MPJE-Federal Law 2025-2026 With Complete
Solutions 100% Correct
What is the name of the act/year it was enacted that was drafted in response to the
sulfanilamide scare (medications diluted with antifreeze) - ANSWER Food, Drug,
Cosmetic Act, 1938
what is the official definition of a drug - ANSWER 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 refer to in the drug manufacturing and distribution process -
ANSWER Refers to improper storage (filth, temperature, facility not registered with
FDA) and improper manufacturing (not made according to GMP)
What does misbranding refer to in the drug manufacturing and distribution process -
ANSWER Misbranding is related to labels/written material/advertising/marketing about
the drug
What are examples of misbranding - ANSWER Drug label is false or misleading
Information is missing or not readable - examples: no med guide was with the
medication, no generic name on bottle of supply medication
Which case resulted in the court ruling that, indeed, the FDA is empowered to regulate
the behavior of retail pharmacists. ANSWER US vs Sullivan
What is the title given to the independent, semi-regulatory agency responsible for
setting standards for pharmacy practice, as well as being the author of drug
monographs? ANSWER United States Pharmacopeia (USP)
,Does the FDA govern the USP - ANSWER NO - the FDA implements the standards
created by the USP especially in terms of 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? - ANSWER
Durham-Humphrey Amendment of 1951
What legend drug statement prevents misbranding- ANSWER Caution: federal law
prohibits dispensing without a prescription
Can you give the elements of a non controlled prescription label?- ANSWER Name of
patient and prescriber
Name and address of the dispenser
Name and dosage of product
Prescriber's directions for use
Rx serial #, Rx fill date
Cautionary statements if any are contained in the Rx
Which legislative amendment was created as a reaction to the thalidomide scare -
ANSWER Kefauver-Harris amendment of 1962 (KH)
Under the KH amendment, what are the changes? - ANSWER 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 legislated act involved CRC - ANSWER Poison Prevention Packaging Act of 1970
What age group does CRC attempt to protect - ANSWER CRC attempts to be too hard for
children <5 YO to open in a reasonable amount of time
Normal adults should still be able to use properly
Who can request to opt out of child resistant packaging/CRC - ANSWER Prescribers and
patients - however prescribers must ask for each individual patient and CANNOT issue a
blanket statement for all his/her patients
Which amendment classifies thing like bandaids, wheelchairs, and pacemakers -
ANSWER Medical Device Amendment of 1976
What are classes of medical devices with an example: ANSWER Class 1 devices present
low risk. It has enough info to assure the safety and effectiveness: Band Aid Class 2
devices present moderate risk. It has insufficient data that is insufficient to assure
safety and effectiveness: Wheelchair Class 3 devices present high risk and used in
supporting or sustaining human life or preventing an unreasonable risk of illness/ injury:
Implantable pacemaker
Which of the following act deals with tamper resistant packaging - ANSWER Federal
Anti-tampering Act of 1982
Note: this is different from CRC!
Where is anti-tampering packaging required - ANSWER Drugs received by a pharmacy
must have anti-tampering packaging on them, as well as certain OTCs, devices, and
cosmetics
Which of the following act encourages research into rare diseases - ANSWER Orphan
Drug Act of 1983
What is defined as a rare disease or condition by the Orphan Drug Act-ANSWER a
disease/condition that affects <200,000 people in the USA
Solutions 100% Correct
What is the name of the act/year it was enacted that was drafted in response to the
sulfanilamide scare (medications diluted with antifreeze) - ANSWER Food, Drug,
Cosmetic Act, 1938
what is the official definition of a drug - ANSWER 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 refer to in the drug manufacturing and distribution process -
ANSWER Refers to improper storage (filth, temperature, facility not registered with
FDA) and improper manufacturing (not made according to GMP)
What does misbranding refer to in the drug manufacturing and distribution process -
ANSWER Misbranding is related to labels/written material/advertising/marketing about
the drug
What are examples of misbranding - ANSWER Drug label is false or misleading
Information is missing or not readable - examples: no med guide was with the
medication, no generic name on bottle of supply medication
Which case resulted in the court ruling that, indeed, the FDA is empowered to regulate
the behavior of retail pharmacists. ANSWER US vs Sullivan
What is the title given to the independent, semi-regulatory agency responsible for
setting standards for pharmacy practice, as well as being the author of drug
monographs? ANSWER United States Pharmacopeia (USP)
,Does the FDA govern the USP - ANSWER NO - the FDA implements the standards
created by the USP especially in terms of 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? - ANSWER
Durham-Humphrey Amendment of 1951
What legend drug statement prevents misbranding- ANSWER Caution: federal law
prohibits dispensing without a prescription
Can you give the elements of a non controlled prescription label?- ANSWER Name of
patient and prescriber
Name and address of the dispenser
Name and dosage of product
Prescriber's directions for use
Rx serial #, Rx fill date
Cautionary statements if any are contained in the Rx
Which legislative amendment was created as a reaction to the thalidomide scare -
ANSWER Kefauver-Harris amendment of 1962 (KH)
Under the KH amendment, what are the changes? - ANSWER 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 legislated act involved CRC - ANSWER Poison Prevention Packaging Act of 1970
What age group does CRC attempt to protect - ANSWER CRC attempts to be too hard for
children <5 YO to open in a reasonable amount of time
Normal adults should still be able to use properly
Who can request to opt out of child resistant packaging/CRC - ANSWER Prescribers and
patients - however prescribers must ask for each individual patient and CANNOT issue a
blanket statement for all his/her patients
Which amendment classifies thing like bandaids, wheelchairs, and pacemakers -
ANSWER Medical Device Amendment of 1976
What are classes of medical devices with an example: ANSWER Class 1 devices present
low risk. It has enough info to assure the safety and effectiveness: Band Aid Class 2
devices present moderate risk. It has insufficient data that is insufficient to assure
safety and effectiveness: Wheelchair Class 3 devices present high risk and used in
supporting or sustaining human life or preventing an unreasonable risk of illness/ injury:
Implantable pacemaker
Which of the following act deals with tamper resistant packaging - ANSWER Federal
Anti-tampering Act of 1982
Note: this is different from CRC!
Where is anti-tampering packaging required - ANSWER Drugs received by a pharmacy
must have anti-tampering packaging on them, as well as certain OTCs, devices, and
cosmetics
Which of the following act encourages research into rare diseases - ANSWER Orphan
Drug Act of 1983
What is defined as a rare disease or condition by the Orphan Drug Act-ANSWER a
disease/condition that affects <200,000 people in the USA
