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503A and 503B compounding

The difference between 503A and 503B compounding, including their limits, oversight, and permissible uses, especially regarding injectable GLP-1s like tirzepatide.

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Jan 16, 2026
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How do 503A and 503B compounding pharmacy regulatory requirements differ for injectable GLP‑1 medications like tirzepatide?

503A and 503B compounding are separate legal pathways with distinct limits that recently converged on tirzepatide after the FDA declared GLP‑1 shortages resolved—503A pharmacies, state‑licensed and pa...