--- title: "Peptide Regulatory Tracker: FDA, PCAC and WADA Status" description: "Dated status of 13 peptides: FDA approval, 503A compounding, Category 2 history, PCAC votes and WADA. Updated October 17, 2026, sources linked." canonical: https://plainlygraded.com/regulatory/ last_updated: 2026-10-17 breadcrumb: "Home > Regulatory tracker" publisher: Plainly Graded policy: "No dosing, no sourcing, no vendor links. Every claim cites a public source." --- > We collect and compare information from public, cited sources. We cannot guarantee that it is complete, current or correct. This is not medical advice. Only a doctor can prescribe, and a doctor should confirm anything you read here before you act on it. **Status as of 17 OCT 2026** # Peptide regulatory tracker This tracker is a dated record of where 13 peptides stand with the US FDA, pharmacy compounding rules and the WADA Prohibited List as of October 17, 2026. Every row links to its primary source, and every change is logged below with its date. LAST CHANGE: 6 OCT 2026 · WADA publishes the 2027 Prohibited List, in force January 1, 2027 · details Written by [Maren Holt](https://plainlygraded.com/about/team/) 20 PUBLIC SOURCES · UPDATED 17 OCT 2026 · NO TIES TO SELLERS [How we source](https://plainlygraded.com/how-we-source/) ## Where each peptide stands | Compound | FDA | 503A compounding | WADA 2026 | Last change | Detail | | --- | --- | --- | --- | --- | --- | | [BPC-157](https://plainlygraded.com/peptides/bpc-157/) | Not approved | Advisers backed it · no rule | S0 prohibited | 23 JUL 2026 | Not FDA-approved for any use. Not on the 503A bulks list. FDA advisers recommended it on July 23, 2026; the vote is non-binding and no rule has been proposed. Prohibited at all times under the 2026 WADA List (S0, non-approved substances).[4,6,8,16,17] | | [Epitalon](https://plainlygraded.com/peptides/epitalon/) | Not approved | Advisers backed it · no rule | Not named · ask USADA | 24 JUL 2026 | Not FDA-approved for any use. Not on the 503A bulks list. FDA advisers recommended it on July 24, 2026; the vote is non-binding and no rule has been proposed. Not named on the 2026 WADA List. Because it is unapproved, the catch-all S0 section may still apply; ask USADA before use.[4,6,8,16,17,18] | | [GHK-Cu](https://plainlygraded.com/peptides/ghk-cu/) | Not approved as a drug | Not eligible | Not named · ask USADA | 15 APR 2026 | Legal as a cosmetic ingredient; not FDA-approved as a drug. Injectable form off Category 2 since April 15, 2026 but not eligible for compounding; FDA advisers are due to review it before the end of February 2027. Not named on the 2026 WADA List. Because it is unapproved, the catch-all S0 section may still apply; ask USADA before use.[6,6,8,18,18] | | [KPV](https://plainlygraded.com/peptides/kpv/) | Not approved | Advisers backed it · no rule | Not named · ask USADA | 23 JUL 2026 | Not FDA-approved for any use. Not on the 503A bulks list. FDA advisers recommended it on July 23, 2026; the vote is non-binding and no rule has been proposed. Not named on the 2026 WADA List. Because it is unapproved, the catch-all S0 section may still apply; ask USADA before use.[4,6,8,16,17,18] | | [MOTS-c](https://plainlygraded.com/peptides/mots-c/) | Not approved | Advisers backed it · no rule | Not named · ask USADA | 23 JUL 2026 | Not FDA-approved for any use. Not on the 503A bulks list. FDA advisers recommended it on July 23, 2026; the vote is non-binding and no rule has been proposed. Not named on the 2026 WADA List. Because it is unapproved, the catch-all S0 section may still apply; ask USADA before use.[4,6,8,16,17,18] | | [PT-141](https://plainlygraded.com/peptides/pt-141/) | Approved, one use | n/a | Being checked | – | Approved as Vyleesi for hypoactive sexual desire disorder in premenopausal women only. WADA status not yet checked against the List.[9,9] | | [Retatrutide](https://plainlygraded.com/peptides/retatrutide/) | Investigational | n/a | Not named · ask USADA | 29 SEP 2026 | Not FDA-approved and not yet filed; Lilly says it plans to submit in early 2027. GLP-1 agonists are not prohibited, but retatrutide is unapproved, so section S0 may apply until approval; ask USADA.[3,5,8,20] | | [Semax](https://plainlygraded.com/peptides/semax/) | Not approved | Advisers backed it · no rule | Not named · ask USADA | 24 JUL 2026 | Not FDA-approved for any use. Not on the 503A bulks list. FDA advisers recommended it on July 24, 2026; the vote is non-binding and no rule has been proposed. Not named on the 2026 WADA List. Because it is unapproved, the catch-all S0 section may still apply; ask USADA before use.[4,6,8,16,17,18] | | [Sermorelin](https://plainlygraded.com/peptides/sermorelin/) | Formerly approved | Being checked | S2 prohibited | – | Previously approved as Geref; discontinued. Compounding status not yet checked against FDA's current lists. Prohibited at all times under the 2026 WADA List (S2.2.4, growth hormone releasing factors).[8,10] | | [SS-31](https://plainlygraded.com/peptides/ss-31/) | Approved, one use | n/a | Not named · ask USADA | – | Reported approved as Forzinity for Barth syndrome only (being verified). Not named on the 2026 WADA List; ask USADA before use.[8,11,11] | | [TB-500](https://plainlygraded.com/peptides/tb-500/) | Not approved | Advisers backed it · no rule | S2 prohibited | 23 JUL 2026 | Not FDA-approved for any use. Not on the 503A bulks list. FDA advisers recommended it on July 23, 2026; the vote is non-binding and no rule has been proposed. Prohibited at all times under the 2026 WADA List (S2.3: thymosin beta-4 and its derivatives, e.g. TB-500).[4,6,8,16,17,18] | | [Tesamorelin](https://plainlygraded.com/peptides/tesamorelin/) | Approved, one use | n/a | S2 prohibited | – | Approved as Egrifta for excess abdominal fat in HIV-associated lipodystrophy only. Prohibited at all times under the 2026 WADA List (S2.2.4, growth hormone releasing factors).[8,12,12] | | [Tirzepatide](https://plainlygraded.com/peptides/tirzepatide/) | Approved | n/a | Not prohibited | – | Approved as Mounjaro (type 2 diabetes) and Zepbound (chronic weight management). GLP-1 agonists are not prohibited; WADA says the status is unchanged for 2027.[13,13,20] | Download the dataset: [CSV](https://plainlygraded.com/regulatory/status.csv) · [JSON](https://plainlygraded.com/regulatory/status.json). Free to reuse with a link back. ## What changed, and when - **7 OCT 2026 · REPORTED, NOT CONFIRMED:** **Reported: a temporary policy for some compounded peptides is being drafted** The Washington Post reported, citing two unnamed sources, that the administration is drafting a temporary policy to let some compounding pharmacies supply certain restricted peptides. HHS did not comment and the peptides were not named.[14,19] **What it changes:** Nothing yet. No policy text has been published. **What it doesn't:** The legal status of every peptide on this page is unchanged. - **6 OCT 2026:** **WADA publishes the 2027 Prohibited List, in force January 1, 2027** WADA published its 2027 Prohibited List. GLP-1 agonists remain unprohibited. Further examples were added to section S0.[1,20] **What it changes:** The 2027 List takes effect on January 1, 2027. **What it doesn't:** The 2026 List stays in force until then. Affects: [BPC-157](https://plainlygraded.com/peptides/bpc-157/), [TB-500](https://plainlygraded.com/peptides/tb-500/), [Retatrutide](https://plainlygraded.com/peptides/retatrutide/), [Tirzepatide](https://plainlygraded.com/peptides/tirzepatide/) - **29 SEP 2026:** **TRIUMPH-1 full results published in NEJM** The full TRIUMPH-1 results for retatrutide were published: 2,339 adults over 80 weeks.[2] **What it changes:** Peer-reviewed phase 3 data for retatrutide is now public. **What it doesn't:** Retatrutide is still not approved. Affects: [Retatrutide](https://plainlygraded.com/peptides/retatrutide/) - **24 AUG 2026:** **FDA sends warning letters to five online peptide sellers** FDA warning letters to five online sellers rejected "research use only" labels as a defence and treated dosing aids, reconstitution calculators and bacteriostatic water sold alongside injectables as evidence of intended human use.[3,15] **What it changes:** FDA has stated in writing that a "research use only" label does not make a product legal when the seller points to human use. **What it doesn't:** The status of the compounds named did not change. Affects: [Retatrutide](https://plainlygraded.com/peptides/retatrutide/), [Tirzepatide](https://plainlygraded.com/peptides/tirzepatide/), [Tesamorelin](https://plainlygraded.com/peptides/tesamorelin/), [SS-31](https://plainlygraded.com/peptides/ss-31/), [PT-141](https://plainlygraded.com/peptides/pt-141/) - **23 JUL 2026:** **FDA advisers vote to recommend six peptides for the 503A bulks list** FDA's Pharmacy Compounding Advisory Committee voted in favor of adding BPC-157, KPV, TB-500 and MOTS-c (July 23) and Epitalon and Semax (July 24) to the 503A bulks list. FDA staff had recommended against all of them. Emideltide (DSIP) was rejected.[4,16,17] **What it changes:** FDA now has an advisory recommendation it can accept or reject. **What it doesn't:** The vote is advisory and non-binding. A peptide joins the bulks list only through notice-and-comment rulemaking, and no proposed rule has been published. Affects: [BPC-157](https://plainlygraded.com/peptides/bpc-157/), [TB-500](https://plainlygraded.com/peptides/tb-500/), [KPV](https://plainlygraded.com/peptides/kpv/), [MOTS-c](https://plainlygraded.com/peptides/mots-c/), [Semax](https://plainlygraded.com/peptides/semax/), [Epitalon](https://plainlygraded.com/peptides/epitalon/) - **23 JUL 2026:** **Lilly says it plans to file retatrutide with FDA in early 2027** With TRIUMPH-2 and TRIUMPH-3 topline results, Eli Lilly said it plans to submit retatrutide to FDA in early 2027.[5] **What it changes:** A filing date is now stated by the maker. **What it doesn't:** Retatrutide is not approved and has not been filed. Affects: [Retatrutide](https://plainlygraded.com/peptides/retatrutide/) - **15 APR 2026:** **FDA removes 12 peptides from Category 2 after nominations were withdrawn** FDA republished its interim 503A categories and removed 12 peptides from Category 2 because their nominations were withdrawn. They were not placed in Category 1.[6,17,18] **What it changes:** The peptides are no longer listed as Category 2 safety concerns. **What it doesn't:** Removal is not approval. Because they were not added to Category 1, pharmacies still cannot compound them under the January 2025 interim policy. Affects: [BPC-157](https://plainlygraded.com/peptides/bpc-157/), [TB-500](https://plainlygraded.com/peptides/tb-500/), [KPV](https://plainlygraded.com/peptides/kpv/), [GHK-Cu](https://plainlygraded.com/peptides/ghk-cu/), [MOTS-c](https://plainlygraded.com/peptides/mots-c/), [Semax](https://plainlygraded.com/peptides/semax/), [Epitalon](https://plainlygraded.com/peptides/epitalon/) - **SEP 2023:** **FDA places BPC-157 and other peptides in Category 2** FDA put BPC-157 and other peptides in Category 2 of its interim 503A bulks categories, citing safety risks such as immune reactions and impurities.[7,16] **What it changes:** Pharmacies could not compound these peptides under FDA's interim policy. **What it doesn't:** No peptide was approved or banned as a drug by this step; it concerned compounding only. Affects: [BPC-157](https://plainlygraded.com/peptides/bpc-157/), [TB-500](https://plainlygraded.com/peptides/tb-500/), [KPV](https://plainlygraded.com/peptides/kpv/), [GHK-Cu](https://plainlygraded.com/peptides/ghk-cu/), [MOTS-c](https://plainlygraded.com/peptides/mots-c/), [Semax](https://plainlygraded.com/peptides/semax/), [Epitalon](https://plainlygraded.com/peptides/epitalon/) Common misstatements - "BPC-157 is a Category 2 peptide." Out of date since April 15, 2026: it was removed from Category 2, not added to Category 1, and still can't be compounded. - "FDA voted to allow these peptides." FDA's advisers voted to recommend; the vote is non-binding and no rule exists. - "Now available from compounding pharmacies." A temporary policy has been reported, not issued. What's pending - Any FDA proposed rule adding peptides to the 503A bulks list (none published as of October 17, 2026). - The next advisory committee review of injectable GHK-Cu and others, expected before the end of February 2027. - The 2027 WADA List, in force January 1, 2027. - Lilly's planned retatrutide filing, early 2027. If you're tested for sport Anti-doping rules work on strict liability. "Not named" on the list does not mean allowed: unapproved substances can fall under section S0. Check with USADA's Global DRO before using anything. **Sources** 1. World Anti-Doping Agency. [2027 Prohibited List, in force January 1, 2027](https://www.wada-ama.org/en/prohibited-list), 2026-10-06. 2. New England Journal of Medicine. Retatrutide for obesity: TRIUMPH-1 (Jastreboff et al.), 2026-09-29. 3. US Food and Drug Administration. Warning letters to five online peptide sellers, August 24, 2026, 2026-08-24. 4. US Food and Drug Administration. Pharmacy Compounding Advisory Committee, meeting of July 23-24, 2026: briefing documents and vote record, 2026-07-23. 5. Eli Lilly and Company. TRIUMPH-2 and TRIUMPH-3 topline results; plan to submit to FDA in early 2027, 2026-07-23. 6. US Food and Drug Administration. 503A bulk drug substances: interim categories, updated April 15, 2026, 2026-04-15. 7. US Food and Drug Administration. Certain bulk drug substances for use in compounding that may present significant safety risks, 2023-09. 8. World Anti-Doping Agency. [2026 Prohibited List (sections S0 and S2)](https://www.wada-ama.org/en/prohibited-list), 2026-01-01. 9. DailyMed / US Food and Drug Administration. Vyleesi (bremelanotide) prescribing information. 10. Drugs@FDA. Geref (sermorelin acetate): approval history and discontinuation. 11. Drugs@FDA. Forzinity (elamipretide): approval for Barth syndrome. 12. DailyMed / US Food and Drug Administration. Egrifta (tesamorelin) prescribing information. 13. DailyMed / US Food and Drug Administration. Mounjaro and Zepbound (tirzepatide) prescribing information. 14. Frier Levitt. [Analysis of the proposed peptide enforcement-discretion policy](https://www.frierlevitt.com/?p=60057), 2026-10-14. (law-firm or secondary summary) 15. ArentFox Schiff. [RUO-ined: five peptide vendors learn research use only is not a legal strategy](https://www.afslaw.com/perspectives/alerts/ruo-ined-five-peptide-vendors-learn-research-use-only-not-legal-strategy), 2026-09-18. (law-firm or secondary summary) 16. DLA Piper. [FDA AdComm recommends adding six peptides to bulk list](https://www.dlapiper.com/en-ae/insights/publications/2026/07/fda-adcomm-recommends-adding-six-peptides-to-bulk-list), 2026-07-31. (law-firm or secondary summary) 17. McDermott Will & Emery. [Bulk list bound? PCAC backs majority of peptides in two-day public meeting](https://www.mcdermottlaw.com/insights/bulk-list-bound-pcac-backs-majority-of-peptides-in-two-day-public-meeting/), 2026-07-27. (law-firm or secondary summary) 18. Frier Levitt. [FDA peptides 'do not compound' list update 2026](https://www.frierlevitt.com/articles/fda-peptides-do-not-compound-list-update-2026/), 2026-04-16. (law-firm or secondary summary) 19. Becker's Hospital Review. [HHS plans stopgap to allow sales of some unapproved peptides: Washington Post](https://www.beckershospitalreview.com/glp-1s/hhs-plans-stopgap-to-allow-sales-of-some-unapproved-peptides-washington-post/), 2026-10-08. (news report) 20. World Rugby. [WADA publishes 2027 Prohibited List (GLP-1 agonists unchanged)](https://www.world.rugby/keep-rugby-clean/news/1048285/wada-publishes-2027-prohibited-list), 2026-10-06. (news report) **Changelog** 17 OCT 2026 Tracker built from the regulatory record dated 2026-10-17. Spotted an error? [Report it](https://plainlygraded.com/corrections/). We never change a page's updated date without changing its content. --- We collect and compare information from public, cited sources. We cannot guarantee that it is complete, current or correct. This is not medical advice. Only a doctor can prescribe, and a doctor should confirm anything you read here before you act on it. Canonical page: https://plainlygraded.com/regulatory/