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ESC

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Regulations & standards

FDA — Bulk drug substances used in compounding

FDA's page on the bulk drug substances that may and may not be used in compounding under sections 503A and 503B.

Several peptides have been the subject of nominations and evaluations on these lists. Current status changes over time and is reviewed per product by counsel; this page is the primary source.

Primary sourcefda.govOpen ↗
FDA — Bulk drug substances used in compounding — ASTEL Labs