[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]
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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Section 503A of the Federal Food, Drug, and Cosmetic Act; Draft
Guidance for Industry; Availability.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the availability of a draft guidance for industry entitled ``Interim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the Federal Food, Drug, and Cosmetic Act'' (draft guidance or 2023 503A
Interim Policy Draft Guidance) to describe FDA's interim policy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 This draft guidance, when finalized, will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DATES: Submit either electronic or written comments on the draft
guidance by January 8, 2024 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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