Wisconsin MPJE 2025 LATEST EXAM VERSION
MOST TESTED QUESTIONS AND ANSWERS
GRADED A+ ASSURED SUCCESS
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1906 - Prohibited drugs that were misbranded or
Pure Food and Drug Act
adulterated, but was difficult to enforce
1938 - Drugs were required to be safe, defined drug
Food Drug and Cosmetic
and labeling requirements. Established FDA. Passed in
Act
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
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1970 - Established child-resistant packaging
*a patient may request NCR-packaging for any/all of
Rxs
*prescribers can only request NCR on per-
Poison Prevention prescription basis
Packaging Act (& CR-
packaging exceptions) Exceptions to child resistant packaging:
-nitroglycerin
-mnemonic packaging
-powders
-inhalers
-topicals
1984 - Streamlined generic drug approval process
Hatch-Waxman Act and ANDA. Generics must prove QUALITY and
BIOEQUIVALENCE to brand drugs
1987 - Prohibited sale of drug samples, re-imported
Prescription Drug
drugs, and resale of drugs by healthcare orgs.
Marketing Act
Required state licensing of wholesalers
Omnibus Budget 1990 - Mandated for Medicaid patients: prospective
Reconciliation Act (OBRA) drug utilization review (DUR) and patient counseling
Prescription Drug Use Fee 1992 - Allowed FDA to charge fees to manufacturers
Act for new drug approvals
1994 - Created "dietary supplements" - regulated
Dietary Supplement more like food than drugs. FDA premarket approval
Health and Education Act not required but they may be removed. Can make
"structure/function" claims but not "disease" claims
1997 - Created fast-track approval processes, affirmed
FDA Modernization Act 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
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2013 - Created 503B to tighten sterile compounding
Drug Quality and Security regulations, established track-and-trace processes for
Act all drugs, and electronic, interoperable system to
track drug products by 2023
-7 WI residents: 5 pharmacist, 2 public
-Appointed by governor to a max of 2 consecutive 4-
Pharmacy Examining
year terms
Board (PEB) - composition
-Cannot be an officer of a private pharmacy org
-Located with DSPS
-enact regulations
-act on applications
-enforce statutes and regulations
Pharmacy Examining
-take disciplinary action
Board (PEB) - duties
-oversee MPJE question creation
-may approve variances in emergencies or pilot
programs
-Location/address
-Floor plan
-Owner name/address
-Managing pharmacist name
-PEB inspection
Pharmacy initial licensure
-Application/fee
requirements
Must be on file 30 days prior to granting license
If OWNER or LOCATION changes, a new license must
be obtained
Pharmacy license renewal June 1st of even-numbered years
date
-must be licensed in WI to dispense to WI residents
(RPhs not required to be licensed in WI)
Out-of-state pharmacy
-knowledge of WI laws
requirements
-licensure in home state (need to have a valid license
in the state they are located)
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