FDA Issues Order To Authorize Naloxone Sale

The Food and Drug Administration (FDA) has issued a notice that could help increase access to opioid overdose-reversing naloxone drug products without a prescription, paving the way for more of them to be available over the counter.

According to the FDA commissioner, the agency will maintain overdose prevention and reduction in substance use disorders as a key priority and area of intense strategic focus for action as soon as possible.

Naloxone is available in all 50 states, and many states have laws that allow pharmacists to dispense naloxone without a prescription, according to the CDC. Naloxone may also be distributed through community-based programmes and syringe exchange services.

When given to an overdosing person in a timely manner, naloxone blocks opiate receptors in the nervous system and rapidly reverses opioid overdoses. According to preliminary data from the Centers for Disease Control and Prevention, more than 107,000 Americans died from an overdose in 2021. Approximately 75% of those overdoses were caused by opioids, such as heroin and fentanyl.

While the assessment is a step forward, it is not a final determination that certain naloxone products are safe and effective for nonprescription use, nor does it require that naloxone products be made available for purchase over the counter immediately. The FDA will make the final decision based on additional data that would normally be included in an application for a proposed nonprescription naloxone product.

This is just one of many steps taken in recent years by the FDA and other public health agencies to combat the nation's overdose crisis. The FDA has established the FDA Overdose Prevention Framework, which aims to take effective, innovative steps to prevent drug overdoses and deaths.

In addition to the FDA's push to make naloxone more widely available, the CDC has advocated for testing strips, a harm reduction tool that allows drug users to check for the presence of fentanyl in their substances. According to preliminary CDC data, fentanyl was present in more than 71,000 overdose deaths in 2021.

Other solutions to reduce overdose deaths are being tested at the state and local levels across the country. New York City opened the country's first legal supervised injection site in late 2021, where people who use drugs can do so in a clean environment with medical staff on hand to administer naloxone or other medications if needed. Colorado and Massachusetts have both considered similar sites.

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