Indiana MPJE Review Complete Study Questions And Answers

Indiana MPJE Review Complete Study Questions And Answers
Where to find federal laws and regulations Correct Answer: United States Code (USC)
The Code of Federal Regulations (CFR)
Majority can be found in Title 21 of both
Where to find Indiana laws and regulations (Rules in Indiana) Correct Answer: The
Indiana Code (IC)
Indiana Administrative Code (IAC)
Pure Food and Drug Act of 1906 Correct Answer: Prevented the manufacture, sale, or
transportation of adulterated or misbranded or poisonous or deleterious foods, drugs,
medicines, and liquors
Food, Drug, and Cosmetic Act (FDCA) of 1938 Correct Answer: Required proof of
safety of a drug
Required labels to provide adequate directions for use
Did not require coverage for pre-1938 drugs already on the market
Durham-Humphrey Amendment of 1951 Correct Answer: Amended 1938 Act
Established legend and non-legend drugs
Prohibited refills of prescriptions without consent from prescriber
Outlined minimal information required on the prescription label
Allowed pharmacists to accept oral order from prescribers
Kefauver-Harris Amendments of 1962 Correct Answer: Amended 1938 Act
Required drugs to be safe and effective
Established CGMPs
Provided for testing in humans
Federal Comprehensive Drug Abuse Prevention and Control Act of 1970 Correct
Answer: Created the DEA
Created a closed system to control the manufacture, distribution, prescribing, and
dispensing of all controls
Poison Prevention Packaging Act of 1970 Correct Answer: Gives Consumer Product
Safety Commission the authority to require special packaging of "hazardous
substances"- pretty much all oral drugs
Medical Device Amendments of 1976 Correct Answer: Called for all devices to be
divided into classes (3), with varying amounts of control required in each one
Orphan Drug Act of 1983 Correct Answer: Provided financial incentives to attract
industry's interest in creating drugs for rare diseases
Drug Price Competition (DPC) and Patent Term Restoration Act (PTRA) of 1984
Correct Answer: Created abbreviated new drug application for generic drugs
Allowed the marketing of a generic drug without conducting clinical studies but still
required CGMPs and proof of bioequivalence
Prescription Drug Marketing Act (PDMA) of 1987 Correct Answer: Established
procedures, requirements, and minimum standards for the distribution of prescription
drugs and samples
Has 6 parts:
Prohibits reimportation of rx's into US unless for emergency use by the FDA
Bans the actual or offer to sell, purchase, or trade a rx drug that was purchased by a
hospital or facility (hospitals can sell to other entities though)
Prohibits selling drug samples and selling/counterfieting coupons; requires drs to ask for
drug samples in writing, prohibits pharmacies from having drug samples, establishes
record keeping and regulations for samples
Details how records should be kept and how to respond to record requests
How to apply for a whistleblower award
Requirements for wholesale distributors that all states must license
The Omnibus Reconciliation Act of 1990 (OBRA 90) Correct Answer: Required that
states develop stands for a reasonable effort to maintain patient profiles for all Medicaid
patients and prospective DUR and an offer to counsel for all Medicaid patients
Prescription Drug User Fee Act of 1992 Correct Answer: Allowed the FDA to collect
fees from drug manufacturers to fund the new drug approval process
Dietary Supplement Health and Education Act (DSHEA) of 1994 Correct Answer: Allows
manufacturers to make certain statements about dietary supplements relating to a
structure or function in the body if the statement includes specific things:
Claims a benefit related to a classical nutrient deficiency disease and discloses the
prevalence of such disease in US
Describes the role of a nutrient or dietary ingredient intended to affect the structure or
function in humans
Characterizes the documented mechanism by which a nutrient or dietary ingredient acts
to maintain such structure/function
Describes general well-being from consumption of a nutrient or dietary ingredient
Manufacturer must have evidence that the claim is truthful and not misleading
Cannot make claims about a disease or a dysfunction
Health Insurance Portability and Accountability Act (HIPAA) of 1996 Correct Answer:
Federal standards for protecting privacy and security of patients' protected health
information
Food and Drug Administration Modernization Act (FDAMA) of 1997 Correct Answer:
Amended 1938 Act
Added Rx only to labels

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