Exam (elaborations)
Wisconsin MPJE 2024-25 (211 QUESTIONS WITH COMPLETE SOLUTIONS)
- Course
- Just Wisconsin
- Institution
- University Of Wisconsin-Madison
Wisconsin MPJE 2024-25 (211 QUESTIONS WITH COMPLETE SOLUTIONS)
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Wisconsin MPJE2024-25 (211
QUESTIONS
WITH COMPLETE
SOLUTIONS)
Pure Food and Drug Act - answer 1906 - Prohibited
drugs that were misbranded or adulterated, but
was difficult to enforce
Food Drug and Cosmetic Act - answer 1938 - Drugs
were required to be safe, defined drug and labeling
requirements. Established FDA. Passed in response
to sulfanilamide tragedy
Durham-Humphrey Amendment - answer 1951 -
Established OTC vs prescription drugs
,Kefauver-Harris Amendment - answer 1962 -
Passed in response to thalidomide tragedy.
Required drugs to be EFFECTIVE and safe.
Established GMPs and informed consent for
research subjects
Poison Prevention Packaging Act (& CR-packaging
exceptions) - answer 1970 - Established child-
resistant packaging
*a patient may request NCR-packaging for any/all
of Rxs
*prescribers can only request NCR on per-
prescription basis
Exceptions to child resistant packaging:
-nitroglycerin
-mnemonic packaging
-powders
-inhalers
-topicals
,Hatch-Waxman Act - answer 1984 - Streamlined
generic drug approval process and ANDA. Generics
must prove QUALITY and BIOEQUIVALENCE to
brand drugs
Prescription Drug Marketing Act - answer 1987 -
Prohibited sale of drug samples, re-imported drugs,
and resale of drugs by healthcare orgs. Required
state licensing of wholesalers
Omnibus Budget Reconciliation Act (OBRA) -
answer 1990 - Mandated for Medicaid patients:
prospective drug utilization review (DUR) and
patient counseling
Prescription Drug Use Fee Act - answer 1992 -
Allowed FDA to charge fees to manufacturers for
new drug approvals
Dietary Supplement Health and Education Act -
answer 1994 - Created "dietary supplements" -
regulated more 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 - answer 1997 - Created
fast-track approval processes, affirmed RPHs ability
to compound based on individual Rx (503A),
established Clinicalrials.gov
Combat Methamphetamine Epidemic Act - answer
2005 - Regulated methamphetamine precursors,
limited quantities to be sold, records of all sales,
sellers must self-certify with DEA
Drug Quality and Security Act - answer 2013 -
Created 503B to tighten sterile compounding
regulations, established track-and-trace processes
for all drugs, and electronic, interoperable system
to track drug products by 2023
Pharmacy Examining Board (PEB) - composition -
answer -7 WI residents: 5 pharmacist, 2 public
-Appointed by governor to a max of 2 consecutive
4-year terms
-Cannot be an officer of a private pharmacy org
-Located with DSPS
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