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FDA Adds Six Bulk Drug Substances to Approved Compounding List

February 22, 2019

The FDA added six bulk substances to its list of substances approved for use by compounding facilities exempt from certain FDA oversight activities under section 503A of the Food, Drug and Cosmetic Act.

The six additions in a final rule released on Friday include Brilliant Blue, cantharidin, diphenylcyclopropenone, N-acetyl-D-glucosamine (NAG), squaric acid dibutyl ester and thymol iodide.

The final rule also identifies four other bulk drug substances the agency decided not to include on the list: oxitriptan, piracetam, silver protein mild and tranilast.

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