New federal guidance aims to improve Naloxone access
The opioid epidemic continues to be a major public health issue in Arkansas.
Harm reduction programs will face fewer barriers to obtaining and distributing naloxone — a lifesaving drug which can rapidly reverse an opioid overdose — thanks to new federal guidance.
Issued by the U.S. Food and Drug Administration (FDA) in September and effective immediately upon release, the new guidanceclarifies existing laws and regulations regarding the distribution of naloxone, also known by the brand name Narcan. Among other things, the guidance clarifies the applicability of a public health emergency exclusion and exemption from certain requirements under the Drug Supply Chain Security Act (DSCSA).
Enacted by Congress in 2013, the DSCSA established an electronic system to track certain prescription drugs distributed in the U.S. and set regulations for pharmaceutical transactions and distribution. However, under a public health emergency — declared for the opioid epidemic in 2017 and subsequently continued every 90 days — some exemptions are permitted. Read more.