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[Federal Register Volume 90, Number 4 (Tuesday, January 7, 2025)]
[Notices]
[Pages 1130-1132]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31545]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-3539]

Interim Policy on Compounding Using Bulk Drug Substances Under 
Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance for industry entitled ``Interim 
Policy on Compounding Using Bulk Drug Substances Under Section 503B of 
the Federal Food, Drug, and Cosmetic Act.'' This guidance describes 
FDA's interim regulatory policy concerning compounding by outsourcing 
facilities using bulk drug substances while FDA develops the list of 
bulk drug substances that outsourcing facilities can use in compounding 
under the applicable section of the Federal Food, Drug, and Cosmetic 
Act (FD&C Act). This guidance finalizes the draft guidance of the same 
title issued in December 2023 and replaces the final guidance of the 
same title issued in January 2017.

DATES: The announcement of the guidance is published in the Federal 
Register on January 7, 2025.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-D-3539 for ``Interim Policy on Compounding Using Bulk Drug 
Substances Under Section 503B of the Federal Food, Drug, and Cosmetic 
Act.'' Received comments will be placed in the docket and, except for 
those submitted as ``Confidential Submissions,'' publicly viewable at 
https://www.regulations.gov or at the Dockets Management Staff between 
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the

[[Page 1131]]

information you claim to be confidential with a heading or cover note 
that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The 
Agency will review this copy, including the claimed confidential 
information, in its consideration of comments. The second copy, which 
will have the claimed confidential information redacted/blacked out, 
will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management 
Staff. If you do not wish your name and contact information to be made 
publicly available, you can provide this information on the cover sheet 
and not in the body of your comments and you must identify this 
information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the 
Division of Drug Information, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale 
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Rechelle Buford, Center for Drug 
Evaluation and Research, 10903 New Hampshire Ave, Bldg., 51, Silver 
Spring, MD 20993-0002, 240-402-0447, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry 
entitled ``Interim Policy on Compounding Using Bulk Drug Substances 
Under Section 503B of the Federal Food, Drug, and Cosmetic Act'' (2024 
503B Interim Policy Guidance). This guidance finalizes the draft 
guidance entitled ``Interim Policy on Compounding Using Bulk Drug 
Substances Under Section 503B of the Federal Food, Drug, and Cosmetic 
Act'' issued on December 7, 2023 (88 FR 85293), and replaces the 
guidance of the same title issued in January 2017 (2017 503B Interim 
Policy Guidance).
    Section 503B of the FD&C Act (21 U.S.C. 353b) sets forth the 
conditions that must be satisfied for human drug products compounded by 
an outsourcing facility to be exempt from the following three sections 
of the FD&C Act: (1) section 505 (21 U.S.C. 355) (concerning the 
approval of drugs under new drug applications or abbreviated new drug 
applications); (2) section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning 
the labeling of drugs with adequate directions for use); and (3) 
section 582 (21 U.S.C. 360eee-1) (concerning drug supply chain security 
requirements). One of the conditions that must be met for a drug 
product compounded by an outsourcing facility to qualify for these 
exemptions is that the outsourcing facility does not compound a drug 
using a bulk drug substance unless: (1) the bulk drug substance appears 
on a list established by the Secretary of the Department of Health and 
Human Services identifying bulk drug substances for which there is a 
clinical need (the 503B bulks list) (see section 503B(a)(2)(A)(i)) or 
(2) the drug product compounded from such bulk drug substances appears 
on the drug shortage list in effect under section 506E of the FD&C Act 
(21 U.S.C. 356e) at the time of compounding, distribution, and 
dispensing (see section 503B(a)(2)(A)(ii) of the FD&C Act).
    FDA is developing the 503B bulks list, and this guidance describes 
FDA's interim policy regarding outsourcing facilities that compound 
human drug products using bulk drug substances while the list is being 
developed. This guidance revises the policy described in FDA's 2017 
503B Interim Policy Guidance with respect to categorization of certain 
substances nominated for inclusion on the 503B bulks list. This 
guidance ends the categorization of bulk drug substances into 
Categories 1, 2, or 3 for those bulk drug substances nominated on or 
after the date of publication of this guidance.
    The 2024 503B Interim Policy Guidance describes the conditions 
under which FDA does not intend to take action against an outsourcing 
facility for compounding a drug product using certain bulk drug 
substances that are not eligible for use in compounding under section 
503B of the FD&C Act because they do not appear on the 503B bulks list 
and are not used to compound a drug product that appears on FDA's drug 
shortage list at the time of compounding, distribution, and dispensing. 
One of these conditions is that the bulk drug substance appears in 
Category 1. As described in this guidance, FDA does not intend to 
categorize bulk drug substances nominated for inclusion on the 503B 
bulks list on or after the publication date of this guidance. However, 
FDA intends to consider such substances for inclusion on the 503B bulks 
list in accordance with the process and clinical need standard 
established in the FD&C Act (see section 503B(a)(2)(A)(i) of the FD&C 
Act). FDA is evaluating bulk drug substances nominated for the 503B 
bulks list on a rolling basis. Substances that appear in Category 1 
(including substances nominated with adequate supporting information 
prior to the date of publication of this guidance) may continue to be 
within the scope of the policy for Category 1 substances, as described 
in the guidance, until FDA makes a final determination whether these 
substances will be placed on the 503B bulks list in accordance with 
section 503B(a)(2)(A)(i) of the FD&C Act or unless the Agency removes 
the substances from Category 1 based on, for example, information about 
safety risks.
    Prior to preparing this guidance, FDA considered comments received 
on the draft guidance. Editorial changes were made to improve clarity, 
such as updating references to the publication date of this final 
guidance.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on the ``Interim Policy on Compounding Using 
Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and 
Cosmetic Act.'' It does not establish any rights for any person and is 
not binding on FDA or the public. You can use an alternative approach 
if it satisfies the requirements of the applicable statutes and 
regulations.

II. Paperwork Reduction Act of 1995

    This guidance contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either

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https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: December 27, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-31545 Filed 1-6-25; 8:45 am]
BILLING CODE 4164-01-P
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