Colorado Pharmacy Law: A Online MPJE® Preparatory Course

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Introduction 2 Topics

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What Is The MPJE?

Quick Test-taking Tips

FEDERAL PHARMACY LAW REVIEW: PART 1 2 Topics

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Investigational New Drug (IND) Application

New Drug Application (NDA)

FEDERAL PHARMACY LAW REVIEW: PART 2 6 Topics

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Prescription Drug User Fee Act (PDUFA)

Abbreviated New Drug Applications (ANDA)

Phase IV and Post-Marketing Surveillance

Over-The-Counter (OTC) Regulations

Marketing Regulations

Violations and Enforcement

FEDERAL PHARMACY LAW REVIEW PART 3: OVERVIEW OF FEDERAL ACTS 3 Topics

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Federal Acts

Drug Recalls

Misbranding vs. Adulteration

FEDERAL PHARMACY LAW REVIEW PART 4: CONTROLLED SUBSTANCES LAWS 8 Topics

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Federal Laws and Regulations for Pharmacies, Pharmacists, and Prescriptions

Drug Enforcement Administration (DEA) Registration

Practitioners

Prescription Basics

Prescription Labeling

Pharmacy Requirements

Drug Enforcement Registration (DEA) Forms

Health Insurance Portability and Accountability Act (HIPAA)

UNITED STATES PHARMACOPOEIA (USP) , , AND COMPOUNDING RULES 4 Topics

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Updates to USP and

Non-Sterile Compounding

Sterile Compounding USP 797

Hazardous Compounding USP 800

MISCELLANEOUS 4 Topics

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Patient Package Insert (PPI)

Scheduled Listed Chemical Products (SLCPS)

Poison Prevention Packaging

Specific Labeling Requirements

FEDERAL PHARMACY LAW PRACTICE EXAM 1 Quiz

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Federal Pharmacy Law Practice Exam

Colorado Law – Pharmacy Business (C.R.S. 12-280-101 – 140) 7 Topics

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Definitions (C.R.S. 12-280-103)

Registration of Facilities (C.R.S. 12-280-119)

Non-resident Pharmacy – Registration (C.R.S. 12-280-133)

Specialized Pharmacy (C.R.S. 12-280-119 and 3 CCR 719-1-25.00.14 – 25.00.24)

Hospital Satellite Pharmacy (3 CCR 719-1-27.00.20)

TelePharmacy (3 CCR 719-1-31.01.10)

State Board of Pharmacy (C.R.S. 12-280-104 – 115.5)

Pharmacists (C.R.S. 12-280-101 – 140) 2 Topics

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Continuing Education (C.R.S. 12-280-117, 117.5)

Prescription Drug Outlet Under Charge of Pharmacist (C.R.S. 12-280-118)

Pharmacists’ Authority (C.R.S. 12-280-101 – 140) 7 Topics

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Minor Prescription Changes (C.R.S. 12-280-125.3)

Dispensing Chronic Maintenance Medications (C.R.S. 12-280-125.5)

Prescribing and Dispensing HIV Infection Prevention Drugs (C.R.S. 12-280-125.7)

Limited Authority to Delegate Pharmacy Practice Activities to Pharmacy Interns or Pharmacy Technicians (C.R.S. 12-280-122)

Dispensing Opiate Antagonists and Selling Non-Prescription Syringe and Needles (C.R.S. 12-280-123)

Insulin Affordability Program – Record Keeping – Reimbursement (C.R.S. 12-280-139)

Emergency Prescription Insulin Supply – Eligibility – Record Keeping (C.R.S. 12-280-140)

Pharmaceuticals (C.R.S. 12-280-101 – 140) 4 Topics

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Dispensing and Sale of Drugs and Devices (C.R.S. 12-280-120)

New Drugs – When Sales Permissible (C.R.S. 12-280-131)

Unused Medication (C.R.S. 12-280-135)

Records (C.R.S. 12-280-134)

Compounding (C.R.S. 12-280-101 – 140 And 3 CCR 719-1-21.00.00 – 21.22.10) 7 Topics

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Compounding Drugs for Office Use by a Veterinarian (C.R.S. 12-280-121)

Labeling (C.R.S. 12-280-124)

Substitution of Prescribed Drugs and Biological Products Authorized (C.R.S. 12-280-125)

Casual Sales and Distribution of Compounded Products (3 CCR 719-1-21.00.20)

Non-Sterile Compounding (3 CCR 719-1-21.10.10 – 21.11.10)

Sterile Compounding (3 CCR 719-1-21.20.10 – 21.20.20, 21.20.40 – 21.21.70)

Cytotoxic Drug Preparation (3 CCR 719-1-21.22.10)

Unprofessional Conduct (C.R.S. 12-280-126 – 134) 3 Topics

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Grounds for Discipline (C.R.S. 12-280-126)

Disciplinary Actions (C.R.S. 12-280-127)

Unlawful Acts (C.R.S. 12-280-129)

Pharmacy Peer Health Assistance Diversion Program (C.R.S. 12-280-201 – 206) 2 Topics

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Legislative Declaration (C.R.S. 12-280-201)

Eligibility – Participants (C.R.S. 12-280-204)

Wholesalers (C.R.S 12-280-301 – 308 and 3 CCR 719-1-15.01.12 – 15.10.12) 2 Topics

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Wholesaler Registration Requirements (C.R.S. 12-280-303 and CCR 719-1-15.01.12)

Restrictions on Transactions (C.R.S. 12-280-305)

Electronic Monitoring of Prescription Drugs (C.R.S 12-280-401 – 410) 4 Topics

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Definitions (C.R.S. 12-280-402)

Prescription Drug Use Monitoring Program (C.R.S. 12-280-403 and 3 CCR 719-1-23.00.30 – 1-23.00.90)

Program Operation (C.R.S. 12-280-404, 406-407)

Exception (C.R.S. 12-280-408)

Selection of Therapeutically Interchangeable and Therapeutically Equivalent Drugs (C.R.S 12-280-501 – 502) 1 Topic

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Nursing Care Facility and Long-Term Acute Care Hospital (C.R.S. 12-280-501 – 502)

Pharmacy Practice (C.R.S 12-280-601 – 602 and 3 CCR 719-1-17.00.10 – 17.00.70) 4 Topics

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Definitions (C.R.S. 12-280-601 and 3 CCR 719-1-17.00.10)

Pharmacists’ Requirements Within the Agreement (C.R.S. 12-280-602 and 3 CCR 719.1-17.00.30)

Patient Counseling – Pharmacist Required to Perform –Patient May Decline (C.R.S. 12-280-138)

Recordkeeping Requirements (3 CCR 719-1-17.01.00 – 17.03.00)

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