US FDA clarifies policies on compounding of GLP-1 medicines
Published on April 1, 2026.
The US Food and Drug Administration has clarified its policies on compounded versions of GLP-1 drugs. Compounders are permitted to produce copies of approved medicines only when these drugs are listed on the FDA's shortage database. This exemption is temporary and strictly tied to supply disruptions. The FDA has advised that as GLP1 therapies stabilize, compounders should transition away from routine production of these drugs. It also warned that continued manufacturing outside these boundaries could result in enforcement.