Short answer. The policy says HHS does not intend to take action when all of the following are present. Not most of them. All of them [2]. As of Oct 29, 2026.

The notice names who this is about: a state-licensed pharmacy, a federal facility, or a licensed physician [1]. The conditions below are from the policy that notice links [2].

The ten

1. The peptide is on Appendix A. Six names.

2. It matches the identity and the route limits in Appendix B. Sequence, structure, molecular weight, and formula count.

3. It comes from a facility registered with FDA under section 510, with a valid certificate of analysis. The policy says that testing is there to check identity, purity, potency, and harmful contaminants such as endotoxins, heavy metals, microbial contamination, and impurities.

4. The original manufacturer, not a later packer or reseller, is FDA-registered, follows current good manufacturing practice, and has its facility location on the certificate. A reseller has to have checked that manufacturer and that certificate itself.

5. The compounder reports what it makes, plus serious adverse events and product-quality problems, to FDA's MedWatch program and to the states where the product is compounded and, if different, where it is sent. The policy says serious events are reported whether or not someone judges them drug-related. How to report goes on the label the patient receives.

6. The label includes: "This is a compounded drug product. Not for resale."

7. The product contains only one active ingredient from Appendix A.

8. If the form is oral, the compounder keeps documentation that the specific formula achieves adequate oral bioavailability in people.

9. The only delivery device co-packaged with the drug, or holding it, is an FDA 510(k)-cleared syringe.

10. Every other applicable requirement still applies, including a patient-specific prescription and a ban on compounding under insanitary conditions.

Each of these has its own short post in this batch. The hub is HHS and 6 peptides: what changed.

FAQ

What if nine of the ten are met? The policy's sentence is written as "when all of the following circumstances are present" [2].

Do these conditions approve the peptide? No. The notice says compounded drugs are not FDA-approved [1].

Sources

1. HHS notice, FR Doc. 2026-22192, filed Oct 28, 2026. https://public-inspection.federalregister.gov/2026-22192.pdf

2. HHS policy, interim enforcement policy, conditions 1 through 10. https://www.hhs.gov/sites/default/files/hhs-503a-peptide-enforcement-discretion-policy-appendix-b.pdf

Sommar Club does not prescribe or sell these six. Education only. Not medical or legal advice. As of Oct 29, 2026.