1. The passage of the Pure Food and Drug Act of 1906 was largely prompted by public outcry following the publication of which book?
2. The Federal Food, Drug, and Cosmetic Act (FDCA) of 1938 was enacted in direct response to which public health tragedy involving a diethylene glycol solvent?
3. What was the most significant new requirement for drugs introduced by the 1938 FDCA?
4. The Durham-Humphrey Amendment of 1951 is most famous for creating which two distinct classes of drugs?
5. The Kefauver-Harris Amendment of 1962, a response to the thalidomide disaster, required manufacturers to prove not only safety but also what?
6. Which amendment transferred jurisdiction of prescription drug advertising from the Federal Trade Commission (FTC) to the Food and Drug Administration (FDA)?
7. According to the FDCA, which of the following is part of the three-pronged definition of a “drug”?
8. An article intended to affect the structure or function of the body, but which does NOT achieve its primary intended purposes through chemical action, is most likely classified as a(n):
9. Under the FDCA, a “new drug” is one that is not generally recognized by qualified experts as:
10. Under the FDCA, which of the following best fits the legal definition of “food”?
11. A product intended to be “rubbed, poured, sprinkled, or sprayed on…the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance” is defined as a:
12. Which of the following items would most clearly be classified as a “device” under the FDCA?
13. The Dietary Supplement Health and Education Act of 1994 (DSHEA) created a new regulatory framework for products intended to supplement the diet, legally defining them as a category of:
14. Under DSHEA, a manufacturer of a dietary supplement is permitted to make which type of claim without the product being regulated as a drug?
15. Which specific disclaimer is required on the label of a dietary supplement that bears a structure/function claim?
16. A dietary supplement claiming to “help maintain healthy cholesterol levels” is an example of a:
17. What is the key distinction between “label” and “labeling” under the FDCA?
18. A Package Insert (PI) included with a shipment of a prescription drug is legally considered part of the drug’s:
19. A Patient Package Insert (PPI) is required by the FDA to be dispensed with which class of medications?
20. According to the FDCA, all information that constitutes “labeling” must not be:
21. The Pure Food and Drug Act of 1906 primarily addressed which two issues, setting the stage for future regulation?
22. Which of the following legends was established by the Durham-Humphrey Amendment to identify prescription drugs?
23. In addition to efficacy, the Kefauver-Harris Amendment established Good Manufacturing Practices (GMP) and required what from subjects in clinical trials?
24. If a product, such as a cherry-flavored lollipop, is marketed with claims to “soothe a sore throat,” how will the FDA likely classify it?
25. All written material provided by the manufacturer with a drug shipment, including brochures and promotional flyers, is considered part of the:
