• Activity INFORMATION

  Overview

  This monograph presents a case study of United States v. Hiland. Several employees of a pharmaceutical manufacturing firm were convicted of introducing an unapproved new drug into interstate commerce.The drug, E-Ferol IV, was responsible for the deaths of several patients, before physicians and pharmacists identified the adverse effects of the drug and reported the problem to the FDA. The monograph reviews the requirements for approval of a new drug. The role of pharmacists in screening newly marketed drugs for safety is considered.

   

  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 :   19250H03.pdf Download

  Financial Support By

  PharmCon, Inc

• Learning OBJECTIVES

  Pharmacist

  Discuss the FDA requirements for approval of a new drug

  List the factors that can lead to classification of a drug as a "new drug"

  Describe strategies to detect the marketing of an illegal unapproved new drug

  Pharmacy Technician

  Discuss the FDA requirements for approval of a new drug

  Describe strategies to detect the marketing of an illegal unapproved new drug

  List the factors that can lead to classification of a drug as a "new drug"

  Nurse

  Describe strategies to detect the marketing of an illegal unapproved new drug

  Discuss the FDA requirements for approval of a new drug

  List the factors that can lead to classification of a drug as a "new drug"

• Activity ACCREDITATION

  Activity Type

  Knowledge

  CE Broker

  20-564203

  Universal Activity Number

  Pharmacist 0798-0000-19-250-H03-P
  Pharmacy Technician 0798-0000-19-250-H03-T
  Nurse 0798-0000-19-250-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).