Peptide Basics
Are Peptides Legal? What FDA, EMA, MHRA, TGA and WADA Records Show
It depends on the peptide and on the regulator. A few peptides are approved prescription medicines; most peptides sold for research have no approval from FDA, EMA, MHRA or TGA, and many are banned in sport. This page explains what “legal” means at each regulator — approval, compounding, and the WADA list — and links each of our 55 compound guides to its dated regulatory table. Regulator positions only; not legal advice.
The short answer
- “Peptide” is not a legal category. Regulators decide substance by substance: semaglutide is an approved medicine, BPC-157 is not.
- Approval is the first question. In the US it is answered by Drugs@FDA; in the EU by EMA’s authorisations and national registers; in the UK by the MHRA products register; in Australia by TGA.
- Compounding is a separate US question. A pharmacy may only compound from a bulk substance that has a USP or NF monograph, is part of an FDA-approved drug, or is on FDA’s 503A bulks list.
- A research-use label is not an approval. It states the seller’s intended use; it does not put a product in Drugs@FDA or on a compounding list.
- Sport has its own rule. WADA’s 2026 list names many peptides and, under class S0, bans any substance no government health regulator has approved for human therapeutic use.
What each regulator’s records answer
| Regulator | The question its records answer | Examples from our guides |
|---|---|---|
| United States — FDA | Whether FDA has approved a product containing the peptide (Drugs@FDA), and whether a pharmacy may compound with it under section 503A or an outsourcing facility under section 503B. | Ozempic, Mounjaro, Egrifta, Vyleesi, Forzinity and Scenesse are approved; most research peptides have no approval and sit in one of FDA's compounding categories, or in none. |
| European Union — EMA | Whether the peptide has an EU-wide (central) marketing authorisation. National licences in single member states are a separate layer. | Semaglutide, tirzepatide and afamelanotide (Scenesse) are authorised EU-wide; cerebrolysin holds a national licence in Poland but no EU-wide one. |
| United Kingdom — MHRA | Whether a licensed product containing the peptide is in the MHRA products register. | Semaglutide, tirzepatide, oxytocin, gonadorelin (HRF) and afamelanotide are licensed; aviptadil only within one combination product. |
| Australia — TGA | Whether TGA holds approved product information for a registered medicine containing the peptide. | Semaglutide (Ozempic, Wegovy), tirzepatide (Mounjaro), oxytocin and afamelanotide are registered. |
| Sport — WADA | Whether athletes may use it. The 2026 Prohibited List names some peptides; class S0 bans any substance no government health regulator has approved for human therapeutic use. | BPC-157 (S0), TB-500 (S2.3), ipamorelin and CJC-1295 (S2.2.4) and MOTS-c (S4.4.1) are banned at all times; approved medicines such as semaglutide fall outside S0. |
Records read 16–22 October 2026: Drugs@FDA, FDA’s 503A and 503B pages, EMA’s medicines data, the MHRA products register, TGA’s product information repository and the WADA 2026 Prohibited List. Each guide’s table names its records and dates.
United States: approval, compounding and research labels
Approval. A peptide is an approved medicine in the US when FDA has approved a product containing it, and Drugs@FDA lists those approvals. Approval covers a specific product for specific uses — Vyleesi (bremelanotide, also known as PT-141) for one form of low sexual desire in premenopausal women, Forzinity (elamipretide, SS-31) for Barth syndrome — not the substance in general. Some approvals have lapsed in practice: every Geref (sermorelin) and every gonadorelin product is now listed as discontinued.
Compounding under section 503A. FDA’s page on 503A bulk substances (current as of 14 May 2026) says state-licensed pharmacists and physicians may only compound from a bulk substance that complies with a USP or NF monograph, is a component of an FDA-approved drug, or appears on the 503A bulks list. While it evaluates nominated substances, FDA uses three categories. Category 1: substances under evaluation, for which FDA does not intend to take action if the conditions in its guidance are met — glutathione, NAD, vasoactive intestinal peptide and, for routes other than injection, GHK-Cu. Category 2: substances with significant safety risks in compounding — kisspeptin-10. Category 3: substances nominated without enough supporting information, for which FDA would consider taking action — for example GHRP-2, GHRP-6, MGF, thymulin acetate and cibinetide (ARA-290).
FDA’s separate safety-risk page lists substances whose nominations were withdrawn after being in Category 2, among them BPC-157, melanotan II, LL-37, dihexa, PEG-MGF, selank acetate, AOD-9604 and injectable GHK-Cu. Its Pharmacy Compounding Advisory Committee reviewed BPC-157, TB-500, KPV and MOTS-c on 23 July 2026 and Semax, DSIP and Epitalon on 24 July; FDA’s briefing documents weighed against listing, news reports say the committee voted in favour of most of them, and FDA had published neither the votes nor a decision when we last read the records on 22 October 2026. Earlier votes went against listing: AOD-9604 and the CJC-1295 forms in December 2024, ipamorelin in October 2024.
Outsourcing facilities under section 503B. FDA’s 503B page says an outsourcing facility may compound from a bulk substance only if it is on the 503B bulks list or the drug is on FDA’s drug-shortage list at the time. FDA has placed GHRP-2, GHRP-6 and ipamorelin acetate in 503B Category 2. For an investigational drug the position can be plainer still: in a warning letter of 9 September 2025, FDA stated that compounded retatrutide meets the conditions of neither section.
Research-use labels. “For research use only” describes what the seller says a product is for. It is not one of the routes above: it does not make a product approved, and it does not place a substance on a compounding list.
European Union, United Kingdom and Australia
EU. EMA’s medicines data covers EU-wide (central) authorisations. Semaglutide (Ozempic, Rybelsus, Wegovy and later products), tirzepatide (Mounjaro) and afamelanotide (Scenesse) hold one. A medicine can also be licensed nationally in one member state without an EU-wide authorisation: Poland’s register lists Cerebrolysin as nationally authorised. Tesamorelin has no EU authorisation; the Egrifta application was withdrawn in June 2012.
UK. The MHRA products register lists licensed products for semaglutide and tirzepatide, oxytocin, gonadorelin (HRF), afamelanotide, and aviptadil in one combination product, Invicorp. Each guide records its MHRA search and what it returned.
Australia. TGA holds approved product information for semaglutide (Ozempic, Wegovy), tirzepatide (Mounjaro), oxytocin products and afamelanotide (Scenesse). Each guide records how its TGA search was run and what it returned.
Sport: the WADA Prohibited List
For athletes the question is not approval but the Prohibited List. The 2026 list names many peptides directly: growth hormone-releasing peptides and GHRH analogues in class S2.2.4 (ipamorelin, GHRP-2, GHRP-6, hexarelin, CJC-1295, sermorelin, tesamorelin), growth hormone fragments in S2.2.3 (AOD-9604, hGH 176-191), growth factors in S2.3 (TB-500 as a thymosin-β4 derivative, MGF, IGF-1 and its analogues), MOTS-c among the metabolic modulators in S4.4.1, and follistatin in S4.3. Gonadorelin and kisspeptin are banned for male athletes under S2.2.1.
Class S0 covers the rest: any pharmacological substance without current approval from a government health regulator for human therapeutic use is banned at all times, and S0 names BPC-157. Not being named on the list therefore does not take a substance outside S0; approved medicines such as semaglutide, tirzepatide and bremelanotide fall outside it because they are approved. Where it is unclear whether any regulator anywhere has approved a substance, the guide says so rather than deciding.
Regulatory status by compound
Grouped by the US position. Each link opens the compound guide at its “Regulatory status by region” table, with the FDA, EMA, MHRA, TGA and WADA entries, the record each rests on and the date it was read.
FDA-approved product listed in Drugs@FDA
Approved for specific uses, by prescription. The guide names the product, the date and what it is approved for.
Approved once; every product now discontinued
FDA approved a product, and Drugs@FDA now lists all of them as discontinued.
No FDA-approved medicine of the compound itself
The guide gives the compounding position, which differs: 503A Category 1, 2 or 3, withdrawn after Category 2, under committee review, or on no list.
- 5-Amino-1MQ
- AHK-Cu
- AOD-9604
- ARA-290 (cibinetide)
- BPC-157
- Cagrilintide
- Cartalax
- Cerebrolysin
- CJC-1295
- Dihexa
- DSIP (emideltide)
- Epitalon
- Follistatin 344
- GHK-Cu
- GHRP-2
- GHRP-6
- Glutathione
- Hexarelin
- hGH Fragment 176-191
- IGF-1 LR3
- Ipamorelin
- Kisspeptin-10
- KPV
- LL-37
- Mazdutide
- Melanotan II
- MGF
- Mod GRF 1-29
- MOTS-c
- N-Acetyl Selank Amidate
- N-Acetyl Semax Amidate
- NAD+
- P11-4
- PE-22-28
- PEG-MGF
- Pinealon
- Retatrutide
- Selank
- Semax
- SLU-PP-332
- Survodutide
- TB-500
- Thymalin
- Thymosin Alpha-1
- Thymulin
- VIP
What this page does not tell you
It reports what regulators’ records show; it does not say what any person may lawfully buy, import, possess or use. Those questions turn on state and national law, customs rules and individual facts that are outside these records, and need a qualified lawyer. Regulators also change their positions: FDA’s compounding lists are updated, committee votes are followed by decisions, and WADA publishes a new list every year. Check the date next to each entry.
Medibact does not sell peptides. We supply USP-grade bacteriostatic water, made in the USA, for research use only, and publish reference material like this page. We are not affiliated with Novo Nordisk, Eli Lilly, Clinuvel, Stealth BioTherapeutics, Theratechnologies, Cosette or any other company named here.
Where this sits in the rest of the reference
FAQ
Are peptides legal?
There is no single answer, because “peptides” covers both approved medicines and compounds no regulator has approved. Status is decided substance by substance and regulator by regulator. Semaglutide and tirzepatide are approved prescription medicines in the US, the EU, the UK and Australia. Most peptides sold for research, such as BPC-157 or TB-500, have no approval from FDA, EMA, MHRA or TGA. Each of our compound guides has a dated table of what those regulators' records show. This page states regulator positions; it is not legal advice.
Are peptides legal in the US?
In the US the question splits in two. First, is there an FDA-approved product? Drugs@FDA lists approvals for semaglutide, tirzepatide, tesamorelin, oxytocin, bremelanotide (PT-141), elamipretide (SS-31) and afamelanotide, among others, and none for most research peptides. Second, may it be compounded? Under section 503A, a pharmacy may only compound from a bulk substance that has a USP or NF monograph, is a component of an FDA-approved drug, or is on FDA's 503A bulks list. Outsourcing facilities under section 503B need the substance on the 503B bulks list or the drug on FDA's shortage list.
What are 503A peptides?
The phrase usually refers to peptides a state-licensed pharmacy or physician may compound under section 503A of the Federal Food, Drug, and Cosmetic Act. FDA's page on 503A bulk substances lists three routes: a USP or NF monograph, being a component of an FDA-approved drug, or a place on the 503A bulks list. While FDA evaluates nominated substances, it sorts them into categories with different enforcement policies.
What are Category 2 peptides?
Category 2 is FDA's category for nominated bulk substances for which it has identified significant safety risks in compounding, pending further evaluation. Substances in Category 2 are outside the policy under which FDA does not intend to take action for Category 1 substances. Kisspeptin-10 is in 503A Category 2 in the list of 14 May 2026. Several others, including BPC-157, melanotan II, LL-37 and dihexa, appear on FDA's safety-risk page among nominations withdrawn after being in Category 2.
Is BPC-157 legal?
No regulator in our table has approved it: Drugs@FDA lists no BPC-157 product, and neither EMA, MHRA nor TGA holds a record of one. FDA's advisory committee reviewed it for the 503A list on 23 July 2026; FDA's briefing weighed against listing, news reports say the committee voted in favour, and FDA had published neither the vote nor a decision when we last read the records (22 October 2026). For athletes, class S0 of WADA's 2026 list names BPC-157. Our BPC-157 guide gives the full, dated record.
Is retatrutide legal?
Retatrutide is an investigational drug with no approval from FDA, EMA, MHRA or TGA in our records. In a warning letter of 9 September 2025, FDA stated that retatrutide is on neither the 503A nor the 503B bulks list, has no USP monograph and is not a component of any approved drug, so compounded retatrutide meets the conditions of neither section. For athletes, WADA's class S0 covers it for as long as no regulator has approved it.
Does a “research use only” label make a peptide legal?
A research-use label is the seller's statement of intended use. It is not an approval: FDA approvals are listed in Drugs@FDA, and a research-use label does not put a product there or on a compounding list. Whether a particular sale, purchase or use is lawful depends on facts and jurisdictions this page does not assess; for that, ask a qualified lawyer.
Are peptides banned in sport?
Many are. WADA's 2026 Prohibited List names peptides such as TB-500, ipamorelin, CJC-1295, GHRP-2, GHRP-6, sermorelin, tesamorelin, AOD-9604, MOTS-c and IGF-1 analogues, and its class S0 bans at all times any pharmacological substance without current approval from a government health regulator for human therapeutic use. Approved medicines such as semaglutide and tirzepatide are not named and fall outside S0. Each compound guide gives the class that applies.
Is this legal advice?
No. This page reports what regulators' own records show, with the date each was read, and links each compound guide's regulatory table. It draws no conclusion about what any person may do, and does not cover import, customs, state law or the law of countries outside the five listed. Medibact does not sell peptides and is not affiliated with any manufacturer named here.
Not legal advice. References: FDA, Bulk Drug Substances Used in Compounding Under Section 503A (current as of 14 May 2026) and Section 503B (current as of 7 January 2025), read 26 October 2026; compound records as cited in each guide’s regulatory table, read 16–22 October 2026.
Educational use only — not medical advice. This guide summarizes information reported in published research and community practice for educational purposes. It is not medical advice and not a recommendation to use any compound. Any doses, schedules, or combinations shown are examples of what has been reported, not instructions for you. Many peptides described here are research compounds that are not FDA-approved for the uses discussed and may be investigational or restricted. Effects, risks, and legal status vary; individual needs and results vary. Consult a qualified, licensed healthcare professional before making any decision. Do not use this content to diagnose, treat, or dose yourself.