Legal Definitions Flashcards
How a bill becomes a law?
Bill is introduced Committee Hearing Floor Action Returning to original house Bill goes to governor Law!!!
Define Ethics
Rules promulgated by a profession or other group and imposed upon all members of the profession by its own organization
Define Mores
Customs that establish standards of conduct enforceable by social pressure
Define Constitution
Broad statement of powers of the government and its branches
What is the highest form of law?
Constiution and all other forms must be consistent with it
Define Treaty
An agreement between or among nations
Define Statutes
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
Define Regulations
Administrative enactments of the executive branch of government that fulfill statutory policies and procedures
Must be consistent with the authorizing statute
Define Administrative Laws
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
Define Judicial or Case Law
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
Define Criminal Law
Define the limitations of the relationship between the individual and society
Define Civil Law
Pertains to the relationship among individuals in society
Define Contract Law
Deals with duties that individuals have because they entered into an agreement
Define Tort Law
Deals with duties created by law
“The law has created a duty that a pharmacist dispensing med must dispense the right drug as prescribed”
Define adulteration
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
Define misbranding
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
Define drug facts panel format
Active drugs Purpose uses Warnings Directions Other information Inactive drugs Questions and telephone number
Define REMS
Risk evaluation and mitigation strategies
Strategies to manage unknown or potentially serious risk associated with the drug or biological products
