Drug Laws and Acts

Question 1

1906 Pure Food and Drug Act

Answer 1

Drugs to be labeled and manufactured according to U.S.P. and N.F.
11 narcotic/habit-forming drugs listed and required to be labeled
Drugs do not have to be safe nor effective

Question 2

1938 Federal Food, Drug and Cosmetic Act

Answer 2

Drugs must be tested for toxicity in animals and clinical trials before petitioning the FDA for approval
Quality and purity of origin must conform to standards in U.S.P. and N.F.
Habit-forming drugs must be named and strengths given with a warning
Label must have adequate directions for use

Question 3

1952 Durham-Humphrey Amendment

Answer 3

Distinguishes prescription drugs from over-the-counter drugs
Expanded laws on dispensing prescription drugs
Established state control over physicians’ licenses to prescribe non-controlled legend drugs

Question 4

1962 Kefauver-Harris Drug Amendments

Answer 4

Expanded experimental data necessary to determine safety

Drug’s usefulness must outweigh dangers

Question 5

1970 Drug Abuse Prevention and Control Act

Answer 5

Applies to all dependence-causing drugs obtainable by prescription
Created resources for research into prevention of drug use
Created resources for treatment and rehab of drug users
Strengthened law enforcement authority
Improved regulation on manufacture and distribution