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 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. We recognize that there continues to be great interest in our work in this important policy area and we’re committed to providing updates as we take a continuing series of actions to implement the comprehensive plan that we outlined earlier this year.”
Today, 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 FDA is also taking steps regarding its approach to bulk drug substances that are used to make compounded drugs.
“Addressing bulk drug substances used in compounding is an important priority for the agency,” said Anna Abram, Deputy Commissioner for Policy, Planning, Legislation and Analysis. “The FDA seeks to implement the statutory requirements for bulk drug substances that can be used in compounding in a way that strikes a balance between preserving access to compounded drugs for patients who have a medical need for them while reducing the safety risks and protecting the FDA drug approval process. Input from stakeholders, including health care professionals, is critical to achieving this balance.”