History

Question 1

Federal Pure Drug and Food act of 1906

Answer 1

Set guidelines for drug labeling

Question 2

Federal Food, Drug and Cosmetic act of 1938

Answer 2

Required demonstration of safety and FDA approval for new drugs

Question 3

Durham-Humphrey Amendment, 1952

Answer 3

Distinguished between prescription and

nonprescription drugs

Question 4

Kefauver-Harris Amendment, 1962

Answer 4

Required demonstration of safety and effectiveness

Question 5

Controlled Substances Act, 1970

Answer 5

Regulated use and distribution of drugs having

addictive or abuse potential

Question 6

Poison Prevention Packaging Act, 1970

Answer 6

Required dispensing of prescriptions in childresistant

containers

Question 7

The Health Insurance Portability and Accountability Act of 1996 (HIPAA)

Answer 7

Rules and regulations passed by Congress to protect the privacy of patients.

Question 8

Medicare Prescription Drug Improvement and Modernization Act (MMA) of 2003

Answer 8

Medicare Part D is an
optional drug coverage plan based on the idea that individual
Medicare beneficiaries should have the ability to choose a
private drug plan that best meets their needs.