FDA Issues Updated Guidance on GLP-1 Receptor Agonist Compounding

The US Food and Drug Administration has released updated guidance clarifying its enforcement position on compounded semaglutide products. The document, issued by the FDA's Center for Drug Evaluation and Research, reiterates that compounded versions of commercially available GLP-1 receptor agonists — including semaglutide and tirzepatide — have not been evaluated for safety, efficacy, or quality by the agency.

The updated guidance comes amid continued growth in demand for compounded GLP-1 products, driven largely by supply shortages of branded products such as Ozempic and Wegovy. With Novo Nordisk reporting improvements in manufacturing capacity, the FDA has signalled that the shortage designation for semaglutide may be reconsidered, which would have significant implications for the compounding pharmacies currently producing these products under Section 503A and 503B exemptions.

The agency notes that patients using compounded semaglutide face risks including incorrect dosing, contamination, and the absence of the quality controls applied during regulated pharmaceutical manufacturing. Healthcare providers are advised to prescribe FDA-approved products where available.

This guidance does not constitute a ban on compounding but strengthens the regulatory framework under which enforcement action may be taken against compounding pharmacies that produce copies of commercially available drugs without meeting the statutory requirements for compounding exemptions.