Wisconsin MPJE 2025 — Latest Exam Version:
Most-Tested Questions & Answers for A+
Success
Pure Food and Drug Act
1906 - Prohibited drugs that were misbranded or adulterated, but was difficult to enforce
Food Drug and Cosmetic Act
1938 - Drugs were required to be safe, defined drug and labeling requirements. Established FDA. Passed
in response to sulfanilamide tragedy
Durham-Humphrey Amendment
1951 - Established OTC vs prescription drugs
Kefauver-Harris Amendment
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)
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
1984 - Streamlined generic drug approval process and ANDA. Generics must prove QUALITY and
BIOEQUIVALENCE to brand drugs
,Prescription Drug Marketing Act
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)
1990 - Mandated for Medicaid patients: prospective drug utilization review (DUR) and patient
counseling
Prescription Drug Use Fee Act
1992 - Allowed FDA to charge fees to manufacturers for new drug approvals
Dietary Supplement Health and Education Act
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
1997 - Created fast-track approval processes, affirmed RPHs ability to compound based on individual Rx
(503A), established Clinicalrials.gov
Combat Methamphetamine Epidemic Act
2005 - Regulated methamphetamine precursors, limited quantities to be sold, records of all sales, sellers
must self-certify with DEA
Drug Quality and Security Act
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
-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
Pharmacy Examining Board (PEB) - duties
-enact regulations
-act on applications
-enforce statutes and regulations
-take disciplinary action
-oversee MPJE question creation
-may approve variances in emergencies or pilot programs
Pharmacy initial licensure requirements
, -Location/address
-Floor plan
-Owner name/address
-Managing pharmacist name
-PEB inspection
-Application/fee
Must be on file 30 days prior to granting license
If OWNER or LOCATION changes, a new license must be obtained
Pharmacy license renewal date
June 1st of even-numbered years
Out-of-state pharmacy requirements
-must be licensed in WI to dispense to WI residents (RPhs not required to be licensed in WI)
-knowledge of WI laws
-licensure in home state (need to have a valid license in the state they are located)
Professional service area (definition & space requirements)
"behind the counter"
-area in which Rx are compounded, dispensed, restricted items available, or patients consulted
-250 sq ft minimum
-Counter for compounding/dispensing: min 12 sq ft and 18 in wide
-<20% of space dedicated to bulk drug storage
Pharmacist absence: Less than 30 min
-not required to close professional service area
-RPh must be accessible and in communications
-pharmacy must indicate pharmacist not available, post time of return
-techs can only perform technical dispensing
Pharmacist absence: Greater than 30 minutes
-Must secure professional service area
-Convert to sundry outlet or close building
-May NOT accept telephoned prescriptions from prescribers
-May NOT accept fill requests from patients
-Telephone answering must NOT imply that pharmacy is in operation
-Notify board of hours
Pharmacy required facilities and resources
-sink with hot & cold water, detergent, waste disposal
-state/federal laws
Most-Tested Questions & Answers for A+
Success
Pure Food and Drug Act
1906 - Prohibited drugs that were misbranded or adulterated, but was difficult to enforce
Food Drug and Cosmetic Act
1938 - Drugs were required to be safe, defined drug and labeling requirements. Established FDA. Passed
in response to sulfanilamide tragedy
Durham-Humphrey Amendment
1951 - Established OTC vs prescription drugs
Kefauver-Harris Amendment
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)
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
1984 - Streamlined generic drug approval process and ANDA. Generics must prove QUALITY and
BIOEQUIVALENCE to brand drugs
,Prescription Drug Marketing Act
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)
1990 - Mandated for Medicaid patients: prospective drug utilization review (DUR) and patient
counseling
Prescription Drug Use Fee Act
1992 - Allowed FDA to charge fees to manufacturers for new drug approvals
Dietary Supplement Health and Education Act
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
1997 - Created fast-track approval processes, affirmed RPHs ability to compound based on individual Rx
(503A), established Clinicalrials.gov
Combat Methamphetamine Epidemic Act
2005 - Regulated methamphetamine precursors, limited quantities to be sold, records of all sales, sellers
must self-certify with DEA
Drug Quality and Security Act
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
-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
Pharmacy Examining Board (PEB) - duties
-enact regulations
-act on applications
-enforce statutes and regulations
-take disciplinary action
-oversee MPJE question creation
-may approve variances in emergencies or pilot programs
Pharmacy initial licensure requirements
, -Location/address
-Floor plan
-Owner name/address
-Managing pharmacist name
-PEB inspection
-Application/fee
Must be on file 30 days prior to granting license
If OWNER or LOCATION changes, a new license must be obtained
Pharmacy license renewal date
June 1st of even-numbered years
Out-of-state pharmacy requirements
-must be licensed in WI to dispense to WI residents (RPhs not required to be licensed in WI)
-knowledge of WI laws
-licensure in home state (need to have a valid license in the state they are located)
Professional service area (definition & space requirements)
"behind the counter"
-area in which Rx are compounded, dispensed, restricted items available, or patients consulted
-250 sq ft minimum
-Counter for compounding/dispensing: min 12 sq ft and 18 in wide
-<20% of space dedicated to bulk drug storage
Pharmacist absence: Less than 30 min
-not required to close professional service area
-RPh must be accessible and in communications
-pharmacy must indicate pharmacist not available, post time of return
-techs can only perform technical dispensing
Pharmacist absence: Greater than 30 minutes
-Must secure professional service area
-Convert to sundry outlet or close building
-May NOT accept telephoned prescriptions from prescribers
-May NOT accept fill requests from patients
-Telephone answering must NOT imply that pharmacy is in operation
-Notify board of hours
Pharmacy required facilities and resources
-sink with hot & cold water, detergent, waste disposal
-state/federal laws
