Definitions relating to compounding of drug products

Section 503A(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353a(b)) is amended— (1) by amending paragraph (1)(D) to read as follows: (D) does not, more than 20 times in a single month, compound any drug product that is essentially a copy of a commercially available drug product.; and (2) by amending paragraph (2) to read as follows: (2) Definitions (A) For purposes of paragraph (1)(D), the term essentially a copy of a commercially available drug product means any drug product— (i) that contains any active ingredient found in a commercially available drug product; and (ii) in which there is no change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug product and the comparable commercially available drug product. (B) For purposes of subparagraph (A), the term commercially available drug product includes any drug product that— (i) is sold in the commercial marketplace in the United States and manufactured in one or more facilities required to comply with section 501(a)(2)(B); and (ii) is not included in the discontinued section of the list of products described in section 505(j)(7)(A)..

Section 503A(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353a(b)) is amended— (1) by amending paragraph (1)(D) to read as follows: (D) does not, more than 20 times in a single month, compound any drug product that is essentially a copy of a commercially available drug product.; and (2) by amending paragraph (2) to read as follows: (2) Definitions (A) For purposes of paragraph (1)(D), the term essentially a copy of a commercially available drug product means any drug product— (i) that contains any active ingredient found in a commercially available drug product; and (ii) in which there is no change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug product and the comparable commercially available drug product. (B) For purposes of subparagraph (A), the term commercially available drug product includes any drug product that— (i) is sold in the commercial marketplace in the United States and manufactured in one or more facilities required to comply with section 501(a)(2)(B); and (ii) is not included in the discontinued section of the list of products described in section 505(j)(7)(A)..