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FDA Clarifies Naloxone Supply Chain Rules

The new guidance aims to improve supply for harm reduction programs.

Following the introduction of Overdose Prevention Framework, the FDA has issued final guidance1,2 geared toward making naloxone available to prevent overdose and death from opioids.

Harm reduction programs have been important to reducing overdoses in underserved communities, but many of these communities have faced difficulties in getting naloxone. This guidance is meant to support those programs by clarifying public health emergency exclusion and exemption from certain requirements under the Drug Supply Chain Security Act (DSCSA).

Enacted in 2013, the DSCSA is intended to secure the drug supply in the United States through a closed prescription drug distribution system. However, declared public health emergencies are exempt from requirements of this act. The opioid epidemic was declared a public health emergency on October 26, 2017—and has been renewed every 90 days since the initial declaration.

The new guidance indicates that the FDA will generally not take enforcement against trading partners during the public health emergency when engaging in either of these activities:

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  • Distributing FDA-approved naloxone directly to harm reduction programs that are not authorized trading partners, which includes product donations
  • Distributing FDA-approved naloxone to harm reductions that would be considered to otherwise meet the DSCSA’s definition of a wholesale supplier, except they are not considered such because “They are currently engaged in distributing FDA-approved naloxone products for emergency medical reasons resulting from the opioid public health emergency.”1

This guidance is in effect only for as long as the opioid public health emergency remains in effect.The emergency ends when either the Secretary of the Department of Health and Human Services declares it over or the 90-day period lapses without renewal, whichever comes first.

Reference

  1. Exemption and exclusion from certain requirements of the drug supply chain security act for the distribution of FDA-approved naloxone products during the opioid public health emergency guidance for industry. FDA. Guidance. Published September 22, 2022. Accessed September 26, 2022. https://www.fda.gov/media/161750/download
  2. Sokolowska M. FDA issues new guidance to help facilitate availability of naloxone to prevent opioid overdoses and reduce death. FDA. Published September 23, 2022. Accessed September 30, 2022. https://www.fda.gov/news-events/fda-voices/fda-issues-new-guidance-help-facilitate-availability-naloxone-prevent-opioid-overdoses-and-reduce

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