The FDA has publicly signaled its intent to take enforcement action against non-approved GLP-1 drugs — a shift that follows the formal end of shortages for both semaglutide and tirzepatide.

The timeline: the FDA removed tirzepatide from its drug shortage list in October 2024, and semaglutide followed in early 2025. Under FDA rules, when a drug is no longer in shortage, 503B outsourcing facilities must cease compounding copies of the commercially available product. The agency set transition deadlines — April and May 2025 — after which compounded versions that are “essentially a copy” of approved products were no longer permitted from 503B facilities.

As of February 2026, the FDA has outlined specific enforcement priorities. The agency is not pursuing a blanket prohibition on all compounded GLP-1 products. Instead, it has identified clear targets: compounding without documented medical necessity, unlicensed manufacturing operations, misleading marketing claims, improper storage and shipping practices, and the use of research-grade active pharmaceutical ingredients not intended for human use.

This distinction matters. State-licensed 503A pharmacies compounding patient-specific prescriptions under physician oversight operate under different rules than 503B outsourcing facilities. The FDA’s enforcement posture targets the most clearly problematic actors — those operating outside any regulatory framework — rather than the entire compounding ecosystem.

The practical reality is messier than the legal framework suggests. Compounded semaglutide and tirzepatide remain widely available through various channels. Enforcement has been selective. Meanwhile, some companies have adapted by reformulating their products to argue they are not “essentially a copy” of the approved drugs.

Patients currently using compounded GLP-1 products should be aware that the regulatory environment is actively tightening, and sourcing through a licensed pharmacy with a valid prescription remains the most legally defensible path.