U.S. House Passes Human Compounding Bill

By: Dr. Ashley Morgan, assistant director, Governmental Relations Division

On Sept. 28, the U.S. House of Representatives passed the Drug Security and Quality Act (H.R. 3204), which would amend the Federal Food, Drug and Cosmetic Act to provide more oversight of human drug compounding and security for the drug supply chain.

The legislation, written in response to the compounded drug that lead to a fungal meningitis outbreak last fall killing more than 60 people, would expand the Food and Drug Administration’s oversight of compounding pharmacies. It would also create a category of outsourcing facilities for large compounding pharmacies, which the FDA would oversee. Outsourcing facilities would register with the FDA, inform the agency of its manufactured products and share adverse event reports about their drugs. Facilities that choose to remain traditional pharmacies will continue to be regulated primarily by their respective state pharmacy boards.

H.R. 3204 incorporated language from both the House and Senate versions of the bill. It blended provisions from the Pharmaceutical Compounding Quality and Accountability Act (S. 959), which the Senate Health, Education, Labor and Pensions Committee approved by a voice vote in May, and the Compounding Clarity Act (H.R. 3089), which the House introduced last month.

Since H.R. 3089 and H.R. 3204 only focused on human compounding and did not include provisions on veterinary compounding, AVMA did not take a position on either piece of legislation. However, after working closely with its stakeholders and several Congressional offices, AVMA supported S. 959, which originally intended to include provisions that would address veterinary compounding.

Moving forward, AVMA will continue to educate congressional offices and the FDA about the needs for veterinarians to have access to and use compounded medications.

For more information, see AVMA’s new video that explains what veterinarians need to know about compounding.

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