Analysis
Full results breakdown published
Our complete write-up of every vote, the dissenting arguments, and what compounding pharmacies can and cannot do today.
Read the results analysisLiving document · Updated July 26, 2026
PCAC regulatory tracker
Everything we know about the FDA's peptide compounding review in one place — the full timeline, every recorded advisory committee vote, and a dated log of updates as the rulemaking process moves forward.
6
Recommended
1
Rejected
7
Peptides voted on
12+ mo
Est. time to rulemaking
Current status: PCAC has voted, but the votes are advisory only. Nothing has changed for compounding pharmacies yet — FDA must accept the recommendations and complete notice-and-comment rulemaking before any peptide is added to Category 1.
Vote ledger
Every recorded vote
Committee tallies as recorded at the FDA White Oak hearing, July 23-24, 2026.
Day 1 — July 23, 2026
| Peptide | Indication reviewed | Vote | Outcome |
|---|---|---|---|
| BPC-157 Committee voted against FDA staff recommendation — a historic outcome. | Ulcerative colitis | 8 Yes · 6 No · 1 Abstain | Recommended |
| KPV Same margin as BPC-157. | Wound healing, inflammatory conditions | 8 Yes · 6 No · 1 Abstain | Recommended |
| TB-500 All three Day 1 repair peptides received identical margins. | Wound healing | 8 Yes · 6 No · 1 Abstain | Recommended |
| MOTS-c Slightly wider margin than the repair peptides. | Obesity, osteoporosis | 7 Yes · 5 No · 2 Abstain | Recommended |
Day 2 — July 24, 2026
| Peptide | Indication reviewed | Vote | Outcome |
|---|---|---|---|
| Emideltide (DSIP) The only rejection, by a single vote. A future nomination remains possible. | Opioid withdrawal, chronic insomnia, narcolepsy | 6 Yes · 7 No | Rejected |
| Semax Day 2 cognitive peptides fared well. | Cerebral ischemia, migraine, trigeminal neuralgia | 8 Yes · 5 No | Recommended |
| Epitalon Strongest relative majority of Day 2. | Insomnia | 7 Yes · 4 No | Recommended |
Hearing 2 — expected Feb 2027
| Peptide | Indication reviewed | Vote | Outcome |
|---|---|---|---|
| 5 additional peptides (list pending) FDA signalled a second hearing before February 2027. | To be announced with the Federal Register notice | Not yet scheduled | Pending |
Timeline
How we got here — and what comes next
- 2023
19 peptides moved to Category 2
FDA reclassifies 19 widely-used peptides overnight, effectively prohibiting 503A compounding and pushing patients toward research-use-only supply.
- 2024
Gray market expands
RUO vendors fill the access gap with no pharmacy-grade quality controls, sterility testing, or dosing accuracy guarantees.
- February 2026
HHS directs a reversal
HHS Secretary directs FDA to restore 14 peptides to Category 1 — the first major reversal of the 2023 restrictions.
- April 15, 2026
12 peptides removed from Category 2
Federal Register Doc. 2026-07361 removes 12 peptides from Category 2 and schedules a PCAC hearing for 7 of them.
- July 9, 2026
Public comment deadline
Comments submitted to the docket by this date were provided directly to the advisory committee.
- July 23-24, 2026
PCAC hearing — votes recorded
The committee recommended 6 of 7 peptides for compounding. DSIP was rejected 6-7.
- Now — Q3/Q4 2026
FDA response window
The Commissioner decides whether to accept the recommendations. PCAC votes are advisory only; nothing changes for pharmacies until FDA acts.
- 2027 and beyond
Proposed rule, comment period, final rule
Category 1 addition requires notice-and-comment rulemaking. Realistic timeline from vote to enforceable listing is 12 months or more.
- Before February 2027
Second PCAC hearing
A further hearing covering 5 additional peptides is expected. Agenda and list to be published in the Federal Register.
Update log
Updates over time
Newest first. We add an entry every time the regulatory picture changes.
Vote
Day 2 concluded — Semax and Epitalon recommended, DSIP rejected
Semax passed 8-5 and Epitalon 7-4. Emideltide (DSIP) was rejected 6-7, the only compound to fail and by the narrowest possible margin.
Vote
Day 1 concluded — BPC-157, KPV, TB-500 and MOTS-c recommended
The three repair peptides each passed 8-6-1 against FDA staff recommendation. MOTS-c passed 7-5-2.
Docket
Public comment period closed
Comments filed by this date were forwarded to committee members ahead of the hearing.
Federal Register
12 peptides removed from Category 2
FDA published Doc. 2026-07361 and announced the July 23-24 advisory committee meeting.
View the Federal Register noticePolicy
HHS directs FDA to restore 14 peptides to Category 1
The directive set the process in motion that led to the April notice and the July hearing.
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We email subscribers whenever this page changes materially — FDA responses, proposed rules, and the second hearing.