1|Page
Arizona MPJE Exam Study Guide-with 100% verified
solutions -tutor verified.docx
Pure Food & Drug Act 1906 - (answers)Prohibited food and drugs that were
distributed through interstate commerce to be adulterated or misbranded. Did
not require manufacturers to label ingredients
Food, Drug and Cosmetic Act of 1938 - (answers)New drugs can not be marketed
until proven safe according to directions on the label.
Labels must have adequate directions for use and warnings for hazardous and
habit forming ingredients
Durham-Humphrey Amendment of 1951 - (answers)Created a distinction
between "OTC" and "Legend Drugs".
Legend Drugs can only be dispensed with a valid Prescription..
• Required Legend Drugs to carry the statement:
"Caution: Federal law prohibits dispensing without a prescription.".
Most people refer to Legend drugs simply as "Prescription Drugs".
• The emphasis of this act was to insure safety through qualified medical
supervision.
Kefauver-Harris Amendment of 1962 - (answers)Required all new drugs marketed
in the US to be shown not only SAFE but also EFFECTIVE.
,2|Page
Who has authority over prescription drug advertisements - (answers)FDA (Food &
Drug Administration)
Orphan Drug Act of 1983 - (answers)Amendment made to provide various tax and
licensing incentives towards treatment of rare diseases.
Medical Device Amendment of 1976 - (answers)Amendment to the FDCA,
provided better clarification of medical devices according to their: specific
function, establishment of performance standards for these devices, pre-market
approval requirements, conformance with GMP standards, and requirements for
adherence to record and reporting requirements.
Who has authority over non-prescription advertisements - (answers)FTC (Federal
Trade Commission)
U.S. Attorney General - (answers)Supervisor of the Drug Enforcement Agency
(DEA)
-Determines classification of Controlled substance medications (CII-CV)
-Appoints Administration of DEA
Drug Price Competition & Patent Term Restoration Act
,3|Page
AKA: Hatch-Waxman Amendment - (answers)Streamlined drug approval process
for GENERIC PRODUCTS by requiring submission of only an ANDA (abbreviated
new drug application).
Proof of bioequivalence and brand name drug required.
Also gave incentives to brand-name drug manufacturers to develop new drug
products.. Being awarded up to five additional years of patent protection.
Prescription Drug Marketing Act of 1987 - (answers)Created to place more
stringent controls on the distribution of prescription products.
-Prevents re-importation of a drug into the US
-Prohibited hospital and healthcare entities from reselling their pharmaceuticals
-Requires prescription drug wholesalers to be licensed by states under federal
guidelines
-Prohibited sale, trade, or purchase of prescription drug samples
-Specify precise storage, handling, and record-keeping requirements for drug
samples.
FDA Modernization Act of 1997 - (answers)SOME Actions of law:
1) provided for fast-track review of some NDA submissions (reason: to expedite
approval of new drugs that treat serious or life-threatening conditions)
, 4|Page
2) clarified conditions under which pharmacies may extemporaneously compound
prescriptions (examples: individual states should regulate compounding;
pharmacies are exempt from strict GMP standards and requirements for NDA
submission)
3) replaced drug legend from Durham-Humphrey Amendment of 1951 with a new
legend stating "Rx only"
4) eliminated provision that required certain substances to be labeled "Warning-
May be habit forming" (that was a requirement of the FDCA of 1938)
5) encouraged manufacturers to conduct research for new USES of drugs and to
submit SUPPLEMENTAL NDAs for these uses (NOTE: manufacturers may publicly
disseminate limited info about unapproved uses as long as a statement is
included specifying that the use has not been approved or cleared by the FDA and
certain other requirements are met)
6) encouraged manufacturers to perform pediatric studies of drugs by providing
them with an additional 6 MONTHS of marketing exclusivity
Patient Protection & Affordable Care Act - (answers)-Requires all individuals to
have health insurance. (Small businesses received credits for employee health
covereage)
-Require standards for financial and administrative transactions including timely
and transparent claims using standard electronic. transactions.
Arizona MPJE Exam Study Guide-with 100% verified
solutions -tutor verified.docx
Pure Food & Drug Act 1906 - (answers)Prohibited food and drugs that were
distributed through interstate commerce to be adulterated or misbranded. Did
not require manufacturers to label ingredients
Food, Drug and Cosmetic Act of 1938 - (answers)New drugs can not be marketed
until proven safe according to directions on the label.
Labels must have adequate directions for use and warnings for hazardous and
habit forming ingredients
Durham-Humphrey Amendment of 1951 - (answers)Created a distinction
between "OTC" and "Legend Drugs".
Legend Drugs can only be dispensed with a valid Prescription..
• Required Legend Drugs to carry the statement:
"Caution: Federal law prohibits dispensing without a prescription.".
Most people refer to Legend drugs simply as "Prescription Drugs".
• The emphasis of this act was to insure safety through qualified medical
supervision.
Kefauver-Harris Amendment of 1962 - (answers)Required all new drugs marketed
in the US to be shown not only SAFE but also EFFECTIVE.
,2|Page
Who has authority over prescription drug advertisements - (answers)FDA (Food &
Drug Administration)
Orphan Drug Act of 1983 - (answers)Amendment made to provide various tax and
licensing incentives towards treatment of rare diseases.
Medical Device Amendment of 1976 - (answers)Amendment to the FDCA,
provided better clarification of medical devices according to their: specific
function, establishment of performance standards for these devices, pre-market
approval requirements, conformance with GMP standards, and requirements for
adherence to record and reporting requirements.
Who has authority over non-prescription advertisements - (answers)FTC (Federal
Trade Commission)
U.S. Attorney General - (answers)Supervisor of the Drug Enforcement Agency
(DEA)
-Determines classification of Controlled substance medications (CII-CV)
-Appoints Administration of DEA
Drug Price Competition & Patent Term Restoration Act
,3|Page
AKA: Hatch-Waxman Amendment - (answers)Streamlined drug approval process
for GENERIC PRODUCTS by requiring submission of only an ANDA (abbreviated
new drug application).
Proof of bioequivalence and brand name drug required.
Also gave incentives to brand-name drug manufacturers to develop new drug
products.. Being awarded up to five additional years of patent protection.
Prescription Drug Marketing Act of 1987 - (answers)Created to place more
stringent controls on the distribution of prescription products.
-Prevents re-importation of a drug into the US
-Prohibited hospital and healthcare entities from reselling their pharmaceuticals
-Requires prescription drug wholesalers to be licensed by states under federal
guidelines
-Prohibited sale, trade, or purchase of prescription drug samples
-Specify precise storage, handling, and record-keeping requirements for drug
samples.
FDA Modernization Act of 1997 - (answers)SOME Actions of law:
1) provided for fast-track review of some NDA submissions (reason: to expedite
approval of new drugs that treat serious or life-threatening conditions)
, 4|Page
2) clarified conditions under which pharmacies may extemporaneously compound
prescriptions (examples: individual states should regulate compounding;
pharmacies are exempt from strict GMP standards and requirements for NDA
submission)
3) replaced drug legend from Durham-Humphrey Amendment of 1951 with a new
legend stating "Rx only"
4) eliminated provision that required certain substances to be labeled "Warning-
May be habit forming" (that was a requirement of the FDCA of 1938)
5) encouraged manufacturers to conduct research for new USES of drugs and to
submit SUPPLEMENTAL NDAs for these uses (NOTE: manufacturers may publicly
disseminate limited info about unapproved uses as long as a statement is
included specifying that the use has not been approved or cleared by the FDA and
certain other requirements are met)
6) encouraged manufacturers to perform pediatric studies of drugs by providing
them with an additional 6 MONTHS of marketing exclusivity
Patient Protection & Affordable Care Act - (answers)-Requires all individuals to
have health insurance. (Small businesses received credits for employee health
covereage)
-Require standards for financial and administrative transactions including timely
and transparent claims using standard electronic. transactions.
