A Review of Laws Enforced by the FDA

The Food and Drug Administration’s (FDA) authority to approve new drugs has been front and center lately. Take this course to learn why the FDA is one of the most trusted, and at the same time most controversial, federal agencies; and how your role on the pharmacy team is an important part of keeping patients safe from harm.

Upon successful completion of this knowledge-based CPE course, pharmacists should be able to:
1. Discuss the FDA’s regulatory authority for the enforcement of legal standards related to new drug approval, the misbranding of drugs, and the adulteration of drugs.
2. Describe the federal requirements for extemporaneous compounding by pharmacies, as distinct from pharmaceutical manufacturing.
3. Identify the requirements for approval and therapeutic equivalency of generic drug products.

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 to disclose.

Course fee includes course, course materials, and CPE credit submission to CPE Monitor.
Initial Release Date: April 8, 2022
Planned Expiration Date: April 8, 2025

This program 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.

RV2-1.24

Universal Activity Number (UAN): 0107-0000-22-175-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 www.MyCPEMonitor.net.