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He mentioned, "There hasn't been a notable opposition from our members in challenging these items, possibly because they don't meet the criteria under 503A." According to 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 the FDA’s 503A Bulks List or Interim Bulks List Category 1
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