Your FREE MPJE Flashcards 2026 – 200+ Cards

The official order form required to purchase or transfer Schedule I and II controlled substances (or the electronic CSOS equivalent).

The application a pharmacy uses to obtain a new DEA registration to dispense controlled substances.

The form used to document the destruction/disposal of unwanted controlled substances.

The form used to report the theft or significant loss of controlled substances to the DEA.

Highest abuse potential, no currently accepted U.S. medical use (e.g., heroin, LSD). Not dispensed at pharmacies.

High abuse potential with accepted medical use; severe dependence risk (e.g., oxycodone, fentanyl, amphetamine). No refills.

Abuse potential less than CI–CII; moderate-to-low physical dependence (e.g., buprenorphine, ketamine, certain codeine combos).

Low abuse potential relative to CIII (e.g., benzodiazepines, tramadol, zolpidem).

Lowest abuse potential; preparations with limited quantities of certain narcotics (e.g., codeine cough syrups, pregabalin).

Schedule II prescriptions may NOT be refilled. A new prescription is required each time.

May be refilled up to 5 times within 6 months of the date written; after that a new prescription is needed.

Generally require a written (or compliant electronic) prescription; oral orders allowed only in a genuine emergency.

Permitted in a bona fide emergency, limited to the amount needed for the emergency period; prescriber must deliver a written prescription within 7 days.

A partial fill is allowed; the remainder may be supplied within 72 hours, otherwise the balance is void and the prescriber must be notified.

Partial fills are allowed as long as each is recorded like a refill and the total dispensed does not exceed the amount prescribed within 6 months.

May be transferred for refill purposes ONE time only; if pharmacies share a real-time online database, up to the maximum number of refills is allowed.

CII prescriptions cannot be transferred for refilling (CII has no refills). Under a 2023 DEA rule, an ELECTRONIC CII–CV prescription may be transferred once, pharmacist-to-pharmacist, for the INITIAL fill.

The 1970 federal law (Title 21) that classifies drugs into Schedules I–V and governs their manufacture, distribution, and dispensing through the DEA.

The Drug Enforcement Administration — the federal agency that registers handlers and enforces the Controlled Substances Act.

A pharmacy's DEA registration must be renewed every 3 years.

First letter shows registrant type; second letter is the registrant's last-name initial. Checksum: add the 1st, 3rd, and 5th digits; double the sum of the 2nd, 4th, and 6th; the last digit of the total equals the 7th (check) digit.

A controlled-substance prescription is valid only if issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice (21 CFR 1306.04).

The dispensing pharmacist shares legal responsibility with the prescriber for ensuring a controlled-substance prescription is legitimate; knowingly filling an invalid one is a violation.

Warning signs of diversion — e.g., cash payment for high-dose opioids, long distances traveled, identical prescriptions for many patients, early refills, dangerous combinations.

A registrant may grant a power of attorney authorizing an individual to sign DEA Form 222 / CSOS orders on the registrant's behalf; it is kept on file at the registered location.

Controlled Substance Ordering System — DEA's program for placing electronic Schedule I/II orders using a DEA-issued digital certificate, replacing the paper Form 222.

Must be filled out and submitted to the supplier within 60 days of the order date.

A pharmacy must notify the DEA in writing within 1 business day of discovering a theft or significant loss, then complete DEA Form 106.

A complete inventory of all controlled substances must be taken at least every 2 years.

A newly registered pharmacy must take an inventory of all controlled substances on hand on the date it first engages in handling them.

Schedule II substances must be counted EXACTLY; Schedule III–V may be estimated unless the container holds more than 1,000 dosage units.

Controlled-substance records must be kept for at least 2 years and be readily retrievable.

Records can be separated from other documents or marked so that controlled-substance information is easily identifiable and produced for inspection.

Schedule II records must be maintained SEPARATELY from all other records.

May be kept separately OR in a readily retrievable form within the other prescription files.

Schedule II–IV labels must bear: “Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.”

Federal law limiting OTC sales of pseudoephedrine, ephedrine, and phenylpropanolamine; requires behind-the-counter storage, a logbook, and ID verification.

A customer may purchase no more than 3.6 grams of pseudoephedrine base per day.

No more than 9 grams may be purchased within a 30-day period (federal CMEA limit).

The CMEA sales logbook must be kept for at least 2 years.

Prescribing controlled substances for oneself or for office stock generally lacks a legitimate prescriber–patient relationship and is not a valid prescription.

A controlled-substance prescription via telemedicine requires a genuine evaluation and a practitioner–patient relationship consistent with federal Ryan Haight Act requirements.

Federal law sets no time limit for filling an unfilled CII prescription, but it must still reflect a legitimate medical need (many states do impose a limit).

Unwanted controlled substances are sent to a DEA-registered reverse distributor (with Form 222 for CII) and documented on DEA Form 41.

Manufacturers, distributors, dispensers (pharmacies/practitioners), importers/exporters, researchers, and analytical labs each register separately by activity.

A faxed CII may serve as the original for long-term-care, hospice, or home-infusion patients (and to confirm an emergency oral order).

A practitioner may issue multiple CII prescriptions on the same day for up to a 90-day supply, with instructions on the earliest fill date for each.

Distributors must design systems to detect and report suspicious controlled-substance orders to the DEA.

Limited to the amount adequate to treat the patient during the emergency period only.

The person who signed the most recent DEA registration application, or a person holding a valid power of attorney from that registrant.

If a Form 222 is lost or unusable, the executed copies are kept and the error is documented; CSOS avoids paper-form errors entirely.

Federal law sets no maximum quantity for a CII prescription, but it must reflect legitimate medical need; states may impose day-supply limits.

Each refill of a CIII–V drug must be documented (date, quantity, dispenser) on the back of the prescription or in an equivalent electronic record.

Permitted between pharmacies under DEA rules, with records identifying which pharmacy did the filling and which received the drug.

Fentanyl is a Schedule II controlled substance.

Alprazolam (Xanax) is a Schedule IV controlled substance.

Buprenorphine products are Schedule III controlled substances.

Limited-quantity codeine cough preparations are Schedule V.

Some states require special serialized prescription forms for controlled substances in addition to federal rules.

Controlled substances may be mailed under USPS rules in plain packaging with no markings indicating the contents.

Inspectors may request an Administrative Inspection Warrant; a registrant can also consent to inspection of records and premises.

A CII prescription label must not indicate refills; none are permitted.

Patient name and address, date, drug name/strength/quantity, directions for use, prescriber name/address (and signature), and prescriber DEA number for controlled drugs.

The Omnibus Budget Reconciliation Act of 1990 — requires offer to counsel and prospective drug-use review (DUR) for Medicaid patients; adopted broadly by states for all patients.

Under OBRA-90, the pharmacist (or designee) must OFFER to counsel the patient; the patient may decline, but the offer is required.

Screening a prescription before dispensing for therapeutic duplication, interactions, contraindications, incorrect dose/duration, and abuse/misuse.

Drug name, intended use, route/dose/duration, special directions, common side effects and how to avoid them, storage, refills, and what to do if a dose is missed.

A pharmacist may substitute a therapeutically equivalent generic unless the prescriber indicates “dispense as written” / “brand medically necessary” or the patient refuses.

FDA's “Approved Drug Products with Therapeutic Equivalence Evaluations” — used to determine if a generic is therapeutically equivalent (A-rated) to the brand.

A prescriber instruction directing that the brand-name product be dispensed without generic substitution.

Physicians (MD/DO), dentists, podiatrists, veterinarians, optometrists, and mid-level practitioners (NP, PA) prescribe within the scope of their license and DEA authority.

A podiatrist may prescribe only for conditions of the foot and ankle within their licensed scope.

Nurse practitioners and physician assistants may prescribe controlled substances only as allowed by state law and with their own DEA registration.

A prescription written while the prescriber's license or DEA registration is suspended/revoked is not valid and must not be filled.

A non-controlled prescription may be transmitted by fax and serve as the original.

Allowed under DEA rules when the system meets identity-proofing, two-factor authentication, and audit requirements.

Non-controlled and CIII–V prescriptions may be taken orally; CII generally may not except in a documented emergency.

When a prescription is unclear, incomplete, or potentially in error, the pharmacist must contact the prescriber to clarify before dispensing.

Substitution swaps a generic for the same drug; therapeutic interchange swaps a different drug in the same class, usually requiring a protocol or prescriber approval.

Refills require prescriber authorization; without remaining authorized refills the pharmacist must obtain a new authorization.

Many states allow a limited emergency supply of a maintenance non-controlled drug when the prescriber cannot be reached; amount and conditions are set by state law.

If ProDUR detects a problem, the pharmacist exercises professional judgment — contacting the prescriber and/or counseling — before dispensing.

A record of the patient's medications, allergies, and conditions that supports DUR and counseling (required under OBRA-90 for Medicaid patients).

Medicaid outpatient prescriptions must be on tamper-resistant pads (or e-prescribed) to be reimbursed.

Quantity is the amount dispensed; days supply is how long it lasts per the directions — both are checked against the prescription.

Pharmacists may immunize and, in many states, test-and-treat under protocols or collaborative practice agreements set by state law.

A written agreement letting a pharmacist manage drug therapy (adjust, initiate, monitor) under a prescriber's authorization, per state law.

A pharmacist may decline to fill a prescription the pharmacist believes is invalid, forged, or not for a legitimate medical purpose, and must document the basis.

OBRA-90 requires the offer; the patient may refuse counseling, which is then documented.

Suspected forgeries should not be filled; verify with the prescriber and follow state/federal reporting requirements.

A prescriber's DEA registration authorizes specific schedules; the pharmacist confirms the prescriber is authorized for the controlled drug ordered.

Many states require ID for controlled-substance pickup; the pharmacist verifies the patient/agent per state rules.

The date beyond which a dispensed prescription should not be used, assigned per USP guidance and the product's stability.

Class I = reasonable probability of serious harm/death; Class II = temporary or reversible harm; Class III = unlikely to cause harm.

Identify affected stock, quarantine it, follow the manufacturer/FDA instructions, and notify patients/prescribers as directed.

A handwritten or e-prescribed indication by the prescriber that overrides generic substitution for a Medicaid prescription.

OBRA-90's offer-to-counsel applies to new prescriptions; many states extend counseling rights to refills and mail order via written information.

Required for certain drugs (e.g., oral contraceptives, estrogens) to be dispensed to the patient with each fill.

FDA-required patient information for certain drugs with serious risks; must be provided when the drug is dispensed.

Risk Evaluation and Mitigation Strategy — an FDA-required safety program for certain high-risk drugs (e.g., clozapine, isotretinoin) that may include pharmacy certification.

A REMS program requiring registration and pregnancy-test verification before dispensing isotretinoin.

A veterinarian may prescribe within the scope of veterinary practice; the pharmacist verifies authority and labels accordingly.

Optometrists may prescribe drugs for eye conditions within their state-defined scope.

Dentists may prescribe drugs related to dental care within their scope and DEA authority.

Non-controlled prescription refills may generally be transferred between pharmacies without the one-time limit that applies to controlled drugs.

A patient may insist on the brand even when substitution is otherwise allowed; cost may then fall to the patient.

When a prescriber is unfamiliar, the pharmacist confirms licensure and DEA authority before filling controlled prescriptions.

A legend drug is exempt from the FDCA's 'adequate directions for layperson' requirement because it is dispensed on a prescription with professional directions.

A pharmacist may fill a valid out-of-state prescription if it meets that prescriber's authority and the dispensing state's rules (controlled-drug rules still apply).

The Multistate Pharmacy Jurisprudence Examination — NABP's computer-adaptive law exam (120 items: 90 scored + 30 pretest, 3 hours) combining federal pharmacy law with a specific state's law.

Per NABP's current Competency Statements: Area 1 Pharmacy Practice (~83%), Area 2 Licensure/Registration/Certification & Operational Requirements (15%), and Area 3 General Regulatory Processes (2%).

A scaled score of 75 on a 0–100 scale; since 2021 results are reported pass/fail. Because it is computer-adaptive, the cut is not a simple percent-correct.

The Uniform MPJE — NABP's newer law exam (launched 2026) testing uniform state-law principles plus federal law using 3-option single-answer questions; replacing the MPJE in adopting jurisdictions.

The National Association of Boards of Pharmacy — develops and administers the NAPLEX and MPJE/UMPJE and supports state boards of pharmacy.

The state agency that licenses pharmacists/pharmacies, sets and enforces practice rules, and disciplines licensees within that jurisdiction.

NAPLEX tests pharmacy practice/clinical competence; the MPJE tests pharmacy law and jurisprudence for a specific state.

Each state's MPJE blends FEDERAL pharmacy law with that state's own pharmacy statutes and board regulations; a separate MPJE is required for each state, and you answer per the prevailing law of that state.

45 boards of pharmacy require an NABP law exam (MPJE or UMPJE). Arkansas, California, Nevada, and Puerto Rico give their own jurisprudence exams; a few jurisdictions require no law exam.

The MPJE application fee is $100 per jurisdiction (plus state board fees). The UMPJE costs $450 total ($100 application + $350 exam), with $105 per additional jurisdiction.

A candidate must wait at least 30 days between attempts and reapply each time; the number of attempts allowed is set by the state board.

Initial licensure path: graduate from an accredited program, pass the NAPLEX and the state's MPJE, and complete required intern hours.

Transferring a license to another state via NABP's licensure transfer process; the candidate must still pass that state's MPJE.

Ongoing education required to renew a license and maintain competence; measured in CE units/hours set by the state.

A standardized measure of CE; 1 CEU = 10 contact hours (so 0.1 CEU = 1 contact hour).

Pharmacist licenses are renewed periodically (commonly every 1–2 years) with required CE; lapse requires reinstatement per state rules.

A student or graduate registered with the board to gain supervised practice experience toward licensure.

The pharmacist legally responsible for a pharmacy's compliance with laws and regulations, including recordkeeping and operations.

Supportive personnel who assist the pharmacist with dispensing tasks under supervision; registration/certification and duties are set by state law.

The maximum number of technicians a pharmacist may supervise, set by state law (varies by state).

Most states require a pharmacist to perform the final check of a dispensed prescription (some allow tech-check-tech under board-approved programs).

A pharmacy must hold a current state permit/registration (and DEA registration for controlled substances) to operate.

A pharmacy mailing prescriptions into a state generally must hold that state's nonresident pharmacy license.

Requires notifying the board (and modifying the DEA registration) per state and federal rules before the change takes effect.

A board may suspend, revoke, fine, place on probation, or reprimand a licensee for violations such as fraud, diversion, or impairment.

Common grounds include unprofessional conduct, drug diversion, fraud, substance impairment, gross negligence, and violation of pharmacy law.

Licensees must report certain events (e.g., disciplinary action in another state, certain crimes) to the board as required by state law.

A confidential recovery/monitoring program some boards offer in lieu of or alongside discipline for substance-use disorders.

Boards and the DEA may inspect a pharmacy's premises and records to verify compliance; controlled-substance records must be readily retrievable.

On closure, controlled stock is transferred or disposed of with proper documentation, and records and the DEA registration are handled per regulation.

A lapsed license is reactivated by meeting the board's requirements, which often include completing back/required CE and paying fees.

A pharmacy may dispense only under the supervision of a licensed pharmacist who is on duty/responsible.

A license authorizes a person to practice; a registration (e.g., technician, intern, DEA) authorizes a specific activity or status.

States require a set number of supervised internship/experiential hours for licensure (commonly ~1,500 hours).

Foreign graduates typically must obtain FPGEC certification (incl. FPGEE and English proficiency) before licensure eligibility.

A NAPLEX/UMPJE score may be transferred to additional jurisdictions through NABP for a per-jurisdiction fee; the state's law exam may still be required.

Some CE hours may be required in specific subjects (e.g., law, patient safety, opioids) as set by the state board.

A current license/registration generally must be displayed or available at the practice site.

Some boards permit a trained technician to verify another technician's product filling under board-approved programs, usually for unit-dose/inpatient settings.

The pharmacist-in-charge ensures the pharmacy's policies, recordkeeping, and personnel comply with applicable law.

A change in the pharmacist-in-charge usually must be reported to the board within a set time and may require a closing inventory.

A lapsed license is reinstated by application, payment of fees, and meeting CE/competency requirements set by the board.

Requires child-resistant containers for most oral prescription drugs unless the prescriber or patient requests otherwise (a per-prescription or blanket patient waiver).

Certain drugs (e.g., sublingual nitroglycerin, some inhalers, oral contraceptives in their dispensing packages) are exempt from child-resistant packaging.

A patient may request non-child-resistant packaging (a blanket waiver is allowed); a prescriber may waive only on a single-prescription basis.

Protects individually identifiable health information (PHI); permits use/disclosure for treatment, payment, and health-care operations and limits other uses to the minimum necessary.

Individually identifiable health information held or transmitted by a covered entity, protected under HIPAA.

HIPAA principle of using or disclosing only the least PHI needed to accomplish the purpose.

A document a pharmacy must provide describing how it uses and discloses PHI and the patient's rights.

Typically: pharmacy name/address, serial/Rx number, date, prescriber name, patient name, directions, drug name/strength, and required cautionary statements.

Drug labeling must include adequate directions for use, ingredients, lot number, expiration date, and required warnings under the FDCA.

Federal law focuses on 2 years for controlled records; non-controlled record retention is largely set by state law (commonly 2–7 years).

CII filed separately; CIII–V either separate or readily retrievable; non-controlled in the general file.

Standards for non-sterile compounding (e.g., creams, capsules, oral liquids), including beyond-use dating and documentation.

Standards for sterile compounding to prevent contamination — air quality, garbing, environmental monitoring, and beyond-use dating.

Standards for handling hazardous drugs to protect personnel and the environment, including storage, containment, and PPE.

Per USP <800>, hazardous drugs are stored separately, in a negative-pressure, externally vented area (refrigerated HDs in a dedicated negative-pressure refrigerator).

Compounding prepares a drug for a specific patient based on a prescriber relationship; manufacturing produces drugs for general distribution and requires FDA registration.

503A = traditional patient-specific compounding pharmacies; 503B = outsourcing facilities that compound in bulk under FDA cGMP oversight.

A pharmacy that fills/refills prescriptions on behalf of another pharmacy under a contractual or common-ownership arrangement, with records linking both.

Establishes an electronic, interoperable system to trace prescription drugs through the supply chain to protect against counterfeit/diverted products.

Trading partners must capture product tracing information and verify suspect/illegitimate product, quarantining and investigating as required.

The foundational FDA law governing drug safety, efficacy, labeling, adulteration, and misbranding.

A drug is adulterated if it is contaminated, prepared/held under unsanitary conditions, or fails to meet purity/strength standards.

A drug is misbranded if its labeling is false or misleading, lacks required information, or lacks adequate directions for use.

A prescription drug bearing “Rx only”; under the FDCA it may be dispensed only on a valid prescription.

A drug that meets FDA monograph standards and may be sold without a prescription with appropriate Drug Facts labeling.

Products kept behind the counter and sold without a prescription but with pharmacist involvement or record (e.g., pseudoephedrine under CMEA).

Pharmacies must remove expired/deteriorated drugs from active stock; controlled stock for destruction is documented (Form 41).

Document recall notices, quarantined stock, and actions taken so the response is traceable on inspection.

Prescription Drug Monitoring Program — a state database tracking dispensed controlled substances; many states require querying it before dispensing certain drugs.

Pharmacies report dispensed controlled-substance data to the state PDMP within the timeframe set by state law.

Controlled substances must be stored in a securely locked, substantially constructed cabinet OR dispersed throughout non-controlled stock to deter theft.

A pharmacy may only purchase controlled substances from a DEA-registered distributor, using Form 222/CSOS for Schedule II.

Dispensed prescription drugs generally cannot be returned to stock once they leave the pharmacy, except in limited settings (e.g., some long-term-care unit-dose).

Each filled prescription receives a unique identifying number, recorded on the label and in the pharmacy record for traceability.

Pharmacies must maintain accurate records (electronic or paper) of dispensing and inventory that are readily retrievable for inspection.

USP <800> requires accessible spill kits and trained personnel to contain and clean hazardous-drug spills.

Refrigerated and frozen drugs (incl. many vaccines) must be stored within labeled ranges with documented temperature monitoring.

When repackaging into a different container, the pharmacy must preserve required labeling, lot number, and a beyond-use date per USP.

National Drug Code — a unique 3-segment identifier (labeler–product–package) the FDA assigns to a drug product.

Required for most OTC products so consumers can detect if a package has been opened or altered.

An expiration date is set by the manufacturer for the original container; a beyond-use date is assigned by the pharmacy for a repackaged or compounded product.

Pharmacies may use FDA shortage resources and, where lawful, compounding to address documented shortages.

Investigational drugs are handled under FDA IND rules and institutional protocols, with controlled distribution and recordkeeping.

The FDA (not the pharmacy) regulates prescription drug advertising for accuracy and fair balance under the FDCA.

Adherence (blister/bingo) packaging must retain required labeling and an appropriate beyond-use date.

Controlled substances must remain secured (locked storage or dispersal) and the prescription department secured when no pharmacist is on duty.

During inventory, CIII–V may be estimated unless a container holds more than 1,000 dosage units, which must be counted exactly.

All required pharmacy records must be produced for board or DEA inspection during normal business hours.

Hazardous drugs are received and unpacked in a neutral/negative-pressure area away from sterile compounding and using appropriate PPE.

Garb is donned dirtiest-to-cleanest (shoe covers, head/facial hair, mask, then hand hygiene and gown, then sterile gloves in the buffer area).

Pharmacy records are confidential under HIPAA and state law; disclosure is limited to permitted purposes and the minimum necessary.

Non-controlled drug disposal follows EPA/state environmental rules; many drugs cannot be flushed and use take-back or hazardous-waste streams.