Are peptides legal in the US?

Short answer: it depends on the peptide and how you get it. FDA-approved peptide drugs are legal with a prescription. Since October 30, 2026, six more peptides (BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500) can be compounded for one patient with a prescription under an interim HHS policy, and only in the forms HHS lists [1], [2], [3].

Status of each peptide

Checked against the source in the last column on November 5, 2026. “Not covered” means the peptide is not on the HHS list; it does not mean any other use is legal.

Peptide	Status	Forms HHS allows	Source
BPC-157 (acetate)	HHS interim policy	Subcutaneous, intramuscular, oral, topical	[1], [2]
TB-500 (acetate)	HHS interim policy	Subcutaneous or intramuscular injection	[1], [2]
Epitalon (acetate)	HHS interim policy	Subcutaneous or intramuscular injection	[1], [2]
MOTS-c (acetate)	HHS interim policy	Subcutaneous or intramuscular injection	[1], [2]
Semax (free base)	HHS interim policy	Intranasal	[1], [2]
KPV (acetate)	HHS interim policy	Topical and oral	[1], [2]
Emideltide (DSIP)	Not covered (not on the HHS list)	—	[1]
Ipamorelin	FDA Category 2 (may present significant safety risks)	—	[5]
GHRP-2	FDA Category 2	—	[5]
GHRP-6	FDA Category 2	—	[5]
Kisspeptin-10	FDA Category 2	—	[5]
CJC-1295	Not covered. Its nomination was withdrawn from Category 2	—	[5]
GHK-Cu (injectable)	Not covered. Nomination withdrawn from Category 2	—	[5]
AOD-9604, melanotan II, LL-37, selank, thymosin alpha-1	Not covered. Nominations withdrawn from Category 2	—	[5]
Sermorelin	Active ingredient of GEREF, an approved drug withdrawn from sale (FDA: not for safety or effectiveness reasons, 2013). Not on the HHS list	—	[7]
NAD and NADH	FDA 503A Category 1 (under evaluation)	—	[8]
Glutathione	FDA 503A Category 1 (under evaluation)	—	[8]

We are still checking tesamorelin, semaglutide, tirzepatide and retatrutide against primary FDA sources. They will be added with their sources.

BPC-157 and KPV were on FDA’s Category 2 list from September 2023 until April 22, 2026. FDA’s drug center (CDER) recommended against adding them to the 503A bulks list; the advisory committee voted in favor [2].

What the HHS policy allows

HHS says it does not intend to take enforcement action against a state-licensed pharmacy, a federal facility or a licensed physician that compounds a drug with a peptide on its list, when all ten of its conditions are met [1]:

1. The peptide is on the list in Appendix A.
2. It matches the identity and the routes in Appendix B.
3. The ingredient comes from an FDA-registered facility and has a valid certificate of analysis (COA) showing identity, purity, potency and the absence of harmful contaminants such as endotoxins, heavy metals and microbes.
4. The original manufacturer is FDA-registered, follows current good manufacturing practice, and its address is on the COA.
5. Serious adverse events and product quality problems are reported to FDA’s MedWatch program and to the states involved.
6. The label says: “This is a compounded drug product. Not for resale.”
7. The product contains only one active ingredient from the list (no blends).
8. For oral forms, the pharmacy keeps documentation that the formulation is absorbed well enough in humans.
9. The only device packed with it is an FDA 510(k)-cleared syringe.
10. It meets all other drug-law requirements, including clean conditions and a prescription for one named patient.

Appendix B adds that injection should be the standard route for peptides, because the body absorbs little of a peptide taken by mouth [2].

Is a peptide a drug?

A peptide sold to treat or prevent a disease, or to change how the body works, is regulated as a drug. Compounded drugs are not FDA-approved, which means FDA does not review their safety, effectiveness, or quality before they are marketed [1].

What about “research use only” peptides?

Many websites sell peptides labeled “for research use only, not for human use.” HHS says the policy is meant to discourage the continued, widespread use of research-use-only peptides from foreign manufacturers, which it says pose a safety risk to US patients [1]. Products under the policy must use an ingredient from an FDA-registered facility with a valid COA [1].

How to get a covered peptide legally

1. See a licensed clinician who decides the peptide is right for you.
2. The clinician writes a prescription for you by name.
3. A state-licensed compounding pharmacy (a 503A pharmacy) prepares and dispenses it, with the label above.

State pharmacy law still applies. We do not yet publish a state-by-state table, because we have not checked each state’s rules.

Is the policy permanent?

No. HHS calls it interim and non-binding, and may revisit it in whole or in part, for example if a safety signal or a product quality problem appears [1], [3]. It lasts until FDA decides in a final rule whether each peptide is included on the 503A bulks list [1]. Public comments are open until November 13, 2026 [4].

Change log

• November 6, 2026: added sermorelin, NAD and glutathione.
• November 5, 2026: page created from the HHS policy, Appendix A and Appendix B.