The practice of compounding medicines can provide important public health opportunities. The FDA’s compounding program – including implementation of the compounding provisions of the law – is a priority for the agency. We recognize that in delivering on implementation commitments, we must balance the need to preserve access to appropriately compounded drugs for patients who have a medical need for these products with the need to help protect patients from poor quality compounded drugs that could cause harm. We’ve taken steps over the last year to advance this goal and we’ve shared the priority areas that we’re focusing on in the 2018 Compounding Policy Priorities Plan.
The FDA will make even more progress on the implementation of this plan over the next few months. And we’ll soon share new policies relating to insanitary conditions at compounding facilities and a risk-based approach to current good manufacturing practice (CGMP) requirements for outsourcing facilities.
Full statement at: www.fda.gov