Info Collection on Outsourcing Facility Challenges

Federal Register notice: FDA is seeking comments on an information collection extension for “Obtaining Information to Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities” (OMB Control Number0910-0883). FDA intends to conduct research to understand better the challenges and opportunities encountered by the outsourcing facility sector in a number of different areas. These include: operational barriers and opportunities related to the outsourcing facility market and business viability; knowledge and operational barriers and opportunities related to compliance with federal policies and good quality drug production; and barriers and opportunities related to outsourcing facility interactions with FDA. The results of the research will be used by FDA to develop a comprehensive understanding of the outsourcing facility sector, its challenges, and opportunities for advancement. To view the notice, click here.