[Federal Register Volume 87, Number 184 (Friday, September 23, 2022)]
[Notices]
[Pages 58102-58103]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20552]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-1847]


Exemption and Exclusion From Certain Requirements of the Drug 
Supply Chain Security Act for the Distribution of Food and Drug 
Administration-Approved Naloxone Products During the Opioid Public 
Health Emergency; 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 final guidance for industry entitled ``Exemption 
and Exclusion from Certain Requirements of the Drug Supply Chain 
Security Act for the Distribution of FDA-Approved Naloxone Products 
During the Opioid Public Health Emergency.'' Combating the opioid 
overdose epidemic is an urgent public health priority for FDA. Naloxone 
hydrochloride (``naloxone'') is a medication that rapidly reverses the 
effects of opioid overdose and is the standard treatment for opioid 
overdose. FDA understands that naloxone is being made available to 
underserved communities through entities such as harm reduction 
programs and is aware of concerns that harm reduction programs are 
having difficulty acquiring naloxone. FDA is issuing this guidance to 
clarify the scope of the public health emergency exclusion and 
exemption under the Drug Supply Chain Security Act as they apply to the 
distribution of FDA-approved naloxone products indicated for the 
emergency treatment of opioid overdose to harm reduction programs 
during the opioid public health emergency. The guidance document is 
immediately in effect, but it remains subject to comment in accordance 
with the Agency's good guidance practices.

DATES: The announcement of the guidance is published in the Federal 
Register on September 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-1847 for ``Exemption and Exclusion from Certain Requirements 
of the Drug Supply Chain Security Act for the Distribution of FDA-
Approved Naloxone Products During the Opioid Public Health Emergency.'' 
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

[[Page 58103]]

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 this guidance to the 
Division of Drug Information, Center for Drug Evaluation and Research 
(CDER), 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: Elizabeth Pepinsky, CDER/Office of 
Compliance, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 4258, Silver Spring, MD 20993-0002, 301-796-8763.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry 
entitled ``Exemption and Exclusion from Certain Requirements of the 
Drug Supply Chain Security Act for the Distribution of FDA-Approved 
Naloxone Products During the Opioid Public Health Emergency.'' We are 
issuing this guidance consistent with our good guidance practices (GGP) 
regulation (Sec.  10.115 (21 CFR 10.115)). We are implementing this 
guidance without prior public comment because we have determined that 
prior public participation is not feasible or appropriate (Sec.  
10.115(g)(2)). The Agency made this determination because the guidance 
requires immediate implementation for public health reasons. Although 
this guidance document is immediately in effect, it remains subject to 
comment in accordance with FDA's GGP regulation.
    Combating the opioid overdose epidemic is an urgent public health 
priority for FDA. Naloxone is a medication that rapidly reverses the 
effects of opioid overdose and is the standard treatment for opioid 
overdose. FDA understands that naloxone is being made available to 
underserved communities through entities such as harm reduction 
programs. FDA is aware of concerns that harm reduction programs are 
having difficulty acquiring naloxone. The Agency is aware that some 
stakeholders have viewed as a contributing factor the current 
availability of approved naloxone products only as prescription drugs 
and FDA has recently become aware that some stakeholders have viewed as 
a contributing factor certain requirements under the Drug Supply Chain 
Security Act (DSCSA) for distribution of FDA-approved prescription drug 
products., e.g., being an authorized trading partner. FDA is issuing 
this guidance to clarify the scope of the public health emergency 
exclusion and exemption under the DSCSA as they apply to the 
distribution of FDA-approved naloxone products indicated for the 
emergency treatment of opioid overdose to harm reduction programs 
during the opioid public health emergency.
    The guidance represents the current thinking of FDA on ``Exemption 
and Exclusion from Certain Requirements of the Drug Supply Chain 
Security Act for the Distribution of FDA-Approved Naloxone Products 
During the Opioid Public Health Emergency.'' 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 is not required.

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: September 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-20552 Filed 9-22-22; 8:45 am]
BILLING CODE 4164-01-P