The Tracker

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 the official list still hasn't published. This tracker keeps the score, row by row, source by source.

As of 2026-09-06 · official FDA list: NOT yet published — all rows are announced/interim · journalism, not endorsement · no vendor links, ever

The two tracks, in one breath: Getting off the FDA's Category 2 restricted list is step one. Being affirmatively cleared for 503A pharmacy compounding (the PCAC review) is step two — and votes can come tied to narrow medical indications. Neither step makes a peptide an FDA-approved drug. The research-use-only (RUO) market is a third lane entirely: legal to sell for lab research, never approved for human use.

Peptide	Category 2 status	PCAC review (503A)	503A compounding	RUO market
BPC-157 Body Protection Compound	Removed Off the Category 2 list effective 2026-04-23	Reviewed 2026-07-23 Voted 8–6 to recommend Category 1 — tied to a proposed ulcerative colitis indication, not general use	Pending FDA final action; narrow indication likely	Available
KPV Lysine-Proline-Valine tripeptide	Restoration announced Among the ~14 announced for return (Feb 2026); individual effective date unconfirmed	Reviewed 2026-07-23 Reviewed; vote outcome pending formal publication	Pending	Available
TB-500 Thymosin beta-4 fragment	Restoration announced Among the ~14 announced for return (Feb 2026); individual effective date unconfirmed	Reviewed 2026-07-23 Reviewed; vote outcome pending formal publication	Pending	Available
MOTS-c Mitochondrial-derived peptide	Restoration announced Among the ~14 announced for return (Feb 2026); individual effective date unconfirmed	Reviewed 2026-07-23 Reviewed; vote outcome pending formal publication	Pending	Available
DSIP (Emideltile) Delta sleep-inducing peptide	Restoration announced Among the ~14 announced for return (Feb 2026); individual effective date unconfirmed	Reviewed 2026-07-24 Reviewed; vote outcome pending formal publication	Pending	Available
Semax ACTH(4-10) analog	Restoration announced Among the ~14 announced for return (Feb 2026); individual effective date unconfirmed	Reviewed 2026-07-24 Reviewed; vote outcome pending formal publication	Pending	Available
Epitalon Epithalamin tetrapeptide	Restoration announced Among the ~14 announced for return (Feb 2026); individual effective date unconfirmed	Reviewed 2026-07-24 Reviewed; vote outcome pending formal publication	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	—

Confidence labels: rows marked "announcement-level" rest on the Feb 2026 HHS announcement and reporting, not a published FDA list. Every row updates the day primary documents drop. Sources per row are in the dataset; key ones: Pharmacy Times · AJMC · Holt Law

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 23, 2026 — BPC-157 comes off Category 2 (per legal/industry reporting).
Jul 23–24, 2026 — PCAC reviews seven peptides for 503A eligibility; BPC-157 gets a narrow 8–6 vote tied to an ulcerative colitis indication.
By Feb 2027 — five more peptides scheduled for PCAC review.
Pending — the FDA's formal updated list. When it publishes, every row above gets re-verified against it the same day.

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.