| 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 |