Are peptides legal in the United States?

Removed from FDA's Category 2 list on 22 April 2026; the Pharmacy Compounding Advisory Committee recommended it for the 503A bulks list in July 2026 (8–6, 1 abstention). Not on the list yet and not an approved drug. Sold otherwise as an unapproved 'research chemical'.

Ozempic, Wegovy and Rybelsus. Compounded copies were tolerated only during the shortage, which the FDA declared resolved in February 2025; enforcement discretion ended 22 April (503A) and 22 May 2025 (503B). 990 adverse-event reports for compounded versions by May 2026.

FDA: retatrutide 'cannot be used in compounding under federal law' and has not been found safe and effective for any condition. Lilly has said it plans to file for approval in the first quarter of 2027.

Mounjaro and Zepbound. On 28 August 2026 the FDA added an indication for Mounjaro to lower the risk of major adverse cardiovascular events in adults with type 2 diabetes at high risk, on the SURPASS-CVOT trial. The shortage was declared resolved in December 2024; compounding enforcement discretion has ended. More than 730 adverse-event reports for compounded versions by May 2026.

Approved for excess abdominal fat in HIV-associated lipodystrophy. Prescribing outside that indication is a clinical decision; selling vials for 'research' is not a lawful supply route.

The advisory committee voted 0–12 against ipamorelin on 29 October 2024. Ipamorelin acetate remains in Category 2 for outsourcing facilities; its 503A nomination is listed as withdrawn (April 2026).

Placed in Category 1 for non-injectable routes in 2023 (may be compounded topically pending review). The injectable nomination is listed as withdrawn since April 2026.

Removed from FDA's Category 2 list on 22 April 2026; the Pharmacy Compounding Advisory Committee recommended it for the 503A bulks list in July 2026 (recommended 24 July 2026). Not on the list yet and not an approved drug. Sold otherwise as an unapproved 'research chemical'.

Removed from FDA's Category 2 list on 22 April 2026; the Pharmacy Compounding Advisory Committee recommended it for the 503A bulks list in July 2026 (8–6, 1 abstention). Not on the list yet and not an approved drug. Sold otherwise as an unapproved 'research chemical'.

FDA: cagrilintide 'cannot be used in compounding under federal law'. Not a component of any approved drug.

Removed from FDA's Category 2 list on 22 April 2026; the Pharmacy Compounding Advisory Committee recommended it for the 503A bulks list in July 2026 (recommended 24 July 2026). Not on the list yet and not an approved drug. Sold otherwise as an unapproved 'research chemical'.

Its 503A nomination is listed as withdrawn since April 2026 and it was not among the peptides reviewed in July 2026. Sold as an unapproved 'research chemical'.

Approved in 2019 for hypoactive sexual desire disorder in premenopausal women. 'Research' vials are unapproved drugs.

Geref was approved in 1997 and withdrawn from the market in 2008 for commercial reasons. Sermorelin acetate is not in Category 2 and is compounded by pharmacies on prescription; it remains unapproved as a product.

The advisory committee excluded all five CJC-1295 forms on 4 December 2024; the nomination is listed as withdrawn since April 2026. Sold otherwise as an unapproved 'research chemical'.

The advisory committee voted 0–12 against AOD-9604 on 4 December 2024; the nomination is listed as withdrawn since April 2026.

Removed from FDA's Category 2 list on 22 April 2026; the Pharmacy Compounding Advisory Committee recommended it for the 503A bulks list in July 2026 (7–5, 2 abstentions). Not on the list yet and not an approved drug. Sold otherwise as an unapproved 'research chemical'.

Victoza (2010), Saxenda (2014); first generic liraglutide launched 2024. Compounded copies are not permitted now that approved generics exist.

Phase 3; FDA has warned sellers marketing 'research' survodutide for human use. Cannot be compounded.

Phase 2 in the US. The FDA has warned companies selling 'research' mazdutide for human use; it cannot be compounded.

Kisspeptin-10 remains in Category 2 of the FDA's 503A list (significant safety risks) as of April 2026 — it may not be compounded.

Orphan designations but no approval. Its 503A compounding nomination is listed as withdrawn (April 2026).

Its 503A nomination (cathelicidin LL-37) is listed as withdrawn since April 2026; it was not among the peptides the advisory committee reviewed in July 2026.

Accelerated approval September 2025 as Forzinity (elamipretide) for Barth syndrome. Any other use, and any product sold as 'SS-31' outside that channel, is unapproved.

The injection is FDA-approved for obstetric indications. Intranasal oxytocin is not FDA-approved and is sold via compounding pharmacies and the grey market.

Not approved by the FDA, which has warned consumers about melanotan products sold for tanning. The properly developed sibling, afamelanotide (Scenesse), is approved for a rare photosensitivity disorder — melanotan II is not.

Not an approved drug and not a dietary-supplement ingredient. Sold as a 'research chemical' outside the medical system; the FDA has warned against several compounds in this class.

Not an FDA-approved drug; sold as a research chemical. The FDA has flagged GHRPs among peptides that should not be in compounded products.

Not an approved drug and not a dietary-supplement ingredient. Sold as a 'research chemical' outside the medical system; the FDA has warned against several compounds in this class.

NR is sold as a dietary supplement. The FDA has taken the position that NMN is excluded from the supplement definition because it was investigated as a drug; enforcement is unsettled. IV NAD+ is offered by clinics without FDA approval.

Not an approved drug and not a dietary-supplement ingredient. Sold as a 'research chemical' outside the medical system; the FDA has warned against several compounds in this class.

Not an approved drug and not a dietary-supplement ingredient. Sold as a 'research chemical' outside the medical system; the FDA has warned against several compounds in this class.

Not an approved drug and not a dietary-supplement ingredient. Sold as a 'research chemical' outside the medical system; the FDA has warned against several compounds in this class.

Not an approved drug and not a dietary-supplement ingredient. Sold as a 'research chemical' outside the medical system; the FDA has warned against several compounds in this class.

Foundayo approved by the FDA on 1 April 2026 to reduce excess body weight and maintain weight reduction in adults with obesity, or with overweight and at least one weight-related condition. Anything sold as orforglipron without a prescription is not the licensed product.

Investigational. Products sold under this name are not the trial drug.

Approved for specific deficiency indications. Distributing growth hormone for anti-ageing or athletic use is expressly unlawful under US law, not merely off-label.

FDA-approved for fertility and hypogonadism. Labelling must state that HCG has no proven effect on weight loss, fat distribution or hunger; homeopathic and over-the-counter 'HCG diet' products are unapproved and have been the subject of enforcement.

Oral products sold as dietary supplements. Injectable glutathione is not FDA-approved. In August 2026 the FDA reminded compounders not to make injectables from supplement-grade glutathione after at least 30 endotoxin-type reactions, and a nationwide recall of contaminated lots followed in September. Another recall of ten lots followed on 1 October 2026, after two patients needed emergency care.

Not an approved drug. Mecasermin (recombinant human IGF-1) is approved for severe primary IGF-1 deficiency; the LR3 analogue is a different, unapproved molecule.

Not an approved drug and not a dietary-supplement ingredient; sold as a research chemical.

Never approved; development discontinued. Sold as a 'research chemical'. Not a lawful dietary-supplement ingredient.

FDA-approved 2014 for type 2 diabetes; 2020 for cardiovascular risk reduction in type 2 diabetes.

FDA-approved 2005 (Byetta) and 2012 (Bydureon) for type 2 diabetes.

Factrel (diagnostic) and Lutrepulse (pulsatile) were FDA-approved and later withdrawn from the market for commercial reasons. It is now supplied by compounding pharmacies on prescription, which is how TRT clinics use it.

FDA-approved October 2019 for erythropoietic protoporphyria, implant only.

FDA-approved November 2020 for POMC, PCSK1 or LEPR deficiency; June 2022 for Bardet-Biedl syndrome.

Sold as a research reagent 'not for human use'; no clinical programme for the protein.

Not an approved drug and not a lawful dietary-supplement ingredient.

Not FDA-approved; imported products are unapproved drugs.

FDA-approved 2002 (Forteo). Two-year lifetime limit and osteosarcoma boxed warning removed in November 2020.

FDA-approved since 1985 (Lupron); multiple depot products.

FDA-approved 2005 (Symlin) for type 1 and type 2 diabetes using mealtime insulin. Boxed warning for insulin-induced severe hypoglycaemia.

FDA-approved since 1988; LAR depot 1998; generics available.

Research reagent 'not for human use'; no clinical programme.

Investigational; one registered phase 1 with no reported result. Sold as a 'research chemical'.

Sold in cosmetics without drug approval; injectable versions are unapproved drugs.

Emergency authorisation for COVID-19 was sought and not granted; no approved aviptadil product.

Investigational; orphan designation for sarcoidosis neuropathy. Sold as a 'research chemical'.

Novo Nordisk filed a New Drug Application for weight management in December 2025 and says it expects an FDA decision in the fourth quarter of 2026. Not approved at review; products sold under the name are not the trial drug.

Investigational; phase 3 running. Products sold under the name are not the trial drug.

Investigational; phase 3 running. Products sold as 'MariTide' online are not the trial drug and cannot be, given the manufacturing involved.

Not FDA-approved. Products sold under the name are unlicensed.

Tymlos, FDA-approved April 2017; men at high fracture risk added 2022.

Miacalcin injection and nasal spray remain approved; an FDA advisory committee voted in March 2013 that the nasal spray's benefit for osteoporosis did not outweigh the cancer risk, and the label carries a malignancy warning.

DDAVP and generics; Nocdurna (2018) and Noctiva nasal spray (2017) for nocturia, the latter with a boxed warning for hyponatraemia.

Not FDA-approved; not on any compounding list.

Not FDA-approved.

Not FDA-approved; no IND announced.

Investigational; phase 3 running since September 2026. Products sold under the name are not the trial drug.

Adlyxin approved 2016; only the Soliqua combination is currently listed on DailyMed, the standalone product having been discontinued.

Analogues are prescription-only. Human regular and NPH insulin (Humulin, Novolin) can be sold over the counter in most states. In 2026 the FDA approved two once-weekly basal insulins for adults with type 2 diabetes: Awiqli (insulin icodec) on 26 March and Onswik (insulin efsitora alfa) on 23 September.

Sold under DSHEA; structure/function claims only.

Sold under DSHEA.

Not FDA-approved.

Not FDA-approved.