1. (a) A veterinary premises that engages in compounding drug preparations shall develop and maintain a written policies and procedures manual, which shall include:

   1. (1) A list of each of the requirements of subsections (b), (d), (e), and (f) and sections 2093 and 2094.
   2. (2) Policies and procedures for the training of an R.V.T. who may perform compounded drug preparations.
   3. (3) Policies and procedures for a quality assurance program established pursuant to section 2095.

2. (b) Except as provided under subsections (d) and (e), a master formula document shall be maintained for each compounded drug preparation and include all of the following:

   1. (1) Name, strength, and quantity of each active ingredients to be used.
   2. (2) Equipment to be used.
   3. (3) Calculation of expiration date of the compounded drug preparation.
   4. (4) Name, strength, and quantity of each inactive ingredients to be used.
   5. (5) Specific compounding steps to be used to prepare the compounded drug preparation.
   6. (6) Instructions for storage, handling, and administration of the compounded drug preparation.
   7. (7) Name assigned to the compounded drug preparation.
3. (c) The master formula document may be included in the policies and procedures manual maintained pursuant to subsection (a).
4. (d) If the compounded drug preparation is not routinely compounded and a master formula document is not otherwise maintained pursuant to subsection (b), a formula record for the compounded drug preparation shall be kept in the medical record of the animal patient and shall include all information required in paragraphs (1) through (6) of subsection (b).
5. (e) Notwithstanding subsections (b) and (d), for intravenous (IV), intramuscular (IM), or subcutaneous (SQ) compounded drug preparations for immediate use on an animal patient that contain a sterile solution, the name and quantity of the sterile solution and the name, strength, and quantity of the ingredient(s) added to the sterile solution shall be recorded in the animal patient's medical record.

6. (f) For each compounded drug preparation prepared for an animal patient, the following information shall be recorded in the animal patient's medical record:

   1. (1) Name or initials of the veterinarian who made or supervised the making of a compounded drug preparation and the name or initials of the R.V.T., if any, who made the compounded drug preparation.
   2. (2) Expiration date of the compounded drug preparation.
   3. (3) Name, amount, and strength of the active ingredient(s) in the compounded drug preparation.
   4. (4) Date the drug preparation was compounded.

7. (g) The veterinarian performing or supervising the compounding of drug preparations is responsible for the following:

   1. (1) Training and supervision of the R.V.T. who is compounding the drug preparation.
   2. (2) Proper storage of the drugs used in compounding and the compounded drug preparations.

Note: Authority cited: Sections 4808 and 4826.5, Business and Professions Code. Reference: Section 4826.5, Business and Professions Code.

History

1. New section filed 1-4-2022; operative 4-1-2022 (Register 2022, No. 1). (OAL review extended 60 calendar days pursuant to Executive Order N-40-20.)

2. Amendment of section and Note filed 1-12-2026; operative 4-1-2026 (Register 2026, No. 3).