Outsourcing Facilities Annual Study

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The FDA Compounding Quality Center of Excellence conducts the Compounding Outsourcing Facilities Annual Study to better understand industry perspectives and challenges, as well as dynamics between suppliers and purchasers.

Each study includes:

• a survey of outsourcing facilities
• discussions with outsourcing facilities and their stakeholders
• an analysis of existing data

The study is conducted by a research partner under FDA’s direction. The research partner develops a report of the study results and findings and provides this information to the agency. Data gathered through surveys and discussions are anonymous to FDA.

Feedback From Outsourcing Facilities

The annual studies have collected information about areas such as:

• Outsourcing facility perceptions of engagement with the FDA
• How current FDA policies affect outsourcing facilities
• Outsourcing facility needs and challenges that can inform FDA’s future policy and programmatic work
• Topics identified by outsourcing facilities as needs for training or additional clarification
• Size, scope, and trends in the outsourcing facility sector
• Outsourcing facility perceptions of quality and implementation of quality practices
• Interactions between outsourcing facilities and various stakeholders (e.g., suppliers of active pharmaceutical ingredients [APIs] and purchasers of outsourcing facility products)

Summaries of the Annual Reports

• Executive summary, 2021–2022: The market for drugs produced by outsourcing facility is durable and evolving. The number of registered outsourcing facilities has remained relatively stable since 2019, and the industry shows wide variation in current good manufacturing practice (CGMP) requirements expertise, resources (i.e., human capital, financial) and ability to grow customer bases. Customer need is playing an increasing role in shaping the industry. Visit Areas of Customer Need for Outsourcing Facility Products for highlights of the research findings.
• Executive summary, 2020–2021: Outsourcing facilities show movement toward stabilization in the number of facilities in the sector, demand for compounded drugs from customers continues and outsourcing facilities continue to improve their understanding of current good manufacturing practice (CGMP) requirements. Financial and regulatory realities continue to shape the industry. Visit State of Outsourcing Facility Sector and Possibilities for the Future for highlights of the research findings.
• Executive summary, 2019–2020: Outsourcing facilities are adjusting and trying to understand how to balance regulation with profitable and sustainable business models. The facilities need consistent, constructive communication with FDA that is sensitive to their challenges.

Selected Research Findings and Subsequent FDA Actions

1. Clarifying FDA Quality Practices and Expectations for Outsourcing Facilities

   The research results of these studies indicate that registered outsourcing facilities enter the market with varying levels of experience and knowledge of quality practices and CGMP requirements. Newly established outsourcing facilities might not be familiar with the expectations associated with FDA regulations, such as inspections or other general requirements. In response, FDA:

   • Expanded new CGMP training opportunities identified by outsourcing facilities:
     • Process Validation
     • Aseptic Process Simulation
     • Supplier/Contractor Qualification and Management
     • Personnel Gowning in Sterile Drug Production
     • Quality Management Systems
   • Added sessions to the Compounding Quality Center of Excellence annual conference based on indicated areas of need:
     • FDA Inspections of Outsourcing Facilities (PDF – 308KB)
     • What to Expect on a 503B Inspection (PDF – 408KB)
     • Analytical Testing (PDF – 271KB)
     • 483s Responses and Reinspection (PDF – 445KB)
     • Elevating SOPs and Work Aids 3 (PDF – 4.93MB)
     • Stability BUDs (PDF – 386KB)
   • Hosted a webinar, FDA Inspections of Outsourcing Facilities, which included a Q&A session with the FDA.

2. Increasing Communication Between Outsourcing Facilities and FDA

   The research results of these studies indicate that outsourcing facilities prefer more two-way communication with the agency. Outsourcing facilities prefer additional avenues for communication rather than relying on FDA inspections, which the facilities view as their primary means of interacting with the agency. In response, FDA:

   • launched, in 2022, a cross-sector stakeholder group with representatives from the agency, outsourcing facilities and other stakeholders. This group promotes information sharing related to quality, production and use across the outsourcing facility sector.
   • is conducting small group listening sessions for groups of outsourcing facilities with similar operations.
   • obtains input from outsourcing facility representatives on potential topics for the annual Compounding Quality Center of Excellence annual conference.

Contact Us

Email questions or suggestions to CompoundingQualityCoE@fda.hhs.gov