FDA action fact
July 23-24, 2026 Pharmacy Compounding Advisory Committee peptide agenda
Dockets: FDA-2025-N-6895, FDA-2026-N-2979
Fact ID 236ef132-83d1-40a7-a7bc-6c3e68a4acdc
PCAC Watch
July 2026 peptide docket watch
Docket facts, comment signals, and peptide status events generated from the structured fact layer. Classification notes remain provisional until human review.
47 public comments observed
7 peptides on PCAC agenda
12 peptides removed from Category 2
1 open source conflict
Docket Status
Federal Register, FDA page, and Regulations.gov records are held apart when they disagree.
FDA action fact
Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List
Dockets: FDA-2025-N-6895 · FR 2026-07361
Fact ID 92ab7a07-350b-4225-8e12-509bcb55e615
FDA action fact
Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments--Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List
Dockets: FDA-2025-N-6895
Fact ID 3e4d9137-dac2-47cf-b200-483ec7b15fa8
PCAC docket ID mismatch
FDA PCAC page observed with FDA-2025-N-6895 in one location and FDA-2026-N-2979 in written/paper instructions. Federal Register and Regulations.gov API identify FDA-2025-N-6895 as the live docket; FDA-2026-N-2979 returned zero API results as of 2026-04-30.
Conflict ID 50132d62-5990-4de1-bf12-4fbb345df548
Peptide Timeline
Rows combine separate status and agenda facts. No row should be read as final FDA authorization.
| Substance | Category 2 event | PCAC agenda | Form | Confidence | Fact support |
|---|---|---|---|---|---|
| BPC-157 | Removed From Category 2 Apr 22, 2026 | Agenda inclusion Jul 23, 2026 | acetate/free base | 95% | |
| KPV | Removed From Category 2 Apr 22, 2026 | Agenda inclusion Jul 23, 2026 | acetate/free base | 95% | |
| MOTs-C | Removed From Category 2 Apr 22, 2026 | Agenda inclusion Jul 23, 2026 | unspecified | 95% | |
| TB-500 | Removed From Category 2 Apr 22, 2026 | Agenda inclusion Jul 23, 2026 | acetate/free base | 95% | |
| Emideltide / DSIP | No Category 2 removal fact | Agenda inclusion Jul 24, 2026 | acetate/free base | 90% | Support1 referenceFact IDs Peptide StatusVerified Emideltide / DSIP fact:f6f69a5c-be84-4b94-840d-50b0668facc6Source |
| Epitalon | Removed From Category 2 Apr 22, 2026 | Agenda inclusion Jul 24, 2026 | acetate/free base | 95% | |
| Semax | Removed From Category 2 Apr 22, 2026 | Agenda inclusion Jul 24, 2026 | acetate/free base | 95% | |
| DiHexa | Removed From Category 2 Apr 22, 2026 | Not observed on agenda | Not specified | 95% | Support1 referenceFact IDs Peptide StatusVerified DiHexa fact:4f383f68-1875-486c-8515-b62ffb6de72eSource |
| DSIP | Removed From Category 2 Apr 22, 2026 | Not observed on agenda | Not specified | 95% | Support1 referenceFact IDs Peptide StatusVerified DSIP fact:797071cd-cd16-4d40-b5ef-f6d7716be17bSource |
| GHK-Cu | Removed From Category 2 Apr 22, 2026 | Not observed on agenda | Not specified | 95% | Support1 referenceFact IDs Peptide StatusVerified GHK-Cu fact:0d823586-a361-4a95-8658-92d29d086f75Source |
| LL-37 | Removed From Category 2 Apr 22, 2026 | Not observed on agenda | Not specified | 95% | Support1 referenceFact IDs Peptide StatusVerified LL-37 fact:24109c3e-9e8a-412a-a4fb-e5b7dd534924Source |
| Melanotan II | Removed From Category 2 Apr 22, 2026 | Not observed on agenda | Not specified | 95% | Support1 referenceFact IDs Peptide StatusVerified Melanotan II fact:f290fed9-8a84-4462-809c-76b2cc810a92Source |
| PEG-MGF | Removed From Category 2 Apr 22, 2026 | Not observed on agenda | Not specified | 95% | Support1 referenceFact IDs Peptide StatusVerified PEG-MGF fact:96f186de-0236-4385-afb2-512a7428e7a1Source |
Comment Signals
Rule-based classifications are directional and queued for human review.
Mentioned substances
- BPC-157 23
- TB-500 15
- KPV 9
- MOTs-C 5
- Semax 5
- DSIP 4
- Emideltide 3
- Epitalon 3
- GHK-Cu 3
- LL-37 1
Argument topics
- Patient Access 13
- Safety Claim 13
- Prescriber Oversight 8
- Bulks List Inclusion 7
- Cost Access 6
- Unregulated Market Risk 6
Submitter type
Clinician · 14Pharmacy Operator · 13Patient Consumer · 10Association · 7Unknown · 2Vendor Industry · 1
Evidence type
Anecdote · 35Access Cost · 17Safety · 14Clinical Scientific · 13Legal Regulatory · 7Uncategorized · 7
Claim Map
Editorial claims display their support IDs. Claims without support do not render.
What changed
Regulations.gov API confirms FDA-2025-N-6895 as the live PCAC docket.
Support1 reference
Fact IDs
FDA ActionVerified
July 23-24, 2026 Meeting of the Pharmacy Compounding Advisory Committee
fact:236ef132-83d1-40a7-a7bc-6c3e68a4acdcSourceThe docket has a public comment document and public comments available through the API.
Support2 references
Fact IDs
FDA ActionVerified
Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List
fact:92ab7a07-350b-4225-8e12-509bcb55e615SourcePublic CommentVerified
totalElements=47
fact:fa371480-526a-4b65-8f9d-5de6234b755aSourceWhat did not change
PCAC agenda inclusion is not the same as FDA approval or final bulks-list inclusion.
Support3 references
Fact IDs
FDA ActionVerified
July 23-24, 2026 Meeting of the Pharmacy Compounding Advisory Committee
fact:236ef132-83d1-40a7-a7bc-6c3e68a4acdcSourceFDA ActionVerified
Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List
fact:92ab7a07-350b-4225-8e12-509bcb55e615SourceFDA ActionVerified
Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments--Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List
fact:3e4d9137-dac2-47cf-b200-483ec7b15fa8SourcePublic comments are advocacy evidence, not clinical-efficacy evidence.
Support1 reference
Fact IDs
Public CommentVerified
totalElements=47
fact:fa371480-526a-4b65-8f9d-5de6234b755aSourceUnknowns
Whether PCAC will recommend any peptide for the 503A bulks list.
Support3 references
Fact IDs
FDA ActionVerified
July 23-24, 2026 Meeting of the Pharmacy Compounding Advisory Committee
fact:236ef132-83d1-40a7-a7bc-6c3e68a4acdcSourceFDA ActionVerified
Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List
fact:92ab7a07-350b-4225-8e12-509bcb55e615SourceFDA ActionVerified
Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments--Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List
fact:3e4d9137-dac2-47cf-b200-483ec7b15fa8SourceWhether FDA will resolve or correct the FDA-2026-N-2979 docket reference.
Support1 reference
Source conflict IDs
PCAC docket ID mismatchOpen
FDA PCAC page observed with FDA-2025-N-6895 in one location and FDA-2026-N-2979 in written/paper instructions. Federal Register and Regulations.gov API identify FDA-2025-N-6895 as the live docket; FDA-2026-N-2979 returned zero API results as of 2026-04-30.
conflict:50132d62-5990-4de1-bf12-4fbb345df548Whether later comments will include more pharmacy-operator and association submissions.
Support1 reference
Fact IDs
Public CommentVerified
totalElements=47
fact:fa371480-526a-4b65-8f9d-5de6234b755aSourceReview Notes
Submitter type, stance, evidence type, and peptide-specific support are rule-based classifications and require human review before publication.
Public comments can mention pharmacies or clinicians without being submitted by pharmacy operators or clinicians; treat submitter-type counts as provisional.