Exam (elaborations)
WEST VIRGINIA MPJE LAW EXAM
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WEST VIRGINIA MPJE LAW EXAM
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WEST VIRGINIA MPJE LAW EXAMhow many public members (non-pharmacists) serve of the BOP? - ANSWER 2
citizen members (who do not perform any services related to the practice of the
pharmacist care)
how many pharmacists members serve of the BOP? must they be actively
practicing? - ANSWER -5 licensed pharmacists in WV
-no, but must have an active license and be in good standing
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
-high school grad or GED
-tech training program (or one provided by a pharmacy) approved by BOP like PTCB
-pass exam approved by BOP
-not alcohol or drug abuser
-no felony within 10 years
-no misdemeanor or felony related to pharmacy
-designated as "technician-in-training" prior to meeting requirements
can a pharmacist whose license has been denied, revoked, suspended, or restricted
for disciplinary purposes in any jurisdiction be eligible to register as a tech? -
ANSWER no
what form is submitted by retail pharmacies, hospitals/clinics, practitioners, teaching
institutions, or mid-level practitioners to apply for a DEA number? - ANSWER DEA
Form 224
t/f? there are different registration forms for companies involved w/ manufacturing
and distributing controlled substances than for individuals and institutions - ANSWER
true
what form is submitted by manufacturers, distributors, researchers, analytical
laboratories, importers, and exporters to apply for a DEA number? - ANSWER DEA
Form 225
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 disciplinary action is this?
license that was taken away is given back, in active status - ANSWER reinstated
what disciplinary action is this?
individual agrees to voluntarily give up licensure, often with compulsion in order to
avoid penalties and/or criminal charges - ANSWER surrendered
do you need to apply for a new registration and submit fees when moving the
pharmacy to a new address or different location within the current building? -
ANSWER yes, and the BOP should inspect the facility before a new registration is
issued
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