Pharmacy Laws

Question 1

Food and Drug Act of 1906

Answer 1

prohibited interstate commerce in adulterated or misbranded food, drinks, and drugs. government pre-approval of drugs is required

Question 2

1914 Harrison Tax Act

Answer 2

established that manufacturers, pharmacists, importers and physicians prescribing narcotics should be licensed and pay a tax

Question 3

1927 Food, Drug, and Insecticide Administration

Answer 3

renamed as the Food and Drug Administration, law enforcement agency

Question 4

1938 Food, Drug, and Cosmetic Act

Answer 4

requires new drugs to be shown to be safe before marketing

Question 5

1950 Alberty Food Products vs. US

Answer 5

purposed for which a drug is to be used must be included on the label

Question 6

1951 Durham-Humphrey Amendment

Answer 6

defines what drugs require a prescription by a licensed practitioner and include the legend

Question 7

1962 Kefauver-Harris Amendment

Answer 7

requires drug manufacturers to provide proof of both safety and effectiveness before marketing

Question 8

1966 Fair Packaging and Labeling Act

Answer 8

consumer products in interstate commerce to be honestly and informatively labeled

Question 9

1970 Poison Prevention Packaging Act

Answer 9

requires child-proof packaging on all controlled and most prescription drug dispensed

Question 10

1970 Controlled Substances Act

Answer 10

classifies five level of drugs that have potential for abuse and therefore restricts their distributions

Question 11

1976 Medical Device Amendment

Answer 11

requires approval for safety and effectiveness of life-sustaining or life-supporting medical devices

Question 12

1983 Orphan Drug Act

Answer 12

provides incentives to promote research, approval, and marketing of drugs needed for treatment of rare diseases

Question 13

1984 Drug Price Competition and Patent Term Restoration Act

Answer 13

allowed extension of drug patents terms and quicker introduction of lower-cost generic drugs

Question 14

1987 Prescription Marketing Act

Answer 14

restricts distribution of prescription drugs to legitimate commercial channels

Question 15

1990 Omnibus Budget Reconciliation Act

Answer 15

requires pharmacists to offer counseling to Medicaid patients regarding medications

Question 16

1990 Anabolic Steroid Control Act

Answer 16

passed to address the abuse of steroids by athletes

Question 17

1996 Health Insurance Portability and Accountability Act

Answer 17

defined the scope of health information that may and may not be shared without patient consent

Question 18

The Combat Methamphetamine Epidemic Act

Answer 18

sets daily and monthly restrictions on the amount of ephedrine and pseudoephedrine (3.6 g per day and 7.5 g per month)