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FDA Corrects Notice on Outsourcing Facility Bulk Drug List


Federal Register Notice: FDA is correcting a notice entitled “List of Bulk Drug Substances That May Be Used by an Outsourcing Facility to Compound Drugs for Use in Animals; Request for Nominations,” that appeared in the 5/19 Federal Register. The document announced the intention to develop a list of bulk drug substances that may be used by outsourcing facilities registered under the FD&C Act to compound animal drugs, in accordance with FDA’s draft guidance for industry #230, “Compounding Animal Drugs from Bulk Drug Substances.” 1. On page 28622, in the second column, in the ADDRESSES section of the document, under Instructions, “Docket No. FDA-2013-N-1524” is corrected to read “Docket No. FDA-2015-N-1196”. To view this notice, click here.