In separate notices in the October 27, 2015, Federal Register, FDA announced it has established public dockets for the purpose of developing lists of bulk drug substances (active ingredients) that can be used to compound drug products in accordance with Section 503A or Section 503B of the FDCA, as applicable. The Agency previously solicited nominations for the list, but some nominated substances were not supported by sufficient information for FDA to evaluate them. For purposes of gathering additional information, FDA has opened Docket No. FDA-2015-N-3534 for "Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket" and Docket No. FDA-2015-N-3469 for "Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503B of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket."
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