In an unusual move, the U.S. Department of Health and Human Services (“HHS”), rather than the U.S. Food and Drug Administration (“FDA”), announced the availability of an interim enforcement policy in the Federal Register on October 30, 2026 (91 Fed. Reg. 68,526), addressing compounding with six peptide bulk drug substances. The policy provides limited enforcement discretion for certain pharmacies and physicians pending final rulemaking on the substances’ inclusion on the federal “503A Bulks List.” Issuance by HHS itself departs from FDA’s traditional lead role in federal compounding policy and raises questions about how HHS will balance patient access and FDA’s safety concerns.
The interim policy covers BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500, subject to the specific forms and routes of administration described in Appendix B. These substances are not components of FDA-approved drugs, do not have applicable United States Pharmacopeia (“USP”) or National Formulary monographs and are not currently on the 503A Bulks List. HHS states that it does not intend to take enforcement action against state-licensed pharmacies, federal facilities or licensed physicians compounding these substances under the policy’s detailed conditions. HHS may revisit the policy before final rulemaking, including in response to safety signals or product quality issues. The policy does not add these substances to the 503A Bulks List or eliminate otherwise applicable federal or state requirements. The Federal Register notice states that the policy does not establish any rights for any person and is not binding on HHS or the public.
The notice also describes the policy as a draft and invites public comment through Docket No. HHS-OASH-2026-0496 until November 13, 2026. Compounders considering reliance on the policy should therefore assess both its detailed conditions and the possibility that the enforcement approach may change.
Background: 503A Compounding and Bulk Drug Substances
Compounding under Section 503A of the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) generally involves combining, mixing or altering drug ingredients to create a medication tailored to the needs of an individual patient. Compounded drugs do not undergo FDA premarket review for safety, effectiveness or quality. Qualifying drugs compounded under Section 503A are exempt from certain requirements that ordinarily apply to manufactured drugs, including the requirements for FDA premarket approval, labeling with adequate directions for use and compliance with current good manufacturing practice. Those exemptions are subject to numerous conditions. A key requirement concerns which bulk drug substances may be used in compounding. A bulk drug substance must comply with the standards of an applicable USP or National Formulary monograph, if one exists, and the USP chapter on pharmacy compounding. If no such monograph exists, the substance must be a component of an FDA-approved drug. If neither applies, it must appear on the list established through rulemaking under Section 503A, commonly called the “503A Bulks List.”
This bulk substance requirement has presented an obstacle for pharmacies seeking to compound certain peptides that are not components of FDA-approved drugs and have not yet been formally placed on the 503A Bulks List. HHS’s new policy does not add the six peptides to that list. Instead, it provides conditional enforcement discretion pending a final rule determining whether they will be included. It does not create a safe harbor for compounding these products.
Scope and Conditions of the Interim Policy
HHS’s enforcement discretion applies only when all of the policy’s conditions are present. In general, a compounder relying on the policy must:
- Use one of the six listed peptide bulk drug substances and comply with the identity, form and route of administration limits described in Appendix B.
- Obtain the bulk drug substance from a facility registered with FDA and ensure that it is characterized and identified in a valid certificate of analysis (“COA”) containing the testing contemplated by the policy.
- Ensure that the original active pharmaceutical ingredient (“API”) manufacturer, not merely a subsequent repacker, relabeler or distributor, is registered with FDA and in compliance with current good manufacturing practice and other FD&C Act requirements, and that the facility’s physical location is listed on the COA. If the material is obtained through a registered repacker, relabeler or reseller, that entity must have performed and documented appropriate vendor validation of the manufacturer and validation of the manufacturer’s COA.
- Report information regarding products compounded, serious adverse events and product quality issues to FDA and to the states where the products are compounded and sent. Report serious adverse events and product quality issues to FDA through MedWatch and include the applicable reporting procedures on labeling provided to patients.
- Include the statement, “This is a compounded drug product. Not for resale.” on product labeling.
- Compound the product with only a single API identified in the policy.
- For oral dosage forms, maintain documentation that the specific formulation provided to the patient achieves adequate oral bioavailability in humans. The only drug delivery device that may be co-packaged with or contain the compounded drug is an FDA 510(k)-cleared syringe.
- Continue to satisfy other applicable requirements of the FD&C Act, including the prohibition on insanitary conditions and Section 503A’s patient-specific prescription requirement.
Appendix B to the policy also contains extensive testing and characterization expectations for peptide APIs, including criteria relating to identity, purity, potency, impurities and microbiological quality.
Why the Source of the Policy Matters
Perhaps the most unusual aspect of the announcement is its source. FDA traditionally serves as the primary federal agency responsible for implementing and enforcing the FD&C Act’s drug-compounding provisions. Here, however, the enforcement discretion document is expressly framed as the policy of the Secretary of HHS, rather than an FDA enforcement policy. HHS explains that the Secretary determined the policy will discourage widespread use of certain “research-use-only” peptides supplied by foreign manufacturers by providing patients access to a more controlled alternative. HHS further concludes that the policy advances patient choice while appropriately protecting patient safety.
Although FDA ordinarily develops and implements federal compounding enforcement policy, it operates within HHS under the Secretary’s supervision. The Secretary’s direct exercise of that role is particularly notable given the differing recommendations described in the policy’s supporting appendix: FDA’s Center for Drug Evaluation and Research (“CDER”) recommended against listing the peptides, while the Pharmacy Compounding Advisory Committee voted in favor of inclusion for the six substances now covered by the HHS policy.
HHS also takes a somewhat different view of the evidence underlying several of CDER’s concerns. For example, HHS characterizes CDER’s safety concerns regarding TB-500 as “inferential rather than observed,” describes the concerns regarding Epitalon and Semax as mechanistic rather than based on observed harm, and characterizes the concern surrounding KPV as an absence of information rather than an observed safety signal. HHS’s assessment provides the rationale for its enforcement discretion. It does not establish the safety or effectiveness of the compounded products.
The policy’s significance may extend beyond the six peptides. It offers an early indication of how HHS may weigh patient access, agency safety concerns and enforcement discretion in compounding policy. Whether it reflects a durable change remains uncertain.
Practical Takeaways
- The Secretary of HHS, not FDA, issued this policy. According to the policy’s supporting appendix, CDER had recommended against listing the peptides, while the Pharmacy Compounding Advisory Committee had voted in favor of inclusion.
- This is enforcement discretion, not a safe harbor. It does not add the peptides to the 503A Bulks List, constitute FDA approval or establish rights for any person.
- The conditions are substantial. Compounders should review their sourcing, testing, labeling, reporting and prescription practices before relying on the policy.
- The policy may change. The notice describes the policy as a draft and invites public comment. HHS may also revisit it, including in response to a safety signal or product quality issue.
At least one company has already announced an agreement for the commercial supply of bulk drug substances for the six peptides, along with plans to begin dispensing compounded versions in reliance on the policy. 503A pharmacies, health systems, prescribers and other organizations considering peptide-related services should carefully evaluate whether their sourcing and compounding practices satisfy the conditions of HHS’s new policy, as well as applicable state requirements.
If you have questions regarding the HHS policy or its implications for your organization’s compounding program, or if you would like assistance in submitting a comment, please contact:
- Carolina Wirth at (202) 780-2989 or cwirth@hallrender.com;
- Benjamin Lockwood at (414) 721-0484 or blockwood@hallrender.com; or
- Your primary Hall Render contact.
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.
