Pharmacy Law Fundamentals

About the Course:
Pharmacy is the most regulated profession in healthcare.  Beginning with the Food, Drug, and Cosmetics Act of 1938, legislation has been enacted to distinguish between prescription and OTC medications and to establish that drugs must be both safe and effective, must be properly labeled, and must be manufactured and stored under sanitary conditions.  The Controlled Substances Act of 1970 provides a regulatory foundation for the distribution of controlled substances.  This course reviews the history and fundamentals of pharmacy law, focusing on the FDCA and Amendments and the CSA, along with implications of these laws for practice and patient care today.

Learning Objectives:
After completing this course, the learner will be able to: 
  • Explain the reasons for and provisions of the Federal Food and Drug Act of 1906.
  • Explain the differences between an adulterated and a misbranded drug.
  • Identify significant Federal Food, Drug, and Cosmetic Act amendments affecting pharmacy practice.
  • Explain the five classes of controlled substances.
  • List the requirements for ordering and dispensing controlled substance medications.
  • Describe the implications of the Combat Methamphetamine Epidemic Act
About the Author:
Debra A. Notturno-Strong, RPh, MS, MSA, is an Associate Professor in the Pharmacy Practice Administration Department at Texas Tech University Health Sciences Center School of Pharmacy where she has been a member of the faculty since 2011. Lt. Col. Notturno-Strong teaches Health Policy, Quality Improvement, Patient Safety, Leadership, and Pharmacy Law. Her research interests include medication safety and professional conduct. She is currently a doctoral candidate in Health Sciences and Leadership at the Massachusetts College of Pharmacy and Health Sciences University. In addition to her Bachelor’s degree in Pharmacy, she holds three master’s degrees in Business (Central Michigan University), Pharmacy Administration, and Health Policy (University of the Sciences in Philadelphia). She is a highly decorated Air Force veteran, retired with 23 years of leadership and operational experience in directing high volume Department of Defense healthcare benefit programs and pharmacies.

How to receive credit:
  • A minimum test score of 75 percent is needed to obtain a credit.

Activity Type - Knowledge-based

Target Audience - Pharmacists, Pharmacists Technicians


  • Contact hours will be awarded through the expiration date.
  • You must score 75% or higher on the final exam and complete the course evaluation to pass this course and have your record of completion submitted through CPE Monitor and to the NABP.
  • Through our review process, Elite ensures that this course content is presented in a balanced, unbiased manner and is free from commercial influence. It is Elite's policy not to accept commercial support.
  • All persons involved in the planning and development of this course have disclosed no relevant financial relationships or other conflicts of interest related to the course content.


Colibri Healthcare, LLC is accredited by the Accreditation Council of Pharmacy Education (ACPE) as a provider of continuing pharmaceutical education. (Provider #0607).