KS MPJE key terms
KS MPJE · Get comfortable with the vocabulary.
- Legend drug
- Related: Prescription drug monitoring program, Dispensing
A medication that federal law requires to be dispensed only on prescription because it is not safe for unsupervised self-use. Its label must carry the legend statement 'Rx only', replacing the older caution wording.
- Behind-the-counter drug
- Related: Legend drug, Combat methamphetamine epidemic act
A medication that is not a federal legend drug but that a state restricts to sale through a pharmacy, often with pharmacist involvement, ID checks, or recordkeeping, as with many pseudoephedrine products.
- Combat Methamphetamine Epidemic Act
- Related: Behind-the-counter drug, List I chemical
Federal law that places pseudoephedrine, ephedrine, and phenylpropanolamine products behind the counter, caps daily and monthly purchase amounts, and requires photo ID, a written log, and self-certification of sellers.
- List I chemical
- Related: Combat Methamphetamine Epidemic Act, Controlled substance
A precursor chemical that the DEA regulates because it is used to manufacture controlled substances. Sellers must register, keep records, verify buyer identity, and report suspicious or large orders.
- Controlled substance
- Related: Schedule II, Registration
A drug or other substance whose manufacture, distribution, and possession are restricted because of abuse potential, placed in one of five federal schedules or a state schedule that may be stricter.
- Schedule II
- Related: Controlled substance, EPCS, Partial fill
The most restricted schedule available for medical use. It covers drugs with high abuse potential and accepted medical use, such as oxycodone, and requires written or EPCS prescriptions with no refills.
- EPCS
- Related: Schedule II, Prescription drug monitoring program
Electronic prescribing of controlled substances. It requires DEA-compliant identity proofing, two-factor authentication, and audit trails, and states may add their own mandates or exceptions.
- Registration
- Related: Controlled substance, Form 222
The DEA or state license that lets a person or business manufacture, distribute, dispense, or conduct research with controlled substances. It is site- and activity-specific and must be renewed and kept current.
- Form 222
- Related: Registration, Schedule II
The DEA order form used to transfer Schedule I and II substances between registrants. It is serially numbered, must be completed accurately, and is now largely replaced by the CSOS electronic equivalent.
- CSOS
- Related: Form 222, Registration
The Controlled Substance Ordering System, a DEA electronic equivalent of Form 222. Each purchaser needs a digital certificate, and orders are signed and transmitted electronically without a paper form.
- Perpetual inventory
- Related: Biennial inventory, Schedule II
A running, transaction-by-transaction record of controlled substance receipts, dispensings, and returns that lets a pharmacy reconcile its expected balance with the physical count at any time.
- Biennial inventory
- Related: Perpetual inventory, Registration
A complete count of controlled substances on hand, taken at least every two years and on any change of registrant, ownership, or location. Schedule II counts must be exact and records retained.
- DEA 106 theft or loss report
- Related: Perpetual inventory, Registration
The form a registrant files with DEA when controlled substances are lost, stolen, or significantly discrepant. In-transit losses are reported by the purchaser, and states may require a parallel report.
- Prescription drug monitoring program
- Related: EPCS, Controlled substance
A state database that collects dispensing data for controlled and other monitored drugs so prescribers and pharmacists can review patient history, and that some states require to be checked before dispensing.
- Partial fill
- Related: Schedule II, Emergency oral prescription
Dispensing less than the full quantity prescribed. Schedule II partial fills are limited by federal rules, such as 30 days for LTCF or terminally ill patients and 72 hours for emergency oral orders.
- Emergency oral prescription
- Related: Partial fill, Schedule II
A telephone order for a Schedule II drug in a genuine emergency. Quantity is limited to the emergency period, and the prescriber must deliver a written or electronic prescription within seven days.
- Refill
- Related: Schedule II, Prescription transfer
An additional dispensing authorized in advance on the original prescription. Federal law bars refills on Schedule II drugs; Schedules III and IV allow up to five refills within six months of issue.
- Prescription transfer
- Related: Refill, Controlled substance
Moving a prescription's remaining refills from one pharmacy to another. Federal rules permit one-time transfers of Schedule III-V prescriptions between retail pharmacies, and states may add documentation steps.
- Prescription validity period
- Related: Refill, Schedule II
The window during which a prescription may lawfully be filled. State limits vary, and Schedule II prescriptions typically expire sooner, often within 30 days, unless state law says otherwise.
- Corresponding responsibility
- Related: Red flag, Due diligence
The pharmacist's duty to judge whether a prescription was issued for a legitimate medical purpose in the usual course of professional practice before dispensing, independent of the prescriber's own duty.
- Red flag
- Related: Corresponding responsibility, Due diligence
A circumstance that signals possible diversion or misuse, such as long-distance prescribers, cash payment, early refills, or unusual combinations. Pharmacists must resolve flags before dispensing.
- Due diligence
- Related: Red flag, Prescription drug monitoring program
The documented steps a pharmacist takes to verify a questionable prescription, such as contacting the prescriber, reviewing the PDMP, checking identification, or confirming a diagnosis, and recording the outcome.
- Therapeutic substitution
- Related: Generic substitution, Formulary
Dispensing a different drug within the same therapeutic class than the one prescribed. It generally requires prescriber authorization and is governed by state law, unlike generic substitution.
- Generic substitution
- Related: Therapeutic substitution, Orange book
Dispensing a therapeutically equivalent, lower-cost product for a prescribed brand drug. State law sets whether substitution is permitted, how the patient is notified, and how the prescriber can block it.
- Orange Book
- Related: Generic substitution, Legend drug
The FDA publication that rates drug products as therapeutically equivalent, using codes that support substitution decisions. Products with an AB rating are considered interchangeable by many state substitution rules.
- Formulary
- Related: Prior authorization, Therapeutic substitution
The list of drugs a payer, PBM, or institution prefers or covers, often tiered by cost. Formulary status affects coverage and prior authorization but does not by itself override prescribing law.
- Prior authorization
- Related: Formulary, Dispensing
A payer's requirement that specific drugs be approved before dispensing or coverage. It is a coverage rule, not a prescribing restriction, and pharmacists must still meet legal dispensing requirements.
- Dispensing
- Related: Legend drug, Patient counseling
The act of preparing and transferring a drug to a patient or caregiver under a lawful prescription, including verification, labeling, counseling, and recordkeeping duties set by state and federal law.
- Patient counseling
- Related: Dispensing, OBRA-90
The pharmacist's discussion of proper use, storage, interactions, and warnings with the patient or caregiver. Federal rules require an offer to counsel on Medicaid prescriptions, and states define scope and exceptions.
- OBRA-90
- Related: Patient counseling, Drug utilization review
The federal budget law whose Medicaid pharmacy provisions require prospective drug use review and an offer of counseling. States apply these standards broadly through their pharmacy practice acts.
- Drug utilization review
- Related: OBRA-90, Patient counseling
A structured review of drug therapy before or after dispensing to catch duplication, interactions, dosing errors, and misuse. Prospective review occurs at dispensing; retrospective review looks at patterns over time.
- Collaborative practice agreement
- Related: Prescriptive authority, Protocol
A written arrangement letting a pharmacist manage drug therapy under defined protocols with a prescriber. Scope, required elements, and whether it needs board approval vary by state.
- Prescriptive authority
- Related: Collaborative practice agreement, Protocol
The legal power to initiate, modify, or discontinue drug therapy. Pharmacists gain limited authority through state statutes, protocols, or agreements, and federal law separately governs controlled substances.
- Protocol
- Related: Prescriptive authority, Collaborative practice agreement
A written, preapproved set of criteria and steps that authorizes a pharmacist to act in defined situations, such as immunizations or naloxone, without a patient-specific prescription.
- Immunization authority
- Related: Protocol, Prescriptive authority
State-granted permission for pharmacists to administer vaccines, often with age limits, training, notification, and record-reporting duties, plus federal PREP Act coverage in declared emergencies.
- Compounding
- Related: 503A pharmacy, 503B outsourcing facility
Preparing a customized medication from ingredients for an identified patient's need when an approved product is unsuitable. Federal law distinguishes traditional compounding from essentially copying a marketed drug.
- 503A pharmacy
- Related: Compounding, 503B outsourcing facility
A state-licensed pharmacy that compounds for individual patients on a prescription. It is overseen mainly by state boards and exempt from certain FDA new drug requirements if statutory conditions are met.
- 503B outsourcing facility
- Related: Compounding, 503A pharmacy
A facility that compounds sterile drugs in larger volumes, may sell without patient-specific prescriptions, and must register with FDA and follow current good manufacturing practice requirements.
- Board of pharmacy
- Related: Reciprocity, Intern license
The state agency that licenses pharmacists, technicians, and pharmacies, adopts rules, and disciplines licensees. Its practice act and regulations are the core of state-specific MPJE content.
- Reciprocity
- Related: Board of pharmacy, Intern license
A process by which a licensee obtains a license in another state, often through license transfer or score transfer. Most states require the MPJE for the new state and may impose additional conditions.
- Intern license
- Related: Board of pharmacy, Reciprocity
A registration that lets a pharmacy student or graduate obtain supervised practice hours toward licensure. Hour requirements, supervisor ratios, and expiration rules are set by each state board.