Module 8

Question 1

also called ethical drugs

Answer 1

Prescription drugs

Question 2

also called OTC or proprietary drugs

Answer 2

Over-the-counter drugs

Question 3

A group consisting of industry and academic
personnel, medical practitioners, and government officials who:
o Provide test standards
o Establish classification systems
o Conduct drug research and testing
o Assist medical practitioners in using drugs effectively
o Publish the U.S. Pharmacopeia and the National Formulary

Answer 3

U.S. Pharmacopeial Convention

Question 4

are products or articles intended for use in dealing with disease or injury, including the treatment, cure, and mitigation of disease and disease prevention in humans and animals.

Answer 4

Pharmaceuticals (drugs)

Question 5

Experts from industry, government, and academia are elected every five years to work on the publication of these two voluntary standards.

Answer 5

U.S. Pharmacopeia (USP) and the National Formulary (NF)

Question 6

a specification published in the USP for a particular drug product.

Answer 6

Monograph

Question 7

a product that is recognized by the Homeopathic Pharmacopoeia of the United States, the National Formulary, and the USP. In addition:
o It must be intended for use in treatment, mitigation, diagnosis, cure, or prevention of disease in humans or other animals.
o It affects the structure or any function of the body of humans or animals and is not food.

Answer 7

Drug

Question 8

The recent increase in health claims on food packages led to a new product grouping called

Answer 8

neutraceuticals

Question 9

Is a product that can be obtained legally only through a doctor’s (physician’s) written prescription.

Answer 9

prescription drug

Question 10

can be purchased for self-medication without the approval of a doctor. These products are also referred to as proprietary drugs.

Answer 10

OTC drugs

Question 11

refers to methods of administering the drug that do not involve the intestines. In other words, the product is not swallowed.

Answer 11

Parenteral drugs

Question 12

Instruments, apparatuses, implements, machines, contrivances, implants, in vitro reagents, and similar articles, including parts, components, and accessories, are referred to as

Answer 12

medical devices

Question 13

refers to the way that the packaged product is delivered for use.

Answer 13

Presentation