FDA has issued a final version of its outsourcing facility guidance, issued in draft form in 2016. The final version responds to comments on the draft and questions the agency has been receiving on interpreting the definition in the 2013 Drug Quality and Security Act (DQSA) of an outsourcing facility as “a facility at one geographic location or address.” The new version addresses whether multiple suites used for compounding human drugs at a single street address constitute one or multiple facilities, or whether a single location where human drugs are compounded can be subdivided into separate operations compounding under different standards. The agency clarifies that a 503a compounder can be located next to an outsourcing facility provided that there is “complete segregation.” [To understand the context for Congress’ and FDA’s increased focus on pharmacy compounding and the development of the 503b outsourcing category begin with IPQ’s November 2012 “Special Report” on “The Crisis in Pharmacy Compounding and its Implications,” and search “pharmacy compounding” on our homepage for IPQ’s subsequent coverage.]
[/membership][membership level=”0,4″][The content continues for paid members only.]
Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership]
