With the FDA declaring the shortage of semaglutide over and the recent development that “U.S. District Judge Mark Pittman denied the Outsourcing Facilities Association’s bid for a preliminary injunction that would have prevented the FDA from taking action against its members for making copies of semaglutide, the active ingredient in Ozempic and Wegovy” (see here), this chapter of the compounding status of these drugs is closed.
503B compounders (also known as outsourcing facilities) have until May 22, 2025 to stop selling compounded copies of the drugs. 503A compounders, which are typically pharmacies, have to stop the practice immediately. So, the issue regarding compounding of these products appears (at least for now) to be settled in favor of the FDA and its policy and regulatory scheme for legal compounding, much like the fate of its related GLP-1 “cousin” peptide tirzapatide.
