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FDA paves a path for OTC naloxone

August 12, 2016
by Julie Miller, Editor in Chief
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In a blog posted by Karen Mahoney, MD, a deputy director for FDA, the agency vowed that it would assist pharmaceutical manufacturers in submitting applications for approval of over-the-counter (OTC) naloxone. The drug is still classified as a prescription product as far as FDA is concerned, and a specific process is required for a prescription product to be approved for dispensing OTC.

One recent example of the “Rx to OTC” switch is in the class of allergy medications. Rhinocort (budesonide) nasal spray received its OTC classification in 2015, and Flonase nasal spray (fluticasone proprionate) in 2014. A number of antihistamine, antifungal and acid reducers are also familiar OTC products that previously required a prescription. However, Rx to OTC switches are relatively few and far between.

The reason why naloxone can be dispensed without a prescription at so many pharmacy counters today is because the authority to regulate the practice of pharmacy is left up to the states—FDA is only responsible for approving the products themselves. A spokesperson for FDA tells Behavioral Healthcare that  standing orders to allow OTC dispensing are a different regulatory area, so it’s not within FDA’s purview. Ideally, FDA would approve OTC versions of naloxone in advance of their being dispensed, but it’s up to the manufacturers to apply for such a designation.

FDA is also helping manufacturers pursue approvals for the package labels that would be required for OTC naloxone. Labels would contain consumer-facing information, rather than information in the language of clinical professionals. Manufacturers must conduct studies to show that consumers can follow the new label without the help of a healthcare professional. According to Mahoney, FDA created a pictogram label that manufacturers can use as a model.

The FDA spokesperson, who is a pharmacist, also says that naloxone seems like a good fit for OTC because of its current use in the community. As part of a new opioid crisis response, federal agencies are trying to encourage greater use of naloxone.

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