Short answer. For each of the six, the policy says placement in Category 2 until April 22, 2026, and removal from that category, did not change the substance's status under section 503A [2]. Coming off a safety-risk list was not the same thing as landing on the bulks list. As of Oct 29, 2026.

Three different piles

People stack these as if they were one event. They are three.

Section 503A still says a bulk substance used in compounding generally needs a USP or NF monograph, or has to be a component of an FDA-approved drug, or has to appear on the list the Secretary builds by regulation [2]. The policy exists because these six are in the gap while that list is still being written [1][2].

What you can stop repeating

"It left Category 2, so pharmacies can compound it freely" was not accurate in April. The October policy does not go back and make it accurate. The policy says the status under 503A did not change with that category move [2]. What changed on Oct 28 is a draft statement about enforcement discretion, with conditions, and the notice says that statement is not binding [1].

The category explainer is Are peptides legal?.

FAQ

Are the six on the 503A bulks list now? Not by this notice. The notice says rulemaking may propose adding some or all of them later [1].

Did removal mean FDA decided they were safe? The policy does not say that. It says the category move did not change 503A status, and it records that CDER still recommended against listing [2].

Sources

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

2. HHS policy, background and Appendix B. 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.