Living document

Peptide legal status tracker

Where each major peptide actually stands with US regulators — including the ones we can't offer and won't pretend otherwise. Updated whenever the FDA moves.

Last reviewed: August 3, 2026

FDA-approved

An FDA-approved medication. Available with a prescription from a licensed provider.

Compoundable today

May be prepared by licensed US compounding pharmacies under applicable rules, with a valid prescription.

Advisory-recommended — not yet legal

An FDA advisory committee recommended this substance for the 503A list, but FDA rulemaking is not complete. It cannot be legally compounded today.

Not legally available

Not legally available for human use in the US. Sold online only under 'research use only' labeling, which is not a legal pathway.

Semaglutide

GLP-1 receptor agonistApproved

An FDA-approved peptide medication for specified indications, prescribed by licensed providers. The clearest example of peptide therapy that completed the full approval pathway.

Metabolic·Approved medication

Tirzepatide

GIP/GLP-1 receptor agonistApproved

An FDA-approved dual-agonist peptide medication for specified indications, prescribed by licensed providers.

Metabolic·Approved medication

Sermorelin

GHRH analogCompoundable

A growth-hormone-releasing hormone analog that licensed US compounding pharmacies have prepared for patients with a valid prescription. Availability and formulation vary by pharmacy and state.

Endocrine·Available via licensed compounding

BPC-157

Not yet legal

Removed from FDA Category 2 in April 2026; recommended for the 503A bulks list by an 8–6 advisory vote (one abstention) in July 2026, reviewed in the context of ulcerative colitis. Rulemaking incomplete — not legally compoundable today. Prohibited by WADA.

Tissue repair·PCAC recommended, Jul 24 2026

TB-500

thymosin beta-4 fragmentNot yet legal

Recommended for the 503A bulks list at the July 2026 advisory meeting. Human clinical evidence remains limited. Rulemaking incomplete — not legally compoundable today.

Tissue repair·PCAC recommended, Jul 2026

KPV

Not yet legal

A short tripeptide derived from alpha-MSH, studied for anti-inflammatory activity. Recommended at the July 2026 advisory meeting; rulemaking incomplete.

Anti-inflammatory·PCAC recommended, Jul 2026

MOTs-c

Not yet legal

A mitochondrial-derived peptide studied in metabolic and exercise-biology research. Recommended at the July 2026 advisory meeting; rulemaking incomplete.

Metabolic / mitochondrial·PCAC recommended, Jul 2026

Epitalon

Not yet legal

Studied primarily in early-stage and non-human longevity research. Recommended at the July 2026 advisory meeting; rulemaking incomplete.

Longevity·PCAC recommended, Jul 2026

Semax

Not yet legal

Studied for cognitive and neuroprotective effects, largely in research conducted outside the US. Recommended at the July 2026 advisory meeting; rulemaking incomplete.

Cognitive·PCAC recommended, Jul 2026

Emideltide

Not available

The one peptide reviewed at the July 2026 meeting that the advisory committee voted NOT to recommend for the 503A bulks list.

Sleep / neuro·PCAC declined, Jul 2026

Melanotan II

Not available

Widely sold online despite not being legally available for human use in the US. Associated with documented safety concerns.

Pigmentation·Long-standing FDA concern

GHK-Cu (injectable)

Not available

Copper peptide studied for skin and tissue effects. Topical cosmetic formulations exist; the injectable form is not legally available for human use in the US.

Tissue / skin·Injectable form not legally available

DSIP

delta sleep-inducing peptideNot available

Sold widely under research-use labeling; not legally available for human use in the US.

Sleep·Not legally available

Ipamorelin

Not available

A growth-hormone secretagogue that has been restricted for compounding by the FDA. Frequently marketed online regardless.

Endocrine·Restricted for compounding

Spot something out of date?

Regulatory status changes, and we'd rather be corrected than wrong. If you have a primary source showing a different status, tell us and we'll review it.

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Common questions

Which peptides are legal in the US right now?

As of August 2026: FDA-approved peptide medications such as semaglutide and tirzepatide are legal with a prescription, and some peptides like sermorelin have been available through licensed compounding pharmacies. BPC-157, TB-500, KPV, MOTs-c, Epitalon and Semax were recommended by an FDA advisory committee in July 2026 but are NOT yet legal to compound because rulemaking is incomplete. Many others, including Melanotan II and injectable GHK-Cu, are not legally available for human use at all.

What does 'advisory-recommended but not yet legal' mean?

An FDA advisory committee has voted to recommend adding the substance to the 503A bulk drug substances list, which would let licensed pharmacies compound it. That vote is advice, not law. The FDA must still complete its rulemaking process, which historically takes months, and it is not obligated to follow the committee.

How often is this tracker updated?

We review it whenever the FDA, its Pharmacy Compounding Advisory Committee, or another authority takes a documented action, and we publish the date of the last review at the top of the page. If a status here is out of date, we want to know.

Does a status of 'not legally available' mean I can't find it for sale?

No — many of these are easy to buy online from sellers using 'research use only' labeling. That labeling is a workaround for the seller, not a legal or safe pathway for you. Legality and availability are different things.

This tracker is general educational information, not medical or legal advice, and it does not represent products offered for sale by Peptaven. Regulatory status can change without notice; confirm any specific situation with a licensed provider or the FDA's published materials.