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.
Hearing status: The July 23–24, 2026 PCAC meeting has not yet occurred. All compounds are shown in their current pre-hearing Category 2 status. This tracker will be updated with committee recommendations on hearing days. PCAC recommendations are advisory — FDA formal determinations follow later. Full disclaimer.
Day 1 — July 23, 2026
BPC-157 · KPV · TB-500 · MOTS-cDay 2 — July 24, 2026
DSIP · Semax · EpitalonLast updated: June 1, 2026. Tracker updated on hearing days following PCAC session conclusion. PCAC recommendations are advisory — formal FDA determinations follow later. 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.