FDA regulatory event · Concluded · Docket FDA-2025-N-6895
The FDA peptide votes, July 23-24, 2026
The FDA's Pharmacy Compounding Advisory Committee recommended 6 of 7 peptides - including BPC-157, TB-500 and Semax - for the Section 503A list that governs what pharmacies may legally compound. It has been reported as the FDA clearing them. It is not that. Here is every vote and tally, what the committee's advice legally does, and what it does not.
- When
- July 23-24, 2026 ET
- Who voted
- FDA advisory committee (PCAC)
- Binding on the FDA
- No
- Status changes
- None
What was decided - and what wasn't
The only federal pathway for a pharmacy to compound one of these peptides is the Section 503A Bulk Drug Substances List. A substance on the list may be compounded under FDA enforcement discretion; a substance that is not on it has no affirmative federal authorization, regardless of how it is marketed. Over two days the committee reviewed the science on each nominated peptide and voted on whether to recommend adding it.
It recommended 6 and declined Emideltide (DSIP). Notably, the FDA's own review staff had recommended against listing every one of the 7; the committee voted the other way on most of them.
None of that is a decision. The vote is advisory - the FDA is not bound by it and has not acted on it. A favorable recommendation still has to clear formal rulemaking before anything changes in practice. So the honest summary of these two days is: the advice changed; the law did not.
Every vote
By day, as reported. The FDA has not yet published the meeting minutes, so treat the tallies as reported rather than official - our sources are listed below. Tap any compound for its full, sourced status.
Two things the coverage mostly left out, both from the FDA's own meeting documents. First, each substance was voted on twice - the free base and the acetate separately - so the single figure per compound reported below is a summary of a pair of votes. Second, the totals genuinely differ from one substance to the next because the panel was not the same size each time: the roster seats temporary voting members for single topics, so a compound can be decided by a differently constituted committee than the one before it.
| Compound | Committee vote | For | Against | Abstain | Legal to compound today? |
|---|---|---|---|---|---|
| BPC-157 | Recommended | 8 | 6 | 1 | No not on the 503A list |
| KPV | Recommended | 8 | 6 | 1 | No not on the 503A list |
| MOTS-c | Recommended | 7 | 5 | 2 | No not on the 503A list |
| TB-500 (Thymosin Beta-4) | Recommended | 8 | 6 | 1 | No not on the 503A list |
| Compound | Committee vote | For | Against | Abstain | Legal to compound today? |
|---|---|---|---|---|---|
| Emideltide (DSIP) | Not recommended | 6 | 7 | 1 | No not on the 503A list |
| Epitalon | Recommended | 7 | 4 | 1 | No not on the 503A list |
| Semax | Recommended | 8 | 5 | 1 | No not on the 503A list |
Related - same window, separate process
This is a 503A compounding review. Separately, the public comment period on the FDA's proposal to permanently exclude the 503B GLP-1 drugs, including Semaglutide and Tirzepatide, from the outsourcing-facility bulks list closed July 30, 2026 (Docket FDA-2018-N-3240). The FDA's final determination is pending, with no announced date - and that proposal runs in the opposite direction to these votes. Semaglutide (compounded)Tirzepatide (compounded)
What happens next
- Jul 23-24, 2026 · done
The committee voted. 6 of 7 recommended for the 503A list, Emideltide (DSIP) rejected. Advisory only - nothing was legalized.
- Now · no date
The FDA decides whether to accept. It is under no obligation to follow the committee, or to act quickly. There is no announced date - a proposed rule can appear in the Federal Register on any business day. This is the step we watch daily.
- If it proceeds · ~60-90 days
Proposed rule, then public comment. A listing change has to be proposed and opened to comment before it can be finalized. The requirement cannot be skipped.
- ~12-24 months total
Final rule - the only step that changes the law. Only when a final rule adds a substance to the 503A list may a pharmacy compound it. Until then the answer on every page here stays "no".
- Expected before end of Feb 2027
A second committee meeting on five more substances - LL-37, GHK-Cu, Dihexa acetate, Melanotan II, PEG-MGF. The FDA has signalled the window but has not published a date.
Get alerted when any status changes
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Sources & transparency
- FDA - PCAC meeting page, July 23-24, 2026primary regulator
- Federal Register - PCAC notice of meeting (Docket FDA-2025-N-6895)primary regulator
- Regulations.gov - full docket FDA-2025-N-6895primary regulator
- Healio - FDA committee recommends looser restrictions for several peptidesvote tallies
- Mintz - FDA's advisory committee votes on peptides: what it does and doesn't dolegal effect
On the tallies: the FDA had not published minutes or an official vote record for this meeting as of Aug 22, 2026 (ET). The counts above are as reported by the named secondary sources and are labelled that way throughout the site. We will replace them with the official record the moment it publishes.
Informational only - not medical or legal advice, and no health claim. Always confirm against the linked primary source. Full disclaimer.