1. (a) For the purposes of this article, sterile compounding occurs, by or under the direct supervision and control of a licensed pharmacist, pursuant to a patient specific prescription, unless otherwise specified in this article.

   1. (2) If the sterile compounding equipment or environment fail(s) to meet any required specification, after attempts to remediate pursuant to the facility's SOPs are unsuccessful, an immediate use CSP may be compounded without the requirement for there to be loss of life or intense suffering of an identifiable patient. This provision may only be used for 48 hours after such failure(s). All such failures shall be documented in accordance with facility's SOP. Failures requiring use of immediate use provisions shall be reported to the Board within 72 hours of the transition to immediate use provisions.
   2. (3) If the sterile compounding equipment or environment fail(s) to meet any required specification in a critical access hospital, as defined in section 1395i-4(c)(2)(B) of title 42, United States Code, after attempts to remediate pursuant to the facility's SOPs are unsuccessful, an immediate use CSP may be compounded without the requirement for there to be loss of life or intense suffering of an identifiable patient. This provision may be used for 120 hours after such failure(s). All such failures shall be documented in accordance with facility's SOPs. Failures requiring use of immediate use provisions shall be reported to the Board within 72 hours of the transition to immediate use provisions.

   (b)(1) Except as allowed in paragraphs (2) and (3), CSPs for direct and immediate administration as provided in USP Chapter 797 shall only be compounded in those limited situations where the failure to administer such CSP could result in loss of life or intense suffering of an identifiable patient. Any such compounding shall be only in such quantity as is necessary to meet the immediate need of the patient. If not already documented in the patient's medical record, documentation for each such CSP shall also include the compounded date and time, the patient's name and patient's unique identifier and the circumstance causing the immediate need of the patient. Such documentation need not be redocumented by the compounding staff if already available.

2. (c) Notwithstanding subdivision (a), a limited quantity of CSP may be prepared and stored in advance of receipt of a patient specific prescription document where, and solely in such quantity, as is necessary to ensure continuity of care for identified patients based on a documented history of prescriptions for that patient population.

3. (d) A reasonable quantity of a CSP 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 not more than a 7-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.

      1. (A) With the exception of a topical ophthalmic where up to a 28-day supply may be furnished to veterinarian's office for an individual patient. Such topical ophthalmics shall be compliant with USP Chapter 797 section 14.5, Multiple-Dose CSPs.

4. (e) In addition to prohibitions and requirements for compounding established in federal law, no CSP may be compounded that:

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

      1. (A) that 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 and at the time of dispensing, 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 preparation produces a clinically significant difference based on the medical need of an identified individual patient.
      3. (C) Documentation describing the conditions in subsections (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 CSP for the intended veterinary population, unless allowable under 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 compounding shall be done in compliance with the Center for Veterinary Medicine Guidance for Industry #256 -- Compounding Animal Drugs from Bulk Drug Substances issued in August 2022, which is hereby incorporated by reference.
   3. (3) is made with a non-sterile component for which a conventionally manufactured sterile component is available unless the CSP master formula supports such use and is appropriate for the intended CSP.
   4. (4) requires end product sterilization unless sterilization occurs within the same licensed compounding location.
5. (f) Prior to allowing any CSP to be compounded within a pharmacy, the pharmacist-in-charge shall complete a self-assessment consistent with the requirements established in section 1715.
6. (g) In addition to the provisions in Section 1707.2 of this Division, consultation includes proper use, storage, handling and disposal of the CSP 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 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.
7. (h) CSPs with human whole blood or human whole blood derivatives shall be produced in compliance with Health and Safety Code section 1602.5. This shall not apply to the compounding of an FDA-approved human whole blood or human whole blood derivative product.

In addition to the standards set forth in USP Chapter 797 and 353a of title 21, United States Code, the following requirements of this article apply to the compounding of a CSP that is performed by or through a licensee of the Board.

Note: Authority cited: Sections 4005, 4126.8 and 4127, Business and Professions Code. Reference: Sections 4005, 4123, 4126.8, 4127.1 and 4127.2, Business and Professions Code; and Section 353a, Title 21, United States Code.

History

1. New section filed 6-19-2025; operative 10-1-2025 (Register 2025, No. 25).