Legal Definitions

Question 1

How a bill becomes a law?

Answer 1

Bill is introduced
Committee Hearing
Floor Action
Returning to original house
Bill goes to governor
Law!!!

Question 2

Define Ethics

Answer 2

Rules promulgated by a profession or other group and imposed upon all members of the profession by its own organization

Question 3

Define Mores

Answer 3

Customs that establish standards of conduct enforceable by social pressure

Question 4

Define Constitution

Answer 4

Broad statement of powers of the government and its branches

Question 5

What is the highest form of law?

Answer 5

Constiution and all other forms must be consistent with it

Question 6

Define Treaty

Answer 6

An agreement between or among nations

Question 7

Define Statutes

Answer 7

Laws enacted by Congress at the federal level or by legislature at the state level
States: can legislate in areas not prohibited or reserved for the federal government

Question 8

Define Regulations

Answer 8

Administrative enactments of the executive branch of government that fulfill statutory policies and procedures
Must be consistent with the authorizing statute

Question 9

Define Administrative Laws

Answer 9

Civil in nature
Includes the vast number of state and federal regulations that govern the relationship between government and some regulated profession, trade or industry

Question 10

Define Judicial or Case Law

Answer 10

Decisions made in prior cases are followed in current cases and will be followed in future cases where the same facts exist
- Allows layers to anticipate how courts will decide legal cases in the future

Question 11

Define Criminal Law

Answer 11

Define the limitations of the relationship between the individual and society

Question 12

Define Civil Law

Answer 12

Pertains to the relationship among individuals in society

Question 13

Define Contract Law

Answer 13

Deals with duties that individuals have because they entered into an agreement

Question 14

Define Tort Law

Answer 14

Deals with duties created by law

“The law has created a duty that a pharmacist dispensing med must dispense the right drug as prescribed”

Question 15

Define adulteration

Answer 15

Filthy, putrid, or decompose substance
Been contaminated
Not done by GMP
Poisonous or deleterious substance
Strength differs from or it’s quality or purity falls below the compendium standards
Strength it differs from or it’s quality falls below what it represented if not in a compendium

AKA dirty or strength

Question 16

Define misbranding

Answer 16

Labeling is false or misleading
Manufacturer’s labeling fails to contain: name and address of manufacturer or distributor name of the drug, quantity, weight of active ingredient, “RX only”, if not orally than the route, storage, lot number, expiration, package insert
OTC labeling: principal display panel with identity, name and address of manufacturer or distributor, quantity, cautions and warnings, directions
I.E.: not giving package insert = Misbranded

Question 17

Define drug facts panel format

Answer 17

Active drugs 
Purpose uses 
Warnings 
Directions
Other information 
Inactive drugs 
Questions and telephone number

Question 18

Define REMS

Answer 18

Risk evaluation and mitigation strategies

Strategies to manage unknown or potentially serious risk associated with the drug or biological products