WEST VIRGINIA MPJE | 416 QUESTIONS AND ANSWERS | 2026 UPDATE | WITH COMPLETE
SOLUTION
how 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
,WEST VIRGINIA MPJE | 416 QUESTIONS AND ANSWERS | 2026 UPDATE | WITH COMPLETE
SOLUTION
_____ 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
,WEST VIRGINIA MPJE | 416 QUESTIONS AND ANSWERS | 2026 UPDATE | WITH COMPLETE
SOLUTION
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
, WEST VIRGINIA MPJE | 416 QUESTIONS AND ANSWERS | 2026 UPDATE | WITH COMPLETE
SOLUTION
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?
SOLUTION
how 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
,WEST VIRGINIA MPJE | 416 QUESTIONS AND ANSWERS | 2026 UPDATE | WITH COMPLETE
SOLUTION
_____ 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
,WEST VIRGINIA MPJE | 416 QUESTIONS AND ANSWERS | 2026 UPDATE | WITH COMPLETE
SOLUTION
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
, WEST VIRGINIA MPJE | 416 QUESTIONS AND ANSWERS | 2026 UPDATE | WITH COMPLETE
SOLUTION
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?
