On January 4, 2022, the Food and Drug Administration (FDA or the agency) published a notice in the Federal Register titled “Obtaining Information To Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities,” announcing that it is moving forward to collect information on outsourcing facility operations from industry stakeholders.
As we discussed in a previous client alert, the FDA is undertaking a research initiative to understand, in its own words, “challenges” and to “support compliance and advancement” within the outsourcing facility industry. The first step in this research initiative, according to the FDA, is to collect a broad range of information from and about the industry. The FDA is primarily focused on investigating operational barriers and opportunities related to:
- Outsourcing facility market and business viability
- Compliance with federal policies and good quality drug production
- Outsourcing facility interactions with the agency
The FDA intends to use this research to help identify information gaps and operational barriers that may exist and to gauge industry views on interactions with the agency. According to the FDA, the research will inform the FDA’s future approaches to communication, education, training, and engagement with the outsourcing industry more broadly. The FDA has finalized the following questions, which it had proposed in its earlier notice. These questions will be used when seeking information from industry stakeholders:
- What financial and operational considerations inform outsourcing facility operational and business model decisions?
- What factors impact developing a sustainable outsourcing facility business?
- What financial and operational considerations inform outsourcing facility product decisions?
- Do outsourcing facilities understand the federal laws and policies that apply to them? What, if any, knowledge gaps do we need to address?
- What are outsourcing facilities’ challenges when implementing federal current good manufacturing practice (cGMP) requirements?
- How do outsourcing facilities implement quality practices at their facilities?
- How do outsourcing facilities develop cGMP and quality expertise? How do they obtain this knowledge, and what training do they need?
- What are the economic consequences of cGMP noncompliance and product failures for outsourcing facilities?
- What are outsourcing facility management and staff views on current interactions with the FDA? How do they want the interactions to change?
- What are outsourcing facilities’ understanding of how to engage with the FDA during and following an inspection?
The FDA will now be reaching out to engage with outsourcing facility pharmacists, staff, and management through the use of surveys, interviews, and focus groups to collect information for its research initiative, though the FDA has not provided specifics regarding the logistics of this operation. While the FDA has stated the reasoning behind this initiative, its ultimate goals for using this information with respect to the outsourcing facility industry remain unclear.
Client Alert 2022-010