May 19, 2023

APC issues statement on shortage-drug compounding and semaglutide

Earlier this week, APC released an extensive statement on compounding copies of FDA approved drugs when those drugs are in shortage. The statement focuses in particular on semaglutide.

“This statement represents our understanding of the regulatory framework regarding compounding ‘essentially a copy’ of an FDA-approved drug when that drug is listed as ‘currently in shortage’ on the FDA drug shortage website,” said APC Chief Executive Officer Scott Brunner.

Brunner said the statement also addresses the issue of compounding drugs containing semaglutide active pharmaceutical ingredient (API) during this period when the FDA-approved drugs containing that API are listed as “currently in shortage” on the FDA drug shortage website.