Off the Grid: Implications for Use of Unapproved Medications in Pharmacy Practice

Off the Grid: Implications for Use of Unapproved Medications in Pharmacy Practice

Marketing of unapproved drugs provides challenges for pharmacists. This course suggests ways pharmacists can formulate a policy for the identification and explanation of risks to patients, as well as discusses an FDA program to identify and remove from the market, unapproved drugs that pose the greatest risk to the public. 

Upon successful completion of this knowledge-based CPE course, pharmacists should be able to:
1. Identify the standards for approval and marketing of new drugs.
2. Discuss the legal status of a marketed drug based on contentions of the FDA.
3. Describe a policy for the identification of unapproved new drugs and the explanation to patients of the risks posed by such drugs.

David B. Brushwood, R.Ph, J.D.
Senior Lecturer, The University of Wyoming School of Pharmacy
Pharmacy Law Content Developer, CEimpact

David B. Brushwood has no relevant financial relationships with ineligible companies to disclose.

Course fee includes course, course materials, and CPE credit submission to CPE Monitor.
Initial Release Date: January 28, 2024
Planned Expiration Date: January 28, 2027

This course is provided for educational purposes. CEimpact is not a law firm and does not provide legal advice of any kind. For legal advice, please contact a licensed attorney. 

Copyright 2024, CEimpact. All Rights Reserved. Any reproduction of this course without express permission is strictly forbidden.


Universal Activity Number (UAN): 0107-0000-24-013-H03-P
Application-based CPE Activity

CEImpact is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Obtain CPE credit by completing the course, followed by the exam and evaluation (if applicable). Once successfully completed, your course will appear in your Completed Courses tab. Access your CPE statement of credit at

¹CEImpact provides you with two (2) opportunities to complete the exam. The learner will not receive CPE credit after two failed attempts.

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1h 0m

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03 Law





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