Scientifically reviewed by Dr Stephan Hansberg
Peptide regulation tracker 2026: FDA, MHRA, TGA updates
A dated, sourced timeline of peptide regulation in the US, UK and Australia from 2023 to October 2026: FDA compounding categories and the July 2026 advisory votes, MHRA enforcement, the TGA's 2026 peptide crackdown and the WADA Prohibited List.
Key takeaways
- •In the US, BPC-157, TB-500, KPV and MOTS-c went from the FDA's Category 2 safety list (September 2023) to a favourable advisory committee vote (July 2026), but FDA rulemaking was still pending in October 2026.
- •The next FDA Pharmacy Compounding Advisory Committee meeting is planned before the end of February 2027, with GHK-Cu, LL-37, dihexa acetate, Melanotan II and PEG-MGF on the agenda.
- •In the UK, MHRA action in 2026 focused on medicinal claims by clinics and on unlicensed weight loss injections, including its largest ever seizure in May 2026.
- •Australia moved fastest: BPC-157 has been Schedule 4 since June 2024, and from June 2026 the TGA made unapproved peptides a compliance priority, followed by seizures, infringement notices and court action.
- •WADA's 2026 List names BPC-157 (S0), TB-500 (S2) and MOTS-c (S4), and the 2027 List, in force from 1 January 2027, names peptides in general within S0.
Where peptide regulation stands in October 2026
As of October 2026, no peptide covered on this site is an approved medicine in the US, UK or Australia, but the direction of travel differs sharply by country. The US is moving towards allowing pharmacy compounding of some peptides, the UK is enforcing against medicinal claims, and Australia is actively seizing products and fining sellers.
This page is a living tracker. Each row below is dated and tied to a primary source or reputable report, and rows we could not verify were left out. We update it when a regulator publishes something new, and the updated date at the top of the page shows when it was last checked.
Timeline: 2023 to October 2026
Dates are the date of the regulator's action or publication. Where an action and its announcement fall on different days, both are shown.
| Date | Country | Body | Event | Source |
|---|---|---|---|---|
| 29 Sep 2023 | US | FDA | BPC-157, thymosin beta-4 fragment (LKKTETQ, sold as TB-500), KPV, MOTs-C, injectable GHK-Cu, Epitalon, Semax, emideltide (DSIP) and Melanotan II placed in 503A Category 2 (substances that may present significant safety risks in compounding). | FDA, Certain bulk drug substances for use in compounding that may present significant safety risks |
| 22 May 2024 (in force 1 Jun 2024) | AU | TGA | Final decision to add BPC-157 to Schedule 4 of the Poisons Standard and to Appendix D, clause 5 (possession without authority is illegal), after 48 import referrals since July 2022. | TGA, Notice of final decisions (November 2023 ACMS meeting) |
| Apr 2025 | AU | TGA | Safety alert: NAD, NAD+ and NADH are not permitted ingredients in listed medicines, and products making NAD claims without an AUST number may be unapproved goods. | TGA safety alert, NAD, NAD+, NADH or NMN medicines sold in Australia |
| 12 Dec 2025 | US | FDA | Warning letter to Atomix LLC (SARMs, not peptides): FDA said research use only and not for human consumption labels did not control where the website showed human use. | FDA warning letter 719111 |
| 1 Jan 2026 | Global | WADA | 2026 Prohibited List in force: BPC-157 named in S0, thymosin beta-4 and TB-500 in S2.3, MOTS-c in S4.4.1, IV infusions over 100 mL per 12 hours prohibited under M2.2. | WADA 2026 Prohibited List |
| 26 Mar 2026 (announced Apr 2026) | AU | ABF, TGA, Victoria Police | Warrants in Melbourne's west after an eight-month investigation; over 10,000 vials of steroids and peptides seized, valued above $2 million, three people charged. | TGA and ABF joint media release |
| 31 Mar 2026 (published 7 Apr) | US | FDA | Warning letters to seven online sellers of GLP-1 class compounds labelled for laboratory research. FDA said the labels did not control because website evidence showed the products were intended for people. | FDA warning letter to Gram Peptides; RAPS, 7 Apr 2026 |
| 4 Apr 2026 | UK | MHRA | MHRA looks into clinics promoting peptide injections with health claims; a clinic's claim that BPC-157 aided tissue repair was removed after contact. | The Guardian, 4 Apr 2026; Aesthetics Journal |
| Apr 2026 | AU | TGA | Safety advisory: Understanding your responsibilities when importing, compounding and supplying unapproved peptide products. | TGA safety alert |
| 22 Apr 2026 | US | FDA | BPC-157, the TB-500 fragment, KPV, MOTs-C and other peptides moved off Category 2 after the nominators withdrew; FDA announces it will consult its advisory committee. | FDA 503A categories list; Goodwin, May 2026 |
| 14 May 2026 | US | FDA | GHK-Cu for non-injectable routes restored to Category 1 after a nominator clarified its withdrawal covered injectable use only; advisory committee review planned before end of February 2027. | FDA, Bulk drug substances nominated under 503A (updated 14 May 2026) |
| 28 May 2026 (announced 29 May) | UK | MHRA | Largest ever MHRA seizure of unlicensed weight loss medicines: around 12,000 doses, including retatrutide, tirzepatide and peptide products, at a site near Northampton; two men arrested under the Human Medicines Regulations 2012. | GOV.UK MHRA press release, 29 May 2026 |
| 10 Jun 2026 | AU | TGA | Unapproved peptide products added to the TGA's compliance priority areas after increased detection of unlawful importation, supply and advertising. | TGA media release |
| 19 Jun 2026 | AU | TGA and Chief Medical Officer | Joint statement on public health risks, naming products containing BPC-157, GHK-Cu, TB-500, retatrutide and CJC-1295. | TGA media release |
| 20 Jul 2026 | AU | TGA | Promoters and suppliers of unapproved peptides put on notice of increased compliance action, including warning letters, infringement notices, seizures and prosecution. | TGA media release |
| 23 Jul 2026 | US | FDA PCAC | Advisory committee votes to recommend adding BPC-157 (8-6, 1 abstention), KPV (8-6-1), TB-500 (8-6-1) and MOTS-c (7-5, 2 abstentions) to the 503A bulks list, against FDA staff recommendations. | FDA meeting page; FDA Law Blog, 24 Jul 2026 |
| 24 Jul 2026 | US | FDA PCAC | Semax and Epitalon recommended; emideltide (DSIP) rejected 7-6 with 1 abstention. | AJMC, 31 Jul 2026 |
| 4 Aug 2026 | AU | TGA and NSW Police | Products worth over $120,000 seized from two NSW premises linked to a social media influencer, including retatrutide, CJC-1295 and a BPC-157 and TB-500 combination. | TGA media release |
| 10 Sep 2026 | Global | WADA | Executive Committee approves the 2027 Prohibited List, in force 1 January 2027. USADA reports that peptides in general are now named in S0. | USADA athlete advisory; Athletics Illustrated, 28 Sep 2026 |
| 28 Sep 2026 | AU | TGA | Federal Court proceedings started against BioV8 (in liquidation) and its former directors over alleged unlawful advertising of peptides including BPC-157, CJC-1295 and GHRP-6. | TGA media release |
| 6 Oct 2026 | AU | TGA | 12 infringement notices totalling $126,720 issued to 2 companies and 5 individuals for unlawful importation and advertising of prescription-only medicines. | TGA media release |
| Before end Feb 2027 (planned) | US | FDA PCAC | Next advisory committee meeting on LL-37, GHK-Cu, dihexa acetate, Melanotan II and PEG-MGF. Date, venue and docket not yet published. | FDA Pharmacy Compounding Advisory Committee page |
United States: what the FDA steps mean
The FDA's 503A categories govern what licensed pharmacies may compound for individual patients, not what research suppliers may sell. Category 2 meant the FDA had identified significant safety risks. Moving off Category 2 in April 2026 happened because the nominators withdrew their nominations, not because the FDA found the substances safe, and it did not place them on the bulks list.
The July 2026 votes are recommendations. Under section 503A the FDA must still decide, then complete notice-and-comment rulemaking, before BPC-157, KPV, TB-500, MOTS-c, Semax or Epitalon can join the bulks list. As of 8 October 2026 we found no proposed rule. Meanwhile, the FDA has continued to issue warning letters where a seller's website showed products labelled for research were really intended for people.
United Kingdom: claims and unlicensed medicines
UK law has not changed for these peptides; what changed in 2026 is enforcement. The MHRA's stated position is that if a clinic offering peptide injections makes medicinal claims, the product will be treated as a medicine under the Human Medicines Regulations 2012, which requires a marketing authorisation. The May 2026 Northampton seizure shows the MHRA's criminal enforcement unit also acting against unlicensed injectable products at scale.
Australia: scheduling plus active enforcement
Australia combines named scheduling with active enforcement. BPC-157 has been a Schedule 4 substance with an Appendix D possession offence since 1 June 2024, and thymosin beta-4 and TB-500 were brought into the Poisons Standard in 2016. From June 2026 the TGA treated unapproved peptides as a priority, and the run of releases from June to October shows what that means in practice: warnings, seizures, infringement notices and Federal Court action.
What to watch next
These are the open items we are tracking. Each will be added to the timeline when it happens.
- FDA decision on the July 2026 recommendations: whether it proposes a rule adding BPC-157, KPV, TB-500, MOTS-c, Semax and Epitalon to the 503A bulks list, and whether it places any of them in Category 1 in the meantime.
- The next PCAC meeting, due before the end of February 2027: watch the Federal Register for the date, briefing documents and docket for GHK-Cu, LL-37, dihexa acetate, Melanotan II and PEG-MGF.
- WADA 2027 Prohibited List, in force 1 January 2027: the published text and WADA's explanatory notes on the new general reference to peptides in S0.
- TGA enforcement: further infringement notices, the BioV8 Federal Court case, and any new Poisons Standard scheduling proposals for named peptides.
- MHRA: outcomes of the 2026 clinic investigations and of the May 2026 Northampton arrests.
Sources
Primary sources first, checked 8 October 2026:
- FDA: Certain bulk drug substances for use in compounding that may present significant safety risks (archived version current as of 27 Sep 2024; current page as of 22 Apr 2026), fda.gov
- FDA: Bulk drug substances nominated for use in compounding under section 503A, updated 14 May 2026, fda.gov
- FDA: July 23-24, 2026 meeting of the Pharmacy Compounding Advisory Committee, fda.gov
- FDA: Pharmacy Compounding Advisory Committee, upcoming meeting before end of February 2027 (page current as of 15 Apr 2026), fda.gov
- FDA warning letter to Gram Peptides, 31 Mar 2026; FDA warning letter to Atomix LLC, 12 Dec 2025, fda.gov
- MHRA: Two arrested during the MHRA's largest ever seizure of unlicensed weight loss medicines, 29 May 2026, gov.uk
- TGA: Notice of final decisions to amend (or not amend) the current Poisons Standard, November 2023 meetings, published 22 May 2024, tga.gov.au
- TGA media releases: compliance focus on unapproved peptide products (10 Jun 2026); concerns regarding public health risks of unapproved peptide products (19 Jun 2026); promoters and suppliers put on notice (20 Jul 2026); TGA flexes its muscle against illegal peptides and steroids (Aug 2026); BioV8 proceedings (28 Sep 2026); more than $126k in infringement notices (6 Oct 2026), tga.gov.au
- TGA and ABF: Three Victorians arrested following seizure of over $2 million worth of steroids and peptides, April 2026, tga.gov.au and abf.gov.au
- TGA safety alerts: NAD, NAD+, NADH or NMN medicines sold in Australia (April 2025); Understanding your responsibilities when importing, compounding and supplying unapproved peptide products (April 2026), tga.gov.au
- WADA: World Anti-Doping Code International Standard, Prohibited List 2026, wada-ama.org
- USADA: Athlete advisory, What's new on the 2027 WADA Prohibited List, September 2026, usada.org
- The FDA Law Blog: PCAC approves four bulk drug substances for the 503A list, 24 Jul 2026
- AJMC: FDA panel backs 6 peptides for compounding, 31 Jul 2026
- RAPS: FDA warning letters target marketers of unapproved weight loss drugs, 7 Apr 2026
- The Guardian: Medicines watchdog to investigate UK peptide clinics over health claims, 4 Apr 2026
- Goodwin: FDA signals potentially evolving stance toward compounding of certain peptides, May 2026
Research use only
Celyfe supplies research peptides for laboratory and research use only. Nothing on this page is guidance on use in humans or animals. This is general information, not legal advice. Rules in all three countries changed several times in 2026, so check the regulator's current publications or speak to a qualified adviser before relying on anything here.
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