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Expecting The Unexpected: How To Prepare For And Respond To An FDA Inspection
Published by International Academy of Compounding Pharmacists



Summary
In order to adequately prepare for an FDA inspection, it is critical that compounders comply with local laws, USP and § 503A requirements, that they know their rights and the FDA’s limitations, and that they have a procedure in place for responding to FDA inspections before the FDA knocks on their door. Taught from the perspective of a pharmacy owner who has weathered the storm and his pharmacy regulation attorneys who stood by his side throughout the process, this presentation will educate compounders on FDA inspections, how to protect themselves from FDA overreach, and how to give themselves the greatest opportunity of passing an FDA inspection without receiving a FDA Form-483 or Warning Letter.

At the end of this program, attendees will be able to:
• Identify the statutory limitations on the FDA’s inspection authority.
• Discuss the FDA’s inspection objectives and tactics.
• Explain the FDA’s inspection process.
• Review compounders’ § 374(a)(2) exemptions and how to assert exempt status.
• Recognize how to effectively interact with FDA inspectors during an inspection.
• Illustrate the importance of compliance with local laws, USP and § 503A requirements in daily pharmacy practices.


Accreditation Information:
This lesson is a knowledge-based CE activity and is targeted to pharmacists and technicians.

ACPE logo The American College of Apothecaries (ACA) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACA has accredited this program for 1.0 contact hours (0.1 CEUs) of continuing education credit for pharmacists and technicians. ACPE UAN 0201-9999-17-080-H03-P; 0201-9999-17-080-H03-T.

If you are interested in earning credit for this program, please note that you will be asked to enter your NABP e-Profile ID during the credit selection step of the registration process. If you have not yet registered your NABP e-Profile ID, please visit www.nabp.net.


Presenters
Shawn E Hodges
Shawn E. Hodges, PharmD is an owner and pharmacist at Innovation Compounding, Inc., a compounding-only pharmacy located in Kennesaw, GA. Innovation Compounding provides both sterile and non-sterile preparations for patients across the US. Shawn...More
Robert W Stannard
Robert is a partner at Bendin Sumrall & Ladner with an AV peer rating from Martindale Hubbell. Robert has a litigation practice which focuses on medical malpractice and healthcare law. He represents hospitals, physicians, and allied health...More
Originally Published
June 12, 2017

Program Titles and Supporting Materials
This program contains the following components:
  1. Expecting The Unexpected: How To Prepare For And Respond To An FDA Inspection - Video
  2. Expecting The Unexpected: How To Prepare For And Respond To An FDA Inspection - Paper

How To Attend
Join the self-paced program from your office, home, or hotel room using a computer and high speed internet connection. You may start and stop the program at your convenience, continue where you left off, and review supporting materials as often as you like. Please note: Internet Explorer is no longer a supported browser. We recommend using Google Chrome, Mozilla Firefox or Safari for best results.

Technical Requirements
You may access this course on a computer or mobile device with high speed internet (iPhones require iOS 10 or higher). Recommended browsers are Google Chrome or Mozilla Firefox.

Credit
If applicable, you may obtain credit in multiple jurisdictions simultaneously for this program (see pending/approved list below). If electing credit for this program, registrants in jurisdictions not listed below will receive a Certificate of Completion that may or may not meet credit requirements in other jurisdictions. Where applicable, credit will be only awarded to a paid registrant completing all the requirements of the program as determined by the selected accreditation authority.

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