[Federal Register Volume 88, Number 31 (Wednesday, February 15, 2023)]
[Notices]
[Pages 9883-9885]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03158]


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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 by outsourcing 
facilities to provide to hospitals and health systems for 
administration within the hospital or health-system and State-licensed 
pharmacies (including those within hospitals and health systems), and 
applicable Federal facilities, to dispense to patients for use at home 
after receiving a valid, patient-specific prescription. This final 
guidance revises and replaces the guidance of the same name issued on 
January 25, 2023. Revisions were made to describe the Agency's 
regulatory and enforcement priorities regarding the compounding of 
certain ibuprofen oral suspension products by outsourcing facilities to 
provide to State-licensed pharmacies (including those within hospitals 
and health systems), and applicable Federal facilities, to dispense to 
patients for use at home after receiving a valid, patient-specific 
prescription.

DATES: The announcement of the guidance is published in the Federal 
Register on February 15, 2023.

ADDRESSES: You may submit either electronic or written comments on 
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

[[Page 9884]]

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 is being implemented immediately to 
bolster consumer access to ibuprofen oral suspension products at State-
licensed pharmacies and applicable Federal facilities during the winter 
months when respiratory infections are likely to be elevated, but it 
remains subject to comment in accordance with the Agency's good 
guidance practices.
    The United States is currently experiencing a significant number of 
infections involving 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 State-licensed pharmacies experiencing 
challenges with obtaining these medications for use at home for fever 
and pain treatment of pediatric patients as well as for adults who are 
unable to swallow solid oral dosage forms.
    As explained in the Federal Register of January 25, 2023, this 
guidance describes the Agency's regulatory and enforcement priorities 
regarding the compounding of certain ibuprofen oral suspension products 
by outsourcing facilities to provide to hospitals and health systems 
for administration within the hospital or health system (see 88 FR 
4828). FDA has revised this guidance to also describe the Agency's 
regulatory and enforcement priorities regarding the compounding of 
certain ibuprofen oral suspension products by outsourcing facilities to 
provide to State-licensed pharmacies (including those within hospitals 
and health systems), and applicable Federal facilities, to dispense to 
patients for use at home after receiving a valid, patient-specific 
prescription. 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 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.

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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 (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 (21 U.S.C. 353a and 353b) 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 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: February 9, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-03158 Filed 2-10-23; 11:15 am]
BILLING CODE 4164-01-P


