ABSTRACT
The regulation of drug quality involves three arrangements in the United States that has led the world in creating and promulgating ordinances to regulate the drug industry. First, the U.S. Congress gave the U.S. Pharmacopeia (USP) and the National Formulary (NF) revision committees the authority to set standards of strength, quality, and purity of drugs and their nished preparations. Nevertheless, the USP and NF remain as private entity with no authority over the Food and Drug Administration (FDA). The FDA, also authorized by the U.S. Congress, establishes regulations for the development and manufacture of safe and effective drugs. Finally, in-house good manufacturing practices of the manufacturer, mostly dictated by the FDA regulations, assure quality of drug products. The FDA has also decreed on the bioavailability (BA) and bioequivalence (BE) of drug products. All new drug applications (NDAs) and amended new drug applications must demonstrate in vivo BA of the drug product that is followed by an in vitro test, usually a dissolution test, of individual batches to assure the quality. Table 5.1 shows a comparison of regulatory ling requirements under various applications.
