Wisconsin MPJE 2025 LATEST EXAM
QUESTIONS AND ANSWERS
Practice questions for this set
Terms in this set (211)
,Pure Food and Drug Act 1906 - Prohibited drugs that were misbranded or adulterated,
but was difficult to enforce
Food Drug and Cosmetic 1938 - Drugs were required to be safe, defined drug and
Act labeling requirements. Established FDA. Passed in
response to sulfanilamide tragedy
Durham-Humphrey 1951 - Established OTC vs prescription drugs
Amendment
1962 - Passed in response to thalidomide tragedy.
Kefauver-Harris
Required drugs to be EFFECTIVE and safe.
Amendment
Established GMPs and informed consent for research subjects
Poison Prevention 1970 - Established child-resistant packaging
Packaging Act (&
CRpackaging *a patient may request NCR-packaging for any/all of
exceptions)
Rxs
*prescribers can only request NCR on perprescription
basis
Exceptions to child resistant packaging:
-nitroglycerin
-mnemonic packaging
-powders
-inhalers
-topicals
, Hatch-Waxman Act 1984 - Streamlined generic drug approval process and
ANDA. Generics must prove QUALITY and
BIOEQUIVALENCE to brand drugs
Prescription Drug 1987 - Prohibited sale of drug samples, re-imported drugs,
Marketing Act and resale of drugs by healthcare orgs.
Required state licensing of wholesalers
Omnibus Budget 1990 - Mandated for Medicaid patients: prospective drug
Reconciliation Act (OBRA) utilization review (DUR) and patient counseling
Prescription Drug Use Fee 1992 - Allowed FDA to charge fees to manufacturers for
Act new drug approvals
Dietary Supplement 1994 - Created "dietary supplements" - regulated more
Health and Education Act like food than drugs. FDA premarket approval not
required but they may be removed. Can make
"structure/function" claims but not "disease" claims
FDA Modernization Act 1997 - Created fast-track approval processes, affirmed
RPHs ability to compound based on individual Rx
(503A), established Clinicalrials.gov
Combat 2005 - Regulated methamphetamine precursors,
Methamphetamine limited quantities to be sold, records of all sales,
Epidemic Act sellers must self-certify with DEA
QUESTIONS AND ANSWERS
Practice questions for this set
Terms in this set (211)
,Pure Food and Drug Act 1906 - Prohibited drugs that were misbranded or adulterated,
but was difficult to enforce
Food Drug and Cosmetic 1938 - Drugs were required to be safe, defined drug and
Act labeling requirements. Established FDA. Passed in
response to sulfanilamide tragedy
Durham-Humphrey 1951 - Established OTC vs prescription drugs
Amendment
1962 - Passed in response to thalidomide tragedy.
Kefauver-Harris
Required drugs to be EFFECTIVE and safe.
Amendment
Established GMPs and informed consent for research subjects
Poison Prevention 1970 - Established child-resistant packaging
Packaging Act (&
CRpackaging *a patient may request NCR-packaging for any/all of
exceptions)
Rxs
*prescribers can only request NCR on perprescription
basis
Exceptions to child resistant packaging:
-nitroglycerin
-mnemonic packaging
-powders
-inhalers
-topicals
, Hatch-Waxman Act 1984 - Streamlined generic drug approval process and
ANDA. Generics must prove QUALITY and
BIOEQUIVALENCE to brand drugs
Prescription Drug 1987 - Prohibited sale of drug samples, re-imported drugs,
Marketing Act and resale of drugs by healthcare orgs.
Required state licensing of wholesalers
Omnibus Budget 1990 - Mandated for Medicaid patients: prospective drug
Reconciliation Act (OBRA) utilization review (DUR) and patient counseling
Prescription Drug Use Fee 1992 - Allowed FDA to charge fees to manufacturers for
Act new drug approvals
Dietary Supplement 1994 - Created "dietary supplements" - regulated more
Health and Education Act like food than drugs. FDA premarket approval not
required but they may be removed. Can make
"structure/function" claims but not "disease" claims
FDA Modernization Act 1997 - Created fast-track approval processes, affirmed
RPHs ability to compound based on individual Rx
(503A), established Clinicalrials.gov
Combat 2005 - Regulated methamphetamine precursors,
Methamphetamine limited quantities to be sold, records of all sales,
Epidemic Act sellers must self-certify with DEA
