Pharmacy Laws & Regulations

Question 1

Prescription drug advertising is regulated primarily by the ____.

Answer 1

FDA

Question 2

OTC drug advertising is regulated primarily by the Consumer Product Safety Commission, which is under the _____.

Answer 2

FTC (Federal Trade Commission)

Question 3

The FDA’s minimum requirements for what an advertisement must contain are the following 3 points:

1. ______
2. ______
3. ______

Answer 3

1. At least 1 approved use
2. The generic name
3. Brief summary or major statement or “adequate provision” of the drug’s risks (adequate provision means a way for the audience to find the drug’s important safety information)

Question 4

Any false or misleading statements about a drug in an advertisement could be considered ______.

Answer 4

Misbranding

Question 5

The _________ of 1890 attempted to outlaw monopolies that blocked competition by nefarious methods, such as price-fixing, deceptive marketing practices, and excluding competition from markets.

Answer 5

Sherman Antitrust Act of 1890

Question 6

The Pure Food and Drug Act of 1906 is also known as the ____.

Answer 6

Wiley Act

Question 7

The ______ Act requires that no adulterated or misbranded drug’s could be sent through interstate commerce.

Answer 7

The Pure Food and Drug Act of 1906

Question 8

______ means that the drug itself is bad (drug quality is not up to standard).

A. Adulteration
B. Misbranding

Answer 8

A. Adulteration

Question 9

______ means the label is inaccurate.

Answer 9

Misbranding

Question 10

This act mandated accurate product labeling, and required the ingredients used in drugs meet the standards of strength, quality, and purity in the USP/NF

Answer 10

The Pure Food and Drug Act of 1906 (The Wiley Act)

Question 11

This act required the food or drug label could not be false or misleading, and the presence and amount of 11 dangerous ingredients (including alcohol, heroin, and cocaine) had to be listed.

Answer 11

The Pure Food and Drug Act of 1906 (The Wiley Act)

Question 12

This act required that the manufacturer prove the safety of a drug before it could be marketed.

Answer 12

The Food, Drug, and Cosmetic Act (FDCA) of 1938

Question 13

Due to this act in 1938, drug claims from that point forward must be accurate and all ingredients must be list d on the label so that the public is aware of what they are ingesting.

Answer 13

The Food, Drug, and Cosmetic Act (FDCA) of 1938

Question 14

True or False: Under the FDCA of 1938, drugs only have to be proven safe, NOT effective.

Answer 14

True

Question 15

True or False: the Durham-Humphrey Amendment of 1951 was an amendment to the FDCA that established 2 classes of drugs.

Answer 15

True

Question 16

This act, established in 1944, required that biologics be approved for purity, potency, and safety.

Answer 16

Public Health Service Act of 1944

Question 17

Biologics are NOT approved under an NDA, but rather, under a _____ application.

Answer 17

Biologics License Application (BLA)

Question 18

Another term used for prescription drugs are ____ drugs.

Answer 18

Legend

Question 19

The _____ made a clear distinction between OTC and prescription dugs by classifying 3 conditions that would make drug available only by prescription.

Answer 19

The Durham-Humphrey Amendment of 1951

Question 20

The Durham-Humphrey Amendment was established in this year.

Answer 20

1951

Question 21

What are the 3 conditions established by the Durham-Humphrey Amendment of 1951 that make a drug available only by prescription?

Answer 21

1. Drugs that are habit-forming
2. Drugs considered unsafe for use except under expert supervision due to toxicity concerns
3. Drugs limited to prescription use only under a manufacturer’s NDA

Question 22

This amendment to the FDCA required drugs to be safe AND effective.

Answer 22

Kefauver-Harris Amendment of 1962