Most comments on the HHS peptide policy are one form letter seeking three peptides FDA advisers rejected

The public comment period on the federal policy that lets pharmacies compound BPC-157 and five other unapproved peptides closed on November 13. Of the 115 comments the Department of Health and Human Services has posted, 104 carry the same form letter, and it asks for more: that HHS reconsider thymosin alpha-1, kisspeptin-10 and ipamorelin, three peptides FDA's advisers voted against in 2024.

HHS opened the docket, HHS-OASH-2026-0496, when it published its enforcement-discretion notice in the Federal Register on October 30. The notice says the department will not act against licensed pharmacies and physicians compounding BPC-157, TB-500, KPV, MOTS-c, epitalon or semax under stated conditions while FDA decides by rule whether to add them to the 503A bulks list. It gave the public two weeks to comment. On the morning of November 2 the docket held no comments. Every comment now on it was posted on November 3, 4, 5 or 6, and the docket record shows no change since November 6.

The posted record is therefore thin, and most of it is one voice. Eleven comments were written individually. Two oppose the policy outright. One, from a state-licensed compounding pharmacy, makes the point this library has made since the notice appeared: a pharmacy can meet every federal condition and still lose its license. Whatever was filed after November 6, including anything from state boards or national associations, is not yet public.

The form letter on the HHS peptide docket

The letter is 201 words long. It opens Thank you for advancing a policy to expand access to six compounded peptides and argues that supervised compounding is safer than the alternative. Its center is a request to widen the policy:

I urge HHS to build on this progress by reconsidering excluded peptides, particularly thymosin alpha-1 (Ta1), as well as kisspeptin-10 and ipamorelin.

It asks HHS to publish the criteria used to select peptides for this policy, to explain how they were applied to the excluded substances, and to say what evidence would support including them. It also says Previous advisory committee votes should not close the door to a fresh, consistent assessment.

Those votes were lopsided. FDA's Pharmacy Compounding Advisory Committee voted 0 to 12, with one abstention, against putting ipamorelin on the 503A bulks list, and 0 to 11 against kisspeptin-10, on October 29, 2024. It voted 4 to 17 against thymosin alpha-1 on December 4, 2024. Kisspeptin-10 is the only peptide still in FDA's Category 2 for state-licensed pharmacies, and ipamorelin remains in the Category 2 kept for outsourcing facilities. FDA's Category 2 peptide list sets out the record.

Of the 104 copies, 101 are identical, word for word. Two change a word or add a line, and one pastes the letter beneath a paragraph of its own. Sixty-three were posted on November 5 and 41 on November 6. The docket does not say who drafted the letter or how it was distributed, and this piece does not guess.

A compounding pharmacy names the state-law problem with the peptide policy

The most consequential of the individual comments came from a state-licensed 503A pharmacy. It supports access, and it says plainly what the federal notice does not do:

Federal enforcement discretion does not necessarily establish legal authorization under Section 503A or protect pharmacies from state regulatory action.

The pharmacy points to Mississippi, where, it says, the Board of Pharmacy has publicly emphasized that the peptides addressed by this policy are not FDA-approved for human use. Mississippi's medical, nursing and pharmacy boards told licensees in August that Under no circumstances is it permissible to compound or dispense a research-grade peptide. A pharmacy, the comment says, could satisfy every condition of HHS's interim enforcement policy, including API qualification, analytical testing, and documentation, yet remain exposed to disciplinary action by its state licensing authority. It asks HHS and FDA to state the policy's legal status under section 503A, to publish a timeline for the 503A list decisions, and to coordinate with state boards. Our piece on the state boards and our piece on Louisiana's peptide law set out why that gap exists.

What commenters want from the peptide quality conditions

Three of the individual comments address the conditions on the bulk peptide itself, and all three want them kept. A Florida company being formed to verify peptide products by independent testing called the certificate-of-analysis condition the center of the policy and asked for two additions. The certificate should be specific to the lot the compounder receives, naming the laboratory, the methods and the acceptance limits. And compounders should be told they may rely on independent testing as well as the manufacturer's certificate. A COA issued by the seller of the substance carries an obvious conflict of interest, it wrote.

A self-pay telehealth service supported the policy and asked HHS to keep it in force until FDA finishes rulemaking on each peptide, to publish the criteria that would trigger narrowing or withdrawal, and to give notice before any change. A clinic owner asked HHS to adopt the policy as drafted.

Two comments wanted the policy wider in other directions. One asked for a cheaper route than a prescription and a compounding pharmacy, buying more like vitamins. Another objected to the condition that each compounded product contain a single peptide, which rules out blends.

The case against the HHS peptide policy, in its strongest form

Two comments ask HHS to withdraw the policy. The fuller of them comes from a commenter who described a career as a compounding pharmacist and a former state board of pharmacy inspector of compounding pharmacies and outsourcing facilities. The commenter attached a legal memorandum. The argument is about the statute, not the peptides:

These six peptides are not FDA-approved drug products, and they have not been added to the codified 503A bulks list through the required regulatory process. Nevertheless, HHS proposes to facilitate their use while that process remains unfinished. Possible future eligibility cannot substitute for present compliance with the statute.

The same comment argues that Testing identity and purity does not establish clinical safety or effectiveness, and that if officials can use an open-ended enforcement policy to reach substances outside the statute, the law's protections risk becoming dependent on the preferences of whichever officials hold office. The second comment in opposition cites the objections of FDA's own staff, which the Associated Press reported when the notice was filed.

That argument has the statute on its side, and the pharmacy's comment, from the other direction, agrees with its premise: enforcement discretion is not compliance. Where the two part company is on what follows. The opponents want the policy withdrawn. The pharmacy wants HHS to make it lawful.

What the posted peptide docket does not yet show

No comment from a state board of pharmacy or medicine, a national pharmacy or medical association, or a consumer-safety organization appears among the 115 posted. The Alliance for Pharmacy Compounding said on October 28 that it would seek clarification on how the policy would be coordinated with state boards; no comment from it has been posted. Whether such comments were filed after November 6 cannot be known until HHS posts them.

The weight of a comment docket is not a vote. A notice of enforcement discretion is not a rule, and HHS is not choosing between 104 letters and 11. What the posted record does show is where the pressure is coming from: toward more peptides, not fewer. It also shows a policy that does not yet do the one thing its most careful supporter asked of it, which is to protect the pharmacist.

What to watch after the HHS peptide docket

• The rest of the docket. Comments filed between November 6 and the close on November 13 should appear on regulations.gov under HHS-OASH-2026-0496. This piece will be updated with the final count.
• A final policy. The October notice called the policy a draft. Whether HHS changes the conditions, the list of six or the legal framing in response to comments.
• FDA rulemaking. Only a final rule adding the six to the 503A bulks list makes compounding them lawful under section 503A. FDA has also said it will consult its advisory committee on five more peptides by the end of February 2027.
• State boards. Whether any board answers the pharmacy's question in either direction.

Frequently asked questions

When did comments on the HHS peptide policy close?

November 13, 2026, two weeks after the notice was published in the Federal Register on October 30. The docket is HHS-OASH-2026-0496 on regulations.gov.

How many comments were filed on the HHS peptide policy?

As of November 14, 2026, HHS had posted 115, all dated November 3 to 6. Comments filed after that had not yet been posted, so the final number will be higher.

What do most of the comments ask for?

104 of the 115 posted comments carry one form letter supporting the policy and asking HHS to reconsider thymosin alpha-1, kisspeptin-10 and ipamorelin, which FDA's advisory committee voted against listing in 2024.

Did anyone oppose the HHS peptide policy?

Two posted comments ask HHS to withdraw it, arguing that the six peptides are not on the 503A bulks list and that enforcement discretion cannot substitute for the statutory process.

Does the HHS policy protect pharmacies from state boards?

No. It is a federal promise not to act and binds no state. A compounding pharmacy raised exactly this point in its comment, citing Mississippi. This is not legal advice.

Sources & Further Reading

1. regulations.gov, Docket HHS-OASH-2026-0496, Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances: all 115 posted comments read through the regulations.gov API on November 14, 2026; docket last modified November 6, 2026. Commenters' names omitted by this library's policy.
2. Department of Health and Human Services. Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances; notice of availability. 91 FR 68526, October 30, 2026, FR Doc. 2026-22192.
3. Food and Drug Administration, Center for Drug Evaluation and Research. Final Summary Minutes of the Pharmacy Compounding Advisory Committee Meeting, October 29, 2024; December 4, 2024.
4. Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A (category list), May 14, 2026; Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, April 22, 2026.
5. Mississippi State Board of Medical Licensure, Mississippi Board of Nursing, Mississippi Board of Pharmacy. Joint Statement Concerning the Prescribing of Non-FDA Approved (Research-Grade) Peptides. August 19, 2026.
6. Alliance for Pharmacy Compounding. Statement on the HHS peptide enforcement discretion policy, October 28, 2026.

Cosmic Peptides. (2026, November 14). Most comments on the HHS peptide policy are one form letter seeking three peptides FDA advisers rejected. Cosmic Peptides Research Library. Retrieved November 14, 2026, from https://cosmicpeptides.com/research/perspectives/hhs-peptide-docket-closes

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