Module 2 Ch 1

Question 1

1906

Answer 1

Pure Food and Drug Act

Question 2

1914

Answer 2

Harrison Narcotics Tax Act

Question 3

1938

Answer 3

Federal food drug and cosmetic act

Question 4

1951

Answer 4

Durham-Humphrey Amendment

Question 5

1962

Answer 5

Kefauver-Harris Amendment

Question 6

1970

Answer 6

Poison Packaging Act
Occupational Safety and Health Act
Controlled Substances Act

Question 7

1983

Answer 7

Federal Anti-Tampering
Orphan Drug Act

Question 8

1984

Answer 8

Drug Price Competition and Patent term Restoration act

Question 9

1987

Answer 9

Prescription Drug Marketing

Question 10

1990

Answer 10

Omnibus Budget Reconciliation Act

Question 11

1994

Answer 11

Dietary Supplement Health and Education Act

Question 12

1996

Answer 12

Health Insurance Portability Act (HIPAA)

Question 13

1997

Answer 13

Food and Drug Modernization Act

Question 14

2003

Answer 14

Medicare Modernization Act

Question 15

2005

Answer 15

Combat Methamphetamine Epidemic Act

Question 16

2007

Answer 16

The Food and Drug Administration Amendments Act

Question 17

2010

Answer 17

Patient Protection and Affordable Care Act

Question 18

Centers for Medicaid and Medicare Services CMS

Answer 18

Oversees Medicare and Medicaid

Question 19

Drug Enforcement Administration (DEA)

Answer 19

Enforces prescriber and pharmacy compliance with the Controlled Substances Act

Question 20

Food and Drug Administration

Answer 20

Oversees drug purity, safety, and effectiveness

Question 21

Joint Comission

Answer 21

Set standards and grant accreditation to promote patient safety and quality

Question 22

State Boards of Pharmacies (BOPs)

Answer 22

Regulate pharmacy practice within each state

Question 23

EPA

Answer 23

Resource Conservation and Recovery Act
(RCRA) and Management Standards for Hazardous Waste Pharmaceuticals

Question 24

OSHA

Answer 24

Hazardous Communication Standard (HCS)

Question 25

NIOSH

Answer 25

List of Antineoplastic and Other Hazardous Drugs

Question 26

USP

Answer 26

General Ch 800,795,797

Question 27

ASHP

Answer 27

Guidelines on Handling Hazardous Drugs

Question 28

Hazardous Drugs

Answer 28

Drugs that pose a health risk through occupational or environmental exposure

Question 29

category 1

Answer 29

antineoplastic drugs known to be hazardous with repeated exposure

Question 30

category 2

Answer 30

non-antineoplastic drugs that meet the previously listed criteria for “hazardous”

Question 31

Category 3

Answer 31

Medications with adverse effects on reproduction

Question 32

Pharmaceuticals

Answer 32

anything containing drugs besides hazardous waste

Question 33

Hazard Communication Standard

Answer 33

Facilities must maintain Safety data sheets

Question 34

PPE

Answer 34

PPE must be worn at all times when compounding, cleaning, or administering hazardous drugs

Question 35

Handling of Hazardous Drugs

Answer 35

During the course of sterile compounding, hazardous drugs should only be prepared in vertical laminar airflow workstations

Question 36

P List

Answer 36

Acute hazardous Wastes from discarded commercial chemical products

Question 37

U List

Answer 37

Hazardous wastes from discarded commercial chemical products
-Important listed medications include Warfarin, nicotine replacement products, and certain chemo drugs

Question 38

D List

Answer 38

Ignitability, Corrosivity, Toxicity, Reactivity

Question 39

Federal Disposal of Hazardous Waste

Answer 39

EPA regulates waste disposal

Question 40

State Disposal of Hazardous Waste

Answer 40

All states except Iowa and Alaska are allowed to implement their own hazardous waste program

Question 41

Disposal of Hazardous Wastes

Answer 41

-No waste can be sewered (disposed down and toilet or drain)
-Hazardous Waste can only be accumulated for 1 year before disposal
-Potentially creditable pharmaceuticals can be shipped to a reverse distributor
-Unused, less than one year past expiration date, and in the manufacturer’s original container