
[Federal Register Volume 88, Number 234 (Thursday, December 7, 2023)]
[Notices]
[Pages 85293-85295]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26845]


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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Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft 
Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Interim 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 503B of 
the Federal Food, Drug, and Cosmetic Act'' (draft guidance or 2023 503B 
Interim Policy Draft Guidance) to describe FDA's interim policy 
regarding the use of bulk drug substances in compounding by outsourcing 
facilities 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 
draft guidance, when finalized, will replace the guidance for industry 
entitled, ``Interim Policy on Compounding Using Bulk Drug Substances 
Under section 503B of the Federal Food, Drug, and Cosmetic Act'' issued 
in January 2017 (2017 503B 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DATES: Submit either electronic or written comments on the draft 
guidance by January 8, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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.

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-

[[Page 85294]]

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 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: Rechelle Buford, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-0447.

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Interim Policy on Compounding Using Bulk Drug Substances 
Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' This 
draft guidance, when finalized, will replace the 2017 503B Interim 
Policy Guidance, available at https://www.fda.gov/media/94402/download.
    Section 503B of the FD&C Act (21 U.S.C. 353b) describes 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 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 
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).
    This draft guidance, when finalized, will revise FDA's current 
interim policy with respect to categorization of certain substances 
nominated for inclusion on the 503B bulks list. The guidance, when 
finalized, would 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 503B Interim Policy Guidance describes the conditions 
under which FDA does not intend to take action against an outsourcing 
facility for compounding a drug using certain bulk drug substances that 
are not eligible for use in compounding under section 503B because they 
do not appear on the 503B bulks list and that are not used to compound 
a drug that appears on the FDA drug shortage list at the time of 
compounding, distribution, and dispensing. One of those conditions is 
that the bulk drug substance appears in Category 1. If the 2023 503B 
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 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). 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 
makes a final determination whether they 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.
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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 
503B 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 503B 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 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.

[[Page 85295]]

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. 2023-26845 Filed 12-6-23; 8:45 am]
BILLING CODE 4164-01-P


