meto
Pharmacy & Regulation

Bulks List

The FDA's list of substances permitted for compounding under Section 503A — the list that determines which peptides are legally compoundable.

Definition

The FDA Bulks List (under Section 503A of the FD&C Act) names substances that may be used by 503A compounding pharmacies when no FDA-approved drug product containing the substance is commercially available. HHS announced in February 2026 that ~14 peptides were being reclassified back to compounding-eligible status; the FDA's advisory committee meets in July 2026 for further guidance on the list.

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