1. (a)

   1. (1) This rule describes the requirements of minimum current good compounding practice for the preparation of drug products by pharmacies or other facilities with permits issued by the Arkansas State Board of Pharmacy.

   2. (2)

      1. (A) Compounding a drug product that is commercially available in the marketplace or that is essentially a copy of a commercially available Food and Drug Administration-approved drug product is generally prohibited.
      2. (B) However, in special circumstances a pharmacist may compound an appropriate quantity of a drug that is only slightly different than a Food and Drug Administration-approved drug that is commercially available:

2. (i) Based on documentation provided by the prescribing physician of a patient-specific medical need, e.g., the physician requests an alternate product due to hypersensitivity to excipients or preservative in the Food and Drug Administration-approved product, or the physician requests an effective alternate dosage form; or

   1. (ii) If the drug product is not commercially available.
   2. (3) The unavailability of such drug product must be documented prior to compounding.
   3. (4) The recommended methodology for documenting unavailability is to print the screen of wholesalers showing back-ordered, discontinued, or out-of-stock items.
   4. (5) This or similar documentation must be available when requested by the board.

3. (b) Definitions. The following words or terms, when used in this part, shall have the following meaning unless the context clearly indicates otherwise:

   1. (1) “Component” means any ingredient used in the compounding of a drug product, including those that may not appear in such product;

   2. (2) “Compounding” means preparation, mixing, assembling, packaging, and labeling of a drug or device as the result of a duly authorized practitioner’s prescription drug order or initiative based on the practitioner/patient/pharmacist relationship in the course of professional practice.

      1. (A) Compounding may also be for the purpose of, or as an incident to:

         1. (i) Research;
         2. (ii) Teaching; or
         3. (iii) Chemical analysis.
      2. (B) Compounding includes the preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns.
      3. (C) Reconstitution of commercial products is not considered compounding for the purposes of this part;

   3. (3)

      1. (A) “Manufacturing” means 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:

         1. (i) Any packaging or repackaging of the substance or substances or labeling or relabeling of its container; and
         2. (ii) The promotion and marketing of such drugs or devices.

      2. (B) Manufacturing also includes any preparation of a drug or device that is given or sold for resale by:

         1. (i) Pharmacies;
         2. (ii) Practitioners; or
         3. (iii) Other persons.
      3. (C) The distribution of inordinate amounts of compounded products without a practitioner/patient/pharmacist relationship is considered manufacturing; and

   4. (4) “Pharmacy-generated products” means a medical product that is prepared, packaged, and labeled in a pharmacy that can be sold by the pharmacy without a prescription.

      1. (c) Pharmacist responsibilities.

   5. (1) All pharmacists who engage in drug compounding shall:

      1. (A) Be proficient in compounding; and
      2. (B) Continually expand their compounding knowledge by participating in seminars and/or studying appropriate literature.

   6. (2) The pharmacist has the responsibility to:

      1. (A) Ensure the validity of all prescriptions;
      2. (B) Approve or reject all components, drug product containers, closures, in-process materials, and labeling;
      3. (C) Prepare and review all compounding records and procedures to ensure that no errors have occurred in the compounding process;
      4. (D) Ensure the proper maintenance, cleanliness, and use of all equipment used in a prescription compounding practice; and

      5. (E) Ensure only personnel authorized by the pharmacist-in-charge shall be in the immediate vicinity of the drug compounding operation.

         1. (d) Drug compounding facilities.
   7. (1) Pharmacies engaging in compounding shall have a specifically designated and adequate area (space) for the orderly compounding of prescriptions, including the placement of equipment and materials.
   8. (2) The aseptic processing for sterile products shall be in an area separate and distinct from the area used for the compounding of nonsterile drug products.
   9. (3) The area or areas used for the compounding of drugs shall be maintained in a good state of repair.

   10. (4) Bulk drugs and other chemicals or materials used in the compounding of drugs must be stored in adequately labeled containers:

       1. (A) In a clean, dry area; or
       2. (B) If required, under proper refrigeration.
   11. (5) Adequate lighting and ventilation shall be provided in all compounding areas.
   12. (6) Potable water shall be supplied under continuous positive pressure in a plumbing system free of defects that could contribute contamination to any compounded drug product.
   13. (7) These areas used for compounding shall be maintained in a clean and sanitary condition.
   14. (8) If parenteral products are being compounded, standards set out in 17 CAR § 160-2201 must be met.

4. (e) Compounding equipment.

   1. (1) Equipment used in the compounding of drug products shall be of appropriate design and capacity as well as suitably located to facilitate operations for its:

      1. (A) Intended use;
      2. (B) Cleaning; and
      3. (C) Maintenance.
   2. (2) Compounding equipment shall be of suitable composition so the surfaces that contact components shall not be reactive, additive, or absorptive so as to alter the purity of the product compounded.
   3. (3) Equipment and utensils used for compounding shall be cleaned and sanitized immediately prior to use to prevent contamination.
   4. (4) Equipment and utensils must be stored in a manner to protect from contamination.

   5. (5)

      1. (A) Automated, mechanical, electronic, limited commercial scale manufacturing or testing equipment, and other types of equipment may be used in the compounding of drug products.
      2. (B) If such equipment is used, it shall be routinely inspected, calibrated if necessary, or checked to ensure proper performance.

   6. (6) Immediately prior to the initiation of compounding operations, the equipment and utensils must be:

      1. (A) Inspected by the pharmacist; and
      2. (B) Determined to be suitable for use.

   7. (7)

      1. (A) When drug products with special precautions (antibiotics, hazardous materials, and cytotoxins) are involved:

         1. (i) Appropriate measures must be utilized in order to prevent cross-contamination; and
         2. (ii) Proper disposal procedures must be followed.
      2. (B) These measures include either the dedication of equipment for such operations or the meticulous cleaning of equipment prior to its use for the preparation of other drugs.

5. (f) Component selection requirements.

   1. (1) Pharmacists shall first attempt to use United States Pharmacopoeia — The National Formulary (USP-NF) drug substances for compounding that have been made in a Food and Drug Administration-registered facility.
   2. (2) If components are not obtainable from a Food and Drug Administration-registered facility or if the Food and Drug Administration and/or the company cannot document Food and Drug Administration registration, pharmacists compounding prescriptions shall use their professional judgment in first receiving, storing, or using drug components that meet official compendia requirements or another high-quality source.

6. (g) Control of drug products.

   1. (1) Drug product containers and closures shall be handled and stored in a manner to:

      1. (A) Prevent contamination; and
      2. (B) Permit inspection and cleaning of the work area.

   2. (2) Containers and closures shall be suitable material so as to not alter the compounded drug as to:

      1. (A) Quality;
      2. (B) Strength; or
      3. (C) Purity.

7. (h) Drug compounding controls.

   1. (1) There shall be written procedures for the compounding of drug products to ensure that the finished products have the identity, strength, quality, and purity they purport or are represented to possess.

   2. (2) Procedures shall include a listing of:

      1. (A) The components;
      2. (B) Their amounts in weight or volume;
      3. (C) The order of component mixing; and
      4. (D) A description of the compounding process.
   3. (3) All equipment and utensils and the container/closure system relevant to the sterility and stability of the intended use of the drug shall be listed.
   4. (4) All written procedures shall be followed in the execution of the compounding procedure.

   5. (5)

      1. (A) Components shall be accurately weighed, measured, or subdivided as appropriate.
      2. (B) These operations should be checked and rechecked by the compounding pharmacist at each stage of the process to ensure that each weight and measure is correct as stated in the written compounding procedures.

   6. (6)

      1. (A) Written procedures shall be established and followed that describe the tests or examination to be conducted on the product compounded (e.g., degree of weight variation among capsules) to ensure reasonable uniformity and integrity of compounded drug products.
      2. (B) Such control procedures shall be established to monitor the output and to validate the performance of those compounding processes that may be responsible for causing variability in the final drug product.

      3. (C) Such control procedures shall include, but are not limited to, the following, where appropriate:

         1. (i) Capsule weight variation;
         2. (ii) Adequacy of mixing to ensure uniformity and homogeneity; and
         3. (iii) Clarity, completeness, or pH of solutions.

   7. (7)

      1. (A) Appropriate written procedures designed to prevent microbiological contamination of compounded drug products purporting to be sterile shall be established and followed.

      2. (B) Such procedures shall:

         1. (i) Follow accepted standards of practice; and/or
         2. (ii) Include validation of any sterilization process.

   8. (8)

      1. (A) Beyond-use dates and storage requirements (e.g., refrigeration) should be established.

      2. (B) The USP-NF guidelines should be used.

         1. (i) Labeling.

   9. (1) If a component is transferred from the original container to another (e.g., a powder is taken from the original container, weighed, placed in a container) and stored in another container, the new container shall be identified with the:

      1. (A) Component name;
      2. (B) Lot and expiration date if available;
      3. (C) Strength and concentration;
      4. (D) Weight or measure; and
      5. (E) Route of administration.

   10. (2)

       1. (A) Products prepared in anticipation of a prescription prior to receiving a valid prescription should not be an inordinate amount.
       2. (B) A regularly used amount should be prepared based on a history of prescriptions filled by the pharmacy.

       3. (C) These products shall be labeled or documentation referenced with the:

          1. (i) Complete list of ingredients or preparation name and reference;
          2. (ii) Federal expiration date, up to one (1) year;
          3. (iii) Assigned beyond-use date:
8. (a) (a) Based on published data;

9. (b) (b) Appropriate testing; or

   1. (c) (c) USP-NF standards;

      1. (iv) Storage under conditions dictated by their composition and stability, e.g., in a clean, dry place or in the refrigerator; and

         1. (v) Batch or lot number.
   2. (3) Upon the completion of the drug preparation operation, the pharmacist shall examine the product for correct labeling.

   3. (4) The prescription label shall contain the following:

      1. (A) Patient name;
      2. (B) Prescriber's name;
      3. (C) Name and address of pharmacy;
      4. (D) Directions for use;
      5. (E) Date filled;
      6. (F) Beyond-use date and storage (may be auxiliary labels); and
      7. (G) An appropriate designation that this is a compounded prescription, with reference to active ingredients.

10. (j) Records and reports.

    1. (1) Any procedures or other records required to comply with good compounding practices shall be retained for the same period of time as required for retention of prescription records.
    2. (2) All records required to be retained under good compounding practices, or copies of such records, shall be readily available for authorized inspection.
    3. (3) Computer information and the hard copy of the prescription should indicate that the prescription is to be compounded.
    4. (4) Adequate records must be kept of controlled substances (scheduled drugs) used in compounding.

11. (k) Pharmacy-generated product requirements.

    1. (1) A pharmacy-generated product (PGP) may be prepared from legend drugs, not to exceed recommended strengths and doses.
    2. (2) PGP will be labeled properly and will be sold with the public’s health and welfare in mind.

    3. (3)

       1. (A) PGP cannot be bulk compounded to sell to a second entity for resale.

       2. (B) This would require a manufacturer’s permit.

          1. (l) Compounding for a prescriber’s office use.
    4. (1) Pharmacies may prepare compounded drug products for a duly authorized prescriber’s office use.
    5. (2) An order by the duly authorized prescriber, indicating the formula and quantity ordered, will be filed in the pharmacy.

    6. (3)

       1. (A) The product is to be administered in the office and not dispensed to the patient.
       2. (B) The product shall be labeled “For Office Use Only—Not for Resale”.
    7. (4) A record of the compounded drug product may be kept as a prescription record in the pharmacy computer.
    8. (5) A label may be generated and a number assigned by the pharmacy computer for the compounded drug product.
    9. (6) Patient-specific prescriptions for controlled substances cannot be filled “for office or medical bag use”.

    10. (7)

        1. (A) A retail pharmacy is not precluded from making more than five percent (5%) of its annual sales to licensed practitioners.

        2. (B) The pharmacy must, however, obtain a State Wholesale Legend Drug and/or Controlled Substance Distributor Permit.

           1. (m) Compounding veterinary products.
    11. (1) Prescriptions for animals may be compounded based on an order or prescription from a duly authorized prescriber.
    12. (2) These prescriptions are to be handled and filled the same as the human prescriptions.
    13. (3) Patient-specific prescriptions for controlled substances cannot be filled “for office or medical bag use”.

    14. (4) Veterinary office use.

        1. (A) Compounded preparations distributed for veterinary office use in accordance with the labeling requirements do not require a patient-specific prescription but do require that the compounded preparation be administered to a patient in the course of the veterinary practitioner’s professional practice.
        2. (B) Compounded preparations distributed for office use pursuant to this rule shall not be further distributed to other practitioners or dispensed to a patient for self-administration except as provided below.

    15. (5)

        1. (A) Veterinary compounded preparations may be sold to a veterinary practitioner for office use if the preparations are compounded by an Arkansas-licensed Class A pharmacy or Food and Drug Administration-registered and Arkansas-permitted 503B outsourcing facility and sold directly to the veterinary practitioner by the pharmacy or outsourcing facility in compliance with Food and Drug Administration guidance and regulations.

        2. (B) Veterinary compounded preparations sold to a veterinary practitioner for veterinary office use may be dispensed to the owner of a veterinary patient to treat an immediate emergency medical need when:

           1. (i) Timely access to a patient-specific supply of compounded medication is not available;
           2. (ii) No commercially available product can meet the need of the patient;
           3. (iii) Lack of treatment will likely result in patient harm; and
           4. (iv) The supply does not exceed seven (7) days.

Codification Notes: This section as promulgated prior to codification into the Code of Arkansas Rules provided as follows: “(Adopted 2/2001, Amended emergency 6/2003 & 10/26/2003, Amended 11/30/2010, 5/10/2022 and 12/31/2022)"