NORTH CAROLINA MPJE EXAM WITH GUARANTEED ACCURATE ANSWERS |VERIFIED
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Module
NORTH CAROLINA MPJE
Institution
NORTH CAROLINA MPJE
Pure Food and Drug Act of 1906 - ACCURATE ANSWERprohibited the adulteration and misbranding of foods and drugs in interstate commerce
Food, Drug, and Cosmetic Act of 1938 - ACCURATE ANSWERCore of today's drug laws. No new drug can be marketed/sold until proven safe and approved by FDA. Labels mu...
NORTH CAROLINA MPJE EXAM
NORTH CAROLINA MPJE EXAM WITH GUARANTEED ACCURATE ANSWERS |
VERIFIED
Pure Food and Drug Act of 1906 - ACCURATE ANSWER✅✅prohibited the
adulteration and misbranding of foods and drugs in interstate commerce
Food, Drug, and Cosmetic Act of 1938 - ACCURATE 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 - ACCURATE
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 - ACCURATE 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 -
ACCURATE ANSWER✅✅AKA Controlled substances act.
Medical Device Amendments of 1976 - ACCURATE ANSWER✅✅Established
criteria for classifying devices into one of three classes
Orphan Drug Act of 1983 - ACCURATE 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 -
ACCURATE 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 - ACCURATE
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 - ACCURATE
ANSWER✅✅AKA OBRA-90. Included prospective drug use review, patient
counseling, patient profiles
,Prescription Drug User Fee Act of 1992 - ACCURATE ANSWER✅✅Drug
manufacturers required to pay fees when submitting a new drug application
Dietary Supplement Health & Education Act (DSHEA) of 1994 - ACCURATE
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) -
ACCURATE 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 - ACCURATE
ANSWER✅✅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
Drug Addiction Treatment Act (DATA) of 2000 - ACCURATE
ANSWER✅✅Allows office-based opioid addiction treatment (i.e. Suboxone)
Anabolic Steroids Act of 2004 - ACCURATE ANSWER✅✅All anabolic steroids
are Schedule III
Combat Methamphetamine Epidemic Act of 2005 & Methamphetamine Prevention
Act of 2008 - ACCURATE ANSWER✅✅Pseudoephedrine laws
, The Patient Safety and Quality Improvement Act of 205 (PSQIA) - ACCURATE
ANSWER✅✅Creates a voluntary program through which health care providers,
including pharmacies, share information related to patient safety events with
patient safety organizations
Food & Drug Administration Amendments Act (FDAAA) of 2007 - ACCURATE
ANSWER✅✅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)
Biologics Price Competition and Innovation Act (included in the Affordable Care
Act of 2010) - ACCURATE ANSWER✅✅Allows a pathway for biosimilar
approval
FDA Safety and Innovation Act of 2012 - ACCURATE ANSWER✅✅Contains
provisions directed at reducing drug counterfeiting, blocking the import of
adulterated products, detecting and reducing drug shortages
Drug Quality and Security Act of 2013 - ACCURATE ANSWER✅✅Regulated
pharmacy compounding and tracking of medications throughout the distribution
system
Comprehensive Addiction and Recovery Act of 2016 - ACCURATE
ANSWER✅✅Extends time frame in which C-II's can be partially filled, allows
NPs and PAs to apply for a waiver to prescribe buprenorphine for opioid addiction
How many members comprise the NC BOP? - ACCURATE ANSWER✅✅6
(Six)
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