NCPA and the Alliance for Pharmacy Compounding submitted joint comments to the FDA opposing requests from Novo Nordisk and Eli Lilly to place semaglutide and tirzepatide on the 503A and 503B "Demonstrably Difficult to Compound" lists. We argued that these requests are unwarranted given the millions of doses of compounded GLP-1s that have been dispensed to meet patient need during the past 24-plus months that the brand-name products have been in severe shortage.
We also argued that GLP-1 medications as compounded by state-licensed compounding pharmacies following USP guidelines and state laws are demonstrably not difficult to compound, and that adverse event profiles for compounded versions of GLP-1 medications align closely with those of the branded drugs, suggesting that the adverse events are related to the drugs themselves and not the way they are produced.
