Peptide Policy Watch

Where peptide regulation stands right now: a plain-English timeline

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The entrance of the Hubert H. Humphrey Building in Washington, D.C., with pale stone walls carved with the department's name, glass doors and a trimmed shrub in a large planter.
Entrance of the Hubert H. Humphrey Building, Washington, D.C., headquarters of HHS. Photo: G. Edward Johnson, CC BY 4.0. Image credits

Not medical advice, and the site owner isn't a medical professional. Facts are as of October 25, 2026, and sources with retrieval dates are at the bottom.

Key facts (from the sources below)

  • A recommendation from an FDA advisory committee is not a rule. As of October 25, 2026, we found no FDA final action adding any of the peptides discussed in this post to the 503A bulks list.
  • FDA's briefing document for the July 23–24, 2026 advisory committee meeting says FDA was proposing that none of the seven peptides be included on the 503A bulks list.
  • [S] AJMC reported (July 31, 2026) that the committee recommended six of the seven peptides. This is not confirmed in an FDA document we read.
  • OMB's record shows a received date of 10/14/2026 for an HHS/FDA item titled "Interim Access Policy for Compounding Using Certain Peptides". We have not found its text.
  • FDA's Category 2 page (current as of April 22, 2026) has a section for substances "nominated but withdrawn". That is a list move. It is not a safety clearance or an approval.
  • FDA proposed on April 30, 2026 to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list. The 503B proposal is not final.
  • FDA's advisory committee page says FDA is planning another Pharmacy Compounding Advisory Committee meeting for February 2027 or earlier, and five substances on the agenda: GHK-Cu, PEG-MGF, melanotan II, LL-37 and dihexa acetate. The date is not set.

[S] = reported by a secondary source and not confirmed in a primary document we read.

What this means in plain English

  • A vote is not a rule. FDA's own staff proposed against all seven peptides, and the committee's recommendations are non-binding.
  • Off Category 2 is not "allowed." Leaving Category 2 removes a safety-risk label. It does not add approval.
  • GLP-1 compounding is being narrowed, but the 503B proposal is not final.
  • We have not found the text of the interim policy, so what it would do is unconfirmed.

Updated October 25, 2026. We corrected two items after re-checking primary records. (1) The White House review of the interim peptide policy: the Office of Management and Budget (OMB) record shows it was received on October 14, 2026, not October 15 (October 15 is the date of the AP and CNBC reports). (2) FDA's page for the next advisory committee meeting lists five substances (GHK-Cu, PEG-MGF, melanotan II, LL-37 and dihexa acetate), not GHK-Cu alone. We also clarified that Dr. Makary was FDA Commissioner when he made the February statement. See our corrections page.

Seen a headline lately saying peptide rules are about to change, and wondered which parts are real? Rules really are shifting quickly, and online summaries often mix official actions with rumor. So this timeline sorts them. For each item, we say what an official document shows. Where we only have a news report, we say who reported it and that we couldn't confirm it in an FDA primary document.

At a glance

The gist

  • A recommendation from an FDA advisory committee is not a rule. As of October 25, 2026, we found no FDA final action adding any of the peptides discussed below to the 503A bulks list.
  • Two separate FDA tracks are moving in different directions: more openness on some peptides, and tighter limits on compounded GLP-1 drugs.
  • A new FDA peptide policy is under White House review (OMB received it on October 14, 2026). We have not found its text.

Timeline at a glance

  1. February 6, 2026

    FDA statement on compounded GLP-1s. It states an intent to restrict GLP-1 active ingredients. It is not a final rule.

    FDA document
  2. April 2026

    Many peptides come off the Category 2 list. FDA's Category 2 page is current as of April 22, 2026. A list move, not a safety clearance or an approval.

    FDA document
  3. April 30, 2026

    FDA is proposing to keep semaglutide, tirzepatide and liraglutide off the 503B list. Comments extended to July 30, 2026.

    FDA document
  4. May 14, 2026

    FDA updates its 503A category list. GHK-Cu (except injectable routes) is added back to Category 1.

    FDA document
  5. July 23–24, 2026

    Advisory committee reviews seven peptides. FDA's briefing document says FDA was proposing that none of them be included on the 503A bulks list.

    FDA document
  6. July 31, 2026

    AJMC reports the committee recommended six of the seven peptides and rejected emideltide.

    Reported, not confirmed
  7. October 14, 2026

    OMB's record shows an "Interim Access Policy for Compounding Using Certain Peptides" received for review. We have not found its text.

    Government record
  8. February 2027 or earlier

    Next Pharmacy Compounding Advisory Committee meeting, per FDA's page. Five substances are listed. The date is not set.

    Pending
Source: the dated entries in this post, retrieved October 25, 2026. Full source list at the bottom of this page.

Timeline

February 6, 2026: FDA statement on compounded GLP-1s. then-FDA Commissioner Martin Makary (FDA's page lists his term as April 2025 to May 2026) said FDA intends to restrict GLP-1 active ingredients used in compounded drugs without FDA approval that are mass-marketed as alternatives to approved drugs. The statement names Hims & Hers and "other compounding pharmacies," and says companies cannot claim compounded products are generic versions of, or the same as, FDA-approved drugs (FDA, Feb. 6, 2026). It states an intent. It is not a final rule.

April 2026: many peptides come off the Category 2 list. FDA's Category 2 page (current as of April 22, 2026) now has a section for substances "nominated but withdrawn," meaning the nominators withdrew them. It includes BPC-157, KPV, TB-500, MOTS-c, CJC-1295 and others (FDA Category 2 page). The law firm Orrick reported that FDA removed 12 peptides from Category 2 and scheduled advisory committee meetings (Orrick). The count of 12 is reported by Orrick, not confirmed in an FDA primary document. The change is a list move. It is not a safety clearance or an approval. Our Category 1 and 2 explainer covers the difference.

April 30, 2026: FDA proposes to exclude three GLP-1 drugs from the 503B list. FDA announced it is proposing to leave semaglutide, tirzepatide and liraglutide off the 503B bulks list, finding "no clinical need" for outsourcing facilities to compound them from bulk substances (FDA press release). The Federal Register notice (91 FR 23431, published May 1) set a comment deadline of June 30, 2026 (Federal Register). FDA's press release said June 29, so we use the Federal Register date. On June 26, FDA extended comments to July 30, 2026 (91 FR 38719) (Federal Register). FDA said it will consider comments before a final determination. A Federal Register search on October 25 found no final determination.

May 14, 2026: FDA updates its 503A category list. FDA added GHK-Cu (except injectable routes) back to Category 1 after a nominator clarified it withdrew only the injectable route. FDA also said it intends to consult its advisory committee on GHK-Cu before the end of February 2027 (FDA category list, PDF). FDA's page for that meeting now lists five substances on the agenda (see "Next advisory committee" below). Our GHK-Cu explainer covers what the carve-out means.

July 23–24, 2026: advisory committee reviews seven peptides. FDA's Pharmacy Compounding Advisory Committee (PCAC) discussed BPC-157, KPV, TB-500, MOTS-c, emideltide, epitalon and semax. FDA's briefing document laid out a proposal to keep all seven off the 503A bulks list (FDA briefing document). FDA states that advisory committees "make non-binding recommendations" (FDA).

The votes (reported, not confirmed in an FDA document we read). AJMC reported that the committee recommended six of the seven, overriding FDA staff, and rejected emideltide. It reported 8–6 with one abstention for BPC-157, KPV and TB-500, and 7–5 with two abstentions for MOTS-c (AJMC, July 31, 2026). Outlets disagree on the day-two tallies, so we do not repeat them. AJMC also reported that FDA has not yet decided whether to adopt the recommendations, and that proposed and final rules would both have to be finished before pharmacies could lawfully compound the substances.

The reported committee votes, July 2026

Reported, not confirmed in an FDA document we read

For Against Abstained (numbers as reported)

  • BPC-157861
  • KPV861
  • TB-500861
  • MOTS-c752

AJMC also reported that the committee rejected emideltide. FDA's briefing document proposed that none of the seven peptides be included on the 503A bulks list.

Outlets disagree on the day-two tallies, so we do not repeat them.

Source: AJMC, July 31, 2026 (secondary). Not confirmed in an FDA document we read. Advisory committees "make non-binding recommendations" (FDA).

October 14–15, 2026: an "interim access policy" goes to the White House for review. OMB's regulatory review page lists an HHS/FDA item titled "Interim Access Policy for Compounding Using Certain Peptides" (RIN 0910-ZD94, stage: Notice, not economically significant, no legal deadline) with a received date of 10/14/2026 (OMB record). A separate OMB meeting record lists a meeting on this item on October 23, 2026, requested by Hims & Hers Health (OMB meeting record). AP and CNBC reported the plan on October 15 (AP; CNBC). A trade site says its text is not public (Amino Wire). We have not found an FDA or HHS document with the policy text, so what the policy says, and when it might issue, is reported, not confirmed in an FDA primary document.

Next advisory committee (date not set). FDA's advisory committee page says a Pharmacy Compounding Advisory Committee meeting is planned for February 2027 or earlier. The agenda names five candidates for the 503A bulks list: GHK-Cu, PEG-MGF, melanotan II, LL-37 and dihexa acetate. The time and location were not yet scheduled, and FDA said a Federal Register notice would follow (FDA, page current as of 04/15/2026). A Federal Register search on October 25 found no such notice.

What it means

What this means in plain words

  1. A vote is not a rule. FDA's own staff proposed against all seven peptides, and the committee's recommendations are non-binding.
  2. Off Category 2 is not "allowed." Category 2 flags significant safety risks. Leaving it removes that label. It does not add approval.
  3. GLP-1 compounding is being narrowed. Both the February statement and the April proposal point that way, but the 503B proposal is not final.
  4. Watch for: the interim policy text, any FDA notice responding to the committee, a final 503B determination, and the date of the next advisory committee meeting, which FDA said it would hold in February 2027 or sooner, on GHK-Cu, PEG-MGF, melanotan II, LL-37 and dihexa acetate.

For the history of the approved medicines behind the GLP-1 shortage decisions, see our timeline from insulin to GLP-1 drugs.

Sources (all retrieved October 25, 2026)

  1. FDA, "FDA Intends to Take Action Against Non-FDA-Approved GLP-1 Drugs," Feb. 6, 2026 — https://www.fda.gov/news-events/press-announcements/fda-intends-take-action-against-non-fda-approved-glp-1-drugs
  2. FDA, Category 2 page, content current as of 04/22/2026 — https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
  3. Orrick (secondary), April 2026 — https://www.orrick.com/en/Insights/2026/04/FDA-Announces-Removal-of-12-Peptides-from-Category-2-and-Schedules-PCAC-Meetings
  4. FDA press release, Apr. 30, 2026 — https://www.fda.gov/news-events/press-announcements/fda-proposes-exclude-semaglutide-tirzepatide-and-liraglutide-503b-bulks-list
  5. Federal Register 2026-08552, 91 FR 23431 — https://www.federalregister.gov/documents/2026/05/01/2026-08552/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal
  6. Federal Register 2026-12937, 91 FR 38719 — https://www.federalregister.gov/documents/2026/06/26/2026-12937/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal
  7. FDA, 503A category list (PDF), updated May 14, 2026 — https://www.fda.gov/media/94155/download
  8. FDA, PCAC briefing document, July 23–24, 2026 — https://www.fda.gov/media/193342/download
  9. FDA, PCAC meeting page — https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026
  10. AJMC (secondary), July 31, 2026 — https://www.ajmc.com/view/fda-panel-backs-6-peptides-for-compounding
  11. AP (secondary; headline and opening paragraphs only) — https://apnews.com/article/peptides-kennedy-drugs-trump-bpc157-fb12641dfe791f443f7b7d1eb3bd4a0a
  12. CNBC (secondary; headline and search excerpt only), Oct. 15, 2026 — https://www.cnbc.com/2026/10/15/peptides-trump-rfk-jr-maha.html
  13. Amino Wire (secondary; trade site) — https://aminowire.news/regulation/peptide-interim-access-policy/
  14. OMB/OIRA, Pending EO 12866 Regulatory Review, RIN 0910-ZD94, received 10/14/2026 — https://www.reginfo.gov/public/do/eoDetails?rrid=1568964
  15. OMB/OIRA, EO 12866 meeting record, Oct. 23, 2026 — https://www.reginfo.gov/public/do/viewEO12866Meeting?meetingId=1588573&viewRule=true
  16. FDA, Meeting of the Pharmacy Compounding Advisory Committee (upcoming; agenda of five substances), content current as of 04/15/2026 — https://www.fda.gov/advisory-committees/pharmacy-compounding-advisory-committee/meeting-pharmacy-compounding-advisory-committee

Spot a mistake? See how we source and our corrections policy.