Title 21 CFR reference

(a) The following bulk drug substances can be used in compounding under section 503A(b)(1)(A)(i)(III) of the Federal Food, Drug, and Cosmetic Act. (1) Brilliant Blue G, also known as Coomassie Brilliant Blue G-250. (2) Cantharidin (for topical use only). (3) Diphenylcyclopropenone (for topical use only). (4) N-acetyl-D-glucosamine (for topical use only). (5) Squaric acid dibutyl ester (for topical use only). (6) Thymol iodide (for topical use only). (b) After balancing the criteria set forth in paragraph (c) of this section, FDA has determined that the following bulk drug substances will not be included on the list of substances that can be used in compounding set forth in paragraph (a) of this section: (1) Oxitriptan. (2) Piracetam. (3) Silver Protein Mild. (4) Tranilast. (c) FDA will use the following criteria in evaluating substances considered for inclusion on the list set forth in paragraph (a) of this section: (1) The physical and chemical characterization of the substance; (2) Any safety issues raised by the use of the substance in compounded drug products; (3) The available evidence of the effectiveness or lack of effectiveness of a drug product compounded…

The following drug products were withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective. The following drug products may not be compounded under the exemptions provided by section 503A(a) or section 503B(a) of the Federal Food, Drug, and Cosmetic Act: [81 FR 69676, Oct. 7, 2016, as amended at 83 FR 63573, Dec. 11, 2018]