FDA statement on court ruling related to compounded bulk drug substances and the agency’s ongoing efforts to implement its compounding authorities

For Immediate Release:

August 06, 2019

Statement From:

Acting Commissioner of Food and Drugs - Food and Drug Administration

Norman E. "Ned" Sharpless MD

Director - Center for Drug Evaluation and Research

Janet Woodcock M.D.

Late last week, a U.S. District Court judge in Washington, D.C. issued a decision that upheld FDA’s interpretation of clinical need regarding the bulk substances that may be used by outsourcing facilities in drug compounding. We are pleased with the court’s decision, which is a victory for public health in the first such case since the Drug Quality and Security Act (DQSA) was enacted.

FDA had previously announced that vasopressin is not a “bulk drug substance for which there is a clinical need” because there is already a product on the market that is FDA-approved to meet patients’ medical needs. The agency, therefore, decided not to place the bulk drug substance vasopressin on a list of bulk drug substances that can be used in compounding by outsourcing facilities (the “503B Bulks List”). Last week, the court agreed, finding that the agency’s method of determining whether there is a “clinical need” for a bulk drug substance is consistent with the law. We will continue to evaluate bulk drug substances nominated for use in compounding by outsourcing facilities in accordance with our interpretation of clinical need.

Our compounding work remains a top priority at the agency. We’ve long recognized that compounded drugs can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug product. But compounded drugs are not approved by the FDA and, therefore, have not been evaluated for safety, efficacy or quality. We’ve seen first-hand the harm they can cause patients when they’re not appropriately compounded.

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.

Since the enactment of the DQSA, we’ve taken significant new steps to modernize and clarify our policies related to the quality of compounding in an effort to ensure continued access to compounded drugs for patients who need them, while also protecting patients from the risks of contaminated or otherwise harmful products. For example, we’re facilitating research efforts on bulk drug substances with the National Academy of Science, Engineering, and Medicine (NASEM) and through the FDA's Centers of Excellence in Regulatory Science and Innovation with the University of Maryland and Johns Hopkins University. These efforts will help us further advance the development of the bulks list. We’ve also held meetings discussing current good manufacturing practice for outsourcing facilities. Later this year, we plan to finalize our Memorandum of Understanding between FDA and the states to ensure coordinated safety actions and maximize our joint resources.

We also continue to take action when we observe significant violations of law. While some compounders work hard to meet quality standards including avoiding insanitary conditions, we recognize that there are still compounders that are not in compliance. To address these risks, a key component of our work continues to include our risk-based inspections and pursuing other enforcement efforts to identify compounders who produce drugs under substandard conditions or use inappropriate practices that could lead to serious harm. Since 2018, the FDA has sent warning letters to 40 facilities for adulterated product violations. These include insanitary conditions. We also worked with compounders on over 90 recalls of products from the marketplace that raised safety concerns. Since 2018, FDA has entered into six consent decrees of permanent injunction to address the risk of patient harm from exposure to unsafe compounded drugs.

We look forward to continuing to advance a robust compounding policy framework as part of our commitment to fulfilling our vital consumer protection role.

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.

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