HHS Peptide Policy: Public Comments Close Nov. 13

What happened / Why it matters

Comment period status. Public comments on HHS’s peptide compounding policy close on Nov. 13, 2026, at 11:59 p.m. Eastern, according to regulations.gov. The Federal Register notice set the window at two weeks after its Oct. 30 publication.

Why it matters. The comment period is the window HHS opened for written public comments on the policy. HHS has said the policy is interim, that it is not binding, and that it may revisit it. This page covers only the deadline and its context. For what the policy says and its conditions, see our report on the policy, our changelog of peptide regulatory actions and Best Peptides For’s guides on whether peptides are legal in the US and how 503A compounding works. It is not legal advice.

When exactly does it close?

• Nov. 13, 2026, 11:59 p.m. Eastern. Regulations.gov shows the end of the comment period as Nov. 13 at 11:59 p.m. EST. Its data feed records the same moment as 04:59 UTC on Nov. 14, so a page that says “Nov. 14” is likely using UTC.
• The notice itself gives no date. It says written comments can be submitted “until 2 weeks after date of publication in the Federal Register.” Two weeks from Oct. 30 is Nov. 13.
• Late comments. Regulations.gov’s data for the docket’s documents says they do not accept late comments.

What does the docket show?

• Docket: HHS-OASH-2026-0496, titled “HHS Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances.” Regulations.gov classifies it as a nonrulemaking docket, meaning it is not a proposed rule.
• Comments so far: as of Nov. 6, regulations.gov showed 72 comments posted to the docket and 122 submissions received. Agencies review comments before posting them and may not post all of them.
• What HHS asks: the notice does not pose specific questions; it invites written comments on the policy.
• How comments are submitted: according to the notice, through regulations.gov on that docket.

What does the policy cover?

The policy covers six peptides: BPC-157, TB-500, epitalon, semax, KPV and MOTS-c. Each is covered only in specific forms and routes, and under conditions:

• BPC-157 (acetate): subcutaneous, intramuscular, oral and topical.
• TB-500 (acetate): subcutaneous and intramuscular.
• Epitalon (acetate): subcutaneous and intramuscular, in intermittent courses.
• Semax (free base): intranasal.
• KPV (acetate): topical and oral.
• MOTS-c (acetate): subcutaneous and intramuscular.

HHS says it does not intend to take enforcement action against state-licensed pharmacies, federal facilities and licensed physicians that compound these peptides under its conditions. See the HHS policy for the conditions.

What is the policy not?

• Not FDA approval. The notice says compounded drugs are not FDA-approved and that FDA does not review their safety, effectiveness or quality before they are marketed.
• Not a change to the 503A list. The policy applies while the list of bulk drug substances allowed for 503A compounding is developed through rulemaking. The notice says FDA’s future rulemakings “may propose adding some or all of these peptides” to the list.
• Not binding. The notice says the policy “does not establish any rights for any person and is not binding on HHS or the public.”
• Open to revision. HHS says it may revisit the policy if, among other things, a safety signal or a product quality issue arises.
• Not for 503B or online sellers. It names state-licensed pharmacies, federal facilities and licensed physicians. It does not name outsourcing facilities (503B) or sellers of “research” peptides.

What could happen next?

Based on the notice and the policy text:

• HHS may revise the policy, for example in response to a safety signal or a product quality issue.
• FDA’s future rulemaking may propose adding some or all of the six peptides to the 503A list, based on the available evidence. The notice does not give a date.
• The notice gives no date by which the policy will be finalized, and we are not predicting one.

U.S. regulatory status checked Nov. 6, 2026. This page will be updated after the comment period closes.