ID MPJE flashcards

32 cards. Read the term and the definition here. The deck at the top of this page is optional.

FDCA legend drug

A drug that is not safe for use except under the supervision of a licensed practitioner and therefore must bear the federal legend 'Rx only' on its labeling.

ANDA bioequivalence

An Abbreviated New Drug Application requires demonstration that a generic product is bioequivalent to the reference listed drug, with no need for independent clinical safety and efficacy studies.

DEA Form 222

The triplicate order form used to order Schedule II controlled substances; it contains 11 line items, must be signed by the registrant or power of attorney, and expires with the registration.

DSCSA serialization

The Drug Supply Chain Security Act requires package-level product identifiers and transaction information, history, and statements to support tracing of prescription drugs through the supply chain.

REMS ETASU

Elements to Assure Safe Use are REMS components that may restrict prescribing or dispensing to certified practitioners and pharmacies, require patient monitoring, or mandate documentation of safe-use conditions.

Pseudoephedrine sales limits

Scheduled listed chemicals sold at retail require photo identification, a written log, and quantity limits; daily and monthly limits apply to each purchaser under the Combat Methamphetamine Epidemic Act.

Practice of pharmacy

The interpretation, evaluation, and dispensing of prescription drug orders, participation in drug selection and monitoring, and provision of pharmaceutical care as defined by state law.

Pharmacy license site-specific

A pharmacy license is issued for a specific location and is not transferable; relocating or changing ownership generally requires board notification or a new license.

Grounds for discipline

Statutory bases for board action, including unprofessional conduct, dispensing without a valid prescription, falsifying records, diversion, impairment, and failure to meet continuing education requirements.

Technician ratio rules

State rules that limit the number of technicians a pharmacist may supervise and define which tasks may be delegated, with final verification and counseling reserved to pharmacists.

Prescription validity elements

Required components of a prescription, including patient and prescriber identifiers, drug name, strength, quantity, directions, date, and prescriber signature, as defined by state law.

Generic substitution

Dispensing a therapeutically equivalent generic product in place of a prescribed brand when state law permits and the prescriber has not prohibited substitution, with patient notification.

CIII-CV refill limit

Schedule III through V prescriptions may be refilled up to five times within six months of the issue date, unless the prescriber specifies a shorter period.

CII emergency oral prescription

An oral Schedule II order may be filled only in an emergency; the prescriber must provide a written prescription within seven days, and the pharmacy must document the emergency.

CII partial fill

A Schedule II prescription may be partially filled when the pharmacy lacks sufficient stock; the remainder must be supplied within 72 hours or a new prescription is required, with limited exceptions.

Prescription transfer

The transfer of prescription information between pharmacies for refill purposes, subject to state rules; Schedule II prescriptions generally cannot be transferred for refill.

DEA registration renewal

DEA registration is required for each principal place of business and must be renewed every three years; a separate registration is needed for each location.

Biennial inventory

A complete inventory of controlled substances required every two years on May 1 of odd-numbered years or on the date business begins, signed, dated, and retained for two years.

Theft or significant loss

A theft or significant loss of controlled substances must be reported in writing to the DEA field office within one business day of discovery, using DEA Form 106.

CSOS ordering

The Controlled Substance Ordering System allows electronic ordering of Schedule II substances using digital certificates and an audit trail in place of paper DEA Form 222.

Controlled substance records retention

Prescriptions, invoices, inventories, and DEA forms for controlled substances must be maintained for at least two years and be readily retrievable for inspection.

Pharmacist licensure requirements

Graduation from an accredited pharmacy program, completion of internship hours, and passage of NAPLEX and MPJE, with licensure granted by the state board of pharmacy.

Supervising pharmacist responsibility

The licensed pharmacist on duty is responsible for the accuracy and legality of all dispensing activities performed by interns and technicians under their supervision.

Scope of practice

The services a pharmacist may legally provide, such as immunization administration, collaborative practice prescribing, or medication therapy management, as authorized by state law.

Continuing education renewal

License renewal requires completion of board-specified continuing education hours by the expiration date; late renewal may incur fees and affect the ability to practice.

Room temperature storage

Room temperature is 20-25°C (68-77°F); controlled room temperature permits excursions between 15-30°C (59-86°F) under defined conditions.

Refrigerated storage

Refrigerated drugs must be stored at 2-8°C (36-46°F); freezing is -25 to -10°C, and temperature excursions should be documented and evaluated.

Expired drug segregation

Expired, damaged, or recalled drugs must be separated from active inventory and disposed of according to law, with controlled substances requiring DEA-authorized destruction and documentation.

Perpetual controlled substance inventory

An ongoing record of receipts and disbursements for controlled substances that is reconciled with periodic physical counts; discrepancies must be investigated and documented.

USP 800 hazardous drugs

Standards for handling hazardous drugs, including negative-pressure rooms, personal protective equipment, closed-system transfer devices, and documented spill procedures.

Patient counseling offer

Pharmacists must offer counseling on new prescriptions and when professional judgment requires it, covering directions, side effects, interactions, storage, and missed doses.

MedWatch reporting

Pharmacists report suspected serious adverse drug reactions and product quality or labeling problems to the FDA MedWatch program for postmarketing surveillance.