Course Description

This course provides a comprehensive examination of Federal and Florida laws governing pharmacy practice, with emphasis on controlled substances regulation, recordkeeping, security, and diversion prevention. Participants will explore the Controlled Substances Act, Drug Enforcement Administration (DEA) requirements, and Florida Statutes Chapters 465, 499, and 893, as well as applicable Florida Administrative Code rules. The course highlights prescription requirements, ordering and inventory controls, theft and loss reporting, prescription drug monitoring programs, and emergency exceptions. Through real-world examples and case-based discussions, participants will develop practical skills in legal compliance, professional judgment, and patient safety. Emphasis is placed on the pharmacist’s corresponding responsibility, ethical decision-making, and regulatory enforcement processes. This course prepares participants to navigate inspections, audits, and disciplinary actions while ensuring lawful, safe, and effective pharmacy operations in diverse practice settings.

Learning Objectives

Upon successful completion of this course, pharmacists will be able to:

• Interpret and apply Federal and Florida pharmacy laws and administrative rules to pharmacy practice.
• Identify legal requirements for prescribing, dispensing, labeling, and recordkeeping of controlled substances.
• Explain the pharmacist’s corresponding responsibility under the Controlled Substances Act.
• Demonstrate compliance with DEA registration, ordering, inventory, and security requirements.
• Recognize and respond appropriately to controlled substance theft, loss, or diversion.
• Analyze exceptions for emergency dispensing, electronic prescriptions, and telepharmacy.
• Apply Florida-specific statutes and rules to real-world pharmacy practice scenarios.
• Prepare for regulatory inspections, audits, and professional disciplinary processes.

Table of Contents

Introduction

Chapter 1: The Impact of Federal Laws on Pharmacy Practice

1.1 Drug Quality and Security Act (DQSA)

1.2 Health Insurance Portability and Accountability Act (HIPAA)

1.3 Medicare Modernization Act (MMA)

1.4 National Institute for Occupational Safety and Health (NIOSH)

1.5 Occupational Safety and Health Administration (OSHA)

1.6 Omnibus Budget Reconciliation Act of 1990 (OBRA ’90)

1.7 Tamper-Resistant Prescription Law

Chapter 2: Drug Enforcement Administration (DEA) and Controlled Substances Act (CSA)

2.1 Drug Enforcement Administration (DEA)
2.2 The Federal Controlled Substances Act (CSA)

• Pharmacist’s Manual
• CSA Definition
• Protecting Patient Access to Emergency Medications Act of 2017
• Application of the CSA to Dispensing
• Required Information for Labels of Controlled Substances
• United States Postal Service Mailing Requirements for Controlled Substances

2.3 Controlled Substance Schedules

• Schedules I-V Controlled Substances
• DEA Forms and Registration
• DEA Number Validation Prescriptions
• Inventory
• Recordkeeping
• Security and Screening

Chapter 3: Florida Statutes

3.1 Florida Statutes Chapter 120: Administrative Procedure Act

• Chapter 465, Florida Statutes & Chapter 64B16, Florida Administrative Code
• Definitions §465.003, F.S., Rule 64B16-26.100, F.A.C.
• The Florida Board of Pharmacy §465.004, F.S. Pharmacist Licensure §465.006–§465.015, F.S., Rules 64B16-26.300, 64B16-26.500, 64B16-26.700, F.A.C.
• Unlawful Acts and Consequences §465.016, F.S., Rules 64B16-30.001, 64B16-30.003, F.A.C.
• Pharmacy Permits §465.019–§465.023, F.S., Rules 64B16-28.100, 64B16-28.108, 64B16-28.300, F.A.C.
• Pharmacy Standards §465.022–§465.023, F.S., Rules 64B16-27.100, 64B16-27.300, 64B16-27.400, F.A.C.

3.2 Florida Statutes Chapter 395: Hospital Licensing and Regulation

3.3 Florida Statutes Chapter 456: Health Professions and Occupations

3.4 Florida Statutes Chapter 499: Florida Drug and Cosmetic Act

3.5 Florida Controlled Substances Law Chapter 893, Florida Statutes

• Standards and Schedules §893.02, §893.03, F.S.
• Pharmacist and Practitioner §893.02(13), §893.02(21), F.S.
• The Florida Prescription Drug Monitoring Program (PDMP) §893.055, F.S.
• Prohibited Acts §893.13, §893.135, F.S.

3.6 Miscellaneous Florida Statutes

Chapter 4: Florida Administrative Codes

4.1 Florida Board of Pharmacy (64B16, F.A.C.)

• Licensure Rules (64B16‑26, F.A.C.)
• Pharmacy Practice Rules 64B16‑27.800, 64B16‑27.820, and 64B16‑27.830, F.A.C.,
• Pharmacy Permits Rules in 64B16‑28, F.A.C.
• Disciplinary Guideline Rules 64B16‑30.001 and 64B16‑30.003, F.A.C.,
• Nonresident Pharmacy Rules 64B16‑32.001, F.A.C.,
• Prescriber Practice Rules– Weight Loss/Obesity/Telemedicine

Chapter 5: Updates

• Biennial Inventory (Chapter 893.07)
• DEA Report of Significant Loss (FS 465.015)
• Sheriff / Local Police Requirements (FS 465.015)
• Controlled Substance Ordering System (eCFR)
• Mid Level Practitioners

Chapter 6: Laws and Rules Supplemental Materials

Video: Board of Pharmacy

Video: PDM Roles and Responsibilities

Video: DEA

Video: CMS

Video: DSCSA

Video: Pharmacist Discipline