1. The OTC monograph for a specific class of ingredients was codified in an official, legally binding

A. Treatment IND Program.

B. FDA journal.

C. Code of Federal Regulations (CFR).

D. amendment to the Orphan Drug Act of 1983.

2. Phase _______ of clinical testing is required by the FDA before drug approval and uses the greatest number of subjects.

A. 1

B. 4

C. 2

D. 3

3. The Controlled Substances Act of 1970 categorized drugs such as morphine and meperidine as Schedule _______ drugs.

A. I

B. II

C. IV

D. III

4. Phase _______ of clinical testing uses the fewest number of subjects and establishes the dose at which signs of toxicity appear.

A. 3

B. 4

C. 2

D. 1

5. Given the following information for three new drugs, which drug has the greatest margin of safety?

LD50 (milligrams) ED50 (milligrams)
Drug A 200 60
Drug B 120 10
Drug C 240 2

A. Drug A

B. Drug C

C. They all have the same margin of safety.

D. Drug B

6. A tragedy with which drug was responsible for the passage of the Federal Food, Drug, and Cosmetic Act of 1938 that required the establishment of drug safety standards?

A. Strychnine

B. Thalidomide

C. Sulfanilamide

D. Ergot

7. The Federal Pure Food and Drug Act of 1906 defined an adulterated drug as a drug that

A. was prepared with alcohol or similar substances.

B. contains ergot, digitalis, or quinine.

C. contains a decomposed substance or whose strength, quality, or purity is different from what's indicated on the label.

D. has false or misleading labeling.

8. A tragedy with which drug was responsible for the passage of the Kefauver-Harris Amendment in 1962 that called for more drug safety?

A. Ergot

B. Sulfanilamide

C. Thalidomide

D. Strychnine

9. Phase 4 of Clinical Trials and the New Drug Application may take _______ years to monitor durability of response.

A. 5-10

B. 3-5

C. 10-15

D. 1-5

10. The dose of a test drug that causes death in the animal during short-term toxicity testing is referred to as the

A. lethal dose.

B. control.

C. placebo.

D. effective dose.

11. The Kefauver-Harris Amendment of 1962 required that a drug be

A. not only safe but effective.

B. inventoried by the pharmacist every two years.

C. labeled as either an over-the-counter (OTC) or prescription drug.

D. used prior to proof of effectiveness, if necessary.

12. According to the Controlled Substances Act of 1970, drugs that have the lowest abuse rate are under what schedule?

A. IV

B. V

C. III

D. I

13. How long does it take for the average new drug to be tested and approved for sale in the United States?

A. 2 years

B. 30 days

C. 3 to 5 years

D. 11 years

14. Which of the following is not a birth defect that's caused by a teratogenic effect?

A. Missing ears

B. Cleft palate

C. Different colored eyes

D. Open spinal cord

15. The "treatment use" of investigational drugs usually occurs at which stage of drug testing?

A. During FDA review of a new drug application (NDA)

B. During Phase 1 clinical testing

C. During long-term animal toxicity testing

D. During FDA review of the investigational new drug application

16. Quinine, which is found in the bark of the cinchona tree, is effective in

A. reducing the burning sensations of St. Anthony's Fire.

B. reducing convulsions caused by the use of strychnine.

C. reducing fever and other symptoms associated with malaria.

D. treating serious bacterial infections.

17. The approval of a new drug application (NDA) by the FDA allows for which of the following?

A. The drug is allowed to be shipped for the first time through interstate commerce.

B. The manufacturer is allowed to sell the drug in the United States.

C. The drug is allowed to be tested in humans for the first time.

D. The drug is allowed to be tested in animals for safety.

18. The post-marketing surveillance phase of drug development

A. reports previously discovered toxic reactions.

B. includes surveys and reports of adverse reactions as well as consumer watchdog information.

C. reports only short-term toxicity test results.

D. depends solely on the reports of prescribers of the drug.

19. The Federal Pure Food and Drug Act of 1906 was concerned with

A. establishing guidelines for drug labeling and interstate transport of certain foods and drugs.

B. establishing guidelines for dispensing controlled substances.

C. placing regulations on drug manufacturers and pharmacists.

D. safety issues regarding botanicals and adulterated drugs.

20. The law that prohibited the marketing of new drugs unless they were adequately tested to demonstrate safety was the

A. Federal Food, Drug, and Cosmetic Act of 1938.

B. Controlled Substances Act of 1970.

C. Poison Prevention Packaging Act of 1970.

D. Federal Pure Food and Drug Act of 1906.