This nonprescription availability is an important milestone for states and territories, community organizations, harm reduction advocates, those working to prevent overdose, and people at risk for overdose. State policy has evolved since the initial FDA approval of naloxone in 1971 to reduce access barriers and allow distribution to laypersons for emergency response. More than 20 years ago, harm reduction organizations spearheaded efforts to distribute naloxone to laypersons, particularly people who use drugs and their friends and families. Significant research has demonstrated naloxone is safe and effective for layperson use even with brief training.

The U.S. Food and Drug Administration on Wednesday approved selling the leading version of naloxone without a prescription, setting the overdose-reversing drug on course to become the first opioid treatment drug to be sold over the counter. It’s a move that some advocates have long sought as a way to improve access to a life-saving drug, though the exact impact will not be clear immediately.