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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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Georgia RPh Licensure Requirements
Application, ≥18 years old, good moral character, ACPE-accredited PharmD, 1,500 internship hours, pass NAPLEX & MPJE, pay all fees
Georgia RPh License Renewal Cycle
Biennially on 12/31 of even-numbered years
Late Renewal Grace Period (RPh)
May renew through 1/31 with late fee; revoked after 1/31
Georgia RPh CE Requirement
30 hours every 2-year cycle
Internship Hour Requirement (GA)
1,500 hours
Intern/Extern Definition – Georgia
Student registered with Board; intern is paid, extern is school-assigned experiential student
Intern License Validity (GA)
Up to 5 years unless earlier termination event occurs
Certified Pharmacy Technician (GA)
Registered technician certified by PTCB
GA Technician CE & Renewal
20 CE hours; renew every odd-numbered year
Pharmacist:Technician Ratio (GA)
Maximum 4:1 (two must be certified if supervising four)
GDNA (Georgia Drugs and Narcotics Agency)
Law-enforcement arm that inspects, investigates, seizes, and subpoenas for drug law compliance
GDNA Special Agent Qualifications
Active GA RPh license, 2 years practice, POST training, clean record
Board of Pharmacy Composition (GA)
8 members – 7 pharmacists + 1 consumer
Code of Professional Conduct – Core Duty
Protect public health & maintain trust in pharmacy profession
Refusal to Fill – Acceptable Basis
Professional judgment or deeply held ethical/moral belief
Generic Substitution Requirement (GA)
Must dispense pharmaceutically equivalent (Orange Book) unless prescriber writes “brand necessary”
Purple Book Purpose
Lists interchangeable biological products
Emergency Dispensing (State of Emergency)
Up to 30-day maintenance med, no C-II, notify prescriber within 48 h
Emergency Refill (Unable to Reach Prescriber)
One-time 72-hour supply of non-controlled; notify prescriber within 7 days
Drug Therapy Modification Certification
Board-approved course + 3 CE hours; renew annually 12/31
DTM Protocol Record Retention
Keep 10 years after protocol terminates; protocol expires every 2 years
Mail Delivery – Controlled Substance Rule
Schedule II-V must be signed for on delivery
PIC Immediate Notification Items
Closure, ownership/PIC change, drug loss, disaster, break-in, adverse reaction, etc. within 24 h
Retail Pharmacy Minimum Space
150 sq ft prescription department
Pharmacist Absence Limit (Retail)
≤3 hours/day; ≤1.5 hours per single interval
Night Cabinet Inventory Frequency
At least weekly in hospitals
Hospital Pharmacy Director Internal Inspection
Monthly
Emergency Kit Inspection Interval
Every 90 days by pharmacist
Partial Fill C-II – Stock Shortage
Fill remainder within 72 h
Partial Fill C-II – LTCF/Hospice
May partial fill up to 60 days
C-III–V Expiration & Refill Limit
6 months; ≤5 refills
C-III–V Transfer Rule
One transfer only unless real-time shared database
PDMP Reporting Interval (GA)
Within 24 hours of dispensing
DEA Form 106 Purpose
Report theft or significant loss of controlled substances
Pseudoephedrine Daily/30-Day Limits
3.6 g/day; 9 g/30 days
OTC CV Non-PSE Sale Limit
≤4 oz or 32 dosage units per 48 h (≥18 y, photo ID)
Schedule I Definition
High abuse, no accepted medical use (research only)
Dangerous Drug (GA)
Any Rx-only drug not scheduled
Class I Recall
Reasonable probability of serious adverse health; notify patients
Poison Prevention Packaging Act
Child-resistant closures for Rx & many OTC products
DSCSA Goal
Electronic traceability of prescription drug supply chain
VIPPS Certification
NABP seal indicating legitimate internet pharmacy
DEA Registration Form 224
Initial registration for pharmacies to handle controlled substances
DEA Number Checksum Rule
(1st+3rd+5th) + 2×(2nd+4th+6th) → last digit = 9th digit
DEA Form 222
Order or transfer Schedule I & II drugs
Biennial Controlled Inventory Requirement
Every 2 years; exact count C-II, estimated C-III–V (<1,000 tabs)
Multiple C-II Rx 90-Day Supply Rule
Allowed with ‘Do Not Fill Until’ dates; each Rx dated actual issue date
DATA Waiver Eliminated
X-number no longer required for buprenorphine addiction RX
USP 795 Scope
Non-sterile compounding standards for human & animal
Master Formulation Record
Pre-established recipe and procedure for compounded prep
Compounding Record
Actual preparation log documenting lot, ingredients, personnel
BUD – Non-Sterile Solid Dosage
Up to 180 days room temperature
BUD – Non-Preserved Aqueous Prep
14 days refrigerated
Category 1 CSP
Made in SCA, ISO 5 PEC; BUD ≤12 h RT or 24 h fridge
Category 2 CSP
Made in cleanroom suite; BUD >24 h; more controls
Category 3 CSP
Sterility tested; BUD up to 180 days
ISO Class 5
≤3,520 particles ≥0.5 µm/m³; critical work zone for sterile compounding
Hazardous Drug Negative Pressure Storage
External ventilation, negative pressure room, ≥12 ACPH
Assessment of Risk (HD)
Document allowing alternatives to full USP 800 containment
5 Percent Rule (Wholesale Exemption)
Pharmacy transfers ≤5% of total annual dosage units without wholesaler license
Remote Order Entry Pharmacist
GA-licensed RPh processing orders offsite; no dispensing or counseling
Automated Pharmacy System Stocking
Only pharmacist or supervised intern/tech may load meds
Remote Automated Medication System (RAMS)
Automated system in SNF/hospice dispensing up to 30-day supply; nurses retrieve doses
Adulterated Drug
Filthy, decomposed, unsanitary, incorrect strength/quality
Misbranded Drug
False/misleading label or missing required information
Orphan Drug
Treats ≤200,000 patients; receives incentives
Narrow Therapeutic Index (NTI) Drug
Small difference between effective and toxic dose
iPledge Program
REMS for isotretinoin to prevent fetal exposure
Clozapine REMS Requirement
ANC monitoring to mitigate agranulocytosis risk
Class A (III) Balance
Traditional torsion balance accurate to 6 mg; required equipment
Laminar Airflow Hood
Primary engineering control (ISO 5) for sterile compounding
USP 800 Training Frequency
Initially and every 12 months
Pharmacy Drive-Thru Lane Limit
Maximum of two; farthest no more than 24 ft from window
Hospital Schedule II Storage
Locked safe or dedicated controlled-access room
Perpetual Inventory Requirement (Hospital C-II)
Continuous running log of all C-II transactions
Consultant Pharmacist (LTCF) Role
Monthly drug regimen review and irregularity reporting
Vendor Pharmacist (LTCF) Role
Dispensing, labeling, delivery, record-keeping for facility
Standing Orders in Nursing Facilities
Prohibited; must use complete order instead
LTCF Emergency Kit Prescription Window
Physician must provide new order within 72 hours after kit access
Veterinary Office-Use Compounding 5 % Cap
Dispensed amounts for office/emergency use ≤5% of pharmacy’s yearly compounded volume
Veterinary Emergency Dispensing Supply
≤10-day supply (updated 2025) for urgent condition
“Brand Necessary” Requirement
Prescriber’s own handwriting on Rx to block substitution
Security Paper for Hardcopy C-II
Mandatory to deter duplication/alteration
Pharmacist Initials on Controlled Rx
Initials, fill date, serial number on face or rear (back-tag)
Federal Caution Statement
“Caution: Federal law prohibits the transfer of this drug to any person other than the patient…”
DEA Theft/Loss Reporting Deadline (GA)
Notify DEA/GDNA within 3 days; initial Board notice 24 h
Pseudoephedrine Logbook Retention
2 years
Pharmacy Record Retention (General)
≥2 years; compounded records 5 years (GA) or 2 years (USP)
Drug Sample Record Requirement
Practitioners must log receipt and each sample dispensed
Optometrist Oral Analgesic Limit (GA)
72-hour non-controlled; 48-hour hydrocodone
Mid-Level C-II Emergency Authority (2025)
PA/APRN may prescribe oxycodone/hydrocodone only in emergencies with protocol, 1-year experience, extra CE
Institutional C-II Floor Stock Dispensing Limit
7-day supply
Institutional C-III–V Floor Stock Limit
34-day supply or 100 dosage units
Phase 1 Clinical Trial Goal
Evaluate safety, PK, toxicity in 20–80 subjects
Phase 3 Clinical Trial Goal
Confirm efficacy & safety in 1,000–3,000 subjects
ANDA Purpose
Abbreviated New Drug Application for generics
SNDA Purpose
Supplemental NDA to change manufacture or new indication
Prescription Drug Marketing Act Sample Rule
Practitioners may receive/dispense samples; must keep detailed records
Pharmacy Remote Processing Patient Notice
Must inform patients their Rx may be processed elsewhere
Central Fill Pharmacy Counseling
Originating pharmacy retains counseling duty