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Compounded drug products must satisfy the conditions of section 503A or section 503B of the FD&C Act to qualify for certain statutory exemptions listed under each section. Both sections 503A and 503B contain conditions that concern whether a compounded drug product is one that the Agency has identified as presenting demonstrable difficulties for compounding. FDA is proposing to establish the criteria by which it will evaluate drug products and categories of drug products for inclusion on the list of drug products and categories of drug products that present demonstrable difficulties for compounding under section 503A and/or under section 503B. Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists.