October 2, 2019
“As part of our compounding oversight efforts, we’re working collaboratively with states and other stakeholders to protect patients from the potential risks associated with compounded drugs, while ensuring appropriate access to needed medicines. We recently awarded a grant to the National Association of Boards of Pharmacy to help improve the information available to federal and state regulators about the interstate distribution of compounded drugs.” said Donald D. Ashley, director of compliance for the FDA's Center for Drug Evaluation and Research. “This partnership with NABP will further our combined efforts to protect the public health by helping regulators address risks, including those related to large-scale compounding pharmacies that distribute poor quality compounded drugs in multiple states. This system is also intended to facilitate information sharing between states and the FDA under memorandum of understanding agreements addressing interstate distribution of compounded drugs, once implemented. We’ll continue to work closely with the NABP, states and other stakeholders on this and additional efforts to improve the quality of compounded drugs for patients who need them.”
Today, the U.S. Food and Drug Administration is announcing that it has awarded a cooperative agreement grant to the National Association of Boards of Pharmacy (NABP) to establish an information-sharing system for drug compounding activities that are primarily overseen by states. The roughly three-year pilot project undertaken through this grant will work to improve the information available to state regulators and the FDA about state-licensed entities, primarily pharmacies, that engage in drug compounding and distribute compounded drugs interstate. The overall goal is to help provide more targeted regulation and oversight of compounded drugs, while ultimately reducing risk to patients.
The agency’s goal for the system developed through this grant is to help enable states to enter into memorandum of understanding (MOU) agreements, once finalized, with the FDA that will reduce the potential resource burden associated with collecting and sharing information on interstate distribution. The FDA plans to finalize the MOU later this year. At the conclusion of the grant, a final pilot project assessment report will be provided to the agency, including recommendations for future collaboration.
The FDA announced the grant opportunity in June 2019.
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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.