Federal policy · Draft released · Checked
On October 28, 2026, HHS released a draft policy on compounding six peptides: BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500.
Compounding means a pharmacy or doctor mixes a drug for one patient.
For these six, HHS does not plan to take action against state-licensed pharmacies, federal facilities, or licensed doctors that compound them and meet its conditions.
It is meant to last until FDA finishes a rule on each one. HHS can change it sooner.
This is not FDA approval. Compounded drugs are not FDA-approved.
Whether you may buy, sell, or use a product also depends on pharmacy (compounding) rules, a prescription, and state law.
Have a product in hand? Check if it is a prescription, compounded, or research-only product.
The policy names six peptides. It covers each one only in the forms HHS lists for it. HHS also names one exact chemical form of each, such as BPC-157 acetate (a salt form).
Forms HHS lists for BPC-157: a shot under the skin or into a muscle, a form taken by mouth, or a form put on the skin.
HHS wording: “subcutaneous, intramuscular, oral, and topical dosage forms”
Exact form HHS names: BPC-157 acetate
FDA compounding risk page: Nomination withdrawn
Is BPC-157 legal?Forms HHS lists for Epitalon: a shot under the skin or into a muscle, given in courses with breaks between them.
HHS wording: “subcutaneous or intramuscular injectable dosage forms that are dispensed in intermittent courses”
Exact form HHS names: epitalon acetate
FDA compounding risk page: Nomination withdrawn
Is Epitalon legal?Forms HHS lists for KPV: a form taken by mouth or put on the skin.
HHS wording: “topical and oral dosage forms”
Exact form HHS names: KPV acetate
FDA compounding risk page: Nomination withdrawn
Read the KPV guideForms HHS lists for MOTS-c: a shot under the skin or into a muscle.
HHS wording: “subcutaneous or intramuscular injectable dosage forms”
Exact form HHS names: MOTS-c acetate
FDA compounding risk page: Nomination withdrawn
Is MOTS-c legal?Forms HHS lists for Semax: a form used in the nose.
HHS wording: “intranasal use”
Exact form HHS names: semax free base
FDA compounding risk page: Nomination withdrawn
Is Semax legal?Forms HHS lists for TB-500: a shot under the skin or into a muscle.
HHS wording: “subcutaneous or intramuscular injectable dosage forms”
Exact form HHS names: TB-500 acetate
FDA compounding risk page: Nomination withdrawn
Is TB-500 legal?HHS lists ten conditions. A pharmacy or doctor must meet all of them. They include:
Read the HHS policy for the full list.
No. HHS says compounded drugs are not FDA-approved. That means FDA does not review their safety, how well they work, or their quality before they are sold.
When we checked FDA's compounding risk page on October 15, 2026, it listed all six as withdrawn nominations. That means a request to let pharmacies use them was taken back. The HHS policy is a separate, newer document.
No. It covers only products a licensed pharmacy, federal facility, or licensed doctor compounds for one patient's prescription.
HHS says the policy is meant to steer people away from “research use only” peptides made overseas.
No. A product under the policy may hold only one active ingredient from the list. It does not cover blends of these peptides.
It also does not cover forms HHS did not list for a peptide, or any peptide that is not one of the six.
No. HHS published it as a draft. HHS says it may change the policy if safety or quality problems come up. The notice says the policy is not binding on HHS or the public.
The notice appears in the Federal Register on October 30, 2026. HHS takes written comments for 2 weeks after that, through about November 13, 2026.
Comments go to regulations.gov under docket HHS-OASH-2026-0496.
We checked the HHS documents on . We plan to check them again after the comment period ends.