Chapter 3: Drug Regulation, Development, Names, and Information

Question 1

Federal Pure Food and Drug Act of 1906.

Answer 1

-law set standards for drug quality and purity in addition to strength.

-It specifically focused on product labeling and required that any variations from the standards be placed on the label.

Question 1

The first American law to regulate drugs was

Answer 1

Federal Pure Food and Drug Act of 1906.

Question 2

First legislation to address drug safety.

Answer 2

Food, Drug, and Cosmetic Act, passed in 1938,

Question 3

Food, Drug, and Cosmetic Act, passed in 1938,

Answer 3

Congress required that all new drugs undergo testing for safety.

Question 4

Harris-Kefauver Amendments

Answer 4

sought to strengthen all aspects of drug regulation.

established rigorous procedures for testing new drugs.

Question 5

A major provision of Harris-Kefauver Amendments

Answer 5

A major provision of the bill required that drugs be proved effective before marketing.

Question 6

First law to demand that drugs offer some benefit:

Answer 6

Harris-Kefauver Amendments

Question 7

Controlled Substances Act

Answer 7

This legislation set rules for the manufacture and distribution of drugs considered to have the potential for abuse.

Question 8

One provision of Controlled Substances Act

Answer 8

One provision of the law defines five categories of controlled substances, referred to as Schedules I, II, III, IV, and V.

Question 9

What does Schedule I drug mean?

Answer 9

Drugs in Schedule I have no accepted medical use in the United States and are deemed to have a high potential for abuse.

Question 10

What does Schedule II-V drug mean?

Answer 10

Drugs in Schedules II through V have accepted medical applications but also have a high potential for abuse.

Question 11

Pediatric Research Equity Act (PREA) of 2003

Answer 11

—were designed to promote much-needed research on drug efficacy and safety in children.

Question 12

The PREA gave the FDA power to what?

Answer 12

The PREA gives the FDA the power, for the first time, to require drug companies to conduct pediatric clinical trials on new medications that might be used by children.

Question 13

The three Types of Drug Names:

Answer 13

Drugs have three types of names:
1) a chemical name,

(2) a generic or nonproprietary name, and

(3) a brand or proprietary name

Question 14

Chemical Name:

Answer 14

The chemical name constitutes a description of a drug using the nomenclature of chemistry.

Question 15

Generic name is known as

Answer 15

nonproprietary name.

Question 16

Generic name:

Answer 16

The generic name of a drug is assigned by the U.S. Adopted Names Council.

Question 17

Brand Name is also known as

Answer 17

Brand names, also known as proprietary or trade names,

Question 18

Brand name:

Answer 18

Brand names, also known as proprietary or trade names, are the names under which a drug is marketed.

Question 19

Brand names must

Answer 19

• be approved by the FDA
• must not supposed to imply efficacy

Question 20

Problems with Brand Names:

Answer 20

1. A single drug can have multiple brand names
2. Over-the-Counter Products With the Same Brand Name May Have Different Active Ingredients
3. Brand Names Can Endanger International Travelers

Question 21

Brand Names Can Endanger International Travelers why?

Answer 21

1. First, the brand name used in one country may differ from the brand name used in another country.
2. The second (and more disturbing) problem is this: Products with the identical brand names may have different active ingredients, depending on where you buy the drug