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TITLE 22EXAMINING BOARDS
PART 15TEXAS STATE BOARD OF PHARMACY
CHAPTER 291PHARMACIES
SUBCHAPTER GSERVICES PROVIDED BY PHARMACIES
RULE §291.131Pharmacies Compounding Non-Sterile Preparations

(a) Purpose. Pharmacies compounding non-sterile preparations, prepackaging pharmaceutical products, and distributing those products shall comply with all requirements for their specific license classification and this section. The purpose of this section is to provide standards for the:

  (1) compounding of non-sterile preparations pursuant to a prescription or medication order for a patient from a practitioner in Class A (Community), Class C (Institutional), and Class E (Non-resident) pharmacies;

  (2) compounding, dispensing, and delivery of a reasonable quantity of a compounded non-sterile preparation in a Class A (Community), Class C (Institutional), and Class E (Non-resident) pharmacy to a practitioner's office for office use by the practitioner;

  (3) compounding and distribution of compounded non-sterile preparations by a Class A (Community) pharmacy for a Class C (Institutional) pharmacy; and

  (4) compounding of non-sterile preparations by a Class C (Institutional) pharmacy and the distribution of the compounded preparations to other Class C (Institutional) pharmacies under common ownership.

(b) Definitions. In addition to the definitions for specific license classifications, the following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise.

  (1) Beyond-use date--The date or time after which the compounded non-sterile preparation shall not be stored or transported or begin to be administered to a patient. The beyond-use date is determined from the date or time when the preparation was compounded.

  (2) Cleaning--The process of removing soil (e.g., organic and inorganic material) from objects and surfaces, normally accomplished by manually or mechanically using water with detergents or enzymatic products.

  (3) Component--Any ingredient intended for use in the compounding of a drug preparation, including those that may not appear in such preparation.

  (4) Compounding--The preparation, mixing, assembling, packaging, or labeling of a drug or device:

    (A) as the result of a practitioner's prescription drug or medication order, based on the practitioner-patient-pharmacist relationship in the course of professional practice;

    (B) for administration to a patient by a practitioner as the result of a practitioner's initiative based on the practitioner-patient-pharmacist relationship in the course of professional practice;

    (C) in anticipation of prescription drug or medication orders based on routine, regularly observed prescribing patterns; or

    (D) for or as an incident to research, teaching, or chemical analysis and not for sale or dispensing, except as allowed under §562.154 or Chapter 563 of the Occupations Code.

  (5) Hot water--The temperature of water from the pharmacy's sink maintained at a minimum of 105 degrees F (41 degrees C).

  (6) Reasonable quantity--An amount of a compounded drug that:

    (A) does not exceed the amount a practitioner anticipates may be used in the practitioner's office or facility before the beyond use date of the drug;

    (B) is reasonable considering the intended use of the compounded drug and the nature of the practitioner's practice; and

    (C) for any practitioner and all practitioners as a whole, is not greater than an amount the pharmacy is capable of compounding in compliance with pharmaceutical standards for identity, strength, quality, and purity of the compounded drug that are consistent with United States Pharmacopoeia guidelines and accreditation practices.

  (7) Sanitizing--A process for reducing on inanimate surfaces the number of all forms of microbial life including fungi, viruses, and bacteria using an appropriate agent.

  (8) SOPs--Standard operating procedures.

  (9) USP/NF--The current edition of the United States Pharmacopeia/National Formulary.

(c) Personnel.

  (1) Pharmacist-in-charge. In addition to the responsibilities for the specific class of pharmacy, the pharmacist-in-charge shall have the responsibility for, at a minimum, the following concerning non-sterile compounding:

    (A) determining that all personnel involved in non-sterile compounding possess the education, training, and proficiency necessary to properly and safely perform compounding duties undertaken or supervised;

    (B) determining that all personnel involved in non-sterile compounding obtain continuing education appropriate for the type of compounding done by the personnel;

    (C) assuring that the equipment used in compounding is properly maintained;

    (D) maintaining an appropriate environment in areas where non-sterile compounding occurs; and

    (E) assuring that effective quality control procedures are developed and followed.

  (2) Pharmacists. Special requirements for non-sterile compounding.

    (A) All pharmacists engaged in compounding shall:

      (i) possess the education, training, and proficiency necessary to properly and safely perform compounding duties undertaken or supervised; and

      (ii) obtain continuing education appropriate for the type of compounding done by the pharmacist.

    (B) A pharmacist shall inspect and approve all components, drug product containers, closures, labeling, and any other materials involved in the compounding process.

    (C) A pharmacist shall review all compounding records for accuracy and conduct in-process and final checks to ensure that errors have not occurred in the compounding process.

    (D) A pharmacist is responsible for the proper maintenance, cleanliness, and use of all equipment used in the compounding process.

  (3) Pharmacy technicians and pharmacy technician trainees. All pharmacy technicians and pharmacy technician trainees engaged in non-sterile compounding shall:

    (A) possess the education, training, and proficiency necessary to properly and safely perform compounding duties undertaken;

    (B) obtain continuing education appropriate for the type of compounding done by the pharmacy technician or pharmacy technician trainee; and

    (C) perform compounding duties under the direct supervision of and responsible to a pharmacist.

  (4) Training.

    (A) All training activities shall be documented and covered by appropriate SOPs as outlined in subsection (d)(8)(A) of this section.

    (B) All personnel involved in non-sterile compounding shall be well trained and must participate in continuing relevant training programs.

    (C) Training shall include instruction, experience, and demonstrated proficiency in the following areas:

      (i) hand hygiene;

      (ii) garbing;

      (iii) cleaning and sanitizing;

      (iv) handling and transporting components and compounded non-sterile preparations;

      (v) measuring and mixing;

      (vi) proper use of equipment and devices selected to compound non-sterile preparations; and

      (vii) documentation of the compounding process (e.g., Master Formulation Records and Compounding Records).

(d) Operational Standards.

  (1) General requirements.

    (A) Non-sterile drug preparations may be compounded in licensed pharmacies:

      (i) upon presentation of a practitioner's prescription drug or medication order based on a valid pharmacist/patient/prescriber relationship;

      (ii) in anticipation of future prescription drug or medication orders based on routine, regularly observed prescribing patterns; or

      (iii) in reasonable quantities for office use by a practitioner and for use by a veterinarian.

    (B) Non-sterile compounding in anticipation of future prescription drug or medication orders must be based upon a history of receiving valid prescriptions issued within an established pharmacist/patient/prescriber relationship, provided that in the pharmacist's professional judgment the quantity prepared is stable for the anticipated shelf time.

      (i) The pharmacist's professional judgment shall be based on the criteria used to determine a beyond-use date outlined in paragraph (5)(C) of this subsection.

      (ii) Documentation of the criteria used to determine the stability for the anticipated shelf time must be maintained and be available for inspection.

      (iii) Any preparation compounded in anticipation of future prescription drug or medication orders shall be labeled. Such label shall contain:

        (I) name and strength of the compounded preparation or list of the active ingredients and strengths;

        (II) facility's lot number;

Cont'd...

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