Peptide policy tracker: status and dated change log
Where 15 peptides stand with FDA, HHS, the compounding advisory committee and WADA, plus a dated log of every status change we have verified. One data file drives this page, the status lookup and the table in our 14-peptide guide, so the three cannot disagree.
By Peptide Policy Watch staff. Status facts as of October 30, 2026; page updated .
Open right now
Public comment window on HHS’s six-peptide policy, docket HHS-OASH-2026-0496. It closes at 11:59 PM Eastern, November 13, 2026, and the docket record says late comments are not accepted. [V]
0 public comments posted on regulations.gov as of October 31, 2026, 2:31 AM CT, from the site’s public data service. [V] A comment appears there only after the agency posts it, so this count can trail what has been sent in. Our comment-period explainer covers what the window can and cannot decide.
What changed in the last seven days
- Compounding BPC-157, TB-500, Epitalon, KPV, MOTS-c, SemaxHHS's interim 503A policy was published in the Federal Register (91 FR 68526). It says HHS won't take enforcement action against licensed pharmacies and physicians that compound these six under ten conditions, until a final rule decides each peptide's place on the 503A bulks list. It also opened a comment window that closes at 11:59 PM Eastern on November 13, 2026. Nomination withdrawn; on FDA's category 2 withdrawn table → Covered by HHS's interim 503A policyFederal Register, 91 FR 68526 (FR Doc. 2026-22192) [V]
- Compounding BPC-157, TB-500, Epitalon, KPV, MOTS-c, SemaxHHS's policy text naming the six peptides went on the Federal Register's public inspection desk, two days before formal publication.Federal Register public inspection, document 2026-22192 [V]
- Policy process All peptides in the policyThe White House regulatory office (OIRA) concluded its review of FDA's "Interim Access Policy for Compounding Using Certain Peptides" (RIN 0910-ZD94), recorded as consistent with change.OMB/OIRA, EO 12866 review record for RIN 0910-ZD94 [V]
Where each peptide stands
| Peptide | Approved drug? | Compounding status (FDA 503A/503B) | Advisory committee, July 2026 | WADA 2026 List | Human evidence record |
|---|---|---|---|---|---|
| BPC-157 | No U.S. approval found | Covered by HHS's interim 503A policy, published Oct 30, 2026 (91 FR 68526), under ten conditions; still in FDA's category 2 withdrawn table | In favor, 8-6, 1 abstention [S] | Named, S0 | Early-stage research, mostly cells and animals; three small human studies in newer reviews |
| TB-500 | No U.S. approval found | Covered by HHS's interim 503A policy, published Oct 30, 2026 (91 FR 68526), under ten conditions; still in FDA's category 2 withdrawn table | In favor, 8-6, 1 abstention [S] | Named, S2.3 | Early-stage research; FDA found no human exposure data. The parent protein, thymosin beta-4, has phase 2-3 trials [V] |
| CJC-1295 | No U.S. approval found | Nomination withdrawn; listed on FDA's category 2 page | Not reviewed | Named, S2.2.4 | Small controlled trials in healthy adults |
| Ipamorelin | No U.S. approval found | 503A nomination withdrawn; still category 2 for 503B | Not reviewed | Named, S2.2.4 | Phase 2 surgery trial completed, well tolerated |
| Sermorelin | Formerly FDA-approved (1990 and 1997 products) | Category 1 on the 503B list; not on the 503A category lists | Not reviewed | Named, S2.2.4 | Long human record from the approval era |
| AOD-9604 | No U.S. approval found | Nomination withdrawn; listed on FDA's category 2 page | Not reviewed | Named, S2.2.3 | Animal studies, then a human weight-loss study |
| MOTS-c | No U.S. approval found | Covered by HHS's interim 503A policy, published Oct 30, 2026 (91 FR 68526), under ten conditions; still in FDA's category 2 withdrawn table | In favor, 7-5, 2 abstentions [S] | Named, S4.4.1 | Mouse studies and human observational data |
| Thymosin alpha-1 | Approved in several countries; no U.S. approval | 503A nomination withdrawn; category 3 on 503B | Not reviewed | Not named | Long trial record, including meta-analyses |
| KPV | No U.S. approval found | Covered by HHS's interim 503A policy, published Oct 30, 2026 (91 FR 68526), under ten conditions (topical and oral forms); still in FDA's category 2 withdrawn table | In favor, 8-6, 1 abstention [S] | Not named | Early-stage research: mouse colitis and cell studies |
| GHK-Cu | Cosmetic ingredient; no U.S. drug approval found | Category 1 on 503A, except injectable routes | Later agenda, before end of February 2027 | Not named | Small human skin studies; a phase 2 study is recruiting |
| Epitalon | No U.S. approval found | Covered by HHS's interim 503A policy, published Oct 30, 2026 (91 FR 68526), under ten conditions; still in FDA's category 2 withdrawn table | In favor, 7-4 or 7-5 by outlet [S] | Not named | Cell, monkey and small human biomarker studies |
| Selank | No U.S. approval found | Nomination withdrawn; listed on FDA's category 2 page | Not reviewed | Not named | One small Russian comparison with an active drug |
| Semax | Registered in Russia as nasal drops; no U.S. approval | Covered by HHS's interim 503A policy, published Oct 30, 2026 (91 FR 68526), under ten conditions (intranasal form); still in FDA's category 2 withdrawn table | In favor, 8-5, 1 abstention [S] | Not named | Rat studies and small Russian clinical work |
| Dihexa | No U.S. approval found | Nomination withdrawn; listed on FDA's category 2 page | Later agenda, before end of February 2027 | Not named | Early-stage research; FDA found no human exposure data |
| Tesamorelin | Yes, for one use (Egrifta, approved November 10, 2010) | Not on the category lists, as searched; it is the ingredient of an approved drug | Not reviewed | Named, S2.2.4 | Two phase 3 trials (806 adults randomized) plus later randomized trials |
Colour key (neutral facts, not grades):Approved or long human recordListed, favored, named or early human dataNeutral status factPending or later agenda
Each name links to our explainer for that peptide. Want to filter by status instead? The status lookup has search and filters.
The change log
Newest first. Each line is one dated event from the linked source. [V] means we read it in the primary document; [S] means it rests on press reports. Where a source gives a page date rather than an event date, the line says so.
October 2026
- Compounding BPC-157, TB-500, Epitalon, KPV, MOTS-c, SemaxHHS's interim 503A policy was published in the Federal Register (91 FR 68526). It says HHS won't take enforcement action against licensed pharmacies and physicians that compound these six under ten conditions, until a final rule decides each peptide's place on the 503A bulks list. It also opened a comment window that closes at 11:59 PM Eastern on November 13, 2026. Nomination withdrawn; on FDA's category 2 withdrawn table → Covered by HHS's interim 503A policyFederal Register, 91 FR 68526 (FR Doc. 2026-22192) [V]
- Compounding BPC-157, TB-500, Epitalon, KPV, MOTS-c, SemaxHHS's policy text naming the six peptides went on the Federal Register's public inspection desk, two days before formal publication.Federal Register public inspection, document 2026-22192 [V]
- Policy process All peptides in the policyThe White House regulatory office (OIRA) concluded its review of FDA's "Interim Access Policy for Compounding Using Certain Peptides" (RIN 0910-ZD94), recorded as consistent with change.OMB/OIRA, EO 12866 review record for RIN 0910-ZD94 [V]
- Policy process All peptides in the policyOIRA received FDA's interim peptide access policy for review.OMB/OIRA, EO 12866 review record for RIN 0910-ZD94 [V]
July 2026
- Advisory committee BPC-157, TB-500, Epitalon, KPV, MOTS-c, SemaxFDA's Pharmacy Compounding Advisory Committee met on these six. Press reports say it voted in favor of listing each one for compounding, often by narrow margins and sometimes over FDA staff recommendations. A committee vote is advice to FDA, not a decision. Not yet reviewed → Voted in favor (press-reported)FDA meeting page for July 23-24, 2026 (agenda) and AJMC report of the votes [S]
May 2026
- Compounding GHK-CuFDA updated its 503A bulk drug substance category list. The current version places GHK-Cu in category 1, except for injectable routes.FDA, 503A bulk drug substances category list, updated May 14, 2026 [V]
April 2026
- Compounding BPC-157, TB-500, CJC-1295, Ipamorelin, AOD-9604, MOTS-c, Thymosin alpha-1, KPV, Epitalon, Selank, Semax, DihexaFDA's category 2 page carries this as its current-as-of date. It lists these peptides in a table of nominations that their nominators withdrew. The page does not give a date for each withdrawal.FDA, category 2 page, content current as of April 22, 2026 [V]
- Advisory committee GHK-Cu, DihexaFDA posted an early announcement of a further compounding committee meeting "before the end of February 2027," with GHK-Cu and dihexa acetate among the substances named (with LL-37, melanotan II and PEG-MGF). Later agendaFDA, early announcement for the next Pharmacy Compounding Advisory Committee meeting [V]
January 2026
- WADA list BPC-157, TB-500, CJC-1295, Ipamorelin, Sermorelin, AOD-9604, MOTS-c, TesamorelinWADA's 2026 Prohibited List took effect. It names these peptides, each under a listed section, for athletes in tested sport.WADA, 2026 Prohibited List [V]
September 2023
- Compounding IpamorelinFDA added ipamorelin acetate to category 2 for 503B outsourcing facilities, the date shown in FDA's category 2 table.FDA, category 2 page (date added column) [V]
March 2013
- FDA approval SermorelinFDA determined, after a citizen petition, that the Geref (sermorelin) products were not withdrawn from sale for reasons of safety or effectiveness.Federal Register, 78 FR 14095 (FR Doc. 2013-04827) [V]
November 2010
- FDA approval TesamorelinFDA approved tesamorelin as Egrifta (NDA 22-505) to reduce excess abdominal fat in adults with HIV-related lipodystrophy. Approved for one useFDA, approval package for NDA 22-505 [V]
June 2009
- FDA approval SermorelinFDA's withdrawal of the two Geref approvals took effect, after the maker told FDA in 2008 that it was discontinuing both products. Approved (two products) → Formerly approvedFederal Register, 78 FR 14095 (FR Doc. 2013-04827) [V]
September 1997
- FDA approval SermorelinFDA approved the Geref version for children with idiopathic growth hormone deficiency.Federal Register, 78 FR 14095 (FR Doc. 2013-04827) [V]
December 1990
- FDA approval SermorelinFDA approved Geref (sermorelin acetate) for evaluating pituitary function.Federal Register, 78 FR 14095 (FR Doc. 2013-04827) [V]
Common questions
What counts as a change in this tracker?
A dated public action that moves a peptide's standing with FDA, HHS, the compounding advisory committee or WADA, such as an approval, a list update, a committee vote or a Federal Register policy. Each line links to the document it comes from. Source: FDA, 503A bulk drug substance categories
Which peptides did the October 30, 2026 Federal Register policy cover?
Six: BPC-157, TB-500, epitalon, KPV, MOTS-c and semax. HHS described it as an interim enforcement policy for 503A compounding while FDA finishes rulemaking on each substance. Source: Federal Register, 91 FR 68526
When does the public comment window close?
At 11:59 PM Eastern on November 13, 2026, on docket HHS-OASH-2026-0496. The docket record says late comments are not accepted. Source: Regulations.gov docket HHS-OASH-2026-0496
Why are some lines marked [S] instead of [V]?
[V] means we read the fact in the primary document. [S] means it rests on secondary reports, as with the July 2026 committee vote counts, which come from trade-press coverage of the meeting. Outlets sometimes differ by a vote, and we note that where it happens. Source: FDA, July 23-24, 2026 committee meeting page
Download and cite
Download the change log as a CSV file (15 entries) or the current status table. Every row carries its source link and label. To cite the tracker, name Peptide Policy Watch, give the date you read it and link to this page; each log line has its own anchor, so you can link to a single change.
See a line that no longer matches its source? Tell us through the corrections page. This page records what public documents said and when. It is not medical or legal advice, and the owner of this site is not a medical professional.