FDA’s final guidance on traditional compounding essentially unchanged from draft guidance

Additional guidance expected with policy changes on office use, MOUs

FDA announced the availability of its final guidance for traditional compounding, Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act, in the Federal Register on July 2. Reflecting the agency’s thinking on the compounding part of the Drug Quality and Security Act (the compounding and track-and-trace legislation signed into law late last year), the final guidance closely tracks the draft guidance.

APhA had submitted comments February 3 on the draft guidance. APhA’s comments focused on office-use compounding and limits on out-of-state distribution of compounded drug products, including a 5% limit on such drug products and a Memorandum of Understanding (MOU) between FDA and the states.

It appears that pharmacists can expect additional guidance with policy changes on both issues, according to Jillanne Schulte, JD, APhA Director of Regulatory Affairs.

“Essentially, FDA kept the guidance as it was,” Schulte said. “Based on the listening session with FDA last week, it sounds like they’ll be making policy changes in additional guidance (both for office use and the MOU) that has yet to be released.”

The final guidance doesn’t apply to registered outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act; the agency will issue this guidance separately. Guidance documents are suggestions or recommendations that do not establish legally enforceable responsibilities, according to FDA.

As intended by the Drug Quality and Security Act, FDA’s final guidance noted that traditional compounding under section 503A will continue to be overseen by states, not the agency.


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