PHARMACY JURISPRUDENCE (MPJ)
LATEST ACTUAL EXAM VERSION A, B &
C ALL QUESTIONS AND CORRECT
ELABORATED ANSWERS A+ GRADED
|UPDATED|
What disciplinary action is this?
License is inactive; may be reinstated after conditions are
met (like completion of recovery program, probation, etc.) -
Answer-suspended
What disciplinary action is this?
License is taken away by the licensing agency - answer-
revoked
What is the term of service for bop members? - answer-after
the initial appointment term, the appointment term is 5
years.
A member may not serve >2 consecutive terms.
A member who has served 2 consecutive full terms may not
be reappointed for at least 1 year after completion of his or
her 2nd full term.
A member may continue to serve until his or her successor
has been appointed and qualified
When is an ind submitted to the fda? - answer-after
preclinical animal research indicates a relatively safe drug
with a potential therapeutic use
,When is an nda or bla submitted to the fda? - answer-if
phase iii trials are submitted successfully
What is a snda used for? - answer-when a product has a new
label, formulation, package, manufacture, or indication
What is anda used for? - answer-generic drugs
What are nada and anada used for? - answer-new animal
drug application and abbreviated new animal drug
application (generic)
T/f? A grandfathered unapproved drug will have an ndc #
and will be listed in the fda's approved drug products with
therapeutic equivalence evaluations (orange book) -
answer-false, will have ndc #, not in orange book
_____ attempted to outlaw monopolies that blocked
competition by nefarious methods, like price-fixing,
deceptive marketing practices, and excluding competition
from markets - answer-sherman antitrust act of 1890
_____ means the drug itself is bad (drug quality is not up to
standard) - answer-adulteration
_____ means the drug label is inaccurate - answer-
misbranding
What law mandated accurate product labeling and required
ingredients to meet standards of strength, quality, and
purity in the usp and nf? - answer-pure food and drug act of
1906 (wiley act)
,Which law made a clear distinction between otc and rx
drugs? - answer-durham-humphrey amendment of 1951
What are legend drugs? - answer-rx drugs
What law required for the first time that manufacturers
prove to the fda that a drug is both safe and effective for the
claims made in the product's labeling, and created the nda
and snda? - answer-kefauver-harris amendment of 1962
What law required all rx and otc drugs to have a unique ndc
number? - answer-drug listing act of 1972
What do the different segments of ndc number mean? -
answer-first 4 or 5 numbers are labeler (manufacturer) code
Second is 3 or 4 numbers identifying strength, dosage, and
formulation
Third is package code identifying package size and type and
is 1 or 2 numbers
T/f? The poison prevention and packaging act of 1970 deals
with rx drugs and the federal anti-tampering act of 1982
deals with otc drugs - answer-true
What law made falsely billing medicare and medicaid a
federal crime? - answer-federal false claims act of 1982
What law established the anda and the 505(b)(2) application
(paper nda) for generic drug approval, and established the
orange book? - answer-hatch-waxman act (price
competition and patent act) of 1984
, What law stated that all patients should receive counseling
on their medications? - answer-omnibus budget
reconciliation act of 1990 (obra 90)
How often are pharmacist licenses renewed in wv? What is
the due date? - answer-biennial, june 30
What are the ce requirements for wv? - answer-30 hours per
2 years: 6 hours live, minimum of 3 hours of drug diversion
4 hours immunization if immunizing pharmacist
What are the required intern hours for pharmacist licensure
in wv? - answer-1500 hours
How long is a wv intern license valid before it expires? -
answer-1 year
T/f? The intern hours for a wv license must be completed
under the instruction and supervision of a pharmacist -
answer-true
Will the wvbop accept internship hours completed outside of
wv? - answer-yes, need a letter of credit from that state's
bop or from the school where you completed the experience
Up to 1/3 can be in a foreign country, need letter of credit
from the responsible body
Are criminal background checks required in wv? - answer-
as of july 1, 2017, all initial license applications for interns,
pharmacists, technicians, and technician trainees require
one
What are the requirements for registration of pharmacy
technicians in wv? - answer--written app and pay fees