https://greypeptides.com/regulatory/alerts/ Every regulatory change on peptides, newest first: FDA bulks lists and categories, PCAC meetings and votes, warning letters, import alerts, compounded GLP-1 policy, WADA, US states and regulators abroad. Each alert links the regulator's own document. en-us © 2026 Grey Peptides editors@greypeptides.com (Grey Peptides Editorial Board) editors@greypeptides.com (Grey Peptides Editorial) Fri, 09 Oct 2026 12:00:00 +0000 Fri, 09 Oct 2026 12:00:00 +0000 1440 https://greypeptides.com/regulatory/alerts/#fda-import-alert-66-80-revised greypeptides-regulatory-alert-fda-import-alert-66-80-revised Fri, 09 Oct 2026 12:00:00 +0000 Import alert Grey Peptides Editorial Board FDA published a major revision of Import Alert 66-80, which lets it detain GLP-1 bulk ingredients from foreign sites not on its Green List without examination, updating the Green List criteria and adding product codes, including one for orforglipron. What it means: The alert governs the raw ingredient that compounders import, not a finished product a patient buys. FDA says 21% of the 48 GLP-1 ingredient sites it reviewed were noncompliant, and that some sites registered, offered ingredients for import, refused records requests and deregistered. Source: FDA Import Alert 66-80, major revision published October 9, 2026. https://greypeptides.com/regulatory/alerts/#wada-2027-list-published greypeptides-regulatory-alert-wada-2027-list-published Mon, 21 Sep 2026 12:00:00 +0000 WADA Grey Peptides Editorial Board WADA published the 2027 Prohibited List, approved September 10 and in force January 1, 2027. S0, the catch-all for unapproved substances, now lists peptides among its examples. What it means: Unapproved research peptides were already caught by S0; the wording now says so outright. For an athlete, the List in force on the day of the sample is the one that applies, so the 2026 List governs until December 31. Source: WADA Prohibited List 2027 (PDF). https://greypeptides.com/regulatory/alerts/#fda-wl-vitamin-glp1-copies greypeptides-regulatory-alert-fda-wl-vitamin-glp1-copies Fri, 18 Sep 2026 12:00:00 +0000 Warning letter Grey Peptides Editorial Board FDA warned a Houston compounding pharmacy that its tirzepatide with niacinamide and semaglutide with vitamin B12 appear to be essentially copies of approved GLP-1 drugs, made in volumes suggesting the added vitamin is pretextual. Posted September 22. What it means: Adding a vitamin does not by itself make a compounded GLP-1 lawful. The statute's condition is a prescriber's documented, patient-specific significant difference; pre-written prescriber determinations were part of FDA's case. Source: FDA warning letter 738238, September 18, 2026. https://greypeptides.com/regulatory/alerts/#igj-penalty-order-online-seller greypeptides-regulatory-alert-igj-penalty-order-online-seller Mon, 31 Aug 2026 12:00:00 +0000 Outside the US Grey Peptides Editorial Board The Dutch health inspectorate imposed a penalty order on the online seller it had ordered on August 24 to stop selling retatrutide, tirzepatide and semaglutide, after the seller kept selling. What it means: Dutch enforcement moved from an order to escalating penalties within a week. Retatrutide is approved nowhere, and the two approved GLP-1s are prescription medicines that a webshop may not supply. Source: IGJ news release: penalty order (last onder dwangsom), August 31, 2026. https://greypeptides.com/regulatory/alerts/#fda-wl-five-online-sellers greypeptides-regulatory-alert-fda-wl-five-online-sellers Mon, 24 Aug 2026 12:00:00 +0000 Warning letter Grey Peptides Editorial Board FDA sent warning letters to five online peptide sellers in North Carolina, Florida, Texas and Arizona, calling retatrutide, semaglutide, tirzepatide and other peptides unapproved new drugs. Posted September 1. What it means: A 'research use only' label did not decide the case: FDA read intended use from the whole website. Selling bacteriostatic water and offering a peptide calculator counted as evidence of human use. Source: FDA warning letter 733652, August 24, 2026 (first of five). https://greypeptides.com/regulatory/alerts/#igj-order-online-seller greypeptides-regulatory-alert-igj-order-online-seller Mon, 24 Aug 2026 12:00:00 +0000 Outside the US Grey Peptides Editorial Board The Dutch health inspectorate ordered an online webshop trading under several names to end the supply, delivery and trade of medicines containing retatrutide, tirzepatide and semaglutide. What it means: In the EU, selling these as 'peptides' online does not take them outside medicines law; the inspectorate treats them as medicines supplied without the required licences. Source: IGJ news release: order to an online webshop, August 24, 2026. https://greypeptides.com/regulatory/alerts/#mississippi-joint-statement greypeptides-regulatory-alert-mississippi-joint-statement Wed, 19 Aug 2026 12:00:00 +0000 US state Grey Peptides Editorial Board Mississippi's medical, nursing and pharmacy boards jointly said no licensed provider may compound, administer, dispense, advise on, recommend, supply or prescribe research-grade or non-FDA-approved peptides. What it means: A Mississippi clinician who supplies or recommends a research peptide risks discipline; a 'research-grade' label does not reduce a provider's liability. A patient acting alone is not the boards' target. Source: Joint statement of the Mississippi State Board of Medical Licensure, Board of Nursing and Board of Pharmacy, August 19, 2026 (PDF). https://greypeptides.com/regulatory/alerts/#mexico-215-bis-bill greypeptides-regulatory-alert-mexico-215-bis-bill Wed, 29 Jul 2026 12:00:00 +0000 Outside the US Grey Peptides Editorial Board A bill was introduced to add Article 215 Bis to Mexico's General Health Law, defining research peptides and banning their sale to the public without sanitary registration. What it means: It is a bill, not law. Until it passes, research peptides sit in a gap in Mexican law: they hold no sanitary registration. Source: Chamber of Deputies, initiative to add Article 215 Bis to the General Health Law (SIL record, PDF). https://greypeptides.com/regulatory/alerts/#pcac-july-2026-votes greypeptides-regulatory-alert-pcac-july-2026-votes Fri, 24 Jul 2026 12:00:00 +0000 Advisory committee Grey Peptides Editorial Board The Pharmacy Compounding Advisory Committee voted to recommend BPC-157, KPV, TB-500, MOTS-c, semax and epitalon for FDA's 503A bulks list and voted against emideltide, as reported (BPC-157 8–6, 1 abstention; KPV 8–6, 1 abstention; TB-500 8–6, 1 abstention; MOTS-c 7–5, 2 abstentions; emideltide 6–7, 1 abstention; semax 8–5, 1 abstention; epitalon 7–4 or 7–5, 1 abstention). What it means: A committee recommendation is not a rule. As of November 2, 2026, FDA had posted no minutes or tallies, its 503A category list was still dated May 14, 2026, and none of the six was on the list or in Category 1, so 503A pharmacies still cannot compound them. Source: FDA meeting page: July 23-24, 2026 Pharmacy Compounding Advisory Committee. https://greypeptides.com/regulatory/alerts/#ansm-peptides-online-warning greypeptides-regulatory-alert-ansm-peptides-online-warning Thu, 02 Jul 2026 12:00:00 +0000 Outside the US Grey Peptides Editorial Board France's medicines agency told the public not to buy or inject peptides sold online, on social media or through informal contacts, naming retatrutide, BPC-157, TB-500 and GHK-Cu among others. Updated August 31. What it means: In France these products are neither evaluated nor authorised, and their contents are uncertain. Anyone who has used them and has side effects should see a health professional. Source: ANSM news: peptides sold online, July 2, 2026 (updated August 31, 2026). https://greypeptides.com/regulatory/alerts/#anvisa-peptides-not-registered greypeptides-regulatory-alert-anvisa-peptides-not-registered Thu, 02 Jul 2026 12:00:00 +0000 Outside the US Grey Peptides Editorial Board Brazil's health regulator said GHK-Cu, BPC-157, TB-500, CJC-1295 and ipamorelin are not registered in any category and are illegal for any health or aesthetic use. What it means: In Brazil an injectable peptide cannot be sold as a supplement or a cosmetic: supplements cannot be injectable and injectable cosmetics do not exist in its rules. Source: ANVISA fact-check on peptides, July 2, 2026. https://greypeptides.com/regulatory/alerts/#pcac-briefing-staff-against greypeptides-regulatory-alert-pcac-briefing-staff-against Mon, 29 Jun 2026 12:00:00 +0000 Advisory committee Grey Peptides Editorial Board FDA released its briefing documents for the seven peptides before the July committee meeting; staff proposed adding none of them to the 503A bulks list. What it means: FDA's own reviewers made the case against all seven, in free-base and acetate form. The briefing documents are the most detailed public statement of FDA's safety concerns about each. Source: FDA meeting page with the seven briefing documents. https://greypeptides.com/regulatory/alerts/#503b-glp1-comment-extended greypeptides-regulatory-alert-503b-glp1-comment-extended Fri, 26 Jun 2026 12:00:00 +0000 Compounded GLP-1 Grey Peptides Editorial Board FDA extended the comment period on its proposal not to put semaglutide, tirzepatide or liraglutide on the 503B bulks list by 30 days, to July 30, 2026 (91 FR 38719). What it means: Comments are closed. As of November 2, 2026 the Federal Register held no final determination: the June 26 extension is the newest document in docket FDA-2018-N-3240. Source: Federal Register, 91 FR 38719, June 26, 2026. https://greypeptides.com/regulatory/alerts/#victoria-retatrutide-liver-alert greypeptides-regulatory-alert-victoria-retatrutide-liver-alert Fri, 19 Jun 2026 12:00:00 +0000 Outside the US Grey Peptides Editorial Board Victoria's Department of Health issued a health alert after six cases of acute liver toxicity linked to unapproved products labelled Retatrutide, Reta, R-10 or R-20. What it means: The cause may be a contaminant, so every such product is treated as at risk. Fatigue, abdominal pain, yellow skin or eyes, dark urine or easy bruising after use call for prompt medical care. Source: Victorian Department of Health alert, June 19, 2026. https://greypeptides.com/regulatory/alerts/#fda-wl-florida-seller-gonadorelin greypeptides-regulatory-alert-fda-wl-florida-seller-gonadorelin Wed, 17 Jun 2026 12:00:00 +0000 Warning letter Grey Peptides Editorial Board FDA warned a Florida online peptide seller that two products it sold, gonadorelin and one sold as Prostamax, are unapproved new drugs. Posted July 16. What it means: Another letter that looks past 'research use only' and 'not for human consumption' labelling to what the website shows. Source: FDA warning letter 729447, June 17, 2026. https://greypeptides.com/regulatory/alerts/#alabama-bme-notice greypeptides-regulatory-alert-alabama-bme-notice Tue, 26 May 2026 12:00:00 +0000 US state Grey Peptides Editorial Board Alabama's Board of Medical Examiners and Medical Licensure Commission issued a notice that physicians may not compound, administer or dispense non-FDA-approved, research-grade peptides. What it means: Alabama physicians must buy prescription products only from entities the state Board of Pharmacy permits; a patient consent form does not remove the physician's liability. Source: Alabama Board of Medical Examiners, official notice on research-grade peptides. https://greypeptides.com/regulatory/alerts/#louisiana-act-374 greypeptides-regulatory-alert-louisiana-act-374 Fri, 22 May 2026 12:00:00 +0000 US state Grey Peptides Editorial Board Louisiana enacted Act 374 (Senate Bill 253), effective August 1, 2026: licensing boards may not bar prescribers or pharmacists from peptides compounded by pharmacies or outsourcing facilities that comply with the federal compounding statutes. What it means: It sounds permissive but adds no ingredient: federal law still decides what may be compounded, so BPC-157 and most popular peptides remain out of reach. It protects only compounding that is already federally lawful. Source: Louisiana Legislature, SB 253 (2026 Regular Session), Act 374. https://greypeptides.com/regulatory/alerts/#china-online-sales-rules greypeptides-regulatory-alert-china-online-sales-rules Fri, 15 May 2026 12:00:00 +0000 Outside the US Grey Peptides Editorial Board China's revised drug regulations (Order No. 828) took effect, barring online retail and online prescribing of higher-risk medicines. What it means: The online route through which GLP-1 injections had been reaching weight-loss buyers in China was closed. Source: State Council Order No. 828, Regulations for the Implementation of the Drug Administration Law. https://greypeptides.com/regulatory/alerts/#ghk-cu-non-injectable-category-1 greypeptides-regulatory-alert-ghk-cu-non-injectable-category-1 Thu, 14 May 2026 12:00:00 +0000 Bulks list Grey Peptides Editorial Board FDA put GHK-Cu, except for injectable routes, back in 503A Category 1, after a nominator clarified on May 5 that it had withdrawn only the injectable nomination. What it means: 503A pharmacies may compound GHK-Cu for non-injectable use under Category 1 while FDA decides; injectable GHK-Cu is in no category and cannot be compounded. FDA plans to take GHK-Cu to the committee before the end of February 2027. Source: FDA 503A bulk drug substances category list, updated May 14, 2026 (PDF). https://greypeptides.com/regulatory/alerts/#fda-wl-peptide-api-maker greypeptides-regulatory-alert-fda-wl-peptide-api-maker Fri, 01 May 2026 12:00:00 +0000 Warning letter Grey Peptides Editorial Board FDA warned a Chinese maker of peptide ingredients, including semaglutide and tirzepatide, over manufacturing-quality failures and relabelling semaglutide bought from other suppliers as its own. It had been put on Import Alert 66-40 and removed from the Import Alert 66-80 Green List on February 27. Posted May 19. What it means: The quality problem FDA describes sits upstream of any vial: the ingredient, and who really made it. Compounders depend on that ingredient, and 503A pharmacies are exempt from the manufacturing rules that would catch it. Source: FDA warning letter 320-26-73, May 1, 2026. https://greypeptides.com/regulatory/alerts/#503b-glp1-proposal greypeptides-regulatory-alert-503b-glp1-proposal Fri, 01 May 2026 12:00:00 +0000 Compounded GLP-1 Grey Peptides Editorial Board FDA proposed not to include semaglutide, tirzepatide or liraglutide on the 503B bulks list (91 FR 23431, docket FDA-2018-N-3240). What it means: A proposal, not a rule. It concerns outsourcing facilities compounding from bulk when there is no shortage; the three were never on the list, so nothing was removed. Source: Federal Register, 91 FR 23431, May 1, 2026. https://greypeptides.com/regulatory/alerts/#category-2-twelve-withdrawn greypeptides-regulatory-alert-category-2-twelve-withdrawn Wed, 22 Apr 2026 12:00:00 +0000 Bulks list Grey Peptides Editorial Board FDA's list of substances that may present significant safety risks now shows twelve peptides, including BPC-157, TB-500, KPV and MOTS-c, among nominations withdrawn, so they are no longer in Category 2. What it means: Off Category 2 is not cleared: none moved to Category 1 or onto the 503A list, so 503A pharmacies still cannot compound them. Seven went to the July committee; five wait for a meeting before the end of February 2027. Source: FDA: bulk drug substances that may present significant safety risks (content current as of April 22, 2026). https://greypeptides.com/regulatory/alerts/#pcac-july-meeting-noticed greypeptides-regulatory-alert-pcac-july-meeting-noticed Thu, 16 Apr 2026 12:00:00 +0000 Advisory committee Grey Peptides Editorial Board FDA gave notice in the Federal Register (91 FR 20465) of a July 23-24, 2026 committee meeting on seven peptides nominated for the 503A bulks list: BPC-157, KPV, TB-500, MOTS-c, emideltide, semax and epitalon. What it means: The first public review of these peptides for compounding, with a public docket (FDA-2025-N-6895) that took comments until July 22. Source: Federal Register, 91 FR 20465, April 16, 2026. https://greypeptides.com/regulatory/alerts/#pcac-second-meeting-planned greypeptides-regulatory-alert-pcac-second-meeting-planned Wed, 15 Apr 2026 12:00:00 +0000 Advisory committee Grey Peptides Editorial Board FDA said it will hold a second committee meeting before the end of February 2027 on five more substances: LL-37, GHK-Cu, dihexa, melanotan II and PEG-MGF. No date had been set as of November 2, 2026. What it means: Until that meeting and an FDA decision after it, none of the five can be compounded by a 503A pharmacy, except GHK-Cu for non-injectable use. Source: FDA: Pharmacy Compounding Advisory Committee meetings page. https://greypeptides.com/regulatory/alerts/#health-canada-peptides-advisory greypeptides-regulatory-alert-health-canada-peptides-advisory Thu, 09 Apr 2026 12:00:00 +0000 Outside the US Grey Peptides Editorial Board Health Canada warned against injecting peptides bought online, saying unauthorized drug products are illegal in Canada and research-use labelling does not exempt them. What it means: Health Canada lists the contamination it is concerned about: solvents, heavy metals, particles and microbes. It works with border services to stop unauthorized shipments. Source: Health Canada public advisory, April 9, 2026. https://greypeptides.com/regulatory/alerts/#fda-wl-503b-mould greypeptides-regulatory-alert-fda-wl-503b-mould Tue, 07 Apr 2026 12:00:00 +0000 Warning letter Grey Peptides Editorial Board FDA warned an outsourcing facility making tirzepatide and semaglutide after inspectors recovered mould during a tirzepatide run and found products released despite microbial recoveries. What it means: Even regulated compounders fail sterility; the firm had recalled multidose vials. A grey-market vial has no inspection at all before it ships. Source: FDA warning letter to a 503B outsourcing facility, April 7, 2026. https://greypeptides.com/regulatory/alerts/#fda-wl-two-online-sellers-march greypeptides-regulatory-alert-fda-wl-two-online-sellers-march Tue, 31 Mar 2026 12:00:00 +0000 Warning letter Grey Peptides Editorial Board FDA warned two online sellers, in California and Arizona, that retatrutide, tirzepatide, semaglutide, cagrilintide and mazdutide, sold under code names such as 'GLP-1-R peptide' and 'GLP1-T', are unapproved new drugs. Posted April 7. What it means: The code names did not hide the drugs, and 'laboratory research purposes only' labels did not change FDA's finding. Bacteriostatic water sold alongside was again part of the evidence. Source: FDA warning letter 721806, March 31, 2026. https://greypeptides.com/regulatory/alerts/#fda-wl-503a-sterility greypeptides-regulatory-alert-fda-wl-503a-sterility Fri, 16 Jan 2026 12:00:00 +0000 Warning letter Grey Peptides Editorial Board FDA warned a state-licensed compounding pharmacy that released products, including a compounded tirzepatide injection, among nine lots that failed sterility testing. What it means: A compounded GLP-1 is only as safe as the pharmacy's sterile practice; checking that a pharmacy is licensed and has no recent FDA letter is part of choosing one. Source: FDA warning letter to a 503A compounding pharmacy, January 16, 2026. https://greypeptides.com/regulatory/alerts/#usao-ndin-peptide-seller-pleas greypeptides-regulatory-alert-usao-ndin-peptide-seller-pleas Wed, 10 Dec 2025 12:00:00 +0000 Prosecution Grey Peptides Editorial Board In a federal prosecution in the Northern District of Indiana of a US online seller of peptides, hCG and SARMs, the defendants pleaded guilty; sentencing was set for July 30, 2026. What it means: Selling research peptides online can end in criminal charges, not only a warning letter. Source: US Attorney's Office, Northern District of Indiana, case page. https://greypeptides.com/regulatory/alerts/#ohio-board-guidance greypeptides-regulatory-alert-ohio-board-guidance Mon, 08 Dec 2025 12:00:00 +0000 US state Grey Peptides Editorial Board Ohio's Board of Pharmacy updated its guidance on clinic and medical-spa violations: BPC-157 and other substances in FDA's Categories 2 and 3 cannot be compounded, and it has summarily suspended more than 30 clinics and medical spas since the start of 2025. What it means: Ohio acts on a clinic's licence rather than waiting for FDA. BPC-157 has since left Category 2, but it is still not compoundable under federal law. Source: Ohio Board of Pharmacy guidance, updated December 8, 2025 (PDF). https://greypeptides.com/regulatory/alerts/#fda-glp1-green-list greypeptides-regulatory-alert-fda-glp1-green-list Fri, 05 Sep 2025 12:00:00 +0000 Import alert Grey Peptides Editorial Board FDA launched a 'Green List' import alert (66-80): GLP-1 ingredients such as semaglutide and tirzepatide from foreign sites it has not found compliant can be detained without physical examination. What it means: It is aimed at ingredients for compounding, not at personal parcels: ingredients from sites on the Green List can still be imported. Source: FDA press announcement, September 5, 2025. https://greypeptides.com/regulatory/alerts/#ema-illegal-glp1-warning greypeptides-regulatory-alert-ema-illegal-glp1-warning Wed, 03 Sep 2025 12:00:00 +0000 Outside the US Grey Peptides Editorial Board The European Medicines Agency and the Heads of Medicines Agencies warned of a sharp rise in illegal medicines advertised and sold online as GLP-1 receptor agonists. What it means: In the EU, GLP-1 drugs are prescription medicines, to be bought only from authorised pharmacies or retailers on a prescription. Source: EMA news: warning about a sharp rise in illegal medicines sold in the EU, September 3, 2025. https://greypeptides.com/regulatory/alerts/#503b-semaglutide-discretion-ends greypeptides-regulatory-alert-503b-semaglutide-discretion-ends Thu, 22 May 2025 12:00:00 +0000 Compounded GLP-1 Grey Peptides Editorial Board FDA's enforcement discretion for outsourcing facilities compounding semaglutide ended. What it means: This is when mass-market compounded semaglutide ended in the US, not in 2026. Source: FDA: policies for compounders as GLP-1 supply stabilizes. https://greypeptides.com/regulatory/alerts/#503a-semaglutide-discretion-ends greypeptides-regulatory-alert-503a-semaglutide-discretion-ends Thu, 24 Apr 2025 12:00:00 +0000 Compounded GLP-1 Grey Peptides Editorial Board FDA's enforcement discretion for 503A pharmacies compounding semaglutide copies ended when a court denied a preliminary injunction. What it means: State-licensed pharmacies may no longer routinely compound copies of semaglutide; a compounded product needs a patient-specific clinical difference documented by the prescriber. Source: FDA: policies for compounders as GLP-1 supply stabilizes. https://greypeptides.com/regulatory/alerts/#503b-tirzepatide-discretion-ends greypeptides-regulatory-alert-503b-tirzepatide-discretion-ends Wed, 19 Mar 2025 12:00:00 +0000 Compounded GLP-1 Grey Peptides Editorial Board FDA's enforcement discretion for outsourcing facilities compounding tirzepatide ended. What it means: Outsourcing facilities lost the shortage-era route to compounding tirzepatide. Source: FDA: policies for compounders as GLP-1 supply stabilizes. https://greypeptides.com/regulatory/alerts/#503a-tirzepatide-discretion-ends greypeptides-regulatory-alert-503a-tirzepatide-discretion-ends Wed, 05 Mar 2025 12:00:00 +0000 Compounded GLP-1 Grey Peptides Editorial Board FDA's enforcement discretion for 503A pharmacies compounding tirzepatide copies ended when a court denied a preliminary injunction. What it means: State-licensed pharmacies lost the routine route to compounding tirzepatide first. Source: FDA: policies for compounders as GLP-1 supply stabilizes. https://greypeptides.com/regulatory/alerts/#semaglutide-shortage-resolved greypeptides-regulatory-alert-semaglutide-shortage-resolved Fri, 21 Feb 2025 12:00:00 +0000 Compounded GLP-1 Grey Peptides Editorial Board FDA declared the semaglutide shortage resolved. What it means: The shortage listing was the legal hook for compounding copies; its end started the clock on the enforcement dates that followed. Source: FDA: policies for compounders as GLP-1 supply stabilizes.