GMP (Good Manufacturing Practice) is a set of regulatory standards, enforced by agencies like the FDA, that govern how medications must be produced, tested, and quality-controlled to ensure consistency, purity, and safety. Facilities that manufacture GLP-1 medications and FDA-registered 503B outsourcing facilities must follow current GMP (CGMP); traditional 503A compounding pharmacies follow USP compounding standards instead. Asking which of these a source operates under is a useful question when evaluating whether it is legitimate, especially compared to unregulated grey market sellers that operate outside these standards. Source: FDA on outsourcing facilities (external link).
GMP (Good Manufacturing Practice)
A regulatory standard ensuring medications are consistently produced and controlled to quality standards — a key marker of legitimacy for compounded or manufactured drugs.
Updated Sep 26, 2026
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Related terms
- Semaglutide salt forms — Versions of semaglutide such as semaglutide sodium and semaglutide acetate, which the FDA says are different active ingredients from the semaglutide base used in approved drugs, with no known lawful basis for compounding.
- Open enrollment — The annual window when you can enroll in or change your health plan, and the time to compare GLP-1 coverage across the plans available to you.
- P&T committee (Pharmacy and Therapeutics committee) — The panel of physicians, pharmacists, and other clinicians that reviews the clinical evidence behind a plan's formulary: which drugs are acceptable, which are interchangeable, and what restrictions apply.
- API (active pharmaceutical ingredient) — The raw drug substance in a medication that produces its effect — for example, semaglutide itself, before it is formulated into a pen or vial.
- Certificate of analysis (CoA) — A document reporting the lab test results for a specific batch of a drug ingredient or product, such as identity, purity, and contaminants.
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