Is BPC-157 legal in the United States?

BPC-157 is not FDA-approved and was never added to the FDA's 503A bulk substances list, meaning it cannot be legally compounded for human use by licensed 503A pharmacies. It is sold as a research chemical but is not authorized for human administration under current FDA regulations.

What is the 503A bulk substances list?

The FDA's 503A bulk substances list identifies compounds that licensed compounding pharmacies may use to prepare medications for individual patients with a valid prescription. Peptides on this list include GHK-Cu (topical) and gonadorelin. Most research peptides — including BPC-157, TB-500, and CJC-1295 — are not on this list.

What peptides are FDA approved?

FDA-approved peptides include semaglutide (Ozempic, Wegovy), tirzepatide (Mounjaro, Zepbound), bremelanotide/PT-141 (Vyleesi), sermorelin, gonadorelin, and thymosin alpha-1 (approved in 35+ countries but not the US). See the full list in our Regulatory Tracker.

What happened to peptide compounding after the GLP-1 shortage ended?

The FDA removed semaglutide and tirzepatide from its drug shortage list in late 2024, which prohibits 503A compounding pharmacies from continuing to compound these drugs. Enforcement is ongoing as of 2025-2026.

What peptides are under FDA review in 2026?

In April 2026, the FDA announced a July 2026 advisory panel review of seven peptides: BPC-157, TB-500, AOD-9604, Thymosin Alpha-1, CJC-1295, Ipamorelin, and Epithalon. The panel will evaluate evidence and regulatory classification for each compound.

TB-500 (Thymosin Beta-4 fragment) is not FDA-approved and is not on the 503A compounding bulk substances list. It is sold for research purposes only. Human use is not authorized under current US regulations.

Regulatory Tracker

US regulatory status for all 75 peptides in the database.

Last updated: May 2026. Regulatory landscapes change — verify current status with FDA.gov.

FDA Approved

503A Listed

Restricted

Research Only

⚠️

GLP-1 Compounding Update (2024)

FDA removed semaglutide and tirzepatide from shortage lists in October 2024. Compounding of these drugs is now federally prohibited for 503A pharmacies. Enforcement is ongoing. Read full analysis →

FDA Approved — Full FDA approval; prescribable for approved indications; off-label use at practitioner discretion

Peptide	Brand Name(s)	Indication	Evidence
Exenatide	Byetta, Bydureon BCise	FDA approved — Byetta (twice daily), Bydureon (weekly ER)	Strong Evidence
Gonadorelin	GnRH, Luteinizing hormone-releasing hormone (LHRH)	FDA approved (Factrel). 503A listed for compounding.	Strong Evidence
Liraglutide	Victoza, Saxenda	FDA approved — Victoza (T2D), Saxenda (obesity)	Strong Evidence
Melanotan I	MT-1, Afamelanotide	FDA approved as Scenesse (afamelanotide) for EPP	Strong Evidence
Oxytocin	Syntocinon, Pitocin	FDA approved (Pitocin, Syntocinon) for obstetric use	Strong Evidence
Pramlintide	Symlin, Pramlintide acetate	FDA approved as Symlin (T1D and T2D adjunct)	Strong Evidence
PT-141	Bremelanotide, Vyleesi	FDA approved as Vyleesi for HSDD in premenopausal women	Strong Evidence
Semaglutide	Ozempic, Wegovy	FDA approved — Ozempic (T2D), Wegovy (obesity), Rybelsus (oral T2D)	Strong Evidence
Sermorelin	GHRH 1-29, GRF 1-29	FDA-approved for pediatric GH deficiency; compounded for adult anti-aging use under 503A	Moderate Evidence
Tesamorelin	Egrifta, Egrifta SV	FDA approved as Egrifta SV for HIV-associated lipodystrophy	Strong Evidence
Thymosin Alpha-1	Tα1, Thymalfasin	Approved in 35+ countries (Zadaxin). 503A listed for US compounding.	Strong Evidence
Tirzepatide	Mounjaro, Zepbound	FDA approved — Mounjaro (T2D), Zepbound (obesity)	Strong Evidence
Triptorelin	Trelstar, Decapeptyl	FDA approved (Trelstar) for prostate cancer and other indications	Strong Evidence
Ziconotide	Prialt, SNX-111	FDA approved as Prialt (intrathecal use only)	Strong Evidence

503A Listed — Available through 503A compounding pharmacies with valid prescription

Peptide	Compounding Notes	Evidence
GHK	503A bulk substance	Moderate Evidence
GHK-Cu	Listed on 503A bulk substances list for topical compounding	Moderate Evidence

Restricted — Previously available through compounding but now restricted; check current FDA guidance

Peptide	Primary Uses	Evidence
CJC-1295	GH stimulation, Muscle gain	Moderate Evidence
Ipamorelin	GH stimulation, Fat loss	Moderate Evidence

Research Only — Not approved; not on 503A list; legally sold for research; human use is not FDA-authorized

Peptide	Primary Uses	Evidence	Risk
AHK-Cu	Hair growth, Hair loss prevention	Preliminary	low
Alamandine	Cardiovascular protection, Anti-fibrotic	Preliminary	low
Alpha-MSH	Anti-inflammatory, Melanogenesis	Moderate Evidence	low
Angiotensin (1-7)	Cardiovascular protection, Anti-hypertension	Moderate Evidence	low
AOD-9604	Fat metabolism, Weight loss	Preliminary	unknown
ARA 290	Neuroprotection, Diabetic neuropathy	Preliminary	unknown
Argireline	Expression lines, Wrinkle reduction	Moderate Evidence	low
BPC-157	Gut healing, Tendon repair	Moderate Evidence	low
Cagrilintide	Weight management, Metabolic syndrome	Preliminary	unknown
Cathelicidins	Antimicrobial, Innate immunity	Moderate Evidence	low
CGRP	Migraine pathophysiology, Vasodilation	Strong Evidence	low
Cholecystokinin	Satiety signaling, Digestive enzyme release	Strong Evidence	low
Cortagen	Cardiovascular protection, Heart aging	Preliminary	unknown
Davalintide	Weight loss, Obesity	Preliminary	moderate
Defensins	Innate immunity, Antimicrobial	Moderate Evidence	low
Dihexa	Cognitive enhancement, Neurogenesis	Preliminary	unknown
DSIP	Sleep induction, Stress modulation	Preliminary	unknown
Epithalon	Telomere elongation, Anti-aging	Preliminary	unknown
Follistatin	Myostatin inhibition, Muscle growth	Preliminary	unknown
Foxo4-DRI	Senolysis, Senescent cell clearance	Preliminary	unknown
Fragment 176-191	Fat loss, Lipolysis	Preliminary	low
Ghrelin	Educational reference, Appetite stimulation	Strong Evidence	low
GHRP-2	GH secretagogue, Body composition	Preliminary	unknown
GHRP-6	GH secretagogue, Muscle building	Preliminary	unknown
GLP-1 (Native)	Educational reference, Incretins physiology	Strong Evidence	low
Hexarelin	GH secretagogue, Cardioprotection	Preliminary	unknown
Humanin	Neuroprotection, Anti-aging	Preliminary	unknown
IGF-1 (Native)	Educational reference, GH axis physiology	Strong Evidence	low
IGF-1 DES	Local muscle growth, Tissue-specific anabolic	Preliminary	high
IGF-1 LR3	Muscle growth, Tissue repair	Preliminary	high
Kisspeptin	Reproductive hormone regulation, GnRH stimulation	Moderate Evidence	low
Kisspeptin-10	LH/FSH stimulation, Male testosterone	Preliminary	low
Klotho Peptide Fragments	Anti-aging, Cognitive enhancement	Preliminary	unknown
KPV	Gut inflammation, Anti-inflammatory	Preliminary	unknown
Leuphasyl	Expression line reduction, Enkephalin-based wrinkle treatment	Preliminary	low
LL-37	Antimicrobial, Wound healing	Preliminary	unknown
Mastoparan	Antimicrobial, Mast cell activation	Preliminary	high
Matrixyl	Collagen stimulation, Anti-aging	Moderate Evidence	low
Melanotan II	Tanning, Sexual arousal	Preliminary	high
MK-677 (Ibutamoren)	GH secretagogue, Muscle mass	Preliminary	unknown
MOTS-c	Mitochondrial health, Metabolic health	Preliminary	unknown
Myostatin Inhibitor Peptides	Myostatin inhibition, Muscle growth	Preliminary	unknown
Orforglipron	Weight loss, Type 2 diabetes	Moderate Evidence	moderate
P21 Peptide	Cognitive enhancement, Neurogenesis	Preliminary	unknown
PEGylated MGF	Muscle repair, Post-workout recovery	Preliminary	moderate
Pinealon	Neuroprotection, Circadian rhythm	Preliminary	unknown
Retatrutide	Obesity, Type 2 diabetes	Preliminary	unknown
Selank	Anxiolytic, Cognitive enhancement	Preliminary	unknown
Semax	Neuroprotection, Cognitive enhancement	Preliminary	unknown
SNAP-8	Expression line reduction, Neuromuscular relaxation	Preliminary	low
Spadin	Antidepressant, TREK-1 antagonism	Preliminary	unknown
SS-31 (Elamipretide)	Mitochondrial cardioprotection, Heart failure	Preliminary	unknown
TB-500	Wound healing, Muscle repair	Moderate Evidence	low
Thymalin	Immune modulation, Anti-aging	Preliminary	unknown
Vasoactive Intestinal Peptide	Anti-inflammatory, GI motility	Moderate Evidence	moderate
Vesugen	Cardiovascular health, Vascular anti-aging	Preliminary	unknown
Vilon	Immune modulation, Anti-aging	Preliminary	unknown

Disclaimer: Regulatory status changes. This tracker reflects Ercle's best understanding as of May 2026. Always verify current status with FDA.gov, the 503A bulk substances list, and qualified legal/regulatory counsel before prescribing or compounding any compound.