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CENTER FOR DRUG EVALUATION AND RESEARCHOUTSOURCING
FACILITY
INFORMATION September 2017
www.fda.govContents
I.
INTRODUCTION .....................................................................................................................................
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What is profile of outsourcing facilities?
The profile of outsourcing facilities is a document that provides information about outsourcing facilities and their operations.
Who is required to file profile of outsourcing facilities?
Outsourcing facilities engaged in compounding activities are required to file a profile with the FDA.
How to fill out profile of outsourcing facilities?
The profile of outsourcing facilities can be filled out online through the FDA's Electronic Drug Registration and Listing System (eDRLS).
What is the purpose of profile of outsourcing facilities?
The purpose of the profile of outsourcing facilities is to provide the FDA with important information about outsourcing facilities and their compounding activities.
What information must be reported on profile of outsourcing facilities?
The profile of outsourcing facilities must include information such as the facility's name, address, contact information, and compounding activities.
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