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Dissecting the FDA ‘Essentially Copies’ Guidance Document for 503A Compounding Pharmacies: Best Practice Solutions
Published by Alliance for Pharmacy Compounding and Ohio Pharmacists Association

We'll dissect and discuss the FDA 'Essentially a Copy' Guidance Document for 503A pharmacies, as well as how this applies to the compounding pharmacy and provider. We'll also address best practice solutions for proper documentation and run through multiple scenarios involving compounds, with appropriate action steps noted. Join us, and get tips on how to best approach providers and achieve positive collaboration to ensure continued patient care.

Learning Objectives for Pharmacists and Technicians:
1. Outline the history and scope of the FDA ‘Essentially Copies’ Guidance Document and how it applies to 503A pharmacies
2. Recognize prescription requests that may be considered ‘Essentially a Copy’ and how to proceed to ensure appropriate patient care
3. Consult with providers regarding the FDA ‘Essentially Copies’ Guidance Document and how it applies to their practice

Accreditation Information:
This lesson is a knowledge-based CE activity and is targeted to pharmacists and technicians.
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The American Society of Health-System Pharmacists and UNC Eshelman School of Pharmacy are accredited by the Accreditation Council for Pharmacy Education as providers of continuing pharmacy education. This program is approved for 1.0 contact hours (0.1 CEUs) of continuing education credit for pharmacists and technicians. UAN #: 0046-9999-20-171-L07-P and 0046-9999-20-171-L07-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.

CE credit and certificates of attendance will be provided only to those individuals who registered and logged into the webinar online. If you want CE credit and your certificate of attendance, you must have purchased the program and logged into the web portion under that registration so that we can verify attendance.

Reuben K. Nielsen, PharmD, MBA
Staff Pharmacist - MedQuest Pharmacy
Reuben K. Nielsen, PharmD, MBA is employed as a staff pharmacist with MedQuest Pharmacy, located near Salt Lake City, Utah. He graduated in 2007 from Midwestern University in Glendale, Arizona, and obtained an MBA from Western Governors University in 2015. He spends his days at MedQuest ensuring the compliance, accuracy, and quality of mainly HRT compounded preparations.He is an active member of the communications committee for APC, and has contributed several articles for use on the Facebook...More
How To Attend
Join the live program from your office, home, or hotel room using a computer with high speed internet. You may ask questions, participate in surveys, and post comments from your computer during the program. Please note that credit (if available) is only provided to registered attendees participating at their own computer and phone. Simple instructions with a link to the program will be sent when you register and again the day before the webinar.

If applicable, you may obtain credit in multiple jurisdictions simultaneously for this program (see pending/approved list below). Registrants in jurisdictions not listed below will receive a Certificate of Attendance/Completion that may or may not meet credit requirements in other jurisdictions. Where applicable, credit will be only awarded to a paid registrant attending the live program at their own computer and phone.

 Click on jurisdiction for specific details  

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