FDA Revises Compounding Policy Priorities Plan

The FDA is taking new steps to better ensure the quality of compounded drugs, while also preserving patient access to these medications. In a prepared statement, FDA Commissioner Scott Gottlieb said the agency’s compounding program, which includes implementation and provisions of the law, is a priority.

In a revised draft memorandum of understanding (MOU), the FDA is making changes to its 2018 Compounding Policy Priorities Plan

. The MOU addresses investigations of complaints related to compounded drug products distributed outside the state, distribution of inordinate amounts of compounded drug products interstate, and submission and disclosure of information.

“The goal of the MOU is to collaborate with the states so that, working together, we can have the greatest public health impact while also maximizing our resources,” said Gottlieb, in a prepared statement. “Toward these goals, the revised draft MOU addresses patient access concerns previously raised by stakeholders, while retaining critical safety provisions.”

In addition, the FDA is working on new policies addressing insanitary conditions at compounding facilities and a risk-based approach to current good manufacturing practice (CGMP) requirements for outsourcing facilities.

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