Which peptides did the FDA advisory committee recommend in July 2026?

On 23 and 24 July 2026 the Pharmacy Compounding Advisory Committee recommended six peptides for the section 503A bulk drug substances list: BPC-157 by 8 to 6, KPV by 8 to 6, TB-500 by 8 to 6, Semax by 8 to 5, MOTS-c by 7 to 5 and Epitalon by 7 to 4. DSIP was rejected 6 to 7. The recommendations are non-binding and the FDA has not issued a final decision.

Does removal from Category 2 make a peptide legal to compound?

No. The twelve peptides removed on 15 April 2026 were not moved to Category 1. Removal takes away an explicit adverse finding but does not create permission, and placement on the 503A list would still require notice-and-comment rulemaking after any FDA decision.

Which peptides are actually FDA approved?

Bremelanotide is approved as Vyleesi, tesamorelin as Egrifta, rapamycin as Rapamune, and elamipretide as Forzinity under accelerated approval for Barth syndrome. Naltrexone is approved at 50 mg, with low-dose use being off-label. Sermorelin and human gonadorelin products were previously approved and later discontinued.

Which peptides are still in Category 2?

The current FDA 503A Category 2 list includes ibutamoren mesylate and kisspeptin-10. AOD-9604, CJC-1295, ipamorelin acetate and thymosin alpha-1 are instead listed by FDA as substances whose 503A nominations were withdrawn; ipamorelin is separately in Category 2 under the 503B policy.

Updated 2026-08-27

Peptide FDA compounding status: 47 substances, with the July 2026 vote counts

Almost every peptide page online is written as though regulation is fixed. It moved three times in five months. Twelve peptides came off the Category 2 do-not-compound list on 15 April 2026. Seven were heard by the Pharmacy Compounding Advisory Committee on 23 and 24 July. Five more are scheduled before the end of February 2027. This page tracks where each one actually stands.

FDA approved

5

Formerly approved

2

503A Category 1

2

Recommended for 503A list

6

Rejected by committee

1

Scheduled for review

4

503A Category 2

2

503A nomination withdrawn

4

503A Category 3

2

Investigational

3

No compounding pathway

16

What each status means, and what it does not

The distinctions below are where most coverage goes wrong. Coming off Category 2 is not approval. A committee recommendation is not an FDA decision. An approved drug used off-label is not the same thing as an unapproved substance being compounded.

FDA approved

There is an approved product with a label, an indication and trial data behind it. This is the strongest position a peptide can be in and it is frequently misreported.

Formerly approved

Had FDA approval and no longer does. Why it was withdrawn matters: a manufacturing withdrawal is a very different fact from a safety withdrawal.

503A Category 1

Nominated with enough support for FDA evaluation and covered by the agency's Category 1 interim enforcement policy when all conditions are met. Category 1 is not FDA approval and is not the final 503A bulks list.

Recommended for 503A list

The Pharmacy Compounding Advisory Committee voted to recommend adding it to the section 503A bulk drug substances list on 23 to 24 July 2026. The recommendation is non-binding, the FDA has not issued a final decision, and Category 1 placement would still require notice-and-comment rulemaking.

Rejected by committee

Heard by the committee on 23 to 24 July 2026 and voted down. It came off Category 2 in April and did not gain a recommendation, so it sits outside both lists.

Scheduled for review

FDA announced that it will consult the committee before the end of February 2027. Scheduled describes the next review event, not current permission to compound or placement on the final 503A bulks list.

503A Category 2

FDA has identified significant safety risks and does not extend its Category 1 interim enforcement policy. A Category 2 substance is not on the final 503A bulks list.

503A nomination withdrawn

The 503A nomination was withdrawn, so the substance is not in any current 503A category. Withdrawal does not erase FDA's published safety concerns or create permission to compound from bulk drug substance.

503A Category 3

Nominated without enough supporting information for FDA to evaluate it. It can be renominated with adequate support, but it is not covered by the Category 1 interim enforcement policy.

Investigational

An active pharmaceutical development programme rather than a compounding question. Not approved, and being studied in registered trials by a sponsor.

No compounding pathway

Not on the 503A bulk drug substances list, not in Category 2, and not scheduled for review. There is no current route to lawful compounding, which is why these are sold as research chemicals.

Every peptide, current status

Peptide	Status	Vote	Detail
Bremelanotide · PT-141	FDA approved	Vyleesi	Hypoactive sexual desire disorder in premenopausal women. An approved drug since 2019, not a research peptide. Most content about PT-141 does not mention that an approved product exists.
Tesamorelin	FDA approved	Egrifta	HIV-associated lipodystrophy. Approved with a specific indication. Use outside that indication is off-label prescribing, which is lawful and is a different thing from compounding an unapproved substance.
Rapamycin · sirolimus	FDA approved	Rapamune	Prophylaxis of organ rejection in renal transplant. A long-approved immunosuppressant. Longevity interest is entirely off-label and the approved indication has nothing to do with it.
Naltrexone, low dose · LDN	FDA approved	Revia and others	Opioid and alcohol dependence at 50 mg. The molecule is approved. Low-dose use is off-label and requires compounding because no low-dose product is marketed.
SS-31 · elamipretide	FDA approved	Forzinity	Improve muscle strength in patients with Barth syndrome weighing at least 30 kg. FDA granted accelerated approval in September 2025. That approval is indication- and product-specific; it does not validate research-chemical versions.
Sermorelin	Formerly approved	Geref	Growth hormone deficiency in children. Approved in 1997 and discontinued in 2008 for manufacturing reasons rather than a safety finding. That distinction is the most important fact about sermorelin and it is almost never made.
Gonadorelin	Formerly approved	Factrel and Lutrepulse	Human gonadorelin products were approved and later discontinued; Lutrepulse was discontinued for commercial reasons. Unapproved products sold today are not those approved products.
GHK-Cu · copper peptide	503A Category 1	—	Non-injectable GHK-Cu is in Category 1. Its injectable nomination was withdrawn; FDA plans committee review before the end of February 2027.
VIP · vasoactive intestinal peptide	503A Category 1	—	Vasoactive intestinal peptide is in 503A Category 1 under FDA's interim policy; that is not final approval for a compounded product.
BPC-157	Recommended for 503A list	8 to 6	Recommended for the 503A list on the closest margin heard that day. FDA evaluated it for ulcerative colitis.
KPV	Recommended for 503A list	8 to 6	Recommended after FDA evaluated it for wound healing and inflammatory conditions. Search demand has risen roughly fivefold in a year and coverage anywhere is thin.
TB-500 · thymosin beta-4 fragment	Recommended for 503A list	8 to 6	Recommended alongside BPC-157, with which it is most often stacked.
Semax	Recommended for 503A list	8 to 5	Recommended on a cerebral ischemia indication.
MOTS-c	Recommended for 503A list	7 to 5	Recommended, on the narrowest attendance of the seven heard.
Epitalon · epithalon	Recommended for 503A list	7 to 4	Recommended by the widest proportional margin of the seven.
DSIP · emideltide, delta sleep-inducing peptide	Rejected by committee	6 to 7 against	The only one of the seven voted down, by a single vote, on an insomnia indication. It came off Category 2 in April and gained no recommendation in July, so it now sits outside both lists.
Melanotan II	Scheduled for review	—	Scheduled for review despite a long history of unregulated sale.
LL-37 · cathelicidin	Scheduled for review	—	Scheduled for review. Almost no serious coverage exists anywhere.
Dihexa acetate	Scheduled for review	—	Scheduled for review.
PEG-MGF · mechano growth factor, pegylated	Scheduled for review	—	Scheduled for review.
MK-677 · ibutamoren mesylate	503A Category 2	—	Ibutamoren mesylate is in 503A Category 2; FDA cites a potential congestive-heart-failure safety signal.
Kisspeptin · kisspeptin-10	503A Category 2	—	Kisspeptin-10 is in 503A Category 2; FDA cites immunogenicity, impurity-characterization and limited safety information concerns.
AOD-9604	503A nomination withdrawn	—	Its 503A nomination was withdrawn. FDA continues to publish significant safety concerns, including limited safety information and reports of serious adverse events with unclear causality.
CJC-1295	503A nomination withdrawn	—	Its 503A nomination was withdrawn; FDA continues to identify peptide-characterization concerns and serious adverse events in the limited clinical data.
Ipamorelin	503A nomination withdrawn	—	Its 503A nomination was withdrawn. Ipamorelin acetate remains Category 2 under the separate 503B interim policy, not under 503A.
Thymosin alpha-1 · Ta1	503A nomination withdrawn	—	Its 503A nomination was withdrawn; FDA continues to publish immunogenicity and characterization concerns.
GHRP-2	503A Category 3	—	503A Category 3 because the nomination lacked adequate support. Injectable and nasal GHRP-2 are separately Category 2 under the 503B policy.
GHRP-6	503A Category 3	—	503A Category 3 because the nomination lacked adequate support. It is separately Category 2 under the 503B policy.
Retatrutide	Investigational	—	An Eli Lilly triple agonist in late-stage trials. At roughly 450,000 searches a month it is the largest peptide term in this table, and the honest page about it is a trial tracker rather than a protocol guide.
Cagrilintide	Investigational	—	A Novo Nordisk amylin analogue in development, usually studied with semaglutide.
Tesofensine	Investigational	—	A triple monoamine reuptake inhibitor studied for obesity. Roughly 18,100 searches a month and no coverage on this site at all.
Selank	No compounding pathway	—	No pathway, and demand up roughly fourfold in a year.
Hexarelin	No compounding pathway	—	No pathway. Low competition on the term.
Follistatin-344	No compounding pathway	—	No pathway. One of the least contested terms in this table.
5-Amino-1MQ	No compounding pathway	—	No pathway. Rising demand and no coverage on this site.
IGF-1 LR3	No compounding pathway	—	No pathway.
Fragment 176-191	No compounding pathway	—	No pathway, and demand is falling.
FOXO4-DRI	No compounding pathway	—	No pathway. Senolytic research compound.
Humanin	No compounding pathway	—	No pathway.
P21	No compounding pathway	—	No pathway.
Pinealon	No compounding pathway	—	No pathway.
Snap-8	No compounding pathway	—	No pathway. Cosmetic use.
Matrixyl	No compounding pathway	—	No pathway. Cosmetic use.
Larazotide	No compounding pathway	—	Studied by a sponsor for coeliac disease; no compounding pathway.
ACE-031	No compounding pathway	—	No pathway. Development discontinued.
Adipotide	No compounding pathway	—	No pathway.
AICAR	No compounding pathway	—	No pathway.

What changes next

The next scheduled event is a Pharmacy Compounding Advisory Committee meeting before the end of February 2027, covering GHK-Cu, melanotan II, LL-37, dihexa acetate and PEG-MGF. Separately, the FDA has not yet acted on the six recommendations from July, and any addition to the 503A list would still require notice-and-comment rulemaking after a decision.

AOD-9604, CJC-1295, ipamorelin and thymosin alpha-1 have withdrawn 503A nominations and no announced review. Ibutamoren mesylate and kisspeptin-10 remain in 503A Category 2.

This page is maintained rather than published once. It was last checked on 2026-08-27. If you are reading a peptide page anywhere, including elsewhere on this site, that describes these compounds as Category 2 substances without a date, it was written before April 2026.

What each status means, and what it does not

Every peptide, current status

What changes next

Primary sources