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TITLE 22EXAMINING BOARDS
PART 15TEXAS STATE BOARD OF PHARMACY
CHAPTER 291PHARMACIES
SUBCHAPTER GSERVICES PROVIDED BY PHARMACIES
RULE §291.133Pharmacies Compounding Sterile Preparations

      (ii) Records may be maintained in an alternative data retention system, such as a data processing system or direct imaging system provided the data processing system is capable of producing a hard copy of the record upon the request of the board, its representative, or other authorized local, state, or federal law enforcement or regulatory agencies.

    (B) Orders. The pharmacy shall maintain a record of all sterile compounded preparations ordered by a practitioner for office use or by an institutional pharmacy for administration to a patient. The record shall include the following information:

      (i) date of the order;

      (ii) name, address, and phone number of the practitioner who ordered the preparation and if applicable, the name, address and phone number of the institutional pharmacy ordering the preparation; and

      (iii) name, strength, and quantity of the preparation ordered.

    (C) Distributions. The pharmacy shall maintain a record of all sterile compounded preparations distributed pursuant to an order to a practitioner for office use or by an institutional pharmacy for administration to a patient. The record shall include the following information:

      (i) date the preparation was compounded;

      (ii) date the preparation was distributed;

      (iii) name, strength and quantity in each container of the preparation;

      (iv) pharmacy's lot number;

      (v) quantity of containers shipped; and

      (vi) name, address, and phone number of the practitioner or institutional pharmacy to whom the preparation is distributed.

    (D) Audit Trail.

      (i) The pharmacy shall store the order and distribution records of preparations for all sterile compounded preparations ordered by and or distributed to a practitioner for office use or by a pharmacy licensed to compound sterile preparations for administration to a patient in such a manner as to be able to provide an audit trail for all orders and distributions of any of the following during a specified time period:

        (I) any strength and dosage form of a preparation (by either brand or generic name or both);

        (II) any ingredient;

        (III) any lot number;

        (IV) any practitioner;

        (V) any facility; and

        (VI) any pharmacy, if applicable.

      (ii) The audit trail shall contain the following information:

        (I) date of order and date of the distribution;

        (II) practitioner's name, address, and name of the institutional pharmacy, if applicable;

        (III) name, strength and quantity of the preparation in each container of the preparation;

        (IV) name and quantity of each active ingredient;

        (V) quantity of containers distributed; and

        (VI) pharmacy's lot number.

  (4) Labeling. The pharmacy shall affix a label to the preparation containing the following information:

    (A) name, address, and phone number of the compounding pharmacy;

    (B) the statement: "For Institutional or Office Use Only--Not for Resale"; or if the preparation is distributed to a veterinarian the statement: "Compounded Preparation";

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

    (D) pharmacy's lot number;

    (E) beyond-use date as determined by the pharmacist using appropriate documented criteria;

    (F) quantity or amount in the container;

    (G) appropriate ancillary instructions, such as storage instructions or cautionary statements, including hazardous drug warning labels where appropriate; and

    (H) device-specific instructions, where appropriate.

(g) Recall Procedures.

  (1) The pharmacy shall have written procedures for the recall of any compounded sterile preparation provided to a patient, to a practitioner for office use, or a pharmacy for administration. Written procedures shall include, but not be limited to the requirements as specified in paragraph (3) of this subsection.

  (2) The pharmacy shall immediately initiate a recall of any sterile preparation compounded by the pharmacy upon identification of a potential or confirmed harm to a patient.

  (3) In the event of a recall, the pharmacist-in-charge shall ensure that:

    (A) each practitioner, facility, and/or pharmacy to which the preparation was distributed is notified, in writing, of the recall;

    (B) each patient to whom the preparation was dispensed is notified, in writing, of the recall;

    (C) the board is notified of the recall, in writing, not later than 24 hours after the recall is issued;

    (D) if the preparation is distributed for office use, the Texas Department of State Health Services, Drugs and Medical Devices Group, is notified of the recall, in writing;

    (E) the preparation is quarantined; and

    (F) the pharmacy keeps a written record of the recall including all actions taken to notify all parties and steps taken to ensure corrective measures.

  (4) If a pharmacy fails to initiate a recall, the board may require a pharmacy to initiate a recall if there is potential for or confirmed harm to a patient.

  (5) A pharmacy that compounds sterile preparations shall notify the board immediately of any adverse effects reported to the pharmacy or that are known by the pharmacy to be potentially attributable to a sterile preparation compounded by the pharmacy.


Source Note: The provisions of this §291.133 adopted to be effective December 10, 2013, 38 TexReg 8869; amended to be effective September 11, 2014, 39 TexReg 7128; amended to be effective June 11, 2015, 40 TexReg 3647; amended to be effective September 14, 2015, 40 TexReg 6111; amended to be effective June 12, 2016, 41 TexReg 4257; amended to be effective September 11, 2016, 41 TexReg 6718; amended to be effective January 4, 2018, 42 TexReg 7700; amended to be effective September 16, 2018, 43 TexReg 5784

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