Naloxone is a lifesaving emergency treatment that reverses opioid overdose. It is a medicine with no abuse potential, and it is not a controlled substance. It can also be administered by individuals with or without medical training to help reduce opioid overdose deaths, as shown on CDC’s website.

FDA understands the importance of having all forms of naloxone available for community use. FDA continues to take key steps in making this emergency treatment more readily available and more accessible.

Stakeholder Meetings

• FDA Stakeholder Call: Expanding Access to Naloxone
  • March 2023: Stakeholder call to discuss next steps for nonprescription naloxone following the first nonprescription naloxone approval.
• FDA Stakeholder Call: Harm Reduction and Naloxone Access
  • November 2022: Stakeholder call to discuss naloxone access and emphasize support for harm reduction programs’ ability to acquire FDA-approved naloxone products.
• Naloxone Access: Answering Questions
  • March 2022: Public workshop facilitated by the Reagan-Udall Foundation to explore some of the most frequently asked questions about access to naloxone.

Public Workshops

• Understanding Fatal Overdoses to Inform Product Development and Public Health Interventions to Manage Overdose
  • March 2023: Public workshop facilitated by the Reagan-Udall Foundation to understand fatal overdoses, with the goal of informing product development and public health interventions to manage overdoses.

Resources

• Food and Drug Administration Overdose Prevention Framework | FDA
• Timeline of Selected FDA Activities and Significant Events Addressing Substance Use and Overdose Prevention
• Having Naloxone on Hand Can Save a Life During an Opioid Overdose
• Opioid Medications