503A pharmacy
Also called 503A compounding pharmacy, traditional compounding pharmacy
A 503A pharmacy is a state-licensed pharmacy that compounds medications under section 503A of the Federal Food, Drug, and Cosmetic Act, which lets it prepare drugs for individual patients without FDA approval as long as it meets the conditions that section sets. The central condition is a valid prescription for an identified patient: a 503A pharmacy compounds for a named person, not for stock.
Day-to-day oversight of these pharmacies sits mainly with state boards of pharmacy, not the FDA, although the FDA can inspect them. Their products are exempt from federal manufacturing-practice rules that apply to drug makers and to 503B outsourcing facilities. The 503A label describes how a pharmacy is regulated; it is not a quality rating, and a medication compounded there is still not FDA-approved.
Why it matters after 45
Most compounded prescriptions written through telehealth, including hormone and weight-loss preparations people meet in midlife, are filled patient by patient, which is the 503A model. Whether a compounded drug is lawful can turn on that detail, as it has for compounded semaglutide since its shortage ended.
Where it comes up
References
- U.S. Food and Drug Administration. Human Drug Compounding Laws. https://www.fda.gov/drugs/human-drug-compounding/human-drug-compounding-laws
- U.S. Food and Drug Administration. Compounding and the FDA: Questions and Answers. https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers
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