GLPwatch
Compounding & regulation
Compounded versions of GLP-1 drugs became widespread during shortages. This hub explains the regulatory framework and links to the primary sources — it is not legal or medical advice.
503A vs 503B
503A pharmacies compound drugs for an individual patient pursuant to a prescription; they are regulated primarily by state boards of pharmacy and are not required to follow CGMP. 503B outsourcing facilities register with the FDA, must follow CGMP, and may produce larger batches. Both are defined in the Federal Food, Drug, and Cosmetic Act. FDA: compounding & the FD&C Act ↗
Why GLP-1 compounding surged
When a drug is on the FDA shortage list, compounding of that drug is generally permitted within statutory limits; when a shortage resolves, those allowances change. Track the current shortage status of GLP-1 products on the shortages leaderboard, sourced from openFDA.
FDA enforcement
The FDA publishes warning letters and recall enforcement reports related to compounded products. Recalls affecting tracked GLP-1 products appear in our news feed. FDA warning letters ↗