Abstract
As a practicing pharmacist, one must deal with two distinct types of drug products that include FDA-approved brand or generic, and compounded product in a pharmacy. A brand-name drug product is approved by FDA after strict pre- and postclinical evaluations to make sure the drug product is effective, safe, and reliable. This further assures that the drug product can be made consistently to a high-quality standard. FDA can also grant a generic version of the brand after the expiration of the patent protection period of the drug product. Such approval needs only confirmation that the generic product is bioequivalent to the brand name product without any toxicological and safety evaluations. Both FDA-approved drug products (brand and generic) are manufactured under Good Manufacturing Practice (GMP) guidelines. These federal mandates govern the production and testing of these products. The FDA regulates and regularly inspects pharmaceutical manufacturing facilities to ensure compliance with GMPs.