Arizona MPJE
Arizona MPJE Study Guide Exam
Questions with Verified Answers 2025
Pure Food & Drug Act 1906 -Correct Answer ✔Prohibited food and drugs that were
distributed through interstate commerce to be adulterated or misbranded. Did not
require manufacturers to label ingredients
Food, Drug and Cosmetic Act of 1938 -Correct Answer ✔New drugs can not be
marketed until proven safe according to directions on the label.
Labels must have adequate directions for use and warnings for hazardous and habit
forming ingredients
Durham-Humphrey Amendment of 1951 -Correct Answer ✔Created a distinction
between "OTC" and "Legend Drugs".
Legend Drugs can only be dispensed with a valid Prescription..
• Required Legend Drugs to carry the statement:
"Caution: Federal law prohibits dispensing without a prescription.".
Most people refer to Legend drugs simply as "Prescription Drugs".
• The emphasis of this act was to insure safety through qualified medical supervision.
Kefauver-Harris Amendment of 1962 -Correct Answer ✔Required all new drugs
marketed in the US to be shown not only SAFE but also EFFECTIVE.
Who has authority over prescription drug advertisements -Correct Answer ✔FDA (Food
& Drug Administration)
Orphan Drug Act of 1983 -Correct Answer ✔Amendment made to provide various tax
and licensing incentives towards treatment of rare diseases.
Medical Device Amendment of 1976 -Correct Answer ✔Amendment to the FDCA,
provided better clarification of medical devices according to their: specific function,
establishment of performance standards for these devices, pre-market approval
requirements, conformance with GMP standards, and requirements for adherence to
record and reporting requirements.
Who has authority over non-prescription advertisements -Correct Answer ✔FTC
(Federal Trade Commission)
U.S. Attorney General -Correct Answer ✔Supervisor of the Drug Enforcement Agency
(DEA)
-Determines classification of Controlled substance medications (CII-CV)
Arizona MPJE
,Arizona MPJE
-Appoints Administration of DEA
Drug Price Competition & Patent Term Restoration Act
AKA: Hatch-Waxman Amendment -Correct Answer ✔Streamlined drug approval
process for GENERIC PRODUCTS by requiring submission of only an ANDA
(abbreviated new drug application).
Proof of bioequivalence and brand name drug required.
Also gave incentives to brand-name drug manufacturers to develop new drug products..
Being awarded up to five additional years of patent protection.
Prescription Drug Marketing Act of 1987 -Correct Answer ✔Created to place more
stringent controls on the distribution of prescription products.
-Prevents re-importation of a drug into the US
-Prohibited hospital and healthcare entities from reselling their pharmaceuticals
-Requires prescription drug wholesalers to be licensed by states under federal
guidelines
-Prohibited sale, trade, or purchase of prescription drug samples
-Specify precise storage, handling, and record-keeping requirements for drug samples.
FDA Modernization Act of 1997 -Correct Answer ✔SOME Actions of law:
1) provided for fast-track review of some NDA submissions (reason: to expedite
approval of new drugs that treat serious or life-threatening conditions)
2) clarified conditions under which pharmacies may extemporaneously compound
prescriptions (examples: individual states should regulate compounding; pharmacies
are exempt from strict GMP standards and requirements for NDA submission)
3) replaced drug legend from Durham-Humphrey Amendment of 1951 with a new
legend stating "Rx only"
4) eliminated provision that required certain substances to be labeled "Warning-May be
habit forming" (that was a requirement of the FDCA of 1938)
5) encouraged manufacturers to conduct research for new USES of drugs and to submit
SUPPLEMENTAL NDAs for these uses (NOTE: manufacturers may publicly
disseminate limited info about unapproved uses as long as a statement is included
specifying that the use has not been approved or cleared by the FDA and certain other
requirements are met)
6) encouraged manufacturers to perform pediatric studies of drugs by providing them
with an additional 6 MONTHS of marketing exclusivity
Arizona MPJE
,Arizona MPJE
Patient Protection & Affordable Care Act -Correct Answer ✔-Requires all individuals to
have health insurance. (Small businesses received credits for employee health
covereage)
-Require standards for financial and administrative transactions including timely and
transparent claims using standard electronic. transactions.
-Stop agreements between brand and generics that may limit or delay completion of
generic drugs
-Phase elimination of catastrophic threshold, better known as the donut hole or
coverage gap
USP/NF (United States Pharmacopoeia/ National Formulary) -Correct Answer
✔Contains monographs of recognized drugs. Each monograph has the drug's chemical
characteristics and standards of quality.
Proposed changes of the USPF/NF -Correct Answer ✔Pharmacopoeial Forum
Investigational New Drug Application -Correct Answer ✔The first application that is
submitted by a sponsor for a new Rx.
-FDA has 30 days to decide if IND is suitable for testing
New Drug Application -Correct Answer ✔Application that a Rx manufacturer submits to
the FDA following successful completion of Phase 1-3 research.
-FDA reviews application for 6 months
Abbreviated New Drug Application -Correct Answer ✔An application for Generic
products that are approved following the expiration of a patent held by an innovator
company.
-Must provide proof of similar PK, bioavailability, and clinical activity.
-First applicant to complete the review is granted SIX MONTHS of rights to sell
generic.term-21
Supplemental New Drug Application -Correct Answer ✔Changes made by the original
company to file a NDA.
-Changes made to Rx synthesis, production procedures, manufacturing locations,
packaging, and labeling. Rather than
Arizona MPJE
, Arizona MPJE
FDA Expedited Review Programs -Correct Answer ✔A group of four programs that are
used to review all Rx's efficiently.
-Priority Review
-Fast Track
-Breakthrough Therapy
-Accelerated Approval
Clinical Trials -Correct Answer ✔Phases created before the final approval of a Rx
Consists of three phases before final approval and one post-marketing phase
Phase 1 clinical trials -Correct Answer ✔Tests an Rx on a small group of healthy
individuals to evaluate the SAFETY of an Rx.
: Toxicological, phamacokinetic, and pharmacological properties
Phase 2 clinical trials -Correct Answer ✔Tests a larger group (100 pt's) that have
disease or condition, and evaluates the EFFECTIVENESS of an Rx.
-Also looks to obtain info on adequate dosage, safety, and adverse effects
Phase 3 clinical trials -Correct Answer ✔Tests large groups of pt's (thousands) in
controlled clinical studies. The purpose is to obtain Rx effectiveness in comparison to a
placebo
Phase 4 clinical trials -Correct Answer ✔Post-marketing studies taken to view drug
effectiveness on patient populations.
Priority Review -Correct Answer ✔-Used for Biologics License Applications (BLA) or
New Drug Application (NDA) submissions.
-Reduces a drug's FDA review period from TEN MONTHS to SIX
-Drugs qualifying for Fast Track, Breakthrough Therapy and Accelerated Approval can
also be eligible for Priority Review.
Fast Track -Correct Answer ✔Intended for drugs that address unmet medical needs by
either treating a condition for which no other treatment exists or drugs that offer
substantial benefit over existing treatment
-May be requested for Investigational New Drug Application and prior to BLA or NDA
submission.
Arizona MPJE
Arizona MPJE Study Guide Exam
Questions with Verified Answers 2025
Pure Food & Drug Act 1906 -Correct Answer ✔Prohibited food and drugs that were
distributed through interstate commerce to be adulterated or misbranded. Did not
require manufacturers to label ingredients
Food, Drug and Cosmetic Act of 1938 -Correct Answer ✔New drugs can not be
marketed until proven safe according to directions on the label.
Labels must have adequate directions for use and warnings for hazardous and habit
forming ingredients
Durham-Humphrey Amendment of 1951 -Correct Answer ✔Created a distinction
between "OTC" and "Legend Drugs".
Legend Drugs can only be dispensed with a valid Prescription..
• Required Legend Drugs to carry the statement:
"Caution: Federal law prohibits dispensing without a prescription.".
Most people refer to Legend drugs simply as "Prescription Drugs".
• The emphasis of this act was to insure safety through qualified medical supervision.
Kefauver-Harris Amendment of 1962 -Correct Answer ✔Required all new drugs
marketed in the US to be shown not only SAFE but also EFFECTIVE.
Who has authority over prescription drug advertisements -Correct Answer ✔FDA (Food
& Drug Administration)
Orphan Drug Act of 1983 -Correct Answer ✔Amendment made to provide various tax
and licensing incentives towards treatment of rare diseases.
Medical Device Amendment of 1976 -Correct Answer ✔Amendment to the FDCA,
provided better clarification of medical devices according to their: specific function,
establishment of performance standards for these devices, pre-market approval
requirements, conformance with GMP standards, and requirements for adherence to
record and reporting requirements.
Who has authority over non-prescription advertisements -Correct Answer ✔FTC
(Federal Trade Commission)
U.S. Attorney General -Correct Answer ✔Supervisor of the Drug Enforcement Agency
(DEA)
-Determines classification of Controlled substance medications (CII-CV)
Arizona MPJE
,Arizona MPJE
-Appoints Administration of DEA
Drug Price Competition & Patent Term Restoration Act
AKA: Hatch-Waxman Amendment -Correct Answer ✔Streamlined drug approval
process for GENERIC PRODUCTS by requiring submission of only an ANDA
(abbreviated new drug application).
Proof of bioequivalence and brand name drug required.
Also gave incentives to brand-name drug manufacturers to develop new drug products..
Being awarded up to five additional years of patent protection.
Prescription Drug Marketing Act of 1987 -Correct Answer ✔Created to place more
stringent controls on the distribution of prescription products.
-Prevents re-importation of a drug into the US
-Prohibited hospital and healthcare entities from reselling their pharmaceuticals
-Requires prescription drug wholesalers to be licensed by states under federal
guidelines
-Prohibited sale, trade, or purchase of prescription drug samples
-Specify precise storage, handling, and record-keeping requirements for drug samples.
FDA Modernization Act of 1997 -Correct Answer ✔SOME Actions of law:
1) provided for fast-track review of some NDA submissions (reason: to expedite
approval of new drugs that treat serious or life-threatening conditions)
2) clarified conditions under which pharmacies may extemporaneously compound
prescriptions (examples: individual states should regulate compounding; pharmacies
are exempt from strict GMP standards and requirements for NDA submission)
3) replaced drug legend from Durham-Humphrey Amendment of 1951 with a new
legend stating "Rx only"
4) eliminated provision that required certain substances to be labeled "Warning-May be
habit forming" (that was a requirement of the FDCA of 1938)
5) encouraged manufacturers to conduct research for new USES of drugs and to submit
SUPPLEMENTAL NDAs for these uses (NOTE: manufacturers may publicly
disseminate limited info about unapproved uses as long as a statement is included
specifying that the use has not been approved or cleared by the FDA and certain other
requirements are met)
6) encouraged manufacturers to perform pediatric studies of drugs by providing them
with an additional 6 MONTHS of marketing exclusivity
Arizona MPJE
,Arizona MPJE
Patient Protection & Affordable Care Act -Correct Answer ✔-Requires all individuals to
have health insurance. (Small businesses received credits for employee health
covereage)
-Require standards for financial and administrative transactions including timely and
transparent claims using standard electronic. transactions.
-Stop agreements between brand and generics that may limit or delay completion of
generic drugs
-Phase elimination of catastrophic threshold, better known as the donut hole or
coverage gap
USP/NF (United States Pharmacopoeia/ National Formulary) -Correct Answer
✔Contains monographs of recognized drugs. Each monograph has the drug's chemical
characteristics and standards of quality.
Proposed changes of the USPF/NF -Correct Answer ✔Pharmacopoeial Forum
Investigational New Drug Application -Correct Answer ✔The first application that is
submitted by a sponsor for a new Rx.
-FDA has 30 days to decide if IND is suitable for testing
New Drug Application -Correct Answer ✔Application that a Rx manufacturer submits to
the FDA following successful completion of Phase 1-3 research.
-FDA reviews application for 6 months
Abbreviated New Drug Application -Correct Answer ✔An application for Generic
products that are approved following the expiration of a patent held by an innovator
company.
-Must provide proof of similar PK, bioavailability, and clinical activity.
-First applicant to complete the review is granted SIX MONTHS of rights to sell
generic.term-21
Supplemental New Drug Application -Correct Answer ✔Changes made by the original
company to file a NDA.
-Changes made to Rx synthesis, production procedures, manufacturing locations,
packaging, and labeling. Rather than
Arizona MPJE
, Arizona MPJE
FDA Expedited Review Programs -Correct Answer ✔A group of four programs that are
used to review all Rx's efficiently.
-Priority Review
-Fast Track
-Breakthrough Therapy
-Accelerated Approval
Clinical Trials -Correct Answer ✔Phases created before the final approval of a Rx
Consists of three phases before final approval and one post-marketing phase
Phase 1 clinical trials -Correct Answer ✔Tests an Rx on a small group of healthy
individuals to evaluate the SAFETY of an Rx.
: Toxicological, phamacokinetic, and pharmacological properties
Phase 2 clinical trials -Correct Answer ✔Tests a larger group (100 pt's) that have
disease or condition, and evaluates the EFFECTIVENESS of an Rx.
-Also looks to obtain info on adequate dosage, safety, and adverse effects
Phase 3 clinical trials -Correct Answer ✔Tests large groups of pt's (thousands) in
controlled clinical studies. The purpose is to obtain Rx effectiveness in comparison to a
placebo
Phase 4 clinical trials -Correct Answer ✔Post-marketing studies taken to view drug
effectiveness on patient populations.
Priority Review -Correct Answer ✔-Used for Biologics License Applications (BLA) or
New Drug Application (NDA) submissions.
-Reduces a drug's FDA review period from TEN MONTHS to SIX
-Drugs qualifying for Fast Track, Breakthrough Therapy and Accelerated Approval can
also be eligible for Priority Review.
Fast Track -Correct Answer ✔Intended for drugs that address unmet medical needs by
either treating a condition for which no other treatment exists or drugs that offer
substantial benefit over existing treatment
-May be requested for Investigational New Drug Application and prior to BLA or NDA
submission.
Arizona MPJE
