Glossary
503A vs 503B
Also called 503A pharmacy, 503B outsourcing facility, Outsourcing facility, Section 503A, Section 503B
The two federal paths for drug compounding in the US. 503A covers state-licensed pharmacies filling patient prescriptions; 503B covers FDA-registered outsourcing facilities that follow manufacturing standards.
In more detail
Per FDA: 503A compounders are licensed pharmacists in state-licensed pharmacies (or physicians), overseen day to day by state boards of pharmacy, and are exempt from CGMP manufacturing rules if they meet the law's conditions. 503B outsourcing facilities were created in 2013 by the Drug Quality and Security Act, register with FDA, are inspected on a risk-based schedule and must follow CGMP.
Each path has its own list of bulk ingredients it may use. Peptides that FDA has flagged for safety concerns sit in Category 2 under the interim policies.
Why it matters
When a telehealth or clinic offers a peptide, which kind of facility made it tells you what quality rules applied.
Related terms
- Compounded vs brandedA branded drug is the FDA-approved product from its maker. A compounded drug is mixed by a pharmacy or outsourcing facility and is not FDA approved.
- FDA Category 2An FDA list of bulk ingredients that were nominated for compounding but that FDA says may present significant safety risks. Pharmacies are not expected to compound with them under the interim policy.
- Research use only (RUO)A label sellers put on compounds that are not approved drugs, stating they are sold for laboratory research and not for human use.
Sources
Each source is labeled by where the information comes from. How we label sources
- RegulatoryCompounding and the FDA: Questions and Answers(opens in a new tab)
FDA · checked
- RegulatoryRegistered Outsourcing Facilities(opens in a new tab)
FDA · checked
- RegulatoryBulk drug substances used in compounding under section 503A of the FD&C Act(opens in a new tab)
FDA · checked
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