By way of background, the Drug Quality and Security Act of 2013 amended the Food, Drug, and Cosmetic Act (FDCA) to create a new class of drug compounders known as “outsourcing facilities.” Under Section 503B of the FDCA, outsourcing facilities are exempt from FDA’s new drug approval process, yet are held to federal current good manufacturing practices (cGMP). Outsourcing facilities deliver compounded medication for hospitals, clinics, and other providers.
FDA recognizes the vital role that outsourcing facilities serve for patients in need of medications that are not otherwise available on the commercial drug market. Nevertheless, according to the agency, five years since its inception the industry is experiencing “growth and market challenges,” a purported state of affairs that FDA does not further describe in its announcement.
In order to address these “challenges” and “support compliance and advancement” within the outsourcing facility industry, FDA intends to undertake several initiatives. The first step, according to the agency, is to embark on a research program to collect a broad range of information from and about the industry. 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; and
- Outsourcing facility interactions with the agency.
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 FDA, the research will inform the FDA’s future approaches to communication, education, training, and engagement with the outsourcing industry more broadly.
To conduct this research, FDA will engage with outsourcing facility pharmacists, staff, and management through the use of surveys, interviews, and focus groups, though FDA has not yet announced specifics regarding the logistics of this operation. In order to prepare participants, FDA has provided a list of questions that may be examined:
- What financial and operational considerations inform outsourcing facility operational and business model decisions?
- What factors impact the development of a sustainable outsourcing facility business?
- What financial and operational considerations inform outsourcing facility product decisions?
- Do outsourcing facilities understand the federal legislative and regulatory policies that apply to them? What, if any, knowledge gaps need to be addressed?
- What challenges do outsourcing facilities face when implementing federal 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 non-compliance/product failures for outsourcing facilities?
- What are outsourcing facility management and staff views on current interactions with FDA? How do they want the interactions to change?
- What are outsourcing facilities’ understanding of how to engage with FDA during and following an inspection?
To our knowledge, FDA has yet to reach out to industry stakeholders to conduct this research, nor has it indicated when such research will commence. Furthermore, while FDA has stated the reasoning behind this project, its ultimate goals for using this information with respect to the outsourcing facility industry remain unclear.
Client Alert 2020-433
