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Section 503A of the Federal Food, Drug, and Cosmetic Act; Draft 
Guidance for Industry; Availability.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the availability of a draft guidance for industry entitled ``Interim 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the Federal Food, Drug, and Cosmetic Act'' (draft guidance or 2023 503A 
Interim Policy Draft Guidance) to describe FDA's interim policy 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 This draft guidance, when finalized, will 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DATES: Submit either electronic or written comments on the draft 
guidance by January 8, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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

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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