FDA awards grant for information-sharing system and research of interstate distribution of compounded drugs, as part of agency’s effort to help address risks with poor-quality compounded drugs

FDA awards grant for information-sharing system and research of interstate distribution of compounded drugs, as part of agency’s effort to help address risks with poor-quality compounded drugs

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. For details, refer to the FDA in Brief: FDA awards grant for information-sharing system and research of interstate distribution of compounded drugs, as part of agency’s effort to help address risks with poor-quality compounded drugs

For more information, please visit FDA's Human Drug Compounding web site.