This week, the AVMA submitted a letter asking the U.S. Food and Drug Administration (FDA) to clarify its latest proposal to regulate animal drug compounding from bulk substances and allow at least a 120-day extension for commenting on the proposal.
If granted, the extension would extend the deadline for commenting until mid-June. The current deadline is February 18.
Since the draft guidance was released in November, the AVMA has been actively seeking feedback from our members and other veterinary associations. The responses we have received indicate there are several areas of confusion in the draft guidance, which need to be clarified in order for veterinarians to provide needed feedback. These include:
- How the draft guidance intersects with USP chapters and monographs
- How it should be interpreted in the context of existing FDA veterinary compliance policy guides
- Whether the FDA intends to take enforcement action against veterinarians for compounding from bulk drug substances in certain specific situations
The AVMA asked the FDA to clarity its intent in these areas and allow us more time to gather and compile input from the veterinary community, which we will then submit to the FDA.
Read our letter to the FDA, which includes specifics about the areas that require clarification in the draft guidance, known as draft Guidance for Industry (GFI) #256, Compounding Animal Drugs from Bulk Drug Substances.
Webinar on animal drug compounding
For more detail about the draft guidance, take advantage of the resources provided by the FDA, including a recorded webinar available for free.