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PHAR 441 - Pharmacy Law NV Questions with Correct Answers
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PHAR 441 - Pharmacy Law NV Questions with Correct Answers
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PHAR 441 - Pharmacy Law NV Questions withCorrect Answers
Administrative Agencies Correct Answer-created to implement desired
changes to policies or to administer a body of substantive law when the
legislature itself cannot perform these functions
Department of Health and Human Services (DHHS) Correct Answer-
Federal administrative agency that includes the Health Care Financing
Administration, Food and Drug Administration.
Health Care Financing Administration (HCFA) Correct Answer-
responsible for reimbursement policies and procedures for pharmacies
and other health care providers participating in the medicare and
Medicaid programs
Food and Drug Administration (FDA) Correct Answer-Administers the
Food, Drug and Cosmetic Act
Federal Trade Commission (FTC) Correct Answer-federal
administrative agency that enforces unfair business practices and
antitrust violations
U.S. Justice Department Correct Answer-Oversees the Drug
Enforcement Agency (DEA) that administers controlled Substances Act
,State Board of Pharmacy Correct Answer-considered a state
administrative agency
gives details of what continuing education (CE) are necessary;
legislature makes the rubric and states they need to have CE, Board sets
the specifics of what/when/how much
Types of Law Correct Answer-Criminal Law, Civil Law, Administrative
Law and Common Law
Criminal Law Correct Answer-specifies what conduct constitutes crime
and establishes appropriate punishments for such conduct. (Relates to
individuals' roles in society)
Civil Law Correct Answer-determines private rights and liabilities, as
distinguished from criminal law. (Relationship between individuals)
Administrative Law Correct Answer-Created and enforced by
government agencies
Common Law Correct Answer-made by the courts; duty of the court is
to apply the proper law to the facts before it and resolve the matter
through judicial decisions in which there is no specific statute that
applies.
What laws are Pharmacists subject to? Correct Answer-Criminal, Civil
and/or administrative; could be all 3 at the same time
,Negligence (pharmacist definition) Correct Answer-a unintentionally
causes harm to a patient through inattentiveness or carelessness (civil
wrong rather than a criminal wrong)
Omission (negligence) Correct Answer-failing to do something that a
reasonable person would do
Commission (negligence) Correct Answer-doing something that a
reasonable person would not do
Elements of Negligence Correct Answer-Duty Owed, Breach of Duty,
Causation and Damage
Duty Owed Correct Answer-legal obligation imposed on individual
requiring that they exercise a reasonable standard of care while
performing any acts that could potentially harm others.
Breach of Duty Correct Answer-violation of the legal obligation of an
individual
EX: pharmacist who fills Rx in a manner other than the way it was
ordered by a prescriber
Causation Correct Answer-law requires proof that the pharmacist's
misconduct caused the alleged damage
, Damage Correct Answer-loss/injury to person/property.
Federal vs State Law Correct Answer-if conflict exists, federal law
always prevails over state law UNLESS the state law is more strict than
federal law
New Drug Application Correct Answer--to obtain FDA pre-testing
approval (requires drug to be safe AND effective)
-Approval of newchemical entities (new indications/dosage/routes for
pre-approved drugs)
-up to 18-24 months for approval
Abbreviated New Drug Application (ANDA) Correct Answer-generic
products can have ANDA submitted once the patent of an approved
parent drug expires; only requires bioequivalence studies or dosage
forms (rate/extent of drug in body)
~6-8 months
Supplemental New Drug Application (SNDA) Correct Answer-
previously approved drug wants label or manufacturing process changed
National Drug Code (NDC) Correct Answer-11 digit, 3 segment number
identifying all drug products (required on all OTC and Rx drug labels)
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