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PHAR 441 - Pharmacy Law Questions with Correct Answers
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PHAR 441 - Pharmacy Law Questions with Correct Answers
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PHAR 441 - Pharmacy Law Questions with CorrectAnswers
omission Correct Answer-failing to do something that a reasonable
person would do
commission Correct Answer-doing something that a reasonable person
would not do
Elements of Negligence Correct Answer-1. Duty owed (legal obligation
imposed on an individual requiring they perform a reasonable standard
of care while performing any acts that could potentially harm others)
2. Breach of Duty (violation of legal obligation to an individual; ie.
dispensing errors)
3. Causation (proof that the pharmacist misconduct caused the alleged
damage)
4. Damage (loss or injury to a person or property)
** all 4 elements must be proven for there to be legal liability
adulteration Correct Answer-Any drug's physical conditions not in
compliance with CGMP
prepped and packaged in unsanitary environments
varies from official compendia
new unsafe animal drug
container composed of poisonous materials that may leech
contains unsafe color additive
,OTC not packaged in tamper resistant packaging
class III medical device without premarket approval
misbranding Correct Answer-Any drug that is label falsely
does not have generic name
does not bear adequate directions for use
not prominently placed
misleading
no exp date/subject to deterioration
health endangering and no caution listed
not labeled and packed by compendia standards
Federal v. State Law Correct Answer-Federal law over state, unless state
is stricter
**always go with stricter law
Drug Correct Answer-substance intended for use in the treatment of
disease; substance other than food intended to affect the structure or any
function of the body
Legend Drug Correct Answer-Prescription Drug
Dangerous Drug Correct Answer-NV Law; any non-controlled
prescription drug
, "Rx only"
OTC Correct Answer-Must comply with CGMP, must contain adequate
instructions for use
OTC Monograph Correct Answer-regulation specifying conditions in
which active ingredients and combinations may be formulated without
prior FDA approval;
companies can manufacture own OTCs if they have monograph
Central Fill Pharmacy Correct Answer-Sends meds to retail; needs
unique identifier (DEA #) indicating location filled; cannot accept new
scripts from pt or pbr
CGMP (current good manufacturing practice) Correct Answer-Set of
regulations establishing minimum requirements for methods, facilities,
or controls used in the manufacture, processing, packing, or holding of a
drug product; intent is to ensure drug is safe; mfg inspected every 2
years
Label Correct Answer-drug info upon the immediate container
Labelling Correct Answer-additional drug info accompanying label
Adequate Directions for Use Correct Answer-directions in which any
layperson can understand to safely use the drug and know its purpose
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