FDA Issues Guidance to Expand Naloxone Access in Harm Reduction

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.