Utah Law Exam

Question 1

Prescriptive authority

Answer 1

Laws telling you what you MUST do

Question 2

Proscriptive authority

Answer 2

Laws telling you what you must NOT do

Question 3

Federal Law is primarily concerned with:

Answer 3

Manufacture and distribution of drugs

Question 4

State Law is primarily concerned with

Answer 4

Licensing standards

Question 5

Pure Food and Drugs Act (1906) Purpose

Answer 5

Safety: prohibited misbranding/adulteration of drugs

Question 6

Pure Food and Drugs Act (1906) Loopholes

Answer 6

Labels not required
Only applied to ingredients, not efficacy claims
Didn’t ban UNSAFE drugs

Question 7

Food, Drug, Cosmetic Act (FDCA, 1938) was prompted by what?

Answer 7

Sulfanilimide tragedy, diethylene glycol killed many children

Question 8

Food, Drug, Cosmetic Act (FDCA, 1938) requires

Answer 8

All drugs to be tested for safety prior to approval

Label required to have “adequate directions for use”

Question 9

Which legislation required “adequate directions for use”?

Answer 9

Food, Drug, Cosmetic Act (FDCA, 1938)

Question 10

Durham-Humphrey Amendment (1951)

Answer 10

Exempted rx drugs from “adequate directions for use”
Created “legend drugs” (prescriptions)
Allowed verbal rx and refills

Question 11

Which legislation created “legend drugs”?

Answer 11

Durham-Humphrey Amendment (1951)

Question 12

Kefauver-Harris Amendments (1962)

Answer 12

Required drugs be tested for efficacy
Good manufacturing practices
New Drug Approval Process

Question 13

What legislation required drugs to be tested for safety?

Answer 13

Food, Drug, Cosmetic Act (FDCA, 1938)

Question 14

What legislation required drugs to be tested for efficacy?

Answer 14

Kefauver Harris Amendments (1962)

Question 15

Poison Prevention Packaging Act (1970)

Answer 15

Special packaging for CS and rx

Child resistant containers