FDA Issues Guidance on Outsourcing Registration

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The agency issues guidance for companies considering registering with FDA as an outsourcing facility.


FDA released guidance on Aug. 11, 2015 directed at companies that are considering registering with the agency as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).  The guidance is in response to questions the agency received from companies about which activities (e.g., drug compounding) would require a company to register as an outsourcing facility and, therefore, be subject to registration fees.


The FDA guidance gives more information about the regulatory impact of registering as an outsourcing facility, so companies may be better prepared to make the decision to register. FDA issued a separate guidance that details the process for registering. 

Source: FDA