Georgia MPJE Comprehensive Review – Vocabulary Flashcards

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Vocabulary flashcards covering licensure, CE, technician rules, GDNA, controlled substances, dispensing regulations, compounding, institutional practice, REMS, USP standards, DEA forms, recalls, and other Georgia-specific MPJE topics.

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129 Terms

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Georgia RPh Licensure Requirements

Application, ≥18 years old, good moral character, ACPE-accredited PharmD, 1,500 internship hours, pass NAPLEX & MPJE, pay all fees

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Georgia RPh License Renewal Cycle

Biennially on 12/31 of even-numbered years

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Late Renewal Grace Period (RPh)

May renew through 1/31 with late fee; revoked after 1/31

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Georgia RPh CE Requirement

30 hours every 2-year cycle

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Internship Hour Requirement (GA)

1,500 hours

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Intern/Extern Definition – Georgia

Student registered with Board; intern is paid, extern is school-assigned experiential student

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Intern License Validity (GA)

Up to 5 years unless earlier termination event occurs

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Certified Pharmacy Technician (GA)

Registered technician certified by PTCB

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GA Technician CE & Renewal

20 CE hours; renew every odd-numbered year

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Pharmacist:Technician Ratio (GA)

Maximum 4:1 (two must be certified if supervising four)

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GDNA (Georgia Drugs and Narcotics Agency)

Law-enforcement arm that inspects, investigates, seizes, and subpoenas for drug law compliance

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GDNA Special Agent Qualifications

Active GA RPh license, 2 years practice, POST training, clean record

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Board of Pharmacy Composition (GA)

8 members – 7 pharmacists + 1 consumer

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Code of Professional Conduct – Core Duty

Protect public health & maintain trust in pharmacy profession

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Refusal to Fill – Acceptable Basis

Professional judgment or deeply held ethical/moral belief

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Generic Substitution Requirement (GA)

Must dispense pharmaceutically equivalent (Orange Book) unless prescriber writes “brand necessary”

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Purple Book Purpose

Lists interchangeable biological products

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Emergency Dispensing (State of Emergency)

Up to 30-day maintenance med, no C-II, notify prescriber within 48 h

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Emergency Refill (Unable to Reach Prescriber)

One-time 72-hour supply of non-controlled; notify prescriber within 7 days

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Drug Therapy Modification Certification

Board-approved course + 3 CE hours; renew annually 12/31

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DTM Protocol Record Retention

Keep 10 years after protocol terminates; protocol expires every 2 years

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Mail Delivery – Controlled Substance Rule

Schedule II-V must be signed for on delivery

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PIC Immediate Notification Items

Closure, ownership/PIC change, drug loss, disaster, break-in, adverse reaction, etc. within 24 h

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Retail Pharmacy Minimum Space

150 sq ft prescription department

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Pharmacist Absence Limit (Retail)

≤3 hours/day; ≤1.5 hours per single interval

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Night Cabinet Inventory Frequency

At least weekly in hospitals

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Hospital Pharmacy Director Internal Inspection

Monthly

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Emergency Kit Inspection Interval

Every 90 days by pharmacist

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Partial Fill C-II – Stock Shortage

Fill remainder within 72 h

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Partial Fill C-II – LTCF/Hospice

May partial fill up to 60 days

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C-III–V Expiration & Refill Limit

6 months; ≤5 refills

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C-III–V Transfer Rule

One transfer only unless real-time shared database

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PDMP Reporting Interval (GA)

Within 24 hours of dispensing

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DEA Form 106 Purpose

Report theft or significant loss of controlled substances

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Pseudoephedrine Daily/30-Day Limits

3.6 g/day; 9 g/30 days

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OTC CV Non-PSE Sale Limit

≤4 oz or 32 dosage units per 48 h (≥18 y, photo ID)

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Schedule I Definition

High abuse, no accepted medical use (research only)

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Dangerous Drug (GA)

Any Rx-only drug not scheduled

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Class I Recall

Reasonable probability of serious adverse health; notify patients

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Poison Prevention Packaging Act

Child-resistant closures for Rx & many OTC products

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DSCSA Goal

Electronic traceability of prescription drug supply chain

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VIPPS Certification

NABP seal indicating legitimate internet pharmacy

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DEA Registration Form 224

Initial registration for pharmacies to handle controlled substances

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DEA Number Checksum Rule

(1st+3rd+5th) + 2×(2nd+4th+6th) → last digit = 9th digit

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DEA Form 222

Order or transfer Schedule I & II drugs

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Biennial Controlled Inventory Requirement

Every 2 years; exact count C-II, estimated C-III–V (<1,000 tabs)

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Multiple C-II Rx 90-Day Supply Rule

Allowed with ‘Do Not Fill Until’ dates; each Rx dated actual issue date

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DATA Waiver Eliminated

X-number no longer required for buprenorphine addiction RX

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USP 795 Scope

Non-sterile compounding standards for human & animal

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Master Formulation Record

Pre-established recipe and procedure for compounded prep

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Compounding Record

Actual preparation log documenting lot, ingredients, personnel

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BUD – Non-Sterile Solid Dosage

Up to 180 days room temperature

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BUD – Non-Preserved Aqueous Prep

14 days refrigerated

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Category 1 CSP

Made in SCA, ISO 5 PEC; BUD ≤12 h RT or 24 h fridge

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Category 2 CSP

Made in cleanroom suite; BUD >24 h; more controls

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Category 3 CSP

Sterility tested; BUD up to 180 days

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ISO Class 5

≤3,520 particles ≥0.5 µm/m³; critical work zone for sterile compounding

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Hazardous Drug Negative Pressure Storage

External ventilation, negative pressure room, ≥12 ACPH

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Assessment of Risk (HD)

Document allowing alternatives to full USP 800 containment

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5 Percent Rule (Wholesale Exemption)

Pharmacy transfers ≤5% of total annual dosage units without wholesaler license

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Remote Order Entry Pharmacist

GA-licensed RPh processing orders offsite; no dispensing or counseling

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Automated Pharmacy System Stocking

Only pharmacist or supervised intern/tech may load meds

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Remote Automated Medication System (RAMS)

Automated system in SNF/hospice dispensing up to 30-day supply; nurses retrieve doses

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Adulterated Drug

Filthy, decomposed, unsanitary, incorrect strength/quality

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Misbranded Drug

False/misleading label or missing required information

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Orphan Drug

Treats ≤200,000 patients; receives incentives

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Narrow Therapeutic Index (NTI) Drug

Small difference between effective and toxic dose

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iPledge Program

REMS for isotretinoin to prevent fetal exposure

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Clozapine REMS Requirement

ANC monitoring to mitigate agranulocytosis risk

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Class A (III) Balance

Traditional torsion balance accurate to 6 mg; required equipment

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Laminar Airflow Hood

Primary engineering control (ISO 5) for sterile compounding

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USP 800 Training Frequency

Initially and every 12 months

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Pharmacy Drive-Thru Lane Limit

Maximum of two; farthest no more than 24 ft from window

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Hospital Schedule II Storage

Locked safe or dedicated controlled-access room

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Perpetual Inventory Requirement (Hospital C-II)

Continuous running log of all C-II transactions

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Consultant Pharmacist (LTCF) Role

Monthly drug regimen review and irregularity reporting

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Vendor Pharmacist (LTCF) Role

Dispensing, labeling, delivery, record-keeping for facility

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Standing Orders in Nursing Facilities

Prohibited; must use complete order instead

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LTCF Emergency Kit Prescription Window

Physician must provide new order within 72 hours after kit access

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Veterinary Office-Use Compounding 5 % Cap

Dispensed amounts for office/emergency use ≤5% of pharmacy’s yearly compounded volume

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Veterinary Emergency Dispensing Supply

≤10-day supply (updated 2025) for urgent condition

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“Brand Necessary” Requirement

Prescriber’s own handwriting on Rx to block substitution

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Security Paper for Hardcopy C-II

Mandatory to deter duplication/alteration

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Pharmacist Initials on Controlled Rx

Initials, fill date, serial number on face or rear (back-tag)

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Federal Caution Statement

“Caution: Federal law prohibits the transfer of this drug to any person other than the patient…”

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DEA Theft/Loss Reporting Deadline (GA)

Notify DEA/GDNA within 3 days; initial Board notice 24 h

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Pseudoephedrine Logbook Retention

2 years

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Pharmacy Record Retention (General)

≥2 years; compounded records 5 years (GA) or 2 years (USP)

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Drug Sample Record Requirement

Practitioners must log receipt and each sample dispensed

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Optometrist Oral Analgesic Limit (GA)

72-hour non-controlled; 48-hour hydrocodone

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Mid-Level C-II Emergency Authority (2025)

PA/APRN may prescribe oxycodone/hydrocodone only in emergencies with protocol, 1-year experience, extra CE

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Institutional C-II Floor Stock Dispensing Limit

7-day supply

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Institutional C-III–V Floor Stock Limit

34-day supply or 100 dosage units

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Phase 1 Clinical Trial Goal

Evaluate safety, PK, toxicity in 20–80 subjects

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Phase 3 Clinical Trial Goal

Confirm efficacy & safety in 1,000–3,000 subjects

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ANDA Purpose

Abbreviated New Drug Application for generics

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SNDA Purpose

Supplemental NDA to change manufacture or new indication

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Prescription Drug Marketing Act Sample Rule

Practitioners may receive/dispense samples; must keep detailed records

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Pharmacy Remote Processing Patient Notice

Must inform patients their Rx may be processed elsewhere

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Central Fill Pharmacy Counseling

Originating pharmacy retains counseling duty