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ALEXANDRIA, Va.— The Alliance for Pharmacy Compounding, the national trade association representing the pharmacy compounding profession, has released an extensive statement on compounding copies of FDA approved drugs when those drugs are in shortage. The statement focuses in particular on semaglutide.
In recent months, with Wegovy and Ozempic listed as “currently in shortage” by the U.S. Food & Drug Administration, the compounding of medications containing the active pharmaceutical ingredient in those drugs, semaglutide, has been a topic widely covered in the media and a focus of state boards of pharmacy (which regulate traditional compounding pharmacies). Unfortunately, many media accounts and some licensee communications issued by state boards have contained misstatements and errors. The statement is intended to provide accurate information on the issue.
“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.
It also speaks to arguments made by some compounders about preparing semaglutide drugs using semaglutide sodium. “APC does not endorse those arguments,” Brunner said, “But as we mention in the statement, we do find them worthy of discussion.”
