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Examen

WEST VIRGINIA MPJE EXAM LATEST 2025 KEY CONCEPT QUESTIONS GRADED A+(COMPLETE QUESTIONS)

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WEST VIRGINIA MPJE EXAM LATEST 2025 KEY CONCEPT QUESTIONS GRADED A+(COMPLETE QUESTIONS)

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Institución
WEST VIRGINIA MPJE
Grado
WEST VIRGINIA MPJE

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Subido en
13 de febrero de 2025
Número de páginas
45
Escrito en
2024/2025
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Examen
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WEST VIRGINIA MPJE EXAM LATEST 2025 KEY
CONCEPT QUESTIONS GRADED A+(COMPLETE
QUESTIONS)
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

, 2


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)

, 3


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

, 4


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
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