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Dissecting the FDA ‘Essentially Copies’ Guidance Document for 503A Compounding Pharmacies: Best Practice Solutions

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Date Published

May 12, 2020


Alliance for Pharmacy Compounding


Compounding Law, Compounding Pharmacy, FDA


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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-H07-P and 0046-9999-20-171-H07-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

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.

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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.... Read More

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Program Titles and Supporting Materials

This program contains the following components:

Dissecting the FDA ‘Essentially Copies’ Guidance Document for 503A Compounding Pharmacies - Video
Dissecting the FDA ‘Essentially Copies’ Guidance Document for 503A Compounding Pharmacies - Slide Handout
Summary of the Guidance Document - Paper
EC for 503A - Paper
EC Decision Tree - Paper
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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.

Click on jurisdiction for specific details:

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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.

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