“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.