NORTH CAROLINA MPJE EXAM |
QUESTIONS & ANSWERS (VERIFIED) |
LATEST UPDATE | GRADED A+
Pure Food and Drug Act of 1906
Correct Answer: prohibited the adulteration and misbranding of foods and drugs
in interstate commerce
Food, Drug, and Cosmetic Act of 1938
Correct Answer: 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
Durham-Humphrey Amendment of 1951
Correct Answer: Established two classes of medications: Rx and OTC.
Authorized oral prescriptions and refills of prescription drugs. Introduced label
requirements for pharmacies
Kefauver-Harris Amendment of 1962
Correct Answer: 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
Federal Comprehensive Drug Abuse Prevention and Control Act of 1970
Correct Answer: AKA Controlled substances act.
Medical Device Amendments of 1976
Correct Answer: Established criteria for classifying devices into one of three
classes
Orphan Drug Act of 1983
Correct Answer: Provides tax and licensing initiatives for manufacturers who
develop drugs or biologicals for rare diseases or conditions
Drug Price Competition (DPC) and Patent Term Restoration Act (PTRA) of 1984
Correct Answer: Also known as the Waxman-Hatch Amendment. Streamlined the
generic drug approval process while giving patent extensions for innovative drugs
Prescription Drug Marketing Act (PDMA) of 1987
Correct Answer: 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
The Omnibus Budget Reconciliation Act of 1990
Correct Answer: AKA OBRA-90. Included prospective drug use review, patient
counseling, patient profiles
Prescription Drug User Fee Act of 1992
Correct Answer: Drug manufacturers required to pay fees when submitting a new
drug application
Dietary Supplement Health & Education Act (DSHEA) of 1994
Correct Answer: 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 foods than drugs
Health Insurance Portability and Accountability Act of 1996 (HIPAA)
Correct Answer: Regulated the privacy and security of health information;
improved efficiency and effectiveness of the health care system; improved the continuity
of health insurance coverage and prohibits discrimination in health coverage
Food & Drug Administration Modernization Act (FDAMA) of 1997
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CorrectfzAnswer:f z
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marketfzclinicalfzstudiesfztofzassessfzriskfz(Phasefz4fzstudies)
QUESTIONS & ANSWERS (VERIFIED) |
LATEST UPDATE | GRADED A+
Pure Food and Drug Act of 1906
Correct Answer: prohibited the adulteration and misbranding of foods and drugs
in interstate commerce
Food, Drug, and Cosmetic Act of 1938
Correct Answer: 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
Durham-Humphrey Amendment of 1951
Correct Answer: Established two classes of medications: Rx and OTC.
Authorized oral prescriptions and refills of prescription drugs. Introduced label
requirements for pharmacies
Kefauver-Harris Amendment of 1962
Correct Answer: 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
Federal Comprehensive Drug Abuse Prevention and Control Act of 1970
Correct Answer: AKA Controlled substances act.
Medical Device Amendments of 1976
Correct Answer: Established criteria for classifying devices into one of three
classes
Orphan Drug Act of 1983
Correct Answer: Provides tax and licensing initiatives for manufacturers who
develop drugs or biologicals for rare diseases or conditions
Drug Price Competition (DPC) and Patent Term Restoration Act (PTRA) of 1984
Correct Answer: Also known as the Waxman-Hatch Amendment. Streamlined the
generic drug approval process while giving patent extensions for innovative drugs
Prescription Drug Marketing Act (PDMA) of 1987
Correct Answer: 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
The Omnibus Budget Reconciliation Act of 1990
Correct Answer: AKA OBRA-90. Included prospective drug use review, patient
counseling, patient profiles
Prescription Drug User Fee Act of 1992
Correct Answer: Drug manufacturers required to pay fees when submitting a new
drug application
Dietary Supplement Health & Education Act (DSHEA) of 1994
Correct Answer: 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 foods than drugs
Health Insurance Portability and Accountability Act of 1996 (HIPAA)
Correct Answer: Regulated the privacy and security of health information;
improved efficiency and effectiveness of the health care system; improved the continuity
of health insurance coverage and prohibits discrimination in health coverage
Food & Drug Administration Modernization Act (FDAMA) of 1997
, CorrectfzAnswer:f z
Streamlinedfzregulatoryfzproceduresfztofzexpeditefzthefzavailabilit
yfzoffzsafefzandfzeffectivefzdrugsfzandfzdevices;fzexpandsfzFDAfzauthorityfzoverfzOTCfzdru
gs;fzestablishesfzafzdatafzbankfzoffzinformationfzonfzclinicalfztrials
DrugfzAddictionfzTreatmentfzActfz(DATA)fzoffz2000
CorrectfzAnswer:f z Allowsfzoffice-basedfzopioidfzaddictionfztreatmentfz(i.e.fzSuboxone)
AnabolicfzSteroidsfzActfzoffz2004
CorrectfzAnswer:f z AllfzanabolicfzsteroidsfzarefzSchedulefzIII
CombatfzMethamphetaminefzEpidemicfzActfzoffz2005fz&fzMethamphetaminefzPreventionfz
Actfzoffz2008
CorrectfzAnswer:f z Pseudoephedrinefzlaws
ThefzPatientfzSafetyfzandfzQualityfzImprovementfzActfzoffz205fz(PSQIA)
CorrectfzAnswer:f z
Createsfzafzvoluntaryfzprogramfzthroughfzwhichfzhealthfzcarefzpr
oviders,fzincludingfzpharmacies,fzsharefzinformationfzrelatedfztofzpatientfzsafetyfzeventsfz
withfzpatientfzsafetyfzorganizations
Foodfz&fzDrugfzAdministrationfzAmendmentsfzActfz(FDAAA)fzoffz2007
CorrectfzAnswer:f z
FDAfzmayfzmandatefzlabelingfzchangesfzrelatedfztofzsafety;fzreq
uirefzclinicalfztrialfzdatafzreportingfzandfzregistries;fzrequirefzpost-
marketfzclinicalfzstudiesfztofzassessfzriskfz(Phasefz4fzstudies)
