Monday, July 23, 2018

FDA continues taking key actions on bulk drug substances used for compounding to advance the regulatory framework governing compounded drugs and to protect patients





Agency responds to citizen petition, announces agreements with universities, updates bulks categories and schedules advisory committee meeting
As part of its ongoing implementation of the Drug Quality and Security Act and to advance the goals of its 2018 Compounding Policy Priorities Plan, the U.S. Food and Drug Administration is announcing several actions to protect public health related to the compounding of human drug products. 

“We continue to implement the compounding provisions of federal law and advance a modern framework for the development of compounded drugs,” said FDA Commissioner Scott Gottlieb, M.D. “Our actions underscore our focus on protecting patients while making sure we have an enduring framework for better compoun

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