ABSTRACT
Over-the-counter (OTC) drug research deals primarily with active ingredients and combinations of active ingredients that have been shown to be safe and effective for their intended use and can be labeled with appropriate directions and warnings such that the consumer can utilize the product for the purposes of self-medication. Generally, OTC products do not contain new chemical entities but are, in fact, old ingredients or new combinations of old ingredients and/or new brand names. The development and marketing of products for OTC use typically ranges from 1 to 3 years in duration. A team effort is involved in identifying a concept or claim which has a unique selling point (USP) and in formulating and making available for sale a product which delivers the USP. This chapter demonstrates the unique characteristics of the OTC market in the pharmaceutical industry by evaluating the organizational makeup or structure of competing companies.
