Legal Guidelines

Question 1

What did the Pure Food and Drug Act of 1906 do?

Answer 1

Required proper labelling of all drugs and proven effectiveness, prohibits adulteration and misbranding in interstate commerce

Question 2

What law requires proper labeling of all drugs?

Answer 2

Pure Food and Drug Act of 1906

Question 3

What law requires that all drugs are proven effective?

Answer 3

Pure Food and Drug Act of 1906

Question 4

What law prohibits misbranding and adulteration for drugs in interstate commerce?

Answer 4

Pure Food and Drug Act of 1906

Question 5

When was the Pure Food and Drug Act passed?

Answer 5

1906

Question 6

What did the Harrison Narcotics Act of 1914 do?

Answer 6

Stopped recreational use of opium, requires practitioners to be registered and document use of narcotics, restricted and taxed products that help create narcotics

Question 7

What law required all practitioners to be registered and document the use/ dispensing of narcotics?

Answer 7

Harrison Narcotics Act of 1914

Question 8

What law restricted and taxed products used to create narcotics?

Answer 8

Harrison Narcotics Act of 1914

Question 9

What did the Food, Drug, and Cosmetic Act of 1930 do?

Answer 9

Created the USP and National Formulary, bans false product claims, requires PPI and exact labeling

Question 10

What law created the USP and National Formulary?

Answer 10

Food, Drug, and Cosmetic Act of 1930

Question 11

What did the Durham-Humphrey Act of 1951 do?

Answer 11

Defined OTC and prescription and added a new label stating dispensing without a prescription is illegal

Question 12

What law defined OTC and prescription drugs?

Answer 12

Durham-Humphrey Act of 1951

Question 13

What did the Kefauver-Harris Amendment of 1962 do?

Answer 13

Required proof of a drug’s effectiveness and safety, requires accurate side effect information, and prevented generic names from being marketed

Question 14

What law reqiured proof of a drug’s effectiveness and safety before approval?

Answer 14

Kefauver-Harris Amendment of 1962

Question 15

What did the Comprehensive Drug Abuse Act and Prevention Act of 1970/ Controlled Substances Act require?

Answer 15

Created the drug schedules and required record keeping and security of Scheduled drugs

Question 16

What law created the Drug Schedules?

Answer 16

Controlled Substances Act

Question 17

What did the Poison Prevention Act of 1970 require?

Answer 17

Required child-proof caps for all drugs

Question 18

What law required child-proof caps?

Answer 18

Poison Prevention Act of 1970

Question 19

What did the Medical Device Amendment of 1976 do?

Answer 19

Created three regulatory classes for medical devices

Question 20

In the Medical Device Amendment of 1976, what is a Class I device?

Answer 20

General controlled devices with low risk for human use

Question 21

In the Medical Device Amendment of 1976, what is a Class II device?

Answer 21

Performance standard device with moderate risk for human use

Question 22

In the Medical Device Amendment of 1976, what is a Class III device?

Answer 22

High risk for human use and requires premarket approval

Question 23

What did the Resource Conservation and Recovery Act of 1976 do?

Answer 23

gives EPA authority in disposal of hazardous substances

Question 24

What did the Orphan Drug Act do?

Answer 24

Regulates orphan drugs and encouraged development of treatments for rare diseases

Question 25

What does HIPAA stand for?

Answer 25

Health Insurance Portability and Accountability Act

Question 26

What does HIPAA do?

Answer 26

Defined Protected Health Information and required patient authorization to transmit PHI

Question 27

When we received a drug recall notice, what must we do?

Answer 27

Act on the recall immediately and remove medication from inventory and place in designated place