Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability., 85296-85298 [2023-26886]
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Federal Register / Vol. 88, No. 234 / Thursday, December 7, 2023 / Notices
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
3128, 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:
Sarah Venti, Office of Compliance,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–3130, drugtrackandtrace@
fda.hhs.gov; or Anne Taylor, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION:
ddrumheller on DSK120RN23PROD with NOTICES1
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Verification Systems Under the Drug
Supply Chain Security Act for Certain
Prescription Drugs.’’ The DSCSA (title II
of Pub. L. 113–54) was signed into law
on November 27, 2013. Section 202 of
the DSCSA added section 582 to the
FD&C Act (21 U.S.C. 360eee–1), which
established the requirement that trading
partners have systems in place to enable
them to comply with certain verification
obligations. This guidance provides
recommendations for robust verification
systems for the determination,
quarantine, and investigation of suspect
products, as well as the quarantine,
notification, and disposition of
illegitimate products. This guidance
also addresses the manner in which
FDA recommends that trading partners
submit cleared product notifications
(i.e., notifications that a suspect product
is not an illegitimate product), the
statutory requirements for responding to
requests for verification, and the
statutory requirements for processing
saleable returns.
FDA initially published the draft
guidance ‘‘Verification Systems Under
the Drug Supply Chain Security Act for
Certain Prescription Drugs’’ on October
25, 2018 (83 FR 53880). Comments were
received on the initial draft guidance
and the Agency made revisions to the
draft. This guidance finalizes the
revised draft guidance entitled
‘‘Verification Systems Under the Drug
Supply Chain Security Act for Certain
Prescription Drugs,’’ issued on March
10, 2022 (87 FR 13738). FDA considered
comments received on the revised draft
guidance in finalizing this guidance.
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Changes from the revised draft to the
final guidance include: (1) clarifying
that dispensers need not provide
transaction information for saleable
return product; (2) clarifying that
‘‘verification’’ as defined in section 581
of the FD&C Act (21 U.S.C. 360eee)
involves confirming that the product
identifier affixed or imprinted upon a
package or homogeneous case
corresponds to the Standardized
Numerical Identifier or lot number and
expiration date assigned to the product
by the manufacturer or repackager by
more closely mirroring the statutory
language; (3) further clarifying when the
discussion is about the verification
systems requirements in section 582 of
the FD&C Act and when it is about the
requirement to verify the product
identifier; (4) clarifying FDA’s
understanding about the statutory
requirement that manufacturers and
repackagers respond to requests for
verification within 24 hours or within
other such reasonable time as
determined by the Secretary of Health
and Human Services; (5) clarifying that
when a trading partner does not receive
a timely response to a verification
request, the product that is the subject
of the request need not automatically be
classified as suspect; and (6) clarifying
that certain system attributes are
suggested as best practices even though
they are not specifically required under
the DSCSA. In addition, editorial
changes were made to improve clarity.
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 ‘‘Verification
Systems Under the Drug Supply Chain
Security Act for Certain Prescription
Drugs.’’ 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
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information pertaining to
implementation of the Drug Supply
Chain Security Act are approved in
OMB control no. 0910–0806.
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III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/default.htm,
https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics/
biologics-guidances, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.regulations.gov.
Dated: December 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–26846 Filed 12–6–23; 8:45 am]
BILLING CODE 4164–01–P
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; 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 ‘‘Interim
Policy on Compounding Using Bulk
Drug Substances Under section 503A of
the Federal Food, Drug, and Cosmetic
Act’’ (draft guidance or 2023 503A
Interim Policy Draft Guidance) to
describe FDA’s interim policy regarding
the use of bulk drug substances by
human drug compounders that are not
registered with FDA as outsourcing
facilities 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 draft
guidance, when finalized, will replace
the guidance for industry entitled,
‘‘Interim Policy on Compounding Using
Bulk Drug Substances under section
503A of the Federal Food, Drug, and
Cosmetic Act’’ issued in January 2017
(2017 503A Interim Policy Guidance).
DATES: Submit either electronic or
written comments on the draft guidance
by January 8, 2024 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
SUMMARY:
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Federal Register / Vol. 88, No. 234 / Thursday, December 7, 2023 / Notices
You may submit comments
on any guidance at any time as follows:
ADDRESSES:
ddrumheller on DSK120RN23PROD with NOTICES1
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.
• 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
VerDate Sep<11>2014
20:23 Dec 06, 2023
Jkt 262001
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-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. 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:
Mariestela Buhay, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 5199, Silver
Spring, MD 20993–0002, 301–796–7313.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
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85297
‘‘Interim Policy on Compounding Using
Bulk Drug Substances Under section
503A of the Federal Food, Drug, and
Cosmetic Act.’’ This draft guidance,
when finalized, will replace the 2017
503A Interim Policy Guidance, available
at https://www.fda.gov/media/94398/
download. Section 503A of the FD&C
Act (21 U.S.C. 353a) describes 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.)
This draft guidance, when finalized,
will revise FDA’s current interim policy
with respect to categorization of certain
substances nominated for inclusion on
the 503A bulks list. The guidance, when
finalized, will end 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 the final guidance.
The 2017 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
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Federal Register / Vol. 88, No. 234 / Thursday, December 7, 2023 / Notices
section 503A because they are not the
subject of an applicable USP or NF
monograph, components of FDAapproved drug products, or on the 503A
bulks list. One of those conditions is
that the bulk drug substance appears in
Category 1. If the 2023 503A Interim
Policy Draft Guidance is finalized in its
current form, a substance nominated on
or after the date of publication of that
final guidance would not be categorized
and would not be within the scope of
the policy for substances that appear in
Category 1.1 However, FDA would
consider the substance 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 21 CFR 216.23(c)). Substances that
already appear in Category 1 (including
substances nominated with adequate
supporting information prior to the date
of publication of the final guidance)
may continue to be eligible for the
policy that applies to Category 1
substances, as described in the final
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.
FDA encourages interested parties to
focus their comments on the limited
revisions to the interim policy included,
for public comment, in the 2023 503A
Interim Policy Draft Guidance.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current 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.
ddrumheller on DSK120RN23PROD with NOTICES1
II. Paperwork Reduction Act of 1995
FDA tentatively concludes that this
draft guidance contains no collection of
information. Therefore, clearance by the
Office of Management and Budget under
1 FDA recognizes that some compounders and
other stakeholders may currently be in the process
of compiling a nomination for the 503A bulks list
for submission to the Agency. FDA intends to
categorize nominations of bulk drug substances
received prior to the date in which FDA announces
the availability of the final guidance. FDA believes
that this will provide a sufficient amount of time
in which to submit nominations that are currently
in progress.
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the Paperwork Reduction Act of 1995 is
not required.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at 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 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–26886 Filed 12–6–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: The Alliance
for Innovation on Maternal Health
Biannual Survey, OMB No. 0915–
xxxx—New
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than February 5, 2024.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N39, 5600 Fishers
Lane, Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Joella Roland, the HRSA
Information Collection Clearance
Officer, at (301) 443–3983.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the ICR title
for reference.
SUMMARY:
PO 00000
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Fmt 4703
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Information Collection Request Title:
The Alliance for Innovation on Maternal
Health Biannual Survey, OMB No.
0915–xxxx—New.
Abstract: The Alliance for Innovation
on Maternal Health (AIM) program is
administered by HRSA and authorized
by 42 U.S.C. 254c–21 (Public Health
Service Act, title III section 330O), as
added by the Consolidated
Appropriations Act, 2022 (Pub. L. 117–
103).
The AIM program supports the
identification, development,
implementation, and dissemination of
maternal (patient) safety bundles to
promote safe care for every U.S. birth
and assist with addressing the complex
problem of high maternal mortality and
severe maternal morbidity rates within
the U.S. The mission of AIM is to
support best practices that make birth
safer, improve the quality of maternal
health care and outcomes, and save
lives. Maternal patient safety bundles
address topics commonly associated
with health complications or risks
related to prenatal, labor and delivery,
and postpartum care.
The AIM program consists of two
components: The AIM Capacity program
and the AIM Technical Assistance (TA)
Center. The AIM Capacity awards began
in fiscal year 2023 and directly fund 28
States and jurisdictions (including U.S.
Territories and the District of Columbia)
to implement AIM maternal patient
safety bundles. The second component,
the AIM TA Center, is funded through
a cooperative agreement to provide TA
to all 50 States, the District of Columbia,
jurisdictions, U.S. Territories, Tribal
communities, and birthing facilities
who participate in the AIM program.
The TA Center builds data capacity for
participating entities to track progress
on bundle implementation and support
improvement of data collection.
The funding amount for the AIM
program was increased in fiscal year
2023, which allowed HRSA to directly
fund States and Territories to support
AIM bundle implementation.
Previously, HRSA supported AIM
through one cooperative agreement to
develop maternal patient safety bundles,
provide TA on bundle implementation,
and enroll States and Territories in the
program. The shift to directly fund
States and jurisdictions for the work
makes the collection of information
about the reach of the program,
participation by birthing facilities, and
TA needs necessary. The AIM Biannual
Survey will be administered to AIM
State Teams (the State-or jurisdictionlevel entity leading AIM
implementation) twice a year in all
States and jurisdictions enrolled in
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]]>Agencies
[Federal Register Volume 88, Number 234 (Thursday, December 7, 2023)]
[Notices]
[Pages 85296-85298]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26886]
-----------------------------------------------------------------------
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; Draft
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 draft guidance for industry entitled ``Interim
Policy on Compounding Using Bulk Drug Substances Under section 503A of
the Federal Food, Drug, and Cosmetic Act'' (draft guidance or 2023 503A
Interim Policy Draft Guidance) to describe FDA's interim policy
regarding the use of bulk drug substances by human drug compounders
that are not registered with FDA as outsourcing facilities 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 draft guidance, when finalized, will
replace the guidance for industry entitled, ``Interim Policy on
Compounding Using Bulk Drug Substances under section 503A of the
Federal Food, Drug, and Cosmetic Act'' issued in January 2017 (2017
503A Interim Policy Guidance).
DATES: Submit either electronic or written comments on the draft
guidance by January 8, 2024 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
[[Page 85297]]
ADDRESSES: You may submit comments on any guidance 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.
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 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. 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: Mariestela Buhay, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 5199, Silver Spring, MD 20993-0002, 301-796-7313.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Interim Policy on Compounding Using Bulk Drug Substances
Under section 503A of the Federal Food, Drug, and Cosmetic Act.'' This
draft guidance, when finalized, will replace the 2017 503A Interim
Policy Guidance, available at https://www.fda.gov/media/94398/download.
Section 503A of the FD&C Act (21 U.S.C. 353a) describes 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.)
This draft guidance, when finalized, will revise FDA's current
interim policy with respect to categorization of certain substances
nominated for inclusion on the 503A bulks list. The guidance, when
finalized, will end 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 the final guidance.
The 2017 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
[[Page 85298]]
section 503A 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. One of those conditions is that the bulk drug substance
appears in Category 1. If the 2023 503A Interim Policy Draft Guidance
is finalized in its current form, a substance nominated on or after the
date of publication of that final guidance would not be categorized and
would not be within the scope of the policy for substances that appear
in Category 1.\1\ However, FDA would consider the substance 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 21 CFR 216.23(c)). Substances that
already appear in Category 1 (including substances nominated with
adequate supporting information prior to the date of publication of the
final guidance) may continue to be eligible for the policy that applies
to Category 1 substances, as described in the final 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.
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\1\ FDA recognizes that some compounders and other stakeholders
may currently be in the process of compiling a nomination for the
503A bulks list for submission to the Agency. FDA intends to
categorize nominations of bulk drug substances received prior to the
date in which FDA announces the availability of the final guidance.
FDA believes that this will provide a sufficient amount of time in
which to submit nominations that are currently in progress.
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FDA encourages interested parties to focus their comments on the
limited revisions to the interim policy included, for public comment,
in the 2023 503A Interim Policy Draft Guidance.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current 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
FDA tentatively concludes that this draft 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 draft 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 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26886 Filed 12-6-23; 8:45 am]
BILLING CODE 4164-01-P
