Status and Applicability of U.S. Regulations

Abstract

The Food and Drug Administration (FDA) is responsible for ensuring the quality of drug products by carefully monitoring drug manufacturers’ compliance with Current Good Manufacturing Practice (CGMP) regulations. The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. Decisions regarding compliance with CGMP regulations are based on inspection of the facilities, sample analysis, and compliance history of the firm. FDA will continue to perform some inspections in European Union countries with capable inspectorates, such as product manufacturing assessment inspections to support marketing approval decisions. The FDA has the authority to deny entry to any drug if there is a question regarding its safety, identity, strength, quality, or purity. CGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. A consumer usually cannot detect that a drug product is safe or if it will work.