[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draft guidance of the same title issued in December 2023 and replaces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