Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability, 1130-1132 [2024-31545]
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Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices
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[Document Identifier: CMS–R–65 and CMS–
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VerDate Sep<11>2014
18:44 Jan 06, 2025
Jkt 265001
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.
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finalizes the draft guidance of the same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:
SUMMARY:
PO 00000
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Fmt 4703
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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
E:\FR\FM\07JAN1.SGM
07JAN1
ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices
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-201509-18/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,
compounding@fda.hhs.gov.
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
VerDate Sep<11>2014
18:44 Jan 06, 2025
Jkt 265001
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
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1131
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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Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices
https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–D–4245]
Study of Sex Differences in the Clinical
Evaluation of Medical Products; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Study of
Sex Differences in the Clinical
Evaluation of Medical Products.’’
Clinical trials and non-interventional
studies of medical products should be
designed to enroll sufficient numbers of
females and males to reflect the
prevalence of the disease or condition
for which the medical product is being
investigated to help ensure the
generalizability of results and facilitate
exploration of potential differences in
effects by sex. This guidance provides
recommendations for increasing
enrollment of females in clinical trials,
analyzing and interpreting sex-specific
data, and including sex-specific
information in regulatory submissions
of medical products. When finalized,
this guidance will replace the guidance
entitled ‘‘Guideline for the Study and
Evaluation of Gender Differences in the
Clinical Evaluation of Drugs’’ issued in
July 1993.
DATES: Submit either electronic or
written comments on the draft guidance
by April 7, 2025 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
VerDate Sep<11>2014
18:44 Jan 06, 2025
Jkt 265001
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–
2024–D–4245 for ‘‘Study of Sex
Differences in the Clinical Evaluation of
Medical Products.’’ 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
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
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
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-201509-18/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 the draft 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; the Office of Communication,
Outreach and Development, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
3128, Silver Spring, MD 20993–0002;
the Office of Policy, Center for Devices
and Radiological Health, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993–0002; or the
Office of Women’s Health, 10903 New
Hampshire Ave., Bldg. 32, Rm. 2333,
Silver Spring, 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 draft
guidance document.
FOR FURTHER INFORMATION CONTACT: Dat
Doan, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 3334, Silver Spring,
MD 20993–0002, 240–402–8926,
Dat.Doan@fda.hhs.gov; James Myers,
Center for Biologics Evaluation and
E:\FR\FM\07JAN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 1132]]
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
