Short answer. Condition 3 says the bulk substance comes from a facility registered with FDA under section 510 and is identified in a valid certificate of analysis [2]. The policy says that testing is meant to show the ingredient is what it claims to be, and that it has been tested for identity, purity, potency, and contaminants such as endotoxins, heavy metals, microbes, and impurities [2]. As of Oct 29, 2026.

This page is a list of questions. It is not instructions for manufacturing a peptide.

What the policy says should be identifiable

The policy's testing section says the record for the ingredient should be able to show, among other things [2]:

• The substance name, structure, amino acid sequence, molecular formula, and molecular weight.

• The original manufacturer's name, FDA establishment identifier, and address.

• The batch number, synthesis date, release date, and expiration or retest date.

• A grade line to the effect of "intended for human drug compounding," and the intended dosage form.

• Storage conditions.

• A statement that it was manufactured and tested in compliance with current good manufacturing practice, signed and dated by the manufacturer's quality unit.

A certificate that names only a reseller, with no original manufacturer and no batch, is not the document this section describes [2].

What you can ask, without becoming the lab

Ask the pharmacy, not a group chat:

• Is the original manufacturer FDA-registered, and is that facility on the certificate?

• Does the certificate match the form in Appendix B, acetate or free base, not a nickname?

• Does it report identity, purity, and the contaminant tests the policy describes?

• What is the batch, and is the certificate for that batch?

You do not need to run the tests. The policy assigns the certificate to the supply chain and the compounder [2]. If they will not show the identifying parts, you do not have the assurance the policy is talking about.

The policy points to USP and ICH methods for how a manufacturer tests. Those citations are standards for the people making and checking the ingredient [2]. They are not a home protocol.

FAQ

Does a certificate of analysis mean FDA approved the peptide? No. It is a manufacturer's test record. FDA approval is a different thing, and the notice says these compounded products are not FDA-approved [1].

Is a screenshot from a research-chemical site enough? The policy is about an FDA-registered manufacturer and a valid certificate tied to that facility [2]. A marketing PDF is not automatically that.

Sources

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

2. HHS policy, conditions 3 and 4, and the testing standard for peptides used in compounding. 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.