FDA Guidance Clarifies Definition of 'Facility' for Drug Compounding
The U.S. Food and Drug Administration (FDA) has issued new guidance to clarify definitions with regards to drug compounding facilities. The FDA is issuing this guidance to provide the agency’s current thinking on these issues, and related issues regarding how to ensure that the compounding of drugs in an outsourcing facility occurs only in accordance with section 503B.
According to the FDA, Section 503B defines an outsourcing facility, in part, as “a facility at one geographic location or address.” The FDA has received questions from outsourcing facilities and other stakeholders about the meaning of this term, such as:
- Whether multiple suites used for compounding human drugs at a single street address constitute one or multiple facilities
- Whether a single location where human drugs are compounded can be subdivided into separate operations compounding under different standards.
The FDA interprets “facility,” as used in Section 503B, to mean a business or other entity under one management, direct or indirect, engaged in the compounding of human drug products. The Agency considers all activities, equipment, and materials related to human drug compounding that are under the supervision of the facility’s management at the geographic location or address to be part of the facility, unless they are completely segregated from the facility by clearly identified boundaries. For purposes of this interpretation, such boundaries may include permanent physical barriers, such as walls, or doors that are locked to effectively exclude other human drug compounding.
Under this interpretation, a “facility” may be comprised of one or multiple suites within a single building, or one or multiple buildings “at one geographic location or address.” Further, a geographic location could include two or more addresses, provided that FDA is capable of inspecting the addresses within a single inspection
Follow the link below to review the FDA’s guidance in its entirety.
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