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Switch Movement: Overview of Various Key Attributes on Regulatory Scenario of OTC Legislations in U.S.

Gaurav Agnihotri, Deepak Pandurang Belsare



The Rx-to-OTC switch was a phenomenal success in USA, which was based on risk/benefit ratio of all scientific evidences in collaboration with FDA, manufacturer and consumers. Different surveys speak about the success stories of Rx-to-OTC movement as consumers experience the benefit from self-care in terms of empowerment, convenience, savings of money and time, etc. OTC perspective of scientific and regulatory bodies is based upon a valid procedure and just not goes on the benefits of manufacturers. Before switching any of the drug or molecule or ingredient, specific target population is looked out and followed by easily recognizable conditions, symptoms and evaluating the actual need of identified switch. There are various regulatory angles to OTC legislations, and this article have focused on few key of them such as safety, efficacy, clinical trial requirements, manner of labeling to be, and available regulatory pathways.

Keywords: Switch, over-the-counter, safety, efficacy, labeling, regulations


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