PHAR 100 Chapter 5: Module 5
10 Sep 2020
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Document Summary
Drugs are divided into two main categories: prescription drugs: drugs restricted to sale by prescription only, non-prescription drugs: drugs that can be sold to the general public without a prescription. This category includes over the counter (otc) drugs. Over the counter (otc) drugs are sold without prescription based on the premise that the general public is able to diagnose mild symptoms and to select appropriate agents to treat these symptoms. The sale of otc is controlled by a section of the food and drugs act, which controls the safety, efficacy, advertising, and sale of these products. Not all otc products have been subjected to controlled clinical trials. They are available because they have been on the market and have been used for decades (e. g. acetaminophen). This is known as grandparenting (a process where new regulations do not apply to those products already on the market). All new otc products are subjected to rigorous preclinical testing for safety.
