1. (a) Nonsterile compounding is performed by or under the direct supervision and control of a licensed pharmacist pursuant to a patient specific prescription, unless otherwise specified in this article.
2. (b) Reconstitution of a conventionally manufactured drug product that is not done in accordance with the FDA approved directions is considered compounding.
3. (c) Notwithstanding subdivision (a), a limited quantity of a CNSP may be prepared and stored in advance of receipt of a patient specific prescription document where it is necessary, and solely in such quantity to ensure continuity of care of individual patients based on a documented history of prescriptions for those patient populations.

4. (d) A reasonable quantity of a compounded drug preparation may be furnished to a veterinary office for use by the veterinarian that is sufficient:

   1. (1) for administration or application to veterinary patients solely in the veterinarian's office.
   2. (2) for furnishing of no more than a 14-day supply, for an individual patient, as fairly estimated by the prescriber and documented on the purchase order or other documentation submitted to the pharmacy prior to furnishing.

5. (e) In addition to prohibitions and requirements for compounding established in federal law, no CNSP shall be prepared that:

   1. (1) is essentially a copy of one or more commercially available drug products, unless:

      1. (A) the drug product appears in an American Society of Health-System Pharmacists (ASHP) Drug Shortages List or FDA Drug Shortages Database of drugs that are in short supply at the time of compounding or within 60 days of the end of the shortage, or in a health care facility licensed pursuant to Health and Safety Code Section 1250 where the drug product cannot be obtained from the manufacturer or wholesaler and documentation is maintained, or
      2. (B) the pharmacist verifies and documents that the compounding produces a clinically significant difference for the medical need of an identified individual patient.
      3. (C) Documentation describing the conditions in (1)(A) and (1)(B) is maintained in a readily retrievable format.
   2. (2) is made with any component not suitable for use in a CNSP for the intended veterinary population, unless allowable under the Animal Medicinal Drug Use Clarification Action of 1994 (AMDUCA). When a veterinarian acting within a valid veterinarian-client-patient relationship (VCPR) determines there is no medically appropriate human or animal drug that is FDA-approved, conditionally approved, or indexed to treat the animal, a pharmacy may use a bulk drug substance to compound an animal drug. This compound shall be in compliance with the Center for Veterinary Medicine Guidance for Industry #256 -- Compounding Animal Drugs from Bulk Drug Substances issued August 2022, which is hereby incorporated by reference.
6. (f) Prior to allowing any CNSP to be compounded within a pharmacy, the pharmacist-in-charge shall complete a self-assessment consistent with the requirements established in section 1715.

7. (g) In addition to the provisions in section 1707.2, consultation includes proper use, storage, handling, and disposal of the CNSP and related supplies furnished.

   A pharmacist is not required by this subsection to provide oral consultation to an inpatient of a health care facility licensed pursuant to section 1250 of the Health and Safety Code, or to an inmate of an adult correctional facility or a juvenile detention facility, except upon the patient's discharge. A pharmacist is not obligated to consult about discharge compounded medications if a health facility licensed pursuant to subdivision (a) or (b) of Health and Safety Code Section 1250 has implemented a written policy about discharge compounded medications that meets the requirements of Business and Professions Code Section 4074.

8. (h) CNSPs with human whole blood or human whole blood derivatives shall be compounded in compliance with Health and Safety Code section 1602.5.
9. (i) A facility that limits its compounding to combining a flavoring agent with a prescribed FDA approved drug in an oral liquid dosage form at the request of a prescriber, patient, or patient's agent shall be exempt from the requirements established in subdivision (f) and Sections 1735.2 - 1735.13. A facility that performs any other form of nonsterile compounding at any time is not exempt as provided in this subdivision.

In addition to the standards in USP Chapter 795 and section 353a of title 21, United States Code, the compounding of a CNSP that is performed by or through a licensee of the Board shall meet the following requirements of this article.

Note: Authority cited: Sections 4005 and 4126.8, Business and Professions Code. Reference: Sections 4005, 4051, 4052, 4076, 4081, 4105, 4126.8, 4169, 4301, 4306.5 and 4332, Business and Professions Code; Section 355, Title 21 United States Code; and Part 530, Title 21, Code of Federal Regulations.

History

1. New section filed 1-6-2010; operative 7-6-2010 (Register 2010, No. 2).

2. New subsection (a) and subsection relettering filed 2-6-2013; operative 4-1-2013 (Register 2013, No. 6).

3. Amendment filed 9-13-2016; operative 1-1-2017 (Register 2016, No. 38).

4. Amendment of subsections (c) and (f) and amendment of Note filed 1-30-2019; operative 1-30-2019 pursuant to Government Code section 11343.4(b)(3) (Register 2019, No. 5).

5. Repealer and new section filed 6-19-2025; operative 10-1-2025 (Register 2025, No. 25).