Outsourcing Facilities | Annual Study
Review key findings and industry insights
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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.
Outsourcing Facilities Feedback
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)
Annual Report Summaries
Executive Summary | 2021 - 2022 (PDF - 300 KB):
- The market for drugs produced by outsourcing facility is 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 (PDF - 338 KB) key takeaways:
- 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 (PDF - 257 KB) key takeaways:
- 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.
Contact Us
Email questions or suggestions to CompoundingQualityCoE@fda.hhs.gov