[Federal Register Volume 88, Number 16 (Wednesday, January 25, 2023)]
[Notices]
[Pages 4828-4830]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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

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Agency guidances 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-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 
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 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

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(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 
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: 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


