Question Answer
The Pure Food and Drug Act of 1906? prohibited interstate commerce in misbranded or adulterated foods and drugs
The Food Drug & Cosmetic Act of 1938? required new drugs to be shown safe before marketing
The Durham-Humphrey Amendment of 1951? established a clear distinction between Rx and OTC drugs
The Kefauver-Harris Amendment of 1962? required new drug sponsors to show efficacy of their product prior to marketing
The Medical Device Amendments of 1976? established quality control procedures for devices
The Drug Price Competition and Patent Term Restoration Act of 1984? expedited the availability of generic products after patent expiration of the innovator product
The Food and Drug Administration Modernization Act of 1997? established the first safe harbor for compounding by pharmacists
The Food and Drug Administration Amendments Act of 2007? established Risk Evaluation and Mitigation Strategies (REMS) to assure safe use of safe drugs
The Drug Quality and Security Act of 2013? created a distinction between compounding pharmacies and compounding outsourcing facilities; tract and trace requirements
The FDA is led by who? a Commissioner who is appointed by the US President
What is the goal of the Center for Drug Evaluation and Research (CDER)? is to promote and protect the public by assuring that all Rx and OTC are safe and effective
What does the Office of New Drugs (OND) do? they are within the CDER; they are responsible for investigational studies during drug development, and making decisions regarding marketing approval for new drugs
CDER's Office of Surveillance and Epidemiology (OSE)? postmarket surveillance; identify ADE that didn't appear during new drug development process.
What are two types of misbranding? Commission and omission
What is considered FDA adulterated product? If the product is contaminated with an unwanted substance, held in unsanitary conditions, or not manufactured, processed, packed, or held with current good manufacturing practices (cGMP)
What is a Drug according to the FDCA? an article that is recognized in the United States Pharmacopeia or National Formulary and is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease; intended to affect the structure of the body of man or animals
What is dietary supplement? categorized as food not drug; e.g. vitamins, minerals, herbs, amino acids, enzymes, organ tissues, glandulars, and metabolites.
What is food? article used for its taste, aroma, or nutritive value
What is a device? an instrument, implant recognized by USP intended for use in diagnosis, cure, treatment, prevention; intended to affect the structure or function of the body