Are Peptides FDA Approved? What Approval Covers and Where Compounded Sits

Semaglutide is the active ingredient of three approved products from Novo Nordisk: Ozempic, approved 5 December 2017 under NDA 209637; Rybelsus, the oral tablet, under NDA 213051 approved 20 September 2019; and Wegovy, NDA 215256, approved 4 June 2021, which has since accumulated more than thirty supplements including a higher-strength presentation in March 2026.

The compounded semaglutide a pharmacy prepares contains the same active ingredient and is not any of those products. It has not been reviewed by the FDA for safety or effectiveness, and it should never be described as the brand under another name.

Tirzepatide has two approved products from Eli Lilly: Mounjaro, NDA 215866, approved 13 May 2022, and Zepbound, NDA 217806, approved 8 November 2023. Same molecule, two names, two sets of indications.

Compounded tirzepatide is prepared with cyanocobalamin in a multi-dose vial. It is not Mounjaro or Zepbound and carries none of their approval. The SURMOUNT and SURPASS trials belong to the branded product; the compounded vial shares the active ingredient, not the trial programme.

Tesamorelin is the active ingredient of Egrifta, application 022505, held by Theratechnologies and originally approved 10 November 2010, with later presentations under the same application, most recently in March 2025. The indication is specific to HIV-associated lipodystrophy, and the randomised trials behind it — in the New England Journal of Medicine in 2007 and pooled in the Journal of Clinical Endocrinology and Metabolism in 2010 — measured visceral adipose tissue in that population. Compounded tesamorelin is a different product at a different concentration, prescribed for reasons the approval does not cover, and it is not FDA approved.

Bremelanotide is approved as Vyleesi, NDA 210557, approved 21 June 2019 and now held by Cosette. It is the same molecule sold in compounding as PT-141. PT-141 is one of the few peptides in this catalogue where the human evidence is a proper randomised programme — the bremelanotide trials in Obstetrics & Gynecology in 2019 and Women's Health in 2016 — and where the active ingredient carries an approval. The approved product is a fixed-dose autoinjector; the compounded PT-141 vial is a different strength and presentation with physician-set directions, and it is not approved.

Elamipretide received accelerated approval on 19 September 2025 as Forzinity, NDA 215244, from Stealth BioTherapeutics, for Barth syndrome. Accelerated approval means the agency accepted an intermediate endpoint on condition that a confirmatory trial is completed. The compounded SS-31 vial is not Forzinity: a different concentration prepared to an individual prescription, and not approved. What the 2025 approval changed is the compounding pathway rather than the approval status, for the reason set out below.

Sermorelin is the only peptide here whose approval is in the past tense. As Geref it was approved twice: the diagnostic presentation under NDA 019863 on 28 December 1990, and the treatment presentation for idiopathic growth hormone deficiency in children in 1997. Drugs@FDA lists NDA 019863 as discontinued. EMD Serono discontinued both in 2008, and in March 2013 the FDA published a determination in the Federal Register that Geref had not been withdrawn from sale for reasons of safety or effectiveness.

So the accurate sentence about sermorelin is "was the active ingredient of an FDA-approved drug, discontinued in 2008 for commercial reasons" — never "FDA approved." There is no currently marketed approved sermorelin product in the United States, and the compounded vial is not one.

Oxytocin has approved injectable products, including Pitocin under NDA 018261 approved in 1980, all for obstetric use by intravenous or intramuscular route. Compounded oxytocin for the uses discussed on this site is a different product, route and purpose, and is not approved.

Glutathione, methylcobalamin, NAD and acetyl-L-carnitine sit differently again. None is approved as a finished injectable for the uses in question; all four appear in Category 1 of the FDA's 503A bulk drug substances list dated 14 May 2026, the category of substances under evaluation. That is a compounding permission, not an approval, and it is worth saying plainly because Category 1 is sometimes marketed as though it were one.

BPC-157, TB-500, KPV, GHK-Cu, MOTS-c, Semax, Selank, epithalon, ipamorelin, CJC-1295, AOD-9604, thymosin alpha-1, dihexa, melanotan II and the rest of the catalogue have no approved product anywhere in the United States. The FDA's briefing document for the July 2026 advisory committee meeting states that BPC-157 is not the subject of an approved application, has no USP or NF monograph, and is not a component of an approved drug.

For these the honest framing is mechanism plus prescriber experience, not proof of outcome. The evidence for BPC-157 is a large animal and cell literature — the Journal of Orthopaedic Research in 2006 on Achilles tendon detachment in rats, Current Pharmaceutical Design in 2011 on the gastrointestinal work — with no large randomised human trials. Saying so is not a criticism of BPC-157; it is the difference between a reference and a sales page.

Section 503A of the Federal Food, Drug, and Cosmetic Act exempts a compounded drug from the approval requirement and from the manufacturing rules that go with it. In exchange it imposes conditions, the first of which is about the bulk substance: a pharmacy may compound with a substance that complies with an applicable United States Pharmacopeia or National Formulary monograph, or that is a component of a drug approved by the Secretary, or that appears on a list developed by the Secretary through regulations. Three routes, and a substance needs only one.

This is why elamipretide and bremelanotide sit comfortably and BPC-157 does not. Since September 2025 elamipretide has been a component of an approved drug, satisfying the second route on its own; bremelanotide has been since 2019. BPC-157 satisfies none of the three, which is why the bulks list matters so much for it.

The statute requires compounding "for an identified individual patient based on the receipt of a valid prescription order" from a licensed prescriber, by a licensed pharmacist in a state-licensed pharmacy or by a licensed physician. There is no lawful retail route. Whatever the FDA eventually lists, a listing is permission for a licensed pharmacy to compound pursuant to a prescription — never permission to sell a peptide over a counter. The contrast with vials sold as research chemicals is covered in research peptides vs prescription peptides.

The third condition governs every peptide with an approved counterpart. A pharmacy may not compound regularly or in inordinate amounts any drug product that is essentially a copy of a commercially available drug product. The FDA's guidance treats a compounded drug as not a copy where the prescriber determines that a change — a different strength, dosage form or route — produces a significant difference for that identified patient, and documents it on the prescription.

That is the framework under which compounded semaglutide, tirzepatide, tesamorelin, PT-141 and SS-31 are prescribed today. It puts the decision where it belongs: with a physician who has to write down why. None of the three conditions turns a compounded preparation into an approved product; they determine whether compounding it is lawful. Approval and lawfulness are separate axes, and most of the confusion in this category comes from collapsing them into one.

While the FDA works through nominations for the 503A bulks list, it sorts substances into three interim categories. Category 1 is "Bulk Drug Substances Under Evaluation," and the agency has said it does not intend to act against compounding with them while evaluation proceeds. Category 2 is "Bulk Drug Substances that Raise Significant Safety Concerns." Category 3 is "Bulk Drug Substances Nominated Without Adequate Support."

None of the three is an approval. Category 1 is the most favourable position a nominated substance can hold, and it still means only that the FDA is evaluating it.

The live list is dated 14 May 2026. Category 1 includes glutathione, methylcobalamin, nicotinamide adenine dinucleotide, acetyl-L-carnitine, vasoactive intestinal peptide and "GHK-Cu (except for injectable routes of administration)." Category 2 contains six entries in total: cesium chloride, domperidone, germanium sesquioxide, ibutamoren mesylate, kisspeptin-10, and quinacrine hydrochloride for intrauterine administration. Category 3 includes GHRP-2, GHRP-6, cibinetide (ARA-290) and pegylated mechano growth factor.

Read that Category 2 list again. BPC-157 is not on it. TB-500 is not on it. KPV, MOTS-c, Semax, epithalon and GHK-Cu are not on it. A page still describing those peptides as Category 2 substances is describing 2023.

In September 2023 the FDA had placed a group of peptides in Category 2. On 15 April 2026 the agency announced it would remove twelve peptide bulk drug substances from Category 2, effective about a week later, and would instead take them to its Pharmacy Compounding Advisory Committee. The FDA's safety-risk page, last updated 22 April 2026, now lists BPC-157, TB-500 (thymosin beta-4), KPV, MOTS-c, epitalon, Semax, Selank, CJC-1295, ipamorelin acetate, AOD-9604, GHK-Cu, dihexa acetate, cathelicidin LL-37, melanotan II, thymosin alpha-1 and emideltide among substances previously nominated and since withdrawn from that designation. Removal did not put any of them on the bulks list or into Category 1; it moved them out of the "significant safety risk" designation and into formal evaluation.

The committee met over two days. On 23 July it considered BPC-157, KPV, TB-500 and MOTS-c; on 24 July it considered emideltide — the FDA's name for delta sleep-inducing peptide — Semax and epitalon.

Six of the seven were recommended for inclusion on the 503A bulks list. The recorded votes were 8 in favour to 6 against with one abstention for BPC-157, KPV and TB-500; 7 to 5 with two abstentions for MOTS-c; 8 to 5 with one abstention for Semax; and 7 to 4 with one abstention for epitalon. Emideltide was the exception, at 6 in favour to 7 against with one abstention.

It is a recommendation, not a listing. The FDA's own briefing materials state that the agency "will not issue a final determination on the issues at hand until input from the advisory committee process has been considered and all reviews have been finalized." Adding a substance to the 503A bulks list is done by notice-and-comment rulemaking, which follows the vote and takes its own time.

So the accurate description of BPC-157, TB-500, KPV, MOTS-c, Semax and epithalon in September 2026 is: no longer flagged for significant safety risk, recommended by the advisory committee, awaiting the FDA's final determination through rulemaking. None of them is an FDA-approved drug product, and none will become one by being listed.

The FDA has said it will consult the advisory committee again before the end of February 2027 on five further peptides: GHK-Cu, melanotan II, cathelicidin LL-37, dihexa acetate and pegylated mechano growth factor.

GHK-Cu is the entry whose wording repays close reading. It was removed from Category 1 on 22 April 2026 because its nominations were withdrawn; on 5 May 2026 one nominator clarified it had meant to withdraw only the injectable route, so the FDA added "GHK-Cu (except for injectable routes of administration)" back to Category 1 and stated its intention to consult the committee before the end of February 2027. Injectable GHK-Cu is therefore not in Category 1, not in Category 2, and not on the bulks list, with review scheduled. Nobody should describe it as approved, and nobody should describe it as banned.

Honesty requires naming the exception. Kisspeptin-10 remains in Category 2 on the current list. It was placed there in September 2023, reviewed by the advisory committee on 29 October 2024 for the nominated use of secondary hypogonadism in men, and voted against 0 to 11. It was not among the twelve peptides moved out of Category 2 in April 2026 and was not on the July 2026 agenda. The kisspeptin product page carries that status in full, and your physician is the person to discuss it with.

Both are components of approved drug products, so they satisfy the second of the three statutory routes on their own. Neither appears in any category of the 14 May 2026 list. The constraint that applies to them is the "essentially a copy" rule, not the bulks list.

Semaglutide and tirzepatide both spent years on the FDA drug shortage list, and a drug in shortage may be compounded even where it would otherwise be an essential copy. The FDA declared the tirzepatide shortage resolved in late 2024 and the semaglutide shortage resolved on 21 February 2025, with wind-down periods running to 22 April 2025 for 503A pharmacies and 22 May 2025 for 503B outsourcing facilities. Shortage-based compounding is over. What remains is the ordinary patient-specific 503A route, where a prescriber determines and documents that the compounded preparation differs from the commercial product in a way that matters for that patient.

On 30 April 2026 the FDA proposed to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list, stating it had not identified a clinical need for outsourcing facilities to compound them from bulk substances. That is a proposal on a different list governing a different kind of facility: 503B outsourcing facilities make large batches without patient-specific prescriptions. It does not by itself change the 503A framework under which a pharmacy compounds a named patient's vial on a physician's prescription.

Whatever happens to it, compounded semaglutide and compounded tirzepatide remain what they are today: not FDA approved, not the branded medications, and prescribable only through a physician. The safety questions specific to the compounded preparation are in is compounded semaglutide safe.