Which peptides did the FDA review in 2026?

On July 23 and 24, 2026 the Pharmacy Compounding Advisory Committee reviewed BPC-157, KPV, TB-500, MOTS-c, emideltide, epitalon and semax. It recommended six of them for the 503A Bulks List and voted against emideltide; FDA has not decided.

Are peptides still available from compounding pharmacies?

Twelve peptides were removed from 503A Category 2 in April 2026 without being placed in Category 1, so they sit outside the 503A exemption. Availability from a pharmacy is not the same as an approval or a listing.

When does this tracker change next?

A further advisory committee meeting is announced for February 2027 to reconsider LL-37, dihexa, melanotan II and PEG-MGF. Each line here carries the date of our last verification.

§ — Regulatory status tracker

FDA compounding and approval status of peptides — tracker

The FDA's position on compounded peptides moved three times in 2026 and an interim policy is under White House review. Each line below carries the date of our last verification — currently October 22, 2026.

Peptide	Researched for	Evidence	Regulatory status	As of
PT-141	Hypoactive sexual desire disorder in women; erectile dysfunction in men (earlier programs).	A	FDA-approved (Vyleesi) for hypoactive sexual desire disorder in premenopausal women. Use in men or for other purposes is off-label.	2026-10-22
Semaglutide	Type 2 diabetes, obesity, cardiovascular outcomes, NASH, kidney outcomes, alcohol use, Alzheimer's disease.	A	FDA-approved for type 2 diabetes (Ozempic, Rybelsus), chronic weight management (Wegovy) and cardiovascular risk reduction in adults with obesity. FDA declared the shortage resolved in February 2025; the grace periods for compounding pharmacies ended in April (503A) and May (503B) 2025. Compounded copies are no longer permitted on shortage grounds.	2026-10-22
Sermorelin	Growth hormone deficiency; GH axis stimulation in adults.	A	Previously FDA-approved as Geref; the product was discontinued in 2008 for commercial reasons. It is not marketed as an approved product today. Some pharmacies compound it; whether a given preparation has a lawful basis is a question for the dispensing pharmacy.	2026-10-22
Tesamorelin	Visceral fat reduction in HIV lipodystrophy; NAFLD; cognitive function in older adults.	A	FDA-approved (Egrifta) for reduction of excess abdominal fat in adults with HIV-associated lipodystrophy. Use for any other purpose is off-label.	2026-10-22
Tirzepatide	Obesity, type 2 diabetes, sleep apnea, heart failure with preserved ejection fraction, cardiovascular outcomes.	A	FDA-approved for type 2 diabetes (Mounjaro), chronic weight management and obstructive sleep apnea in obesity (Zepbound). FDA declared the shortage resolved in December 2024; the grace periods for compounding pharmacies ended in 2025. Compounded copies are no longer permitted on shortage grounds.	2026-10-22
CJC-1295	Sustained growth hormone and IGF-1 elevation in adults; body composition.	B	Not FDA-approved. Its nomination was withdrawn and it left 503A Category 2 in September 2024. The advisory committee reviewed it on December 4, 2024, and did not recommend it for the 503A Bulks List. It cannot be compounded under section 503A.	2026-10-22
GHK-Cu	Skin aging, wound healing, hair growth, gene expression modulation.	B	Not an approved drug. Topical use is regulated as a cosmetic ingredient. The injectable form was removed from 503A Category 2 on April 15, 2026, and is scheduled for review by the advisory committee at a meeting before the end of February 2027. It is not on the 503A Bulks List.	2026-10-22
Ipamorelin	Postoperative ileus (a completed phase 2 program); growth hormone release.	B	Not FDA-approved. Its nomination was withdrawn and it left 503A Category 2 in September 2024. The advisory committee reviewed it on October 29, 2024, and did not recommend it for the 503A Bulks List. It cannot be compounded under section 503A.	2026-10-22
Selank	Generalized anxiety disorder, cognitive function under stress.	B	Not FDA-approved. It has not been reviewed by the advisory committee and is not on the 503A Bulks List.	2026-10-22
Semax	Ischemic stroke recovery, cognitive impairment, attention disorders.	B	Not FDA-approved. Removed from 503A Category 2 on April 15, 2026. On July 24, 2026, the advisory committee voted 8–5 (one abstention) to recommend it for the 503A Bulks List, against the advice of FDA's scientists. FDA has not decided; it cannot yet be compounded under section 503A.	2026-10-22
Thymosin alpha-1	Hepatitis B and C adjunct, sepsis, vaccine response, cancer adjunct, COVID-19.	B	Not FDA-approved in the United States. The advisory committee reviewed it on December 4, 2024, and did not recommend it for the 503A Bulks List. It is not on the list and cannot be compounded under section 503A.	2026-10-22
BPC-157	Tendon, ligament and muscle healing; gastrointestinal mucosal protection; ulcerative colitis (the indication FDA reviewed in 2026).	C	Not FDA-approved for any use. Removed from 503A Category 2 on April 15, 2026, after its nomination was withdrawn — which is not a listing in Category 1. On July 23, 2026, the Pharmacy Compounding Advisory Committee voted 8–6 (one abstention) to recommend it for the 503A Bulks List; FDA's own scientists had recommended against. FDA has not decided. It is not on the 503A Bulks List, so it cannot yet be compounded under section 503A.	2026-10-22
Emideltide	Sleep induction, stress response, chronic pain, opioid withdrawal.	C	Not FDA-approved. Removed from 503A Category 2 on April 15, 2026. On July 24, 2026, the advisory committee voted 6–7 (one abstention) against recommending it for the 503A Bulks List. It cannot be compounded under section 503A.	2026-10-22
KPV	Inflammatory bowel disease, skin inflammation.	C	Not FDA-approved. Removed from 503A Category 2 on April 15, 2026. On July 23, 2026, the advisory committee voted 8–6 (one abstention) to recommend it for the 503A Bulks List, against the advice of FDA's scientists. FDA has not decided; it cannot yet be compounded under section 503A.	2026-10-22
LL-37	Chronic wound infection, biofilm disruption, venous leg ulcers.	C	Not FDA-approved. Removed from 503A Category 2 on April 15, 2026, and scheduled for review by the advisory committee before the end of February 2027. It is not on the 503A Bulks List.	2026-10-22
MOTS-c	Insulin sensitivity, exercise capacity, metabolic regulation, aging biology.	C	Not FDA-approved. Removed from 503A Category 2 on April 15, 2026. On July 23, 2026, the advisory committee voted 7–5 (two abstentions) to recommend it for the 503A Bulks List, against the advice of FDA's scientists. FDA has not decided; it cannot yet be compounded under section 503A.	2026-10-22
TB-500	Wound healing, cardiac tissue repair after injury, corneal healing.	C	Not FDA-approved. Removed from 503A Category 2 on April 15, 2026. On July 23, 2026, the advisory committee voted 8–6 (one abstention) to recommend it for the 503A Bulks List, against the advice of FDA's scientists. FDA has not decided; it is not on the list and cannot yet be compounded under section 503A.	2026-10-22
Epitalon	Telomerase activation, melatonin regulation, lifespan extension.	D	Not FDA-approved. Removed from 503A Category 2 on April 15, 2026. On July 24, 2026, the advisory committee voted 7–4 (one abstention) to recommend it for the 503A Bulks List, against the advice of FDA's scientists. FDA has not decided; it cannot yet be compounded under section 503A.	2026-10-22
Melanotan II	Skin tanning, erectile dysfunction (abandoned development).	D	Not FDA-approved; FDA has issued consumer warnings. Removed from 503A Category 2 on April 15, 2026, and scheduled for review by the advisory committee before the end of February 2027. It is not on the 503A Bulks List.	2026-10-22

Approved drug with randomized controlled trials for the approved indication

Human clinical data exists, but no approval for the researched use

Animal or in-vitro data only, no controlled human trials

No published clinical data; use rests on anecdote

Reviewed October 2026 · Sources: FDA, EMA

This page reports on the state of research and regulation for orientation. It is not medical advice, not a recommendation for or against any substance, and not an offer. Regulatory status changes; the date shown is the date of our last verification. Discuss any treatment with a licensed physician.

01 — Recent changes

What moved, and when.

2026-10-14FDA sent an “Interim Access Policy for Compounding Using Certain Peptides” to the White House Office of Management and Budget for review. Its text and scope have not been published. Until it is, nothing changes for compounding.
2026-08-24FDA warning letters to online peptide sellers: a “research use only” label did not protect sellers whose products were clearly meant for people.
2026-07-23/24The Pharmacy Compounding Advisory Committee recommended six peptides for the 503A Bulks List — BPC-157, KPV, TB-500, MOTS-c, Semax and Epitalon — and voted against emideltide. FDA's scientists had advised against all seven. The votes are advisory; adding a substance takes formal rulemaking.
2026-04-15Twelve peptides left 503A Category 2 after their nominations were withdrawn: BPC-157, TB-500, MOTS-c, GHK-Cu (injectable), melanotan II, Semax, PEG-MGF, emideltide, Epitalon, KPV, LL-37 and dihexa acetate. Leaving Category 2 is not a listing in Category 1.
Before 2027-02-28 (announced)Advisory committee review of GHK-Cu, LL-37, dihexa acetate, melanotan II and PEG-MGF.

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Primary sources