Pharmacy Law and Ethics

Question 1

A

Answer 1

Deprecated (used by older entities)

Question 2

B

Answer 2

Hospital or clinic

Question 3

C

Answer 3

Practitioner

Question 4

D

Answer 4

Teaching institution

Question 5

E

Answer 5

Manufacturer

Question 6

F

Answer 6

Distributor

Question 7

G

Answer 7

Researcher

Question 8

H

Answer 8

Analytical lab

Question 9

J

Answer 9

Importer

Question 10

K

Answer 10

Exporter

Question 11

L

Answer 11

Reverse distributor

Question 12

M

Answer 12

Mid-level practitioner

Question 13

P to U

Answer 13

Narcotic treatment program

Question 14

X

Answer 14

Suboxone prescribing program

Question 15

Describe the arithmetic used to verify a DEA number

Answer 15

Add the first, third and fifth numbers; add the second, fourth and sixth numbers, multiply by two; and then add the two values. The last digit should match the last number in the DEA number

Question 16

Food, Drug, and Cosmetic Act of 1938

Answer 16

Resulted from the Sulfanilamide Tragedy of 1937. This act banned false claims, required a package insert with directions for use and also exact labeling on the product.

Question 17

Durham-Humphrey Amendment of 1951

Answer 17

Required drug manufacturers to label “Caution: Federal Law Prohibits Dispensing without a Prescription” and distinguishing between OTC products and prescription

Question 18

Harrison Narcotics Tax Act of 1914

Answer 18

This required dispensing opium by prescription only and stopped recreational use of the drug.

Question 19

Sulfanilamide Tragedy of 1937

Answer 19

This tragedy resulted from use of sulfanilamide to treat strep.

Question 20

Pure Food and Drug Act

Answer 20

Required all manufacturers to properly label a drug with truthful information

Question 21

What Act contributed to the development of the US Pharmacopeia (USP) and National Formulary?

Answer 21

Food, Drug, and Cosmetic Act of 1938

Question 22

US Pharmacopeia and National Formulary

Answer 22

Organized standards for purity, strength and quality

Question 23

What was the Thalidomide Tragedy of 1962 and what did it lead to?

Answer 23

Over 10,000 children were born with phocomelia. Thalidomide was given to pregnant women to alleviate symptoms of nausea. This lead to the Kefauver-Harris Amendment of 1962, which granted authority to the FDA to reject a manufacturers application. This required drugs to be researched prior to being marketed to the public.

Question 24

Poison Prevention Packaging Act of 1970

Answer 24

Required manufacturers and pharmacies to secure all medication in containers with childproof packaging or caps.

Question 25

Drug Listing Act

Answer 25

Implemented the National Drug code number (NDC).

Question 26

Medical Device Amendment of 1976

Answer 26

Established three regulatory classes for medical devices.

Question 27

Resource Conservation and Recovery Act

Answer 27

Grants the Environmental Protection Agency (EPA) complete authority in the disposal of hazardous substances.

Question 28

Orphan Drug Act

Answer 28

Regulates orphan drugs, pharmaceuticals developed for treating rare diseases.

Question 29

Drug Price Competition and Patent Term Restoration

Answer 29

Encourages the manufacturing of generic drugs by drug companies and it outlines the process by which the company can be approved by the FDA. This process starts by completion of an abbreviated new drug application (ANDA).

Question 30

Distinguish between class III, class II, and class I medical devices addressed by the Medical Device Amendment.

Answer 30

Class III devices are the most regulated and pose high risk for human use; class II are of moderate risk and class I are of low risk