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

FDA issued this guidance to support efforts by harm reduction entities to facilitate public availability of and access to FDA-approved naloxone products for emergency treatment of opioid overdoses, particularly in underserved communities. The FDA is issuing this guidance to help address some of the obstacles to naloxone access identified during community engagements. Further, the guidance supports the FDA Overdose Prevention Framework’s priority to encourage harm reduction by seeking to expand availability and access to naloxone.