June 2, 2023

FDA issues public statement on compounded semaglutide

Earlier this week, FDA issued its first public statement on semaglutide compounding. The statement elaborates on what the agency said in its April letter to NABP on the subject.

FDA permits the compounding of copies of FDA-approved drugs when those drugs appear on the agency’s drug shortage list to assure patient access to medications when the manufacturer cannot maintain its supply chain. “Semaglutide, the active ingredient in Wegovy and Ozempic, has appeared on that shortage list for well over a year, so it’s helpful that FDA has now provided some perspective,” said APC’s Scott Brunner.

“Like FDA, we’re concerned concerned about consumers purchasing substances purporting to be semaglutide online from unregulated, unlicensed sources without a prescription. That’s not compounding. Those aren’t even pharmacies,” said Brunner.

The agency’s statement warns against taking a compounded medication made from an active pharmaceutical ingredient that is not the same active ingredient as found in Wegovy and Ozempic. 

Last month, APC released an extensive statement on compounding copies of FDA-approved drugs when those drugs are in shortage, as is the case with semaglutide.