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Food and Drug Administration) Separately, FDA documentation around the 503A bulks process shows AOD-9604s status has moved around as nominations were withdrawn and advisory committee discussions occurred

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Specifically, the panel will assess whether those substances should be moved off the Category 2 list a designation reserved for bulk drug substances that present potential safety risks and are therefore ineligible for routine compounding under Section 503A of the Federal Food, Drug, and Cosmetic Act