.
(C) A pharmacist shall review distribution records with medication orders on a periodic basis to verify proper usage of drugs, not to exceed 30 days between such reviews.
(6) General requirements for records maintained in a data processing system.
(A) Noncompliance with data processing requirements. If a hospital pharmacy's data processing system is not in compliance with the board's requirements, the pharmacy must maintain a manual recordkeeping system.
(B) Requirements for backup systems. The facility shall maintain a backup copy of information stored in the data processing system using disk, tape, or other electronic backup system and update this backup copy on a regular basis, at least monthly, to assure that data is not lost due to system failure.
(C) Change or discontinuance of a data processing system.
(i) Records of distribution and return for all controlled substances. A pharmacy that changes or discontinues use of a data processing system must:
(I) transfer the records to the new data processing system; or
(II) purge the records to a printout which contains the same information as required on the audit trail printout as specified in paragraph (7)(B) of this subsection. The information on this printout shall be sorted and printed by drug name and list all distributions/returns chronologically.
(ii) Other records. A pharmacy that changes or discontinues use of a data processing system must:
(I) transfer the records to the new data processing system; or
(II) purge the records to a printout which contains all of the information required on the original document.
(iii) Maintenance of purged records. Information purged from a data processing system must be maintained by the pharmacy for two years from the date of initial entry into the data processing system.
(D) Loss of data. The pharmacist-in-charge shall report to the board in writing any significant loss of information from the data processing system within 10 days of discovery of the loss.
(7) Data processing system maintenance of records for the distribution and return of all controlled substances to the pharmacy.
(A) Each time a controlled substance is distributed from or returned to the pharmacy, a record of such distribution or return shall be entered into the data processing system.
(B) The data processing system shall have the capacity to produce a hard copy printout of an audit trail of drug distribution and return for any strength and dosage form of a drug (by either brand or generic name or both) during a specified time period. This printout shall contain the following information:
(i) patient's name and room number or patient's facility identification number;
(ii) prescribing or attending practitioner's name;
(iii) name, strength, and dosage form of the drug product actually distributed;
(iv) total quantity distributed from and returned to the pharmacy;
(v) if not immediately retrievable via electronic image, the following shall also be included on the printout:
(I) prescribing or attending practitioner's address; and
(II) practitioner's DEA registration number, if the medication order is for a controlled substance.
(C) An audit trail printout for each strength and dosage form of the drugs distributed during the preceding month shall be produced at least monthly and shall be maintained in a separate file at the facility unless the pharmacy complies with subparagraph (D) of this paragraph. The information on this printout shall be sorted by drug name and list all distributions/returns for that drug chronologically.
(D) The pharmacy may elect not to produce the monthly audit trail printout if the data processing system has a workable (electronic) data retention system which can produce an audit trail of drug distribution and returns for the preceding two years. The audit trail required in this paragraph shall be supplied by the pharmacy within 72 hours, if requested by an authorized agent of the board, or other authorized local, state, or federal law enforcement or regulatory agencies.
(8) Failure to maintain records. Failure to provide records set out in this subsection, either on site or within 72 hours for whatever reason, constitutes prima facie evidence of failure to keep and maintain records.
(9) Data processing system downtime. In the event that a hospital pharmacy that uses a data processing system experiences system downtime, the pharmacy must have an auxiliary procedure which will ensure that all data is retained for on-line data entry as soon as the system is available for use again.
(10) Ongoing clinical pharmacy program records. If a pharmacy has an ongoing clinical pharmacy program and allows pharmacy technicians to verify the accuracy of work performed by other pharmacy technicians, the pharmacy must have a record of the pharmacy technicians and the duties performed.
(d) Distribution of controlled substances to another registrant. A pharmacy may distribute controlled substances to a practitioner, another pharmacy or other registrant, without being registered to distribute, under the following conditions:
(1) The registrant to whom the controlled substance is to be distributed is registered under the Controlled Substances Act to dispense that controlled substance; and
(2) The total number of dosage units of controlled substances distributed by a pharmacy may not exceed 5.0% of all controlled substances dispensed or distributed by the pharmacy during the 12-month period in which the pharmacy is registered; if at any time it does exceed 5.0%, the pharmacy is required to obtain an additional registration to distribute controlled substances.
(3) If the distribution is for a Schedule III, IV, or V controlled substance, a record shall be maintained which indicates:
(A) the actual date of distribution;
(B) the name, strength, and quantity of controlled substances distributed;
(C) the name, address, and DEA registration number of the distributing pharmacy; and
(D) the name, address, and DEA registration number of the pharmacy, practitioner, or other registrant to whom the controlled substances are distributed.
(4) If the distribution is for a Schedule I or II controlled substance, the following is applicable:
(A) The pharmacy, practitioner or other registrant who is receiving the controlled substances shall issue copy 1 and copy 2 of a DEA order form (DEA 222) to the distributing pharmacy; and
(B) The distributing pharmacy shall:
(i) complete the area on the DEA order form (DEA 222) titled TO BE FILLED IN BY SUPPLIER;
(ii) maintain copy 1 of the DEA order form (DEA 222) at the pharmacy for two years; and
(iii) forward copy 2 of the DEA order form (DEA 222) to the divisional office of the Drug Enforcement Administration.
(e) Other records. Other records to be maintained by a pharmacy:
(1) a log of the initials or identification codes which identifies pharmacy personnel by name. The initials or identification code shall be unique to ensure that each person can be identified, i.e., identical initials or identification codes cannot be used. Such log shall be maintained at the pharmacy for at least seven years from the date of the transaction;
(2) copy 3 of DEA order forms (DEA 222) which have been properly dated, initialed, and filed, and all copies of each unaccepted or defective order form and any attached statements or other documents;
(3) a hard copy of the power of attorney to sign DEA 222 order forms (if applicable);
(4) suppliers' invoices of dangerous drugs and controlled substances; a pharmacist shall verify that the controlled drugs listed on the invoices were actually received by clearly recording his/her initials and the actual date of receipt of the controlled substances;
(5) suppliers' credit memos for controlled substances and dangerous drugs;
(6) a hard copy of inventories required by §291.17 of this title (relating to Inventory Requirements) except that a perpetual inventory of controlled substances listed in Schedule II may be kept in a data processing system if the data processing system is capable of producing a hard copy of the perpetual inventory on-site;
(7) hard copy reports of surrender or destruction of controlled substances and/or dangerous drugs to an appropriate state or federal agency;
(8) a hard copy Schedule V nonprescription register book;
(9) records of distribution of controlled substances and/or dangerous drugs to other pharmacies, practitioners, or registrants; and
(10) a hard copy of any notification required by the Texas Pharmacy Act or these sections including, but not limited to, the following:
(A) reports of theft or significant loss of controlled substances to DEA and the board;
(B) notifications of a change in pharmacist-in-charge of a pharmacy; and
(C) reports of a fire or other disaster which may affect the strength, purity, or labeling of drugs, medications, devices, or other materials used in diagnosis or treatment of injury, illness, and disease.
(f) 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 DEA as required by Title 21, Code of Federal Regulations, §1304.04(a), and submits a copy of this written notification to the board. Unless the registrant is informed by the divisional director of DEA 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;
(B) The pharmacy maintains a copy of the notification required in subparagraph (A) of this paragraph; and
(C) The records to be maintained at the central record location shall not include executed DEA order forms, prescription drug orders, or controlled substance inventories, which shall be maintained at the pharmacy.
(2) Dangerous drug records. Invoices and financial data for dangerous drugs may be maintained at a central location.
(3) Access to records. If the records are kept in any form requiring special equipment to render the records easily readable, the pharmacy shall provide access to such equipment with the records.
(4) Delivery of records. The pharmacy agrees to deliver all or any part of such records to the pharmacy location within two business days of written request of a board agent or any other authorized official.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on May 31, 2019.
TRD-201901617
Allison Vordenbaumen Benz, R.Ph., M.S.
Executive Director
Texas State Board of Pharmacy
Effective date: June 20, 2019
Proposal publication date: April 5, 2019
For further information, please call: (512) 305-8010
The Texas State Board of Pharmacy adopts amendments to §291.76, concerning Class C Pharmacies Located in a Freestanding Ambulatory Surgical Center. These amendments are adopted without changes to the proposed text as published in the April 5, 2019, issue of the Texas Register (44 TexReg 1661); therefore, the rules will not be republished.
The amendments remove an outdated reference to the Department of Public Safety as one of the agencies to which reports of theft or loss of controlled substances are made and correct grammatical errors.
No comments were received.
The amendments are adopted under §§551.002 and 554.051 of the Texas Pharmacy Act (Chapters 551- 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by these amendments: Texas Pharmacy Act, Chapters 551- 569, Texas Occupations Code.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on May 31, 2019.
TRD-201901618
Allison Vordenbaumen Benz, R.Ph., M.S.
Executive Director
Texas State Board of Pharmacy
Effective date: June 20, 2019
Proposal publication date: April 5, 2019
For further information, please call: (512) 305-8010
The Texas State Board of Pharmacy adopts amendments to §291.123, concerning Central Prescription Drug or Medication Order Processing. These amendments are adopted with changes to the proposed text as published in the April 5, 2019, issue of the Texas Register (44 TexReg 1670). The Board made changes to include pharmacy technician trainees in those allowed to perform certain duties remotely.
The amendments allow a pharmacy technician employee or a pharmacy technician trainee employee who is licensed in Texas to remotely access a Class A, Class C, or Class E pharmacy engaged in centralized prescription drug or medication order processing's data base in order to process prescription or medication drug orders.
No comments were received.
The amendments are adopted under §§551.002 and 554.051 of the Texas Pharmacy Act (Chapters 551 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by these amendments: Texas Pharmacy Act, Chapters 551 - 569, Texas Occupations Code.
§291.123.Central Prescription Drug or Medication Order Processing.
(a) Purpose.
(1) The purpose of this section is to provide standards for centralized prescription drug or medication order processing by a Class A (Community), Class C (Institutional), or Class E (Non-Resident) pharmacy.
(2) Any facility established for the purpose of processing prescription drug or medication drug orders shall be licensed as a Class A, Class C, or Class E pharmacy under the Act. However, nothing in this subsection shall prohibit an individual pharmacist employee, individual pharmacy technician employee, or individual pharmacy technician trainee employee who is licensed in Texas from remotely accessing the pharmacy's electronic data base from outside the pharmacy in order to process prescription or medication drug orders, provided the pharmacy establishes controls to protect the privacy and security of confidential records.
(b) Definitions. The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise. Any term not defined in this section shall have the definition set out in the Act. Centralized prescription drug or medication order processing--the processing of a prescription drug or medication orders by a Class A, Class C, or Class E pharmacy on behalf of another pharmacy, a health care provider, or a payor. Centralized prescription drug or medication order processing does not include the dispensing of a prescription drug order but includes any of the following:
(1) receiving, interpreting, or clarifying prescription drug or medication drug orders;
(2) data entering and transferring of prescription drug or medication order information;
(3) performing drug regimen review;
(4) obtaining refill and substitution authorizations;
(5) interpreting clinical data for prior authorization for dispensing;
(6) performing therapeutic interventions; and
(7) providing drug information concerning a patient's prescription.
(c) Operational Standards.
(1) General requirements.
(A) A Class A, Class C, or Class E Pharmacy may outsource prescription drug or medication order processing to another Class A, Class C, or Class E pharmacy provided the pharmacies:
(i) have:
(I) the same owner; or
(II) entered into a written contract or agreement which outlines the services to be provided and the responsibilities and accountabilities of each pharmacy in compliance with federal and state laws and regulations; and
(ii) share a common electronic file or have appropriate technology to allow access to sufficient information necessary or required to process a non-dispensing function.
(B) A pharmacy that performs centralized prescription drug or medication order processing shall comply with the provisions applicable to the class of pharmacy contained in either §§291.31 - 291.35 of this title (relating to Definitions, Personnel, Operational Standards, Records, and Official Prescription Requirements in Class A (Community) Pharmacies), or §§291.72 - 291.75 of this title (relating to Definitions, Personnel, Operational Standards, and Records in a Class C (Institutional) Pharmacy), or §§291.102 - 291.105 of this title (relating to Definitions, Personnel, Operational Standards, and Records in a Class E (Non-Resident) Pharmacy) to the extent applicable for the specific processing activity and this section including:
(i) duties which must be performed by a pharmacist; and
(ii) supervision requirements for pharmacy technicians and pharmacy technician trainees.
(2) Notifications to patients.
(A) A pharmacy that outsources prescription drug or medication order processing to another pharmacy shall prior to outsourcing their prescription:
(i) notify patients that prescription processing may be outsourced to another pharmacy; and
(ii) give the name of that pharmacy; or if the pharmacy is part of a network of pharmacies under common ownership and any of the network pharmacies may process the prescription, the patient shall be notified of this fact. Such notification may be provided through a one-time written notice to the patient or through use of a sign in the pharmacy.
(B) The provisions of this paragraph do not apply to patients in facilities where drugs are administered to patients by a person required to do so by the laws of the state (i.e., hospitals or nursing homes).
(3) Policy and Procedures. A policy and procedure manual as it relates to central processing shall be maintained at all pharmacies involved in central processing and be available for inspection. Each pharmacy is required to maintain only those portions of the policy and procedure manual that relate to that pharmacy's operations. The manual shall:
(A) outline the responsibilities of each of the pharmacies;
(B) include a list of the name, address, telephone numbers, and all license/registration numbers of the pharmacies involved in centralized prescription drug or medication order processing; and
(C) include policies and procedures for:
(i) protecting the confidentiality and integrity of patient information;
(ii) maintenance of appropriate records to identify the name(s), initials, or identification code(s) and specific activity(ies) of each pharmacist or pharmacy technician who performed any processing;
(iii) complying with federal and state laws and regulations;
(iv) operating a continuous quality improvement program for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, and resolve identified problems; and
(v) annually reviewing the written policies and procedures and documenting such review.
(d) Records. All pharmacies shall maintain appropriate records which identify, by prescription drug or medication order, the name(s), initials, or identification code(s) of each pharmacist, pharmacy technician, or pharmacy technician trainee who performs a processing function for a prescription drug or medication order. Such records may be maintained:
(1) separately by each pharmacy and pharmacist; or
(2) in a common electronic file as long as the records are maintained in such a manner that the data processing system can produce a printout which lists the functions performed by each pharmacy and pharmacist.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on May 31, 2019.
TRD-201901622
Allison Vordenbaumen Benz, R.Ph., M.S.
Executive Director
Texas State Board of Pharmacy
Effective date: June 20, 2019
Proposal publication date: April 5, 2019
For further information, please call: (512) 305-8010
The Texas State Board of Pharmacy adopts amendments to §291.151, concerning Pharmacies Located in a Freestanding Emergency Medical Care Facility (Class F). These amendments are adopted without changes to the proposed text as published in the April 5, 2019, issue of the Texas Register (44 TexReg 1671). The amended rule will not be republished.
The amendments remove an outdated reference to the Department of Public Safety as one of the agencies to which reports of theft or loss of controlled substances are made and correct grammatical errors.
No comments were received.
The amendments are adopted under §§551.002 and 554.051 of the Texas Pharmacy Act (Chapters 551 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by these amendments: Texas Pharmacy Act, Chapters 551 - 569, Texas Occupations Code.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on May 31, 2019.
TRD-201901623
Allison Vordenbaumen Benz, R.Ph., M.S.
Executive Director
Texas State Board of Pharmacy
Effective date: June 20, 2019
Proposal publication date: April 5, 2019
For further information, please call: (512) 305-8010
The Texas State Board of Pharmacy adopts amendments to §291.153, concerning Central Prescription Drug or Medication Order Processing Pharmacy (Class G). These amendments are adopted with changes to the proposed text as published in the April 5, 2019, issue of the Texas Register (44 TexReg 1680). The Board made changes to include pharmacy technician trainees in those allowed to perform certain duties remotely. The rule will be republished.
The amendments allow a pharmacy technician employee or a pharmacy technician trainee employee who is licensed in Texas to remotely access a Class G pharmacy's data base in order to process prescription or medication drug orders.
No comments were received.
The amendments are adopted under §§551.002 and 554.051 of the Texas Pharmacy Act (Chapters 551 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by these amendments: Texas Pharmacy Act, Chapters 551 - 569, Texas Occupations Code.
§291.153.Central Prescription Drug or Medication Order Processing Pharmacy (Class G).
(a) Purpose.
(1) The purpose of this section is to provide standards for a centralized prescription drug or medication order processing pharmacy.
(2) Any facility established for the primary purpose of processing prescription drug or medication drug orders shall be licensed as a Class G pharmacy under the Act. A Class G pharmacy shall not store bulk drugs, or dispense a prescription drug order. Nothing in this subsection shall prohibit an individual pharmacist employee, individual pharmacy technician employee, or individual pharmacy technician trainee employee who is licensed in Texas from remotely accessing the pharmacy's electronic data base from a location other than a licensed pharmacy in order to process prescription or medication drug orders, provided the pharmacy establishes controls to protect the privacy and security of confidential records, and the Texas-licensed pharmacist, pharmacy technician, or pharmacy technician trainee does not engage in the receiving of written prescription or medication orders or the maintenance of prescription or medication drug orders at the non-licensed remote location.
(b) Definitions. The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise. Any term not defined in this section shall have the definition set out in the Act.
(1) Centralized prescription drug or medication order processing--The processing of a prescription drug or medication orders by a Class G pharmacy on behalf of another pharmacy, a health care provider, or a payor. Centralized prescription drug or medication order processing does not include the dispensing of a prescription drug but includes any of the following:
(A) receiving, interpreting, or clarifying prescription drug or medication drug orders;
(B) data entering and transferring of prescription drug or medication order information;
(C) performing drug regimen review;
(D) obtaining refill and substitution authorizations;
(E) verifying accurate prescription data entry;
(F) interpreting clinical data for prior authorization for dispensing;
(G) performing therapeutic interventions; and
(H) providing drug information concerning a patient's prescription.
(2) 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.
(c) Personnel.
(1) Pharmacist-in-charge.
(A) General. Each Class G pharmacy shall have one pharmacist-in-charge who is employed on a full-time basis, who may be the pharmacist-in-charge for only one such pharmacy.
(B) Responsibilities. The pharmacist-in-charge shall have responsibility for the practice of pharmacy at the pharmacy for which he or she is the pharmacist-in-charge. The pharmacist-in-charge may advise the owner on administrative or operational concerns. The pharmacist-in-charge shall have responsibility for, at a minimum, the following:
(i) educating and training pharmacy technicians and pharmacy technician trainees;
(ii) maintaining records of all transactions of the Class G pharmacy required by applicable state and federal laws and sections;
(iii) adhering to policies and procedures regarding the maintenance of records in a data processing system such that the data processing system is in compliance with Class G pharmacy requirements; and
(iv) legally operating the pharmacy, including meeting all inspection and other requirements of all state and federal laws or sections governing the practice of pharmacy.
(2) Owner. The owner of a Class G pharmacy shall have responsibility for all administrative and operational functions of the pharmacy. The pharmacist-in-charge may advise the owner on administrative and operational concerns. The owner shall have responsibility for, at a minimum, the following, and if the owner is not a Texas licensed pharmacist, the owner shall consult with the pharmacist-in-charge or another Texas licensed pharmacist:
(A) providing the pharmacy with the necessary equipment and resources commensurate with its level and type of practice; and
(B) establishing policies and procedures regarding maintenance, storage, and retrieval of records in a data processing system such that the system is in compliance with state and federal requirements.
(3) Pharmacists.
(A) General.
(i) The pharmacist-in-charge shall be assisted by sufficient number of additional licensed pharmacists as may be required to operate the Class G pharmacy competently, safely, and adequately to meet the needs of the patients of the pharmacy.
(ii) All pharmacists shall assist the pharmacist-in-charge in meeting his or her responsibilities.
(iii) Pharmacists are solely responsible for the direct supervision of pharmacy technicians and pharmacy technician trainees and for designating and delegating duties, other than those listed in subparagraph (B) of this paragraph, to pharmacy technicians and pharmacy technician trainees. Each pharmacist shall be responsible for any delegated act performed by pharmacy technicians and pharmacy technician trainees under his or her supervision.
(iv) Pharmacists shall directly supervise pharmacy technicians and pharmacy technician trainees who are entering prescription data into the pharmacy's data processing system by one of the following methods.
(I) Physically present supervision. A pharmacist shall be physically present to directly supervise a pharmacy technician or pharmacy technician trainee who is entering prescription order or medication order data into the data processing system. Each prescription or medication order entered into the data processing system shall be verified at the time of data entry.
(II) Electronic supervision. A pharmacist may electronically supervise a pharmacy technician or pharmacy technician trainee who is entering prescription order or medication order data into the data processing system provided the pharmacist:
(-a-) the pharmacist has the ability to immediately communicate directly with the technician/trainee;
(-b-) has immediate access to any original document containing prescription or medication order information or other information related to the dispensing of the prescription or medication order. Such access may be through imaging technology provided the pharmacist has the ability to review the original, hardcopy documents if needed for clarification; and
(-c-) verifies the accuracy of the data entered information prior to the release of the information to the system for storage.
(III) Electronic verification of data entry by pharmacy technicians or pharmacy technician trainees. A pharmacist may electronically verify the data entry of prescription information into a data processing system provided:
(-a-) the pharmacist has the ability to immediately communicate directly with the technician/trainee;
(-b-) the pharmacist electronically conducting the verification is either a:
(-1-) Texas licensed pharmacist; or
(-2-) pharmacist employed by a Class E pharmacy that has the same owner as the Class G pharmacy where the pharmacy technicians/trainees are located or that has entered into a written contract or agreement with the Class G pharmacy, which outlines the services to be provided and the responsibilities and accountabilities of each pharmacy in compliance with federal and state laws and regulations;
(-c-) the pharmacy establishes controls to protect the privacy and security of confidential records; and
(-d-) the pharmacy keeps permanent records of prescriptions electronically verified for a period of two years.
(v) All pharmacists while on duty, shall be responsible for complying with all state and federal laws or rules governing the practice of pharmacy.
(B) Duties. Duties which may only be performed by a pharmacist are as follows:
(i) receiving oral prescription drug or medication orders and reducing these orders to writing, either manually or electronically;
(ii) interpreting prescription drug or medication orders;
(iii) selecting drug products;
(iv) verifying the data entry of the prescription drug or medication order information at the time of data entry prior to the release of the information to a Class A, Class C, or Class E pharmacy for dispensing;
(v) communicating to the patient or patient's agent information about the prescription drug or device which in the exercise of the pharmacist's professional judgment, the pharmacist deems significant, as specified in §291.33(c) of this title (relating to Operational Standards);
(vi) communicating to the patient or the patient's agent on his or her request information concerning any prescription drugs dispensed to the patient by the pharmacy;
(vii) assuring that a reasonable effort is made to obtain, record, and maintain patient medication records; and
(viii) interpreting patient medication records and performing drug regimen reviews.
(4) Pharmacy Technicians and Pharmacy Technician Trainees.
(A) General. All pharmacy technicians and pharmacy technician trainees shall meet the training requirements specified in §297.6 of this title (relating to Pharmacy Technician and Pharmacy Technician Trainee Training).
(B) Duties.
(i) Pharmacy technicians and pharmacy technician trainees may not perform any of the duties listed in paragraph (3)(B) of this subsection.
(ii) A pharmacist may delegate to pharmacy technicians and pharmacy technician trainees any nonjudgmental technical duty associated with the preparation and distribution of prescription drugs provided:
(I) a pharmacist verifies the accuracy of all acts, tasks, and functions performed by pharmacy technicians and pharmacy technician trainees;
(II) pharmacy technicians and pharmacy technician trainees are under the direct supervision of and responsible to a pharmacist; and
(iii) Pharmacy technicians and pharmacy technician trainees may perform only nonjudgmental technical duties associated with the preparation of prescription drugs, as follows:
(I) initiating and receiving refill authorization requests; and
(II) entering prescription or medication order data into a data processing system.
(C) Ratio of on-site pharmacists to pharmacy technicians and pharmacy technician trainees. A Class G pharmacy may have a ratio of on-site pharmacists to pharmacy technicians and pharmacy technician trainees of 1:8 provided:
(i) at least seven are pharmacy technicians and not pharmacy technician trainees; and
(ii) the pharmacy has written policies and procedures regarding the supervision of pharmacy technicians and pharmacy technician trainees.
(5) Identification of pharmacy personnel. All pharmacy personnel shall be identified as follows.
(A) Pharmacy technicians. All pharmacy technicians shall wear an identification tag or badge that bears the person's name and identifies him or her as a pharmacy technician, or a certified pharmacy technician, if the technician maintains current certification with the Pharmacy Technician Certification Board or any other entity providing an examination approved by the board.
(B) Pharmacy technician trainees. All pharmacy technician trainees shall wear an identification tag or badge that bears the person's name and identifies him or her as a pharmacy technician trainee.
(C) Pharmacist interns. All pharmacist interns shall wear an identification tag or badge that bears the person's name and identifies him or her as a pharmacist intern.
(D) Pharmacists. All pharmacists shall wear an identification tag or badge that bears the person's name and identifies him or her as a pharmacist.
(d) Operational Standards.
(1) General requirements.
(A) A Class A, Class C, or Class E Pharmacy may outsource prescription drug or medication order processing to a Class G pharmacy provided the pharmacies:
(i) have:
(I) the same owner; or
(II) entered into a written contract or agreement which outlines the services to be provided and the responsibilities and accountabilities of each pharmacy in compliance with federal and state laws and regulations; and
(ii) share a common electronic file or have appropriate technology to allow access to sufficient information necessary or required to perform a non-dispensing function.
(B) A Class G pharmacy shall comply with the provisions applicable to the class of pharmacy contained in either §§291.31 - 291.35 of this title (relating to Definitions, Personnel, Operational Standards, Records, and Official Prescription Requirements in Class A (Community) Pharmacies), or §§291.72 - 291.75 of this title (relating to Definitions, Personnel, Operational Standards, and Records in a Class C (Institutional) Pharmacy), or §§291.102 - 291.105 of this title (relating to Definitions, Personnel, Operational Standards, and Records in a Class E (Non-Resident) Pharmacy) to the extent applicable for the specific processing activity and this section including:
(i) duties which must be performed by a pharmacist; and
(ii) supervision requirements for pharmacy technicians and pharmacy technician trainees.
(2) Licensing requirements.
(A) A Class G pharmacy shall register 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) A Class G pharmacy which changes ownership shall notify the board within 10 days of the change of ownership and apply for a new and separate license as specified in §291.3 of this title (relating to Required Notifications).
(C) A Class G pharmacy which changes location and/or name shall notify the board of the change within 10 days and file for an amended license as specified in §291.3 of this title.
(D) A Class G pharmacy owned by a partnership or corporation which changes managing officers shall notify the board in writing of the names of the new managing officers within 10 days of the change, following the procedures in §291.3 of this title.
(E) A Class G pharmacy shall notify the board in writing within 10 days of closing, following the procedures in §291.5 of this title (relating to Closing a Pharmacy).
(F) A fee as specified in §291.6 of this title (relating to Pharmacy License Fees) will be charged for issuance and renewal of a license and the issuance of an amended license.
(G) A separate license is required for each principal place of business and only one pharmacy license may be issued to a specific location.
(3) Environment.
(A) General requirements.
(i) The pharmacy shall be arranged in an orderly fashion and kept clean. All required equipment shall be in good operating condition.
(ii) The pharmacy shall be properly lighted and ventilated.
(B) Security.
(i) Each pharmacist while on duty shall be responsible for the security of the prescription department, including provisions for effective control against theft or diversion of prescription drug records.
(ii) Pharmacies shall employ appropriate measures to ensure that security of prescription drug records is maintained at all times to prohibit unauthorized access.
(4) Policy and Procedures. A policy and procedure manual shall be maintained by the Class G pharmacy and be available for inspection. The manual shall:
(A) outline the responsibilities of each of the pharmacies;
(B) include a list of the name, address, telephone numbers, and all license/registration numbers of the pharmacies involved in centralized prescription drug or medication order processing; and
(C) include policies and procedures for:
(i) protecting the confidentiality and integrity of patient information;
(ii) maintaining appropriate records to identify the name(s), initials, or identification code(s) and specific activity(ies) of each pharmacist or pharmacy technician who performed any processing;
(iii) complying with federal and state laws and regulations;
(iv) operating a continuous quality improvement program for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, and resolve identified problems; and
(v) annually reviewing the written policies and procedures and documenting such review.
(e) Records.
(1) every record required to be kept under the provisions of this section shall be:
(A) kept by the pharmacy and be available, for at least two years from the date of such inventory or record, for inspecting and copying by the board or its representative and to other authorized local, state, or federal law enforcement agencies; and
(B) supplied by the pharmacy within 72 hours, if requested by an authorized agent of the Texas State Board of Pharmacy. If the pharmacy maintains the records in an electronic format, the requested records must be provided in a mutually agreeable electronic format if specifically requested by the board or its representative. Failure to provide the records set out in this section, either on site or within 72 hours, constitutes prima facie evidence of failure to keep and maintain records in violation of the Act.
(2) The pharmacy shall maintain appropriate records which identify, by prescription drug or medication order, the name(s), initials, or identification code(s) of each pharmacist, pharmacy technician, or pharmacy technician trainee who performs a processing function for a prescription drug or medication order. Such records may be maintained:
(A) separately by each pharmacy and pharmacist; or
(B) in a common electronic file as long as the records are maintained in such a manner that the data processing system can produce a printout which lists the functions performed by each pharmacy and pharmacist.
(3) In addition, the pharmacy shall comply with the record keeping requirements applicable to the class of pharmacy to the extent applicable for the specific processing activity and this section.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on May 31, 2019.
TRD-201901624
Allison Vordenbaumen Benz, R.Ph., M.S.
Executive Director
Texas State Board of Pharmacy
Effective date: June 20, 2019
Proposal publication date: April 5, 2019
For further information, please call: (512) 305-8010
The Texas State Board of Pharmacy adopts amendments to §295.1, concerning Change of Address and/or Name. These amendments are adopted without changes to the proposed text as published in the April 5, 2019, issue of the Texas Register (44 TexReg 1682).
The amendments update the change of address or name requirements for pharmacists to reflect the board's new procedure of issuing electronic renewal certificates.
No comments were received.
The amendments are adopted under §551.002 and §554.051 of the Texas Pharmacy Act (Chapters 551 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by these amendments: Texas Pharmacy Act, Chapters 551 - 569, Texas Occupations Code.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on May 31, 2019.
TRD-201901607
Allison Vordenbaumen Benz, R.Ph., M.S.
Executive Director
Texas State Board of Pharmacy
Effective date: June 20, 2019
Proposal publication date: April 5, 2019
For further information, please call: (512) 305-8010
The Texas State Board of Pharmacy adopts amendments to §295.5, concerning Pharmacist License or Renewal Fees. These amendments are adopted without changes to the proposed text as published in the April 5, 2019, issue of the Texas Register (44 TexReg 1683). The rule will not be republished.
The amendments remove the fees for duplicate or amended renewal certificates to reflect the board's new procedure of issuing electronic renewal certificates and correct a subsection reference.
No comments were received.
The amendments are adopted under §551.002 and §554.051 of the Texas Pharmacy Act (Chapters 551 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by these amendments: Texas Pharmacy Act, Chapters 551 - 569, Texas Occupations Code.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on May 31, 2019.
TRD-201901608
Allison Vordenbaumen Benz, R.Ph., M.S.
Executive Director
Texas State Board of Pharmacy
Effective date: June 20, 2019
Proposal publication date: April 5, 2019
For further information, please call: (512) 305-8010
The Texas State Board of Pharmacy adopts amendments to §297.4, concerning Fees. These amendments are adopted without changes to the proposed text as published in the April 5, 2019, issue of the Texas Register (44 TexReg 1684).
The amendments remove the fees for duplicate or amended certificates to reflect the board's new procedure of issuing electronic renewal certificates.
No comments were received.
The amendments are adopted under §551.002 and §554.051 of the Texas Pharmacy Act (Chapters 551 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by these amendments: Texas Pharmacy Act, Chapters 551 - 569, Texas Occupations Code.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on May 31, 2019.
TRD-201901609
Allison Vordenbaumen Benz, R.Ph., M.S.
Executive Director
Texas State Board of Pharmacy
Effective date: June 20, 2019
Proposal publication date: April 5, 2019
For further information, please call: (512) 305-8010
The Texas State Board of Pharmacy adopts amendments to §315.2, concerning Official Prescription Form. These amendments are adopted without changes to the proposed text as published in the April 5, 2019, issue of the Texas Register (44 TexReg 1685).
The amendments remove the effective date from the short title and remove language pertaining to the validity of official prescription forms previously issued by the Texas Department of Public Safety.
No comments were received.
The amendments are adopted under §§551.002 and 554.051 of the Texas Pharmacy Act (Chapters 551- 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by these amendments: Texas Pharmacy Act, Chapters 551 - 569, Texas Occupations Code.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on May 31, 2019.
TRD-201901610
Allison Vordenbaumen Benz, R.Ph., M.S.
Executive Director
Texas State Board of Pharmacy
Effective date: June 20, 2019
Proposal publication date: April 5, 2019
For further information, please call: (512) 305-8010
The Texas State Board of Pharmacy adopts amendments to §315.15, concerning Access Requirements. These amendments are adopted without changes to the proposed text as published in the April 5, 2019, issue of the Texas Register (44 TexReg 1685).
The amendments clarify which pharmacist is responsible for the review of the Texas Prescription Monitoring Program database prior to dispensing an opioid, benzodiazepine, barbiturate, or carisoprodol.
No comments were received.
The amendments are adopted under §§551.002 and 554.051 of the Texas Pharmacy Act (Chapters 551 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.
The statutes affected by these amendments: Texas Pharmacy Act, Chapters 551 - 569, Texas Occupations Code.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on May 31, 2019.
TRD-201901620
Allison Vordenbaumen Benz, R.Ph., M.S.
Executive Director
Texas State Board of Pharmacy
Effective date: June 20, 2019
Proposal publication date: April 5, 2019
For further information, please call: (512) 305-8010