Texas Pharmacy Law: A MPJE® Online Preparatory Course

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INTRODUCTION: WHAT IS THE MPJE?

Quick Test Taking Tips for TX MPJE

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

ORIENTING YOURSELF TO TEXAS LAWS, RULES, AND RESOURCES 2 Topics

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TEXAS LAWS VS RULES

THE “LAW BOOKS” (COMPILATIONS OF TEXAS PHARMACY LAWS AND RULES USED IN PRACTICE)

Chapter 552: Texas State Board of Pharmacy 6 Topics

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Membership (552.001)

Qualifications (552.002-003)

Terms; Vacancy (552.005)

Officers (552.007)

Grounds For Removal (552.008)

Meetings (552.010-012)

Chapter 553: Executive Director And Other Board Personnel 1 Topic

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Executive Director (553.001-003)

Chapter 554: Board Powers And Duties; Rulemaking Authority 7 Topics

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General Powers And Duties (554.001)

Regulation Of Practice Of Pharmacy (554.002-003)

Administration Of Medicine (554.004)

Prescription Drugs And Devices (554.005)

Notifications (554.012, 554.014)

Rulemaking

Immunizations And Vaccinations; Physician Supervision (554.052)

Chapter 555: Public Interest Information And Complaint Procedures 1 Topic

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Public Interest Information; Complaints (555.001-012)

Chapter 556: Administrative Inspections And Warrants 2 Topics

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Inspections (556.051-556.057)

Warrants (556.101-105)

Chapter 557: Pharmacist-Interns 4 Topics

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Registration (557.001-004)

Definitions

Internship Requirements (TSBP Rule 283.4)

Preceptors (TSBP Rule 283.6)

Chapter 558: License To Practice Pharmacy 4 Topics

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Licensing By Examination (558.051-056)

License By Reciprocity (558.101)

Initial Licensing (TSBP Rule 283.9)

Military Licensing (TSBP Rule 283.12)

Chapter 559: Renewal Of License To Practice Pharmacy 3 Topics

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General Provisions (559.001-006)

Mandatory Continuing Education (CE) (559.051-055)

Inactive Status (559.101-104)

Chapter 560: Licensing Of Pharmacies 5 Topics

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License Required (560.001-004)

Closing A Pharmacy (TSBP Rule 291.5)

Manufacture Recalls (TSBP Rule 291.7)

Pharmacy Classifications (560.051-053)

License Restrictions (560.101-102)

Chapter 561: Renewal Of Pharmacy License 1 Topic

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Renewal Of Pharmacy License (561.001-005)

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