In recent months, with Wegovy, Ozempic, and Mounjaro listed as “currently in shortage,” the compounding of medications containing semaglutide (the active pharmaceutical ingredient in Wegovy and Ozempic) or tirzepatide (the active pharmaceutical ingredient in Mounjaro) has been a focal point in the media and for 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. Responses in this briefing are intended to provide accurate information on the issue, as well as to provide perspective on legal action brought against certain compounding pharmacies by drug manufacturers.

The Alliance for Pharmacy Compounding is committed to promoting a safe and lawful environment for the compounding, prescribing, dispensing, and use of drug products. To that end, this brief will focus on ensuring that compounders, regulators, physicians, and other prescribers have an overview of the regulatory framework surrounding active ingredients that may be used in human compounding, particularly peptides.

 “Peptides” are a group of protein substances, some of which are FDA-approved products, that may have health benefits for certain patient populations. Recently, compounding pharmacies have received numerous inquiries from prescribers regarding peptides. As a result, pharmacists frequently reference FDA guidance and federal law when advising prescribers on what can and cannot be used as an active ingredient in a human compound.

This briefing, originally adopted by APC’s Board of Directors in 2010 has been updated in 2024 to highlight the stance the DEA has recently taken with regard to the constructive transfers of controlled substances to physicians. 

As drug manufacturers have stopped production of drugs for lethal injection, and as states increasingly look to compounding pharmacies for such drugs, the Board of Directors of the Alliance for Pharmacy Compounding has adopted a position on the issue.