MPJE-Federal Law 2024 Exam Practice Questions and Answers (100% Pass)
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Course
Mpje
Institution
Mpje
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 ...
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
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