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FDA Finalizes Outsourcing Facility Guidance

Posted 10 May 2018 | By Zachary Brennan 

FDA Finalizes Outsourcing Facility Guidance

The US Food and Drug Administration (FDA) on Thursday finalized guidance to help outsourcing facilities register with FDA.

FDA said it received 19 comments on the draft. “In response to received comments, FDA made certain changes,” the agency said. “In particular, FDA revised the guidance to provide for a compounder seeking to operate under section 503A of the FD&C Act (21 U.S.C. 353a) to be located next to an outsourcing facility provided that there is complete segregation between the outsourcing facility and the 503A compounder.”

The draft continued: “In determining whether a section 503A facility and an outsourcing facility are completely segregated, FDA intends to proceed case by case. Indicia of complete segregation include:

• The outsourcing facility and section 503A establishment do not share any rooms.

• The outsourcing facility and section 503A establishment do not share any fixed equipment or supplies for use in compounding.

• The outsourcing facility and section 503A establishment have separate entrance(s) and exit(s), do not share an internal pass-through opening, and are separated by permanent physical barriers. For example, it should not be necessary to go through the outsourcing facility to reach any part of the section 503A establishment.”

Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry

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