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Theres been no groundswell from our members about challenging these items, perhaps because they dont meet the criteria under 503A. Under Section 503A of the Food, Drug & Cosmetic Act, an eligible bulk drug substance for compounding must be a component of an FDA-approved drug, must have a USP or NF monograph, or must appear on FDAs 503A Bulks List or Interim Bulks List Category 1

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You may also report adverse reactions directly via the reporting system of the member states of the Eurasian Economic Union

Guru Reddy, Unicycive is committed to addressing unmet needs in kidney disease treatment