FDA Exempts Naloxone From DSCSA Requirements To Boost Access

By Beth Wang / September 22, 2022 at 4:19 PM
FDA on Thursday (Sept. 22) announced it is exempting approved naloxone products, specifically those that are distributed to harm reduction programs, from certain drug tracking, tracing and distribution requirements during the opioid public health emergency in a bid to boost access to naloxone. The Biden administration has said it wants to increase access to and affordability of the overdose reversal drug as part of its broader strategy to address the opioid overdose epidemic, but the administration’s plan is focused more...

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