ASSURED SUCCESS
Pure Food and Drug Act - correct answer 1906 - Prohibited drugs that were misbranded or
adulterated, but was difficult to enforce
Food Drug and Cosmetic Act - correct answer 1938 - Drugs were required to be safe, defined
drug and labeling requirements. Established FDA. Passed in response to sulfanilamide tragedy
Durham-Humphrey Amendment - correct answer 1951 - Established OTC vs prescription drugs
Kefauver-Harris Amendment - correct 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) - correct 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 - correct answer 1984 - Streamlined generic drug approval process and
ANDA. Generics must prove QUALITY and BIOEQUIVALENCE to brand drugs
Prescription Drug Marketing Act - correct 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) - correct answer 1990 - Mandated for Medicaid
patients: prospective drug utilization review (DUR) and patient counseling
Prescription Drug Use Fee Act - correct answer 1992 - Allowed FDA to charge fees to
manufacturers for new drug approvals
Dietary Supplement Health and Education Act - correct 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
,Wisconsin MPJE 2025 LATEST EXAM VERSION MOST TESTED QUESTIONS AND ANSWERS GRADED A+
ASSURED SUCCESS
FDA Modernization Act - correct answer 1997 - Created fast-track approval processes, affirmed
RPHs ability to compound based on individual Rx (503A), established Clinicalrials.gov
Combat Methamphetamine Epidemic Act - correct 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 - correct 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 - correct 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
Pharmacy Examining Board (PEB) - duties - correct answer -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 - correct answer -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 - correct answer June 1st of even-numbered years
,Wisconsin MPJE 2025 LATEST EXAM VERSION MOST TESTED QUESTIONS AND ANSWERS GRADED A+
ASSURED SUCCESS
Out-of-state pharmacy requirements - correct answer -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) - correct answer "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 - correct answer -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 - correct answer -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 - correct answer -sink with hot & cold water,
detergent, waste disposal
-state/federal laws
-resources: DIs, patient counseling, compounding, calculations, drug substitution (Orange Book)
-WI Poison Center contact info
Pharmacy drug storage requirements - correct answer -secure, neat, clean, orderly
, Wisconsin MPJE 2025 LATEST EXAM VERSION MOST TESTED QUESTIONS AND ANSWERS GRADED A+
ASSURED SUCCESS
-CS are stored either in locked cabinet OR dispersed throughout inventory
-appropriate temp/humidity to prevent adulteration -- continuously monitored, min/max
recorded at least once per business day
State recordkeeping requirements: how long - correct answer 5 years
Pharmacy security requirements - correct answer -centrally monitored alarm system
-safe or time lock NOT required
-lock and secure area when closed
Required signage and posting in every pharmacy - correct answer -Hours
-WI Poison Center info
-Patient's right to consultation
-How to file a complaint to the board
-Description of the pharmacist's ability to substitute less expensive generics and biologics
-Make available info on how to access PEB list of top 100 drugs, interchangeable biologics, top
100 retail price list
Licenses and certificates are NOT required to be posted
Pharmacist requirements for original licensure - correct answer -graduate from ACPE-
accredited school of pharmacy
-submit proof of internship
-pass NAPLEX
-pass WI MPJE
-complete application
-pay fee
Pharmacist requirements for transfer to WI (reciprocity) - correct answer -Application to PEB
-NABP transfer applications
-Pay fee
-Pass WI MPJE
Pharmacist licensure renewal - correct answer June 1 of even-numbered years