REGULATORY EVENT
PCAC Meeting Tracker — July 23–24, 2026
The FDA's Pharmacy Compounding Advisory Committee will evaluate 7 peptides for potential addition to the 503A bulk drug substances list. Track each compound's progress and sign up for same-day email alerts.
Day 1 — July 23, 2026
BPC-157
Day 1Healing & Recovery
Gut healingTendon repairAnti-inflammatory
Regulatory Progress1/4 stages
Cat 2 RemovalPublic CommentPCAC ReviewFDA Decision
KPV
Day 1Anti-Inflammatory
Gut inflammationIBD supportImmune modulation
Regulatory Progress1/4 stages
Cat 2 RemovalPublic CommentPCAC ReviewFDA Decision
MOTS-c
Day 1Metabolic
Metabolic regulationExercise mimeticInsulin sensitivity
Regulatory Progress1/4 stages
Cat 2 RemovalPublic CommentPCAC ReviewFDA Decision
TB-500
Day 1Healing & Recovery
Wound healingTissue repairAnti-fibrotic
Regulatory Progress1/4 stages
Cat 2 RemovalPublic CommentPCAC ReviewFDA Decision
Day 2 — July 24, 2026
Emideltide (DSIP)
Day 2Sleep & Recovery
Sleep regulationStress reductionOpioid withdrawal
Regulatory Progress1/4 stages
Cat 2 RemovalPublic CommentPCAC ReviewFDA Decision
Epitalon
Day 2Anti-Aging & Longevity
Telomerase activationCircadian regulationAnti-aging
Regulatory Progress1/4 stages
Cat 2 RemovalPublic CommentPCAC ReviewFDA Decision
Semax
Day 2Nootropic & Cognitive
BDNF upregulationNeuroprotectionCognitive enhancement
Regulatory Progress1/4 stages
Cat 2 RemovalPublic CommentPCAC ReviewFDA Decision
Group 2 — By February 2027
5 additional compounds will be reviewed at a second PCAC meeting: GHK-Cu, Melanotan II, LL-37 (Cathelicidin), Dihexa, and PEG-MGF. Exact date TBD.
What to Expect
Before the Meeting
- → FDA publishes briefing documents (~2 weeks before)
- → Public comment period closes July 9
- → Oral presentation requests due June 30
- → Committee member list published
During the Meeting
- → FDA presents safety/efficacy data per compound
- → Public oral presentations (if approved)
- → Committee discussion and questions
- → Advisory vote per compound (recommend or not)
After the Meeting
- → PCAC recommendation is advisory (not binding)
- → FDA decides whether to accept the recommendation
- → If accepted, formal rulemaking to add to 503A list
- → Timeline from vote to final rule: weeks to months
Important Context
- ⚠ A favorable vote ≠ immediate compounding authorization
- ⚠ The prior PCAC panel voted to keep restrictions
- ⚠ New committee composition may change the outcome
- → Read our legal analysis