©PREP4EXAMS@2024 [REAL-EXAM-DUMPS] Sunday, August 4, 2024 12:41 AM
WEST VIRGINIA UNIVERSIRTY- (WV) : 26506
MPJE-Federal Law 2024 Exam Practice
Questions and Answers (100% Pass)
What is the name of the act/year it was enacted that was drafted in response to the
sulfanilamide scare (medications diluted with antifreeze) - ✔️✔️Food, Drug, Cosmetic
Act, 1938
what is the official definition of a drug - ✔️✔️an article listed in USP or NF
OR
an article intended to affect body structure or function that also
mitigates/cures/prevents/diagnoses/treats disease
What does adulteration pertain to in the drug manufacturing and distribution process -
✔️✔️Refers to improper storage (filth, temperature, facility not registered with FDA) and
improper manufacturing (not made according to GMP)
What does misbranding pertain to in the drug manufacturing and distribution process -
✔️✔️Misbranding is related to labels/written material/advertising/marketing about the drug
What are some examples of misbranding - ✔️✔️Drug label is false or misleading
1
,©PREP4EXAMS@2024 [REAL-EXAM-DUMPS] Sunday, August 4, 2024 12:41 AM
WEST VIRGINIA UNIVERSIRTY- (WV) : 26506
Required information is missing or unreadable (such as no med guide dispensed with
medication or no generic name on stock bottle)
Which court case determined that the FDA can regulate the acts of individual
pharmacists - ✔️✔️US vs Sullivan
What organization is an independent quasi-regulatory body that sets standards for
pharmacy practice and issues drug monographs - ✔️✔️United States Pharmacopeia
(USP)
Does the FDA regulate the USP - ✔️✔️NO - the FDA enforces the standards developed
by the USP particularly when it comes to compounding (795, 797, 800)
Which legislative act established OTC vs Legend classifications, outlines prescription
label reqs, and allows prescribers to call in refills over the phone? - ✔️✔️Durham-
Humphrey Amendment of 1951
What phrase must be on a legend drug to avoid misbranding - ✔️✔️Caution: federal law
prohibits dispensing without a prescription
Can you name the requirements of a non controlled prescription label? - ✔️✔️Name of
patient and prescriber
Name and address of the dispenser
Name and dosage of product
2
, ©PREP4EXAMS@2024 [REAL-EXAM-DUMPS] Sunday, August 4, 2024 12:41 AM
WEST VIRGINIA UNIVERSIRTY- (WV) : 26506
Prescriber's directions for use
Rx serial #, Rx fill date
Cautionary statements if any are contained in the Rx
Which legislative amendment was drafted in response to the thalidomide scare -
✔️✔️Kefauver-Harris amendment of 1962 (KH)
Under the KH amendment, what changed? - ✔️✔️Drugs now had to be proven effective
(retroactive)
FDA regulated prescription drug labeling while the federal trade commission (FTC)
regulated OTC
Enacted GMP
Provided informed consent reqs
Allowed for DESI drugs (grandfathered in but not proven effective - example is Lomotil)
Which legislative act dealt with child-resistant closures (CRC) - ✔️✔️Poison Prevention
Packaging Act of 1970
What age group does CRC seek to protect - ✔️✔️CRC seeks to be difficult for children <5
YO to open within a reasonable amount of time
Normal adults should still be able to use properly
3
WEST VIRGINIA UNIVERSIRTY- (WV) : 26506
MPJE-Federal Law 2024 Exam Practice
Questions and Answers (100% Pass)
What is the name of the act/year it was enacted that was drafted in response to the
sulfanilamide scare (medications diluted with antifreeze) - ✔️✔️Food, Drug, Cosmetic
Act, 1938
what is the official definition of a drug - ✔️✔️an article listed in USP or NF
OR
an article intended to affect body structure or function that also
mitigates/cures/prevents/diagnoses/treats disease
What does adulteration pertain to in the drug manufacturing and distribution process -
✔️✔️Refers to improper storage (filth, temperature, facility not registered with FDA) and
improper manufacturing (not made according to GMP)
What does misbranding pertain to in the drug manufacturing and distribution process -
✔️✔️Misbranding is related to labels/written material/advertising/marketing about the drug
What are some examples of misbranding - ✔️✔️Drug label is false or misleading
1
,©PREP4EXAMS@2024 [REAL-EXAM-DUMPS] Sunday, August 4, 2024 12:41 AM
WEST VIRGINIA UNIVERSIRTY- (WV) : 26506
Required information is missing or unreadable (such as no med guide dispensed with
medication or no generic name on stock bottle)
Which court case determined that the FDA can regulate the acts of individual
pharmacists - ✔️✔️US vs Sullivan
What organization is an independent quasi-regulatory body that sets standards for
pharmacy practice and issues drug monographs - ✔️✔️United States Pharmacopeia
(USP)
Does the FDA regulate the USP - ✔️✔️NO - the FDA enforces the standards developed
by the USP particularly when it comes to compounding (795, 797, 800)
Which legislative act established OTC vs Legend classifications, outlines prescription
label reqs, and allows prescribers to call in refills over the phone? - ✔️✔️Durham-
Humphrey Amendment of 1951
What phrase must be on a legend drug to avoid misbranding - ✔️✔️Caution: federal law
prohibits dispensing without a prescription
Can you name the requirements of a non controlled prescription label? - ✔️✔️Name of
patient and prescriber
Name and address of the dispenser
Name and dosage of product
2
, ©PREP4EXAMS@2024 [REAL-EXAM-DUMPS] Sunday, August 4, 2024 12:41 AM
WEST VIRGINIA UNIVERSIRTY- (WV) : 26506
Prescriber's directions for use
Rx serial #, Rx fill date
Cautionary statements if any are contained in the Rx
Which legislative amendment was drafted in response to the thalidomide scare -
✔️✔️Kefauver-Harris amendment of 1962 (KH)
Under the KH amendment, what changed? - ✔️✔️Drugs now had to be proven effective
(retroactive)
FDA regulated prescription drug labeling while the federal trade commission (FTC)
regulated OTC
Enacted GMP
Provided informed consent reqs
Allowed for DESI drugs (grandfathered in but not proven effective - example is Lomotil)
Which legislative act dealt with child-resistant closures (CRC) - ✔️✔️Poison Prevention
Packaging Act of 1970
What age group does CRC seek to protect - ✔️✔️CRC seeks to be difficult for children <5
YO to open within a reasonable amount of time
Normal adults should still be able to use properly
3
