FDA Issues Exemptions, Exclusions for Acquiring FDA-Approved Naloxone Products

By Leah Lawrence - Last Updated: October 11, 2022

The U.S. Food and Drug Administration (FDA) recently issued the Exemption and Exclusion from Certain Requirements of the Drug Supply Chair Security Act (DSCSA) for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency industry guidance.

Naloxone is a medication that rapidly reverses the effects of and is the standard treatment for opioid overdose. The FDA issued this guidance to support efforts by entities such as harm reduction programs to facilitate public availability of and access to FDA-approved naloxone products for emergency treatment of opioid overdoses.

This exemption and exclusion provided under the DSCSA during the opioid public health emergency is designed to strike a balance between the need to facilitate the effective distribution of lifesaving FDA-approved naloxone products to harm reduction programs and harm reduction suppliers under emergency conditions while helping to protect consumers from exposure to products that may be counterfeit, stolen, or otherwise harmful.

The scope of this guidance is limited to FDA’s interpretation of the DSCSA exemption from “transaction” and the exclusion from “wholesale distribution,” for emergency medical reasons including a public health emergency, only as they apply to the distribution of FDA-approved naloxone products to harm reduction programs and to harm reduction suppliers during the opioid public health emergency.

These exclusions and exemptions will last only until the HHS Secretary declares that the public health emergency no longer exists or until it expires 90 days after the date of an opioid public health emergency determination, whichever occurs first.

FDA provides information to help educate health care providers about buying medicines from licensed sources, which may be a helpful resource for harm reduction programs. See FDA’s “Know Your Source” web page, available here.

 

Reference

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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