Educational only. Not medical or legal advice. This site summarizes public U.S. government statements as of October 22, 2026. It does not sell, recommend or endorse any product, and it does not give dosing information. Talk to a licensed clinician about any medicine, and check the linked FDA pages for the latest version.
Every source was retrieved on October 22, 2026.
- FDA CDER MAPP 5016.3: Quality Assessment of Products Containing Peptide or Protein Drug Substances
- FDA: FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss
- FDA: FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize
- FDA Declaratory Order: Resolution of Shortages of Semaglutide Injection Products (Feb 21, 2025)
- FDA: Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act
- FDA: Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks
- FDA: About Warning and Close-Out Letters