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1. Who has the authority to decide whether a drug is marketed as an OTC or prescription only product?

A. The FDA B. The manufacturer. C. The DEA. D. Either the FDA or the manufacturer.

2. The Kefauver Harris Amendment mandated that:

A. OTC drugs marketed prior to 1962 had to be shown to be effective B. OTC drugs prove that they have a wide margin of safety, C. OTC drugs could be marketed as a generic version. D. OTC drugs list non-active ingredients on their label.

3. A “monograph” refers to:

A. A guide to manufacturing an OTC drug. B. A list of active ingredients found in an individual drug product. C. A list of acceptable active ingredients for an OTC drug that meet the standard of being generally recognized as safe and effective. D. A listing of adverse events associated with OTC drug use.

4. The following criteria may justify the classification of a drug as OTC instead of prescription EXCEPT:

A. It can be used safely without the supervision of a health care professional. B. The patient can make an adequate self-diagnosis. C. It has been recommended by the appropriate advisory committee. D. It has been used as a prescription drug for more than five years without a history of abuse.

5. The FDA recently enacted a change in OTC acetaminophen pediatric formulations that:

A. Prohibits dosing instructions expressed as milliliters. B. Requires a change in the solvent found in the product. C. Limits the number of dose units in a pediatric product to no more than 30. D. Sets a recommended limit on the concentration of acetaminophen in a pediatric product.

6. The most commonly abused OTC drug is generally considered to be:

A. Pseudoephedrine. B. Dextromethorphan. C. Loperamide. D. Antihistamines.

7. Which of the following is NOT a requirement for selling pseudoephedrine?

A. An ID must be presented. B. Purchaser must sign a log book. C. No more than 9 grams of pseudoephedrine may be sold per transaction. D. The drug product must be stored where it is inaccessible to the general public.

8. Which of the following is NOT a risk associated with laxative abuse?

A. Electrolyte disturbances. B. Tolerance. C. Headache. D. Abnormal heart rhythm.

9. Which statement is correct with respect to the FDA's regulation of e-cigarettes?

A. The FDA has had the authority to regulate tobacco/nicotine for more than 50 years but failed to exercise the authority. B. In enacting regulations, one of the FDA's concerns was the rise in e-cigarette use by adolescents. C. The FDA can limit the amount of nicotine in e-cigarettes but cannot regulate other ingredients. D. The FDA can restrict the advertising and promotion of e-cigarettes but cannot prohibit sales.

10. The FDA is considering modifying its OTC approval process because:

A. There are too many drugs containing acetaminophen. B. Many OTC drugs need to be reclassified as prescription products. C. The existing process is too cumbersome to quickly institute new warnings or labelling. D. The existing process does not account for the special needs of seniors.