Which peptides a US pharmacy may lawfully compound

The most-sold peptide in this category has no lawful basis for compounding in the United States. It is not on the 503A list, it is not a component of any approved drug, and it has no applicable USP monograph — so a pharmacy compounding it is outside all three routes section 503A allows. The July vote was advice, not permission, and the use FDA reviewed was ulcerative colitis, not tendons.

The use FDA actually evaluated: Ulcerative colitis (UC). Not athletic recovery, tendon or ligament healing, injury repair, muscle growth or performance — none of those were on the agenda for any substance at this meeting.

The vote: 8–6 with one abstention, for both the free base and the acetate — in favor. FDA has published no minutes for this meeting, so this count is as reported by FDA Law Blog (Hyman, Phelps & McNamara, P.C.), Regulatory Focus (RAPS), NBC News rather than from any FDA document.

Also worth knowing: this substance sits in FDA's “nominated but withdrawn” table — the nomination that could have created a lawful route was pulled by the nominator. FDA's own briefing document records that it elected to take the substance to the advisory committee anyway.

Our evidence review: BPC-157. Competing? Check it in the WADA prohibited-status checker.

No lawful compounding route exists today. FDA's own written evaluation was that it had identified no human exposure data for KPV by any route of administration — not thin data, none — and the committee recommended it anyway.

The use FDA actually evaluated: Wound healing and inflammatory conditions. Not athletic recovery, tendon or ligament healing, injury repair, muscle growth or performance — none of those were on the agenda for any substance at this meeting.

The vote: 8–6 with one abstention, for both the free base and the acetate — in favor. FDA has published no minutes for this meeting, so this count is as reported by FDA Law Blog (Hyman, Phelps & McNamara, P.C.), Regulatory Focus (RAPS), NBC News rather than from any FDA document.

Also worth knowing: this substance sits in FDA's “nominated but withdrawn” table — the nomination that could have created a lawful route was pulled by the nominator. FDA's own briefing document records that it elected to take the substance to the advisory committee anyway.

Our evidence review: KPV.

No lawful compounding route today, and the sharpest anti-doping problem on this page: TB-500 has been banned in tested sport for over a decade, and a favorable compounding vote does nothing to change that.

The use FDA actually evaluated: Wound healing. Not athletic recovery, tendon or ligament healing, injury repair, muscle growth or performance — none of those were on the agenda for any substance at this meeting.

The vote: 8–6 with one abstention, for both the free base and the acetate — in favor. FDA has published no minutes for this meeting, so this count is as reported by FDA Law Blog (Hyman, Phelps & McNamara, P.C.), Regulatory Focus (RAPS), NBC News rather than from any FDA document.

Also worth knowing: this substance sits in FDA's “nominated but withdrawn” table — the nomination that could have created a lawful route was pulled by the nominator. FDA's own briefing document records that it elected to take the substance to the advisory committee anyway.

FDA calls it: Thymosin beta-4, fragment (LKKTETQ), also known as TB-500 — the exact string on the federal page, so you can find this row there yourself.

Our evidence review: TB-500. Competing? Check it in the WADA prohibited-status checker.

No lawful compounding route today. MOTS-c is sold to athletes for endurance and mitochondrial performance; FDA evaluated it for obesity and osteoporosis, and recorded that it had identified no human exposure data for it by any route.

The use FDA actually evaluated: Obesity and osteoporosis. Not athletic recovery, tendon or ligament healing, injury repair, muscle growth or performance — none of those were on the agenda for any substance at this meeting.

The vote: 7–5 with two abstentions — in favor. FDA has published no minutes for this meeting, so this count is as reported by FDA Law Blog (Hyman, Phelps & McNamara, P.C.), Regulatory Focus (RAPS), NBC News rather than from any FDA document.

Also worth knowing: this substance sits in FDA's “nominated but withdrawn” table — the nomination that could have created a lawful route was pulled by the nominator. FDA's own briefing document records that it elected to take the substance to the advisory committee anyway.

FDA calls it: MOTs-C — the exact string on the federal page, so you can find this row there yourself.

Our evidence review: MOTS-c.

No lawful compounding route today. Semax is approved as a medicine in Russia and nowhere in the United States, and the uses FDA reviewed — stroke-related brain injury, migraine, facial nerve pain — are not the nootropic use it is sold for.

The use FDA actually evaluated: Cerebral ischemia, migraine, and trigeminal neuralgia. Not athletic recovery, tendon or ligament healing, injury repair, muscle growth or performance — none of those were on the agenda for any substance at this meeting.

The vote: 8–5 in favor — in favor. FDA has published no minutes for this meeting, so this count is as reported by Regulatory Focus (RAPS) rather than from any FDA document.

Also worth knowing: this substance sits in FDA's “nominated but withdrawn” table — the nomination that could have created a lawful route was pulled by the nominator. FDA's own briefing document records that it elected to take the substance to the advisory committee anyway.

FDA calls it: Semax (heptapeptide) — the exact string on the federal page, so you can find this row there yourself.

Our evidence review: Semax.

No lawful compounding route today. Epitalon is sold on a longevity and telomerase pitch; FDA reviewed it for insomnia, and reviewers noted there was no published efficacy data for that indication at all.

The use FDA actually evaluated: Insomnia. Not athletic recovery, tendon or ligament healing, injury repair, muscle growth or performance — none of those were on the agenda for any substance at this meeting.

The vote: 7–5 with one abstention — in favor. FDA has published no minutes for this meeting, so this count is as reported by Regulatory Focus (RAPS) rather than from any FDA document. Outlets differ on this count — at least one reported 7–4. Until FDA posts minutes, treat the direction (narrowly favorable) as reliable and the exact number as approximate.

Also worth knowing: this substance sits in FDA's “nominated but withdrawn” table — the nomination that could have created a lawful route was pulled by the nominator. FDA's own briefing document records that it elected to take the substance to the advisory committee anyway.

Our evidence review: Epitalon.

The one substance on the July slate that a committee stacked in favor of peptides still would not endorse. No lawful compounding route, and now an explicit negative recommendation on the record against it.

The use FDA actually evaluated: Opioid withdrawal, chronic insomnia, and narcolepsy. Not athletic recovery, tendon or ligament healing, injury repair, muscle growth or performance — none of those were on the agenda for any substance at this meeting.

The vote: 6–7 against, with one abstention — against. FDA has published no minutes for this meeting, so this count is as reported by Regulatory Focus (RAPS) rather than from any FDA document.

Also worth knowing: this substance sits in FDA's “nominated but withdrawn” table — the nomination that could have created a lawful route was pulled by the nominator. FDA's own briefing document records that it elected to take the substance to the advisory committee anyway.

Our evidence review: Emideltide (DSIP).

Worse than unlisted. FDA has affirmatively identified safety risks — immunogenicity, peptide-related impurities, and reports of serious adverse events including death in critically ill study subjects — and says it would consider enforcement action against a compounder using it.

FDA calls it: Growth hormone releasing peptide-2 (GHRP-2) (for injectable and nasal routes of administration) — the exact string on the federal page, so you can find this row there yourself.

Category 2 scope: 503B · added September 29, 2023

Our evidence review: GHRP-2. Competing? Check it in the WADA prohibited-status checker.

Worse than unlisted, for the same reason as GHRP-2. FDA's stated concerns include an effect on cortisol and rising blood glucose from decreased insulin sensitivity.

FDA calls it: Growth hormone releasing peptide-6 (GHRP-6) — the exact string on the federal page, so you can find this row there yourself.

Category 2 scope: 503B · added September 29, 2023

Our evidence review: GHRP-6. Competing? Check it in the WADA prohibited-status checker.

The most-prescribed peptide on this page has the most confused paper trail, and it is worth reading carefully: ipamorelin appears in BOTH of FDA's tables — still a category 2 safety concern under the 503B policy, and a withdrawn nomination on the 503A side. Neither is a lawful basis. FDA cites a published report of serious adverse events including death when it was given intravenously.

Also worth knowing: this substance sits in FDA's “nominated but withdrawn” table — the nomination that could have created a lawful route was pulled by the nominator. FDA's own briefing document records that it elected to take the substance to the advisory committee anyway.

FDA calls it: Ipamorelin acetate — the exact string on the federal page, so you can find this row there yourself.

Category 2 scope: 503B · added September 29, 2023

Our evidence review: Ipamorelin. Competing? Check it in the WADA prohibited-status checker.

The only compound here flagged under both interim policies. FDA's stated reason is specific rather than generic: a randomized, placebo-controlled trial in patients recovering from hip fracture was terminated early over a potential congestive heart failure signal.

FDA calls it: Ibutamoren mesylate — the exact string on the federal page, so you can find this row there yourself.

Category 2 scope: both · added 503A: September 29, 2023; 503B: December 29, 2022

Our evidence review: MK-677 (ibutamoren).

Flagged under the 503A policy specifically, which is the one that governs the pharmacy filling a personal prescription. FDA says it has no or only limited safety information for the proposed routes and cannot tell whether the drug would cause harm.

Category 2 scope: 503A · added September 29, 2023

Our evidence review: Kisspeptin-10.

No lawful compounding route, and no pending route either: the nomination that could have created one was pulled. CJC-1295 was not on the July 2026 agenda and is not scheduled for the next meeting, so nothing about its status is moving. FDA has recorded serious adverse events associated with it, including increased heart rate and systemic vasodilatory reaction.

Our evidence review: CJC-1295. Competing? Check it in the WADA prohibited-status checker.

No lawful compounding route and no pending nomination. FDA also records serious adverse events that may be associated with it, though it says causality is not clear.

Our evidence review: AOD-9604. Competing? Check it in the WADA prohibited-status checker.

No lawful compounding route and no pending nomination. Worth knowing if you read about the July votes: Semax got a favorable recommendation and Selank, its usual shelf-mate, was not even on the agenda.

FDA calls it: Selank acetate (TP-7) — the exact string on the federal page, so you can find this row there yourself.

Our evidence review: Selank.

No lawful compounding route in the United States and no pending nomination — despite thymalfasin being an approved medicine in a number of other countries. Approval elsewhere is not a US compounding basis.

FDA calls it: Thymosin-alpha 1 (Ta1) — the exact string on the federal page, so you can find this row there yourself.

Our evidence review: Thymosin alpha-1.

No lawful compounding route for the injectable form, which is the form FDA's entry covers. Trade press reports GHK-Cu on the agenda for the next PCAC meeting, expected before the end of February 2027 — reporting, not an FDA-confirmed agenda.

FDA calls it: GHK-Cu (for injectable routes of administration) — the exact string on the federal page, so you can find this row there yourself.

Our evidence review: GHK-Cu.

No lawful compounding route. FDA states it has identified no human exposure data on PEG-MGF products by any route of administration.

FDA calls it: Mechano growth factor pegylated (PEG-MGF) — the exact string on the federal page, so you can find this row there yourself.

Our evidence review: PEG-MGF. Competing? Check it in the WADA prohibited-status checker.

No lawful compounding route, and the longest list of published harms on this page: FDA cites case reports of melanoma, posterior reversible encephalopathy syndrome, sympathomimetic toxidrome and priapism.

Our evidence review: Melanotan II.

No lawful compounding route. FDA's entry is unusually pointed: nonclinical findings suggest detrimental effects on male reproduction, and that it can be protumorigenic in some tissues.

No lawful compounding route. FDA states it has not identified any human exposure data on dihexa acetate by any route, and lacks the information to say whether it would cause harm in humans.

FDA calls it: Dihexa acetate — the exact string on the federal page, so you can find this row there yourself.

An investigational drug with no approved product anywhere in the world, and no entry on any FDA compounding table — so there is no route, no pending route, and no safety review to point at either. Everything sold under this name is an unapproved drug.

Our evidence review: Retatrutide. Competing? Check it in the WADA prohibited-status checker.

No approved product, no listing, no nomination on any current table. Absence here is not neutral — it means nobody has ever assembled enough supporting information for FDA to evaluate it, for a compound whose mechanism aligns with a serious cancer signal.

Our evidence review: IGF-1 LR3. Competing? Check it in the WADA prohibited-status checker.

No approved product and no entry on any FDA compounding table. Note the distinction buyers routinely miss: AOD-9604, an analog of this fragment, does have a withdrawn nomination on the record. This one has nothing at all.

Our evidence review: HGH fragment 176-191. Competing? Check it in the WADA prohibited-status checker.

An approved drug product exists and is marketed, so tesamorelin has a route the peptides above do not. What it is approved FOR is narrow — HIV-associated lipodystrophy — and that has nothing to do with sport or general body composition.

Our evidence review: Tesamorelin. Competing? Check it in the WADA prohibited-status checker.

This is the compound this site ranks providers for, so here is its status held to the same standard as everything above. Sermorelin's basis is genuinely different from BPC-157's: an FDA-approved drug product containing sermorelin acetate exists on the record, and FDA has formally determined it was not withdrawn for safety or effectiveness reasons — which is the clause compounders rely on. It is also not the same thing as an approved, marketed product you can buy: no sermorelin presentation is currently marketed, and compounded sermorelin is not an FDA-approved drug.

Our evidence review: Sermorelin. Competing? Check it in the WADA prohibited-status checker.

Approved products exist, so the bulks list is not the question here. The question that replaced it is the copies rule: compounders may prepare a version of an approved drug when it is officially in shortage, and the semaglutide shortage that permitted mass compounding ended in 2025.

Our evidence review: Semaglutide. Competing? Check it in the WADA prohibited-status checker.

Same shape as semaglutide: approved products exist, so the constraint is the copies rule rather than the bulks list, and the shortage that permitted broad compounding has ended.

Our evidence review: Tirzepatide. Competing? Check it in the WADA prohibited-status checker.