• Activity INFORMATION

  Overview

  This monograph provides an overview of FDA drug regulation through the agency's authority to require approval of all drug labeling prior to its use. The monograph explores the purpose of drug labeling and the necessary content and format of drug labeling. Legal cases involving labeling issues at the dispensing pharmacy level are summarized. The FDA position on off-label use is reviewed.

   

  This monograph is provided for educational purposes only. It is not intended as legal advice and should not be used as legal advice. For legal advice, a licensed attorney should be consulted.

  
  

  Handouts

  • Homestudy PDF :   19237H03.pdf Download

  Financial Support By

  PharmCon, Inc

• Learning OBJECTIVES

  Pharmacist

  List the FDA requirements for drug labeling

  Describe the differences between types of drug labeling

  Discuss the role of labeling and its influence on the practice of health professions

  Pharmacy Technician

  Discuss the role of labeling and its influence on the practice of health professions

  List the FDA requirements for drug labeling

  Describe the differences between types of drug labeling

  Nurse

  Discuss the role of labeling and its influence on the practice of health professions

  Describe the differences between types of drug labeling

  List the FDA requirements for drug labeling

• Activity ACCREDITATION

  Activity Type

  Knowledge

  CE Broker

  20-564119

  Universal Activity Number

  Pharmacist 0798-0000-19-237-H03-P
  Pharmacy Technician 0798-0000-19-237-H03-T
  Nurse 0798-0000-19-237-H03-N
  

  PharmCon is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

  PharmCon is an approved course provider for continuing education for nurses by the Florida Board of Nursing. PharmCon is also recognized by the California Board of Nursing as a provider of nursing programs.

  In order to obtain a Statement of Credit, participants must score no less than a 70% on the activity's test and complete a program evaluation.

• Activity INSTRUCTION

  Faculty

  David  Brushwood, JD, RPh Senior Lecturer, University of Wyoming School of Pharmacy

This continuing education activity is held as copyright by PharmCon, Inc. Through this notice, PharmCon, Inc. grants permission of its use for educational purposes only. These materials may not be used, in whole or in part, for any commercial purposes without prior permission in writing from the copyright owner(s).