Opioid-Reversal Drug Access to Ease Under Relaxed FDA Rules (1)

Harm reduction programs distributing the opioid-reversal drug naloxone are exempt from certain federal product tracing requirements in an effort to better expand supply, the FDA said Thursday.

The Food and Drug Administration said in guidance that it won’t enforce certain Drug Supply Chain Security Act requirements on programs distributing FDA-approved naloxone to underserved communities while an opioid public health emergency declaration is in place.

The document outlines the FDA’s approach to regulating the drug as the Biden administration prioritizes addiction treatments and harm reduction strategies in its fight against the opioid crisis.

“Combating the opioid overdose epidemic is an urgent ...