Compounding pharmacies can resume making tirzepatide as FDA reconsiders shortage
The FDA said in a court filing late Friday that it would allow pharmacists to continue making compounded versions of tirzepatide as it reconsiders whether the drug is in shortage.
The Food and Drug Administration said in a court filing late Friday that it would allow pharmacists to continue making compounded versions of tirzepatide — the active ingredient in Eli Lilly’s diabetes and weight loss drugs Mounjaro and Zepbound — while it reconsiders its decision to remove the drug from its nationwide shortage list.
The surprise move is a major victory for compounding pharmacists and patients who were furious with the FDA after its announcement on Oct. 2 that the tirzepatide shortage was resolved.
Shortages of the drug, along with semaglutide — the active ingredient in Ozempic and Wegovy — have fueled unprecedented demand for compounding pharmacies to make their own versions of the medicines, which patients say are often cheaper and easier to come by than the brand-name versions.
During FDA-declared shortages, it’s legal for compounding pharmacies to make versions that are “essentially a copy” of the brand-name drugs in shortage, though drugmakers have vehemently pushed back against the legitimacy of this practice.
The FDA’s announcement on Oct. 2 declaring the shortage over meant that compounding pharmacists had to stop filling tirzepatide prescriptions. It said at the time that pharmacies that produce large batches of medications would no longer be able to accept new orders of tirzepatide and had 60 days to fill their existing orders.
Rating: 5