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[14] The twelve substances that entered this process were removed from Category 2 of the bulks list effective April 22, 2026 because their original nominators withdrew, and the FDA's published position on what that removal accomplished is explicit: "Removal from Category 2 does not render these bulk drug substances eligible for compounding under section 503A." [15] Approval, meanwhile, is a different statutory process entirely, at 21 U.S.C