(a) A veterinarian shall ensure the safety and efficacy of a compounded drug preparation, through reliance on drug compounding standards in the profession and in accordance with section 2032.
(b) A veterinarian shall not perform either sterile or non-sterile drug compounding when the complexity of the drug compounding exceeds the veterinarian's knowledge, skill, facilities, or available equipment.
(c) A veterinarian shall not perform either sterile or non-sterile drug compounding unless there are no other human or animal drugs approved by the United States Food and Drug Administration (FDA) and available that satisfy the need for this preparation.
(d) Sterile drug compounding shall be for immediate use except in the following conditions:
(1) A dilution of the ingredients is essential for the safe administration of the preparation.
(2) There is historical documentation of the need, safety, and efficacy of the preparation.
(e) Only sterile drugs approved by the FDA shall be used as the ingredients in a sterile compounded drug preparation.
(f) For non-sterile compounded drug preparations, active pharmaceutical ingredients (APIs) shall be purchased from an FDA-registered facility, and all records of such purchases shall be maintained for three (3) years to prove the origin of the APIs.
Credits
Note: Authority cited: Section 4826.5, Business and Professions Code. Reference: Section 4826.5, Business and Professions Code.
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.)
This database is current through 4/12/24 Register 2024, No. 15.
Cal. Admin. Code tit. 16, § 2091, 16 CA ADC § 2091
