Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances

Issuing agencies

Abstract

The Secretary of the Department of Health and Human Services (HHS) is announcing the availability of an "Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances." This document describes the Secretary of HHS's enforcement policy regarding the use of certain peptide bulk drug substances in compounding pursuant to section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) while the list of bulk drug substances that can be used in compounding under section 503A of the FD&C Act (the 503A bulks list) is developed through rulemaking.

Full Text

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<title>Federal Register, Volume 91 Issue 209 (Friday, October 30, 2026)</title>
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[Federal Register Volume 91, Number 209 (Friday, October 30, 2026)]
[Notices]
[Pages 68526-68527]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-22192]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Docket No. HHS-OASH-2026-0496]
RIN 0910-ZD94


Enforcement Discretion Policy Regarding 503A Compounding Using 
Certain Peptide Bulk Drug Substances

AGENCY: Office of the Secretary, Department of Health and Human 
Services.

ACTION: Notice of availability.

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SUMMARY: The Secretary of the Department of Health and Human Services 
(HHS) is announcing the availability of an ``Enforcement Discretion 
Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug 
Substances.'' This document describes the Secretary of HHS's 
enforcement policy regarding the use of certain peptide bulk drug 
substances in compounding pursuant to section 503A of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) while the list of bulk drug 
substances that can be used in compounding under section 503A of the 
FD&C Act (the 503A bulks list) is developed through rulemaking.

DATES: This announcement is published in the Federal Register as of 
October 30, 2026.

ADDRESSES: Written comments can be submitted until 2 weeks after date 
of publication in the Federal Register via <a href="http://regulations.gov">regulations.gov</a> on Docket 
No. HHS-OASH-2026-0496

FOR FURTHER INFORMATION CONTACT: Victoria Marshall, Office of the 
Assistant Secretary for Health, 200 Independence Avenue SW, Washington, 
DC, 202-690-7694, <a href="/cdn-cgi/l/email-protection#115e5042593c435758517979623f767e67"><span class="__cf_email__" data-cfemail="4906081a01641b0f000921213a672e263f">[email&#160;protected]</span></a>

SUPPLEMENTARY INFORMATION:

[[Page 68527]]

I. Background

    HHS is announcing the availability of a draft ``Enforcement 
Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk 
Drug Substances.'' This document describes the HHS Secretary's 
enforcement policy regarding the use of certain peptide bulk drug 
substances in compounding pursuant to section 503A of the FD&C Act 
while the list of bulk drug substances that can be used in compounding 
under section 503A of the FD&C Act (the 503A bulks list) is developed 
through rulemaking (21 U.S.C. 353a).
    Compounding is generally a practice in which a licensed pharmacist, 
a licensed physician or, in the case of an outsourcing facility, a 
person under the supervision of a licensed pharmacist, combines, mixes 
or alters ingredients of a drug to create a medication tailored to the 
needs of an individual patient. Compounded drugs are not FDA-approved, 
which means FDA does not review their safety, effectiveness, or quality 
before they are marketed. Although compounded drugs can serve an 
important medical need for certain patients, they also may pose risks 
to patients. However, based on the Pharmacy Compounding Advisory 
Committee meetings and data regarding utilization of peptides, HHS 
believes that there is significant interest in the use of these 
peptides in compounding given the lack of availability of approved 
products. Therefore, to expand and improve patient access, HHS does not 
intend to take enforcement action against a State-licensed pharmacy, 
Federal facility, or licensed physician compounding a drug product 
using a peptide bulk drug substance found in Appendix A. FDA's future 
rulemakings may propose adding some or all of these peptides to the 
503A bulks list based on the available evidence.
    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 draft Enforcement Discretion Policy Regarding 503A Compounding 
Using Certain Peptide Bulk Drug Substances does not establish any 
rights for any person and is not binding on HHS or the public.

II. Paperwork Reduction Act of 1995

    This policy contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501-3521) is not required.

III. Electronic Access

    Persons with access to the internet may obtain the document at 
<a href="https://www.hhs.gov/sites/default/files/hhs-503a-peptide-enforcement-discretion-policy-appendix-b.pdf">https://www.hhs.gov/sites/default/files/hhs-503a-peptide-enforcement-discretion-policy-appendix-b.pdf</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Use 
the HHS website listed in the previous sentence to find the most 
current version of the policy.

Robert F. Kennedy, Jr.,
Secretary, Department of Health and Human Services.
[FR Doc. 2026-22192 Filed 10-28-26; 11:15 am]
BILLING CODE 4164-01-P


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