Regulatory status

Regulatory Tracker

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

Last updated · Apr 2026 · 16 compounds · 3 categories

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.

Deep dive · July 2026 PCAC Meeting

What the peptide panel is really voting on

Compound-by-compound breakdown, PCAC track record, pricing impact, and the indication gap the coverage is missing.

CompoundStatus
AOD-9604Regulatory Limbo
BPC-157Category 2
CJC-1295 (without DAC)Regulatory Limbo
DSIPCategory 2
EpitalonCategory 2
GHK-Cu (Topical)Category 1
GHK-Cu (Injection)Category 2
IpamorelinRegulatory Limbo
KisspeptinCategory 2
KPVCategory 2
MOTS-cCategory 2
SelankRegulatory Limbo
SemaxCategory 2
SermorelinCategory 1
TB-500Category 2
Thymosin Alpha-1Regulatory Limbo

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Next dispatch · May 2026 · Honest frequency: a few times a month

The rules keep changing.
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