Peps Healthcare

The policy

What HHS actually said on October 28, 2026

The policy is short and its appendices are long. Here is the whole thing in plain English, with nothing added and nothing rounded up.

Read the original (PDF) →

In one sentence

HHS does not intend to take enforcement action against a State-licensed pharmacy, Federal facility, or licensed physician that compounds one of six named peptides, provided every condition in the policy is met.

The six are BPC-157, TB-500, Epitalon, Semax, KPV, MOTS-c. The policy applies while FDA's rulemaking on the 503A bulk drug substances list proceeds. It took effect on publication and HHS has said it may revisit it, in whole or in part, if a safety signal or product quality issue arises.

The ten conditions

All of them, at once. Miss one and the compounding falls outside the policy.

1

It is one of the six

The peptide appears in Appendix A: BPC-157, Epitalon, KPV, MOTS-c, Semax or TB-500. Nothing else is covered.

2

Right form, right route

Appendix B fixes the identity (amino acid sequence, structure, molecular weight and formula), the salt form and the permitted routes for each one. Injectable Semax or injectable KPV, for example, fall outside the policy.

3

FDA-registered source with a real certificate of analysis

The bulk peptide must come from a facility registered with FDA under section 510 and carry a valid certificate of analysis whose tests match the policy's own testing standard.

4

The original manufacturer, not a middleman

The manufacturer named on the certificate must itself be FDA-registered and CGMP-compliant, with its physical location on the certificate. Repackers and resellers must document how they validated the manufacturer.

5

Reporting to FDA and the states

Compounders report what they make, any serious adverse event and any quality problem through FDA MedWatch and to the relevant state boards, naming the active ingredient, strength, manufacturer, dosage form and route.

6

A fixed label statement

Every product is labelled: "This is a compounded drug product. Not for resale."

7

One peptide per product

No blends. Each compounded product contains a single active ingredient from Appendix A.

8

Oral forms must be shown to work orally

An oral dosage form needs documentation that the specific formulation achieves adequate bioavailability in humans. Most peptides do not survive digestion, which is why injection is the usual route.

9

Only a cleared syringe

The only device that may be packaged with or contained in the product is a syringe cleared by FDA under 510(k).

10

Everything else still applies

Section 503A's patient-specific prescription requirement, the ban on insanitary conditions and every other part of the Food, Drug and Cosmetic Act remain in force. The policy relaxes one thing, not the rest.

What the policy does not do

It is not FDA approval

None of the six is an approved drug. No trial has established safety or effectiveness for any use, and HHS says so in the policy.

It is not the 503A bulks list

Final placement on the list needs notice-and-comment rulemaking, which the policy says is still to come. Only six substances in fifteen years have completed that journey.

It is not permanent

HHS may revisit the policy, in whole or in part, if a safety signal or product quality issue arises.

It is not a licence to sell vials

Each product still requires a patient-specific prescription from a licensed clinician. A storefront that ships peptides without one is where it always was: outside the law.

It is not binding on the states

State boards of pharmacy regulate compounding too, and it is not yet clear which will follow HHS and which will set their own rules.

How we got here

  1. Sept 2023

    FDA places BPC-157 and other nominated peptides in Category 2, citing significant safety risks. Compounding effectively stops at reputable pharmacies.

  2. Jan 2025

    FDA stops categorising new nominations to the 503A bulks list.

  3. Apr 2026

    Federal Register notice: twelve peptides scheduled for Pharmacy Compounding Advisory Committee review. From April 22 the six no longer appear in the active Category 2 table.

  4. Jul 23 to 24, 2026

    PCAC votes to recommend BPC-157, KPV and TB-500 (8 to 6, one abstention), MOTS-c (7 to 5, two abstentions), Semax and Epitalon. DSIP is not recommended.

  5. Oct 28, 2026

    HHS issues the enforcement discretion policy covering the six peptides, with ten conditions and a full testing standard. Effective immediately while rulemaking proceeds.

  6. Before end Feb 2027

    Five more peptides go to PCAC: GHK-Cu, LL-37, dihexa, melanotan II and PEG-MGF.

What it means for a business

Nothing in the policy lets a spa, gym or clinic buy peptides and sell them. The patient-specific prescription requirement is untouched, and the compounding must be done by a licensed pharmacy or physician meeting the conditions above.

What the policy does is make a lawful supply chain possible for the first time: a licensed clinician who prescribes, an FDA-registered manufacturer with a certificate of analysis, a 503A pharmacy that tests, labels and reports, and a patient who receives a product made for them. A business can sit at the front of that chain as the seller of a program, under its own brand, while every clinical and pharmaceutical step is done by someone licensed to do it. That is what Peps Healthcare is.

Two cautions. State boards of pharmacy have not all spoken, so availability may vary by state for a while, even though the pharmacies in our network are already compounding under the policy. And the policy can be withdrawn, so any program that depends on it should be ready to pause. We would rather say that now than after you have told your clients.

Sources

This page summarises public regulatory documents and legal commentary. It is not legal advice. Last reviewed October 29, 2026.