What's changing: peptide rules to watch
In short
About 6 minutes for the short version; 10 with every detail open.
- Rules on peptides are changing in the US, in the EU and in sport.
- The US advisory vote of July 2026 was only advice. The FDA has not decided yet.
- Nothing that happens in the US changes the law in the Netherlands or the EU.
- New sport rules start on 1 January 2027. They name peptides more clearly.
- Each item shows its status, a date and an official source.
Each section starts with the short answer. The rest is folded under “In detail”.
What is this page?
The tracker below lists the changes in law and policy that matter most for the peptides on this site. “Last update” is the date of the latest official step in each item. We checked every item against its sources on 22 October 2026.
-
United Kingdom Watching
MHRA raids on unlicensed weight-loss injections
Since October 2025 the UK medicines regulator has raided several sites that made unlicensed retatrutide and tirzepatide pens. On 14 October 2026 it seized more than 12,000 fake pens in Birmingham. The MHRA says products sold as retatrutide outside clinical trials are supplied illegally.
retatrutidetirzepatide Medicines and Healthcare products Regulatory Agency (2026)Medicines and Healthcare products Regulatory Agency (2026)Medicines and Healthcare products Regulatory Agency (2026)
-
European Union Rulemaking
The EU's new medicines law
The EU is replacing its main medicines law, Directive 2001/83/EC, with a new directive and a new regulation. Parliament and Council reached political agreement on 11 December 2025. The Council published its position on 1 October 2026, and both texts now wait for Parliament's second reading. After the new law enters into force, member states get a transition period to update their own laws; the EMA expects it to run until 2028. Until then, today's rules apply.
European Parliament, Legislative Observatory (2026)European Parliament, Legislative Observatory (2026)European Medicines Agency (2026)
-
Sport (WADA) Adopted
The 2027 Prohibited List names peptides in section S0
WADA published the 2027 Prohibited List on 21 September 2026. It takes effect on 1 January 2027. Section S0 now names 'peptides' among its examples, next to BPC-157. WADA says a peptide that the list does not name may still be prohibited. The Dutch Doping Authority will publish its Dutch translation from 1 January 2027.
bpc-157tb-500retatrutide World Anti-Doping Agency (2026)World Anti-Doping Agency (2026)UK Anti-Doping (2026)Dopingautoriteit (2026)
-
Sport (WADA) Watching
Semaglutide and tirzepatide stay on WADA's watch list
Semaglutide and tirzepatide are not banned in sport. WADA keeps them in its 2027 Monitoring Program, in and out of competition, to see whether athletes misuse them. They were also in the 2026 programme.
semaglutidetirzepatide World Anti-Doping Agency (2026)World Anti-Doping Agency (2025)
-
United States Watching
FDA warning letters to 'research use only' peptide sellers
The FDA keeps sending warning letters to online sellers of peptides labelled 'research use only'. Letters of March and August 2026 say the sellers' own websites show the products are drugs for people, so they are unapproved new drugs. Bacteriostatic water sold with them counts as a drug too. The FDA warns that such products are of unknown quality.
semaglutidetirzepatideretatrutide U.S. Food and Drug Administration (2026)U.S. Food and Drug Administration (2026)
-
United States Proposed
FDA proposes to keep semaglutide and tirzepatide off the 503B list
On 30 April 2026 the FDA proposed not to put semaglutide, tirzepatide or liraglutide on the list of bulk ingredients that outsourcing facilities may use, because it found no clinical need. Comments closed on 30 July 2026. The shortages that allowed wider compounding ended earlier: for tirzepatide on 19 December 2024, for semaglutide on 21 February 2025.
semaglutidetirzepatide U.S. Food and Drug Administration (2026)U.S. Food and Drug Administration (2026)U.S. Food and Drug Administration (2026)U.S. Food and Drug Administration (2026)Office of the Federal Register (2026)
-
United States Advisory vote
US advisers back six peptides for pharmacy compounding
On 23 July 2026 the FDA's Pharmacy Compounding Advisory Committee voted 8 to 6, with one abstention, to recommend BPC-157 for the 503A list of ingredients pharmacies may use. Over two days it considered seven peptides and recommended six: BPC-157, KPV, TB-500, MOTS-c, Semax and epitalon, but not emideltide. These results are as reported from the public meeting; the FDA has posted no minutes. The vote is advice only, and went against FDA staff's own proposal. Compounding with these peptides stays prohibited until the FDA adopts the advice and completes rulemaking. None of them is an approved medicine in the EU, the UK or the US (Semax is registered as a medicine in Russia). A listing would let US pharmacies compound them on prescription. It would not be an approval and says nothing about whether they work. Nothing changes in the EU or the Netherlands.
bpc-157kpvtb-500mots-csemaxepitalon U.S. Food and Drug Administration (2026)U.S. Food and Drug Administration (2026)U.S. Food and Drug Administration (2026)U.S. Food and Drug Administration (2026)U.S. Food and Drug Administration (2026)U.S. Food and Drug Administration (2026)U.S. Food and Drug Administration (2026)European Medicines Agency (2026)Staten-Generaal / Koninkrijk der Nederlanden (2007)Office of the Federal Register (2026)
-
United States In force
FDA compounding categories: peptide nominations withdrawn, none in category 1
While it builds the 503A list, the FDA sorts nominated ingredients into three interim categories. By 22 April 2026 it listed BPC-157, TB-500, KPV, MOTS-c, CJC-1295, AOD-9604, Semax, epitalon and other peptides as 'previously in category 2', because their nominations were withdrawn. Its list of 14 May 2026 puts none of them in category 1, the only category for which the FDA says it does not intend to act against pharmacies. The one exception is GHK-Cu for routes other than injection. The FDA no longer sorts ingredients nominated since 7 January 2025 into these categories.
bpc-157kpvtb-500mots-ccjc-1295aod-9604semaxepitalonghk-cu U.S. Food and Drug Administration (2026)U.S. Food and Drug Administration (2026)U.S. Food and Drug Administration (2026)
-
United States Watching
A second FDA advisory meeting on five more substances
The FDA says it will hold another advisory meeting before the end of February 2027. It will discuss LL-37, GHK-Cu, dihexa acetate, melanotan II and pegylated mechano growth factor (PEG-MGF) for the 503A list. The date and place are not yet set.
ghk-cumelanotan-ii U.S. Food and Drug Administration (2026)U.S. Food and Drug Administration (2026)
-
Germany Watching
Germany's doping law follows the WADA list each year
Germany's anti-doping law bans selling and supplying substances on the WADA list, as published each year in the federal law gazette. The 2026 list appeared there on 23 December 2025. A separate annex of the law, last changed in March 2023, decides which substances are a crime to own in large amounts. It names TB-500 and several growth-hormone peptides, but not BPC-157.
tb-500bpc-157 Bundeskanzleramt (2025)Bundesministerium der Justiz (2026)Bundesministerium der Justiz (2023)Bundesministerium der Justiz (2015)
-
Sport (WADA) Adopted
A new World Anti-Doping Code from 1 January 2027
WADA approved the 2027 World Anti-Doping Code and its standards on 5 December 2025, including a new standard for medical exemptions (TUEs). Both take effect on 1 January 2027. Strict liability stays: a banned substance in your sample is a violation, whatever you intended.
World Anti-Doping Agency (2026)World Anti-Doping Agency (2026)World Anti-Doping Agency (2025)
-
Netherlands Watching
Dutch inspectorate: more reports about illegal online medicine sellers
The Dutch Health and Youth Care Inspectorate (IGJ) received 114 reports in 2024 about web shops selling prescription medicines without a prescription, and 187 from January to early October 2025. It investigated 150 sites and had dozens taken down. The reports are not only about peptides. The IGJ can warn or fine websites that offer or advertise illegal medicines to Dutch buyers.
Inspectie Gezondheidszorg en Jeugd (IGJ) (2025)Inspectie Gezondheidszorg en Jeugd (IGJ) (2023)
This page reports what regulators and lawmakers have published. It does not predict what they will decide, and it does not tell anyone how to use a product or where to find one. For the law as it stands today, see the pages on the Netherlands, the EU, Germany, the UK and the US.
How to read the statuses
What do the labels on each item mean?
| Label | What it means |
|---|---|
| Proposed | An authority has put forward a change, but it is not yet decided |
| Public consultation | Anyone can send comments on a draft before a deadline |
| Advisory vote | Experts have given advice. The authority still has to decide |
| Rulemaking | The formal steps to make or change a law or rule are under way |
| Adopted | The change has been decided, but has not started yet |
| In force | The rule applies now |
| Stalled | Nothing has moved for a long time |
| Watching | Not a change in law, but something to follow, such as enforcement |
An advisory vote and a proposal can both come to nothing. Only “adopted” and “in force” mean that a rule has really changed. When an item moves to a new status, we change its date and record the change in our corrections log.
The United States
What is happening in the US?
- Nomination. Someone asks the FDA to add an ingredient to the 503A list.1
- FDA review and advisory meeting. FDA staff write a review, and an advisory committee votes. Seven peptides reached this step in July 2026. Five more substances are on the agenda of a meeting planned before the end of February 2027.2,3
- FDA decision. The FDA says it will not decide until it has considered the committee’s advice and finished its reviews. This is where the seven peptides stand.4
- Proposed rule and comments. The FDA publishes a proposed rule and takes public comments.1
- Final rule. Only a final rule adds an ingredient to the list.1,5
On 23 July 2026, the FDA’s Pharmacy Compounding Advisory Committee voted 8–6, with one abstention, to recommend BPC-157 for the 503A list. It considered seven peptides and recommended six. These results are as reported from the public meeting; the FDA has posted no minutes.6,7 The vote is advisory and non-binding, and went against FDA staff’s own proposal.4
In detail: The July 2026 vote: the five points that matter , about 1 minute to read
- The vote. On 23 July 2026 the committee voted 8–6, with one abstention, to recommend BPC-157 for the 503A bulks list. The count is as reported from the public meeting.6,7
- Seven considered, six recommended. The agenda had BPC-157, KPV, TB-500, MOTS-c, emideltide (also called DSIP), Semax and epitalon. Each was voted on as a free base and as an acetate salt.2,7 As reported from the meeting, all were recommended except emideltide.
- Advice only, against FDA staff. FDA staff had proposed that none of the 14 forms be added.4 Advisory committees make “non-binding recommendations”.3
- Still prohibited for now. Legal compounding stays prohibited until the FDA formally adopts the advice and completes rulemaking.1,5 On 22 October 2026 the Federal Register held no proposed rule.8
- Not an approval. None of these is an approved medicine in the EU, the UK or the US (Semax is registered as a medicine in Russia).9,10 A listing would let US pharmacies compound them on prescription. It is not a marketing authorisation, says nothing about whether they work, and changes nothing in the EU or the Netherlands.11,12
In detail: The other US items, in short , about 1 minute to read
- Interim categories. By 22 April 2026, the FDA listed BPC-157, TB-500, KPV and other peptides as “previously in category 2”. Their nominations were withdrawn. On the FDA’s list of 14 May 2026, none of them is in category 1.13,14 Only category 1 ingredients fall under the FDA’s interim policy of not taking action against pharmacies.1
- Semaglutide and tirzepatide. On 30 April 2026 the FDA proposed to keep them off the list for outsourcing facilities. Comments closed on 30 July 2026, and no final decision has been published.15,16,17,8
- Warning letters. The FDA keeps writing to online sellers of “research use only” peptides. It calls their products unapproved new drugs.18
More on each point: US law.
The European Union
Is EU medicines law changing?
- Political agreement. Parliament and Council agreed on the reform on 11 December 2025.19
- Committee approval. Parliament’s committee approved the agreed text on 18 March 2026.20
- Council position. The Council published its position on 1 October 2026.20,21
- Parliament’s second reading. Still to come. The European Parliament gives 23 November 2026 as an indicative plenary date.20
- Transition. After the law enters into force, member states update their national laws. The EMA expects this to run until 2028.19
The reform replaces the main EU medicines directive with a new directive and a new regulation.20,21 Until it applies, the rules on the EU page stand. We will explain what changes for unlicensed medicines once the final text is published.
In detail: Why the EU reform matters for peptides, and what we do not know yet , about 1 minute to read
The EU directive is the basis of the Dutch, German and Belgian medicines laws. It sets what counts as a medicine, the rule that a medicine needs a licence before sale, and the ban on advertising unlicensed medicines.22 Any change in those rules would reach every member state.
We have not yet read a final, published text of the new law. So we do not say here what it will change for products like those on this site. We will update this item and the EU page when the text appears in the EU’s Official Journal.
Sport
What changes in sport on 1 January 2027?
| 2026 | 2027 | |
|---|---|---|
| Does S0 name “peptides” as an example? | No Not as a word23 | Yes Added for clarity24,25 |
| Is BPC-157 named in S0? | Yes As an example23 | Yes As an example24 |
| Are semaglutide and tirzepatide banned? | No Only monitored26 | No Only monitored27 |
| Does a positive test count without proof of intent? | Yes 2021 Code28 | Yes 2027 Code29 |
WADA published the 2027 list on 21 September 2026.30 The 2027 Code and its standards were approved on 5 December 2025, and also start on 1 January 2027.31 What this means for athletes: sport and doping.
In detail: What the 2027 changes mean in practice , about 1 minute to read
WADA says many unapproved peptides already fell under S0 or other sections. The new word “peptides” in S0 makes that clearer. A peptide that the list does not name “may still be prohibited”.25
The new standard for medical exemptions keeps four tests that must all be met. One is that the substance is an indicated treatment, with no reasonable allowed alternative.32
The Dutch Doping Authority says the 2027 changes are mostly clarifications and a few new examples. It advises athletes who may be tested to check their medicines and supplements again.33
Enforcement in the UK, Germany and the Netherlands
What about the countries closest to us?
| Country | What we follow | Latest step we could check |
|---|---|---|
| United Kingdom | MHRA raids on sites making unlicensed weight-loss pens | Over 12,000 fake pens seized in Birmingham on 14 October 202634 |
| Germany | The yearly doping list in the federal law gazette, which the anti-doping law follows | The 2026 list, published on 23 December 202535 |
| Netherlands | Reports to the health inspectorate (IGJ) about illegal web shops | 187 reports from January to early October 2025, up from 114 in all of 202436 |
None of these is a change in the law. The medicines laws on the UK, Germany and Netherlands pages still apply as written there.
In detail: More detail on the three countries , about 1 minute to read
United Kingdom. Since October 2025, the MHRA has raided several sites that made unlicensed retatrutide and tirzepatide pens. In May 2026, two men were arrested on suspicion of offences under the Human Medicines Regulations.34,37 In 2025 the MHRA and its partners seized almost 20 million doses of illegally traded medicines.38
Germany. The anti-doping law bans selling and supplying substances on the yearly doping list. Owning a large amount is a crime only for substances in the law’s own annex.39 That annex was last changed in March 2023. It names TB-500 and several growth-hormone peptides, but not BPC-157.40 The health ministry can add substances to it by regulation.41
Netherlands. The IGJ can warn or fine websites that offer illegal medicines or advertise them to Dutch buyers. It looks mostly at prescription-only and unregistered medicines.42 Its October 2025 figures are about prescription medicines in general, not peptides only.36
We do not name sellers on this site, even when a regulator does.
How we keep this page up to date
How do you check these items?
- Every item rests on a document from a regulator, a law database or an official register.
- Every item has the date of its latest official step.
- We check the US Federal Register, the FDA’s committee pages, the European Parliament’s register and WADA’s pages.
- A change of status is recorded in the corrections log.
If you see a change that we have missed, or an item that is out of date, please tell us: see about this site. News from regulators and journals appears on the news page.
Sources
Every claim on this page links to one of these sources. Scholarly sources link to their DOI; regulatory sources to the regulator's own page.
In detail: All 42 sources, numbered as in the text , about 7 minutes to read
- (2026). Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act. Regulator fda.gov (opens an external site) — accessed 20 October 2026 ↩
- (2026). Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments — Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List (FR Doc. 2026-07361). Federal Register. Regulator federalregister.gov (opens an external site) — accessed 20 October 2026 ↩
- (2026). Meeting of the Pharmacy Compounding Advisory Committee (early announcement: meeting before the end of February 2027). Regulator fda.gov (opens an external site) — accessed 22 October 2026 ↩
- (2026). FDA Briefing Document Introduction, Pharmacy Compounding Advisory Committee meeting, 23–24 July 2026. Regulator fda.gov (opens an external site) — accessed 20 October 2026 ↩
- (2026). 21 U.S. Code § 353a – Pharmacy compounding (FD&C Act § 503A). United States Code. Law law.cornell.edu (opens an external site) — accessed 22 October 2026 ↩
- (2026). July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee. Regulator fda.gov (opens an external site) — accessed 20 October 2026 ↩
- (2026). Questions, Pharmacy Compounding Advisory Committee meeting, 23–24 July 2026. Regulator fda.gov (opens an external site) — accessed 20 October 2026 ↩
- (2026). Federal Register document search, 22 October 2026: FDA documents since 24 July 2026 on compounding, '503A', '503B' and the Pharmacy Compounding Advisory Committee. Federal Register. Dataset federalregister.gov (opens an external site) — accessed 22 October 2026 ↩
- (2026). FDA Briefing Document for Semax-Related Bulk Drug Substances (Semax (free base) and Semax acetate), Pharmacy Compounding Advisory Committee meeting, 23–24 July 2026. Regulator fda.gov (opens an external site) — accessed 22 October 2026 ↩
- (2026). Medicines (search of centrally authorised medicines and EPARs). Regulator ema.europa.eu (opens an external site) — accessed 20 October 2026 ↩
- (2026). FDA Presentations, Pharmacy Compounding Advisory Committee meeting, 23 July 2026. Regulator fda.gov (opens an external site) — accessed 20 October 2026 ↩
- (2007). Geneesmiddelenwet (BWBR0021505). wetten.overheid.nl. Law wetten.overheid.nl (opens an external site) — accessed 20 October 2026 ↩
- (2026). Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. Regulator fda.gov (opens an external site) — accessed 20 October 2026 ↩
- (2026). Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act (categories 1–3), updated 14 May 2026. Regulator fda.gov (opens an external site) — accessed 20 October 2026 ↩
- (2026). FDA proposes to exclude semaglutide, tirzepatide, and liraglutide on 503B bulks list. Regulator fda.gov (opens an external site) — accessed 20 October 2026 ↩
- (2026). List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act (FR Doc. 2026-08552). Federal Register. Regulator federalregister.gov (opens an external site) — accessed 22 October 2026 ↩
- (2026). List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Extension of Comment Period (FR Doc. 2026-12937). Federal Register. Regulator federalregister.gov (opens an external site) — accessed 20 October 2026 ↩
- (2026). Warning Letters (searchable database). Regulator fda.gov (opens an external site) — accessed 22 October 2026 ↩
- (2026). Reform of the EU pharmaceutical legislation. Regulator ema.europa.eu (opens an external site) — accessed 22 October 2026 ↩
- (2026). Procedure file 2023/0132(COD): Medicinal products for human use (Directive, repealing Directive 2001/83/EC). Trial registration oeil.secure.europarl.europa.eu (opens an external site) — accessed 22 October 2026 ↩
- (2026). Procedure file 2023/0131(COD): Union procedures for the authorisation and supervision of medicinal products for human use and rules governing the European Medicines Agency (Regulation). Trial registration oeil.secure.europarl.europa.eu (opens an external site) — accessed 22 October 2026 ↩
- (2001). Directive 2001/83/EC on the Community code relating to medicinal products for human use (consolidated text). Official Journal of the European Communities, L 311. Law eur-lex.europa.eu (opens an external site) — accessed 20 October 2026 ↩
- (2025). World Anti-Doping Code International Standard: Prohibited List 2026. Regulator wada-ama.org (opens an external site) — accessed 20 October 2026 ↩
- (2026). World Anti-Doping Code International Standard: Prohibited List 2027 (in effect 1 January 2027). Regulator wada-ama.org (opens an external site) — accessed 20 October 2026 ↩
- (2026). Summary of Major Modifications and Explanatory Notes, 2027 Prohibited List. Regulator wada-ama.org (opens an external site) — accessed 22 October 2026 ↩
- (2025). The 2026 Monitoring Program. Regulator wada-ama.org (opens an external site) — accessed 20 October 2026 ↩
- (2026). The 2027 Monitoring Program. Regulator wada-ama.org (opens an external site) — accessed 20 October 2026 ↩
- (2021). World Anti-Doping Code 2021. Regulator wada-ama.org (opens an external site) — accessed 22 October 2026 ↩
- (2026). World Anti-Doping Code 2027 (version 1.0). Regulator wada-ama.org (opens an external site) — accessed 22 October 2026 ↩
- (2026). 2027 Prohibited List: Summary of Changes. Web page ukad.org.uk (opens an external site) — accessed 22 October 2026 ↩
- (2026). 2027 Code and International Standards. Regulator wada-ama.org (opens an external site) — accessed 22 October 2026 ↩
- (2025). International Standard for Therapeutic Use Exemptions (ISTUE) 2027. Regulator wada-ama.org (opens an external site) — accessed 22 October 2026 ↩
- (2026). WADA publiceert Dopinglijst 2027. Web page dopingautoriteit.nl (opens an external site) — accessed 22 October 2026 ↩
- (2026). Counterfeit weight loss pens worth £2 million seized by MHRA and West Midlands Police. GOV.UK. Regulator gov.uk (opens an external site) — accessed 22 October 2026 ↩
- (2025). Bekanntmachung der Neufassung der Anlage I zu dem Internationalen Übereinkommen vom 19. Oktober 2005 gegen Doping im Sport / des Anhangs zu dem Übereinkommen vom 16. November 1989 gegen Doping, vom 18. Dezember 2025. Bundesgesetzblatt 2025 Teil II Nr. 312 (23 December 2025). Law recht.bund.de (opens an external site) — accessed 22 October 2026 ↩
- (2025). Inspectie maakt zich zorgen over toename van online-nepapotheken. Regulator igj.nl (opens an external site) — accessed 22 October 2026 ↩
- (2026). Two arrested during the MHRA's largest ever seizure of unlicensed weight loss medicines. GOV.UK. Regulator gov.uk (opens an external site) — accessed 22 October 2026 ↩
- (2026). MHRA seizes illegal medicines worth almost £45m in 2025 – disrupting major criminal networks. GOV.UK. Regulator gov.uk (opens an external site) — accessed 22 October 2026 ↩
- (2026). Gesetz gegen Doping im Sport (Anti-Doping-Gesetz – AntiDopG), § 2 Unerlaubter Umgang mit Dopingmitteln. gesetze-im-internet.de. Law gesetze-im-internet.de (opens an external site) — accessed 20 October 2026 ↩
- (2023). Gesetz gegen Doping im Sport (Anti-Doping-Gesetz – AntiDopG), Anlage (zu § 2 Absatz 3). gesetze-im-internet.de. Law gesetze-im-internet.de (opens an external site) — accessed 20 October 2026 ↩
- (2015). Anti-Doping-Gesetz (AntiDopG), § 6 Verordnungsermächtigungen. gesetze-im-internet.de. Law gesetze-im-internet.de (opens an external site) — accessed 22 October 2026 ↩
- (2023). Toezicht op online medicijnen. Regulator igj.nl (opens an external site) — accessed 22 October 2026 ↩