Peptide regulatory timeline
Tracking FDA actions on peptide compounding eligibility from the 2023 Category 2 placement through the April 2026 reclassification and the upcoming PCAC review. Verified against the underlying source documents.
This page is generated from content/regulatory/timeline.ts — a hand-curated record sourced from FDA Compounding Bulk Drug Substances bulletins, HHS press releases, and Pharmacy Compounding Advisory Committee meeting documents. Every entry links to its primary source. Updates are committed to git, so the change history is fully auditable. There is no automated FDA feed; manual review is the rule.
FDA places ~19 peptides on Category 2 compounding restriction list
The FDA placed BPC-157, TB-500, Thymosin Alpha-1, AOD-9604, MOTS-c, Selank, Semax, KPV, and approximately a dozen others on its Category 2 list, effectively blocking licensed 503A compounding pharmacies from preparing them for patients.
HHS announces Category 2 → Category 1 reversal for ~14 peptides
HHS Secretary Robert F. Kennedy Jr. publicly announced that approximately 14 of the previously restricted peptides — including BPC-157, TB-500, Thymosin Alpha-1, AOD-9604, MOTS-c, Selank, Semax, and KPV — would return to Category 1 status pending formal reclassification.
Category 1 reclassification effective
The reclassification became effective. Licensed 503A compounding pharmacies can again prepare the reclassified peptides for individual patients with a valid, patient-specific prescription. Category 1 status permits compounding while the substance remains under FDA evaluation; it does not constitute FDA approval.
Pharmacy Compounding Advisory Committee formal review
PCAC convenes for formal review (July 23–24, 2026) to determine official compounding eligibility going forward. The committee's recommendation will inform the FDA's final position on each compound in the reclassified batch.
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