FDA exploring how to expand eligible Rx-to-OTC switches by utilizing pharmacy

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday announced it will hold a public hearing on March 22 and 23 to discuss how technology can expand which drug products can be switched from prescription to over-the-counter status.

"These conditions of safe use would be specific to the drug product and might require sale in certain pre-defined healthcare settings, such as a pharmacy," the agency stated in the Federal Register. "For example, some conditions of safe use could be designed to assist patients in self-selection of an appropriate medication or provide for follow-up monitoring during continued use. The conditions of use could include requiring pharmacist intervention to ensure appropriate nonprescription use."

Other innovative technologies could include diagnostics approved for use in a pharmacy setting, the agency added. "For example, some diseases or conditions might require confirmation of a diagnosis or routine monitoring using a diagnostic test (e.g., a blood test for cholesterol levels or liver function) that could be available in a pharmacy."


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