The FDA issued a Federal Register notice that assessed the safety and effectiveness of certain naloxone hydrochloride products for nonprescription use, hoping to make the opioid overdose reversal agent more accessible to the public. The preliminary assessment is intended to facilitate development and approval of nonprescription naloxone products. The FDA is continuing to collect data, such as product-specific data on non-prescription user interface design, including packaging and labeling. The notice requests comments from the public on whether there is data to support safe and effective nonprescription use of higher dose naloxone products and on potential consequences of a switch from prescription to nonprescription status.
