New webinar explains proposed rules on bulk compounding

Update: The FDA deadline for commenting on Draft Guidance for Industry #256 was extended on June 11. AVMA will collect member comments on the proposal through August 15, 2020. 

A new on-demand webinar on AVMA Axon shares more information about the U.S. Food and Drug Administration’s (FDA) Draft Guidance for Industry #256, which addresses veterinary drug compounding from bulk substances. 

The webinar, presented by an FDA veterinarian, gives important background to help veterinarians provide informed feedback on FDA’s proposed guidance while it’s open for public comment.

Animal drugs compounded from bulk drug substances aren’t FDA-approved. However, the FDA recognizes that compounded drugs can serve an important medical need for animal patients when no FDA-approved or indexed drug is available. 

When the FDA’s Center for Veterinary Medicine issued draft guidance for animal drug compounding from bulk drug substances in November 2019, a variety of questions emerged.

The new AVMA Axon webinar, Compounding: Understanding FDA draft guidance, provides an overview of the proposal. Among the topics it covers:

• Why the FDA cannot assure the safety, effectiveness, or quality of bulk drug substances 
• How the draft guidance attempts to balance the risks of animal drugs compounded from bulk substances when no FDA-approved drug is available for treatment 
• Policies included in the draft guidance and how they impact veterinary practice

Provide comment on the proposed new rules

The webinar gives veterinary professionals the necessary information to provide feedback that will help FDA officials understand how the proposed guidance would impact veterinarians and our patients. The AVMA is gathering comments on the proposal and will provide formal comments to the FDA on behalf of our members. 

The current deadline for commenting on the FDA proposal is June 17, but AVMA has asked the agency to extend the comment period by at least 120 days. AVMA’s request for an extension noted that the COVID-19 pandemic has required veterinarians to refocus attention on how best to continue to serve patients and clients, and left limited time available to consider the proposal. 

AVMA members should email feedback about the draft guidance to compoundingavma [dot] org (compounding[at]avma[dot]org).

Compounding resources for veterinarians

The AVMA provides a range of resources that help veterinarians understand the fine points of prescribing and using compounded medications. Learn more about the rules that apply to compounding, get answers to common questions, and find definitions and AVMA policies at avma.org/Compounding.