What is a Facility?

Question : How does the USFDA define a facility?  If I register as a 503B outsourcing facility – can I also compound under 503A within the same facility?

This has been a common question to FDA from outsourcing facilities and other stakeholders.  To answer this question the FDA issued the Draft Guidance: Facility Definition Under Section 503B of the FD&C act.  Please note that as of September 14, 2016 this document was still in draft form and may be subject to change when approved and published in the Federal Register.

The short answer is no, but why is this and what is the rationale?

First, we have to review the definition of an outsourcing facility.  From Section 503B(d)(4) of the FD&C Act defines an outsourcing facility as a facility at one geographic location or address that

  • is engaged in the compounding of sterile drugs;
  • has elected to register as an outsourcing facility; and
  • complies with all of the requirements of this section. In addition, an outsourcing facility is not required to be a licensed pharmacy, and it may or may not obtain prescriptions for identified individual patients.

Second, Because drugs compounded by outsourcing facilities are not exempt from section 501(a)(2)(B) of the FD&C 50 Act, outsourcing facilities are subject to current good manufacturing practice (CGMP) requirements.

Third, if you register a facility as an outsourcing facility, you are indicating your intent for the facility’s compounded drugs to be regulated under section 503B of the FD&C Act. Under section 503B(a)(11), a compounded drug can only qualify for the exemptions from sections 502(f)(1), 505, and 582 of the FD&C Act if all of the facility’s compounded drugs are compounded in accordance with section 503B.

So ALL drugs compounded within a 503B outsourcing facility MUST follow cGMPs there are no exceptions.

But what does the FDA consider a facility? 

As stated in the draft guidance – Section 503B(d) defines an outsourcing facility, in part, as “a facility at one geographic location or address.” FDA interprets “facility at one geographic location or address” to mean a business or other entity under one management, direct or indirect, engaged in human drug compounding at a geographic location or street address. The agency considers all activities, equipment, appurtenances, and materials part of such a facility if they are related to human drug compounding under the supervision of the facility’s management at the same street address, or in the same building, or in buildings located in close proximity to one another. [bold and italics added for emphasis]

In Section III.A the agency provides the rationale that there is a concern of commingling of compounding activities – where some drugs may be compounded under 503A, others under 503B and the facility (or customers, of FDA) may not be able to distinguish which products were compounded under traditional pharmacy rules and which were compounded under cGMPs.  And because drug products compounded under section 503A must be compounded in accordance with a prescription while drug products made under section 503B may or may not be compounded in accordance with a prescription, if the drug products are made in neighboring suites in the same building,[bold and italics added] it may be impossible to determine whether a prescription was obtained for the a particular product before it was distributed. The agency’s interpretation also provides clarity during inspections with regard to which standards apply to the location that is being inspected.

Again, this information was pulled from a draft guidance which may change between now and final publication in the Federal Register.  But if you are contemplating 503B registration and are currently operating a 503A pharmacy it is critical that you understand the agency’s current thinking on what a facility is. This will allow you the proper planning and guidance to ensure the two facilities have adequate separation to minimize the perception of 503A/B commingling of compounding activities and to minimize FDA considering your 503A pharmacy subject to cGMPs.