FDA releases final guidance on compounding from bulk substances

Update: The FDA announced in September 2022 that it would delay enforcing this guidance through routine pharmacy inspections until April 2023, rather than October 2022. See details here.

The U.S. Food and Drug Administration (FDA) has published final guidance describing the conditions under which it does not intend to take enforcement action against those who compound animal drugs from bulk drug substances. 

Guidance for Industry #256 (GFI #256), Compounding Animal Drugs from Bulk Drug Substances, establishes the parameters within which veterinarians may use compounded drugs that are prepared from bulk drug substances. 

Under the guidance, veterinarians may prescribe such compounded drugs for specific patients with few restrictions.  For a pharmacy to provide compounds prepared from bulk drug substances for office stock or dispensing, however, the compound must be on one of three lists to be maintained by FDA:

• List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals
• List of Bulk Drug Substances for Compounding Drugs for Use in Food-Producing Animals or Free-Ranging Wildlife Species
• List of Bulk Drug Substances Currently Under Review

FDA has indicated that it will work to populate the lists with additional nominations in an expedited manner. Further, FDA has expressed its intent to focus on education and stakeholder engagement before shifting resources toward inspectional activities in Fiscal Year 2023 (October 2022).

Throughout the FDA’s development of this guidance, including before and after the agency’s November 2019 draft, the AVMA has actively communicated our profession’s needs for compounded products. As part of that ongoing communication, and informed by input from AVMA members, volunteer leaders, state and allied veterinary organizations, and other stakeholders, the AVMA submitted formal written comments to FDA on February 3, 2020, May 18, 2020, and October 8, 2020.

The final guidance reflects many changes made in response to advocacy by the AVMA. For example, AVMA voiced considerable opposition to the use of lists due to concerns they could not be compiled and maintained to keep pace with clinical needs. In response, FDA modified its approach to make the process of creating and reviewing the lists more dynamic, and has indicated it will work with the profession to ensure the lists are robust. AVMA will continue to actively work with FDA, and evaluate other options as necessary, to ensure that veterinarians have medically appropriate access to compounded drugs prepared from bulk drug substances and that such access is not unduly burdensome.

Visit the AVMA’s new webpage to learn more about the FDA guidance.