FDA Announces Latest Step Toward Finalizing Memorandum of Understanding with States Addressing Compounded Drug Distribution, While Preserving Access

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FDA Announces Latest Step Toward Finalizing Memorandum of Understanding with States Addressing Compounded Drug Distribution, While Preserving Access

Compounded drugs can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug product, but they can also pose unique risks. They are not approved by the FDA and, therefore, have not been evaluated for safety, effectiveness, or quality prior to marketing. The FDA’s compounding program is a priority for the agency and aims to develop policies that ensure appropriate access to lawfully-marketed compounded drugs for patients who have a medical need for them, while also protecting public health. Over the past several years, one of the most crucial aspects of our work in this area has been to identify opportunities to partner with the states to address these important public health goals. Today, a standard memorandum of understanding (MOU) between the FDA and the states has been made available for public viewing as part of the regulatory process, marking a significant milestone in the agency’s regulation of human drug compounding and reflecting years of collaborative dialogue and stakeholder input. The FDA has developed the MOU in close consultation with the National Association of Boards of Pharmacy (NABP), as described in the Federal Food, Drug, and Cosmetic Act (FD&C Act). Read more

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