Regulation
Peptide Regulatory Tracker
The US regulatory actions that affect peptide compounding and sales, with the status shown in each primary record. Last checked 2026-11-04.
How to read this tracker
“Pending review” means a document is being reviewed. “Review concluded” means OIRA has finished; the agency still has to publish before anything takes effect. Neither is approval. We list an effective date only when a published document states one. Nothing on this page is legal advice. For the published HHS peptide compounding policy, see HHS’s Peptide Compounding Policy: The 6 Peptides Covered and the 10 Conditions.
| Item | Status | Effective date | Source & check |
|---|---|---|---|
| HHS “Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances” (RIN 0910-ZD94) HHS, Office of the Secretary · US federal: 503A compounding only | Published, in force as enforcement policy Issued 28 Oct 2026; Federal Register notice of availability 30 Oct 2026 (FR Doc. 2026-22192, 91 FR 68526). Covers BPC-157 acetate (SC, IM, oral, topical), TB-500 acetate (SC/IM), epitalon acetate (SC/IM, intermittent courses), semax free base (intranasal), KPV acetate (topical, oral), MOTS-c acetate (SC/IM). HHS does not intend to act against state-licensed pharmacies, federal facilities and licensed physicians if all 10 conditions are met (single API, FDA-registered CGMP manufacturer named on COA, testing standard, MedWatch reporting, label statement, 510(k) syringe only, prescription). Not approval; not on the bulks list; not binding; may be revisited. Notice calls the document a draft. Emideltide not included. Explainer: HHS policy explained. | Issued 28 Oct 2026 (no separate effective date stated) | Federal Register 2026-22192 HHS policy PDF Checked 2026-11-04 Updated 2026-11-04: published 30 Oct (OIRA review had concluded 27 Oct, Consistent with Change) |
| Public comments on the HHS peptide policy (docket HHS-OASH-2026-0496) HHS / regulations.gov · US federal | Open until 13 Nov 2026 Written comments accepted for two weeks after Federal Register publication (law firms put the deadline at 13 Nov 2026). HHS says its website will carry the most current version of the policy. | — | Docket Foley & Lardner Checked 2026-11-04 Added 2026-11-04 |
| 503A category 2: 17 peptides listed as “nominated but withdrawn” FDA · US federal: 503A interim bulks policy | In effect (page update) AOD-9604, BPC-157, LL-37, CJC-1295, dihexa, emideltide (DSIP), epitalon, GHK-Cu (injectable), ipamorelin, KPV, PEG-MGF, melanotan II, MOTs-C, selank, semax, thymosin alpha-1 and TB-500 are listed under “nominated but withdrawn”. FDA’s safety statements remain on the page. This does not mean category 1 or bulks-list status. | Page content current as of 22 Apr 2026 | FDA category 2 page Checked 2026-11-04 Rechecked 2026-11-04, no change since 22 Apr 2026 |
| Pharmacy Compounding Advisory Committee: peptides for the 503A bulks list FDA PCAC · US federal: advisory only | Votes acted on via HHS policy; no rule proposed Met 23–24 Jul 2026 (Docket FDA-2025-N-6895) on BPC-157, KPV, TB-500, MOTs-c, emideltide, semax and epitalon-related substances. Committee votes are advice to FDA and do not amend the list. HHS cited the votes in its 28 Oct 2026 enforcement policy for six peptides; emideltide (voted down) excluded. Holland & Knight reported a second meeting on GHK-Cu, LL-37, dihexa, melanotan II and PEG-MGF expected before end Feb 2027, no date set. | — | Federal Register notice FDA briefing Checked 2026-11-04 Updated 2026-11-04 |
| 503A bulks list (rulemaking) FDA · US federal: 503A compounding | No peptide additions proposed Final rule Feb 2019; proposed amendments Sep 2019. Substances nominated on or after 7 Jan 2025 are not placed in the interim categories. No proposed rule adding the peptides above found. | — | FDA 503A page Checked 2026-11-04 Rechecked 2026-11-04; HHS policy does not amend the list |
| FDA warning letters to online peptide sellers (Aug 2026 wave) FDA · US federal: unapproved new drugs / misbranding | Issued Letters (e.g. 735127, 734884) treated RUO disclaimers as not controlling and quoted “studied for” copy, calculators and bacteriostatic water bundles as evidence of intended use. | Issued 24 Aug 2026 | FDA warning letters Checked 2026-11-04 Letter 733652 re-read 2026-11-04; no newer peptide wave found in a news search |
Scope
This tracker covers US federal actions (FDA, OIRA, Federal Register). State pharmacy-board rules and non-US regulators are not tracked here yet. Advertising-platform policies (Google, Microsoft) are covered in our Knowledge Base. A platform policy does not change because of an FDA review.