Federal Legislation

Question 1

Pure Food and Drug Act, 1906

Answer 1

Outlawed sale of compromised/misbranded drugs

Question 2

Food, Drug and Cosmetic Act, 1938

Answer 2

Manufacturers must file an NDA (New Drug Application) to FDA and meet standards
Sulfanilamide tragedy

Question 3

Durham-Humphrey Amendment, 1951

Answer 3

Established clear criteria as to what constituted a “prescription drug” and the circumstances in which it can be dispensed
Prescriptions allowed to be made over phone

Question 4

*Kefauver-Harris Amendment, 1963

Answer 4

Guarantee the safety, purity, and efficacy of both prescription and non-prescription medicines
Require site inspection and FDA supervision
Thalidomide tragedy

Question 5

Controlled Substances Act, 1970

Answer 5

Introduce measures for the safe organization of controlled substances

Question 6

Poison Prevention Packaging Act, 1970

Answer 6

Introduced child resistant packaging

Question 7

*Occupational Health and Safety Act, 1970

Answer 7

Mandated employers to ensure that their employees were working in a safe environment, free from risk
Introduced SDS (safety data sheets) that must contain information on the hazards the drug or chemical poses

Question 8

Drug Listing Act, 1972

Answer 8

Drugs must be identified (NDC)

Question 9

Federal Hazardous Substances Act, 1960

Answer 9

Hazardous drugs were managed and disposed of in the safe and correct manner

Question 10

Orphan Drug Act, 1983

Answer 10

Treat rare diseases

Question 11

Drug Price Competition and Patent Term Restoration Act, 1984

Answer 11

Drug manufacturers were incentivized to develop new medicines
Shorter period to approve generic drugs, reducing costs for medicines

Question 12

Prescription Drug Marketing Act, 1987

Answer 12

Prevented the sale or distribution of drug samples
Prevents reimportation of drug into the US by anyone except the original drug manufacturer

Question 13

*Omnibus Budget Reconciliation Act, 1990

Answer 13

Required pharmacies, who filled prescriptions for Medicaid patients, to keep a database of basic patient information
Introduced DUR (drug utilization review) & patient counseling by pharmacists

Question 14

Anabolic Steroids Control Act, 1990

Answer 14

Allow the CSA (Controlled Substances Act) to regulate anabolic steroids
C-III

Question 15

*Health Insurance Portability and Accountability Act, 1996

Answer 15

The rights of patients over information kept on patient databases – such as access to records.
Confidentiality of PHI, (protected healthcare information)
Patients giving consent that they have no questions regarding confidentiality of their personal data in each scenario.

Question 16

FDA Modernization Act, 1997

Answer 16

Improve the standards of how medical products, food, and cosmetics were produced
Introduced Rx Only on legend medication

Question 17

Medicare Prescription Drug, Improvement, and Modernization Act, 2003

Answer 17

Provided financial benefits for patients eligible for Medicare, specifically Medicare Part D (prescription drugs)
Introduced MTM (medication therapy management)

Question 18

Combat Methamphetamine Epidemic Act, 2005

Answer 18

Prevent the use and manufacture of methamphetamine
Locked up ephedrine & pseudopherdrine