Are peptides legal in the US?

The Food and Drug Administration (FDA) regulates drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act). In its warning letters to peptide sellers, the FDA relies on a short chain of provisions. A product intended to diagnose, treat or affect the body is a drug (section 201(g)(1)). A drug not generally recognised as safe and effective is a "new drug" (section 201(p)). A new drug cannot be sold without an approved application (sections 301(d) and 505(a))^[1].

The Drug Enforcement Administration (DEA) is responsible for controlled substances, and state boards of pharmacy regulate compounding pharmacies within each state. Most research peptides are not controlled substances, so the FDA's drug rules do most of the work. State rules vary and are outside the scope of this page. For background on the products themselves, see what are research peptides.

US peptide sellers almost always label their products "for research use only" or "not for human consumption". The FDA has addressed this directly. In a March 2026 warning letter about retatrutide and tirzepatide, it said that despite those labels, evidence from the seller's website established that the products were intended to be drugs^[1]. It used the same reasoning in August 2026 letters. One, to Royal Peptides LLC, covered tirzepatide, semaglutide, retatrutide, tesamorelin and ipamorelin blends, PT-141 and SS-31^[2].

The FDA's consumer page on unapproved GLP-1 drugs makes the same point. It warns about companies that sold semaglutide, tirzepatide, retatrutide, survodutide or mazdutide falsely labelled "for research purposes"^[3]. In short, the FDA looks at how a product is actually marketed and used, not only at the disclaimer on the label.

A warning letter is not a court ruling. It is the FDA's formal statement that it considers a company to be breaking the law, and it can lead to seizures, injunctions or prosecution if the company does not respond. The FDA's view of research-use labels is consistent with regulators in Canada, Australia and New Zealand.

A handful of peptides are ingredients of approved drugs, including semaglutide and tirzepatide, which are sold under brand names on prescription. Approval applies to the specific approved product, made by its manufacturer and dispensed on prescription. It does not extend to vials of the same molecule sold online.

Retatrutide and cagrilintide are not approved. The FDA says neither is a component of an FDA-approved drug and that neither can be used in compounding under federal law^[3]. BPC-157 is not approved for human clinical use by the FDA or any other regulator, according to the US Anti-Doping Agency^[11]. Our guides on retatrutide, cagrilintide and BPC-157 cover the research behind each.

Compounding pharmacies can in some circumstances make copies of drugs that are in shortage. That is how compounded semaglutide and tirzepatide became widely available in 2023 and 2024. The FDA declared the tirzepatide injection shortage resolved on 19 December 2024 and the semaglutide shortage resolved on 21 February 2025^[4]. The periods in which it would not take action against state-licensed (503A) pharmacies for copies ended on 18 February 2025 for tirzepatide and 22 April 2025 for semaglutide^[4].

On 30 April 2026 the FDA proposed excluding semaglutide, tirzepatide and liraglutide from the list of bulk substances that outsourcing facilities (503B) can use^[5]. Comments closed on 29 June 2026. We found no final decision as of the date this page was reviewed.

For substances that are not part of an approved drug, state-licensed pharmacies can only compound from bulk ingredients on an approved list. Other substances can be nominated for that list. While a nomination is being evaluated, the FDA sorts nominated substances into categories. Category 2 is for substances that "may present significant safety risks".

The FDA's category page, updated on 22 April 2026, still places GHRP-2, GHRP-6, ibutamoren, ipamorelin acetate and kisspeptin-10 in category 2^[6]. A long list of peptides previously in category 2 has moved to a separate "nominated but withdrawn" section because the people who nominated them withdrew the nominations^[6]. They include BPC-157, TB-500 (thymosin beta-4 fragment), CJC-1295, AOD-9604, melanotan II, GHK-Cu, MOTs-C, KPV, semax, selank, epitalon, emideltide (DSIP), LL-37, thymosin alpha-1, dihexa and PEG-MGF.

A withdrawn nomination is not an authorisation. The approved list of bulk substances for 503A compounding, in the Code of Federal Regulations, contains no peptides at all^[7]. The change in April 2026 took these peptides off the safety-risk list. It did not put them on the approved list.

The FDA's Pharmacy Compounding Advisory Committee met on 23 and 24 July 2026 to consider several peptides for the approved list. BPC-157, KPV, TB-500 and MOTs-C were on the agenda on 23 July, and emideltide, semax and epitalon on 24 July^[8]. Vote counts for these meetings have been reported in the press. The FDA's own meeting page did not post votes or an outcome when we checked, and we found no FDA proposal to add any peptide to the list^[8]. An advisory committee's vote is a recommendation; only the FDA can change the list. As of the date on this page, it is not correct to say that BPC-157 or any other peptide is approved for compounding.

US peptide rules moved quickly over two years. The dates below come from the FDA pages cited on this page.

19 December 2024: the FDA declared the tirzepatide injection shortage resolved^[4]. 18 February 2025: the period in which the FDA would not act against state-licensed pharmacies making tirzepatide copies ended^[4]. 21 February 2025: the FDA declared the semaglutide shortage resolved^[4]. 22 April 2025: the equivalent period for semaglutide copies ended^[4].

31 March 2026: the FDA issued a warning letter over retatrutide and tirzepatide sold as research products, rejecting the research-use-only label^[1]. 22 April 2026: the FDA's compounding category page moved BPC-157, TB-500, CJC-1295, GHK-Cu, melanotan II and others to "nominated but withdrawn"^[6]. 30 April 2026: the FDA proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list^[5].

23 and 24 July 2026: the Pharmacy Compounding Advisory Committee met to consider BPC-157, KPV, TB-500, MOTs-C, emideltide, semax and epitalon^[8]. 24 August 2026: further warning letters, including one covering tesamorelin and ipamorelin blends^[2]. 1 September 2026: the FDA's page on unapproved GLP-1 drugs was last updated, confirming retatrutide and cagrilintide are not approved^[3].

BPC-157: not FDA-approved^[11]. Moved to "nominated but withdrawn" in April 2026^[6], not on the approved compounding list^[7], and considered by the advisory committee in July 2026 with no FDA action since^[8].

TB-500, CJC-1295, GHK-Cu, AOD-9604 and melanotan II: not approved as drugs, and in the same "nominated but withdrawn" section as BPC-157^[6]. None is on the approved compounding list^[7].

Ipamorelin, GHRP-2, GHRP-6 and kisspeptin-10: still in category 2, substances that may present significant safety risks in compounding^[6]. Ipamorelin blends were named in an August 2026 warning letter^[2].

Semaglutide and tirzepatide: approved as branded prescription medicines. The shortages that allowed widespread compounding ended in 2024 and 2025^[4], and the FDA has named both in warning letters to research-peptide sellers^[1][2].

Retatrutide and cagrilintide: not approved, and cannot be used in compounding under federal law^[3].

Supplier websites and social media often say a peptide is "legal", "FDA-cleared" or "now approved for compounding". Before relying on a claim like that, check it against the FDA's own pages rather than the seller's summary.

First, look for an approved product. An approved drug has a brand name, a manufacturer and a label. A vial described as "research use only" is, by the FDA's own account, not one^[1]. Second, for compounding claims, check the FDA's category page^[6] and the approved bulks list^[7]. A peptide moving out of category 2 is not the same as being added to the approved list. Third, treat reports of advisory committee votes as recommendations, not decisions, until the FDA publishes an action^[8].

If a supplier makes claims about legality or approval that you cannot find on an FDA page, that is a warning sign in itself. Our guide on how to spot a fake peptide supplier lists others.

Human growth hormone has its own criminal provision in federal law. Under 21 USC 333(e), it is a crime to distribute somatropin or somatrem, or to possess them with intent to distribute, for any use in humans other than the treatment of a disease or recognised condition authorised by the FDA and prescribed by a physician^[9]. The penalty is up to five years in prison. This rule is about growth hormone itself. Peptides that stimulate the body's own release of growth hormone, such as ipamorelin, CJC-1295 and tesamorelin, are covered by the general FDA drug rules above instead.

The FDA says that in most circumstances it is illegal for individuals to import drugs into the US for personal use^[10]. It also describes limited situations in which it may use enforcement discretion and not act. Its examples include a drug for a serious condition with no effective treatment available in the US, no commercial promotion to US residents, and no more than a three-month supply^[10]. The FDA's page is clear that this is discretion, not a legal right, and that it applies case by case.

Ordering a research peptide from an overseas website does not fit the usual conditions. Shipments that the FDA decides are unapproved drugs can be refused entry. Whether you are ordering from abroad or from a US seller, PepFinder lists where each supplier ships from, so you can see which country an order will come from. Browse US peptide suppliers.

For growth hormone, the federal crime covers distribution and possession with intent to distribute^[9]. For other peptides, the FDA's enforcement is directed at the companies that make, import and sell them. We did not find an FDA statement on whether personal possession of a non-controlled, unapproved peptide is a federal offence, and we do not give an answer on it. State laws may differ.

Whatever the legal position, no unapproved peptide sold online has been reviewed by the FDA for safety, quality or dose. Warning letters in 2026 cited both the products themselves and the claims made about them^[1][2]. That is one reason independent testing matters: see third-party peptide testing and how to read a peptide COA.

US athletes in tested sports are covered by the World Anti-Doping Agency's Prohibited List, applied by USADA. The 2026 List names BPC-157 under S0, non-approved substances, which are prohibited at all times^[12]. USADA has confirmed BPC-157 is prohibited^[11].

The List also names TB-500 and thymosin beta-4, the GHRH analogues CJC-1295, sermorelin and tesamorelin, ipamorelin, and the GH-releasing peptides GHRP-1 to GHRP-6 and hexarelin^[12]. Growth hormone and its fragments, including AOD-9604, are prohibited, and HCG is prohibited in men^[12]. A "research use only" label is no defence to a positive test.

PepFinder lists suppliers so buyers can compare them on evidence: independent test results, delivery, service and verified reviews. A listing is not a statement that a supplier's products are legal, and we never describe a supplier as "safe". Our methodology explains how ratings work, and our guide on how to spot a fake peptide supplier covers the warning signs.

This page summarises primary sources read on the date shown. It is general information, not legal advice. FDA policy on compounding in particular changed several times in 2025 and 2026 and may change again, so check the linked sources for the current position.