Short answer. Appendix B says, for each of the six, that the Center for Drug Evaluation and Research recommended against listing the reviewed forms, and that the Pharmacy Compounding Advisory Committee voted in favor of inclusion [2]. The Oct 28 policy is HHS describing enforcement discretion after that split. It is not FDA approval. As of Oct 29, 2026.

What the policy says changed its mind

HHS does not say CDER was wrong and the peptides are now proven. It gives reasons of its own, and they are similar across the six [2].

• Lot-specific certificates from FDA-registered facilities, covering tests CDER had found missing.

• Historical use that HHS says is now documented.

• The conditions in the policy: single ingredient, lot testing, adverse-event reporting.

Those are reasons for discretion. The notice still says compounded drugs are not reviewed for safety, effectiveness, or quality before marketing [1]. CDER's recommendation against listing is still printed in the policy [2]. Both belong in the same paragraph when anyone summarizes this.

Vote counts from the July meeting are on Are peptides legal?. This page does not re-add them. The policy's point is the direction of the vote, not a new tally.

Who this policy speaks for

The notice is from the Office of the Secretary. It says the draft does not establish rights and is not binding on HHS or the public [1]. It also says future FDA rulemakings may propose adding some or all of these peptides to the 503A list based on the evidence [1]. "May" leaves room for a later no.

If a clinic says "FDA approved this in October," they have skipped both the CDER recommendation and the notice. The accurate line is: FDA staff recommended against listing, an advisory committee voted for inclusion, and HHS later published a draft enforcement policy [1][2].

FAQ

Did the committee outrank FDA? The committee advises. The policy records the vote and then states the Secretary's enforcement position. The bulks list still takes rulemaking [1][2].

Should I ignore CDER because HHS moved? No. The policy quotes CDER's recommendation and still allows HHS to revisit the policy if a safety signal appears [2].

Sources

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

2. HHS policy, Appendix B justifications. 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.