Regulatory Tracker

Name: FDA Peptide Regulatory Status Tracker
Creator: Pep
License: https://creativecommons.org/licenses/by/4.0/

Current FDA category status for peptide compounds. Updated when regulations change.

Category 1 means a compound can be legally prepared by compounding pharmacies.

Category 2 means it cannot.

In February 2026, HHS announced ~14 peptides would return to Category 1, but no formal FDA rule has been published yet.

Compound	Status	Compounding	Note
AOD-9604	Category 2	Prohibited	Expected to return to Category 1. Fragment of human growth hormone targeting fat metabolism.
BPC-157	Category 2	Prohibited	Expected to return to Category 1 per Feb 2026 announcement. No formal rule change yet. Not FDA approved and prohibited by WADA (added 2022) under S0: Non-Approved Substances; no TUE available for athletes.
CJC-1295 (without DAC)	Regulatory Limbo	Suspended	Removed from Category 2 in Sept 2024 but not added to Category 1. Compounding effectively suspended.
Epitalon	Category 2	Prohibited	Expected to return to Category 1. Synthetic version of epithalamin.
GHK-Cu	Category 1	Legal	Available through compounding. Quality varies between sources.
Ipamorelin	Regulatory Limbo	Suspended	Removed from Category 2 in Sept 2024 but not added to Category 1. Expected to return to Category 1.
Kisspeptin	Category 2	Prohibited	Expected to return to Category 1. Key regulator of reproductive hormone signaling.
KPV	Category 2	Prohibited	Expected to return to Category 1. Derived from alpha-MSH with NF-kB inhibition.
MOTS-c	Category 2	Prohibited	Expected to return to Category 1. Mitochondria-derived peptide.
Selank	Category 2	Prohibited	Expected to return to Category 1 in 2026. Approved as prescription medication in Russia.
Semax	Category 2	Prohibited	Expected to return to Category 1 in 2026. Approved as prescription medication in Russia.
Sermorelin	Category 2	Prohibited	Expected to return to Category 1. Previously FDA-approved for pediatric GH deficiency.
TB-500	Category 2	Prohibited	Expected to return to Category 1. Currently restricted from compounding.
Thymosin Alpha-1	Category 2	Prohibited	Expected to return to Category 1. Approved in 30+ countries for immune modulation.

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