Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to encourage compounding of better quality drugs under DQSA and help health care professionals access compounded medications needed for patient care from outsourcing facilities

FDA Statement

• For Immediate Release: September 26, 2017

As a physician, I understand how important it is for health care providers to have access to compounded drugs when the needs of their patients cannot be met by FDA-approved drugs. Our commitment to implementing and enforcing the Drug Quality and Security Act (DQSA) provides a pivotal foundation for achieving these goals. FDA oversight of compounding continues to remain essential, because compounded drugs, while important to patients who need them, pose ongoing and serious risks if they are not manufactured properly. Every year, the FDA learns of cases of patient illnesses and deaths due to improperly compounded drugs and caused by issues like contamination in drugs that need to be sterile because they are entering the bloodstream, the eye, or the spine or because the drugs are not made at the right strength and are super-potent.

Supporting access to compounded drugs made under high production standards involves helping new outsourcing facilities as they strive to develop expertise in compounding medicines under current good manufacturing practice standards. Outsourcing facilities can produce and distribute larger amounts of compounded products to meet the needs of individual patients for whom such drugs are appropriate, including by sending office stock used by hospitals and clinics. They are also required to be registered with the FDA and fully comply with the provisions put in place by Congress to protect patients. We are committed to realizing DQSA’s framework for facilities that register as outsourcing facilities, and are working on a number of efforts specific to this growing sector as it works to meet these regulatory standards and fulfill its intended role in the continuum of care for patients.

Today, for the first time, the FDA is posting a new report that provides a list of the drugs that entities registered as outsourcing facilities have produced. Under the DQSA, outsourcing facilities are required to report to the FDA, upon initial registration and each June and December, the drug products that they compounded during the previous six months. We are making the list public, among other reasons, to help the medical community in their efforts to identify and access specific compounded drug products from facilities that are required to follow current good manufacturing practice standards. The first report list compounded drug products that outsourcing facilities reportedly produced between December 2016 and May 2017.

This is just one part of our ongoing efforts to implement the DQSA in a manner that facilitates access to needed compounded medicines, while protecting the public from poorly compounded drugs.

Today, we are also sharing a guide, "Outsourcing Facility Information," a compilation of key regulatory information applicable to the outsourcing facilities. It includes information about the implications of becoming an outsourcing facility, the agency resources available to outsourcing facilities, registration and product listing, and FDA inspections and subsequent actions. The guide will assist compounders in deciding whether to register with the FDA as outsourcing facilities and provide existing outsourcing facilities with a helpful resource on applicable provisions of federal law and FDA policies and procedures. This guide is one step in our efforts to help more pharmacies become outsourcing facilities. We are committed to making this process as efficient as possible.

Toward these goals, we’ll be taking additional steps in the coming months to help more compounders register as outsourcing facilities -- by continuing to streamline the process and appropriately calibrate the regulatory burden of operating as an outsourcing facility. The guide that the FDA is posting today is one part of a larger effort to make the process for becoming an outsourcing facility more transparent and efficient. Appropriately compounded drugs can provide important alternatives for patients who need them. Our ultimate goal is to make it more feasible for compounding pharmacies to register as outsourcing facilities, enabling them to grow their businesses under a legally approved framework, and increase access to better quality compounded drugs in the process.

Today, we also met with our state partners as part of our sixth intergovernmental meeting on drug compounding. Effective, seamless coordination between states and the FDA is critical to conducting strong oversight of compounding in this country to ensure that patients receive high-quality compounded drug products. We greatly value our collaborative work with our state partners under our shared commitment to public health.

We take seriously our responsibility to implement the DQSA consistent with the spirit in which it was enacted — to provide access to compounded drugs for patients who need them and to protect the public health. We’ve come a long way over the past four years, but there is more work to be done by the agency and the compounding industry as a whole. We’ll have more to share in the coming months about how we plan to advance our implementation of the DQSA moving forward.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.