Two federal pathways for legal compounded medication. Both produce compounded sema/tirz; very different rules.
Framework
Both established/refined by the Drug Quality and Security Act of 2013, following the 2012 NECC contamination tragedy.
503A — traditional compounding
- Section 503A FD&C Act
- State pharmacy board licensing only
- FDA registration not required
- Patient-specific compounding pursuant to valid prescription
- USP <797> sterile compounding standard
- Not subject to cGMP
503B — outsourcing facility
- Section 503B FD&C Act (DQSA 2013)
- State pharmacy board AND FDA registration
- Listed on FDA website
- Can produce in bulk for healthcare facilities or telehealth under certain rules
- cGMP standards (same as pharmaceutical manufacturers)
- Routine FDA cGMP inspections
- Required third-party batch testing
Why this matters
When a drug is on FDA's shortage list, both 503A (patient-specific) and 503B (bulk) can compound. When shortage resolves, 503B bulk is generally restricted; 503A continues. This is why 2024–2026 FDA shortage resolutions and the April 2026 FDA action materially changed the landscape.
Why dual 503A+503B is strong signal
Supply chain robust to regulatory changes. NexLife names six partners across both classifications.
Take-away
'Compounded' is not a single category. Look beyond 'we use a U.S. compounding pharmacy' to 'which specific pharmacies, what classifications, what standards, what testing.'