A Review of Laws Enforced by the FDA
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.
Copyright 2022, CEimpact. All Rights Reserved. Any reproduction of this course without express permission is strictly forbidden.
RV2-1.24
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.
¹CEImpact provides you with two (2) opportunities to complete the exam. The learner will not receive CPE credit after two failed attempts.
Additional information
| Duration | 1h 0m |
|---|---|
| Topic Designator | Law |
| ACPE | Yes |
| ACPE Topic | |
| Role | Pharmacist |
| Media-Type | Written |
| Release Date | 4/8/22 |
| CEUs | 0.1 |
| Rating | 4 |
| ACPE Number | 0107-0000-22-175-H03-P |
