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[Federal Register Volume 90, Number 4 (Tuesday, January 7, 2025)]
[Notices]
[Pages 1136-1138]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31546]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-3517]

Interim Policy on Compounding Using Bulk Drug Substances Under 
Section 503A 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 503A of 
the Federal Food, Drug, and Cosmetic Act.'' This guidance describes 
FDA's interim policy concerning compounding by human drug product 
compounders that are not outsourcing facilities using bulk drug 
substances while FDA develops the list of bulk drug substances that can 
be used 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draft guidance of the same title issued in December 2023 and replaces 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-3517 for ``Interim Policy on Compounding Using Bulk Drug 
Substances Under Section 503A 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.

[[Page 1137]]

     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 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: Mariestela Buhay, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Silver Spring, MD 20993-0002, 301-796-7313, 
[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 503A of the Federal Food, Drug, and Cosmetic Act'' (2024 
503A Interim Policy Guidance). This guidance finalizes the draft 
guidance entitled ``Interim Policy on Compounding Using Bulk Drug 
Substances Under Section 503A of the Federal Food, Drug, and Cosmetic 
Act'' issued on December 7, 2023 (88 FR 85296), and replaces the 
guidance of the same title issued in January 2017 (2017 503A Interim 
Policy Guidance).
    Section 503A of the FD&C Act (21 U.S.C. 353a) sets forth the 
conditions that must be satisfied for human drug products compounded by 
a licensed pharmacist in a State-licensed pharmacy or Federal facility, 
or by a licensed physician, 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 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning 
current good manufacturing practice requirements). One of the 
conditions that must be met for a compounded drug product to qualify 
for these exemptions is that a licensed pharmacist or licensed 
physician compounds the drug product using bulk drug substances that 
(1) comply with the standards of an applicable United States 
Pharmacopeia (USP) or National Formulary (NF) monograph, if a monograph 
exists, and the USP chapters on pharmacy compounding; (2) if such a 
monograph does not exist, are drug substances that are components of 
drugs approved by the Secretary of the Department of Health and Human 
Services (Secretary); or (3) if such a monograph does not exist and the 
drug substance is not a component of a drug approved by the Secretary, 
appears on a list developed by the Secretary through regulations issued 
by the Secretary under subsection (c) of section 503A of the FD&C Act 
(the 503A bulks list). (See section 503A(b)(1)(A)(i) of the FD&C Act.)
    FDA is developing the 503A bulks list, and this guidance describes 
FDA's interim policy for licensed pharmacists in State-licensed 
pharmacies and Federal facilities and for licensed physicians who 
compound human drug products using bulk drug substances while the list 
is being developed. This guidance revises the policy described in FDA's 
2017 503A Interim Policy Guidance with respect to categorization of 
certain substances nominated for inclusion on the 503A 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 503A Interim Policy Guidance describes the conditions 
under which FDA does not intend to take action against a State-licensed 
pharmacy, Federal facility, or physician for compounding drug products 
using certain bulk drug substances that are not eligible for use in 
compounding under section 503A of the FD&C Act because they are not the 
subject of an applicable USP or NF monograph, components of FDA-
approved drug products, or on the 503A bulks list at Sec.  216.23(a) 
(21 CFR 216.23(a)). One of these conditions is that the bulk drug 
substance appears in Category 1. As described in the guidance, FDA does 
not intend to categorize bulk drug substances nominated for inclusion 
on the 503A bulks list on or after the publication date of this 
guidance. However, FDA intends to consider such substances for 
inclusion on the 503A bulks list in accordance with the process and 
criteria established in the FD&C Act and FDA regulations (see section 
503A(b)(1)(A) of the FD&C Act and Sec.  216.23(c)). FDA is evaluating 
bulk drug substances nominated for the 503A 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 that applies to Category 1 substances, as described in this 
guidance, until FDA promulgates a final rule determining whether they 
will be placed on the 503A bulks list in accordance with section 
503A(b)(1)(A)(i)(III) 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 guidance.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current

[[Page 1138]]

thinking of FDA on ``Interim Policy on Compounding Using Bulk Drug 
Substances Under Section 503A 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 
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. 2024-31546 Filed 1-6-25; 8:45 am]
BILLING CODE 4164-01-P
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