Food and Drug Administration (FDA) has released new guidance to address the accessibility and availability challenges of naloxone products in underserved communities. The document, “Exemption and Exclusion from Certain Requirements of the DSCSA for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency,” does not include information about the current prescription-only status of FDA-approved naloxone products.
Health care providers, including pharmacists, are encouraged to submit comments regarding this guidance to Docket No. FDA-2022-D-1847, https://www.regulations.gov/docket/FDA-2022-D-1847.
On November 15, FDA issued a Federal Register notice, Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use, that may help facilitate the development and approval of certain nonprescription naloxone drug products, including through the switch of certain naloxone drug products from prescription status to nonprescription status. Naloxone is a medicine that can help reduce opioid overdose deaths when administered in a timely manner, usually within minutes of the first signs of an opioid overdose, to counter the overdose effects.
The Federal Register notice is available at https://www.federalregister.gov/public-inspection/2022-24874/safety-and-effectiveness-of-certain-naloxone-hydrochloride-drug-products-for-nonprescription-use.