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 guidance clarifies 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).
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