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Sharpless Addresses ‘Misunderstanding’ About Naloxone Dispensing

September 30, 2019

Acting FDA Commissioner Ned Sharpless issued an update on the agency’s efforts to increase the availability of naloxone — and to clear up confusion over how the injectable form of the opioid overdose drug can be dispensed.

There is “a persistent misunderstanding” that the labeling for the injectable form of naloxone precludes administration outside a health care setting, he said. “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.”

All three forms of naloxone — injectable, auto-injector and nasal spray forms — “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,” he said.

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