NORTH CAROLINA MPJE EXAM
2026/2027
TRUE or FALSE: Per state law, it is permissible to transfer prescriptions
issued by prescribers in other states. - Precise Answer ✔✔TRUE
accelerated approval - Precise Answer ✔✔Give the FDA
classification for the following description:
For drugs with long term endpoints that are hard to measure during
clinical trials, such as mortality. Approval is based on surrogate
endpoints
fast track - Precise Answer ✔✔Give the FDA classification for the
following description:
Expedited review process intended for drugs that treat serious conditions
and fill an unmet medical need
breakthrough therapy - Precise Answer ✔✔Give the FDA
classification for the following description:
Drugs that provide substantial improvement over current tx
0 (zero) - Precise Answer ✔✔The max number of refills on an
isotretinoin prescription
FALSE (it would have to be 503b) - Precise Answer ✔✔TRUE or
,2
FALSE: A 503a pharmacy can compound medications only for another
503a pharmacy
priority review - Precise Answer ✔✔Give the FDA classification for
the following description:
The FDA's goal is to take action on the application within 6 month
Prior Approval Supplement - Precise Answer ✔✔A drug
manufacturer wants to change the way a drug that is currently on the
market is manufactured/produced. What application would be submitted
to the
FDA?
PIECE of LEGISLATION:
prohibited the adulteration and misbranding of foods and drugs in
interstate commerce - Precise Answer ✔✔Pure Food and Drug Act
of 1906
PIECE of LEGISLATION:
Core of today's drug laws. No new drug can be marketed/sold until
proven safe and approved by FDA. Labels must contain adequate
directions for use and warnings about their habit-forming properties -
Precise Answer ✔✔Food, Drug, and Cosmetic Act of 1938
PIECE of LEGISLATION:
,Established two classes of medications: Rx and OTC. Authorized oral
prescriptions and refills of prescription drugs. Introduced label
requirements for pharmacies - Precise Answer ✔✔Durham-
Humphrey Amendment of 1951
PIECE of LEGISLATION:
Drugs must also be proven effective (in addition to safe). Transferred
prescription drug advertising from Federal Trade Commission (FTC) to
FDA. Established Good Manufacturing Practices. Required informed
consent of research participants and reporting of ADRs - Precise
Answer ✔✔Kefauver-Harris Amendment of 1962
PIECE of LEGISLATION:
AKA Controlled substances act. - Precise Answer ✔✔Federal
Comprehensive Drug Abuse Prevention and Control Act of 1970
PIECE of LEGISLATION:
Established criteria for classifying devices into one of three classes -
Precise Answer ✔✔Medical Device Amendments of 1976
PIECE of LEGISLATION:
Provides tax and licensing initiatives for manufacturers who develop
drugs or biologicals for rare diseases or conditions - Precise
Answer ✔✔Orphan Drug Act of 1983 PIECE of
LEGISLATION:
, 4
Also known as the Waxman-Hatch Amendment. Streamlined the generic
drug approval process while giving patent extensions for innovative
drugs - Precise Answer ✔✔Drug Price Competition (DPC) and
Patent Term Restoration Act (PTRA) of 1984
PIECE of LEGISLATION:
Bans sale, trade, or purchase of Rx drug samples. Established sales
restrictions and recordkeeping requirements for Rx drug samples.
Prohibits hospitals and other health care entities from reselling their Rx
drugs to other businesses. Requires state licensing of wholesalers. Bans
re-importation of Rx drugs except by manufacturer - Precise Answer
✔✔Prescription Drug Marketing Act (PDMA) of 1987
PIECE of LEGISLATION:
AKA OBRA-90. Included prospective drug use review, patient
counseling, patient profiles - Precise Answer ✔✔The Omnibus
Budget Reconciliation Act of 1990
PIECE of LEGISLATION:
Drug manufacturers required to pay fees when submitting a new drug
application - Precise Answer ✔✔Prescription Drug User Fee Act of
1992
PIECE of LEGISLATION:
Created a new category of food called "dietary supplements". Permits
manufacturers to make claims that would have otherwise been illegal
under FDCA. Forced FDA to regulate dietary supplements more as
2026/2027
TRUE or FALSE: Per state law, it is permissible to transfer prescriptions
issued by prescribers in other states. - Precise Answer ✔✔TRUE
accelerated approval - Precise Answer ✔✔Give the FDA
classification for the following description:
For drugs with long term endpoints that are hard to measure during
clinical trials, such as mortality. Approval is based on surrogate
endpoints
fast track - Precise Answer ✔✔Give the FDA classification for the
following description:
Expedited review process intended for drugs that treat serious conditions
and fill an unmet medical need
breakthrough therapy - Precise Answer ✔✔Give the FDA
classification for the following description:
Drugs that provide substantial improvement over current tx
0 (zero) - Precise Answer ✔✔The max number of refills on an
isotretinoin prescription
FALSE (it would have to be 503b) - Precise Answer ✔✔TRUE or
,2
FALSE: A 503a pharmacy can compound medications only for another
503a pharmacy
priority review - Precise Answer ✔✔Give the FDA classification for
the following description:
The FDA's goal is to take action on the application within 6 month
Prior Approval Supplement - Precise Answer ✔✔A drug
manufacturer wants to change the way a drug that is currently on the
market is manufactured/produced. What application would be submitted
to the
FDA?
PIECE of LEGISLATION:
prohibited the adulteration and misbranding of foods and drugs in
interstate commerce - Precise Answer ✔✔Pure Food and Drug Act
of 1906
PIECE of LEGISLATION:
Core of today's drug laws. No new drug can be marketed/sold until
proven safe and approved by FDA. Labels must contain adequate
directions for use and warnings about their habit-forming properties -
Precise Answer ✔✔Food, Drug, and Cosmetic Act of 1938
PIECE of LEGISLATION:
,Established two classes of medications: Rx and OTC. Authorized oral
prescriptions and refills of prescription drugs. Introduced label
requirements for pharmacies - Precise Answer ✔✔Durham-
Humphrey Amendment of 1951
PIECE of LEGISLATION:
Drugs must also be proven effective (in addition to safe). Transferred
prescription drug advertising from Federal Trade Commission (FTC) to
FDA. Established Good Manufacturing Practices. Required informed
consent of research participants and reporting of ADRs - Precise
Answer ✔✔Kefauver-Harris Amendment of 1962
PIECE of LEGISLATION:
AKA Controlled substances act. - Precise Answer ✔✔Federal
Comprehensive Drug Abuse Prevention and Control Act of 1970
PIECE of LEGISLATION:
Established criteria for classifying devices into one of three classes -
Precise Answer ✔✔Medical Device Amendments of 1976
PIECE of LEGISLATION:
Provides tax and licensing initiatives for manufacturers who develop
drugs or biologicals for rare diseases or conditions - Precise
Answer ✔✔Orphan Drug Act of 1983 PIECE of
LEGISLATION:
, 4
Also known as the Waxman-Hatch Amendment. Streamlined the generic
drug approval process while giving patent extensions for innovative
drugs - Precise Answer ✔✔Drug Price Competition (DPC) and
Patent Term Restoration Act (PTRA) of 1984
PIECE of LEGISLATION:
Bans sale, trade, or purchase of Rx drug samples. Established sales
restrictions and recordkeeping requirements for Rx drug samples.
Prohibits hospitals and other health care entities from reselling their Rx
drugs to other businesses. Requires state licensing of wholesalers. Bans
re-importation of Rx drugs except by manufacturer - Precise Answer
✔✔Prescription Drug Marketing Act (PDMA) of 1987
PIECE of LEGISLATION:
AKA OBRA-90. Included prospective drug use review, patient
counseling, patient profiles - Precise Answer ✔✔The Omnibus
Budget Reconciliation Act of 1990
PIECE of LEGISLATION:
Drug manufacturers required to pay fees when submitting a new drug
application - Precise Answer ✔✔Prescription Drug User Fee Act of
1992
PIECE of LEGISLATION:
Created a new category of food called "dietary supplements". Permits
manufacturers to make claims that would have otherwise been illegal
under FDCA. Forced FDA to regulate dietary supplements more as
