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SEPTEMBER 27, 2022

FDA Guidance on Naloxone Distribution Looks to Improve OUD Treatment Access

By PPN News Staff

The FDA issued a new guidance to explain the scope of the public health emergency exclusion and exemption under the Drug Supply Chain Security Act, as they apply to the distribution of naloxone to harm reduction programs during the opioid crisis. 

The  “Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act (DSCSA) for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency” acknowledges