FDA Issues Draft Guidances on Compounding and Repackaging Radiopharmaceuticals

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On December 28th, the FDA issued two draft guidances that describe FDA’s proposed policies regarding the compounding and repackaging of radiopharmaceuticals for human use by state-licensed nuclear pharmacies or federal facilities, and outsourcing facilities. According to FDA, "the policies proposed in the draft guidances attempt to strike an important balance between patient access to radiopharmaceuticals compounded or repackaged by state-licensed nuclear pharmacies, federal facilities, and outsourcing facilities, and the risks that such unapproved drugs present to patients."

To read more please visit http://www.snmmi.org/NewsPublications/NewsDetail.aspx?ItemNumber=21957

Source: Society of Nuclear Medicine and Molecular Imaging