COVID-19 Testing – What is an Emergency Use Authorization?

Description

Due to the urgent nature of the public health crisis caused by Coronavirus Disease-19 (COVID-19), the FDA has enacted its emergency use authorization (EUA) authority to facilitate availability of in vitro diagnostic products for COVID-19. Pharmacists play an important role in responding to COVID-19 and increasing access to urgently needed testing. Recently, the U.S. Department of Health & Human Services authorized pharmacists to order and administer tests for COVID-19. As pharmacists navigate COVID-19, it is important to understand the FDA regulatory process to be able to identify legible, reliable, and non-fraudulent products.

Learning Objectives

At the completion of this activity, participants will be able to:

  • Describe the regulatory process for FDA-approved home and lab tests
  • Explain the FDA’s emergency use authorization (EUA) as it pertains to COVID-19 in vitro diagnostic products
  • Discuss the FDA’s policy for diagnostic tests for COVID-19
  • Identify non-fraudulent COVID-19 in vitro diagnostic products authorized or cleared to develop and distribute without an EUA

Speakers

  • Susan Bain, DRSc, Assistant Professor of Regulatory and Quality Sciences, University of Southern California School of Pharmacy

Continuing Pharmacy Education

The California Pharmacists Association (#0113) is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Upon completing an evaluation form, participants will be awarded 0.5 hours (0.05 CEUs) of Continuing Pharmacy Education Credit. A statement of credit will not be issued. Participants may log onto the CPE monitor website using their individual log in to download their statement of credit. Please allow 4 weeks for processing of CPE credits to the CPE monitor. UAN: 0113-0000-20-101-H04-P; 0113-0000-20-101-H04-T

Activity Type:  Knowledge-based
Target Audience:  Pharmacists and Technicians in all practice settings
Release Date: 4/14/2020
Expiration Date: 4/14/2023

**Free to Members Through May 21, 2020

Registration Fees**
CPhA Member $25 (May 22, 2020 and later)
Non-Member $40

What To Expect After Registration

After registration, you will receive a confirmation email with instructions on how to participate in the webinar.

***No cancellations or refunds will be issued once user login information has been sent. Unfortunately, due to the online format of this program we are unable to offer exceptions to this policy. It’s recommend that each registrant review the course content prior to submitting payment to ensure the content meets individual educational needs. User has 30 days to complete the on-demand program from registration. If you have questions regarding course content or cancellation policy, please contact CPhA at (916) 779-4518.

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