Agency targeting safety risks in bulk drug substances
The U.S. Food and Drug Administration recently announced several actions to protect public health related to the compounding of human drug products as part of their ongoing effort to implement the Drug Quality and Security Act and advance the goals of its 2018 Compounding Policy Priorities Plan.
“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 compounding that is well informed by input from the clinical community. Our aim is to be responsive to the medical needs of patients who require compounded medicines, while making sure that these products are compounded under appropriate standards.”
The FDA is issuing an alert warning about a bulk drug substance (active pharmaceutical ingredient) used in compounding that carries significant safety risks for patients. The agency is also taking steps regarding its approach to bulk drug substances that are used to make compounded drugs.