Encouraging Harm Reduction

To reduce morbidity and mortality associated with overdoses, FDA is:​

  • Expanding availability and access to overdose reversal products, including naloxone, by supporting accelerated review of products and exploring over-the-counter access.
  • Supporting development of novel overdose reversal products.
  • Supporting development and authorization of fentanyl test strips to test human specimens at the point of care.

United States Government Partners

  • Department of Health & Human Services (HHS)
  • National Institutes of Health (NIH)
  • Centers for Disease Control and Prevention (CDC)
  • Centers for Medicare & Medicaid Services (CMS)
  • Substance Abuse and Mental Health Services Administration (SAMHSA)
  • Indian Health Service (IHS)

FDA Activities

  • Naloxone
  • FDA Opioid Systems Modeling Effort
  • Abuse-Deterrent Formulations
  • Disposal of Unused Medicines: What You Should Know
  • Safety Measures for Extended-release and Long-acting (ER/LA) Opioids
  • Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)
  • Safety Measures for Immediate Release (IR) Opioids
  • Oxymorphone (marketed as Opana ER) Information
  • SUPPORT Act Section 6012: Report on Abuse-Deterrent Opioid Formulations and Access Barriers Under Medicare
  • Safety Measures for Opioid Analgesics, Prescription Opioid Cough Products, and Benzodiazepines

Source of information www.fda.gov