Business · 02/07/2014

FDA Reopens Nominations for Bulk Drug Substances for Compounding Drug Products Under Section 503B of the FD&C Act

The FDA is reopening the nomination process for bulk drug substances that may be used to compound drug products in accordance with section 503B of the Federal Food, Drug, and Cosmetic Act, following a previous notice published in the Federal Register on December 4, 2013, and is seeking new nominations with adequate support to justify inclusion on the list.