How to read this table
Four independent questions, four columns. Collapsing them is where nearly every wrong answer about peptide legality comes from.
Legal path. FDA-approved means a real prescription medicine with guaranteed identity, dose and sterility. Investigational means it is in trials and not approved anywhere. Not FDA-approved is the largest group, and it includes several compounds that are approved in other countries — which is not the same thing, and is filed separately here for exactly that reason.
503A compounding. Section 503A covers patient-specific compounding by a pharmacy against an individual prescription; section 503B covers outsourcing facilities compounding from bulk. Each keeps its own list. On the 503A interim list, Category 1 means under evaluation with no significant safety concerns identified, and compounding is generally permitted under enforcement discretion. Category 2 means significant safety concerns — not permitted. Category 3 means the nomination lacked enough information to evaluate.
Limbo is not an FDA term. It is this tracker's label for the twelve peptides removed from Category 2 in April 2026 whose nominations had been withdrawn. They were not cleared and they were not moved to Category 1. They are off the do-not-compound list and still not lawful to compound — a state the category system has no name for, which is precisely why it gets misreported as approval.
PCAC review. The Pharmacy Compounding Advisory Committee advises FDA on whether a substance belongs on the 503A Bulks List. It sits on July 23–24, 2026 for the first seven. A recommendation is non-binding, and even a favourable vote must clear notice-and-comment rulemaking that can run past a year. When the committee last looked at peptides in 2024 it recommended against all of them.
WADA 2026. The section of the 2026 WADA Prohibited List that captures the compound. A code in red means the substance is named in the List by name — we read the List to check, rather than repeating what other sites say. A code in amber with a question mark means it is not named and the S0 catch-all is being applied by inference. That distinction is ours, not WADA's, and it exists because the inference is not always safe: S0 only captures substances with no current approval by any governmental health authority, so for a compound registered in Russia or Japan the catch-all may not apply at all. If you are tested, Global DRO and your anti-doping organisation are the answer, not this page.
One asymmetry worth internalising: non-approval can pull a substance onto the WADA list, but approval never pulls one off. Somatropin, tesamorelin, leuprolide, mecasermin and hCG are all FDA-approved and all prohibited at all times. A PCAC vote in July changes nothing about anti-doping status.
The GLP-1 situation, stated accurately
Most coverage says FDA moved to “remove” or “exclude” semaglutide, tirzepatide and liraglutide from the 503B bulks list. That is not what happened, and the error matters.
Those three were never on the 503B Bulks List. They were nominated for it. On May 1, 2026, FDA published a notice — not a final rule — setting out its proposal not to include them, having found no clinical need for outsourcing facilities to compound them from bulk when approved products are available (91 FR 23431, Docket FDA-2018-N-3240). Nothing was delisted, because nothing was listed.
The practical difference is that a proposal is still open. FDA's original comment window closed June 30. After a request for more time, the agency extended it by thirty days, and comments now close July 30, 2026 (91 FR 38719, published June 26). FDA specifically asked that comments address the clinical-need standard in the statute. Trackers still showing a June deadline — including this one until today — are wrong about a window that is currently open.
What has not changed: 503A patient-specific compounding can still occur where a prescriber documents a specific clinical need for an individual patient, within FDA's “essentially a copy” limits. The shortage pathway, which is what actually enabled mass compounding from 2022, closed when FDA declared the semaglutide shortage resolved in February 2025. The direction of travel is toward the approved products.
Change log
What moved, and when. Newest first.
| Date | Change |
|---|---|
| 2026-07-16 | Tracker rebuilt as a per-compound table with per-row review dates. WADA column added, verified line by line against the 2026 Prohibited List. Corrected the GLP-1 503B framing from “excluded from” to “proposed not to include”. |
| 2026-06-26 | FDA extended the 503B GLP-1 comment period by 30 days, to July 30, 2026 (91 FR 38719). The previous version of this tracker still showed the original June deadline. |
| 2026-06-29 | FDA released briefing documents for all seven PCAC peptides. Staff propose adding none of them. |
| 2026-05-01 | FDA published its proposal not to include semaglutide, tirzepatide or liraglutide on the 503B Bulks List (91 FR 23431, Docket FDA-2018-N-3240). |
| 2026-04-30 | FDA announced the 503B GLP-1 proposal. |
| 2026-04-22 | Twelve peptides formally removed from 503A Category 2 (effective date). |
| 2026-04-15 | FDA announced the Category 2 removals and scheduled PCAC for July 23-24, 2026. |
| 2026-04-01 | Orforglipron (Foundayo) approved by FDA. |
| 2025-02 | FDA declared the semaglutide shortage resolved, beginning the close of GLP-1 compounding. |
| 2023 | FDA placed 19 peptides into 503A Category 2. |
Spot something out of date? This is a living document — email editors@greypeptides.com and we'll verify and update.
Frequently asked questions
Which peptides are FDA approved in 2026?
Approved peptide medicines include semaglutide (Ozempic, Wegovy, Rybelsus), tirzepatide (Mounjaro, Zepbound), liraglutide (Victoza, Saxenda), dulaglutide (Trulicity), exenatide, somatropin, teriparatide, octreotide, leuprolide, tesamorelin (Egrifta), mecasermin (Increlex) and bremelanotide (Vyleesi). Orforglipron (Foundayo, approved April 2026) is a GLP-1 agonist but a small molecule, not a peptide. BPC-157, TB-500, MOTS-c, KPV, semax, epitalon and DSIP are not approved by FDA and are not currently lawful to compound.
Is BPC-157 legal in 2026?
It is not FDA approved and has no USP monograph. In April 2026 it was removed from the 503A Category 2 list because the nomination was withdrawn — not because FDA cleared it — and it was not moved to Category 1, so it is neither flagged nor permitted. FDA's Pharmacy Compounding Advisory Committee reviews it on July 23, 2026, and FDA staff have already proposed not adding it. Separately, BPC-157 is named by name on the 2026 WADA Prohibited List under S0, so it is prohibited at all times for tested athletes.
Did the FDA remove GLP-1s from the 503B bulks list?
No, and this is the most common error in coverage of it. Semaglutide, tirzepatide and liraglutide were never on the 503B Bulks List. They were nominated for it, and on May 1, 2026 FDA published its proposal not to include them, finding no clinical need. Nothing was delisted. The distinction matters because a proposal not to include is still open to comment — through July 30, 2026, under Docket FDA-2018-N-3240.
Does removal from Category 2 mean a peptide is legal to compound now?
No. Removal from Category 2 only lifts the significant-safety-concerns designation. It does not place a substance on the Category 1 list and does not authorise compounding. The twelve peptides removed in April 2026 sit in between: no longer formally flagged, and not permitted either. Reaching the 503A Bulks List requires PCAC review and formal rulemaking, which can take more than a year.
Does a peptide's FDA status affect whether it is banned in sport?
Only in one direction, and not the one people assume. WADA's S0 category captures any substance with no current approval by any governmental regulatory health authority, so non-approval can pull a substance onto the list. But approval never pulls one off: somatropin, tesamorelin, leuprolide, mecasermin and hCG are all FDA-approved and all prohibited. The two regimes are unrelated, and a PCAC vote in July would change nothing about anti-doping status.
Related on Grey Peptides
From the News Wire
Seven peptides, one committee, zero staff endorsements → FDA pulls 12 peptides off its "do not compound" list → The FDA just proposed ending mass GLP-1 compounding →Get regulatory updates
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Sources
Primary documents only. Every WADA cell traces to the 2026 Prohibited List itself; every docket number to the Federal Register notice that carries it. Status reflects each row's own review date and can change.
- World Anti-Doping Agency — International Standard: Prohibited List 2026, valid 1 January 2026. Read in full; every WADA cell on this page traces to it.
View source ↗ - Federal Register — List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B, 91 FR 23431 (May 1, 2026), Docket FDA-2018-N-3240.
View source ↗ - Federal Register — the same notice, Extension of Comment Period, 91 FR 38719 (June 26, 2026). This is the document that moved the deadline to July 30.
View source ↗ - Regulations.gov — Docket FDA-2025-N-6895, the July 2026 PCAC docket, including the seven briefing documents released June 29, 2026.
View source ↗ - FDA — Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A; 503A interim bulks list (Categories 1-3), updated April 15, 2026.
View source ↗
Educational only — not legal or medical advice. An advisory-committee recommendation is not a rule, and nothing here describes how to obtain or use any substance. Compounding rules vary by state and by substance. Regulatory status changes frequently; verify against primary sources and a qualified professional before relying on it.