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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 FDAs 503A Bulks List or Interim Bulks List Category 1

Sohn YJ, Kim HT, Baritugo KA, Jo SY, Song HM, Park SY, Park SK, Pyo J, Cha HG, Kim H, Na JG, Park C, Choi JI, Joo JC, Park SJ (2020) Recent advances in sustainable plastic upcycling and biopolymers