MPJE Competency Statements

The Multistate Pharmacy Jurisprudence Examination® (MPJE®) Competency Statements provide a blueprint of the topics covered on the examination. They offer important information about the knowledge, judgment, and skills you are expected to demonstrate while taking the MPJE. A strong understanding of the Competency Statements will aid you in your preparation to take the examination.

Your formal education, training, practical experience, and self-study prepare you for the MPJE. The MPJE has been designed to assess how well you apply your knowledge, skills, and abilities to evaluate situations involving the applicable federal and state laws and regulations that govern the practice of pharmacy in the state in which you are seeking licensure. Additional information may also be obtained from the state board of pharmacy where you are seeking licensure.

Note: No distinction is made in the examination between federal and state jurisprudence questions. You are required to answer each question in terms of the prevailing laws of the state in which you are seeking licensure.

Area 1 – Pharmacy Practice (Approximately 83% of Test)

1.1 – Legal responsibilities of the pharmacist and other pharmacy personnel:

• 1.1.1 – Unique legal responsibilities of the pharmacist-in-charge (or equivalent), pharmacists, interns, and pharmacy owners
  • Responsibilities for inventory, loss and/or theft of prescription drugs, the destruction/disposal of prescription drugs and the precedence of Local, State, or Federal requirements
• 1.1.2 – Qualifications, scope of duties, and conditions for practice relating to pharmacy technicians and all other non-pharmacist personnel
  • Personnel ratios, duties, tasks, roles, and functions of non-pharmacist personnel

1.2 – Requirements for the acquisition and distribution of pharmaceutical products, including samples:

• 1.2.1 – Requirements and record keeping in relation to the ordering, acquiring, and maintenance of all pharmaceutical products and bulk drug substances/excipients
  • Legitimate suppliers, pedigrees and the maintenance of acquisition records
• 1.2.2 – Requirements for distributing pharmaceutical products and preparations, including the content and maintenance of distribution records
  • Legal possession of pharmaceutical products (including drug samples), labeling, packaging, repackaging, compounding, and sales to practitioners

1.3 – Legal requirements that must be observed in the issuance of a prescription/drug order:

• 1.3.1 – Prescription/order requirements for pharmaceutical products and the limitations on their respective therapeutic uses
  • Products, preparations, their uses and limitations applicable to all prescribed orders for both human and veterinary uses
• 1.3.2 – Scope of authority, scope of practice, and valid registration of all practitioners who are authorized under law to prescribe, dispense, or administer pharmaceutical products, including controlled substances
  • Federal and State registrations, methadone programs, office-based opioid treatment programs, regulations related to retired or deceased prescribers, internet prescribing, limits on jurisdictional prescribing
• 1.3.3 – Conditions under which the pharmacist participates in the administration of pharmaceutical products, or in the management of patients’ drug therapy
  • Prescriptive authority, collaborative practice, consulting, counseling, medication administration (including immunization, vaccines), ordering labs, medication therapy management, and disease state management
• 1.3.4 – Requirements for issuing a prescription/order
  • Content and format for written, telephonic voice transmission, electronic facsimile, computer and internet, during emergency conditions, and tamper-resistant prescription forms
• 1.3.5 – Requirements for the issuance of controlled substance prescriptions/orders
  • Content and format for written, telephonic voice transmission, electronic facsimile, computerized and internet, during emergency conditions, conditions for changing a prescription, time limits for dispensing initial prescriptions/drug orders, and requirements for multiple Schedule II orders
• 1.3.6 – Limits of a practitioner’s authority to authorize refills of a pharmaceutical product, including controlled substances

1.4 – Procedures necessary to properly dispense a pharmaceutical product, including controlled substances, pursuant to a prescription/drug order:

• 1.4.1 – Responsibilities for determining whether prescriptions/orders were issued for a legitimate medical purpose and within all applicable legal restrictions
  • Corresponding responsibility, maximum quantities, restricted distribution systems, red flags/automated alerts, controlled substances, valid patient prescriber relationship, and due diligence to ensure validity of the order
• 1.4.2 – Requirements for the transfer of existing prescription/order information from one pharmacist to another
• 1.4.3 – Conditions under which a prescription/order may be filled or refilled
  • Emergency fills or refills, partial dispensing of a controlled substance, disaster or emergency protocol, patient identification, requirement for death with dignity, medical marijuana, and conscience /moral circumstances
• 1.4.4 – Conditions under which prospective drug use review is conducted prior to dispensing
  • Patient-specific therapy and requirements for patient-specific documentation
• 1.4.5 – Conditions under which product selection is permitted or mandated
  • Consent of the patient and/or prescriber, passing-on of cost savings, and appropriate documentation
• 1.4.6 – Requirements for the labeling of pharmaceutical products and preparations dispensed pursuant to a prescription/order
  • Generic and therapeutic equivalency, formulary use, auxiliary labels, patient package inserts, FDA medication guides, and written drug information
• 1.4.7 – Packaging requirements of pharmaceutical products, preparations, and devices to be dispensed pursuant to a prescription/order
  • Child-resistant and customized patient medication packaging
• 1.4.8 – Conditions under which a pharmaceutical product, preparation, or device may not be dispensed
  • Adulteration, misbranding, and dating
• 1.4.9 – Requirements for compounding pharmaceutical products
  • Environmental controls, release checks and testing, beyond use date (BUD), initial and ongoing training
• 1.4.10 – Requirements for emergency kits
  • Supplying, maintenance, access, security, and inventory
• 1.4.11 – Conditions regarding the return and/or reuse of pharmaceutical products, preparations, bulk drug substances/excipients, and devices
  • Charitable programs, cancer or other repository programs, previously dispensed, and from “will call” areas of pharmacies
• 1.4.12 – Procedures and requirements for systems or processes whereby a non-pharmacist may obtain pharmaceutical products, preparations, bulk drug substances/excipients, and devices
  • Pyxis (vending), after hour’s access, telepharmacies, and secure automated patient drug retrieval centers
• 1.4.13 – Procedures and requirements for establishing and operating central processing and central fill pharmacies
  • Remote order verification
• 1.4.14 – Requirements for reporting to PMP, accessing information in a PMP and the maintenance of security and confidentiality of information accessed in PMPs
• 1.4.15 – Requirements when informed consent must be obtained from the patient and/or a duty to warn must be executed
  • Collaborative practice and investigational drug therapy

1.5 – Conditions for making an offer to counsel or counseling appropriate patients, including the requirements for documentation:

• 1.5.1 – Requirements to counsel or to make an offer to counsel
• 1.5.2 – Required documentation necessary for counseling

1.6 – Requirements for the distribution and/or dispensing of non-prescription pharmaceutical products, including controlled substances:

• 1.6.1 – Requirements for the labeling of non-prescription pharmaceutical products and devices
• 1.6.2 – Requirements for the packaging and repackaging of non-prescription pharmaceutical products and devices
• 1.6.3 – Requirements for the distribution and/or dispensing of poisons, restricted, non-prescription pharmaceutical products, and other restricted materials or devices
  • Pseudoephedrine, dextromethorphan, emergency contraception, and behind the counter products as appropriate

1.7 – Procedures for keeping records of information related to pharmacy practice, pharmaceutical products and patients, including requirements for protecting patient confidentiality:

• 1.7.1 – Requirements pertaining to controlled substance inventories
• 1.7.2 – Content, maintenance, storage, and reporting requirements for records required in the operation of a pharmacy
  • Prescription filing systems, computer systems and backups, and prescription monitoring programs
• 1.7.3 – Requirements for protecting patient confidentiality and confidential health records
  • HIPAA requirements and conditions for access and use of information

1.8 – Requirements for handling hazardous materials such as described in USP:

• 1.8.1 – Requirements for appropriate disposal of hazardous materials
• 1.8.2 – Requirements for training regarding hazardous materials
  • Reverse distributors, quarantine procedures, comprehensive safety programs, Material Safety Data Sheets
• 1.8.3 – Environmental controls addressing the proper storage, handling, and disposal of hazardous materials
  • Ventilation controls, personal protective equipment, work practices, and reporting
• 1.8.4 – Methods for the compounding, dispensing and administration of hazardous materials
  • All hazardous materials including sterile and non-sterile compounding

Area 2 – Licensure, Registration, Certification, and Operational Requirements (Approximately 15% of Test)

2.1 – Qualifications, application procedure, necessary examinations, and internship for licensure, registration, or certification of individuals engaged in the storage, distribution, and/or dispensing of pharmaceutical products (prescription and non-prescription):

• 2.1.1 – Requirements for special or restricted licenses, registration, authorization, or certificates
  • Pharmacists, pharmacist preceptors, pharmacy interns, pharmacy technicians, controlled substance registrants, and under specialty pharmacist licenses (Nuclear, Consultant etc.)
• 2.1.2 – Standards of practice related to the practice of pharmacy
  • Quality assurance programs (including peer review), changing dosage forms, therapeutic substitution, error reporting, public health reporting requirements (such as notification of potential terrorist event, physical abuse, and treatment for tuberculosis), and issues of conscience and maintaining competency
• 2.1.3 – Requirements for classifications and processes of disciplinary actions that may be taken against a registered, licensed, certified, or permitted individual
• 2.1.4 – Requirements for reporting to, and participating in, programs addressing the inability of an individual licensed, registered, or certified by the Board to engage in the practice of pharmacy with reasonable skill and safety
  • Impairment caused by the use of alcohol, drugs, chemicals, or other materials, or mental, physical, or psychological conditions

2.2 – Requirements and application procedure for the registration, licensure, certification, or permitting of a practice setting or business entity:

• 2.2.1 – Requirements for registration, license, certification, or permitting of a practice setting
  • In-state pharmacies, out-of-state pharmacies, specialty pharmacies, controlled substance registrants, wholesalers, distributors, manufacturers/repackagers, computer services providers, and internet pharmacies
• 2.2.2 – Requirements for an inspection of a licensed, registered, certified, or permitted practice setting
• 2.2.3 – Requirements for the renewal or reinstatement of a license, registration, certificate, or permit of a practice setting
• 2.2.4 – Classifications and processes of disciplinary actions that may be taken against a registered, licensed, certified, or permitted practice setting

2.3 – Operational requirements for a registered, licensed, certified, or permitted practice setting:

• 2.3.1 – Requirements for the operation of a pharmacy or practice setting that is not directly related to the dispensing of pharmaceutical products
  • Issues related to space, equipment, advertising and signage, security (including temporary absences of the pharmacist), policies and procedures, libraries and references (including veterinary), and the display of licenses
• 2.3.2 – Requirements for the possession, storage, and handling of pharmaceutical products, preparations, bulk drug substances/excipients, and devices, including controlled substances
  • Investigational new drugs, repackaged or resold drugs, sample pharmaceuticals, recalls, and outdated pharmaceutical products
• 2.3.3 – Requirements for delivery of pharmaceutical products, preparations, bulk drug substances/excipients, and devices, including controlled substances
  • Issues related to identification of the person accepting delivery of a drug, use of the mail, contract delivery, use of couriers, use of pharmacy employees, use of kiosks, secure mail boxes, script centers, use of vacuum tubes, and use of drive-up windows

Area 3 – General Regulatory Processes (Approximately 2% of Test)

3.1 – Application of regulations:

• 3.1.1 – Laws and rules that regulate or affect the manufacture, storage, distribution, and dispensing of pharmaceutical products, preparations, bulk drug substances/excipients, and devices, (prescription and non-prescription), including controlled substances
  • Food, Drug, and Cosmetic Act(s) and Regulations, the Controlled Substances Act(s) and Regulations, OBRA 90’s Title IV Requirements, Practice Acts and Rules, other statutes and regulations, including but not limited to, dispensing of methadone, child-resistant packaging, tamper resistant packaging, drug paraphernalia, drug samples, pharmacist responsibilities in Medicare-certified skilled-nursing facilities, NDC numbers, and schedules of controlled substances