FDA exempts critical opioid reversal drug from DSCSA

The FDA has proposed that the opioid reversal agent naloxone is exempted from the product identification and tracing requirements of the Drug Supply Chain Security Act (DSCSA), to avoid disrupting efforts to tackle the opioid overdose crisis in the US.

The DSCSA was enacted in 2013 to boost the FDA's ability to protect US patients by developing a connected, digital system to trace prescription drugs throughout the country and identify counterfeit, stolen or contaminated medicine before it reaches the hands of consumers.

The overall aim is to make sure that prescription drugs subject to the DSCSA are properly stored, handled, and transported, but the FDA is concerned those requirements could make it harder to deliver naloxone, a drug used to rescue people after overdose and a key weapon in its fight against an epidemic of opioid-related deaths.

"FDA understands that naloxone is being made available to underserved communities through entities such as harm reduction programmes," says the guidance, which is open for comment.

"FDA is issuing this guidance to support efforts by these entities to facilitate public availability of and access to FDA-approved naloxone products for emergency treatment of opioid overdoses, particularly in underserved communities."

The opioid crisis was initially declared a public health emergency in the US in 2017. Just over 100,000 US citizens died of drug overdoses during the year to April 2021, according to the Centres for Disease Control and Prevention (CDC), an increase of nearly 29 per cent from the previous year.

There are three FDA-approved forms of naloxone – injectable, auto-injector, and nasal spray – and all three currently require a prescription.

Photo by NEXT Distro on Unsplash

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