FDA seeks to engage in research to analyze and better understand perspectives on challenges and opportunities faced by outsourcing facilities as they attempt to supply safe, high-quality drug products needed by patients. The Agency currently lacks this information and cannot obtain it from other sources. An electronic survey will be administered to approximately 80 outsourcing facilities to gather information regarding the challenges an opportunities these entities face. The results of this research will be used by FDA to develop a comprehensive understanding of the outsourcing facility sector, its challenges, and opportunities for advancement. The information will be essential to help identify knowledge and information gaps, operational barriers, and views on interactions with FDA. The research results will inform FDA's future approaches to communication, education, training, and other engagement with outsourcing facilities to address challenges and support advancement of the industry in its ability to produce high-quality drug products that are safe for patients.
The latest form for Obtaining Information to Understand and Challenges and Opportunities Encountered by Compounding Outsourcing Facilities expires 2021-01-31 and can be found here.
Supporting Statement B
Supporting Statement A
|Extension without change of a currently approved collection||2020-12-18|
Approved without change
|New collection (Request for a new OMB Control Number)||2020-01-15|