Laws

Question 1

Food and Drug Act of 1906

Answer 1

Prohibited interstate commerce in adulterated or misbramded food, drinks, and drugs. Goverment preapproval of drugs is required

Question 2

1938 Food, Drug and Cosmetic (FDC) Act

Answer 2

In response to fatal poisoning of 107 by an untested sulfanilamide concoction, this comprehensive law requires new drugs to be shown safe before being marketed

Question 3

1951 Durham Humphry Amendment

Answer 3

Defines what drugs require a prescription by a licensed practitioner and requires them to include
“Caution: Federal Law prohibits dispensing without a prescription” on the label

Question 4

1962 Kefauver Harris Amendments

Answer 4

Requires drug manufacturers to provide proof of both saftey and effectiveness before marketing drugs

Question 5

1970 Poison Prevention Packaging Act

Answer 5

Rrquires childproof packaging on all controlled and most prescription drugs dispensed by pharmacies

Question 6

1970 Controlled Substances Act (CSA)

Answer 6

The CSA classifies drugs that may be easiley abused and restricts their distribution. It is enforced by the Drug Enforcement Administration (DEA) within the Justice Department

Question 7

1990 Omnibus Budget Reconciliation Act (OBRA)

Answer 7

Requires pharmacists to offer counseling to Medicaid pateints regarding medications, effectively putting the common practice into law. Among other things.