Regulatory Reference Tool

FDA PCAC Outcomes Tracker

Tracking the July 23–24, 2026 FDA Pharmacy Compounding Advisory Committee decisions on 503A bulk drug substance status for seven peptide compounds. Outcomes are updated following each hearing day.

← Full PCAC 2026 Reference PCAC Overview Article →

Hearing status: The July 23–24, 2026 PCAC meeting concluded on July 24, 2026. All seven outcomes below are final committee votes — six compounds recommended for the 503A positive list, DSIP/Emideltide voted down 6-7. PCAC recommendations are advisory only; formal FDA determinations follow a separate notice-and-comment rulemaking process. Read the full results. Full disclaimer.

Day 1 — July 23, 2026

BPC-157 · KPV · TB-500 · MOTS-c

Compound	Category	Key Evidence	PCAC Outcome	Links
BPC-157	Tissue Repair	Sikiric lab preclinical; no Phase II RCTs	✓ Recommended Committee voted 8-6 to recommend, against FDA staff’s own recommendation	Full Results →Profile →
KPV	Anti-inflammatory	Dalmasso 2008 IBD model; Kannengiesser 2011	✓ Recommended Committee voted 8-6 to recommend, against FDA staff’s own recommendation	Full Results →Profile →
TB-500	Tissue Repair	Goldstein lab; cardiac & wound healing models	✓ Recommended Committee voted 8-6 to recommend, against FDA staff’s own recommendation	Full Results →Profile →
MOTS-c	Mitochondrial / Metabolic	Lee et al. 2015 Cell; Reynolds 2021 Nature Aging	✓ Recommended Committee voted 7-5 to recommend, against FDA staff’s own recommendation	Full Results →Profile →

Day 2 — July 24, 2026

DSIP · Semax · Epitalon

Compound	Category	Key Evidence	PCAC Outcome	Links
DSIP	Neuropeptide / Sleep	Monnier 1977 isolation; endogenous peptide	✕ Not Recommended Committee voted 6-7 against recommending — the only compound of the 7 not to clear	Full Results →Profile →
Semax	Nootropic / Neuroprotective	Approved drug in Russia; human cognitive trial data	✓ Recommended Committee voted 8-5 to recommend, against FDA staff’s own recommendation	Full Results →Profile →
Epitalon	Bioregulator / Longevity	Khavinson 2003 telomerase; Anisimov 2003 longevity	✓ Recommended Committee voted 7-5 to recommend, against FDA staff’s own recommendation	Full Results →Profile →

Last updated: August 1, 2026 — hearing concluded July 24, 2026; all seven outcomes final as of the committee vote. PCAC recommendations are advisory only — formal FDA determinations require a separate notice-and-comment rulemaking process that realistically runs 8–24 months. Read the full post-hearing analysis → · Full PCAC reference →

How to read the outcomes

Category 1 (Positive)

Committee recommends compound be placed on the 503A positive list. Compounding permitted without disruption.

Category 2 (Held)

Committee found evidence insufficient for positive listing but not clearly adverse. Regulatory holding continues.

Restricted

Committee recommends prohibition from 503A compounding. FDA formal rulemaking required before taking effect.