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.
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.
In achieving these goals, the states can play a vital role in reducing the risks associated with compounded drugs, while ensuring appropriate access. 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.
Toward these goals, the revised draft MOU addresses patient access concerns previously raised by stakeholders, while retaining critical safety provisions. Today’s action is also an important step to increase our collaboration with the states to maximize resources and our collective public health impact, and it marks a significant milestone in the agency’s implementation of federal law on compounding.
Compounded drugs can pose unique risks. They’re not FDA approved. Nor do compounded drugs undergo premarket review for safety, effectiveness or quality. Moreover, if a compounder distributes drugs to multiple states, it can be very difficult to gather information about possible adverse events associated with those drugs, connect them to the compounder and undertake coordinated action to address a potentially serious public health problem. These risks were illustrated by the 2012 nationwide fungal meningitis outbreak. This tragic outbreak led to more than 750 cases of illness and the deaths of 64 individuals. They had used a compounded drug for injection that was supposed to be sterile but had become contaminated before distribution to patients and providers.
Following that public health tragedy, the FDA issued a draft MOU to implement a key public health protection in section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Section 503A directs the FDA to develop an MOU for use by the states to address certain interstate distributions of compounded drugs by traditional compounders. These traditional compounders are, among others, pharmacies that operate under section 503A. The MOU also covers states’ investigations of complaints associated with compounded drugs distributed out of their state.
The MOU addresses traditional compounders that distribute a certain percentage, known as inordinate amounts, of their compounded drugs interstate. Under the 2015 draft MOU, the states were expected to take action against a traditional compounder that distributed inordinate amounts of its compounded drugs interstate. At the time, inordinate amounts was defined as an amount of compounded drug product distributed interstate by a compounder in a given month that is equal or greater to 30 percent of all drug products dispensed or distributed by the compounder.
Instead, under the revised draft MOU being issued , states would agree to identify compounders that distribute more than 50 percent of their total prescription orders for compounded drugs interstate and report certain information to the FDA about those compounders. This includes information about the volume of compounded drugs distributed interstate and the number of states in which the compounder is licensed. And the revised MOU also removes a previous draft provision requiring the state to take action when a compounder distributes inordinate amounts of compounded drugs interstate. Under the new approach, the state could consider whether to take action according to a more flexible, risk-based approach. The FDA intends to use this information to prioritize its inspections of compounders based on risk.
