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FDA Issues Guidance to Expand Naloxone Access in Harm Reduction

  • Ann Tucker
  • Oct 14, 2022
  • 1 min read

Recently issued, new guidance from the FDA helps expand availability and access to naloxone for harm reduction programs. The guidance clarifies a public health emergency exclusion and exemption from requirements of the Drug Supply Chain Security Act (DSCSA) regarding the distribution of FDA-approved naloxone products to harm reduction programs and includes a related compliance policy. Although this guidance is immediately in effect, the FDA is accepting comments.

 
 
 

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