Peptide Legal-Status Tracker
In 2026 the FDA began reversing its 2023 peptide restrictions — but "coming back" is two separate legal tracks, most coverage confuses them, and almost nothing actually became compoundable. This tracker keeps the score, row by row, source by source.
| Peptide | Category 2 status | PCAC review (503A) | 503A compounding | RUO market |
|---|---|---|---|---|
| GHK-Cu Copper tripeptide | Category 1 (non-injectable routes only) Restored to Category 1 on 2026-05-14 after a nominator clarified it had meant to withdraw only the injectable nomination. Injectable routes are on no list. | Scheduled for the next advisory committee meeting; no date announced | Yes — non-injectable only, under interim enforcement discretion. The only one of the 19 that is. | Available |
| BPC-157 Body Protection Compound | Removed Off the Category 2 list effective 2026-04-23 | Reviewed 2026-07-23 Recommended for the 503A Bulks List, 8–6 (1 abstention) — nominated tied to an ulcerative colitis indication; FDA staff had recommended against | PCAC-recommended; FDA final action pending | Available |
| KPV Lysine-Proline-Valine tripeptide | Restoration announced Among the ~14 announced for return (Feb 2026); individual effective date pending FDA publication | Reviewed 2026-07-23 Recommended for the 503A Bulks List, 8–6 (1 abstention) | PCAC-recommended; FDA final action pending | Available |
| TB-500 Thymosin beta-4 fragment | Restoration announced Among the ~14 announced for return (Feb 2026); individual effective date pending FDA publication | Reviewed 2026-07-23 Recommended for the 503A Bulks List, 8–6 (1 abstention) | PCAC-recommended; FDA final action pending | Available |
| MOTS-c Mitochondrial-derived peptide | Restoration announced Among the ~14 announced for return (Feb 2026); individual effective date pending FDA publication | Reviewed 2026-07-23 Recommended for the 503A Bulks List, 7–5 (2 abstentions) | PCAC-recommended; FDA final action pending | Available |
| Emideltide (DSIP) Delta sleep-inducing peptide | Restoration announced Among the ~14 announced for return (Feb 2026); individual effective date pending FDA publication | Reviewed 2026-07-24 VOTED AGAINST adding to the 503A Bulks List | No — PCAC voted against (FDA final action pending) | Available |
| Semax ACTH(4-10) analog | Restoration announced Among the ~14 announced for return (Feb 2026); individual effective date pending FDA publication | Reviewed 2026-07-24 Recommended for the 503A Bulks List (narrow margin) | PCAC-recommended; FDA final action pending | Available |
| Epitalon Epithalamin tetrapeptide | Restoration announced Among the ~14 announced for return (Feb 2026); individual effective date pending FDA publication | Reviewed 2026-07-24 Recommended for the 503A Bulks List (narrow margin) | PCAC-recommended; FDA final action pending | Available |
| Five additional peptides Names pending PCAC agenda publication | Varies Scheduled for a PCAC meeting before end of February 2027 | Scheduled before 2027-02-28 | Pending | — |
| ~5 peptides staying restricted Names pending FDA formal list | Remaining on Category 2 The announced restoration covers ~14 of 19; the remainder stay restricted | Not scheduled | No | — |
Every row updates the day primary documents drop, and status here reflects FDA's 503A category list of 14 May 2026 rather than press reporting. Sources per row are in the dataset; key ones: Pharmacy Times · AJMC · Holt Law · Holland & Knight (PCAC outcome)
The timeline so far#
- 2023 — FDA places 19 peptides on the Category 2 list, halting most pharmacy compounding.
- Feb 27, 2026 — HHS announces ~14 of the 19 will move back toward accessible status.
- Apr 2026 — 12 peptides including BPC-157 come off Category 2, because the nominators withdrew their nominations rather than because FDA reassessed safety. They move to no list at all, which carries no enforcement discretion.
- May 14, 2026 — FDA publishes its updated 503A category list, confirming the 12 appear in no category. GHK-Cu is restored to Category 1 for non-injectable routes.
- Jul 23–24, 2026 — PCAC votes to recommend six of seven peptides for the 503A Bulks List (BPC-157 8–6; MOTS-c 7–5), over FDA staff recommendations against; DSIP/Emideltide is voted down. Advisory only — the FDA's final call is pending.
- By Feb 2027 — five more peptides scheduled for PCAC review.
- Pending — a proposed rule. Adding anything to the binding bulks list takes notice-and-comment rulemaking, and none has published. When one does, every row above gets re-verified against it the same day.
News & moves#
PCAC voted to recommend BPC-157, KPV, TB-500, MOTS-c, Semax, and Epitalon for the 503A Bulks List on narrow margins (BPC-157 8–6); DSIP was voted down. FDA staff had recommended against inclusion, and the committee is advisory — the FDA's final call is still pending.
Our Legal-Status Tracker, updated →The most-watched peptide of the reclassification clears its first regulatory hurdle. Category 2 removal is separate from 503A compounding eligibility — two different tracks.
The two-track explainer →The reversal of the 2023 restrictions began here. The FDA's formal updated list remains unpublished; every row of our tracker updates the day it drops.
The Legal-Status Tracker →All tracked news → · Subscribe to this beat (RSS) · Fed by a daily automated scan; entries publish only after primary-source verification.
Go deeper#
Why we cover this market at all#
Millions of people already buy these compounds in the RUO gray market with Reddit threads as their only guide. We think plain-language legal status, honest risk framing, and named sources beat pretending the market doesn't exist. Our line: we report on this market, we never sell into it — no affiliate links to RUO vendors, ever, per our editorial policy.
Nothing here is medical or legal advice. Compounded peptides are not FDA-approved drugs; RUO compounds are not approved for human use. Coming next in this hub: what "research use only" legally means, how the 503A pathway works, and how to read a certificate of analysis.