The HHS peptide policy, in plain words.
On October 28, 2026, HHS published an interim policy for six peptides. Here is what it says, what it doesn't, and how a prescription for one works at Optimize.
Compounded drugs are not FDA-approved and are not the same as brand-name medications.
+What HHS did
HHS published an interim policy for six peptides. It describes the strict conditions under which HHS does not intend to act against a licensed compounding pharmacy that makes one of them for a patient's own prescription. The full policy is on hhs.gov.
- Issued October 28, 2026, and published in the Federal Register on October 30, 2026, as an interim policy that names the six peptides and the conditions.
- It applies to a state-licensed compounding pharmacy making one of the six for one patient's own prescription.
- It is interim, ahead of FDA's own rulemaking. HHS can revise or withdraw it.
- It is not FDA approval. Compounded drugs are not FDA-approved and are not the same as brand-name medications.
The six peptides, and how we offer each
The policy also limits how each one may be given. We offer each peptide on its own, in a form within the policy.
- BPC-157
- By prescription, as injectable or oral capsules.
- TB-500
- By prescription, as injectable.
- MOTS-c
- By prescription, as injectable.
- Epitalon (also spelled Epithalon)
- By prescription, as injectable, in cycles.
- Semax
- By prescription, as nasal spray.
- KPV
- By prescription, as oral capsules.
What the policy does not do
- It does not make any of the six an FDA-approved drug.
- It does not remove the prescription. A licensed provider has to prescribe it for you, by name, and a pharmacy makes it for that prescription.
- It does not cover blends. One ingredient per product. Never blended. Each peptide is its own product and its own prescription.
- It does not say what a peptide does. We don't make claims about that either: evidence in people is limited, and your licensed provider talks with you about what is and isn't known.
How a prescription works at Optimize
- Step 1Tell us about yourselfA short intake, online.
- Step 2A licensed provider decidesWhether a peptide is right for you, and the dose. If the provider doesn't approve it, it's refunded in full automatically.
- Step 3Made for your prescriptionMade by a 503A facility for your prescription. Labeled with your name and shipped to you. No membership needed.
Questions about the policy
Can I get BPC-157 and the other covered peptides from a licensed pharmacy?
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Yes, with a prescription. HHS published an interim policy covering six peptides: BPC-157, TB-500, MOTS-c, Epitalon, Semax and KPV. At Optimize, a licensed provider decides whether one is right for you. If it is, it is made for your prescription and shipped to you. Made by a 503A facility for your prescription.
What did HHS change about peptides?
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HHS published an interim policy for six peptides. It describes the strict conditions under which HHS does not intend to act against a licensed compounding pharmacy that makes one of them for a patient's own prescription. It is not FDA approval, and HHS can revisit it. The full policy, Appendix B, is on hhs.gov.
Which peptides does the HHS policy cover?
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Six: BPC-157, TB-500, MOTS-c, Epitalon (also spelled Epithalon), Semax and KPV. The policy also limits how each one may be given. We offer BPC-157, TB-500 and MOTS-c as injectable vials, BPC-157 also as oral capsules, Epitalon as an injectable prescribed in cycles, Semax as a nasal spray and KPV as oral capsules.
Are compounded peptides FDA-approved?
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No. Compounded drugs are not FDA-approved and are not the same as brand-name medications. The FDA doesn't review compounded medicines for safety, effectiveness or quality before they're dispensed, the way it reviews approved drugs. The HHS policy that covers these six is not FDA approval either. Your provider decides whether one is right for you.
What is a 503A pharmacy?
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A 503A pharmacy is a state-licensed pharmacy where a licensed pharmacist compounds a medicine for one patient's own prescription. The FDA explains that drugs compounded under section 503A are not subject to current good manufacturing practice requirements, that compounded drugs are not FDA-approved, and that the FDA does not verify their safety, effectiveness or quality before they are dispensed. Our six peptides are made this way, for your prescription.
What is the difference between a 503A pharmacy and a 503B outsourcing facility?
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A 503A pharmacy is licensed by its state and compounds a medicine for one patient's prescription. A 503B outsourcing facility is a category of compounder the Drug Quality and Security Act created in 2013; the FDA describes it as primarily overseen by the FDA, inspected on a risk-based schedule and subject to current good manufacturing practice requirements. Our six peptides come from 503A facilities, for your own prescription.
What's the difference between research peptides and pharmacy peptides?
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A research peptide is sold labeled “not for human use,” often with no prescriber and no one to ask. A Pharmacy Peptide is prescribed for you by a licensed provider after a review of your intake, made for your prescription, labeled with your name, and comes with a wellness consultant you can ask between visits.
Can I get a peptide blend?
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Not here. One ingredient per product. Never blended. Each peptide is its own prescription and its own product. If you and your provider want two, a stack ships them as separate products in one order, never mixed in one vial. Each one needs your provider's approval.
Do I need a membership?
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No. You can order a Pharmacy Peptide on its own: a short intake, a licensed provider's review, and your prescription made and shipped. A membership adds four lab panels and four provider visits a year and a wellness consultant between visits, if you want your labs and a plan behind it.
Can I get a Pharmacy Peptide in my state?
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In most states. Checkout checks your state before you pay, and a form that can't ship to your state isn't offered to you, so you never pay for something that can't reach you. A licensed provider then decides whether a peptide is right for you.
Will it treat or fix a specific problem?
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We don't make claims about what any peptide does for a specific problem. Evidence in people is limited for these peptides, and none of them is FDA-approved for any use. Your licensed provider talks with you about what is and isn't known, and decides whether one is right for you.
Policy facts from the HHS interim peptide policy (Appendix B) on hhs.gov
Pharmacy Peptides
If a provider says it's not right for you, you pay nothing.