Notice2022-20552
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
Primary source
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Published
September 23, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 184 (Friday, September 23, 2022)</title>
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[Federal Register Volume 87, Number 184 (Friday, September 23, 2022)]
[Notices]
[Pages 58102-58103]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<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-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 <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
[[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
<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: 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
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</html>Indexed from Federal Register on September 23, 2022.
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