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NHRC Advocates for Change to Naloxone’s Drug Status

In late November, National Harm Reduction Coalition (NHRC) joined policy advocates from across the country in submitting joint comments in response to the U.S. Food and Drug Administration (FDA) proposed rule which would create a new category of medication – between prescription and non-prescription – called “nonprescription drug product with an additional condition for nonprescription use (ACNU).  The rule would require applicants(drug manufacturers) seeking to classify a medication as ACNU to implement requirements to ensure “appropriate self-selection or appropriate actual use, or both, by consumers without the supervision of a healthcare practitioner.”

NHRC’s Director of Overdose Prevention Policy & Strategy, Mary Sylla, led the effort to draft the comments in support of the new rule, and urging the FDA to consider a form of naloxone as suitable for the ACNU designation, on behalf of the Naloxone Policy Section of the Justice Roundtable’s Harm Reduction Working Group.  View the submission

The intent of the proposed FDA rule is to allow manufacturers “to develop and market safe and effective nonprescription drug products, which could improve public health by broadening the types of nonprescription drug products available to consumers.” NHRC believes a low-cost form of naloxone would be an important use of this new designation.

Although a prescription is required to obtain naloxone from a pharmacy, forty-nine states and the District of Columbia have enabled workarounds such as statewide standing prescription orders from doctors and allowing pharmacists to prescribe and dispense naloxone.  

National Harm Reduction Coalition will continue to collaborate with partners and stakeholders to push for easier access to naloxone by people who use drugs.  

Mary Sylla (she/her)

Mary Sylla (she/her)
Director of Overdose Prevention Policy & Strategy


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About NHRC: National Harm Reduction Coalition (NHRC) is a nationwide advocate and ally for people who use drugs, creating spaces for dialogue and action that help heal the harms caused by racialized drug policies. As a national advocacy and capacity-building organization, NHRC promotes the health and dignity of individuals and communities impacted by drug use. From coast to coast, our efforts advance harm reduction policies, practices, and programs that address the adverse effects of drug use including overdose, HIV, hepatitis C, addiction, and incarceration. Learn more.  Follow us on Facebook, Instagram, or Twitter.