Compounding Animal Drugs

Subscribe to Compounding Animal Drugs

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…

Since we first published “FDA Continues Proposed Extra-Statutory Authority Over Compounded Animal Drugs,” a number of impacted stakeholders have been expressing concern about the intended and unintentional consequences of FDA’s current approach.

First, as a result of widespread concern about the proposed guidelines, FDA will be extending the time to comment, previously scheduled…

Without clear statutory authority, FDA has proposed to expand its legal authority over veterinarians and veterinary compounding pharmacies in its newly released “Revised Draft Guidance on Compounding Animal Drugs from Bulk Drug Substances,” (#256) as announced on November 19, 2019.

FDA continues to describe the use of certain compounded medications for animals as violations of…