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RULE §291.131Pharmacies Compounding Non-Sterile Preparations

    (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.

  (5) 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;

        (III) beyond-use date as determined by the pharmacist using appropriate documented criteria as outlined in paragraph (5)(C) of this subsection; and

        (IV) quantity or amount in the container.

    (C) Commercially available products may be compounded for dispensing to individual patients provided the following conditions are met:

      (i) the commercial product is not reasonably available from normal distribution channels in a timely manner to meet patient's needs;

      (ii) the pharmacy maintains documentation that the product is not reasonably available due to a drug shortage or unavailability from the manufacturer; and

      (iii) the prescribing practitioner has requested that the drug be compounded as described in subparagraph (D) of this paragraph.

    (D) A pharmacy may not compound preparations that are essentially copies of commercially available products (e.g., the preparation is dispensed in a strength that is only slightly different from a commercially available product) unless the prescribing practitioner specifically orders the strength or dosage form and specifies why the patient needs the particular strength or dosage form of the preparation. The prescribing practitioner shall provide documentation of a patient specific medical need and the preparation produces a clinically significant therapeutic response (e.g., the physician requests an alternate product due to hypersensitivity to excipients or preservative in the FDA-approved product, or the physician requests an effective alternate dosage form) or if the drug product is not commercially available. The unavailability of such drug product must be documented prior to compounding. The methodology for documenting unavailability includes maintaining a copy of the wholesaler's notification showing back-ordered, discontinued, or out-of-stock items. This documentation must be available in hard-copy or electronic format for inspection by the board.

    (E) A pharmacy may enter into an agreement to compound and dispense prescription/medication orders for another pharmacy provided the pharmacy complies with the provisions of §291.125 of this title (relating to Centralized Prescription Dispensing).

    (F) Compounding pharmacies/pharmacists may advertise and promote the fact that they provide non-sterile prescription compounding services, which may include specific drug products and classes of drugs.

    (G) A pharmacy may not compound veterinary preparations for use in food producing animals except in accordance with federal guidelines.

    (H) A pharmacist may add flavoring to a prescription at the request of a patient, the patient's agent, or the prescriber. The pharmacist shall label the flavored prescription with a beyond-use-date that shall be no longer than fourteen days if stored in a refrigerator unless otherwise documented. Documentation of beyond-use-dates longer than fourteen days shall be maintained by the pharmacy electronically or manually and made available to agents of the board on request. A pharmacist may not add flavoring to an over-the-counter product at the request of a patient or patient's agent unless the pharmacist obtains a prescription for the over-the-counter product from the patient's practitioner.

  (2) Library. In addition to the library requirements of the pharmacy's specific license classification, a pharmacy shall maintain a current copy, in hard-copy or electronic format, of Chapter 795 of the USP/NF concerning Pharmacy Compounding Non-Sterile Preparations.

  (3) Environment.

    (A) Pharmacies engaging in compounding shall have a designated and adequate area for the safe and orderly compounding of non-sterile preparations, including the placement of equipment and materials.

    (B) Only personnel authorized by the responsible pharmacist shall be in the immediate vicinity of a drug compounding operation.

    (C) A sink with hot and cold running water, exclusive of rest room facilities, shall be accessible to the compounding areas and be maintained in a sanitary condition. Supplies necessary for adequate washing shall be accessible in the immediate area of the sink and include:

      (i) soap or detergent; and

      (ii) air-driers or single-use towels.

    (D) Appropriate measures shall be used to prevent cross-contamination between compounding non-sterile preparations, including dedication of equipment for such operations or the meticulous cleaning of contaminated equipment prior to its use for the preparation of subsequent compounds.

    (E) Cleaning and sanitizing of surfaces in the non-sterile compounding area(s) shall occur on a regular basis as defined in appropriate SOPs as outlined in paragraph (8)(A) of this subsection.

  (4) Equipment and Supplies.

    (A) If the pharmacy engages in compounding non-sterile preparations that require weighing a component of the preparation, the pharmacy shall have a Class A prescription balance, or analytical balance and weights which shall be calibrated and have the accuracy of the balance verified by the pharmacy at least every 12 months as specified in the pharmacy's SOPs. The pharmacy shall document the calibration and verification.

    (B) The pharmacy shall have equipment and utensils necessary for the proper compounding of prescription drug or medication orders. Such equipment and utensils used in the compounding process shall be:

      (i) of appropriate design and capacity, and be operated within designed operational limits;

      (ii) of suitable composition so that surfaces that contact components, in-process material, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the desired result;

      (iii) cleaned and sanitized immediately prior to and after each use; and


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