{"title":"Peptlas: the legal status of peptides","publisher":"Peptlas Research Team","url":"https://peptlas.com/","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"attribution":"Peptlas (https://peptlas.com/)","last_checked_url":"https://peptlas.com/heartbeat.json","statuses":{"compounding_legal":{"label":"Compounding-legal","meaning":"A licensed pharmacy may compound it on prescription: it is on the FDA 503A bulk-substances list or is an ingredient of an FDA-approved drug that is not on the market. This is not the same as being an FDA-approved drug."},"under_review":{"label":"Under review","meaning":"Actively before the FDA advisory committee; a decision is pending and the status can move."},"in_limbo":{"label":"In limbo","meaning":"Moved on paper - nominated, removed from a restricted list, or recommended by an FDA committee - but not added to the 503A list. The headline implies a change; the legal status has not moved."},"restricted":{"label":"Restricted","meaning":"Prescription-only, banned, controlled, or under active FDA enforcement."},"unscheduled":{"label":"Unscheduled","meaning":"No specific federal action; unaddressed at this time."}},"compounds":[{"slug":"aod-9604","name":"AOD-9604","aliases":["AOD9604","LAT-8881","AOD-9604 acetate"],"nicknames":[],"url":"https://peptlas.com/entries/aod-9604/","answer":"AOD-9604 is a synthetic fragment of human growth hormone (amino acids 177-191 plus an added tyrosine). It is not FDA-approved, not on the 503A bulks list and in none of FDA's interim compounding categories, so a U.S. pharmacy cannot lawfully compound it. FDA placed it in 503A Category 2 (significant safety risks) on September 29, 2023, and removed it on September 27, 2024 because the nominators withdrew their nominations. Leaving Category 2 did not make it compoundable: only Category 1 substances get FDA's interim enforcement discretion. FDA still put AOD-9604 before its Pharmacy Compounding Advisory Committee on December 4, 2024, where members voted 0-12 against placing it on the 503A bulks list, matching FDA's own proposal. It is not on the agenda of the next committee meeting, and FDA's Category 2 page still lists it among withdrawn nominations with its stated safety concerns. It would become compoundable only if FDA added it to the 503A bulks list by rulemaking, which the committee advised against.","us":{"status":"in_limbo","label":"In limbo","detail":"Withdrawn from Category 2 in Sep 2024; PCAC voted 0-12 against the 503A list; not compoundable","since":"2024-09-27"},"jurisdictions":[{"authority":"United States (FDA)","regulator":"FDA","status":"in_limbo","label":"In limbo","note":"Removed from 503A Category 2 on Sep 27, 2024 after the nominations were withdrawn; PCAC voted 0-12 against the 503A list on Dec 4, 2024; in no category, not compoundable."},{"authority":"Australia (TGA)","regulator":"TGA","status":"restricted","label":"Restricted","note":"Named in Schedule 4 (prescription only) of the Poisons Standard and in Appendix D item 5 (possession without authority is illegal), entries made by a 2015 scheduling decision."},{"authority":"United Kingdom (MHRA)","regulator":"MHRA","status":"restricted","label":"Restricted","note":"No UK marketing authorisation (not in the MHRA products substance index); supply as a medicine would be unlicensed."},{"authority":"European Union (EMA)","regulator":"EMA","status":"restricted","label":"Restricted","note":"No EU marketing authorisation or orphan designation (absent from the Union Register); sale as a medicine is unlawful EU-wide, with enforcement at member-state level."},{"authority":"Canada (Health Canada)","regulator":"Health Canada","status":"restricted","label":"Restricted","note":"Not in the Drug Product Database; Health Canada advisories in Aug and Dec 2025 list seized AOD-9604 among unauthorized injectable peptide drugs, which it regulates as prescription drugs."},{"authority":"Sport / anti-doping (WADA)","regulator":"WADA","status":"restricted","label":"Restricted","note":"Named in S2.2.3 of the 2027 Prohibited List as a growth hormone fragment (\"e.g. AOD-9604 and hGH 176-191\"); prohibited at all times."}],"brazil":null,"next_event":null,"advisory_vote":{"date":"2024-12-04","body":"FDA Pharmacy Compounding Advisory Committee","outcome":"not_recommended","question":"Should AOD-9604 (free base) and AOD-9604 acetate be placed on the 503A Bulks List?","yes":0,"no":12,"abstain":0},"sources":[{"label":"FDA - Certain bulk drug substances that may present significant safety risks (Category 2 page)","url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","primary":true},{"label":"FDA - 503A categories list, updated Sep 27, 2024 (Wayback Machine copy)","url":"https://web.archive.org/web/20241107074712/https://www.fda.gov/media/94155/download","primary":false},{"label":"FDA - Final summary minutes, Pharmacy Compounding Advisory Committee, Dec 4, 2024","url":"https://www.fda.gov/media/185642/download","primary":true},{"label":"FDA - 503A categories list (updated May 14, 2026)","url":"https://www.fda.gov/media/94155/download","primary":true},{"label":"Therapeutic Goods (Poisons Standard - October 2026) Instrument 2026","url":"https://www.legislation.gov.au/F2026L01327/latest/text","primary":true},{"label":"Health Canada - Unauthorized injectable peptide drugs seized and sold by Canada Peptide (Aug 1, 2025)","url":"https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious","primary":true},{"label":"MHRA Products - substance index (A)","url":"https://products.mhra.gov.uk/substance-index/?letter=A","primary":true},{"label":"EU Union Register of medicinal products (active substance index)","url":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm","primary":true},{"label":"WADA - 2027 Prohibited List (in force Jan 1, 2027)","url":"https://www.wada-ama.org/sites/default/files/2026-09/2027list_en_final_clean_26_august_2026_2.pdf","primary":true}],"last_verified":"2026-10-15"},{"slug":"bpc-157","name":"BPC-157","aliases":["Body Protection Compound 157","Bepecin","PL 14736"],"nicknames":[],"url":"https://peptlas.com/entries/bpc-157/","answer":"BPC-157 is not an FDA-approved drug and is not on the FDA's Section 503A Bulk Drug Substances List, so compounding pharmacies still have no affirmative federal authorization to compound it. On July 23, 2026 the FDA's Pharmacy Compounding Advisory Committee voted 8-6, with 1 abstention, to recommend adding it to that list - overriding the FDA's own review staff, whose briefing proposed against listing on characterization, immunogenicity, and efficacy grounds. That vote is advisory and does not bind the FDA. Nothing about BPC-157's legal status changed on the day of the vote. Before it could be compounded lawfully the FDA would have to accept the recommendation and complete notice-and-comment rulemaking - a process the agency has not begun and that is generally estimated at 12 to 24 months. Separately, nominations to add BPC-157 to the 503B bulks list - the list for outsourcing facilities, not the 503A list the committee reviewed - were posted to the FDA's docket on August 25, 2026; a nomination starts a review and changes nothing on its own.","us":{"status":"in_limbo","label":"In limbo","detail":"PCAC recommended listing (8-6, Jul 23, 2026) - advisory only; still not on the 503A list","since":"2026-07-23"},"jurisdictions":[{"authority":"United States (FDA)","regulator":"FDA","status":"in_limbo","label":"In limbo","note":"Not on the 503A Bulks List. PCAC recommended adding it on Jul 23, 2026 (8-6, 1 abstention); the recommendation is advisory and the FDA has not acted."},{"authority":"Australia (TGA)","regulator":"TGA","status":"restricted","label":"Restricted","note":"Reported as Schedule 4 (prescription-only) under the Poisons Standard."},{"authority":"United Kingdom (MHRA)","regulator":"MHRA","status":"restricted","label":"Restricted","note":"No UK marketing authorisation; supply for human use treated as an unlicensed medicine."},{"authority":"European Union (EMA)","regulator":"EMA","status":"restricted","label":"Restricted","note":"No EU marketing authorisation; sale as a medicine is unlawful EU-wide, with enforcement handled at member-state level."},{"authority":"Canada (Health Canada)","regulator":"Health Canada","status":"restricted","label":"Restricted","note":"Not an authorized drug; Health Canada's April 2026 advisory names BPC-157 among unauthorized injectable peptides and states such products are illegal to sell in Canada."},{"authority":"Sport / anti-doping (WADA)","regulator":"WADA","status":"restricted","label":"Restricted","note":"Prohibited at all times under category S0 (non-approved substances). Unchanged on the 2027 List (published Sep 21, 2026; in force Jan 1, 2027)."}],"brazil":{"status_class":"restricted","status_pt":"Sem registro na ANVISA: uso ilegal","summary_pt":"A ANVISA afirma que o BPC-157 não está registrado em nenhuma categoria (medicamento, suplemento, alimento ou cosmético) e que produtos assim são ilegais para qualquer uso em saúde, inclusive estético. Em 6 de outubro de 2026, a Resolução-RE 3.947/2026 proibiu e mandou apreender um produto com BPC-157 e TB-500 vendido pela internet.","verified":"2026-10-09","url":"https://peptlas.com/pt-br/peptideos/bpc-157/","sources":[{"label":"ANVISA - checagem sobre peptídeos sem registro","url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/checamos-peptideos-que-prometem-milagres-nao-estao-registrados-na-anvisa","date":"2026-07-02"},{"label":"ANVISA - checagem sobre peptídeos sem registro","url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/checamos-peptideos-que-prometem-milagres-nao-estao-registrados-na-anvisa","date":"2026-07-02"},{"label":"ANVISA - Resolução-RE 3.947/2026","url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/anvisa-proibe-venda-de-insulina-e-tirzepatida-irregulares-1","date":"2026-10-06"},{"label":"ANVISA - dados abertos de medicamentos registrados (consulta em 9 out. 2026)","url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","date":"2026-10-09"}]},"next_event":null,"advisory_vote":{"date":"2026-07-23","body":"FDA Pharmacy Compounding Advisory Committee (PCAC)","outcome":"recommended","question":"Should BPC-157 (free base) be placed on the list? - and, as a separate vote, BPC-157 acetate?","yes":8,"no":6,"abstain":1,"tally_source":"reported by Healio and the FDA Law Blog (Hyman, Phelps & McNamara). The panel was not the same size for every substance - the meeting roster seats temporary voting members for single topics - so the totals legitimately differ between votes"},"sources":[{"label":"Federal Register - PCAC notice of meeting (Docket FDA-2025-N-6895)","url":"https://www.federalregister.gov/documents/2026/04/16/2026-07361/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request","primary":true},{"label":"FDA - PCAC briefing document, BPC-157 (July 2026 meeting)","url":"https://www.fda.gov/media/193343/download","primary":true},{"label":"USADA - BPC-157 prohibited for athletes","url":"https://www.usada.org/spirit-of-sport/bpc-157-peptide-prohibited/","primary":false},{"label":"FDA - PCAC meeting page, July 23-24, 2026","url":"https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026","primary":true},{"label":"Healio - FDA committee recommends looser restrictions for several peptides","url":"https://www.healio.com/news/primary-care/20260724/fda-committee-recommends-looser-restrictions-for-several-peptides","primary":false},{"label":"Mintz - FDA's Advisory Committee Votes on Peptides: What It Does and Doesn't Do","url":"https://www.mintz.com/insights-center/viewpoints/2146/2026-07-29-fdas-advisory-committee-votes-peptides-what-it-does-and","primary":false},{"label":"FDA - PCAC July 23-24, 2026: questions put to the committee","url":"https://www.fda.gov/media/193711/download","primary":true},{"label":"FDA - PCAC July 23-24, 2026: meeting roster","url":"https://www.fda.gov/media/193772/download","primary":true},{"label":"MHRA Guidance Note 14: supply of unlicensed medicinal products ('specials')","url":"https://assets.publishing.service.gov.uk/media/645e19f5ad8a03000c38b3bc/The_supply_of_unlicensed_medicinal_products__special_GN14.pdf","primary":true},{"label":"Health Canada public advisory (Apr 9, 2026)","url":"https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm","primary":true},{"label":"EMA medicines database - no entry for BPC-157","url":"https://www.ema.europa.eu/en/medicines?search_api_views_fulltext=BPC-157","primary":true},{"label":"Regulations.gov - 503B bulks nomination, BPC-157 (free base), BPI Labs (posted Aug 25, 2026)","url":"https://www.regulations.gov/document/FDA-2015-N-3469-0439","primary":true},{"label":"WADA - 2027 Prohibited List published (Sep 21, 2026)","url":"https://www.wada-ama.org/en/news/wada-publishes-2027-prohibited-list","primary":true}],"last_verified":"2026-09-22"},{"slug":"cagrilintide","name":"Cagrilintide","aliases":["AM833","long-acting amylin analog","CagriSema (combination with semaglutide)"],"nicknames":[],"url":"https://peptlas.com/entries/cagrilintide/","answer":"Cagrilintide is an investigational drug - Novo Nordisk's long-acting amylin analog - with no approved form anywhere in the world. It is furthest along as half of CagriSema, a fixed-dose weekly combination with semaglutide: Novo Nordisk submitted a New Drug Application to the FDA on December 18, 2025 on the strength of the Phase 3 REDEFINE trials, and on September 30, 2026 Novo Nordisk said a decision is expected in the fourth quarter of 2026. Until that decision lands there is no legal commercial product containing cagrilintide, and compounding is not an option either: cagrilintide is not a component of any approved drug and is not an eligible bulk substance, so the FDA states plainly that it cannot be used in compounding. The agency has backed that with enforcement - a March 2026 warning letter names 'Cagrilintide' among unapproved new drugs a seller offered online, alongside coded product names, treating 'research use' framing as immaterial when products are aimed at human use. Note this entry sits outside the 503A pipeline entirely: no advisory-committee review of cagrilintide is scheduled or on record - and even an approval of CagriSema would legalize that finished product, not gray-market cagrilintide powder.","us":{"status":"restricted","label":"Restricted","detail":"Investigational only - no approved form exists anywhere; cannot be compounded; the CagriSema combination is under FDA review","since":"2025-12-18"},"jurisdictions":[{"authority":"United States (FDA)","regulator":"FDA","status":"restricted","label":"Restricted","note":"Investigational; not approved, not compoundable (not a component of an approved drug, not an eligible bulk substance). The CagriSema NDA is under FDA review; warning letters to sellers, including products sold under coded names."},{"authority":"Australia (TGA)","regulator":"TGA","status":"unscheduled","label":"Unscheduled","note":"Not individually named or scheduled in the Poisons Standard."},{"authority":"United Kingdom (MHRA)","regulator":"MHRA","status":"restricted","label":"Restricted","note":"No UK marketing authorisation; supply for human use treated as an unlicensed medicine."},{"authority":"European Union (EMA)","regulator":"EMA","status":"restricted","label":"Restricted","note":"No EU marketing authorisation; not on EMA's August 2026 list of applications under CHMP evaluation; sale as a medicine unlawful EU-wide, with enforcement at member-state level."},{"authority":"Canada (Health Canada)","regulator":"Health Canada","status":"under_review","label":"Under review","note":"Cagrilintide/semaglutide new drug submission (Novo Nordisk) accepted into Health Canada review in March 2026; no cagrilintide product yet authorized in the Drug Product Database."},{"authority":"Sport / anti-doping (WADA)","regulator":"WADA","status":"restricted","label":"Restricted","note":"Prohibited at all times, but not listed by name - captured by the S0 catch-all for substances with no regulatory approval for human use."}],"brazil":null,"next_event":{"date":"2026-12-31","label":"FDA decision on the CagriSema NDA (submitted Dec 18, 2025) expected in Q4 2026, per Novo Nordisk (Sep 30, 2026) - no public action date"},"advisory_vote":null,"sources":[{"label":"FDA - FDA's concerns with unapproved GLP-1 drugs used for weight loss","url":"https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss","primary":true},{"label":"FDA - warning letter, Prime Sciences (Mar 31, 2026)","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-sciences-721805-03312026","primary":true},{"label":"FDA - press announcement: 30 telehealth companies warned over compounded GLP-1 marketing","url":"https://www.fda.gov/news-events/press-announcements/fda-warns-30-telehealth-companies-against-illegal-marketing-compounded-glp-1s","primary":true},{"label":"Novo Nordisk - company announcement: CagriSema NDA filed with the FDA (Dec 18, 2025)","url":"https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916470","primary":false},{"label":"Drugs.com - CagriSema FDA approval status tracker","url":"https://www.drugs.com/nda/cagrisema_251222.html","primary":false},{"label":"USADA - the WADA Prohibited List (S0: non-approved substances)","url":"https://www.usada.org/substances/prohibited-list/","primary":false},{"label":"MHRA Products database (search: cagrilintide)","url":"https://products.mhra.gov.uk/search/?search=cagrilintide&page=1","primary":true},{"label":"Health Canada - New drug submissions under review (SUR list)","url":"https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/submissions-under-review/new-drug-submissions-under-review.html","primary":true},{"label":"EMA - Applications for new human medicines under evaluation: August 2026","url":"https://www.ema.europa.eu/en/documents/report/applications-new-human-medicines-under-evaluation-august-2026_en.xlsx","primary":true},{"label":"Therapeutic Goods (Poisons Standard - June 2026) Instrument 2026","url":"https://www.legislation.gov.au/F2026L00633/asmade","primary":true},{"label":"Novo Nordisk - CagriSema at EASD 2026 (Sep 30, 2026)","url":"https://www.globenewswire.com/news-release/2026/09/30/3371858/0/en/novo-s-investigational-obesity-and-diabetes-drug-cagrisema-reduces-food-noise-and-shows-benefits-in-organ-and-bone-health-easd-2026.html","primary":false}],"last_verified":"2026-10-09"},{"slug":"cjc-1295","name":"CJC-1295","aliases":["Modified GRF 1-29","DAC:GRF","CJC-1295 DAC"],"nicknames":[],"url":"https://peptlas.com/entries/cjc-1295/","answer":"CJC-1295 is not FDA-approved for any use and has no drug-shortage or USP-monograph pathway. It previously appeared in Category 2 of the interim 503A bulks list but was removed around September 2024 after its nominations were withdrawn - which did not create a compounding pathway. At the December 4, 2024 advisory committee (PCAC) meeting, the committee voted against recommending it for the 503A list, citing insufficient efficacy and safety data. It is neither on the 503A list nor otherwise eligible, leaving its legal compounding status effectively unchanged.","us":{"status":"in_limbo","label":"In limbo","detail":"PCAC voted against listing (Dec 2024); off Category 2, not on the 503A list","since":"2024-12-04"},"jurisdictions":[{"authority":"United States (FDA)","regulator":"FDA","status":"in_limbo","label":"In limbo","note":"Removed from Category 2 (~Sept 2024); PCAC voted against inclusion Dec 4, 2024; not on the 503A list; no USP monograph."},{"authority":"Australia (TGA)","regulator":"TGA","status":"restricted","label":"Restricted","note":"Reported as Schedule 4 (prescription-only) under the Poisons Standard."},{"authority":"United Kingdom (MHRA)","regulator":"MHRA","status":"restricted","label":"Restricted","note":"No UK marketing authorisation; supply for human use treated as an unlicensed medicine."},{"authority":"European Union (EMA)","regulator":"EMA","status":"restricted","label":"Restricted","note":"No EU marketing authorisation; absent from the Union Register, so sale as a medicine is unlawful EU-wide, with enforcement handled at member-state level."},{"authority":"Canada (Health Canada)","regulator":"Health Canada","status":"restricted","label":"Restricted","note":"Not authorized by Health Canada; named in an April 2026 public advisory on unauthorized injectable peptides, which states such products are illegal to sell and reports seizures."},{"authority":"Sport / anti-doping (WADA)","regulator":"WADA","status":"restricted","label":"Restricted","note":"Prohibited at all times under S2 as a growth-hormone-releasing factor analogue."}],"brazil":{"status_class":"restricted","status_pt":"Sem registro na ANVISA: uso ilegal","summary_pt":"A ANVISA afirma que os produtos que se apresentam como CJC-1295 não estão registrados e que peptídeos injetáveis sem regularização em nenhuma categoria são ilegais para qualquer uso em saúde, inclusive estético.","verified":"2026-10-09","url":"https://peptlas.com/pt-br/peptideos/cjc-1295/","sources":[{"label":"ANVISA - checagem sobre peptídeos sem registro","url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/checamos-peptideos-que-prometem-milagres-nao-estao-registrados-na-anvisa","date":"2026-07-02"},{"label":"ANVISA - dados abertos de medicamentos registrados (consulta em 9 out. 2026)","url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","date":"2026-10-09"}]},"next_event":null,"advisory_vote":null,"sources":[{"label":"Federal Register - PCAC notice of meeting, Dec 4, 2024","url":"https://www.federalregister.gov/documents/2024/10/25/2024-24828/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request","primary":true},{"label":"FDA - PCAC December 4, 2024 meeting materials","url":"https://www.fda.gov/advisory-committees/advisory-committee-calendar/updated-meeting-time-and-public-participation-information-december-4-2024-meeting-pharmacy","primary":true},{"label":"BSCG - CJC-1295 in sport","url":"https://www.bscg.org/blogs/single/cjc-1295-use-in-sports-and-military-rules-explained","primary":false},{"label":"Health Canada public advisory (Apr 9, 2026)","url":"https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm","primary":true},{"label":"Union Register of medicinal products (European Commission)","url":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm","primary":true}],"last_verified":"2026-09-22"},{"slug":"dihexa","name":"Dihexa","aliases":["Dihexa acetate","PNB-0408","ATH-1001"],"nicknames":[],"url":"https://peptlas.com/entries/dihexa/","answer":"Dihexa is an experimental synthetic compound that was nominated to FDA for compounding as dihexa acetate. It is not FDA-approved and not on the 503A bulks list, so a U.S. pharmacy cannot lawfully compound it. FDA placed dihexa acetate in 503A Category 2 (significant safety risks) on September 29, 2023, and removed it on April 22, 2026 because the nominator withdrew its nomination. Removal from Category 2 does not authorize compounding: only Category 1 substances get FDA's interim enforcement discretion, and dihexa is now in no category. FDA's Category 2 page still lists it, noting that FDA has not identified any human exposure data for it by any route. Dihexa acetate is one of five substances - with LL-37, GHK-Cu, Melanotan II and PEG-MGF - on the agenda of a Pharmacy Compounding Advisory Committee meeting that FDA says it will host before the end of February 2027; no date or Federal Register notice has been published. The vote would be advisory, and dihexa could become compoundable only if FDA then added it to the 503A bulks list by rulemaking.","us":{"status":"in_limbo","label":"In limbo","detail":"Removed from Category 2 Apr 22, 2026, not on the 503A list; PCAC review expected before end of Feb 2027","since":"2026-04-22"},"jurisdictions":[{"authority":"United States (FDA)","regulator":"FDA","status":"in_limbo","label":"In limbo","note":"Removed from 503A Category 2 on Apr 22, 2026 after the nomination was withdrawn; not on the 503A list; PCAC review expected before end of Feb 2027."},{"authority":"Australia (TGA)","regulator":"TGA","status":"unscheduled","label":"Unscheduled","note":"Not individually named in the Poisons Standard (October 2026) and no product on the ARTG; supply for human use is unlawful without ARTG registration, and the TGA is enforcing against unapproved peptides."},{"authority":"United Kingdom (MHRA)","regulator":"MHRA","status":"restricted","label":"Restricted","note":"No UK marketing authorisation (not in the MHRA products substance index); supply as a medicine would be unlicensed."},{"authority":"European Union (EMA)","regulator":"EMA","status":"restricted","label":"Restricted","note":"No EU marketing authorisation or orphan designation (absent from the Union Register); sale as a medicine is unlawful EU-wide, with enforcement at member-state level."},{"authority":"Canada (Health Canada)","regulator":"Health Canada","status":"restricted","label":"Restricted","note":"No product in the Drug Product Database, so it has no DIN and cannot lawfully be sold as a drug; no Health Canada advisory names it."},{"authority":"Sport / anti-doping (WADA)","regulator":"WADA","status":"restricted","label":"Restricted","note":"Not individually named, but prohibited at all times under the S0 catch-all for non-approved substances (2027 List)."}],"brazil":null,"next_event":{"date":"2027-02-28","label":"Second PCAC meeting on peptides, incl. dihexa acetate - expected before end of Feb 2027, no date published"},"advisory_vote":null,"sources":[{"label":"FDA - Certain bulk drug substances that may present significant safety risks (Category 2 page)","url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","primary":true},{"label":"FDA - 503A categories list, updated Apr 22, 2026 (Wayback Machine copy)","url":"https://web.archive.org/web/20260422215502/https://www.fda.gov/media/94155/download","primary":false},{"label":"FDA - Pharmacy Compounding Advisory Committee meeting, before the end of February 2027 (early announcement)","url":"https://www.fda.gov/advisory-committees/pharmacy-compounding-advisory-committee/meeting-pharmacy-compounding-advisory-committee","primary":true},{"label":"FDA - 503A categories list (updated May 14, 2026)","url":"https://www.fda.gov/media/94155/download","primary":true},{"label":"FDA Global Substance Registration System - Dihexa (UNII 9WYX65A5C2)","url":"https://precision.fda.gov/uniisearch/srs/unii/9WYX65A5C2","primary":true},{"label":"Therapeutic Goods (Poisons Standard - October 2026) Instrument 2026","url":"https://www.legislation.gov.au/F2026L01327/latest/text","primary":true},{"label":"Health Canada - Drug Product Database","url":"https://health-products.canada.ca/dpd-bdpp/","primary":true},{"label":"MHRA Products - substance index (D)","url":"https://products.mhra.gov.uk/substance-index/?letter=D","primary":true},{"label":"EU Union Register of medicinal products (active substance index)","url":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm","primary":true},{"label":"WADA - 2027 Prohibited List (in force Jan 1, 2027)","url":"https://www.wada-ama.org/sites/default/files/2026-09/2027list_en_final_clean_26_august_2026_2.pdf","primary":true}],"last_verified":"2026-10-15"},{"slug":"emideltide","name":"Emideltide (DSIP)","aliases":["Delta sleep-inducing peptide","DSIP","Emideltide acetate"],"nicknames":[],"url":"https://peptlas.com/entries/emideltide/","answer":"Emideltide, better known as delta sleep-inducing peptide or DSIP, is not FDA-approved and is not on the FDA's Section 503A Bulk Drug Substances List, so it is not eligible for pharmacy compounding. On July 24, 2026 the FDA's Pharmacy Compounding Advisory Committee voted 6-7, with 1 abstention, against recommending it - the only one of the seven peptides reviewed at this meeting that the committee declined to recommend, and a result consistent with the FDA review staff's own position on all seven. Emideltide therefore stays off the 503A list, with no further FDA action scheduled. Its removal from the interim Category 2 list in April 2026 did not authorize compounding either: it was never in Category 1, the category that does.","us":{"status":"in_limbo","label":"In limbo","detail":"PCAC voted against listing (6-7, Jul 24, 2026); not on the 503A list","since":"2026-07-24"},"jurisdictions":[{"authority":"United States (FDA)","regulator":"FDA","status":"in_limbo","label":"In limbo","note":"Not on the 503A Bulks List. PCAC voted against adding it on Jul 24, 2026 (6-7, 1 abstention). No further FDA action is scheduled."},{"authority":"Australia (TGA)","regulator":"TGA","status":"unscheduled","label":"Unscheduled","note":"Not individually named in the Poisons Standard; supply for human use is unlawful without ARTG registration, and the TGA is enforcing against unapproved peptides."},{"authority":"United Kingdom (MHRA)","regulator":"MHRA","status":"restricted","label":"Restricted","note":"No UK marketing authorisation; supply for human use treated as an unlicensed medicine."},{"authority":"European Union (EMA)","regulator":"EMA","status":"restricted","label":"Restricted","note":"No EU marketing authorisation for emideltide (DSIP); sale as a medicine is unlawful EU-wide, with enforcement handled at member-state level."},{"authority":"Canada (Health Canada)","regulator":"Health Canada","status":"restricted","label":"Restricted","note":"Not authorized in Canada; Health Canada's April 2026 advisory names DSIP among unauthorized injectable peptide drugs that are illegal to sell."},{"authority":"Sport / anti-doping (WADA)","regulator":"WADA","status":"restricted","label":"Restricted","note":"Not individually named, but prohibited at all times under the S0 catch-all for non-approved substances."}],"brazil":null,"next_event":null,"advisory_vote":{"date":"2026-07-24","body":"FDA Pharmacy Compounding Advisory Committee (PCAC)","outcome":"not_recommended","question":"Should Emideltide (free base) be placed on the list? - and, as a separate vote, Emideltide acetate?","yes":6,"no":7,"abstain":1,"tally_source":"reported by Healio and the FDA Law Blog (Hyman, Phelps & McNamara). The panel was not the same size for every substance - the meeting roster seats temporary voting members for single topics - so the totals legitimately differ between votes"},"sources":[{"label":"Federal Register - PCAC notice of meeting (Docket FDA-2025-N-6895)","url":"https://www.federalregister.gov/documents/2026/04/16/2026-07361/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request","primary":true},{"label":"FDA - 503A bulk drug substances: Category 1 & Category 2 lists","url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act","primary":true},{"label":"Frier Levitt - FDA to remove peptides from the Category 2 list (2026)","url":"https://www.frierlevitt.com/articles/fda-peptides-do-not-compound-list-update-2026/","primary":false},{"label":"FDA Law Blog - FDA's Pep(tide) Rally (Hyman, Phelps & McNamara)","url":"https://www.thefdalawblog.com/2026/04/fdas-peptide-rally-what-compounders-and-industry-need-to-know-post-1-of-2/","primary":false},{"label":"FDA - PCAC meeting page, July 23-24, 2026","url":"https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026","primary":true},{"label":"Healio - FDA committee recommends looser restrictions for several peptides","url":"https://www.healio.com/news/primary-care/20260724/fda-committee-recommends-looser-restrictions-for-several-peptides","primary":false},{"label":"Mintz - FDA's Advisory Committee Votes on Peptides: What It Does and Doesn't Do","url":"https://www.mintz.com/insights-center/viewpoints/2146/2026-07-29-fdas-advisory-committee-votes-peptides-what-it-does-and","primary":false},{"label":"FDA - PCAC July 23-24, 2026: questions put to the committee","url":"https://www.fda.gov/media/193711/download","primary":true},{"label":"FDA - PCAC July 23-24, 2026: meeting roster","url":"https://www.fda.gov/media/193772/download","primary":true},{"label":"MHRA Products database - search: emideltide","url":"https://products.mhra.gov.uk/search/?search=emideltide&page=1","primary":true},{"label":"Health Canada public advisory (Apr 9, 2026) - unauthorized injectable peptides","url":"https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm","primary":true},{"label":"EMA medicines search - emideltide (no results)","url":"https://www.ema.europa.eu/en/medicines?search_api_views_fulltext=emideltide","primary":true}],"last_verified":"2026-09-22"},{"slug":"epitalon","name":"Epitalon","aliases":["Epithalon","Epithalone","AEDG","Epitalon acetate"],"nicknames":[],"url":"https://peptlas.com/entries/epitalon/","answer":"Epitalon (also spelled epithalon) is a synthetic tetrapeptide, Ala-Glu-Asp-Gly, marketed around telomerase-activation and longevity claims that remain scientifically unsettled. It is not FDA-approved and is not on the FDA's Section 503A Bulk Drug Substances List, so it is not eligible for pharmacy compounding. On July 24, 2026 the FDA's Pharmacy Compounding Advisory Committee voted to recommend adding it, reported as 7-4 with 1 abstention (some outlets report 7-5) - against the FDA review staff's recommendation, which had also raised a theoretical concern that telomerase activation could relate to cancer risk. The vote is advisory and does not bind the FDA. Nothing about Epitalon's legal status changed on the day of the vote. Before it could be compounded lawfully the FDA would have to accept the recommendation and complete notice-and-comment rulemaking - a process the agency has not begun and that is generally estimated at 12 to 24 months.","us":{"status":"in_limbo","label":"In limbo","detail":"PCAC recommended listing (reported 7-4, Jul 24, 2026) - advisory only; still not on the 503A list","since":"2026-07-24"},"jurisdictions":[{"authority":"United States (FDA)","regulator":"FDA","status":"in_limbo","label":"In limbo","note":"Not on the 503A Bulks List. PCAC recommended adding it on Jul 24, 2026 (7-4, 1 abstention); the recommendation is advisory and the FDA has not acted."},{"authority":"Australia (TGA)","regulator":"TGA","status":"unscheduled","label":"Unscheduled","note":"Not individually named in the Poisons Standard; supply for human use is unlawful without ARTG registration, and the TGA is enforcing against unapproved peptides."},{"authority":"United Kingdom (MHRA)","regulator":"MHRA","status":"restricted","label":"Restricted","note":"No UK marketing authorisation; supply for human use treated as an unlicensed medicine."},{"authority":"European Union (EMA)","regulator":"EMA","status":"restricted","label":"Restricted","note":"No EU marketing authorisation; sale as a medicine is unlawful EU-wide, with enforcement handled at member-state level."},{"authority":"Canada (Health Canada)","regulator":"Health Canada","status":"restricted","label":"Restricted","note":"Named in Health Canada's April 2026 advisory on unauthorized injectable peptides; absent from the Drug Product Database, so sale for human use is illegal under the Food and Drugs Act."},{"authority":"Sport / anti-doping (WADA)","regulator":"WADA","status":"restricted","label":"Restricted","note":"Not individually named, but prohibited at all times under the S0 catch-all for non-approved substances."}],"brazil":null,"next_event":null,"advisory_vote":{"date":"2026-07-24","body":"FDA Pharmacy Compounding Advisory Committee (PCAC)","outcome":"recommended","question":"Should Epitalon (free base) be placed on the list? - and, as a separate vote, Epitalon acetate?","yes":7,"no":4,"abstain":1,"tally_source":"reported by Healio and the FDA Law Blog (Hyman, Phelps & McNamara). The panel was not the same size for every substance - the meeting roster seats temporary voting members for single topics - so the totals legitimately differ between votes. Reporting also conflicts on this vote specifically: some outlets give the against-count as 5 rather than 4"},"sources":[{"label":"Federal Register - PCAC notice of meeting (Docket FDA-2025-N-6895)","url":"https://www.federalregister.gov/documents/2026/04/16/2026-07361/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request","primary":true},{"label":"FDA - 503A bulk drug substances: Category 1 & Category 2 lists","url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act","primary":true},{"label":"Frier Levitt - FDA to remove peptides from the Category 2 list (2026)","url":"https://www.frierlevitt.com/articles/fda-peptides-do-not-compound-list-update-2026/","primary":false},{"label":"FDA Law Blog - FDA's Pep(tide) Rally (Hyman, Phelps & McNamara)","url":"https://www.thefdalawblog.com/2026/04/fdas-peptide-rally-what-compounders-and-industry-need-to-know-post-1-of-2/","primary":false},{"label":"FDA - PCAC meeting page, July 23-24, 2026","url":"https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026","primary":true},{"label":"Healio - FDA committee recommends looser restrictions for several peptides","url":"https://www.healio.com/news/primary-care/20260724/fda-committee-recommends-looser-restrictions-for-several-peptides","primary":false},{"label":"Mintz - FDA's Advisory Committee Votes on Peptides: What It Does and Doesn't Do","url":"https://www.mintz.com/insights-center/viewpoints/2146/2026-07-29-fdas-advisory-committee-votes-peptides-what-it-does-and","primary":false},{"label":"FDA - PCAC July 23-24, 2026: questions put to the committee","url":"https://www.fda.gov/media/193711/download","primary":true},{"label":"FDA - PCAC July 23-24, 2026: meeting roster","url":"https://www.fda.gov/media/193772/download","primary":true},{"label":"MHRA Products database (search: epitalon)","url":"https://products.mhra.gov.uk/search/?search=epitalon&page=1","primary":true},{"label":"Health Canada advisory on unauthorized injectable peptides (Apr 2026)","url":"https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm","primary":true},{"label":"EU Union Register of medicinal products (active-substance index)","url":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm","primary":true}],"last_verified":"2026-09-22"},{"slug":"ghk-cu","name":"GHK-Cu","aliases":["Copper tripeptide-1","Copper peptide","GHK-copper"],"nicknames":[],"url":"https://peptlas.com/entries/ghk-cu/","answer":"GHK-Cu (copper tripeptide-1) is not FDA-approved and its 503A compounding status splits by route of administration. Topical, non-injectable GHK-Cu is treated as a Category 1 substance (compoundable under enforcement discretion during evaluation), while injectable GHK-Cu was removed from Category 2 after its nomination was withdrawn - and removal from Category 2 does not by itself authorize compounding. Injectable GHK-Cu therefore sits in limbo, neither prohibited nor affirmatively permitted, awaiting FDA advisory committee (PCAC) review. It was not on the July 23-24, 2026 PCAC agenda; it is one of five substances - alongside LL-37, Dihexa acetate, Melanotan II and PEG-MGF - expected at a second PCAC meeting the FDA has signalled for before the end of February 2027, though no date has been published. That meeting would also be advisory: the six peptides the committee recommended in July 2026 are still not on the 503A list.","us":{"status":"in_limbo","label":"In limbo","detail":"Injectable removed from Category 2, not on the 503A list; PCAC review expected before end of Feb 2027","since":"2026-04-22"},"jurisdictions":[{"authority":"United States (FDA)","regulator":"FDA","status":"in_limbo","label":"In limbo","note":"Topical route ≈ Category 1; injectable route removed from Category 2, not on the 503A list; PCAC review expected before end of Feb 2027."},{"authority":"Australia (TGA)","regulator":"TGA","status":"unscheduled","label":"Unscheduled","note":"Not individually named in the Poisons Standard; topical cosmetic products are freely available."},{"authority":"United Kingdom (MHRA)","regulator":"MHRA","status":"restricted","label":"Restricted","note":"No UK marketing authorisation; supply as a medicine is unlicensed, though copper tripeptide-1 remains a permitted cosmetic ingredient under GB cosmetics law."},{"authority":"European Union (EMA)","regulator":"EMA","status":"restricted","label":"Restricted","note":"No EU marketing authorisation; sale as a medicine is unlawful EU-wide, with enforcement handled at member-state level."},{"authority":"Canada (Health Canada)","regulator":"Health Canada","status":"restricted","label":"Restricted","note":"Not in the Drug Product Database; Health Canada recalled GHK-Cu powder as an unauthorized active pharmaceutical ingredient in May 2026."},{"authority":"Sport / anti-doping (WADA)","regulator":"WADA","status":"unscheduled","label":"Unscheduled","note":"Not explicitly named on the Prohibited List."}],"brazil":{"status_class":"restricted","status_pt":"Injetável sem registro: uso ilegal","summary_pt":"A ANVISA afirma que produtos de GHK-Cu que prometem efeitos estéticos ou de saúde não estão registrados e que não existem cosméticos injetáveis: um GHK-Cu injetável vendido como cosmético é irregular. Em 2026 a agência apreendeu GHK-Cu no Aeroporto do Galeão e proibiu um produto de GHK-Cu vendido pela internet.","verified":"2026-10-09","url":"https://peptlas.com/pt-br/peptideos/ghk-cu/","sources":[{"label":"ANVISA - checagem sobre peptídeos sem registro","url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/checamos-peptideos-que-prometem-milagres-nao-estao-registrados-na-anvisa","date":"2026-07-02"},{"label":"ANVISA - checagem sobre peptídeos sem registro","url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/checamos-peptideos-que-prometem-milagres-nao-estao-registrados-na-anvisa","date":"2026-07-02"},{"label":"ANVISA - Resolução-RE 3.947/2026","url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/anvisa-proibe-venda-de-insulina-e-tirzepatida-irregulares-1","date":"2026-10-06"},{"label":"ANVISA - apreensão no Aeroporto do Galeão","url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/mais-de-1000-produtos-irregulares-apreendidos-no-aeroporto-do-galeao","date":"2026-09-22"}]},"next_event":{"date":"2027-02-28","label":"Second PCAC meeting on peptides, incl. GHK-Cu - expected before end of Feb 2027, no date published"},"advisory_vote":null,"sources":[{"label":"FDA - 503A bulk drug substances: Category 1 & Category 2 lists","url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act","primary":true},{"label":"FDA - Pharmacy Compounding Advisory Committee meeting, before the end of February 2027 (early announcement)","url":"https://www.fda.gov/advisory-committees/pharmacy-compounding-advisory-committee/meeting-pharmacy-compounding-advisory-committee","primary":true},{"label":"Frier Levitt - FDA to remove peptides from the Category 2 list (2026)","url":"https://www.frierlevitt.com/articles/fda-peptides-do-not-compound-list-update-2026/","primary":false},{"label":"National Law Review - What FDA's latest actions mean for peptide compounding","url":"https://natlawreview.com/article/tiny-chains-big-changes-what-fdas-latest-actions-mean-peptide-compounding","primary":false},{"label":"FDA Law Blog - FDA's Pep(tide) Rally (Hyman, Phelps & McNamara)","url":"https://www.thefdalawblog.com/2026/04/fdas-peptide-rally-what-compounders-and-industry-need-to-know-post-1-of-2/","primary":false},{"label":"Orrick - FDA peptide compounding vote: what to watch at the July PCAC meeting","url":"https://www.orrick.com/en/Insights/2026/07/FDA-Peptide-Compounding-Vote-What-to-Watch-at-the-July-PCAC-Meeting","primary":false},{"label":"MHRA Products database (search: copper tripeptide)","url":"https://products.mhra.gov.uk/search/?search=copper%20tripeptide&page=1","primary":true},{"label":"Health Canada recall: GHK-Cu & BPC-157 powder - unauthorized APIs","url":"https://recalls-rappels.canada.ca/en/alert-recall/ghk-cu-bpc-157-powder-unauthorized-active-pharmaceutical-ingredients","primary":true},{"label":"EU Union Register of medicinal products (active substance index)","url":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm","primary":true}],"last_verified":"2026-09-22"},{"slug":"ipamorelin","name":"Ipamorelin","aliases":["Ipamorelin acetate"],"nicknames":[],"url":"https://peptlas.com/entries/ipamorelin/","answer":"Ipamorelin is not on the FDA's 503A Bulk Drug Substances List, so it is not approved for pharmacy compounding under enforcement discretion. Its interim-list nomination was withdrawn in 2024, removing it from Category 2 (the \"significant safety risks\" bucket) around September 2024; however, at the October 29, 2024 advisory committee (PCAC) meeting the committee voted against adding it to the list, citing insufficient human safety data and endocrine concerns. It is not part of the April 2026 peptide batch and does not appear on the July 2026 or February 2027 PCAC agendas, so it sits off both the restricted list and the permitted list, with no separate federal ban.","us":{"status":"in_limbo","label":"In limbo","detail":"PCAC voted against listing (Oct 2024); off Category 2, not on the 503A list","since":"2024-10-29"},"jurisdictions":[{"authority":"United States (FDA)","regulator":"FDA","status":"in_limbo","label":"In limbo","note":"Removed from Category 2 (~Sept 2024); PCAC voted against 503A inclusion Oct 29, 2024; not on any bulks list; no separate ban."},{"authority":"Australia (TGA)","regulator":"TGA","status":"restricted","label":"Restricted","note":"Reported as Schedule 4 (prescription-only) under the Poisons Standard."},{"authority":"United Kingdom (MHRA)","regulator":"MHRA","status":"restricted","label":"Restricted","note":"No UK marketing authorisation; supply for human use treated as an unlicensed medicine."},{"authority":"European Union (EMA)","regulator":"EMA","status":"restricted","label":"Restricted","note":"No EU marketing authorisation; absent from the Union Register, so sale as a medicine is unlawful EU-wide, with enforcement at member-state level."},{"authority":"Canada (Health Canada)","regulator":"Health Canada","status":"restricted","label":"Restricted","note":"Not authorized for sale; Health Canada's April 2026 advisory names ipamorelin as an unauthorized injectable peptide drug that is illegal to sell in Canada."},{"authority":"Sport / anti-doping (WADA)","regulator":"WADA","status":"restricted","label":"Restricted","note":"Prohibited at all times under S2 as a growth-hormone secretagogue."}],"brazil":{"status_class":"restricted","status_pt":"Sem registro na ANVISA: uso ilegal","summary_pt":"A ANVISA afirma que os produtos que se apresentam como ipamorelina não estão registrados e que peptídeos injetáveis sem regularização em nenhuma categoria são ilegais para qualquer uso em saúde, inclusive estético.","verified":"2026-10-09","url":"https://peptlas.com/pt-br/peptideos/ipamorelin/","sources":[{"label":"ANVISA - checagem sobre peptídeos sem registro","url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/checamos-peptideos-que-prometem-milagres-nao-estao-registrados-na-anvisa","date":"2026-07-02"},{"label":"ANVISA - dados abertos de medicamentos registrados (consulta em 9 out. 2026)","url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","date":"2026-10-09"}]},"next_event":null,"advisory_vote":null,"sources":[{"label":"FDA - 503A bulk drug substances: Category 1 & Category 2 lists","url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act","primary":true},{"label":"A4PC - PCAC votes against four nominated bulk drug substances","url":"https://a4pc.org/news/pcac-votes-against-four-nominated-bulk-drug-substances","primary":false},{"label":"Federal Register - PCAC notice of meeting, Oct 29, 2024","url":"https://www.federalregister.gov/documents/2024/09/18/2024-21241/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request","primary":true},{"label":"FDA Law Blog - FDA's Pep(tide) Rally (Hyman, Phelps & McNamara)","url":"https://www.thefdalawblog.com/2026/04/fdas-peptide-rally-what-compounders-and-industry-need-to-know-post-1-of-2/","primary":false},{"label":"MHRA Products database - search: ipamorelin","url":"https://products.mhra.gov.uk/search/?search=ipamorelin&page=1","primary":true},{"label":"Health Canada advisory on unauthorized injectable peptides (Apr 9, 2026)","url":"https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm","primary":true},{"label":"Union Register of medicinal products (European Commission)","url":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm","primary":true}],"last_verified":"2026-09-22"},{"slug":"kisspeptin","name":"Kisspeptin-10","aliases":["Metastin 45-54","Kisspeptin 112-121","KP10"],"nicknames":[],"url":"https://peptlas.com/entries/kisspeptin/","answer":"Kisspeptin-10 is a ten-amino-acid fragment of the hormone kisspeptin, also known as metastin 45-54. It is not FDA-approved, and the FDA's 2024 review found no approved kisspeptin-10 product in any country. On September 29, 2023 the FDA placed it in Category 2 of its interim 503A policy, the group of nominated bulk substances that raise significant safety risks, citing possible immunogenicity, complexities with peptide-related impurities and characterization, and little or no safety information for the proposed routes. Category 2 substances fall outside the FDA's enforcement discretion for compounders: the agency says it would consider taking action against a pharmacy that compounds with one. On October 29, 2024 the FDA's Pharmacy Compounding Advisory Committee voted 0-11 against adding kisspeptin-10 to the 503A bulks list. The FDA has not yet published a rule finalizing that outcome, and kisspeptin-10 was not on the July 2026 committee agenda. The FDA has not posted a warning letter that names kisspeptin. For pharmacies to compound it, the FDA would have to take it out of Category 2 and add it to the 503A list.","us":{"status":"restricted","label":"Restricted","detail":"FDA 503A Category 2 (significant safety risks) since Sep 29, 2023; advisory committee voted 0-11 against listing","since":"2023-09-29"},"jurisdictions":[{"authority":"United States (FDA)","regulator":"FDA","status":"restricted","label":"Restricted","note":"503A Category 2 since Sep 29, 2023 - FDA would consider taking action against a pharmacy that compounds with it. PCAC voted 0-11 against adding it to the 503A bulks list (Oct 29, 2024); no final rule yet. No FDA-approved kisspeptin product."},{"authority":"Australia (TGA)","regulator":"TGA","status":"unscheduled","label":"Unscheduled","note":"Not individually named in the Poisons Standard (October 2026) and no product on the ARTG; supply for human use is unlawful without ARTG registration, and the TGA is enforcing against unapproved peptides."},{"authority":"United Kingdom (MHRA)","regulator":"MHRA","status":"restricted","label":"Restricted","note":"No UK marketing authorisation; the MHRA products database holds no kisspeptin product (its only matches are other medicines' documents that mention kisspeptin)."},{"authority":"European Union (EMA)","regulator":"EMA","status":"restricted","label":"Restricted","note":"No EU marketing authorisation and no EU orphan designation; absent from the Union Register, so sale as a medicine is unlawful EU-wide, with enforcement at member-state level."},{"authority":"Canada (Health Canada)","regulator":"Health Canada","status":"restricted","label":"Restricted","note":"Not in the Drug Product Database; Health Canada has listed kisspeptin products among unauthorized products seized in Calgary (Apr 2025), from Canada Peptide (Aug 2025) and at Rize Fitness (Dec 2025)."},{"authority":"Sport / anti-doping (WADA)","regulator":"WADA","status":"restricted","label":"Restricted","note":"Named in S2.2.1: \"kisspeptin and its agonist analogues\" are testosterone-stimulating peptides prohibited at all times in males (2026 and 2027 Lists)."}],"brazil":null,"next_event":null,"advisory_vote":{"date":"2024-10-29","body":"FDA Pharmacy Compounding Advisory Committee (PCAC)","outcome":"not_recommended","question":"Should Kisspeptin-10 be placed on the list?","yes":0,"no":11,"abstain":0},"sources":[{"label":"FDA - Safety risks associated with certain bulk drug substances (Category 2)","url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","primary":true},{"label":"FDA - Bulk drug substances used in compounding under section 503A","url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act","primary":true},{"label":"FDA - 503A bulk drug substances: Category 1, 2 and 3 lists (updated May 14, 2026)","url":"https://www.fda.gov/media/94155/download","primary":true},{"label":"FDA - Final summary minutes, Pharmacy Compounding Advisory Committee, Oct 29, 2024","url":"https://www.fda.gov/media/185412/download","primary":true},{"label":"FDA - Briefing document, Pharmacy Compounding Advisory Committee, Oct 29, 2024","url":"https://www.fda.gov/media/182089/download","primary":true},{"label":"TGA - Responsibilities when importing, compounding and supplying unapproved peptide products (Apr 13, 2026)","url":"https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts/understanding-your-responsibilities-when-importing-compounding-and-supplying-unapproved-peptide-products","primary":true},{"label":"MHRA Products database - search: kisspeptin","url":"https://products.mhra.gov.uk/search/?search=kisspeptin&page=1","primary":true},{"label":"Union Register of medicinal products (European Commission)","url":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm","primary":true},{"label":"Health Canada - Unauthorized injectable peptide drugs seized from Optimum Wellness Centre, Calgary (Apr 2, 2025)","url":"https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta","primary":true},{"label":"WADA - 2027 Prohibited List (in force Jan 1, 2027)","url":"https://www.wada-ama.org/sites/default/files/2026-09/2027list_en_final_clean_26_august_2026_2.pdf","primary":true}],"last_verified":"2026-10-15"},{"slug":"kpv","name":"KPV","aliases":["Lysine-proline-valine","Lys-Pro-Val","KPV acetate"],"nicknames":[],"url":"https://peptlas.com/entries/kpv/","answer":"KPV is a tripeptide (lysine-proline-valine) derived from the C-terminal end of alpha-MSH, studied mainly in laboratory and animal models of wound healing and inflammatory conditions. It is not an FDA-approved drug and is not on the FDA's Section 503A Bulk Drug Substances List, so pharmacies have no affirmative federal authorization to compound it. On July 23, 2026 the FDA's Pharmacy Compounding Advisory Committee voted 8-6, with 1 abstention, to recommend adding it - against the recommendation of the FDA's own review staff, who proposed against listing all seven peptides before the committee. The vote is advisory and does not bind the FDA. Nothing about KPV's legal status changed on the day of the vote. Before it could be compounded lawfully the FDA would have to accept the recommendation and complete notice-and-comment rulemaking - a process the agency has not begun and that is generally estimated at 12 to 24 months.","us":{"status":"in_limbo","label":"In limbo","detail":"PCAC recommended listing (8-6, Jul 23, 2026) - advisory only; still not on the 503A list","since":"2026-07-23"},"jurisdictions":[{"authority":"United States (FDA)","regulator":"FDA","status":"in_limbo","label":"In limbo","note":"Not on the 503A Bulks List. PCAC recommended adding it on Jul 23, 2026 (8-6, 1 abstention); the recommendation is advisory and the FDA has not acted."},{"authority":"Australia (TGA)","regulator":"TGA","status":"unscheduled","label":"Unscheduled","note":"Not individually named in the Poisons Standard; supply for human use is unlawful without ARTG registration, and the TGA is enforcing against unapproved peptides."},{"authority":"United Kingdom (MHRA)","regulator":"MHRA","status":"restricted","label":"Restricted","note":"No UK marketing authorisation; supply for human use treated as an unlicensed medicine."},{"authority":"European Union (EMA)","regulator":"EMA","status":"restricted","label":"Restricted","note":"No EU marketing authorisation; not found in EMA's centralised medicines database, so sale as a medicine is unlawful EU-wide, with enforcement handled at member-state level."},{"authority":"Canada (Health Canada)","regulator":"Health Canada","status":"restricted","label":"Restricted","note":"Not authorized for sale; listed in an April 2026 Health Canada advisory among unauthorized injectable peptide drugs it has seized, with peptides generally regulated as prescription drugs in Canada."},{"authority":"Sport / anti-doping (WADA)","regulator":"WADA","status":"restricted","label":"Restricted","note":"Not individually named, but prohibited at all times under the S0 catch-all for non-approved substances."}],"brazil":null,"next_event":null,"advisory_vote":{"date":"2026-07-23","body":"FDA Pharmacy Compounding Advisory Committee (PCAC)","outcome":"recommended","question":"Should KPV (free base) be placed on the list? - and, as a separate vote, KPV acetate?","yes":8,"no":6,"abstain":1,"tally_source":"reported by Healio and the FDA Law Blog (Hyman, Phelps & McNamara). The panel was not the same size for every substance - the meeting roster seats temporary voting members for single topics - so the totals legitimately differ between votes"},"sources":[{"label":"Federal Register - PCAC notice of meeting (Docket FDA-2025-N-6895)","url":"https://www.federalregister.gov/documents/2026/04/16/2026-07361/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request","primary":true},{"label":"FDA - 503A bulk drug substances: Category 1 & Category 2 lists","url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act","primary":true},{"label":"Frier Levitt - FDA to remove peptides from the Category 2 list (2026)","url":"https://www.frierlevitt.com/articles/fda-peptides-do-not-compound-list-update-2026/","primary":false},{"label":"FDA Law Blog - FDA's Pep(tide) Rally (Hyman, Phelps & McNamara)","url":"https://www.thefdalawblog.com/2026/04/fdas-peptide-rally-what-compounders-and-industry-need-to-know-post-1-of-2/","primary":false},{"label":"FDA - PCAC meeting page, July 23-24, 2026","url":"https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026","primary":true},{"label":"Healio - FDA committee recommends looser restrictions for several peptides","url":"https://www.healio.com/news/primary-care/20260724/fda-committee-recommends-looser-restrictions-for-several-peptides","primary":false},{"label":"Mintz - FDA's Advisory Committee Votes on Peptides: What It Does and Doesn't Do","url":"https://www.mintz.com/insights-center/viewpoints/2146/2026-07-29-fdas-advisory-committee-votes-peptides-what-it-does-and","primary":false},{"label":"FDA - PCAC July 23-24, 2026: questions put to the committee","url":"https://www.fda.gov/media/193711/download","primary":true},{"label":"FDA - PCAC July 23-24, 2026: meeting roster","url":"https://www.fda.gov/media/193772/download","primary":true},{"label":"MHRA guidance: supply of unlicensed medicinal products (specials)","url":"https://www.gov.uk/government/publications/supply-unlicensed-medicinal-products-specials","primary":false},{"label":"Health Canada advisory on unauthorized injectable peptides (Apr 9, 2026)","url":"https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm","primary":true},{"label":"EMA medicines database search: KPV","url":"https://www.ema.europa.eu/en/medicines?search_api_fulltext=KPV","primary":true}],"last_verified":"2026-09-22"},{"slug":"ll-37","name":"LL-37 (cathelicidin)","aliases":["Cathelicidin LL-37","Ropocamptide"],"nicknames":[],"url":"https://peptlas.com/entries/ll-37/","answer":"LL-37 (listed by FDA as cathelicidin LL-37; INN ropocamptide) is a peptide of the cathelicidin family. It is not FDA-approved and not on the 503A bulks list, so a U.S. pharmacy cannot lawfully compound it. FDA placed it in 503A Category 2 (significant safety risks) on September 29, 2023, and removed it on April 22, 2026 because the nominator withdrew its nomination. Removal from Category 2 does not authorize compounding: only Category 1 substances get FDA's interim enforcement discretion, and LL-37 is now in no category. FDA's Category 2 page still lists it among withdrawn nominations with its stated safety concerns. LL-37 is one of five substances - with GHK-Cu, dihexa acetate, Melanotan II and PEG-MGF - on the agenda of a Pharmacy Compounding Advisory Committee meeting that FDA says it will host before the end of February 2027; no date or Federal Register notice has been published. The committee's vote would be advisory. LL-37 could become compoundable only if FDA then added it to the 503A bulks list by rulemaking.","us":{"status":"in_limbo","label":"In limbo","detail":"Removed from Category 2 Apr 22, 2026, not on the 503A list; PCAC review expected before end of Feb 2027","since":"2026-04-22"},"jurisdictions":[{"authority":"United States (FDA)","regulator":"FDA","status":"in_limbo","label":"In limbo","note":"Removed from 503A Category 2 on Apr 22, 2026 after the nomination was withdrawn; not on the 503A list; PCAC review expected before end of Feb 2027."},{"authority":"Australia (TGA)","regulator":"TGA","status":"unscheduled","label":"Unscheduled","note":"Not individually named in the Poisons Standard (October 2026) and no product on the ARTG; supply for human use is unlawful without ARTG registration, and the TGA is enforcing against unapproved peptides."},{"authority":"United Kingdom (MHRA)","regulator":"MHRA","status":"restricted","label":"Restricted","note":"No UK marketing authorisation (not in the MHRA products substance index); supply as a medicine would be unlicensed."},{"authority":"European Union (EMA)","regulator":"EMA","status":"restricted","label":"Restricted","note":"No EU marketing authorisation or orphan designation (absent from the Union Register); sale as a medicine is unlawful EU-wide, with enforcement at member-state level."},{"authority":"Canada (Health Canada)","regulator":"Health Canada","status":"restricted","label":"Restricted","note":"Not in the Drug Product Database; a Health Canada advisory (Aug 1, 2025) lists seized LL-37 among unauthorized injectable peptide drugs, which it regulates as prescription drugs."},{"authority":"Sport / anti-doping (WADA)","regulator":"WADA","status":"restricted","label":"Restricted","note":"Not individually named, but prohibited at all times under the S0 catch-all for non-approved substances (2027 List)."}],"brazil":null,"next_event":{"date":"2027-02-28","label":"Second PCAC meeting on peptides, incl. LL-37 - expected before end of Feb 2027, no date published"},"advisory_vote":null,"sources":[{"label":"FDA - Certain bulk drug substances that may present significant safety risks (Category 2 page)","url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","primary":true},{"label":"FDA - 503A categories list, updated Apr 22, 2026 (Wayback Machine copy)","url":"https://web.archive.org/web/20260422215502/https://www.fda.gov/media/94155/download","primary":false},{"label":"FDA - Pharmacy Compounding Advisory Committee meeting, before the end of February 2027 (early announcement)","url":"https://www.fda.gov/advisory-committees/pharmacy-compounding-advisory-committee/meeting-pharmacy-compounding-advisory-committee","primary":true},{"label":"FDA - 503A categories list (updated May 14, 2026)","url":"https://www.fda.gov/media/94155/download","primary":true},{"label":"FDA warning letter - Advanced Nutriceuticals LLC dba The Guyer Institute of Molecular Medicine (Nov 10, 2021)","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/advanced-nutriceuticals-llc-dba-guyer-institute-molecular-medicine-615908-11102021","primary":true},{"label":"Therapeutic Goods (Poisons Standard - October 2026) Instrument 2026","url":"https://www.legislation.gov.au/F2026L01327/latest/text","primary":true},{"label":"Health Canada - Unauthorized injectable peptide drugs seized and sold by Canada Peptide (Aug 1, 2025)","url":"https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious","primary":true},{"label":"MHRA Products - substance index (C)","url":"https://products.mhra.gov.uk/substance-index/?letter=C","primary":true},{"label":"EU Union Register of medicinal products (active substance index)","url":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm","primary":true},{"label":"WADA - 2027 Prohibited List (in force Jan 1, 2027)","url":"https://www.wada-ama.org/sites/default/files/2026-09/2027list_en_final_clean_26_august_2026_2.pdf","primary":true}],"last_verified":"2026-10-15"},{"slug":"melanotan-2","name":"Melanotan II","aliases":["MT-II","MT-2","Melanotan-2"],"nicknames":[],"url":"https://peptlas.com/entries/melanotan-2/","answer":"Melanotan II is not FDA-approved for any indication and is not on the 503A Category 1 list of substances pharmacies may compound. It had been in Category 2 (significant safety risks); in April 2026 the FDA began moving a group of peptides out of Category 2 and scheduling advisory committee (PCAC) reviews, with Melanotan II among them. Removal from Category 2 does not by itself legalize compounding or place a substance on the 503A list, so it sits in a transitional status where compounding still carries regulatory risk. Melanotan II was not on the July 23-24, 2026 PCAC agenda; it is one of five substances - alongside LL-37, GHK-Cu, Dihexa acetate and PEG-MGF - expected at a second PCAC meeting the FDA has signalled for before the end of February 2027, though no date has been published. It is not a DEA-scheduled controlled substance, and the FDA-approved MC1R agonist afamelanotide is a separate compound.","us":{"status":"in_limbo","label":"In limbo","detail":"Off Category 2, not on the 503A list; PCAC review expected before end of Feb 2027","since":"2026-04-22"},"jurisdictions":[{"authority":"United States (FDA)","regulator":"FDA","status":"in_limbo","label":"In limbo","note":"Not on Category 1 / the 503A list; being moved out of Category 2; PCAC review expected before end of Feb 2027. Not DEA-scheduled."},{"authority":"Australia (TGA)","regulator":"TGA","status":"restricted","label":"Restricted","note":"Schedule 4 (prescription-only); no products registered on the ARTG; TGA has issued infringement notices for unlawful supply."},{"authority":"United Kingdom (MHRA)","regulator":"MHRA","status":"restricted","label":"Restricted","note":"No UK marketing authorisation; MHRA has repeatedly removed melanotan products from sale for over 10 years, though nasal sprays without medicinal claims are not generally regulated as medicines."},{"authority":"European Union (EMA)","regulator":"EMA","status":"restricted","label":"Restricted","note":"No EU marketing authorisation - no melanotan II entry in EMA's centrally authorised medicines database; sale as a medicine is unlawful EU-wide, with enforcement handled at member-state level."},{"authority":"Canada (Health Canada)","regulator":"Health Canada","status":"restricted","label":"Restricted","note":"Not authorized for sale; Health Canada names Melanotan I and II among unauthorized injectable peptide drugs it has seized, warning that unauthorized drug products are illegal in Canada."},{"authority":"Sport / anti-doping (WADA)","regulator":"WADA","status":"restricted","label":"Restricted","note":"Prohibited at all times, but not listed by name - captured by the S0 catch-all for non-approved substances (also argued under S2)."}],"brazil":{"status_class":"restricted","status_pt":"Sem medicamento registrado na ANVISA","summary_pt":"Nenhum medicamento com melanotan II consta da base de medicamentos registrados da ANVISA. Sem registro, não pode ser vendido como medicamento no Brasil. Não localizamos um ato da ANVISA específico sobre o melanotan II.","verified":"2026-10-09","url":"https://peptlas.com/pt-br/peptideos/melanotan-2/","sources":[{"label":"ANVISA - dados abertos de medicamentos registrados (consulta em 9 out. 2026)","url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","date":"2026-10-09"},{"label":"ANVISA - plano de ação para canetas de GLP-1","url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/anvisa-anuncia-novas-medidas-de-combate-a-irregularidades-na-importacao-e-manipulacao-de-canetas-emagrecedoras","date":"2026-04-06"}]},"next_event":{"date":"2027-02-28","label":"Second PCAC meeting on peptides, incl. Melanotan II - expected before end of Feb 2027, no date published"},"advisory_vote":null,"sources":[{"label":"FDA - 503A bulk drug substances: Category 1 & Category 2 lists","url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act","primary":true},{"label":"FDA - Pharmacy Compounding Advisory Committee meeting, before the end of February 2027 (early announcement)","url":"https://www.fda.gov/advisory-committees/pharmacy-compounding-advisory-committee/meeting-pharmacy-compounding-advisory-committee","primary":true},{"label":"FDA Law Blog - FDA's Pep(tide) Rally (Hyman, Phelps & McNamara)","url":"https://www.thefdalawblog.com/2026/04/fdas-peptide-rally-what-compounders-and-industry-need-to-know-post-1-of-2/","primary":false},{"label":"Orrick - FDA peptide compounding vote: what to watch at the July PCAC meeting","url":"https://www.orrick.com/en/Insights/2026/07/FDA-Peptide-Compounding-Vote-What-to-Watch-at-the-July-PCAC-Meeting","primary":false},{"label":"Boesen & Snow Law - FDA advances peptide compounding review","url":"https://www.boesensnowlaw.com/blog/fda-advances-peptide-compounding-review-category-2-removals-announced-and-pcac-hearing-confirmed/","primary":false},{"label":"The Conversation - Melanotan and Australian scheduling (secondary)","url":"https://theconversation.com/is-this-injectable-tanning-drug-safe-to-use-60628","primary":false},{"label":"MHRA FOI 21/1237 (gov.uk)","url":"https://assets.publishing.service.gov.uk/media/67bc97a898ea2db44fadddb1/FOI_21-1237_.pdf","primary":true},{"label":"Health Canada advisory - unauthorized peptide drugs","url":"https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm","primary":true},{"label":"EMA medicines database","url":"https://www.ema.europa.eu/en/medicines","primary":true}],"last_verified":"2026-09-22"},{"slug":"mots-c","name":"MOTS-c","aliases":["MOTs-C","Mitochondrial-derived peptide","MOTS-c acetate"],"nicknames":[],"url":"https://peptlas.com/entries/mots-c/","answer":"MOTS-c is a mitochondrial-derived peptide studied in metabolic research, largely in animal and observational work rather than controlled human trials. It is not FDA-approved and is not on the FDA's Section 503A Bulk Drug Substances List, so it is not eligible for pharmacy compounding. On July 23, 2026 the FDA's Pharmacy Compounding Advisory Committee voted 7-5, with 2 abstentions, to recommend adding it, against the FDA review staff's own recommendation. The vote is advisory and does not bind the FDA. Nothing about MOTS-c's legal status changed on the day of the vote. Before it could be compounded lawfully the FDA would have to accept the recommendation and complete notice-and-comment rulemaking - a process the agency has not begun and that is generally estimated at 12 to 24 months. Separately, MOTS-c is named on the 2026 WADA Prohibited List as a metabolic modulator, which the FDA process does not affect. In addition, nominations to add MOTS-c to the 503B bulks list - the list for outsourcing facilities, not the 503A list the committee reviewed - were posted to the FDA's docket on August 25, 2026; a nomination starts a review and changes nothing on its own.","us":{"status":"in_limbo","label":"In limbo","detail":"PCAC recommended listing (7-5, Jul 23, 2026) - advisory only; still not on the 503A list","since":"2026-07-23"},"jurisdictions":[{"authority":"United States (FDA)","regulator":"FDA","status":"in_limbo","label":"In limbo","note":"Not on the 503A Bulks List. PCAC recommended adding it on Jul 23, 2026 (7-5, 2 abstentions); the recommendation is advisory and the FDA has not acted."},{"authority":"Australia (TGA)","regulator":"TGA","status":"unscheduled","label":"Unscheduled","note":"Not individually named in the Poisons Standard; supply for human use is unlawful without ARTG registration, and the TGA is enforcing against unapproved peptides."},{"authority":"United Kingdom (MHRA)","regulator":"MHRA","status":"restricted","label":"Restricted","note":"No UK marketing authorisation; supply for human use treated as an unlicensed medicine."},{"authority":"European Union (EMA)","regulator":"EMA","status":"restricted","label":"Restricted","note":"No EU marketing authorisation in the Union Register; sale as a medicine is unlawful EU-wide, with enforcement handled at member-state level."},{"authority":"Canada (Health Canada)","regulator":"Health Canada","status":"restricted","label":"Restricted","note":"Named in Health Canada's April 2026 advisory on unauthorized injectable peptides; unauthorized drug products are illegal to sell in Canada."},{"authority":"Sport / anti-doping (WADA)","regulator":"WADA","status":"restricted","label":"Restricted","note":"Explicitly named on the 2026 Prohibited List under S4.4.1 (metabolic modulators / AMPK activators); prohibited at all times. Still listed on the 2027 List (published Sep 21, 2026; in force Jan 1, 2027)."}],"brazil":null,"next_event":null,"advisory_vote":{"date":"2026-07-23","body":"FDA Pharmacy Compounding Advisory Committee (PCAC)","outcome":"recommended","question":"Should MOTS-c (free base) be placed on the list? - and, as a separate vote, MOTS-c acetate?","yes":7,"no":5,"abstain":2,"tally_source":"reported by Healio and the FDA Law Blog (Hyman, Phelps & McNamara). The panel was not the same size for every substance - the meeting roster seats temporary voting members for single topics - so the totals legitimately differ between votes"},"sources":[{"label":"Federal Register - PCAC notice of meeting (Docket FDA-2025-N-6895)","url":"https://www.federalregister.gov/documents/2026/04/16/2026-07361/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request","primary":true},{"label":"FDA - 503A bulk drug substances: Category 1 & Category 2 lists","url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act","primary":true},{"label":"WADA - 2026 Prohibited List","url":"https://www.wada-ama.org/en/prohibited-list","primary":true},{"label":"FDA Law Blog - FDA's Pep(tide) Rally (Hyman, Phelps & McNamara)","url":"https://www.thefdalawblog.com/2026/04/fdas-peptide-rally-what-compounders-and-industry-need-to-know-post-1-of-2/","primary":false},{"label":"FDA - PCAC meeting page, July 23-24, 2026","url":"https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026","primary":true},{"label":"Healio - FDA committee recommends looser restrictions for several peptides","url":"https://www.healio.com/news/primary-care/20260724/fda-committee-recommends-looser-restrictions-for-several-peptides","primary":false},{"label":"Mintz - FDA's Advisory Committee Votes on Peptides: What It Does and Doesn't Do","url":"https://www.mintz.com/insights-center/viewpoints/2146/2026-07-29-fdas-advisory-committee-votes-peptides-what-it-does-and","primary":false},{"label":"FDA - PCAC July 23-24, 2026: questions put to the committee","url":"https://www.fda.gov/media/193711/download","primary":true},{"label":"FDA - PCAC July 23-24, 2026: meeting roster","url":"https://www.fda.gov/media/193772/download","primary":true},{"label":"MHRA Products database (no entry)","url":"https://products.mhra.gov.uk/search/?search=mots-c&page=1","primary":true},{"label":"Health Canada public advisory (Apr 9, 2026)","url":"https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm","primary":true},{"label":"Union Register of medicinal products (EC)","url":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm","primary":true},{"label":"Regulations.gov - 503B bulks nomination, MOTS-c (free base), BPI Labs (posted Aug 25, 2026)","url":"https://www.regulations.gov/document/FDA-2015-N-3469-0440","primary":true},{"label":"Regulations.gov - 503B bulks nomination, MOTS-c (acetate), BPI Labs (posted Aug 25, 2026)","url":"https://www.regulations.gov/document/FDA-2015-N-3469-0441","primary":true},{"label":"WADA - 2027 Prohibited List published (Sep 21, 2026)","url":"https://www.wada-ama.org/en/news/wada-publishes-2027-prohibited-list","primary":true}],"last_verified":"2026-09-22"},{"slug":"nad-plus","name":"NAD+","aliases":["Nicotinamide adenine dinucleotide","NAD","β-NAD"],"nicknames":[],"url":"https://peptlas.com/entries/nad-plus/","answer":"In the United States, NAD+ sits in an unresolved regulatory zone rather than a clearly permitted or clearly banned one. It was nominated for the 503A list, but the advisory committee recommended against inclusion (2017) and the FDA's September 2019 proposed rule listed NAD among substances it proposed not to add; no final rule has definitively placed it on the list. It is not an FDA-approved drug, yet there is no formal federal ban: oral NAD+ is sold as a dietary supplement, and pharmacies continue to prepare NAD+ injections and IV infusions in a gray area. Recent FDA activity has focused on ingredient-quality reminders and product-specific recalls rather than scheduling the substance itself.","us":{"status":"in_limbo","label":"In limbo","detail":"Not on the finalized 503A list; no federal ban; compounded in a gray area","since":"2019-09-05"},"jurisdictions":[{"authority":"United States (FDA)","regulator":"FDA","status":"in_limbo","label":"In limbo","note":"Proposed for non-inclusion (2019); no final rule and no ban; oral sold as a supplement; injectable compounded in a gray area."},{"authority":"Australia (TGA)","regulator":"TGA","status":"restricted","label":"Restricted","note":"Per an April 2025 TGA safety alert, NAD/NAD+/NADH are not permitted ingredients in listed medicines."},{"authority":"United Kingdom (MHRA)","regulator":"MHRA","status":"restricted","label":"Restricted","note":"No UK marketing authorisation; injectable NAD+ is supplied only as an unlicensed 'special' on a prescriber's order, while oral NAD+ is sold under food-supplement rules."},{"authority":"European Union (EMA)","regulator":"EMA","status":"restricted","label":"Restricted","note":"No EU marketing authorisation; injectable NAD+ cannot be marketed as a medicine EU-wide, with enforcement handled at member-state level; oral NAD+ circulates under food-supplement law."},{"authority":"Canada (Health Canada)","regulator":"Health Canada","status":"restricted","label":"Restricted","note":"No approved injectable NAD+ in the Drug Product Database; an April 2026 Health Canada advisory lists NAD+ among unauthorized injectable drugs illegal to sell; oral NAD+ is regulated as a natural health product."},{"authority":"Sport / anti-doping (WADA)","regulator":"WADA","status":"unscheduled","label":"Unscheduled","note":"Not named on the Prohibited List, but IV infusions over 100 mL per 12 hours are prohibited as a method (M2.2)."}],"brazil":{"status_class":"restricted","status_pt":"Sem medicamento registrado; injetável proibido","summary_pt":"A ANVISA não tem nenhum medicamento de NAD+ registrado (a base oficial cita apenas um produto homeopático com vários componentes), e em 6 de outubro de 2026 a Resolução-RE 3.947/2026 proibiu e mandou apreender um NAD+ injetável vendido pela internet. Não verificamos o status do NAD+ como ingrediente de suplemento oral.","verified":"2026-10-09","url":"https://peptlas.com/pt-br/peptideos/nad-plus/","sources":[{"label":"ANVISA - Resolução-RE 3.947/2026","url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/anvisa-proibe-venda-de-insulina-e-tirzepatida-irregulares-1","date":"2026-10-06"},{"label":"ANVISA - dados abertos de medicamentos registrados (consulta em 9 out. 2026)","url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","date":"2026-10-09"}]},"next_event":null,"advisory_vote":null,"sources":[{"label":"Federal Register - 2019 proposed rule, 503A bulk drug substances","url":"https://www.federalregister.gov/documents/2019/09/05/2019-18951/amendments-to-the-list-of-bulk-drug-substances-that-can-be-used-to-compound-drug-products-in","primary":true},{"label":"BSCG - NAD+ rules, risks and testing","url":"https://www.bscg.org/blogs/single/nad-rules-risks-and-testing-in-athletics-and-armed-forces","primary":false},{"label":"Partnership for Safe Medicines - FDA sterile-compounding reminder","url":"https://www.safemedicines.org/2024/11/nov-4-2024.html","primary":false},{"label":"eCFR - 21 CFR 216.23 (503A bulk drug substances lists)","url":"https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-216/section-216.23","primary":true},{"label":"MHRA - The supply of unlicensed medicinal products ('specials'), gov.uk","url":"https://www.gov.uk/government/publications/supply-unlicensed-medicinal-products-specials","primary":false},{"label":"Health Canada public advisory - Think twice before injecting peptides bought online (Apr 9, 2026)","url":"https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm","primary":true},{"label":"EMA - Medicines search (no entry for nicotinamide adenine dinucleotide)","url":"https://www.ema.europa.eu/en/medicines?search_api_views_fulltext=nicotinamide+adenine+dinucleotide","primary":true}],"last_verified":"2026-09-22"},{"slug":"pt-141","name":"PT-141 (bremelanotide)","aliases":["Bremelanotide","Vyleesi","Bremelanotide acetate"],"nicknames":[],"url":"https://peptlas.com/entries/pt-141/","answer":"PT-141 (bremelanotide) is a melanocortin receptor agonist peptide that the FDA approved on June 21, 2019 as Vyleesi, a 1.75 mg subcutaneous autoinjector for premenopausal women with acquired, generalized hypoactive sexual desire disorder. That makes it a prescription-only drug in the United States. Cosette Pharmaceuticals now holds the application, and Vyleesi is still marketed. Compounding is narrow. Because bremelanotide is a component of an approved drug, a state-licensed 503A pharmacy may compound it for an individual patient's prescription, using bulk material from an FDA-registered manufacturer, but it may not regularly make essentially copies of Vyleesi (same ingredient, similar strength, same route) unless the prescriber documents a significant difference for that patient. Selling PT-141 as a \"research\" peptide is not lawful: on August 24, 2026 the FDA issued warning letters to five online sellers, including Royal Peptides and Peptide Partners, calling their PT-141 products unapproved new drugs. No FDA rulemaking, advisory committee review or other dated decision on bremelanotide is pending.","us":{"status":"restricted","label":"Restricted","detail":"FDA-approved prescription drug (Vyleesi, 2019); pharmacies may not routinely compound copies of it","since":"2019-06-21"},"jurisdictions":[{"authority":"United States (FDA)","regulator":"FDA","status":"restricted","label":"Restricted","note":"FDA-approved prescription drug: Vyleesi, NDA 210557, approved Jun 21, 2019. As a component of that drug it may be 503A-compounded for an individual patient, but not as regular copies of Vyleesi while it is marketed. Aug 24, 2026: FDA warning letters to five online \"research peptide\" sellers name PT-141."},{"authority":"Australia (TGA)","regulator":"TGA","status":"unscheduled","label":"Unscheduled","note":"Not individually named in the Poisons Standard (October 2026) and no product on the ARTG; supply for human use is unlawful without ARTG registration, and the TGA is enforcing against unapproved peptides."},{"authority":"United Kingdom (MHRA)","regulator":"MHRA","status":"restricted","label":"Restricted","note":"No UK marketing authorisation (no bremelanotide product in the MHRA Products database); supply as a medicine would be unlicensed."},{"authority":"European Union (EMA)","regulator":"EMA","status":"restricted","label":"Restricted","note":"No EU marketing authorisation: absent from the Union Register, and EMA's medicines data lists no application for it. Enforcement against unlicensed supply is handled at member-state level."},{"authority":"Canada (Health Canada)","regulator":"Health Canada","status":"restricted","label":"Restricted","note":"No authorized product in the Drug Product Database; Health Canada named bremelanotide among unauthorized injectable peptide drugs seized from Canada Peptide (advisory updated Aug 1, 2025)."},{"authority":"Sport / anti-doping (WADA)","regulator":"WADA","status":"unscheduled","label":"Unscheduled","note":"Not named on the 2026 or 2027 Prohibited List or the 2027 Monitoring Program; S0 covers only substances with no government approval for human use, and bremelanotide is FDA-approved."}],"brazil":null,"next_event":null,"advisory_vote":null,"sources":[{"label":"Drugs@FDA - NDA 210557 (Vyleesi)","url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210557","primary":true},{"label":"FDA - Bulk drug substances used in compounding under section 503A","url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act","primary":true},{"label":"FDA guidance - Compounded drug products that are essentially copies of a commercially available drug product under section 503A (Jan 2018)","url":"https://www.fda.gov/media/98973/download","primary":true},{"label":"FDA warning letter - Royal Peptides LLC (Aug 24, 2026)","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026","primary":true},{"label":"FDA warning letter - Peptide Partners LLC (Aug 24, 2026)","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026","primary":true},{"label":"Health Canada advisory - Unauthorized injectable peptide drugs seized and sold by Canada Peptide","url":"https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious","primary":true},{"label":"TGA - Australian Register of Therapeutic Goods search: bremelanotide","url":"https://www.tga.gov.au/resources/artg?keywords=bremelanotide","primary":true},{"label":"MHRA Products database - search: bremelanotide","url":"https://products.mhra.gov.uk/search/?search=bremelanotide&page=1","primary":true},{"label":"Union Register of medicinal products (European Commission)","url":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm","primary":true},{"label":"WADA - 2027 Prohibited List (in force Jan 1, 2027)","url":"https://www.wada-ama.org/sites/default/files/2026-09/2027list_en_final_clean_26_august_2026_2.pdf","primary":true}],"last_verified":"2026-10-15"},{"slug":"retatrutide","name":"Retatrutide","aliases":["LY3437943","GIP/GLP-1/glucagon triple agonist","triple G"],"nicknames":["reta"],"url":"https://peptlas.com/entries/retatrutide/","answer":"Retatrutide is an investigational drug - Eli Lilly's GIP/GLP-1/glucagon triple agonist - with no approved form anywhere in the world. Five Phase 3 TRIUMPH trials have read out positively and Lilly has said it plans to submit a Biologics License Application to the FDA in the first quarter of 2027, but until approval there is no legal commercial product. Compounding is not an option either: retatrutide is not a component of any approved drug, has never been on the FDA shortage list, and is not an eligible bulk substance - so the pathways that briefly permitted compounded semaglutide and tirzepatide never applied to it. The FDA states plainly that retatrutide cannot be used in compounding, and it has sent warning letters to sellers offering it as a 'research' chemical - most recently in letters dated August 24, 2026, including under coded names - treating that framing as immaterial when the product is aimed at human use. Note this entry sits outside the 503A pipeline entirely: no advisory-committee review of retatrutide is scheduled or on record.","us":{"status":"restricted","label":"Restricted","detail":"Investigational only - no approved form exists anywhere; cannot be compounded; FDA warning letters target sellers","since":"2025-09-09"},"jurisdictions":[{"authority":"United States (FDA)","regulator":"FDA","status":"restricted","label":"Restricted","note":"Investigational; not approved, not compoundable (never on the shortage list, not an eligible bulk substance). FDA warning letters to sellers, including products sold under coded names."},{"authority":"Australia (TGA)","regulator":"TGA","status":"restricted","label":"Restricted","note":"Not in the ARTG; the TGA names retatrutide among unapproved peptide products and takes enforcement action against unlawful import, compounding, supply and advertising. Victoria's Chief Health Officer issued a health alert on Jun 19, 2026 (still active) after six cases of acute liver injury since January 2026 in people who used products labelled Retatrutide, Reta, R-10 or R-20."},{"authority":"United Kingdom (MHRA)","regulator":"MHRA","status":"restricted","label":"Restricted","note":"No UK marketing authorisation; supply for human use treated as an unlicensed medicine - MHRA has seized unlicensed retatrutide products in enforcement operations."},{"authority":"European Union (EMA)","regulator":"EMA","status":"restricted","label":"Restricted","note":"No EU marketing authorisation and no application under CHMP evaluation as of August 2026; sale as a medicine is unlawful EU-wide, with enforcement handled at member-state level."},{"authority":"Canada (Health Canada)","regulator":"Health Canada","status":"restricted","label":"Restricted","note":"Not authorized by Health Canada; named in an April 2026 advisory on unauthorized injectable peptide drugs - unauthorized drug products are illegal to sell in Canada."},{"authority":"Sport / anti-doping (WADA)","regulator":"WADA","status":"restricted","label":"Restricted","note":"Prohibited at all times, but not listed by name - captured by the S0 catch-all for substances with no regulatory approval for human use."}],"brazil":{"status_class":"restricted","status_pt":"Sem registro em nenhum país; proibida","summary_pt":"A ANVISA afirma que a retatrutida é um medicamento experimental, não aprovado em nenhum lugar do mundo, e que o fabricante ainda não pediu registro. Produtos de retatrutida de todas as marcas foram proibidos e mandados apreender em 2026, e 572 unidades foram apreendidas no Aeroporto do Galeão em setembro.","verified":"2026-10-09","url":"https://peptlas.com/pt-br/peptideos/retatrutida/","sources":[{"label":"ANVISA - retatrutida não está aprovada em nenhum país","url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/retatrutida-ainda-nao-esta-aprovada-para-uso-em-nenhum-lugar-do-mundo","date":"2026-07-24"},{"label":"ANVISA - Resolução-RE 214/2026","url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/canetas-emagrecedoras-lotes-de-tirzepatida-das-marcas-synedica-e-tg-estao-proibidos-e-devem-ser-apreendidos","date":"2026-01-21"},{"label":"ANVISA - Resolução-RE 690/2026","url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/anvisa-determina-apreensao-de-canetas-emagrecedoras-sem-registro-sanitario","date":"2026-02-23"},{"label":"ANVISA - apreensão no Aeroporto do Galeão","url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/mais-de-1000-produtos-irregulares-apreendidos-no-aeroporto-do-galeao","date":"2026-09-22"},{"label":"ANVISA - Resolução-RE 3.947/2026","url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/anvisa-proibe-venda-de-insulina-e-tirzepatida-irregulares-1","date":"2026-10-06"}]},"next_event":{"date":"2027-03-31","label":"Lilly BLA submission to the FDA expected in Q1 2027 - an approval decision would follow well after"},"advisory_vote":null,"sources":[{"label":"FDA - FDA's concerns with unapproved GLP-1 drugs used for weight loss","url":"https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss","primary":true},{"label":"FDA - warning letter, GLP-1 Solution (Sep 9, 2025)","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/glp-1-solution-715883-09092025","primary":true},{"label":"FDA - press announcement: 30 telehealth companies warned over compounded GLP-1 marketing","url":"https://www.fda.gov/news-events/press-announcements/fda-warns-30-telehealth-companies-against-illegal-marketing-compounded-glp-1s","primary":true},{"label":"Eli Lilly - retatrutide Phase 3 TRIUMPH results (investor release)","url":"https://investor.lilly.com/news-releases/news-release-details/lillys-triple-agonist-retatrutide-successful-two-additional","primary":false},{"label":"Eli Lilly - what to know about retatrutide","url":"https://www.lilly.com/news/stories/what-to-know-about-retatrutide","primary":false},{"label":"BioPharma Dive - Lilly, with new data, to seek FDA approval of retatrutide","url":"https://www.biopharmadive.com/news/lilly-retatrutide-fda-application-obesity-drug-results/825987/","primary":false},{"label":"Camino Strategy Group - retatrutide and compounding: regulations and enforcement records","url":"https://caminostrategygroup.com/resources/retatrutide","primary":false},{"label":"USADA - the WADA Prohibited List (S0: non-approved substances)","url":"https://www.usada.org/substances/prohibited-list/","primary":false},{"label":"MHRA press release, GOV.UK (29 May 2026)","url":"https://www.gov.uk/government/news/two-arrested-during-the-mhras-largest-ever-seizure-of-unlicensed-weight-loss-medicines","primary":false},{"label":"Health Canada advisory (9 Apr 2026)","url":"https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm","primary":true},{"label":"EMA - Medicines for human use under evaluation (Aug 2026 list)","url":"https://www.ema.europa.eu/en/medicines/medicines-human-use-under-evaluation","primary":true},{"label":"TGA safety advisory (13 Apr 2026)","url":"https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts/understanding-your-responsibilities-when-importing-compounding-and-supplying-unapproved-peptide-products","primary":true},{"label":"FDA - warning letter, Royal Peptides LLC (Aug 24, 2026)","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026","primary":true},{"label":"Victoria Department of Health - health alert: toxicity linked to products labelled Retatrutide (Jun 19, 2026)","url":"https://www.health.vic.gov.au/health-alerts/toxicity-linked-to-unapproved-peptide-product-labelled-retatrutide","primary":true}],"last_verified":"2026-10-09"},{"slug":"selank","name":"Selank","aliases":["Selank acetate","TP-7"],"nicknames":[],"url":"https://peptlas.com/entries/selank/","answer":"Selank sits in a regulatory gray area in the United States. It was removed from Category 2 of the interim 503A bulks list in 2024 after its nomination was withdrawn - but removal from Category 2 does not place a substance on the 503A list or into Category 1, and the FDA has not stated it will exercise enforcement discretion for it. Legal analyses describe such peptides as being in limbo pending advisory committee review. Selank is not among the seven peptides scheduled for the July 2026 PCAC meeting and has no set decision date, so its compounding status is unresolved.","us":{"status":"in_limbo","label":"In limbo","detail":"Removed from Category 2 (2024); not on the 503A list; no scheduled review","since":"2024-09-27"},"jurisdictions":[{"authority":"United States (FDA)","regulator":"FDA","status":"in_limbo","label":"In limbo","note":"Removed from Category 2 (~Sept 2024); never in Category 1; not on the 503A list; no scheduled PCAC review."},{"authority":"Australia (TGA)","regulator":"TGA","status":"unscheduled","label":"Unscheduled","note":"Not individually named or scheduled in the Poisons Standard."},{"authority":"United Kingdom (MHRA)","regulator":"MHRA","status":"restricted","label":"Restricted","note":"No UK marketing authorisation; supply for human use treated as an unlicensed medicine."},{"authority":"European Union (EMA)","regulator":"EMA","status":"restricted","label":"Restricted","note":"No EU marketing authorisation; Selank does not appear in the Union Register, so sale as a medicine is unlawful EU-wide, with enforcement handled at member-state level."},{"authority":"Canada (Health Canada)","regulator":"Health Canada","status":"restricted","label":"Restricted","note":"Not authorized by Health Canada; a 2025 public advisory named Selank among seized unauthorized injectable peptide drugs, stating that selling unauthorized drugs is illegal in Canada."},{"authority":"Sport / anti-doping (WADA)","regulator":"WADA","status":"restricted","label":"Restricted","note":"Falls under S0 (non-approved substances); prohibited at all times for tested athletes."}],"brazil":null,"next_event":null,"advisory_vote":null,"sources":[{"label":"FDA - 503A bulk drug substances: Category 1 & Category 2 lists","url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act","primary":true},{"label":"Lexology - FDA removes five peptides from Category 2 (Sept 2024)","url":"https://www.lexology.com/library/detail.aspx?g=2e55b76a-3173-4e04-beda-bf021202f18d","primary":false},{"label":"Pharmacy Times - the peptide reclassification, explained","url":"https://www.pharmacytimes.com/view/the-peptide-reclassification-everyone-s-talking-about-a-pharmacist-s-take-on-what-rfk-jr-s-announcement-actually-means","primary":false},{"label":"FDA Law Blog - FDA's Pep(tide) Rally (Hyman, Phelps & McNamara)","url":"https://www.thefdalawblog.com/2026/04/fdas-peptide-rally-what-compounders-and-industry-need-to-know-post-1-of-2/","primary":false},{"label":"MHRA Products database - search: selank","url":"https://products.mhra.gov.uk/search/?search=selank&page=1","primary":true},{"label":"Health Canada public advisory (Aug 1, 2025)","url":"https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious","primary":true},{"label":"Union Register of medicinal products - active substance index","url":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm","primary":true}],"last_verified":"2026-09-22"},{"slug":"semaglutide","name":"Semaglutide (compounded)","aliases":["Ozempic","Wegovy","compounded semaglutide"],"nicknames":[],"url":"https://peptlas.com/entries/semaglutide/","answer":"Semaglutide is an FDA-approved drug (Ozempic, Wegovy), not a 503A bulk substance. Pharmacies were permitted to compound copies of it only while it sat on the FDA drug-shortage list. After the FDA declared the shortage resolved in February 2025, that permission wound down - ending April 22, 2025 for 503A pharmacies and May 22, 2025 for 503B outsourcing facilities - and the FDA now treats mass compounding of \"essentially a copy\" of the approved drug as an actionable violation. A narrow exception survives for patient-specific products that are not essentially a copy, and the FDA is enforcing that limit. On September 18, 2026 it warned Empower Pharmacy, a Houston compounding pharmacy, that its semaglutide/cyanocobalamin (vitamin B12) injections appear to be essentially copies of the approved drug; the letter points to \"significant difference\" statements repeated verbatim across many prescriptions, which suggests they were pre-generated for prescribers to pick rather than written for an individual patient. In April 2026 the FDA proposed to permanently exclude semaglutide - along with tirzepatide and liraglutide - from the 503B bulks list; the public comment period closed July 30, 2026 (extended from June 30) and the FDA's final determination is pending, with no announced date.","us":{"status":"restricted","label":"Restricted","detail":"Enforcement discretion ended; routine compounding no longer permitted. 503B exclusion proposed - comments closed Jul 30, 2026, decision pending","since":"2025-04-22"},"jurisdictions":[{"authority":"United States (FDA)","regulator":"FDA","status":"restricted","label":"Restricted","note":"Enforcement discretion ended Apr 22, 2025 (503A, as announced; the FDA's Sep 2026 Empower letter dates it Apr 24) / May 22, 2025 (503B); FDA proposed permanent 503B exclusion (Apr 2026). Narrow patient-specific 503A exception remains. Sep 18, 2026: FDA warning letter to Empower Pharmacy over semaglutide/B12 injections that appear to be essentially copies."},{"authority":"Australia (TGA)","regulator":"TGA","status":"restricted","label":"Restricted","note":"GLP-1 analogues removed from the pharmacist compounding exemption effective Oct 1, 2024; remains Schedule 4."},{"authority":"United Kingdom (MHRA)","regulator":"MHRA","status":"restricted","label":"Restricted","note":"Licensed prescription-only medicine; unlicensed copies may not be supplied where the licensed product can meet the patient's need, and MHRA enforces against unlicensed semaglutide products."},{"authority":"European Union (EMA)","regulator":"EMA","status":"restricted","label":"Restricted","note":"Centrally authorised prescription-only medicine; compounded versions hold no EU marketing authorisation, with enforcement against unlicensed supply handled at member-state level."},{"authority":"Canada (Health Canada)","regulator":"Health Canada","status":"restricted","label":"Restricted","note":"Authorized prescription-only medicine (Ozempic, Wegovy), and generic semaglutide has been on sale since May 2026 (Dr. Reddy's from May 6, Apotex from May 14); both had Type II recalls in Aug-Sep 2026 (an impurity out of specification; a pen showing the wrong dose). Compounded copies of marketed drugs are not permitted outside a shortage, and Health Canada has recalled compounded semaglutide made with an unauthorized API."},{"authority":"Sport / anti-doping (WADA)","regulator":"WADA","status":"unscheduled","label":"Unscheduled","note":"Not prohibited; on the WADA Monitoring Program since 2024. WADA confirmed GLP-1 status is unchanged for 2027 (Sep 21, 2026)."}],"brazil":{"status_class":"registered_medicine","status_pt":"Registrada (Ozempic, Wegovy e outras), com receita retida","summary_pt":"A semaglutida tem medicamentos registrados na ANVISA (Ozempic, Rybelsus, Wegovy e, desde 2026, versões sintéticas e genérica) e só é vendida com receita em duas vias, retida pela farmácia. A patente expirou em 20 de março de 2026. A manipulação segue regras restritas da Nota Técnica 200/2025, em revisão desde abril de 2026.","verified":"2026-10-09","url":"https://peptlas.com/pt-br/peptideos/semaglutida/","sources":[{"label":"ANVISA - dados abertos de medicamentos registrados (consulta em 9 out. 2026)","url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","date":"2026-10-09"},{"label":"CFF - novas regras para agonistas de GLP-1","url":"https://site.cff.org.br/noticia/Noticias-gerais/16/01/2026/anvisa-estabelece-novas-regras-para-prescricao-e-dispensacao-de-medicamentos-agonistas-de-glp-1","date":"2026-01-16"},{"label":"ANVISA - plano de ação para canetas de GLP-1","url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/anvisa-anuncia-novas-medidas-de-combate-a-irregularidades-na-importacao-e-manipulacao-de-canetas-emagrecedoras","date":"2026-04-06"},{"label":"ANVISA - registro do Ozivy (Resolução-RE 2.122/2026)","url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/anvisa-aprova-primeira-caneta-de-semaglutida-sintetica-analoga-ao-ozempic-para-diabetes","date":"2026-05-26"},{"label":"ANVISA - registro de cinco canetas de semaglutida","url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/anvisa-registra-cinco-novas-canetas-de-semaglutida","date":"2026-07-29"},{"label":"Agência Brasil - primeira semaglutida genérica","url":"https://agenciabrasil.ebc.com.br/saude/noticia/2026-08/anvisa-aprova-novas-canetas-de-semaglutida-incluindo-1a-generica","date":"2026-08-17"},{"label":"ANVISA - regras para manipulação de canetas de GLP-1","url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2025/anvisa-esclarece-e-determina-regras-para-manipulacao-de-canetas-de-glp-1","date":"2025-08-25"}]},"next_event":null,"advisory_vote":null,"sources":[{"label":"Federal Register - 503B bulk drug substances clinical-need proposal (FR 2026-08552)","url":"https://www.federalregister.gov/documents/2026/05/01/2026-08552/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal","primary":true},{"label":"Federal Register - comment-period extension (FR 2026-12937)","url":"https://www.govinfo.gov/content/pkg/FR-2026-06-26/html/2026-12937.htm","primary":true},{"label":"McDermott - semaglutide shortage resolved; compounding wind-down","url":"https://www.mcdermottlaw.com/insights/semaglutide-shortage-resolved/","primary":false},{"label":"Alston & Bird - FDA resolves semaglutide shortage","url":"https://www.alston.com/en/insights/publications/2025/03/fda-resolves-semaglutide-shortage","primary":false},{"label":"EMJ - GLP-1 receptor agonists on WADA Monitoring Program","url":"https://www.emjreviews.com/general-healthcare/news/glp-1ras-monitored-at-2026-winter-olympics/","primary":false},{"label":"GOV.UK - MHRA: No summer shortcut for safe weight loss (24 Jul 2026)","url":"https://www.gov.uk/government/news/no-summer-shortcut-for-safe-weight-loss","primary":false},{"label":"Health Canada recall - compounded Semaglutide + Pyridoxine (21 Jan 2025)","url":"https://recalls-rappels.canada.ca/en/alert-recall/semaglutide-pyridoxine-produced-unauthorized-active-pharmaceutical-ingredient","primary":true},{"label":"EMA - Ozempic (semaglutide) EPAR","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/ozempic","primary":true},{"label":"WADA - 2027 Prohibited List published (Sep 21, 2026)","url":"https://www.wada-ama.org/en/news/wada-publishes-2027-prohibited-list","primary":true},{"label":"FDA - warning letter, Empower Pharmacy (Sep 18, 2026)","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026","primary":true},{"label":"Health Canada Drug Product Database - Dr. Reddy's Semaglutide Injection","url":"https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=107018","primary":true},{"label":"Health Canada Drug Product Database - Apo-Semaglutide Injection","url":"https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=107037","primary":true},{"label":"Health Canada recall - Dr. Reddy's Semaglutide Injection, impurity out of specification (Aug 27, 2026)","url":"https://recalls-rappels.canada.ca/en/alert-recall/semaglutide-injection-out-specification-impurity","primary":true},{"label":"Health Canada recall - Apo-Semaglutide Injection, incorrect dose display (Sep 25, 2026)","url":"https://recalls-rappels.canada.ca/en/alert-recall/apo-semaglutide-injection-incorrect-dose-display-0","primary":true}],"last_verified":"2026-10-09"},{"slug":"semax","name":"Semax","aliases":["Semax acetate"],"nicknames":[],"url":"https://peptlas.com/entries/semax/","answer":"Semax is a synthetic heptapeptide with no FDA-approved drug product and no USP monograph in the United States, so a positive listing on the 503A (or 503B) bulk drug substances list is the only route to legal compounding - and Semax is on neither. On July 24, 2026 the FDA's Pharmacy Compounding Advisory Committee voted 8-5, with 1 abstention, to recommend adding it to the 503A list, against the recommendation of the FDA's own review staff. The vote is advisory and does not bind the FDA. Nothing about Semax's legal status changed on the day of the vote. Before it could be compounded lawfully the FDA would have to accept the recommendation and complete notice-and-comment rulemaking - a process the agency has not begun and that is generally estimated at 12 to 24 months. Separately, nominations to add Semax to the 503B bulks list - the list for outsourcing facilities, not the 503A list the committee reviewed - were posted to the FDA's docket on August 25, 2026; a nomination starts a review and changes nothing on its own.","us":{"status":"in_limbo","label":"In limbo","detail":"PCAC recommended listing (8-5, Jul 24, 2026) - advisory only; still not on the 503A list","since":"2026-07-24"},"jurisdictions":[{"authority":"United States (FDA)","regulator":"FDA","status":"in_limbo","label":"In limbo","note":"Not on the 503A Bulks List. PCAC recommended adding it on Jul 24, 2026 (8-5, 1 abstention); the recommendation is advisory and the FDA has not acted."},{"authority":"Australia (TGA)","regulator":"TGA","status":"unscheduled","label":"Unscheduled","note":"Not individually named in the Poisons Standard; sits in a grey area."},{"authority":"United Kingdom (MHRA)","regulator":"MHRA","status":"restricted","label":"Restricted","note":"No UK marketing authorisation; supply for human use treated as an unlicensed medicine."},{"authority":"European Union (EMA)","regulator":"EMA","status":"restricted","label":"Restricted","note":"No EU marketing authorisation; sale as a medicine is unlawful EU-wide, with enforcement handled at member-state level."},{"authority":"Canada (Health Canada)","regulator":"Health Canada","status":"restricted","label":"Restricted","note":"No Health Canada authorization; named in an August 2025 Health Canada seizure advisory on unauthorized injectable peptides, which cannot legally be sold in Canada."},{"authority":"Sport / anti-doping (WADA)","regulator":"WADA","status":"restricted","label":"Restricted","note":"Not individually named, but prohibited at all times under the S0 catch-all for non-approved substances."}],"brazil":null,"next_event":null,"advisory_vote":{"date":"2026-07-24","body":"FDA Pharmacy Compounding Advisory Committee (PCAC)","outcome":"recommended","question":"Should Semax (free base) be placed on the list? - and, as a separate vote, Semax acetate?","yes":8,"no":5,"abstain":1,"tally_source":"reported by Healio and the FDA Law Blog (Hyman, Phelps & McNamara). The panel was not the same size for every substance - the meeting roster seats temporary voting members for single topics - so the totals legitimately differ between votes"},"sources":[{"label":"Federal Register - PCAC notice of meeting (Docket FDA-2025-N-6895)","url":"https://www.federalregister.gov/documents/2026/04/16/2026-07361/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request","primary":true},{"label":"FDA Law Blog - FDA's Pep(tide) Rally (Hyman, Phelps & McNamara)","url":"https://www.thefdalawblog.com/2026/04/fdas-peptide-rally-what-compounders-and-industry-need-to-know-post-1-of-2/","primary":false},{"label":"FDA - PCAC meeting page, July 23-24, 2026","url":"https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026","primary":true},{"label":"Healio - FDA committee recommends looser restrictions for several peptides","url":"https://www.healio.com/news/primary-care/20260724/fda-committee-recommends-looser-restrictions-for-several-peptides","primary":false},{"label":"Mintz - FDA's Advisory Committee Votes on Peptides: What It Does and Doesn't Do","url":"https://www.mintz.com/insights-center/viewpoints/2146/2026-07-29-fdas-advisory-committee-votes-peptides-what-it-does-and","primary":false},{"label":"FDA - PCAC July 23-24, 2026: questions put to the committee","url":"https://www.fda.gov/media/193711/download","primary":true},{"label":"FDA - PCAC July 23-24, 2026: meeting roster","url":"https://www.fda.gov/media/193772/download","primary":true},{"label":"MHRA guidance: Supply unlicensed medicinal products (specials)","url":"https://www.gov.uk/government/publications/supply-unlicensed-medicinal-products-specials","primary":false},{"label":"Health Canada advisory: Unauthorized injectable peptide drugs seized and sold by Canada Peptide (Aug 1, 2025)","url":"https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious","primary":true},{"label":"Union Register of medicinal products (European Commission)","url":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm","primary":true},{"label":"Regulations.gov - 503B bulks nomination, Semax (free base), BPI Labs (posted Aug 25, 2026)","url":"https://www.regulations.gov/document/FDA-2015-N-3469-0442","primary":true},{"label":"Regulations.gov - 503B bulks nomination, Semax (acetate), BPI Labs (posted Aug 25, 2026)","url":"https://www.regulations.gov/document/FDA-2015-N-3469-0443","primary":true}],"last_verified":"2026-09-22"},{"slug":"sermorelin","name":"Sermorelin","aliases":["GRF 1-29","Geref","Sermorelin acetate"],"nicknames":[],"url":"https://peptlas.com/entries/sermorelin/","answer":"Sermorelin is a synthetic analog of growth hormone-releasing hormone that the FDA approved as Geref in 1990 (a diagnostic, NDA 19-863) and 1997 (growth hormone deficiency in children, NDA 20-443). EMD Serono discontinued both in 2008 and asked the FDA to withdraw the approvals, effective June 18, 2009. On March 4, 2013 the FDA determined that Geref was not withdrawn for safety or effectiveness reasons, so it stays in the Orange Book's discontinued list. Sermorelin is not on the 503A bulks list and has never appeared in the FDA's interim 503A categories. State-licensed 503A pharmacies compound it on prescription as a component of an FDA-approved drug, a route that needs no bulks-list entry; the FDA has not said whether an approval withdrawn at the sponsor's request still counts, and no FDA warning letter to a pharmacy has challenged that. Because Geref is not marketed, the essentially-copies limit does not apply. Selling it as a \"research\" peptide is not lawful: on December 10, 2024 the FDA warned Xcel Research that its sermorelin was an unapproved new drug. No FDA review of sermorelin is pending.","us":{"status":"compounding_legal","label":"Compounding-legal","detail":"Not on any 503A list; compounded as a component of Geref, an FDA-approved drug withdrawn in 2009 for non-safety reasons","since":"2013-03-04"},"jurisdictions":[{"authority":"United States (FDA)","regulator":"FDA","status":"compounding_legal","label":"Compounding-legal","note":"Not on the 503A bulks list or any interim category. Compounded as a component of Geref (NDAs 19-863, 20-443), whose approvals were withdrawn at the sponsor's request effective Jun 18, 2009; FDA found (Mar 4, 2013) it was not withdrawn for safety or effectiveness. FDA has not addressed whether a withdrawn approval still qualifies."},{"authority":"Australia (TGA)","regulator":"TGA","status":"restricted","label":"Restricted","note":"Schedule 4 (prescription-only), named individually in the Poisons Standard (October 2026), and possession without authority is illegal (Appendix D). No product on the ARTG."},{"authority":"United Kingdom (MHRA)","regulator":"MHRA","status":"restricted","label":"Restricted","note":"No UK marketing authorisation; supply for human use treated as an unlicensed medicine."},{"authority":"European Union (EMA)","regulator":"EMA","status":"restricted","label":"Restricted","note":"No centralised EU marketing authorisation (absent from the Union Register); sale as a medicine is unlawful EU-wide, with enforcement handled at member-state level."},{"authority":"Canada (Health Canada)","regulator":"Health Canada","status":"restricted","label":"Restricted","note":"Named on the Prescription Drug List ('Sermorelin or its salts', effective 2013-12-19); no product currently authorized in the Drug Product Database."},{"authority":"Sport / anti-doping (WADA)","regulator":"WADA","status":"restricted","label":"Restricted","note":"Named in S2.2.4 (GHRH and its analogues) on the 2026 and 2027 Prohibited Lists; prohibited at all times."}],"brazil":null,"next_event":null,"advisory_vote":null,"sources":[{"label":"FDA - Bulk drug substances used in compounding under section 503A","url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act","primary":true},{"label":"Federal Register - Determination that Geref was not withdrawn for reasons of safety or effectiveness (Mar 4, 2013)","url":"https://www.federalregister.gov/documents/2013/03/04/2013-04827/determination-that-geref-sermorelin-acetate-injection-05-milligrams-basevial-and-10-milligrams","primary":true},{"label":"Federal Register - Withdrawal of approval of NDAs 19-863 and 20-443 (Geref), effective Jun 18, 2009","url":"https://www.federalregister.gov/documents/2009/05/19/E9-11628/novartis-pharmaceuticals-corp-et-al-withdrawal-of-approval-of-92-new-drug-applications-and-49","primary":true},{"label":"Drugs@FDA - NDA 020443 (Geref)","url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020443","primary":true},{"label":"FDA warning letter - Xcel Research LLC (Dec 10, 2024)","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/xcel-research-llc-694608-12102024","primary":true},{"label":"Frier Levitt - Regulatory status of peptide compounding (2025)","url":"https://www.frierlevitt.com/articles/regulatory-status-of-peptide-compounding-in-2025/","primary":false},{"label":"MHRA Products database - search: sermorelin","url":"https://products.mhra.gov.uk/search/?search=sermorelin&page=1","primary":true},{"label":"Health Canada Prescription Drug List - Human Use","url":"https://hpr-rps.hres.ca/pdl-phu.php","primary":true},{"label":"Union Register of medicinal products (European Commission)","url":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm","primary":true},{"label":"WADA - 2027 Prohibited List (in force Jan 1, 2027)","url":"https://www.wada-ama.org/sites/default/files/2026-09/2027list_en_final_clean_26_august_2026_2.pdf","primary":true}],"last_verified":"2026-10-15"},{"slug":"ss-31","name":"SS-31 (elamipretide)","aliases":["Elamipretide","Elamipretide hydrochloride","Forzinity","MTP-131","Bendavia"],"nicknames":[],"url":"https://peptlas.com/entries/ss-31/","answer":"SS-31 is the code name for elamipretide, a synthetic peptide that its FDA label describes as a mitochondrial cardiolipin binder. In the United States it is a prescription-only drug: on September 19, 2025 the FDA granted accelerated approval to Forzinity (elamipretide hydrochloride injection, Stealth BioTherapeutics) for patients with Barth syndrome who weigh at least 30 kg. Compounding is narrow. Because elamipretide hydrochloride is a component of an approved drug, a state-licensed 503A pharmacy may compound with it for an individual patient's prescription, but not regularly or in large amounts as essentially copies of Forzinity. That does not cover the acetate salt: in a December 2025 warning letter the FDA listed elamipretide (SS-31) acetate among substances ineligible for 503A compounding, and on August 24, 2026 it told four online sellers that their SS-31 products are unapproved new drugs. Elamipretide is not on any of the FDA's 503A category lists. The approval is conditional: Stealth must run a confirmatory trial, and the FDA can withdraw the approval if that trial fails to verify clinical benefit.","us":{"status":"restricted","label":"Restricted","detail":"FDA-approved prescription drug (Forzinity, Sep 2025); copies cannot be compounded and the acetate salt is ineligible","since":"2025-09-19"},"jurisdictions":[{"authority":"United States (FDA)","regulator":"FDA","status":"restricted","label":"Restricted","note":"FDA-approved prescription drug: Forzinity (elamipretide hydrochloride) injection, NDA 215244, accelerated approval Sep 19, 2025. As a component of that drug, the HCl salt may be 503A-compounded for an individual patient, but not regularly or in inordinate amounts as essentially copies of Forzinity. FDA has called elamipretide (SS-31) acetate ineligible for 503A compounding (Dec 2025 warning letter). Not on any 503A category list."},{"authority":"Australia (TGA)","regulator":"TGA","status":"unscheduled","label":"Unscheduled","note":"Not individually named in the Poisons Standard (October 2026) and no product on the ARTG; supply for human use is unlawful without ARTG registration, and the TGA is enforcing against unapproved peptides."},{"authority":"United Kingdom (MHRA)","regulator":"MHRA","status":"restricted","label":"Restricted","note":"No UK marketing authorisation (no result for elamipretide in the MHRA products database); supply as a medicine is unlicensed."},{"authority":"European Union (EMA)","regulator":"EMA","status":"restricted","label":"Restricted","note":"No EU marketing authorisation. Holds EU orphan designations for Barth syndrome (May 20, 2021) and myopathic mitochondrial DNA depletion syndrome (May 16, 2022), which EMA says do not mean the medicine is authorised."},{"authority":"Canada (Health Canada)","regulator":"Health Canada","status":"restricted","label":"Restricted","note":"Not in the Drug Product Database; Health Canada's Apr 9, 2026 advisory names SS-31 among unauthorized injectable peptide drugs it has seized."},{"authority":"Sport / anti-doping (WADA)","regulator":"WADA","status":"unscheduled","label":"Unscheduled","note":"Not named on the 2027 Prohibited List. S0 covers only substances with no current government approval for human therapeutic use, and elamipretide has been FDA-approved since Sep 2025."}],"brazil":null,"next_event":null,"advisory_vote":null,"sources":[{"label":"FDA press release - FDA grants accelerated approval for first treatment for Barth syndrome (Sep 19, 2025)","url":"https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-first-treatment-barth-syndrome","primary":true},{"label":"Drugs@FDA - NDA 215244 (Forzinity)","url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215244","primary":true},{"label":"FDA - Bulk drug substances used in compounding under section 503A","url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act","primary":true},{"label":"FDA warning letter - Darmerica, LLC (Dec 8, 2025)","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025","primary":true},{"label":"FDA warning letter - Royal Peptides LLC (Aug 24, 2026)","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026","primary":true},{"label":"TGA - Responsibilities when importing, compounding and supplying unapproved peptide products (Apr 13, 2026)","url":"https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts/understanding-your-responsibilities-when-importing-compounding-and-supplying-unapproved-peptide-products","primary":true},{"label":"MHRA Products database - search: elamipretide","url":"https://products.mhra.gov.uk/search/?search=elamipretide&page=1","primary":true},{"label":"EMA - Orphan designation EU/3/21/2430, elamipretide for Barth syndrome","url":"https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-21-2430","primary":true},{"label":"Health Canada - Think twice before injecting peptides bought online (Apr 9, 2026)","url":"https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm","primary":true},{"label":"WADA - 2027 Prohibited List (in force Jan 1, 2027)","url":"https://www.wada-ama.org/sites/default/files/2026-09/2027list_en_final_clean_26_august_2026_2.pdf","primary":true}],"last_verified":"2026-10-15"},{"slug":"tb-500","name":"TB-500 (Thymosin Beta-4)","aliases":["TB-500","Thymosin Beta-4","TB-4","Timbetasin","Thymosin Beta-4 fragment"],"nicknames":[],"url":"https://peptlas.com/entries/tb-500/","answer":"TB-500 (a synthetic fragment associated with thymosin beta-4) is not an FDA-approved drug and is not on the Section 503A Bulk Drug Substances List, so pharmacies are not authorized to compound it. On July 23, 2026 the FDA's Pharmacy Compounding Advisory Committee voted 8-6, with 1 abstention, to recommend adding it - despite the FDA's own reviewers reporting that they could not identify a single human clinical study of the substance. The vote is advisory and does not bind the FDA. Nothing about TB-500's legal status changed on the day of the vote. Before it could be compounded lawfully the FDA would have to accept the recommendation and complete notice-and-comment rulemaking - a process the agency has not begun and that is generally estimated at 12 to 24 months. Its earlier removal from the interim Category 2 list, in April 2026, likewise did not authorize compounding: it was never in Category 1, the category that does. Separately, nominations to add TB-500 (Thymosin Beta-4) to the 503B bulks list - the list for outsourcing facilities, not the 503A list the committee reviewed - were posted to the FDA's docket on August 25, 2026; a nomination starts a review and changes nothing on its own.","us":{"status":"in_limbo","label":"In limbo","detail":"PCAC recommended listing (8-6, Jul 23, 2026) - advisory only; still not on the 503A list","since":"2026-07-23"},"jurisdictions":[{"authority":"United States (FDA)","regulator":"FDA","status":"in_limbo","label":"In limbo","note":"Not on the 503A Bulks List. PCAC recommended adding it on Jul 23, 2026 (8-6, 1 abstention); the recommendation is advisory and the FDA has not acted."},{"authority":"Australia (TGA)","regulator":"TGA","status":"restricted","label":"Restricted","note":"Thymosin beta-4 treated as Schedule 4 (prescription-only) under the Poisons Standard."},{"authority":"United Kingdom (MHRA)","regulator":"MHRA","status":"restricted","label":"Restricted","note":"No UK marketing authorisation; supply for human use treated as an unlicensed medicine."},{"authority":"European Union (EMA)","regulator":"EMA","status":"restricted","label":"Restricted","note":"No EU marketing authorisation; sale as a medicine is unlawful EU-wide, with enforcement handled at member-state level."},{"authority":"Canada (Health Canada)","regulator":"Health Canada","status":"restricted","label":"Restricted","note":"Not authorized for sale; Health Canada has seized TB-500 among unauthorized injectable peptides and states selling unauthorized drugs is illegal in Canada."},{"authority":"Sport / anti-doping (WADA)","regulator":"WADA","status":"restricted","label":"Restricted","note":"Prohibited at all times as a growth factor / non-approved substance. Unchanged on the 2027 List (published Sep 21, 2026; in force Jan 1, 2027)."}],"brazil":{"status_class":"restricted","status_pt":"Sem registro na ANVISA: uso ilegal","summary_pt":"A ANVISA afirma que o TB-500 não está registrado como medicamento e não tem autorização como suplemento, e que peptídeos injetáveis sem regularização são ilegais para qualquer uso em saúde, inclusive estético. Em 6 de outubro de 2026, a Resolução-RE 3.947/2026 proibiu um produto com BPC-157 e TB-500 vendido pela internet.","verified":"2026-10-09","url":"https://peptlas.com/pt-br/peptideos/tb-500/","sources":[{"label":"ANVISA - checagem sobre peptídeos sem registro","url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/checamos-peptideos-que-prometem-milagres-nao-estao-registrados-na-anvisa","date":"2026-07-02"},{"label":"ANVISA - checagem sobre peptídeos sem registro","url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/checamos-peptideos-que-prometem-milagres-nao-estao-registrados-na-anvisa","date":"2026-07-02"},{"label":"ANVISA - Resolução-RE 3.947/2026","url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/anvisa-proibe-venda-de-insulina-e-tirzepatida-irregulares-1","date":"2026-10-06"},{"label":"ANVISA - dados abertos de medicamentos registrados (consulta em 9 out. 2026)","url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","date":"2026-10-09"}]},"next_event":null,"advisory_vote":{"date":"2026-07-23","body":"FDA Pharmacy Compounding Advisory Committee (PCAC)","outcome":"recommended","question":"Should TB-500 (free base) be placed on the list? - and, as a separate vote, TB-500 acetate?","yes":8,"no":6,"abstain":1,"tally_source":"reported by Healio and the FDA Law Blog (Hyman, Phelps & McNamara). The panel was not the same size for every substance - the meeting roster seats temporary voting members for single topics - so the totals legitimately differ between votes"},"sources":[{"label":"Federal Register - PCAC notice of meeting (Docket FDA-2025-N-6895)","url":"https://www.federalregister.gov/documents/2026/04/16/2026-07361/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request","primary":true},{"label":"RAPS - FDA considers adding a dozen peptides to its bulk compounding list","url":"https://www.raps.org/resource/fda-considers-adding-a-dozen-peptides-to-its-bulk-drug-compounding-list.html","primary":false},{"label":"FDA Law Blog - FDA's Pep(tide) Rally (Hyman, Phelps & McNamara)","url":"https://www.thefdalawblog.com/2026/04/fdas-peptide-rally-what-compounders-and-industry-need-to-know-post-1-of-2/","primary":false},{"label":"BSCG - TB-500 status in sport","url":"https://www.bscg.org/blogs/single/tb-500-status-risks-and-bans-in-sport-and-military","primary":false},{"label":"FDA - PCAC meeting page, July 23-24, 2026","url":"https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026","primary":true},{"label":"Healio - FDA committee recommends looser restrictions for several peptides","url":"https://www.healio.com/news/primary-care/20260724/fda-committee-recommends-looser-restrictions-for-several-peptides","primary":false},{"label":"Mintz - FDA's Advisory Committee Votes on Peptides: What It Does and Doesn't Do","url":"https://www.mintz.com/insights-center/viewpoints/2146/2026-07-29-fdas-advisory-committee-votes-peptides-what-it-does-and","primary":false},{"label":"FDA - PCAC July 23-24, 2026: questions put to the committee","url":"https://www.fda.gov/media/193711/download","primary":true},{"label":"FDA - PCAC July 23-24, 2026: meeting roster","url":"https://www.fda.gov/media/193772/download","primary":true},{"label":"MHRA Products database - substance index (T)","url":"https://products.mhra.gov.uk/substance-index/?letter=T","primary":true},{"label":"Health Canada public advisory - unauthorized injectable peptide drugs seized (Canada Peptide)","url":"https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-and-sold-canada-peptide-may-pose-serious","primary":true},{"label":"EU Union Register of medicinal products (human, active substances)","url":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm","primary":true},{"label":"Regulations.gov - 503B bulks nomination, TB-500 (Thymosin Beta-4) (free base), BPI Labs (posted Aug 25, 2026)","url":"https://www.regulations.gov/document/FDA-2015-N-3469-0444","primary":true},{"label":"Regulations.gov - 503B bulks nomination, TB-500 (Thymosin Beta-4) (acetate), BPI Labs (posted Aug 25, 2026)","url":"https://www.regulations.gov/document/FDA-2015-N-3469-0445","primary":true},{"label":"WADA - 2027 Prohibited List published (Sep 21, 2026)","url":"https://www.wada-ama.org/en/news/wada-publishes-2027-prohibited-list","primary":true}],"last_verified":"2026-09-22"},{"slug":"tesamorelin","name":"Tesamorelin","aliases":["Egrifta","Egrifta SV","Egrifta WR","Tesamorelin acetate"],"nicknames":[],"url":"https://peptlas.com/entries/tesamorelin/","answer":"Tesamorelin is a 44-amino-acid growth hormone-releasing factor analog that the FDA approved on November 10, 2010 as Egrifta, to reduce excess abdominal fat in adults with HIV and lipodystrophy. Theratechnologies markets it as Egrifta SV and Egrifta WR, a newer formulation approved on March 25, 2025. Because it is a protein of more than 40 amino acids, its application was deemed a biologics license on March 23, 2020, and the FDA's stated position is that biological products subject to licensure are not eligible for the 503A or 503B compounding exemptions. A pharmacy therefore cannot lawfully compound tesamorelin, even though it is the active ingredient of an approved product, and it appears in none of the FDA's 503A bulk substance categories. It is lawfully available only as the licensed prescription product. On August 24, 2026 the FDA sent warning letters to five online \"research peptide\" sellers, including Royal Peptides and Peptide Partners, naming tesamorelin among unapproved new drugs. No FDA review that would change this is pending; any other tesamorelin product would need its own biologics license.","us":{"status":"restricted","label":"Restricted","detail":"Licensed biologic (Egrifta SV, Egrifta WR) since Mar 23, 2020 - outside the 503A and 503B compounding exemptions","since":"2020-03-23"},"jurisdictions":[{"authority":"United States (FDA)","regulator":"FDA","status":"restricted","label":"Restricted","note":"Approved Nov 10, 2010 (Egrifta); deemed a biologics license (BLA 022505) on Mar 23, 2020, so outside the 503A/503B compounding exemptions. Aug 24, 2026: FDA warning letters to five online \"research peptide\" sellers name tesamorelin."},{"authority":"Australia (TGA)","regulator":"TGA","status":"restricted","label":"Restricted","note":"Not named individually in the Poisons Standard (October 2026), but Appendix D lists growth hormone releasing hormones (GHRHs) as a group among poisons that are illegal to possess without authority. No product on the ARTG."},{"authority":"United Kingdom (MHRA)","regulator":"MHRA","status":"restricted","label":"Restricted","note":"No UK marketing authorisation (no tesamorelin product in the MHRA Products database); supply as a medicine would be unlicensed."},{"authority":"European Union (EMA)","regulator":"EMA","status":"restricted","label":"Restricted","note":"No EU marketing authorisation: Ferrer Internacional withdrew its application for Egrifta on June 21, 2012, when the CHMP's provisional opinion was that it could not have been approved."},{"authority":"Canada (Health Canada)","regulator":"Health Canada","status":"restricted","label":"Restricted","note":"On the Prescription Drug List since 2014-04-25 ('Tesamorelin or its salts or derivatives'); both Egrifta DINs are cancelled (2022, 2023), so no product is currently authorized for sale. Named among seized unauthorized peptides (Aug 2025)."},{"authority":"Sport / anti-doping (WADA)","regulator":"WADA","status":"restricted","label":"Restricted","note":"Named in S2.2.4 (GHRH and its analogues) on the 2026 and 2027 Prohibited Lists; prohibited at all times."}],"brazil":null,"next_event":null,"advisory_vote":null,"sources":[{"label":"Drugs@FDA - BLA 022505 (Egrifta)","url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022505","primary":true},{"label":"FDA - Egrifta WR supplemental approval letter (BLA 022505/S-020, Mar 25, 2025)","url":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/022505Orig1s020ltr.pdf","primary":true},{"label":"FDA guidance - Mixing, diluting, or repackaging biological products outside the scope of an approved BLA (Jan 2018)","url":"https://www.fda.gov/media/90986/download","primary":true},{"label":"FDA guidance - Interim policy on compounding using bulk drug substances under section 503A (Jan 2025)","url":"https://www.fda.gov/media/174456/download","primary":true},{"label":"FDA warning letter - Royal Peptides LLC (Aug 24, 2026)","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026","primary":true},{"label":"EMA - Egrifta: withdrawal of the marketing authorisation application","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/egrifta","primary":true},{"label":"Health Canada Prescription Drug List - Human Use","url":"https://hpr-rps.hres.ca/pdl-phu.php","primary":true},{"label":"TGA - Australian Register of Therapeutic Goods search: tesamorelin","url":"https://www.tga.gov.au/resources/artg?keywords=tesamorelin","primary":true},{"label":"MHRA Products database - search: tesamorelin","url":"https://products.mhra.gov.uk/search/?search=tesamorelin&page=1","primary":true},{"label":"WADA - 2027 Prohibited List (in force Jan 1, 2027)","url":"https://www.wada-ama.org/sites/default/files/2026-09/2027list_en_final_clean_26_august_2026_2.pdf","primary":true}],"last_verified":"2026-10-15"},{"slug":"thymosin-alpha-1","name":"Thymosin Alpha-1","aliases":["Thymalfasin","Zadaxin","Tα1"],"nicknames":[],"url":"https://peptlas.com/entries/thymosin-alpha-1/","answer":"Thymosin alpha-1 is not on the FDA's 503A Bulk Drug Substances List and was never in Category 1, so it is not eligible for compounding under Section 503A. It was removed from Category 2 in September 2024 after its nomination was withdrawn, but that removal did not authorize compounding. The FDA's advisory committee reviewed it on December 4, 2024 and did not recommend adding it to the list, citing immunogenicity and characterization concerns and the absence of an approved U.S. indication. There is no FDA-approved thymosin alpha-1 product in the United States (the branded product Zadaxin is approved in some other countries), leaving it in regulatory limbo.","us":{"status":"in_limbo","label":"In limbo","detail":"Off Category 2, never in Category 1; PCAC declined Dec 2024","since":"2024-12-04"},"jurisdictions":[{"authority":"United States (FDA)","regulator":"FDA","status":"in_limbo","label":"In limbo","note":"Removed from Category 2 (Sept 2024); PCAC declined to recommend it on Dec 4, 2024; not on the 503A list; no approved U.S. product."},{"authority":"Australia (TGA)","regulator":"TGA","status":"restricted","label":"Restricted","note":"Regulated as Schedule 4 (prescription-only); the TGA has enforced against unlawful advertising."},{"authority":"United Kingdom (MHRA)","regulator":"MHRA","status":"restricted","label":"Restricted","note":"No UK marketing authorisation; supply for human use treated as an unlicensed medicine."},{"authority":"European Union (EMA)","regulator":"EMA","status":"restricted","label":"Restricted","note":"No EU-wide EMA marketing authorisation - thymalfasin holds only an orphan designation (EU/3/02/110) - and is reported as nationally authorised on prescription in Italy as Zadaxin."},{"authority":"Canada (Health Canada)","regulator":"Health Canada","status":"restricted","label":"Restricted","note":"Not authorized for sale; no Drug Product Database listing, and Health Canada named thymosin alpha-1 among unauthorized injectable peptides seized in April 2025."},{"authority":"Sport / anti-doping (WADA)","regulator":"WADA","status":"unscheduled","label":"Unscheduled","note":"Not specifically named on the Prohibited List (distinct from thymosin beta-4, which is prohibited)."}],"brazil":null,"next_event":null,"advisory_vote":null,"sources":[{"label":"FDA - 503A bulk drug substances: Category 1 & Category 2 lists","url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act","primary":true},{"label":"National Law Review - What FDA's latest actions mean for peptide compounding","url":"https://natlawreview.com/article/tiny-chains-big-changes-what-fdas-latest-actions-mean-peptide-compounding","primary":false},{"label":"FDA - PCAC December 4, 2024 meeting materials","url":"https://www.fda.gov/advisory-committees/advisory-committee-calendar/updated-meeting-time-and-public-participation-information-december-4-2024-meeting-pharmacy","primary":true},{"label":"TGA - enforcement re: thymosin alpha-1 advertising","url":"https://www.tga.gov.au/news/media-releases/sgc-products-fined-63000-alleged-unlawful-advertising-dr-ageless-website-relation-covid-19","primary":true},{"label":"MHRA Products database - search: thymalfasin","url":"https://products.mhra.gov.uk/search/?search=thymalfasin&page=1","primary":true},{"label":"Health Canada public advisory - unauthorized injectable peptide drugs (Apr 2025)","url":"https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-injectable-peptide-drugs-seized-optimum-wellness-centre-calgary-alberta","primary":true},{"label":"EMA - orphan designation EU/3/02/110 (thymalfasin)","url":"https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-02-110","primary":true}],"last_verified":"2026-09-22"},{"slug":"tirzepatide","name":"Tirzepatide (compounded)","aliases":["Mounjaro","Zepbound","compounded tirzepatide"],"nicknames":[],"url":"https://peptlas.com/entries/tirzepatide/","answer":"Tirzepatide is an FDA-approved drug (Mounjaro, Zepbound), not a 503A bulk substance. After the FDA declared its shortage resolved in late 2024, the temporary enforcement discretion for compounding copies ended on February 18, 2025 for 503A pharmacies and March 19, 2025 for 503B outsourcing facilities; a federal court upheld the FDA's shortage determination in 2025. Broad compounding is no longer permitted - only narrow patient-specific 503A compounding for a documented clinical need remains - and the FDA has been issuing warning letters. On September 18, 2026 it warned Empower Pharmacy, a Houston compounding pharmacy, that its tirzepatide/niacinamide injections appear to be essentially copies of the approved drug, and questioned \"significant difference\" statements repeated verbatim across many prescriptions. In April 2026 the FDA proposed to permanently exclude tirzepatide - along with semaglutide and liraglutide - from the 503B bulks list; the public comment period closed July 30, 2026 (extended from June 30) and the FDA's final determination is pending, with no announced date.","us":{"status":"restricted","label":"Restricted","detail":"Enforcement discretion ended; broad compounding no longer permitted. 503B exclusion proposed - comments closed Jul 30, 2026, decision pending","since":"2025-03-19"},"jurisdictions":[{"authority":"United States (FDA)","regulator":"FDA","status":"restricted","label":"Restricted","note":"Enforcement discretion ended Feb 18, 2025 (503A, as announced; the FDA's Sep 2026 Empower letter dates it Mar 5) / Mar 19, 2025 (503B); FDA proposed permanent 503B exclusion (Apr 2026). Narrow 503A exception remains. Sep 18, 2026: FDA warning letter to Empower Pharmacy over tirzepatide/niacinamide injections that appear to be essentially copies."},{"authority":"Australia (TGA)","regulator":"TGA","status":"restricted","label":"Restricted","note":"GLP-1 compounding prohibited since Oct 1, 2024; remains Schedule 4."},{"authority":"United Kingdom (MHRA)","regulator":"MHRA","status":"restricted","label":"Restricted","note":"Licensed prescription-only medicine; no legitimate compounding pathway; MHRA enforces against unlicensed product."},{"authority":"European Union (EMA)","regulator":"EMA","status":"restricted","label":"Restricted","note":"Licensed prescription-only medicine EU-wide (Mounjaro, authorised 2022); unauthorised versions cannot be marketed, with pharmacy compounding exemptions and enforcement handled at member-state level."},{"authority":"Canada (Health Canada)","regulator":"Health Canada","status":"restricted","label":"Restricted","note":"Authorized prescription-only medicine (Mounjaro); compounded copies of marketed drugs are not permitted outside a shortage, and Health Canada warns selling unauthorized versions is illegal in Canada."},{"authority":"Sport / anti-doping (WADA)","regulator":"WADA","status":"unscheduled","label":"Unscheduled","note":"Not prohibited; added to the WADA Monitoring Program effective Jan 1, 2026. WADA confirmed GLP-1 status is unchanged for 2027 (Sep 21, 2026)."}],"brazil":{"status_class":"registered_medicine","status_pt":"Registrada (Mounjaro), com receita retida","summary_pt":"A tirzepatida tem medicamento registrado na ANVISA (Mounjaro) e só é vendida com receita em duas vias, retida pela farmácia. Farmácias podem manipulá-la de forma individual, seguindo a RDC 67/2007 e a Nota Técnica 200/2025, regras em revisão desde abril de 2026. Canetas sem registro, como as paraguaias TG e Lipoless e a T36, são proibidas e apreendidas.","verified":"2026-10-09","url":"https://peptlas.com/pt-br/peptideos/tirzepatida/","sources":[{"label":"ANVISA - checagem sobre peptídeos sem registro","url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/checamos-peptideos-que-prometem-milagres-nao-estao-registrados-na-anvisa","date":"2026-07-02"},{"label":"ANVISA - dados abertos de medicamentos registrados (consulta em 9 out. 2026)","url":"https://dados.anvisa.gov.br/dados/DADOS_ABERTOS_MEDICAMENTOS.csv","date":"2026-10-09"},{"label":"CFF - novas regras para agonistas de GLP-1","url":"https://site.cff.org.br/noticia/Noticias-gerais/16/01/2026/anvisa-estabelece-novas-regras-para-prescricao-e-dispensacao-de-medicamentos-agonistas-de-glp-1","date":"2026-01-16"},{"label":"ANVISA - regras para manipulação de canetas de GLP-1","url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2025/anvisa-esclarece-e-determina-regras-para-manipulacao-de-canetas-de-glp-1","date":"2025-08-25"},{"label":"ANVISA - proibição de ingresso de canetas sem registro","url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2025/anvisa-esclarece-sobre-proibicao-de-ingresso-de-canetas-emagrecedoras","date":"2025-11-20"},{"label":"ANVISA - Resolução-RE 214/2026","url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/canetas-emagrecedoras-lotes-de-tirzepatida-das-marcas-synedica-e-tg-estao-proibidos-e-devem-ser-apreendidos","date":"2026-01-21"},{"label":"ANVISA - canetas do Paraguai sem equivalência comprovada","url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/canetas-do-paraguai-nao-demonstraram-equivalencia-com-medicamentos-registrados-no-brasil","date":"2026-07-06"},{"label":"ANVISA - Resolução-RE 3.947/2026","url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/anvisa-proibe-venda-de-insulina-e-tirzepatida-irregulares-1","date":"2026-10-06"}]},"next_event":null,"advisory_vote":null,"sources":[{"label":"Federal Register - 503B bulk drug substances clinical-need proposal (FR 2026-08552)","url":"https://www.federalregister.gov/documents/2026/05/01/2026-08552/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal","primary":true},{"label":"Federal Register - comment-period extension (FR 2026-12937)","url":"https://www.govinfo.gov/content/pkg/FR-2026-06-26/html/2026-12937.htm","primary":true},{"label":"Pharmacy Times - FDA moves to close the door on compounded GLP-1s","url":"https://www.pharmacytimes.com/view/fda-moves-to-permanently-close-the-door-on-compounded-glp-1s","primary":false},{"label":"EMJ - GLP-1 receptor agonists on WADA Monitoring Program","url":"https://www.emjreviews.com/general-healthcare/news/glp-1ras-monitored-at-2026-winter-olympics/","primary":false},{"label":"Health Canada alert on fake/unauthorized GLP-1 drugs (Jan 21, 2026)","url":"https://recalls-rappels.canada.ca/en/alert-recall/thinking-about-buying-glp-1-drugs-ozempic-or-mounjaro-beware-fake-or-unauthorized","primary":true},{"label":"EMA EPAR - Mounjaro (tirzepatide)","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/mounjaro","primary":true},{"label":"WADA - 2027 Prohibited List published (Sep 21, 2026)","url":"https://www.wada-ama.org/en/news/wada-publishes-2027-prohibited-list","primary":true},{"label":"FDA - warning letter, Empower Pharmacy (Sep 18, 2026)","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026","primary":true}],"last_verified":"2026-10-09"}],"blends":[{"slug":"klow","name":"KLOW","aliases":["KLOW blend","KLOW peptide","KLOW 80"],"ingredients":["bpc-157","tb-500","ghk-cu","kpv"],"url":"https://peptlas.com/blends/klow/","places":[{"authority":"United States (FDA)","status":"in_limbo","label":"In limbo","set_by":["bpc-157","tb-500","ghk-cu","kpv"]},{"authority":"Australia (TGA)","status":"restricted","label":"Restricted","set_by":["bpc-157","tb-500"]},{"authority":"United Kingdom (MHRA)","status":"restricted","label":"Restricted","set_by":["bpc-157","tb-500","ghk-cu","kpv"]},{"authority":"European Union (EMA)","status":"restricted","label":"Restricted","set_by":["bpc-157","tb-500","ghk-cu","kpv"]},{"authority":"Canada (Health Canada)","status":"restricted","label":"Restricted","set_by":["bpc-157","tb-500","ghk-cu","kpv"]},{"authority":"Sport / anti-doping (WADA)","status":"restricted","label":"Restricted","set_by":["bpc-157","tb-500","kpv"]}],"brazil":{"status_class":"restricted","set_by":["bpc-157","tb-500","ghk-cu"]},"sources":[{"label":"Superpower - GLOW peptide blend, and how KLOW differs (updated Sep 28, 2026)","url":"https://superpower.com/guides/peptide-science/glow-peptide"}],"acts":[]},{"slug":"glow","name":"GLOW","aliases":["GLOW blend","GLOW peptide","GLOW 70"],"ingredients":["bpc-157","tb-500","ghk-cu"],"url":"https://peptlas.com/blends/glow/","places":[{"authority":"United States (FDA)","status":"in_limbo","label":"In limbo","set_by":["bpc-157","tb-500","ghk-cu"]},{"authority":"Australia (TGA)","status":"restricted","label":"Restricted","set_by":["bpc-157","tb-500"]},{"authority":"United Kingdom (MHRA)","status":"restricted","label":"Restricted","set_by":["bpc-157","tb-500","ghk-cu"]},{"authority":"European Union (EMA)","status":"restricted","label":"Restricted","set_by":["bpc-157","tb-500","ghk-cu"]},{"authority":"Canada (Health Canada)","status":"restricted","label":"Restricted","set_by":["bpc-157","tb-500","ghk-cu"]},{"authority":"Sport / anti-doping (WADA)","status":"restricted","label":"Restricted","set_by":["bpc-157","tb-500"]}],"brazil":{"status_class":"restricted","set_by":["bpc-157","tb-500","ghk-cu"]},"sources":[{"label":"Superpower - GLOW peptide blend, and how KLOW differs (updated Sep 28, 2026)","url":"https://superpower.com/guides/peptide-science/glow-peptide"},{"label":"Resident - The GLOW peptide blend: why everyone is searching for it (Sep 25, 2026)","url":"https://resident.com/style-and-personal-care-resources/2026/09/25/the-glow-peptide-blend-why-everyone-is-searching-for-it-and-what-the-science-says"}],"acts":[{"date":"2026-10-06","authority":"Brazil (ANVISA)","summary":"Resolution RE 3.947/2026 banned the sale, manufacture, advertising and use of \"Glow GHK-CU 70 mg\" (Alluvi Healthcare), sold online, and ordered it seized.","url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/anvisa-proibe-venda-de-insulina-e-tirzepatida-irregulares-1"}]},{"slug":"wolverine-stack","name":"Wolverine stack","aliases":["Wolverine peptides","Wolverine blend","Wolverine protocol","Wolverine peptide"],"ingredients":["bpc-157","tb-500"],"url":"https://peptlas.com/blends/wolverine-stack/","places":[{"authority":"United States (FDA)","status":"in_limbo","label":"In limbo","set_by":["bpc-157","tb-500"]},{"authority":"Australia (TGA)","status":"restricted","label":"Restricted","set_by":["bpc-157","tb-500"]},{"authority":"United Kingdom (MHRA)","status":"restricted","label":"Restricted","set_by":["bpc-157","tb-500"]},{"authority":"European Union (EMA)","status":"restricted","label":"Restricted","set_by":["bpc-157","tb-500"]},{"authority":"Canada (Health Canada)","status":"restricted","label":"Restricted","set_by":["bpc-157","tb-500"]},{"authority":"Sport / anti-doping (WADA)","status":"restricted","label":"Restricted","set_by":["bpc-157","tb-500"]}],"brazil":{"status_class":"restricted","set_by":["bpc-157","tb-500"]},"sources":[{"label":"Reuters - Use of untested 'Wolverine' peptide backed by US Health Secretary Kennedy on the rise, study finds (Sep 16, 2026; republished by the Hawaii Tribune-Herald)","url":"https://www.hawaiitribune-herald.com/?p=377769"},{"label":"Healthline - Wolverine peptides (medically reviewed, updated Oct 14, 2026)","url":"https://www.healthline.com/health/wolverine-peptides"}],"acts":[{"date":"2026-10-06","authority":"Brazil (ANVISA)","summary":"Resolution RE 3.947/2026 banned the sale, manufacture, advertising and use of \"BPC157 & TB500 40 mg\" (Alluvi Healthcare), sold online, and ordered it seized.","url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/anvisa-proibe-venda-de-insulina-e-tirzepatida-irregulares-1"}]}],"changes":[{"date":"2026-09-18","slug":"semaglutide","compound":"Semaglutide (compounded)","tag":"enforcement","summary":"FDA warning letter to Empower Pharmacy, a Houston compounding pharmacy: its semaglutide/B12 injections appear to be essentially copies of the approved drug. No rule changed; routine compounding of copies was already restricted.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026"},{"date":"2026-09-18","slug":"tirzepatide","compound":"Tirzepatide (compounded)","tag":"enforcement","summary":"FDA warning letter to Empower Pharmacy, a Houston compounding pharmacy: its tirzepatide/niacinamide injections appear to be essentially copies of the approved drug. No rule changed; routine compounding of copies was already restricted.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026"},{"date":"2026-08-25","slug":"bpc-157","compound":"BPC-157","tag":"review_scheduled","summary":"BPI Labs' nomination to add BPC-157 (free base) to the 503B bulks list - the list for outsourcing facilities, not the 503A list the July panel reviewed - was posted to the FDA docket. A nomination starts a review and changes nothing on its own.","source_url":"https://www.regulations.gov/document/FDA-2015-N-3469-0439"},{"date":"2026-08-25","slug":"mots-c","compound":"MOTS-c","tag":"review_scheduled","summary":"BPI Labs' nominations to add MOTS-c (free base and acetate) to the 503B bulks list - the list for outsourcing facilities, not the 503A list the July panel reviewed - were posted to the FDA docket. A nomination starts a review and changes nothing on its own.","source_url":"https://www.regulations.gov/document/FDA-2015-N-3469-0440"},{"date":"2026-08-25","slug":"semax","compound":"Semax","tag":"review_scheduled","summary":"BPI Labs' nominations to add Semax (free base and acetate) to the 503B bulks list - the list for outsourcing facilities, not the 503A list the July panel reviewed - were posted to the FDA docket. A nomination starts a review and changes nothing on its own.","source_url":"https://www.regulations.gov/document/FDA-2015-N-3469-0442"},{"date":"2026-08-25","slug":"tb-500","compound":"TB-500 (Thymosin Beta-4)","tag":"review_scheduled","summary":"BPI Labs' nominations to add TB-500 (free base and acetate) to the 503B bulks list - the list for outsourcing facilities, not the 503A list the July panel reviewed - were posted to the FDA docket. A nomination starts a review and changes nothing on its own.","source_url":"https://www.regulations.gov/document/FDA-2015-N-3469-0444"},{"date":"2026-07-30","slug":"semaglutide","compound":"Semaglutide (compounded)","tag":"comment_deadline","summary":"Public comment period closed on the FDA's proposal to permanently exclude semaglutide from the 503B bulks list (extended from June 30). The proposal is not final - the FDA is now reviewing the record, with no announced decision date.","source_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-26/html/2026-12937.htm"},{"date":"2026-07-30","slug":"tirzepatide","compound":"Tirzepatide (compounded)","tag":"comment_deadline","summary":"Public comment period closed on the FDA's proposal to permanently exclude tirzepatide from the 503B bulks list (extended from June 30). The proposal is not final - the FDA is now reviewing the record, with no announced decision date.","source_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-26/html/2026-12937.htm"},{"date":"2026-07-24","slug":"emideltide","compound":"Emideltide (DSIP)","tag":"not_legalized","summary":"FDA advisory committee (PCAC) voted 6-7, with 1 abstention, AGAINST recommending Emideltide (DSIP) for the 503A list - the only one of the seven peptides reviewed that it declined to recommend. It stays off the list, with no further FDA action scheduled.","source_url":"https://www.healio.com/news/primary-care/20260724/fda-committee-recommends-looser-restrictions-for-several-peptides"},{"date":"2026-07-24","slug":"epitalon","compound":"Epitalon","tag":"not_legalized","summary":"FDA advisory committee (PCAC) voted 7-4, with 1 abstention, to recommend adding Epitalon to the 503A list. Advisory only - Epitalon is still not on the list and still not legal to compound until the FDA accepts the recommendation and completes rulemaking.","source_url":"https://www.healio.com/news/primary-care/20260724/fda-committee-recommends-looser-restrictions-for-several-peptides"},{"date":"2026-07-24","slug":"semax","compound":"Semax","tag":"not_legalized","summary":"FDA advisory committee (PCAC) voted 8-5, with 1 abstention, to recommend adding Semax to the 503A list. Advisory only - Semax is still not on the list and still not legal to compound until the FDA accepts the recommendation and completes rulemaking.","source_url":"https://www.healio.com/news/primary-care/20260724/fda-committee-recommends-looser-restrictions-for-several-peptides"},{"date":"2026-07-23","slug":"bpc-157","compound":"BPC-157","tag":"not_legalized","summary":"FDA advisory committee (PCAC) voted 8-6, with 1 abstention, to recommend adding BPC-157 to the 503A list, overriding the FDA's own reviewers. Widely reported as \"FDA clears BPC-157\" - it does not. The vote is non-binding, BPC-157 is not on the list, and compounding it is no more authorised than the day before.","source_url":"https://www.healio.com/news/primary-care/20260724/fda-committee-recommends-looser-restrictions-for-several-peptides"},{"date":"2026-07-23","slug":"kpv","compound":"KPV","tag":"not_legalized","summary":"FDA advisory committee (PCAC) voted 8-6, with 1 abstention, to recommend adding KPV to the 503A list, against the FDA review staff's own recommendation. Advisory only - KPV is still not on the list and still not legal to compound.","source_url":"https://www.healio.com/news/primary-care/20260724/fda-committee-recommends-looser-restrictions-for-several-peptides"},{"date":"2026-07-23","slug":"mots-c","compound":"MOTS-c","tag":"not_legalized","summary":"FDA advisory committee (PCAC) voted 7-5, with 2 abstentions, to recommend adding MOTS-c to the 503A list, against the FDA review staff's own recommendation. Advisory only - MOTS-c is still not on the list and still not legal to compound.","source_url":"https://www.healio.com/news/primary-care/20260724/fda-committee-recommends-looser-restrictions-for-several-peptides"},{"date":"2026-07-23","slug":"tb-500","compound":"TB-500 (Thymosin Beta-4)","tag":"not_legalized","summary":"FDA advisory committee (PCAC) voted 8-6, with 1 abstention, to recommend adding TB-500 to the 503A list - despite FDA reviewers reporting they could not identify a single human clinical study. Advisory only: TB-500 is still not on the list and still not legal to compound.","source_url":"https://www.healio.com/news/primary-care/20260724/fda-committee-recommends-looser-restrictions-for-several-peptides"},{"date":"2026-04-30","slug":"semaglutide","compound":"Semaglutide (compounded)","tag":"review_scheduled","summary":"FDA proposed to permanently exclude semaglutide from the 503B bulks list, finding no clinical need for outsourcing facilities to compound it from bulk. This is a proposal in a comment period, not a final change.","source_url":"https://www.federalregister.gov/documents/2026/05/01/2026-08552/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal"},{"date":"2026-04-30","slug":"tirzepatide","compound":"Tirzepatide (compounded)","tag":"review_scheduled","summary":"FDA proposed to permanently exclude tirzepatide from the 503B bulks list, alongside semaglutide and liraglutide. This is a proposal in a comment period, not a final change.","source_url":"https://www.federalregister.gov/documents/2026/05/01/2026-08552/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal"},{"date":"2026-04-22","slug":"ghk-cu","compound":"GHK-Cu","tag":"not_legalized","summary":"Injectable GHK-Cu removed from Category 2 without being placed on the 503A list - removal did not authorize compounding.","source_url":"https://www.frierlevitt.com/articles/fda-peptides-do-not-compound-list-update-2026/"},{"date":"2026-04-22","slug":"melanotan-2","compound":"Melanotan II","tag":"not_legalized","summary":"Moved out of Category 2 and slated for a later PCAC review - the change did not legalize compounding.","source_url":"https://www.boesensnowlaw.com/blog/fda-advances-peptide-compounding-review-category-2-removals-announced-and-pcac-hearing-confirmed/"},{"date":"2026-04-22","slug":"tb-500","compound":"TB-500 (Thymosin Beta-4)","tag":"not_legalized","summary":"Removed from FDA Category 2 after nominations were withdrawn - but it was never in Category 1, so it is still not legal to compound.","source_url":"https://www.orrick.com/en/Insights/2026/04/FDA-Announces-Removal-of-12-Peptides-from-Category-2-and-Schedules-PCAC-Meetings"},{"date":"2026-04-16","slug":"bpc-157","compound":"BPC-157","tag":"review_scheduled","summary":"Placed on the July 23, 2026 FDA advisory committee agenda (Docket FDA-2025-N-6895); FDA's briefing proposes not adding it to the 503A list.","source_url":"https://www.federalregister.gov/documents/2026/04/16/2026-07361/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request"},{"date":"2026-04-16","slug":"semax","compound":"Semax","tag":"review_scheduled","summary":"Placed on the July 24, 2026 FDA advisory committee agenda for possible inclusion on the 503A list.","source_url":"https://www.federalregister.gov/documents/2026/04/16/2026-07361/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request"},{"date":"2026-04-16","slug":"tb-500","compound":"TB-500 (Thymosin Beta-4)","tag":"review_scheduled","summary":"Placed on the July 23, 2026 FDA advisory committee agenda for possible inclusion on the 503A list.","source_url":"https://www.federalregister.gov/documents/2026/04/16/2026-07361/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request"},{"date":"2025-05-22","slug":"semaglutide","compound":"Semaglutide (compounded)","tag":"enforcement","summary":"503B enforcement discretion for compounding semaglutide ended (503A ended April 22, 2025), following the resolved shortage.","source_url":"https://www.mcdermottlaw.com/insights/semaglutide-shortage-resolved/"},{"date":"2025-03-19","slug":"tirzepatide","compound":"Tirzepatide (compounded)","tag":"enforcement","summary":"503B enforcement discretion for compounding tirzepatide ended (503A ended February 18, 2025), following the resolved shortage.","source_url":"https://www.pharmacytimes.com/view/fda-moves-to-permanently-close-the-door-on-compounded-glp-1s"},{"date":"2024-12-04","slug":"cjc-1295","compound":"CJC-1295","tag":"not_legalized","summary":"FDA advisory committee voted against adding CJC-1295 to the 503A list.","source_url":"https://www.federalregister.gov/documents/2024/10/25/2024-24828/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request"},{"date":"2024-12-04","slug":"thymosin-alpha-1","compound":"Thymosin Alpha-1","tag":"not_legalized","summary":"FDA advisory committee reviewed thymosin alpha-1 and did not recommend adding it to the 503A list.","source_url":"https://www.federalregister.gov/documents/2024/10/25/2024-24828/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request"},{"date":"2024-10-29","slug":"ipamorelin","compound":"Ipamorelin","tag":"not_legalized","summary":"FDA advisory committee voted against adding ipamorelin to the 503A list.","source_url":"https://a4pc.org/news/pcac-votes-against-four-nominated-bulk-drug-substances"},{"date":"2024-09-27","slug":"selank","compound":"Selank","tag":"not_legalized","summary":"Removed from Category 2 after its nomination was withdrawn - not placed on the 503A list, so compounding remained unauthorized.","source_url":"https://www.onhealthcare.tech/p/the-category-2-peptide-unwind-how"}]}