HI MPJE key terms

The state agency that licenses pharmacists and pharmacies, adopts rules under the pharmacy practice act, investigates complaints, and imposes discipline. It also interprets state pharmacy law through rules and declaratory rulings.

The state statute that defines the practice of pharmacy, sets licensure requirements, and grants the Board of Pharmacy authority to regulate pharmacy, pharmacists, and drug distribution within the state.

A drug required by federal or state law to be dispensed only on prescription, labeled with the statement 'Rx only.' State law may also designate additional drugs as legend drugs or controlled substances beyond federal scheduling.

A lawful written, electronic, or oral order from a prescriber for a specific patient to receive a drug or device. It must include required elements such as patient, drug, directions, and prescriber information.

A licensed health care practitioner authorized by state law and scope of practice to prescribe drugs, such as a physician, dentist, podiatrist, nurse practitioner, or physician assistant. Federal law controls controlled-substance prescribing registration.

The act of preparing and delivering a drug to a patient pursuant to a prescription, including checking for appropriateness, labeling, and providing counseling. State law defines who may dispense and under what conditions.

The pharmacist designated by a pharmacy owner and approved by the Board who is responsible for the pharmacy's compliance with laws, security, recordkeeping, and daily operations. The PIC may be subject to discipline for violations.

A pharmacy student or graduate who is registered with the Board and may practice pharmacy under the direct supervision of a licensed pharmacist while completing required internship hours. Registration is distinct from licensure.

The process by which a state board grants a pharmacist the legal authority to practice, typically requiring graduation from an accredited program, passage of NAPLEX and MPJE, and completion of internship hours.

A process by which a pharmacist licensed in one state may obtain a license in another state based on the original license, often through license transfer or score transfer, subject to the receiving state's requirements.

The degree of care and skill that a reasonably prudent pharmacist would exercise under similar circumstances. It is used to evaluate negligence and professional conduct in pharmacy practice and may be established by expert testimony.

Any preventable event that may cause or lead to inappropriate medication use or patient harm, including prescribing, dispensing, administration, and monitoring errors. State law may require reporting of certain errors to the Board.

A pharmacy's systematic process for detecting, documenting, and analyzing medication errors and near misses, and for implementing improvements. Many states require a written program as a condition of licensure.

An ongoing, data-driven approach to improving pharmacy systems and patient safety by identifying causes of errors and tracking the effectiveness of corrective actions over time. It is often required as part of a quality assurance program.

The pharmacist's provision of information to a patient or caregiver about a prescription, including directions, precautions, and interactions. State law may require counseling unless the patient refuses or an exception applies.

State and federal rules specifying the information that must appear on a prescription container, such as pharmacy name, patient name, drug name and strength, directions, quantity, and prescriber. Federal law sets minimum labeling for legend drugs.

The obligation to create, maintain, and retain records such as prescriptions, dispensing logs, inventories, and purchase records for the period required by state and federal law. Records must be readily retrievable for inspection.

A drug or other substance regulated under the federal Controlled Substances Act because of its potential for abuse. State law may schedule substances differently and impose additional requirements.

A category of controlled substances with a high potential for abuse and accepted medical use, such as oxycodone and amphetamine. Federal law generally prohibits refills and requires written or electronic prescriptions, with limited exceptions.

The federal registration issued by the Drug Enforcement Administration that authorizes a practitioner or pharmacy to handle controlled substances. State licensure is also required, and state law may impose stricter controls.

A state-run electronic database that collects information on dispensed controlled substances. Pharmacists and prescribers may be required to check it before dispensing or prescribing certain drugs, and reporting requirements vary by state.

Dispensing less than the full quantity prescribed for a controlled substance, permitted under federal law for Schedule II prescriptions in specified circumstances, such as when the pharmacy lacks sufficient stock or the patient requests it.

A subsequent dispensing of a prescription without a new prescriber authorization. Federal law limits refills for controlled substances, and state law may impose further restrictions, such as time limits for noncontrolled prescriptions.

An oral prescription for a Schedule II controlled substance permitted in a genuine emergency when written or electronic prescribing is not feasible. The prescriber must follow up with a written prescription within the time required by federal law.

The preparation of a customized medication by combining or altering ingredients to meet a patient's specific needs. State law governs who may compound and under what conditions, while federal law addresses outsourcing facilities.

A facility that compounds sterile drugs without a patient-specific prescription and registers with the FDA under federal law. It is subject to current good manufacturing practice requirements rather than state pharmacy compounding rules.

The removal or correction of a marketed drug that violates federal law or poses a health hazard. Pharmacies must follow instructions from the manufacturer or FDA and may be required to notify patients under state law.

A drug that fails to meet federal standards for identity, strength, quality, or purity, or that was manufactured under unsanitary conditions. Federal law prohibits distribution of adulterated drugs.

A drug whose labeling is false or misleading, lacks required information, or fails to bear adequate directions for use. Federal law prohibits dispensing misbranded drugs in interstate commerce.

The oversight a licensed pharmacist provides to interns, technicians, and other supportive personnel. State law defines the ratio, tasks, and degree of supervision required, including whether direct or indirect supervision is needed.

An unlicensed or registered supportive person who assists pharmacists with dispensing and other tasks under required supervision. State law sets registration, training, and ratio requirements.

The provision of pharmacy services, such as review and dispensing, to a remote site through telecommunications technology. State law determines whether and how telepharmacy may be used and what supervision is required.

The performance of certain pharmacy functions, such as prescription processing or sterile compounding, at a location other than the dispensing pharmacy. State law may require a license or approval for the central location.

A mechanical system that stores and dispenses drugs and devices and is regulated by state law. Requirements address accuracy, security, labeling, and pharmacist oversight of the system.

A process in which a pharmacist evaluates a patient's drug therapy for appropriateness, including interactions, duplications, and dosing. Federal law requires prospective DUR for Medicaid, and state law may require it generally.

A federal safety program required by the FDA for certain drugs with serious risks. It may impose restrictions on prescribing, dispensing, or distribution, and pharmacies must comply with its requirements.