503A pharmacies compound patient-specific prescriptions under state regulation and USP standards.
A 503A pharmacy compounds a medication for an individual patient based on a specific prescription. They are regulated primarily by state boards of pharmacy and are not required to register with the FDA as outsourcing facilities. After a shortage resolves, 503A compounding of an “essentially a copy” is limited to narrow, documented clinical-need cases.
| What to know |
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| 503A pharmacies compound patient-specific prescriptions under state regulation and USP standards. |
| A 503A pharmacy compounds a medication for an individual patient based on a specific prescription. |
The FDA resolved the tirzepatide (Dec 2024) and semaglutide (Feb 2025) shortages, and wind-down deadlines passed in 2025. On Apr 30, 2026 the FDA proposed excluding these drugs from the 503B bulks list; public comments are due by Jun 29, 2026. Patient-specific 503A compounding continues only narrowly, and cost alone is not a clinical need. Full regulatory status →
Compounded semaglutide and tirzepatide are not FDA-approved and are not the same as Wegovy, Ozempic, Zepbound, or Mounjaro. The FDA does not review compounded drugs for safety, effectiveness, or quality before marketing. Primary source: FDA — Human Drug Compounding.