NORTH CAROLINA MPJE – PARISH VERSION
| COMPREHENSIVE PHARMACY LAW EXAM
PREP, PRACTICE QUESTIONS, CORRECT
ANSWERS AND STUDY GUIDE
| GRADED A+ | GUARANTEED SUCCESS
Updated 2026 Questions and Answers
100% Verified Exam Prep
,breakthrough therapy Give the FDA classification for the following description:
Drugs that provide substantial improvement over current tx
0 (zero) The max number of refills on an isotretinoin prescription
FALSE (it would have to be 503b) TRUE or FALSE: A 503a pharmacy can compound medications only for another 503a
pharmacy
priority review 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 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: Pure Food and Drug Act of 1906
prohibited the adulteration and misbranding of foods and
drugs in interstate commerce
PIECE of LEGISLATION: Food, Drug, and Cosmetic Act of 1938
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
PIECE of LEGISLATION: Durham-Humphrey Amendment of 1951
Established two classes of medications: Rx and OTC.
Authorized oral prescriptions and refills of prescription drugs.
Introduced label requirements for pharmacies
PIECE of LEGISLATION: Kefauver-Harris Amendment of 1962
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
PIECE of LEGISLATION: Federal Comprehensive Drug Abuse Prevention and Control Act of 1970
AKA Controlled substances act.
,PIECE of LEGISLATION: Medical Device Amendments of 1976
Established criteria for classifying devices into one of three
classes
PIECE of LEGISLATION: Orphan Drug Act of 1983
Provides tax and licensing initiatives for manufacturers who
develop drugs or biologicals for rare diseases or conditions
PIECE of LEGISLATION: Drug Price Competition (DPC) and Patent Term Restoration Act (PTRA) of 1984
Also known as the Waxman-Hatch Amendment. Streamlined
the generic drug approval process while giving patent
extensions for innovative drugs
PIECE of LEGISLATION: Prescription Drug Marketing Act (PDMA) of 1987
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
PIECE of LEGISLATION: The Omnibus Budget Reconciliation Act of 1990
AKA OBRA-90. Included prospective drug use review, patient
counseling, patient profiles
PIECE of LEGISLATION: Prescription Drug User Fee Act of 1992
Drug manufacturers required to pay fees when submitting a
new drug application
PIECE of LEGISLATION: Dietary Supplement Health & Education Act (DSHEA) of 1994
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
, PIECE of LEGISLATION: Health Insurance Portability and Accountability Act of 1996 (HIPAA)
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
PIECE of LEGISLATION: Food & Drug Administration Modernization Act (FDAMA) of 1997
Streamlined regulatory procedures to expedite the availability
of safe and effective drugs and devices; expands FDA
authority over OTC drugs; establishes a data bank of
information on clinical trials
PIECE of LEGISLATION: Drug Addiction Treatment Act (DATA) of 2000
Piece of legislation that established that allows office-based
opioid addiction treatment (i.e. Suboxone)
PIECE of LEGISLATION: Anabolic Steroids Act of 2004
Established that all anabolic steroids are Schedule III
Pseudoephedrine laws (Give 2) Combat Methamphetamine Epidemic Act of 2005, Methamphetamine Prevention Act of
2008
PIECE of LEGISLATION: The Patient Safety and Quality Improvement Act of 205 (PSQIA)
established that creates a voluntary program through which
health care providers, including pharmacies, share information
related to patient safety events with patient safety
organizations
PIECE of LEGISLATION: Food & Drug Administration Amendments Act (FDAAA) of 2007
FDA may mandate labeling changes related to safety; require
clinical trial data reporting and registries; require post-market
clinical studies to assess risk (Phase 4 studies)
PIECE of LEGISLATION: Biologics Price Competition and Innovation Act (included in the Affordable Care Act of
Allows a pathway for biosimilar approval 2010)
| COMPREHENSIVE PHARMACY LAW EXAM
PREP, PRACTICE QUESTIONS, CORRECT
ANSWERS AND STUDY GUIDE
| GRADED A+ | GUARANTEED SUCCESS
Updated 2026 Questions and Answers
100% Verified Exam Prep
,breakthrough therapy Give the FDA classification for the following description:
Drugs that provide substantial improvement over current tx
0 (zero) The max number of refills on an isotretinoin prescription
FALSE (it would have to be 503b) TRUE or FALSE: A 503a pharmacy can compound medications only for another 503a
pharmacy
priority review 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 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: Pure Food and Drug Act of 1906
prohibited the adulteration and misbranding of foods and
drugs in interstate commerce
PIECE of LEGISLATION: Food, Drug, and Cosmetic Act of 1938
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
PIECE of LEGISLATION: Durham-Humphrey Amendment of 1951
Established two classes of medications: Rx and OTC.
Authorized oral prescriptions and refills of prescription drugs.
Introduced label requirements for pharmacies
PIECE of LEGISLATION: Kefauver-Harris Amendment of 1962
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
PIECE of LEGISLATION: Federal Comprehensive Drug Abuse Prevention and Control Act of 1970
AKA Controlled substances act.
,PIECE of LEGISLATION: Medical Device Amendments of 1976
Established criteria for classifying devices into one of three
classes
PIECE of LEGISLATION: Orphan Drug Act of 1983
Provides tax and licensing initiatives for manufacturers who
develop drugs or biologicals for rare diseases or conditions
PIECE of LEGISLATION: Drug Price Competition (DPC) and Patent Term Restoration Act (PTRA) of 1984
Also known as the Waxman-Hatch Amendment. Streamlined
the generic drug approval process while giving patent
extensions for innovative drugs
PIECE of LEGISLATION: Prescription Drug Marketing Act (PDMA) of 1987
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
PIECE of LEGISLATION: The Omnibus Budget Reconciliation Act of 1990
AKA OBRA-90. Included prospective drug use review, patient
counseling, patient profiles
PIECE of LEGISLATION: Prescription Drug User Fee Act of 1992
Drug manufacturers required to pay fees when submitting a
new drug application
PIECE of LEGISLATION: Dietary Supplement Health & Education Act (DSHEA) of 1994
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
, PIECE of LEGISLATION: Health Insurance Portability and Accountability Act of 1996 (HIPAA)
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
PIECE of LEGISLATION: Food & Drug Administration Modernization Act (FDAMA) of 1997
Streamlined regulatory procedures to expedite the availability
of safe and effective drugs and devices; expands FDA
authority over OTC drugs; establishes a data bank of
information on clinical trials
PIECE of LEGISLATION: Drug Addiction Treatment Act (DATA) of 2000
Piece of legislation that established that allows office-based
opioid addiction treatment (i.e. Suboxone)
PIECE of LEGISLATION: Anabolic Steroids Act of 2004
Established that all anabolic steroids are Schedule III
Pseudoephedrine laws (Give 2) Combat Methamphetamine Epidemic Act of 2005, Methamphetamine Prevention Act of
2008
PIECE of LEGISLATION: The Patient Safety and Quality Improvement Act of 205 (PSQIA)
established that creates a voluntary program through which
health care providers, including pharmacies, share information
related to patient safety events with patient safety
organizations
PIECE of LEGISLATION: Food & Drug Administration Amendments Act (FDAAA) of 2007
FDA may mandate labeling changes related to safety; require
clinical trial data reporting and registries; require post-market
clinical studies to assess risk (Phase 4 studies)
PIECE of LEGISLATION: Biologics Price Competition and Innovation Act (included in the Affordable Care Act of
Allows a pathway for biosimilar approval 2010)
