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Yellow silhouette of a group of people embracing each other, with a blue background. The bottom half of the image reads "Naloxone Saves lives"

By: Marta Sokolowska, Ph.D., Deputy Center Director for Substance Use and Behavioral Health, Center for Drug Evaluation and Research

On August 30, 2022, Commissioner Robert M. Califf introduced the U.S. Food and Drug Administration’s Overdose Prevention Framework – our vision to undertake impactful, creative actions to prevent drug overdoses and reduce deaths. The framework consists of four priorities, including encouraging harm reduction, in part through efforts to expand availability of overdose reversal products, notably naloxone. The FDA is building on our actions to help expand the availability and access to this life saving medication, an effort that we hope will be embraced by harm reduction programs and manufacturers.  

Executive photo of Marta Sokolowska Ph.D.

Marta Sokolowska Ph.D.

To help achieve this priority, we are pleased to announce that the FDA has issued the guidance, Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act (DSCSA) for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency, which is effective immediately. 

This guidance clarifies the applicability of a public health emergency exclusion and exemption from certain requirements under the Drug Supply Chain Security Act (DSCSA), in terms of the distribution of FDA-approved naloxone products to harm reduction programs, and includes a related compliance policy. Entities such as harm reduction programs help save lives by making naloxone available in underserved communities. The agency intends to stand by these efforts by supporting harm reduction groups’ ability to acquire FDA-approved naloxone products. 

Every person who experiences an opioid overdose, whether it is with a prescribed medicine or an illicit drug, should have access to naloxone. With naloxone, anyone can help save the life of someone who is having an opioid overdose. 

In recognition of the importance of naloxone access, the FDA partnered with the Reagan-Udall Foundation to hold a virtual public meeting earlier this year to engage stakeholders across the health care continuum and explore effective approaches that could increase naloxone availability. During this meeting, and across other engagements with the community, we have heard about obstacles to naloxone access.  

We hope that this guidance helps to address some of the obstacles and will facilitate the life-saving work of harm reduction programs by aiding their ability to obtain naloxone directly from manufacturers and distributors while expanding public availability of this critical medicine. At the same time, the agency recognizes that this action alone is not enough. While the guidance supports harm reduction programs’ ability to acquire naloxone, it does not address other challenges to access that communities face, including the current prescription-only status of FDA-approved naloxone products. Thus, there is still more work ahead of us as deaths from drug overdoses remain at historically high levels.

The FDA remains focused and committed to increasing naloxone access as we implement the Overdose Prevention Framework. We welcome working with harm reduction programs as well as all partners to reduce overdose deaths and, ultimately, achieve sustainable long-term recovery outcomes. 

Although this guidance is immediately in effect, the FDA is accepting comments. For more information, please refer to https://www.regulations.gov and the docket number FDA-2022-D-1847.