FDA To Consider Authorizing Certain Naloxone Products for Over-the-Counter Use

January 6, 2023


ACHI Policy Staff

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In November, the U.S. Food and Drug Administration (FDA) released a notice of a preliminary assessment regarding the safety and efficacy of distributing certain naloxone products without a prescription.

The FDA said it will consider whether to authorize certain over-the-counter dispensing of low-dose naloxone products — up to a 4 mg spray and up to a 2 mg auto injector.

Naloxone — frequently distributed under the brand name Narcan — is a lifesaving drug that can reverse the effects of an opioid overdose. With national rates of opioid overdoses increasing in recent years, both federal and state officials are working toward making naloxone more readily available to individuals at risk of opioid overdose.

The opioid epidemic continues to be a major public health issue in Arkansas. Overdose deaths grew in Arkansas from 388 in 2019 to 546 in 2020, an increase of nearly 41%.

Earlier this year, ACHI and the Arkansas Department of Human Services launched a program called NaloxHome. Funded through the federal Substance Abuse and Mental Health Services Administration, the program provides free naloxone to hospitals to dispense at discharge from emergency departments to patients or caregivers of patients who have experienced an overdose or are at risk of an overdose. Since the program’s inception, 30 hospitals across Arkansas have enrolled.

See also our recent analysis of naloxone and opioid prescriptions in Arkansas.