5 Things to Know About HHS's Interim Peptide Compounding Policy

HHS does not intend to take enforcement action against state-licensed pharmacies, federal facilities, or licensed physicians that compound BPC-157 and 5 other unapproved peptides while the FDA works through rulemaking on its 503A bulks list, under an interim policy filed with the Federal Register on October 28, 2026.¹ The other 5 peptides are epitalon, KPV, MOTS-c, Semax, and TB-500.

The policy's terms have drawn most of the early attention, but how it was issued, who weighed in before its release, and the challenges already lining up against it may matter as much for what happens next. Here are 5 things stakeholders should know.

1. The Policy Came From the Secretary's Office, Not the FDA

The notice lists the Office of the Secretary as the issuing agency, describes the policy as the HHS Secretary's own enforcement approach, and is signed by Secretary Robert F. Kennedy Jr. Its public docket and contact sit with the Office of the Assistant Secretary for Health rather than the FDA. By comparison, the framework that governs other nominated 503A ingredients was issued by the FDA as guidance for industry.²

The routing matters because the FDA's own career scientists had recommended against adding any of the 7 peptides reviewed at the July Pharmacy Compounding Advisory Committee (PCAC) meeting, including all 6 now covered by the policy.³

2. Four Outside Groups Met With White House Reviewers Before Release

Although the draft, titled "Interim Access Policy for Compounding Using Certain Peptides," was under review at the White House Office of Management and Budget, 4 organizations requested regulatory review meetings on it under Executive Order 12866.⁴ The American Academy of Peptide Medicine met with reviewers on October 21, followed by telehealth company Hims & Hers Health on October 23. The Alliance for Pharmacy Compounding and the consumer advocacy group Center for Science in the Public Interest each met on October 27, the day before the notice was filed.

The requesters were Lee Rosebush for the peptide academy, Sonya Elling for Hims & Hers, Scott Brunner for the compounding alliance, and Quynh Nguyen for the Center for Science in the Public Interest.

3. HHS Is Framing It as a Black-Market Crackdown

HHS has cited both safety and freedom as reasons for the policy.⁵ "Under President Trump's leadership, HHS is working to put prevention and patient safety at the center of health care—and that includes confronting the risks of black-market peptides," the agency said in a statement.

HHS added that the policy requires patient-specific prescriptions, traceable ingredients, quality testing, and safety reporting, while stressing that it does not grant FDA approval or establish clinical safety and effectiveness.

4. Critics Are Already Targeting the Advisory Panel Behind It

The Partnership for Safe Medicines (PSM) has petitioned the FDA to disregard the PCAC vote and to block compounding of the unapproved peptides.⁶ The petition argues that the scientific evidence for the products' safety is insufficient and that the reconstituted committee was formed in violation of the Federal Advisory Committee Act and the Ethics in Government Act.

In a statement on the policy, PSM Executive Director Shabbir Imber Safdar said the decision leaves Americans uncertain about peptide safety, pointed to apparent conflicts of interest among newly appointed panel members, and urged the administration to focus on prosecuting illegal peptide producers instead.

5. State Responses and More Peptide Reviews Come Next

Written comments on the policy are due 2 weeks after its October 30 publication date.¹ Jeff Cohen, cofounder of the American Peptide Association, told Reuters the move could heighten tension between federal and state regulators and that states may not follow the federal government in relaxing rules.⁷

More peptides are also in the queue. As of July, the PCAC was scheduled to review 5 more unapproved peptides for pharmacy compounding in February.⁸ HHS has also kept an exit open in the notice itself:¹

“HHS may revisit application of this interim policy (in whole or in part) if, among other things, a safety signal or product quality issue arises with a compounded drug product within the scope of this policy,” the notice states.

References

1. Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances. Federal Register. Filed October 28, 2026. Accessed October 29, 2026. https://public-inspection.federalregister.gov/2026-22192.pdf
2. Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act. Federal Register. Accessed October 29, 2026. https://public-inspection.federalregister.gov/2024-31546.pdf
3. Steinzor P. FDA panel backs 6 peptides for compounding. AJMC^®. July 31, 2026. Accessed October 29, 2026. https://www.ajmc.com/view/fda-panel-backs-6-peptides-for-compounding
4. EO 12866 meetings search results. Reginfo.gov. Accessed October 29, 2026. https://www.reginfo.gov/public/do/eom12866SearchResults?pubId=&rin=0910-ZD94&viewRule=true
5. Benadjaoud Y. Some wellness peptides will become widely available, HHS says. ABC News. October 28, 2026. Accessed October 29, 2026. https://abcnews.com/Health/wellness-peptides-become-widely-hhs/story?id=137650076
6. Statement on the FDA and HHS enforcement discretion policy for 503a compounding with certain peptides. Partnership for Safe Medicines. October 28, 2026. Accessed October 29, 2026. https://www.safemedicines.org/2026/10/statement-on-503a-peptide-enforcement.html
7. Sneha SK. US health department to allow temporary sale of some unapproved peptides. Reuters. October 28, 2026. Accessed October 29, 2026. https://kfgo.com/2026/10/28/us-health-department-to-allow-temporary-sale-of-some-unapproved-peptides/
8. Phengsitthy N. FDA advisers back looser rules for six peptides, reject one (1). Bloomberg Law. July 24, 2026. Accessed October 29, 2026. https://news.bloomberglaw.com/health-law-and-business/fda-review-committee-rejects-first-peptide-in-second-day-hearing