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.
Last reviewed
A row of national flags on tall poles in front of a round glass building, with the sun behind clouds.
A row of flags in front of the EU parliament in Strasbourg, France. Photo: Syced (Wikimedia Commons) CC0 1.0 Image details

Each section starts with the short answer. The rest is folded under “In detail”.

What is this page?

A list of rule changes we follow. Each one has its status, a date and a source.

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.

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?

Each label says how far a change has got, from a first idea to a rule in force.
The steps a rule change can go through, from first idea to rule in force.
LabelWhat it means
ProposedAn authority has put forward a change, but it is not yet decided
Public consultationAnyone can send comments on a draft before a deadline
Advisory voteExperts have given advice. The authority still has to decide
RulemakingThe formal steps to make or change a law or rule are under way
AdoptedThe change has been decided, but has not started yet
In forceThe rule applies now
StalledNothing has moved for a long time
WatchingNot 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?

The FDA must decide what to do with its advisers’ vote. The law has not changed yet.
How a new ingredient gets on the US pharmacy list, and where things stand.
  1. Nomination. Someone asks the FDA to add an ingredient to the 503A list.1
  2. 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
  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
  4. Proposed rule and comments. The FDA publishes a proposed rule and takes public comments.1
  5. 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
  1. 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
  2. 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.
  3. 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
  4. 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
  5. 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?

Yes. A new EU medicines law is close to adoption. Countries then get time to adapt.
The steps of the EU medicines reform, with the dates we could check.
  1. Political agreement. Parliament and Council agreed on the reform on 11 December 2025.19
  2. Committee approval. Parliament’s committee approved the agreed text on 18 March 2026.20
  3. Council position. The Council published its position on 1 October 2026.20,21
  4. Parliament’s second reading. Still to come. The European Parliament gives 23 November 2026 as an indicative plenary date.20
  5. 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?

A new list and a new Code start. The list words its catch-all rule for peptides more clearly.
From 1 January 2027, S0 names peptides as an example. The basic rules stay the same. WADA Prohibited Lists 2026 and 2027, Monitoring Programs 2026 and 2027, World Anti-Doping Code 2021 and 2027.
20262027
Does S0 name “peptides” as an example?No Not as a word23Yes Added for clarity24,25
Is BPC-157 named in S0?Yes As an example23Yes As an example24
Are semaglutide and tirzepatide banned?No Only monitored26No Only monitored27
Does a positive test count without proof of intent?Yes 2021 Code28Yes 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?

Officials keep acting against sellers who break the law. The laws have not changed.
What we follow in three countries, with the latest dated step.
CountryWhat we followLatest step we could check
United KingdomMHRA raids on sites making unlicensed weight-loss pensOver 12,000 fake pens seized in Birmingham on 14 October 202634
GermanyThe yearly doping list in the federal law gazette, which the anti-doping law followsThe 2026 list, published on 23 December 202535
NetherlandsReports to the health inspectorate (IGJ) about illegal web shops187 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?

We read the official documents, write down the date, and correct mistakes in public.
  • 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
  1. U.S. Food and Drug Administration (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 ↩
  2. U.S. Food and Drug Administration (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 ↩
  3. U.S. Food and Drug Administration (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 ↩
  4. U.S. Food and Drug Administration (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 ↩
  5. Legal Information Institute, Cornell Law School (text of the United States Code) (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 ↩
  6. U.S. Food and Drug Administration (2026). July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee. Regulator fda.gov (opens an external site) — accessed 20 October 2026 ↩
  7. U.S. Food and Drug Administration (2026). Questions, Pharmacy Compounding Advisory Committee meeting, 23–24 July 2026. Regulator fda.gov (opens an external site) — accessed 20 October 2026 ↩
  8. Office of the Federal Register (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 ↩
  9. U.S. Food and Drug Administration (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 ↩
  10. European Medicines Agency (2026). Medicines (search of centrally authorised medicines and EPARs). Regulator ema.europa.eu (opens an external site) — accessed 20 October 2026 ↩
  11. U.S. Food and Drug Administration (2026). FDA Presentations, Pharmacy Compounding Advisory Committee meeting, 23 July 2026. Regulator fda.gov (opens an external site) — accessed 20 October 2026 ↩
  12. Staten-Generaal / Koninkrijk der Nederlanden (2007). Geneesmiddelenwet (BWBR0021505). wetten.overheid.nl. Law wetten.overheid.nl (opens an external site) — accessed 20 October 2026 ↩
  13. U.S. Food and Drug Administration (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 ↩
  14. U.S. Food and Drug Administration (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 ↩
  15. U.S. Food and Drug Administration (2026). FDA proposes to exclude semaglutide, tirzepatide, and liraglutide on 503B bulks list. Regulator fda.gov (opens an external site) — accessed 20 October 2026 ↩
  16. U.S. Food and Drug Administration (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 ↩
  17. U.S. Food and Drug Administration (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 ↩
  18. U.S. Food and Drug Administration (2026). Warning Letters (searchable database). Regulator fda.gov (opens an external site) — accessed 22 October 2026 ↩
  19. European Medicines Agency (2026). Reform of the EU pharmaceutical legislation. Regulator ema.europa.eu (opens an external site) — accessed 22 October 2026 ↩
  20. European Parliament, Legislative Observatory (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 ↩
  21. European Parliament, Legislative Observatory (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 ↩
  22. European Parliament and Council of the European Union (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 ↩
  23. World Anti-Doping Agency (2025). World Anti-Doping Code International Standard: Prohibited List 2026. Regulator wada-ama.org (opens an external site) — accessed 20 October 2026 ↩
  24. World Anti-Doping Agency (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 ↩
  25. World Anti-Doping Agency (2026). Summary of Major Modifications and Explanatory Notes, 2027 Prohibited List. Regulator wada-ama.org (opens an external site) — accessed 22 October 2026 ↩
  26. World Anti-Doping Agency (2025). The 2026 Monitoring Program. Regulator wada-ama.org (opens an external site) — accessed 20 October 2026 ↩
  27. World Anti-Doping Agency (2026). The 2027 Monitoring Program. Regulator wada-ama.org (opens an external site) — accessed 20 October 2026 ↩
  28. World Anti-Doping Agency (2021). World Anti-Doping Code 2021. Regulator wada-ama.org (opens an external site) — accessed 22 October 2026 ↩
  29. World Anti-Doping Agency (2026). World Anti-Doping Code 2027 (version 1.0). Regulator wada-ama.org (opens an external site) — accessed 22 October 2026 ↩
  30. UK Anti-Doping (2026). 2027 Prohibited List: Summary of Changes. Web page ukad.org.uk (opens an external site) — accessed 22 October 2026 ↩
  31. World Anti-Doping Agency (2026). 2027 Code and International Standards. Regulator wada-ama.org (opens an external site) — accessed 22 October 2026 ↩
  32. World Anti-Doping Agency (2025). International Standard for Therapeutic Use Exemptions (ISTUE) 2027. Regulator wada-ama.org (opens an external site) — accessed 22 October 2026 ↩
  33. Dopingautoriteit (2026). WADA publiceert Dopinglijst 2027. Web page dopingautoriteit.nl (opens an external site) — accessed 22 October 2026 ↩
  34. Medicines and Healthcare products Regulatory Agency (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 ↩
  35. Bundeskanzleramt (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 ↩
  36. Inspectie Gezondheidszorg en Jeugd (IGJ) (2025). Inspectie maakt zich zorgen over toename van online-nepapotheken. Regulator igj.nl (opens an external site) — accessed 22 October 2026 ↩
  37. Medicines and Healthcare products Regulatory Agency (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 ↩
  38. Medicines and Healthcare products Regulatory Agency (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 ↩
  39. Bundesministerium der Justiz (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 ↩
  40. Bundesministerium der Justiz (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 ↩
  41. Bundesministerium der Justiz (2015). Anti-Doping-Gesetz (AntiDopG), § 6 Verordnungsermächtigungen. gesetze-im-internet.de. Law gesetze-im-internet.de (opens an external site) — accessed 22 October 2026 ↩
  42. Inspectie Gezondheidszorg en Jeugd (IGJ) (2023). Toezicht op online medicijnen. Regulator igj.nl (opens an external site) — accessed 22 October 2026 ↩