[Federal Register Volume 87, Number 225 (Wednesday, November 23, 2022)]
[Notices]
[Pages 71654-71655]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25622]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-2922]


Compounding Certain Beta-Lactam Products in Shortage Under 
Section 503A of the Federal Food, Drug, and Cosmetic Act; 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, Agency, or we) is 
announcing the availability of a final guidance for industry entitled 
``Compounding Certain Beta-Lactam Products in Shortage Under Section 
503A of the Federal Food, Drug, and Cosmetic Act.'' This guidance 
describes FDA's regulatory and enforcement priorities regarding 
preparation of beta-lactam oral antibiotic suspension products that 
appear on FDA's drug shortage list by a licensed pharmacist in a State-
licensed pharmacy or Federal facility.

DATES: The announcement of the guidance is published in the Federal 
Register on November 23, 2022.

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 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-2022-D-2922 for ``Compounding Certain Beta-Lactam Products in 
Shortage 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

[[Page 71655]]

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: Tracy Rupp, Office of Compounding 
Quality and Compliance, Center for Drug Evaluation and Research, Food 
and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 
20993, 301-796-3100.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a guidance for industry 
entitled ``Compounding Certain Beta-Lactam Products in Shortage Under 
Section 503A 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 
because of the public health need for amoxicillin oral antibiotic 
suspension products, 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 preparation of beta-lactam oral antibiotic 
suspension products that appear on FDA's drug shortage list by a 
licensed pharmacist in a State-licensed pharmacy or Federal facility. 
FDA has received a number of reports related to increased demand for 
amoxicillin oral antibiotic suspension products in particular. 
Amoxicillin oral antibiotic powder for suspension products currently 
appear on FDA's drug shortage list. FDA has also received requests for 
clarification about preparation of compounded versions of those 
products from FDA-approved tablets and capsules.
    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 Beta-Lactam Products 
in Shortage Under Section 503A 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

    This guidance contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501-3521) is not required.

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: November 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-25622 Filed 11-22-22; 8:45 am]
BILLING CODE 4164-01-P