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
- Batch testing required under cGMP
Why this matters
When a drug is on FDA's shortage list, 503A pharmacies and 503B facilities have more room to compound it. When the shortage ends, 503B facilities lose the shortage basis for bulk compounding and 503A pharmacies may not regularly compound copies of the approved drug. The tirzepatide (2024) and semaglutide (2025) shortage decisions changed the market, and on April 30, 2026 FDA proposed not to add semaglutide, tirzepatide or liraglutide to the 503B bulks list (no final decision as of October 15, 2026; see our analysis).
Why naming the pharmacy matters
A named pharmacy can be checked: its state license, its 503A or 503B status and FDA's warning-letter list. NexLife's plan pages, read October 15, 2026, name three state-licensed 503A pharmacies: Absolute Pharmacy (Lutz, FL), Premium Compounding (Decatur, AL) and Boudreaux's New Drug Store (Lake Charles, LA).
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.'