The California Veterinary Medical Board has proposed amending the California Code of Regulations to clarify the process for veterinarians to compound drugs in a veterinary office for the treatment of an animal patient. As reported in the “Initial Statement of Reasons,”
[t]he regulatory proposal is intended to provide guidance and an enforcement mechanism for inspectors to determine whether veterinarians and RVTs [registered veterinary technicians] are compounding drugs in accordance with their scope of practice, experience, and premises. The rulemaking is necessary to provide veterinarians with guidance on the proper procedures for storing, handling, and preparing compounded drugs.
The Board’s regulations require the establishment of a valid veterinary client patient relationship before administering, dispensing or prescribing a drug, including a compounded drug.
The proposed regulations include a definition of “Compounding” which
means any of the following activities performed in a registered veterinary premises by a licensed veterinarian that has established the veterinarian-client-patient relationship for the animal patient(s) or a registered veterinary technician under the direct or indirect supervision of that veterinarian:
(1) Altering the dosage form or delivery system of a drug.
(2) Altering the strength of a drug.
(3) Combining components or active ingredients.
(4) Preparing a compounded drug preparation from chemicals.
The regulations would permit use of bulk substances for compounding but would require the direct supervision of a RVT if they were preparing the compounded medication from bulk substances. Medications would not be considered compounded if they were reconstituted “pursuant to a manufacturer’s direction(s) for oral, rectal, topical, or injectable administration” or were simply split, crushed or a capsule was opened or flavorings were added to increase palatability.
The regulations require veterinarians to list an expiration date on a label of any dispensed compounded drug and to “ensure the safety and efficacy of a compounded drug preparation.” It is unclear how safety and efficacy will be determined, keeping in mind that since the 1962, Congress amended the Federal Food, Drug and Cosmetic Act requiring that drug manufacturers must demonstrate to FDA that a drug is effective and safe before its approval and marketing. While FDA has stated in Guidance #256, it “does not intend to take enforcement action for violations of the FD&C Act” when veterinarians compound medications for animal patients in compliance with its guidance, it also states that “[a]nimal drugs that are not FDA-approved, conditionally approved, or indexed are considered ‘unsafe’ and, therefore ‘adulterated’ under sections 512(a)(1) and 501(a)(5) of the FD&C Act.” See Guidance #256, at n. 6.
California would also require veterinarians to conduct appropriate staff training and record keeping for the preparation, use and storage of compounded medications including, for example: written policies and procedures manuals; formula documents for each compounded medication; the strength of the compounded formula; and a quality assurance program.
Veterinarians, pharmacists, registered veterinary technicians and other stakeholders should comment as described in the Notice of Regulatory Action about any concerns they may have about the proposed regulations and its potential impact no later than August 31, 2020.
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