ID MPJE study plan
ID MPJE · Give each week a clear focus.
8 weeks · About 7 hours per week
Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)
Map the FDCA prohibited acts and adulteration/misbranding provisions to the dispensing decisions a pharmacist makes daily
Trace a new drug from IND through NDA approval and identify where pharmacist dispensing obligations attach
Distinguish prescription from OTC status and explain the switch process and its labeling consequences
Build a one-page timeline of major federal drug law amendments and the compliance duty each created
Your checkpoint
A 2-page annotated flowchart of the FDCA drug-approval pathway with at least 12 pharmacist-facing compliance checkpoints labeled
Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS) & Controlled substances: scheduling, ordering, records, and reporting
Assign all five CSA schedules using the eight-factor analysis and statutory criteria
Differentiate registration requirements by activity type (dispenser, distributor, researcher, reverse distributor)
Apply CSA order-form, invoice, and recordkeeping rules to a simulated pharmacy purchase
Identify which CSA violations trigger reporting to DEA versus internal remediation
Your checkpoint
A completed 30-question self-quiz on CSA scheduling and registration with a written rationale for every missed item
Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS)
Outline DSCSA transaction-information, verification, and serialization duties at each point in the supply chain
Determine how trading-partner roles change what a pharmacy must capture and retain
Explain REMS elements and how a pharmacist confirms and documents compliance before dispensing
Distinguish REMS restrictions from routine prior authorization and from risk evaluation in controlled substances
Your checkpoint
A one-page DSCSA and REMS compliance checklist a pharmacist could post at a dispensing workstation, with citations to the governing requirement
State pharmacy practice acts and board of pharmacy rules & Prescription processing, labeling, and dispensing requirements
Compare the state practice act's definition of practice with board rulemaking and identify conflicts with federal law
Apply prescription validity elements to accept, clarify, or refuse an order
Determine labeling content requirements and identify which elements are federally versus state mandated
Sequence the steps for handling an oral prescription for a controlled substance, including documentation
Your checkpoint
A side-by-side table of federal and state requirements for prescription validity and labeling, with at least 10 rows and a note on which rule controls when they differ
State pharmacy practice acts and board of pharmacy rules & Licensure, registration, and scope of practice for pharmacy personnel
Map licensure, registration, and renewal obligations for pharmacists, technicians, and interns in the jurisdiction
Delineate scope-of-practice boundaries for technician duties and identify tasks requiring pharmacist judgment
Explain the board's disciplinary process and the pharmacist's duty to report certain conduct
Identify continuing education and immunization or collaborative-practice authorities and their limits
Your checkpoint
A personal licensure and renewal calendar plus a technician-task delegation matrix marking each task as permitted, conditional, or prohibited
Controlled substances: scheduling, ordering, records, and reporting & Prescription processing, labeling, and dispensing requirements
Apply controlled-substance inventory rules to an initial, biennial, and change-of-responsible-person inventory
Reconcile a simulated perpetual inventory and explain how to resolve and document a discrepancy
Determine the correct handling of expired, returned, or transferred controlled substances
Evaluate a suspicious order pattern and describe the corresponding-record and reporting obligations
Your checkpoint
A worked inventory reconciliation exercise with a discrepancy log and a written narrative of the corrective action taken
Pharmacy operations, drug storage, and inventory management & Professional and ethical standards, patient counseling, and error reporting
Design storage conditions that satisfy temperature, security, and segregation requirements across the pharmacy
Distinguish recalls, returns, and quarantine procedures and assign responsibility for each step
Apply error-reporting and patient-counseling standards to a set of realistic dispensing scenarios
Identify ethical obligations around impaired colleagues, privacy, and conflicts of interest
Your checkpoint
A written response to three dispensing-error scenarios, each including root-cause analysis, disclosure and reporting steps, and required counseling documentation
Federal drug laws and regulations (FDCA, CSA, DSCSA, REMS) & State pharmacy practice acts and board of pharmacy rules & Controlled substances: scheduling, ordering, records, and reporting
Synthesize federal and state requirements into a single decision framework for a controlled-substance prescription
Complete timed practice sets under exam conditions and log error patterns by domain
Re-drill every missed item from weeks 1 through 7 until each can be explained without notes
Review the highest-yield statutes, schedules, and recordkeeping deadlines in a condensed reference
Your checkpoint
A full-length timed practice exam with a domain-by-domain score report and a one-page personal weak-spot remediation list
Milestones
Week 2: Score at least 80 percent on the CSA scheduling and registration self-quiz and correctly assign schedules for 25 substances without notes
Week 4: Explain the federal-state interplay for prescription validity and labeling from memory, and correctly resolve 8 of 10 conflict scenarios
Week 6: Complete the inventory reconciliation with a discrepancy log that identifies every seeded error and states the correct reporting obligation
Week 8: Score at least 75 percent overall on the timed practice exam with no single domain below 70 percent