West Virginia MPJE - Exam Questions & Verified Answers
how many public members (non-pharmacists) serve of the 2 citizen members (who do not perform any services related to the practice of the
BOP? pharmacist care)
how many pharmacists members serve of the BOP? must -5 licensed pharmacists in WV
they be actively practicing? -no, but must have an active license and be in good standing
what is the term of service for BOP members? 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? after preclinical animal research indicates a relatively safe drug with a potential
therapeutic use
when is an NDA or BLA submitted to the FDA? if Phase III trials are submitted successfully
what is a sNDA used for? when a product has a new label, formulation, package, manufacture, or indication
what is aNDA used for? generic drugs
what are NADA and ANADA used for? new animal drug application and abbreviated new animal drug application (generic)
t/f? a grandfathered unapproved drug will have an NDC # false, will have NDC #, not in Orange Book
and will be listed in the FDA's Approved Drug Products
with Therapeutic Equivalence Evaluations (Orange Book)
_____ attempted to outlaw monopolies that blocked Sherman Antitrust Act of 1890
competition by nefarious methods, like price-fixing,
deceptive marketing practices, and excluding competition
from markets
_____ means the drug itself is bad (drug quality is not up adulteration
to standard)
_____ means the drug label is inaccurate misbranding
what law mandated accurate product labeling and required Pure Food and Drug Act of 1906 (Wiley Act)
ingredients to meet standards of strength, quality, and
purity in the USP and NF?
which law made a clear distinction between OTC and Rx Durham-Humphrey Amendment of 1951
drugs?
Stuvia 2026-2027
, West Virginia MPJE - Exam Questions & Verified Answers
what are legend drugs? Rx drugs
what law required for the first time that manufacturers Kefauver-Harris Amendment of 1962
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?
what law required all Rx and OTC drugs to have a unique Drug Listing Act of 1972
NDC number?
what do the different segments of NDC number mean? 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 true
with Rx drugs and the federal anti-tampering act of 1982
deals with OTC drugs
what law made falsely billing Medicare and Medicaid a Federal False Claims Act of 1982
federal crime?
what law established the ANDA and the 505(b)(2) Hatch-Waxman Act (Price Competition and Patent Act) of 1984
application (paper NDA) for generic drug approval, and
established the Orange Book?
what law stated that all patients should receive counseling Omnibus Budget Reconciliation Act of 1990 (OBRA 90)
on their medications?
how often are pharmacist licenses renewed in WV? What biennial, June 30
is the due date?
what are the CE requirements for WV? 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 1500 hours
in WV?
how long is a WV intern license valid before it expires? 1 year
t/f? the intern hours for a WV license must be completed true
under the instruction and supervision of a pharmacist
will the WVBOP accept internship hours completed outside yes, need a letter of credit from that state's BOP or from the school where you
of WV? 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? as of July 1, 2017, all initial license applications for interns, pharmacists,
technicians, and technician trainees require one
Stuvia 2026-2027
, West Virginia MPJE - Exam Questions & Verified Answers
what are the requirements for registration of pharmacy -written app and pay fees
technicians in WV? -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, no
revoked, suspended, or restricted for disciplinary purposes
in any jurisdiction be eligible to register as a tech?
what form is submitted by retail pharmacies, DEA Form 224
hospitals/clinics, practitioners, teaching institutions, or mid-
level practitioners to apply for a DEA number?
t/f? there are different registration forms for companies true
involved w/ manufacturing and distributing controlled
substances than for individuals and institutions
what form is submitted by manufacturers, distributors, DEA Form 225
researchers, analytical laboratories, importers, and
exporters to apply for a DEA number?
what disciplinary action is this? suspended
license is inactive; may be reinstated after conditions are
met (like completion of recovery program, probation, etc.)
what disciplinary action is this? revoked
license is taken away by the licensing agency
what disciplinary action is this? reinstated
license that was taken away is given back, in active status
what disciplinary action is this? surrendered
individual agrees to voluntarily give up licensure, often with
compulsion in order to avoid penalties and/or criminal
charges
do you need to apply for a new registration and submit yes, and the BOP should inspect the facility before a new registration is issued
fees when moving the pharmacy to a new address or
different location within the current building?
do you need to apply for a new registration when a yes, this causes the registration to expire, and need to be reinspected
pharmacy changes ownership?
do inspectors in WV have to be licensed pharmacists? yes
where do wholesalers operating in WV get their licenses? WVBOP
does WV require a license for distributors of medical no
devices that require a "prescription" order?
Stuvia 2026-2027
how many public members (non-pharmacists) serve of the 2 citizen members (who do not perform any services related to the practice of the
BOP? pharmacist care)
how many pharmacists members serve of the BOP? must -5 licensed pharmacists in WV
they be actively practicing? -no, but must have an active license and be in good standing
what is the term of service for BOP members? 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? after preclinical animal research indicates a relatively safe drug with a potential
therapeutic use
when is an NDA or BLA submitted to the FDA? if Phase III trials are submitted successfully
what is a sNDA used for? when a product has a new label, formulation, package, manufacture, or indication
what is aNDA used for? generic drugs
what are NADA and ANADA used for? new animal drug application and abbreviated new animal drug application (generic)
t/f? a grandfathered unapproved drug will have an NDC # false, will have NDC #, not in Orange Book
and will be listed in the FDA's Approved Drug Products
with Therapeutic Equivalence Evaluations (Orange Book)
_____ attempted to outlaw monopolies that blocked Sherman Antitrust Act of 1890
competition by nefarious methods, like price-fixing,
deceptive marketing practices, and excluding competition
from markets
_____ means the drug itself is bad (drug quality is not up adulteration
to standard)
_____ means the drug label is inaccurate misbranding
what law mandated accurate product labeling and required Pure Food and Drug Act of 1906 (Wiley Act)
ingredients to meet standards of strength, quality, and
purity in the USP and NF?
which law made a clear distinction between OTC and Rx Durham-Humphrey Amendment of 1951
drugs?
Stuvia 2026-2027
, West Virginia MPJE - Exam Questions & Verified Answers
what are legend drugs? Rx drugs
what law required for the first time that manufacturers Kefauver-Harris Amendment of 1962
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?
what law required all Rx and OTC drugs to have a unique Drug Listing Act of 1972
NDC number?
what do the different segments of NDC number mean? 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 true
with Rx drugs and the federal anti-tampering act of 1982
deals with OTC drugs
what law made falsely billing Medicare and Medicaid a Federal False Claims Act of 1982
federal crime?
what law established the ANDA and the 505(b)(2) Hatch-Waxman Act (Price Competition and Patent Act) of 1984
application (paper NDA) for generic drug approval, and
established the Orange Book?
what law stated that all patients should receive counseling Omnibus Budget Reconciliation Act of 1990 (OBRA 90)
on their medications?
how often are pharmacist licenses renewed in WV? What biennial, June 30
is the due date?
what are the CE requirements for WV? 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 1500 hours
in WV?
how long is a WV intern license valid before it expires? 1 year
t/f? the intern hours for a WV license must be completed true
under the instruction and supervision of a pharmacist
will the WVBOP accept internship hours completed outside yes, need a letter of credit from that state's BOP or from the school where you
of WV? 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? as of July 1, 2017, all initial license applications for interns, pharmacists,
technicians, and technician trainees require one
Stuvia 2026-2027
, West Virginia MPJE - Exam Questions & Verified Answers
what are the requirements for registration of pharmacy -written app and pay fees
technicians in WV? -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, no
revoked, suspended, or restricted for disciplinary purposes
in any jurisdiction be eligible to register as a tech?
what form is submitted by retail pharmacies, DEA Form 224
hospitals/clinics, practitioners, teaching institutions, or mid-
level practitioners to apply for a DEA number?
t/f? there are different registration forms for companies true
involved w/ manufacturing and distributing controlled
substances than for individuals and institutions
what form is submitted by manufacturers, distributors, DEA Form 225
researchers, analytical laboratories, importers, and
exporters to apply for a DEA number?
what disciplinary action is this? suspended
license is inactive; may be reinstated after conditions are
met (like completion of recovery program, probation, etc.)
what disciplinary action is this? revoked
license is taken away by the licensing agency
what disciplinary action is this? reinstated
license that was taken away is given back, in active status
what disciplinary action is this? surrendered
individual agrees to voluntarily give up licensure, often with
compulsion in order to avoid penalties and/or criminal
charges
do you need to apply for a new registration and submit yes, and the BOP should inspect the facility before a new registration is issued
fees when moving the pharmacy to a new address or
different location within the current building?
do you need to apply for a new registration when a yes, this causes the registration to expire, and need to be reinspected
pharmacy changes ownership?
do inspectors in WV have to be licensed pharmacists? yes
where do wholesalers operating in WV get their licenses? WVBOP
does WV require a license for distributors of medical no
devices that require a "prescription" order?
Stuvia 2026-2027
