Notice2023-01467
Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
Primary source
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Published
January 25, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled "Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act." This guidance describes FDA's regulatory and enforcement priorities regarding compounding certain ibuprofen oral suspension products in outsourcing facilities for administration in hospitals and health systems.
Full Text
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<title>Federal Register, Volume 88 Issue 16 (Wednesday, January 25, 2023)</title>
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[Federal Register Volume 88, Number 16 (Wednesday, January 25, 2023)]
[Notices]
[Pages 4828-4830]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-01467]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-0169]
Compounding Certain Ibuprofen Oral Suspension Products Under
Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for
Industry; Availability
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of a final guidance for industry entitled
``Compounding Certain Ibuprofen Oral Suspension Products Under Section
503B of the Federal Food, Drug, and Cosmetic Act.'' This guidance
describes FDA's regulatory and enforcement priorities regarding
compounding certain ibuprofen oral suspension products in outsourcing
facilities for administration in hospitals and health systems.
DATES: The announcement of the guidance is published in the Federal
Register on January 25, 2023.
ADDRESSES: You may submit either electronic or written comments on
[[Page 4829]]
Agency guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2023-D-0169 for ``Compounding Certain Ibuprofen Oral Suspension
Products 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
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 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: Ian Reynolds, Office of Compounding
Quality and Compliance, Center for Drug Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD
20993, 240-402-7079.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of a guidance for industry
entitled ``Compounding Certain Ibuprofen Oral Suspension Products Under
Section 503B of the Federal Food, Drug, and Cosmetic Act.'' This
guidance is being implemented without prior public comment because FDA
has determined that prior public participation for this guidance is not
feasible or appropriate (see section 701(h)(1)(C) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C)) and 21 CFR
10.115(g)(2)). This guidance document is being implemented immediately
to bolster access to ibuprofen oral suspension products in hospitals
and health systems during the current surge in respiratory infections,
but it remains subject to comment in accordance with the Agency's good
guidance practices.
This guidance describes the Agency's regulatory and enforcement
priorities regarding the compounding of certain ibuprofen oral
suspension products in outsourcing facilities for administration in
hospitals and health systems. The United States is currently
experiencing a surge in three viruses: Coronavirus Disease 2019 (COVID-
19), respiratory syncytial virus (RSV), and influenza. Each of these
viruses may produce fever in young children. FDA has received reports
related to increased demand for pediatric fever-reducing medications,
including ibuprofen oral suspension products. Further, FDA has received
a number of reports related to hospitals and health systems
experiencing challenges with obtaining these medications to use in the
treatment of pediatric patients with fevers as well as for adults who
are unable to swallow solid oral dosage forms (e.g. persons with
feeding tubes). FDA is continually assessing the needs and
circumstances related to the temporary policy set forth in this
guidance, and as relevant needs and circumstances evolve, FDA intends
to update, modify, or withdraw this policy as appropriate.
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 ``Compounding Certain Ibuprofen Oral
Suspension Products Under Section 503B of the FD&C 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
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget
[[Page 4830]]
(OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521) is not required for this guidance. The previously approved
collections of information are subject to review by OMB under the PRA.
The collection of information for current good manufacturing practice
requirements has been approved under OMB control number 0910-0139. The
collections of information for adverse event reporting and human drug
compounding under sections 503A and 503B of the FD&C Act have been
approved under OMB control number 0910-0800. The collections of
information for adverse event and product experience reporting under
the MedWatch System has been approved under OMB control number 0910-
0291.
III. Electronic Access
Persons with access to the internet may obtain the document at
<a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: January 20, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-01467 Filed 1-23-23; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on January 25, 2023.
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