FDA Encourages OTC Naloxone and Expanded Access at Pharmacies


Approved forms should be considered as options for community distribution.


Despite confusion over injectable naloxone and the need for OTC naloxone, Acting FDA Commissioner Norman E. "Ned" Sharpless, MD, assured consumers and healthcare professionals that the agency is working to provide more access to the opioid-reversal drug.

“Naloxone is a critical tool for individuals, families, first responders and communities to help reduce opioid overdose deaths,” says Sharpless in a statement. “Access to naloxone, however, continues to be limited in some communities.”

There are three FDA-approved forms of naloxone-injectable, auto-injector, and nasal spray-and all three currently require a prescription, which can be a barrier for people without access to a healthcare provider or are apprehensive about admitting to issues with substance abuse, Sharpless acknowledges.

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“There is also a persistent misunderstanding that the FDA-approved labeling for the injectable form of naloxone, the least expensive option, precludes administration outside a healthcare setting. This has created confusion among public health officials and community-based organizations about whether the injectable form of naloxone can be used as part of their distribution programs,” Sharpless says. 

In fact, the FDA-approved product labeling for the three forms of naloxone does not exclude dispensing by pharmacies or community distribution programs. “All three forms of naloxone are FDA-approved and may be considered as options for community distribution and use by individuals with or without medical training to stop or reverse the effects of an opioid overdose,” Sharpless says.

Most states and the District of Columbia have passed laws that allow pharmacists to dispense naloxone under a standing order, which takes the place of an individual prescription. Some states also have given pharmacists direct authority to prescribe and sell naloxone to consumers. 

“Still, many pharmacists may be unaware of the standing orders and direct authority in their states or are unwilling to provide all forms of naloxone to consumers without an individual prescription,” Sharpless says.

FDA also approved the first generic naloxone hydrochloride nasal spray in April. 

“The FDA is also granting priority review to all generic applications for products that can be used as emergency treatment of known or suspected opioid overdose. As part of the priority review, sponsors will receive shorter goal dates or standard goal dates with earlier reviewer deadlines; enhanced agency communication with sponsors; and expanded agency engagement, such as pre-submission and mid-cycle meetings,” FDA says.

The agency is also working to make naloxone more widely available in every pharmacy as an approved OTC product. “In January, we took an unprecedented step in helping to encourage development of OTC naloxone products. To encourage drug companies to enter the OTC market, the FDA designed, tested and validated the key labeling requirements necessary to approve an OTC version of naloxone,” Sharpless says.

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FDA developed a model Drug Facts label (DFL) with pictogram instructions so “anyone with access to the drug can better understand how to administer it,” Sharpless says. To ensure the pictograms are easy to understand, FDA also conducted label comprehension testing with consumers. “This was the first time the FDA proactively developed and tested a DFL to support development of an OTC product,” Sharpless says.

“With one of the key components for OTC availability now in place, drug companies can use this information as part of an application to obtain approval for OTC naloxone. We are continuing to work with industry partners who are interested in developing these OTC naloxone products,” Sharpless adds.


Following a public meeting, FDA is also exploring more ways to increase the availability of all forms of naloxone, such as working with manufacturers to see if shelf-life extensions for naloxone products are possible; conducting additional research on naloxone; and considering situations where co-prescribing of naloxone may be appropriate including possible updated product labeling, Sharpless says.

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