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  4. 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 Guidance for Industry
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GUIDANCE DOCUMENT

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 Guidance for Industry September 2022

Download the Final Guidance Document
Final
Docket Number:
FDA-2022-D-1847
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research, Office of Regulatory Policy

Combating the opioid overdose epidemic is an urgent public health priority for FDA. The Agency is committed to advancing solutions to reduce opioid overdose deaths in the United States, including by supporting efforts to increase public availability of and access to naloxone.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2022-D-1847.

 
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