Issue link: https://www.e-digitaleditions.com/i/541292
T 28 July 2015 Tablets & Capsules lifecycle management A bright future for Rx-to-OTC switches Helmut H. Albrecht H2A Associates Bob Nissen Nissen Consulting Group Manufacturers and consumers alike benefit when prescription drug products become available over the counter. This article summarizes those benefits, describes how Rx-to-OTC switches come about, and describes why more products are likely to migrate from the shelves of pharmacies to the aisles of drug stores and other retailers. o receive prescription (Rx) drug products, you must present a valid prescription from a healthcare professional (HCP), while over-the-counter (OTC) drugs are sold directly to consumers without a prescription. The FDA has issued guidance documents specific to OTC medi- cines [1]. How each drug product is sold is for the FDA to decide. For it to be sold as an OTC, the product must: