Statement from FDA Commissioner Scott Gottlieb, M.D., on the importance of the Drug Quality and Security Act and overseeing the safety of compounded drugs.
In late 2012, the United States faced the most serious outbreak associated with contaminated compounded drugs in recent history, involving hundreds of people, in many states, who developed fungal infections related to a compounded product. It was an incident that resulted in dozens of deaths.
The fungal meningitis outbreak underscores the need for robust oversight over human drug compounding, the importance of dispensing prescription drugs pursuant to valid prescriptions and the need for strong coordination with state regulatory partners to protect public health.
Since that outbreak and the subsequent enactment of the Drug Quality and Security Act (DQSA) on Nov. 27, 2013, the FDA has devoted significant resources to oversee compounding and implement the compounding provisions of the law. As of June 1, 2017, the FDA has conducted more than 400 inspections, including 109 inspections of outsourcing facilities; issued more than 150 warning letters advising compounders of significant violations of federal law; issued more than 50 letters referring inspectional findings to state regulatory agencies; overseen over 125 recalls involving compounded drugs; and worked with the Department of Justice on a number of civil and criminal enforcement actions.
As part of the implementation of DQSA, we have also issued 21 draft guidances, ten final guidances, three proposed rules, a final rule, and a draft memorandum of understanding. We have taken a risk-based approach to all of these efforts, in order to make sure that we are maximizing the public health purpose of these new provisions relative to the resources we use to achieve them, and any obligations that these new requirements place on market participants. These foundational regulations and guidance documents provide predictability and transparency to compounders, providers, and other enterprises; and inform them of how to comply with the law’s provisions in the most efficient manner.
These efforts are part of our commitment to doing all we can to protect the public from poorly compounded drugs. We will continue to actively oversee drug compounders and, when appropriate, initiate regulatory action as it fulfills the FDA public health mission on behalf of patients.
The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, 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.