Pharmacy Laws

Question 1

Pure Food and Drug Act (1906)

Answer 1

Required labels to contain accurate information and banned those that did

Question 2

Food, Drug, and Cosmetic Act (1938)

Answer 2

Prohibited misbranding and required drugs to be beneficial

Question 3

Harrison Narcotics Tax Act (1914)

Answer 3

Required prescription to purchase opium

Question 4

Durham Humphrey Amendment (1951)

Answer 4

Separated drugs into OTC and prescription

Question 5

Kefauver-Harris Amendment (1962)

Answer 5

Gave FDA authority to approve or reject a manufacturer’s marketing application before releasing it to consumer use (must provide appropriate research)

Question 6

Controlled Substance Act (CSA) (19570)

Answer 6

Set up drug schedules and regulated use/distribution of meds that could lead to abuse

Question 7

Poison Prevention Packaging Act (1970)

Answer 7

All meds have to be secures with childproof caps

Question 8

Drug Listing Act (1972)

Answer 8

Implemented national drug code number

Question 9

Medical Device Amendment (1976)

Answer 9

Established 3 regulatory classes for medical devices with 3 being the most regulated

Question 10

Resource Conservation and Recovery Act (1976)

Answer 10

Gave Environmental Protection Agency (EPA) authority to dispose of hazardous substances

Question 11

Orphan Drug Act (1983)

Answer 11

Receive benefits such as tax incentive and grants for manufacturing meds for rare diseases

Question 12

Drug Competition and Patent Term Restoration Act (1984)

Answer 12

Encourages manufacturing of generic drugs and outlined approval by FDA and gave market exclusivity for brand name

Question 13

Prescription Drug Marketing Act (1987)

Answer 13

Prevent counterfeit drugs by providing legal safeguards in the chain of distribution (no expired, counterfeit, discontinued, or misbranded drugs)

Question 14

Omnibus Budget Reconciliation Act (OBRA) (1990)

Answer 14

Require pharmacist to to counsel patients on medical coverage

Question 15

FDA Safe Medical Devices Act (1990)

Answer 15

Implemented medical device reporting (MDR) to track serious incidents that occurred from using medical devices

Question 16

Anabolic Steroids Control Act (1990)

Answer 16

Classified anabolic steroids as CIII and increased penalties for illegal use

Question 17

Americans with Disabilities Act (1990)

Answer 17

Protects against discrimination based on disability and must make accommodations to employees with disability

Question 18

Dietary Supplement Health and Education (1994)

Answer 18

FDA defined dietary supplement and required to follow strict labelling guidelines

Question 19

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

Answer 19

Protected health information (PHI) and patient confidentiality

Question 20

FDA Modernization Act (1997)

Answer 20

Updated Food, Drug, and Cosmetic act to include technological, trade, and public health issues (changed “caution: Federal Law prohibits dispensing without a prescription” to “Rx Only”)

Question 21

Medicare Prescription Drug Modernization Act (2003)

Answer 21

“Medicare Part D”: assistance to low-income patients with increasing drug costs with discount card