Regulatory · Alerts
Peptide regulatory alerts
Every regulatory change on peptides we track, one dated entry each, newest first: what changed, what it means for you, the regulator's own document, and the page here that explains it. 37 alerts from February 21, 2025 to October 9, 2026.
Last checked against FDA's own pages November 2, 2026 · By the Grey Peptides Editorial Board · Not legal advice
What counts as an alert: FDA bulks-list actions and categories, advisory-committee meetings and votes, warning letters and import alerts on peptides, compounded GLP-1 policy, WADA List changes, US state laws and board actions, prosecutions, and notable actions by regulators outside the US. Drug approvals are not listed here; they are on the pipeline tracker. Each source is the regulator's, legislature's or prosecutor's own page; where an enforcement document names a business in its address, the link describes the document and this page does not repeat the name. For where each compound stands today, use the regulatory tracker; this page is the history of how it got there.
October 2026
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 ↗ · read November 2, 2026
On Grey Peptides: The 2025 crackdown and the GLP-1 Green List
September 2026
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) ↗; WADA 2027 List: summary of major modifications (PDF) ↗ · read September 27, 2026
On Grey Peptides: Peptides on the WADA Prohibited List
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 ↗ · read October 27, 2026
On Grey Peptides: Our report on the letter
August 2026
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 ↗ · read October 3, 2026
On Grey Peptides: Peptide laws in the Netherlands
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) ↗ · read September 30, 2026
On Grey Peptides: Our report on the five letters
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 ↗ · read October 3, 2026
On Grey Peptides: Peptide laws in the Netherlands
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) ↗ · read November 2, 2026
On Grey Peptides: State pharmacy boards and peptides
July 2026
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) ↗ · read October 3, 2026
On Grey Peptides: Peptide laws in Mexico
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 ↗ · read November 2, 2026
On Grey Peptides: The votes, and what has happened since
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) ↗ · read November 2, 2026
On Grey Peptides: Peptide laws in France
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 ↗ · read October 3, 2026
On Grey Peptides: Peptide laws in Brazil
June 2026
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 ↗ · read November 2, 2026
On Grey Peptides: The PCAC July 2026 hub
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 ↗ · read November 2, 2026
On Grey Peptides: Our report on the extension
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 ↗ · read November 2, 2026
On Grey Peptides: Peptide laws in Australia
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 ↗ · read November 2, 2026
On Grey Peptides: What 'research use only' means
May 2026
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 ↗ · read October 27, 2026
On Grey Peptides: State pharmacy boards and peptides
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 ↗ · read November 2, 2026
On Grey Peptides: State pharmacy boards and peptides
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 ↗ · read October 3, 2026
On Grey Peptides: Peptide laws in China
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) ↗ · read November 2, 2026
On Grey Peptides: The regulatory tracker
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 ↗ · read November 2, 2026
On Grey Peptides: The 2025 crackdown and the GLP-1 Green List
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 ↗; FDA press announcement, April 30, 2026 ↗ · read November 2, 2026
On Grey Peptides: Compounded GLP-1s
April 2026
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) ↗ · read November 2, 2026
On Grey Peptides: Our report on the twelve
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 ↗ · read November 2, 2026
On Grey Peptides: The PCAC July 2026 hub
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 ↗ · read November 2, 2026
On Grey Peptides: The regulatory tracker
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 ↗ · read October 28, 2026
On Grey Peptides: The legal risks
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 ↗ · read October 28, 2026
On Grey Peptides: Contamination and reactions
March 2026
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 ↗; FDA warning letter 721805, March 31, 2026 ↗ · read November 2, 2026
On Grey Peptides: What 'research use only' means
January 2026
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 ↗ · read October 28, 2026
On Grey Peptides: Contamination and reactions
December 2025
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 ↗ · read October 28, 2026
On Grey Peptides: The 2025 crackdown
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) ↗ · read November 2, 2026
On Grey Peptides: State pharmacy boards and peptides
September 2025
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 ↗ · read November 2, 2026
On Grey Peptides: The 2025 crackdown and the GLP-1 Green List
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 ↗ · read October 3, 2026
On Grey Peptides: Peptide laws in the European Union
May 2025
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 ↗ · read September 25, 2026
On Grey Peptides: Compounded GLP-1s
April 2025
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 ↗ · read September 25, 2026
On Grey Peptides: Compounded GLP-1s
March 2025
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 ↗ · read September 25, 2026
On Grey Peptides: Compounded GLP-1s
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 ↗ · read September 25, 2026
On Grey Peptides: Compounded GLP-1s
February 2025
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 ↗ · read September 25, 2026
On Grey Peptides: Compounded GLP-1s
How this log is kept
Each alert is dated by the action itself: the letter, the publication, the signature or the vote. Where a document carries no date of its own, the entry says how we dated it. The read date is when we last read the source. The log was seeded from changes the site already documented and then checked against FDA's warning letters, import alerts, compounding lists, advisory-committee pages and Federal Register dockets on November 2, 2026, which added 4 letters and alerts the site had not covered.
See also the PCAC July 2026 hub, the WADA hub, peptide laws by country, state boards and peptides and the News Wire. The data is public: regulatory-alerts.json.
This page reports regulators' actions and our reading of them. It is not legal advice, and nothing here describes how to obtain or use any substance.