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 It is this tracker's label for the twelve peptides removed from Category 2 in April 2026 whose nominations had been withdrawn.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 met on July 23–24, 2026 for the first seven and recommended 6 of them, overruling FDA staff (result above). 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; each row's detail says what the 2027 List does. A code in red means the List's own text captures the substance — by name in every red row but PEG-MGF, which is caught as a form of a class the List names — and 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, and for one FDA has approved it cannot apply. If you are tested, Global DRO and your anti-doping organisation are the answer, not this page.
The 2027 List. WADA's Executive Committee approved it on September 10, 2026; it was published on September 21 and takes effect on January 1, 2027. We read it in full and compared it with the 2026 List section by section. No compound on this page changes section. The one change that touches peptides is in S0, which now lists “peptides” among its examples of non-approved substances, next to drugs in development and designer drugs; WADA's explanatory note says it made the change for clarity, and that a peptide not named on the List may still be prohibited. It names no additional peptide. GLP-1 agonists stay off the List, and semaglutide and tirzepatide stay on the Monitoring Program.
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 not a decision. FDA's original comment window was due to close June 30; after a request for more time the agency extended it by thirty days, and comments closed July 30, 2026 (91 FR 38719, published June 26). FDA had asked that comments address the clinical-need standard in the statute. As of September 25, 2026 it had not published a final determination: the newest FDA document in the docket is still the June 26 extension.
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 |
|---|---|
| 2026-09-27 | 503A category re-read for GHRP-6 and GHRP-2 (pralmorelin) against FDA's category list (updated May 14, 2026): both are in Category 3, nominated without adequate support, which this table had shown as no category. Either way no pharmacy can compound them. Only this field was re-read, so the rows' review dates are unchanged. |
| 2026-09-27 | WADA column re-read for all 44 rows against the 2026 List and the 2027 List (approved September 10, published September 21, in force January 1, 2027), and it now renders from the wadaStatus field of our public encyclopedia dataset. Corrected: SS-31 (elamipretide) showed S0? although FDA approved it in September 2025; S0 cannot apply to an approved substance and no other section names it, so it is on neither List. PEG-MGF is no longer counted as named: the List names mechano growth factors, and PEG-MGF is caught as a pegylated one. No row changes section in 2027; the one peptide change is that S0 now lists peptides among its examples. Only the WADA fields were re-read, so row review dates are unchanged. |
| 2026-09-27 | AOD-9604's 503A note re-read against FDA's category list (updated May 14, 2026) and its Category 2 page (current as of April 22, 2026): it was in 503A Category 2 until its nominators withdrew it, and the list now names it in no category, so 503A pharmacies cannot compound it; FDA cites immunogenicity risk and serious adverse events of unclear cause. The note had said only that its trials failed. Only this field was re-read, so the row's review date is unchanged. |
| 2026-09-26 | 503A and 503B fields re-read against FDA's own lists: the 503A category list (updated May 14, 2026) and the Category 2 safety-risks page (current as of April 22, 2026). Corrected: CJC-1295, ipamorelin and thymosin α-1 were shown in 503A Category 2, but their nominations were withdrawn and the list names them in no category, so 503A pharmacies still cannot compound them. MK-677 (ibutamoren) is in Category 2 for 503A and 503B, which this table had missed. Ipamorelin, GHRP-6 and pralmorelin (GHRP-2) are in 503B Category 2. Non-injectable GHK-Cu is back in Category 1. Only these fields were re-read, so row review dates are unchanged. |
| 2026-09-25 | The 503B GLP-1 comment period closed July 30. As of September 25, FDA has not published a final determination: the newest FDA document in docket FDA-2018-N-3240 is still the June 26 extension. The semaglutide, tirzepatide and liraglutide 503B notes now say so, dated; their review dates were not moved, because only that field was re-read. |
| 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 reviewed it on July 23, 2026 and recommended adding it to the 503A list (8–6, 1 abstention), against FDA staff's proposal; as of September 25, 2026 FDA had not acted on the vote. Separately, BPC-157 is named on the 2026 WADA Prohibited List under S0, and on the 2027 List too, 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 is not a decision: comments closed July 30, 2026 under Docket FDA-2018-N-3240, and as of September 25, 2026 FDA had not published its final determination.
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.
Did the 2027 WADA Prohibited List change anything for peptides?
One thing. The 2027 List, published September 21, 2026 and in force January 1, 2027, adds the word “peptides” to S0's examples of non-approved substances, which makes explicit what the catch-all already covered. It names no new peptide and moves none of the compounds in this table to a different section: BPC-157 stays named in S0, TB-500 in S2.3, MOTS-c in S4.4.1 and the growth hormone secretagogues in S2.2.4. GLP-1 agonists stay off the List, and semaglutide and tirzepatide stay on WADA's Monitoring Program, which tracks substances that are not prohibited.
Related on Grey Peptides
From the News Wire
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Sources
Primary documents only. Every WADA cell traces to the 2026 and 2027 Prohibited Lists themselves; 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 on July 16 and again on September 27, 2026; every WADA cell on this page traces to it.
View source ↗ - World Anti-Doping Agency — International Standard: Prohibited List 2027, approved by WADA's Executive Committee on September 10, 2026, published September 21, 2026, in force January 1, 2027. Read in full on September 27, 2026 and compared with the 2026 List section by section.
View source ↗ - World Anti-Doping Agency — 2027 Prohibited List: Summary of Major Modifications and Explanatory Notes. Source of the S0 change: peptides are now named among S0's examples.
View source ↗ - World Anti-Doping Agency — 2026 and 2027 Monitoring Programs: semaglutide and tirzepatide are monitored, in and out of competition, and GnRH analogues in female athletes under 18. Monitored substances are, by definition, not prohibited.
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 May 14, 2026; read 2026-09-26.
View source ↗ - US FDA — Certain bulk drug substances for use in compounding that may present significant safety risks: the substances in Category 2 for 503A and 503B, and those whose nominations were withdrawn. Content current as of April 22, 2026; read 2026-09-26.
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.