Are peptides legal in the US? Six unapproved peptides can now be compounded under a temporary HHS policy. What it covers and what it leaves out.
Written by the Peptide Labs Research Team
Some peptides are FDA-approved drugs and are legal with a prescription. Six unapproved peptides, including BPC-157 and TB-500, can now be made by licensed compounders under a temporary US policy. None of the six is FDA approved, and the policy was not written for online sellers.
The US Department of Health and Human Services (HHS) filed a draft policy on 28 October. NBC News reported that HHS will use "enforcement discretion", meaning no legal action against compounding pharmacies making the six. The policy requires a prescription written for each patient. Our policy summary lists the other conditions.
Until the FDA finalises a rule. CBS News reported that "at this point, the FDA has not proposed one". NBC says a rule needs a proposal and public comment first, "a process that can take several months". Comments on the draft policy close on 13 November 2026.
No. An HHS spokesperson told CBS: "The policy does not grant FDA approval or establish clinical safety and effectiveness." A July advisory panel backed the six. That vote went against the FDA's own scientists, who said there was not enough evidence of safety and effectiveness.
They sit outside this policy. In August the FDA sent warning letters to five peptide vendors whose products carried research labels. Australian law is separate, as our Australian legal guide explains.
Peptide Labs supplies research peptides strictly for in-vitro laboratory use, not for human or animal use. This article reports public news and gives no use or dosing guidance.
The TGA warned Australians to discard Synedica peptide products after testing found no detectable TB-500 and less retatrutide than labelled.
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