Monday, January 29, 2018

Question of the Day January 29, 2018 How does the FDA make sure "it obtains the necessary data to identify large-scale, multi-state distributors, to help focus our inspection and enforcement resources on the subset of pharmacy compounders that engage in compounding activities that merit FDA oversight if owners of these types of compounding pharmacies serve on the state board of pharmacies? What should the FDA do then?

"With respect to section 503A pharmacies, we are working with the states to obtain the necessary data to identify large-scale, multi-state distributors, to help focus our inspection and enforcement resources on the subset of pharmacy compounders that engage in compounding activities that merit FDA oversight."  quote from The Honorable Scott Gottlieb, M.D., Commissioner, Food and Drug Administration, Witness Statement, found here 
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