- What is the difference between 503A and 503B compounding?
- 503A pharmacies compound patient-specific prescriptions in smaller volumes under state board oversight. 503B outsourcing facilities are FDA-registered, follow cGMP (current Good Manufacturing Practice), undergo FDA inspection, and can compound in larger batches. 503B is the higher quality-control standard.
- Is compounded semaglutide FDA-approved?
- No. Compounded medications are not FDA-approved. They are legal to compound under 503A/503B rules, but the FDA does not verify their safety, efficacy, or quality the way it does for branded Wegovy or Ozempic. After the May 2026 shortage resolution, population-scale compounding lost its shortage exemption.
- How do I verify a compounding pharmacy is legitimate?
- Check: (1) state board of pharmacy license lookup, (2) for 503B, the FDA registered outsourcing facility list, (3) LegitScript certification, (4) whether they provide third-party potency and sterility test results (Certificate of Analysis) on request.
- What is a Certificate of Analysis (COA)?
- A COA is a third-party lab document confirming the compounded product’s potency (actual mg vs labeled), purity, and sterility. Reputable compounders provide COAs on request. If a provider cannot or will not produce one, treat that as a red flag.