Uniform MPJE (UMPJE) Exam Preparation Vocabulary Flashcards

Vocabulary flashcards covering core concepts, statutory frameworks, numeric rules, and legal definitions for the Uniform Multistate Pharmacy Jurisprudence Examination (UMPJE).

USP

The default stability framework for nonsterile compounded preparations when no specific stability data exists: 14 days refrigerated for nonpreserved aqueous; 35 days (room or refrigerated) for preserved aqueous; 90 days (room or refrigerated) for nonaqueous oral liquids; and 180 days (room or refrigerated) for other nonaqueous dosage forms.

USP

Compounded sterile preparations assigned a maximum BUD of 12 hours at controlled room temperature or 24 hours refrigerated.

USP

Compounded sterile preparations prepared for immediate emergency administration, requiring that administration begin within 4 hours from the start of preparation.

503A Compounding Facility

A traditional compounding pharmacy operating primarily based on individual patient-specific prescriptions with limited anticipatory compounding, exempt from CGMP requirements and FDA drug approvals.

503B Outsourcing Facility

An FDA-registered facility that compounds sterile or nonsterile products, subject to CGMP requirements and FDA inspection, which may distribute products without individual patient-specific prescriptions.

Adulteration

A legal classification for drug products with deficiencies in quality, strength, purity, or composition, or those manufactured/held under insanitary conditions or CGMP violations.

Misbranding

A legal classification for drug products with false, misleading, incomplete, or improper labeling, representations, or child-resistant packaging.

DEA Form 222

Official DEA document required for ordering, purchasing, transferring, or distributing Schedule I and Schedule II controlled substances.

CSOS (Controlled Substance Ordering System)

An electronic ordering system that serves as an authorized electronic alternative to paper DEA Form 222 for Schedule I and II controlled substances.

DEA Form 106

Official DEA form used to report theft or significant loss of controlled substances, required to be completed and submitted within 45 calendar days of discovery.

DEA Form 41

Official DEA form used to document the authorized destruction or disposal of controlled substances.

Corresponding Responsibility

The legal doctrine placing accountability on the dispensing pharmacist, alongside the prescribing practitioner, to ensure that a controlled substance prescription is issued for a legitimate medical purpose in the usual course of professional practice.

CMEA Sales Limits

Federal limits on pseudoephedrine and listed chemical sales: 3.6 g per day per purchaser, 9 g per 30-day period for retail, and 7.5 g per 30-day period for mail-order or mobile vendors.

DSCSA Illegitimate Product Notification

The requirement under the Drug Supply Chain Security Act to notify the FDA and immediate trading partners within 24 hours of determining a drug product is illegitimate.

Orange Book

FDA's official publication containing Approved Drug Products with Therapeutic Equivalence Evaluations.

Purple Book

FDA's database listing licensed biological products, including biosimilar and interchangeable biological products.

Poison Prevention Packaging Act (PPPA)

Federal legislation requiring child-resistant packaging for covered oral prescription medications, subject to individual patient requests for non-CR packaging or prescriber directions per prescription.

HIPAA Minimum Necessary Standard

The requirement that disclosures or uses of Protected Health Information (PHI) be limited to the minimum amount necessary, which generally does not apply to healthcare providers requesting PHI for treatment purposes.

Emergency Oral C-II Prescription

An emergency verbal authorization for a Schedule II drug limited to the quantity needed for the emergency period, requiring immediate reduction to writing and receipt of a written cover prescription from the prescriber within 7 days.

Inability-to-Supply C-II Partial Fill Rule

The rule permitting a partial fill of a Schedule II prescription when a pharmacy is unable to supply the full quantity, requiring the remaining portion to be filled within 72 hours.

Patient/Prescriber-Requested C-II Partial Fill Rule

The statutory pathway allowing partial fills of a Schedule II prescription at patient or prescriber request, with remaining quantities allowed to be completed up to 30 days from the original issue date.

LTCF / Terminal Illness C-II Partial Fill Rule

The exception allowing repeated partial fills of Schedule II prescriptions for terminally ill patients or LTCF residents for up to 60 days from the issue date.

Schedule III and IV Refill Limits

Federal statutory caps restricting Schedule III and IV prescriptions to a maximum of 5 refills within 6 months from the date issued.

Initial Unfilled EPCS Transfer Rule

DEA rule allowing a one-time electronic transfer of an unfilled electronic controlled substance prescription (Schedules II–V) between retail pharmacies at patient request, provided it remains electronic and state law permits.

Biennial CS Inventory

The federal requirement for DEA registrants to conduct a physical count or estimate of all controlled substances on hand at least every 2 years.

Open Container CS Inventory Count Rules

The inventory standard requiring an exact count for open Schedule I and II containers, and an estimated count for open Schedule III–V containers unless the container holds more than 1,000 tablets or capsules.

Theft / Significant Loss Initial Notice

The federal mandate to provide written notification to the DEA within 1 business day of discovering a theft or significant loss of controlled substances.

Reverse Distributor

A DEA registrant authorized to receive controlled substances directly from other registrants for destruction or disposal.

Authorized Collector

A registered entity authorized by the DEA to collect controlled substances from ultimate users (patients) via collection receptacles or take-back programs.

Practitioner 5% CS Distribution Rule

The rule allowing a pharmacy/practitioner to distribute controlled substances to another practitioner without registering as a distributor, provided total units distributed do not exceed 5% of total controlled dosage units distributed and dispensed during the calendar year.

Medication Guide

FDA-required written patient labeling for specific prescription drugs that pose serious and significant public health concerns.

Risk Evaluation and Mitigation Strategy (REMS)

An FDA-mandated risk management plan requiring specific interventions, elements to assure safe use (ETASU), or restricted distribution systems to ensure a drug's benefits outweigh its risks.