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136 STAT. 1839 PUBLIC LAW 117–169—AUG. 16, 2022 ‘‘(C) DRUGS NOT INCLUDED AS SMALL BIOTECH DRUGS.— A new formulation, such as an extended release formula- tion, of a qualifying single source drug shall not be consid- ered a qualifying single source drug described in subpara- graph (A). ‘‘(3) CLARIFICATIONS AND DETERMINATIONS.— ‘‘(A) PREVIOUSLY SELECTED DRUGS AND SMALL BIOTECH DRUGS EXCLUDED.—In applying subparagraphs (A) and (B) of paragraph (1), the Secretary shall not consider or count— ‘‘(i) drugs that are already selected drugs; and ‘‘(ii) for initial price applicability years 2026, 2027, and 2028, qualifying single source drugs described in paragraph (2)(A). ‘‘(B) USE OF DATA.—In determining whether a quali- fying single source drug satisfies any of the criteria described in paragraph (1) or (2), the Secretary shall use data that is aggregated across dosage forms and strengths of the drug, including new formulations of the drug, such as an extended release formulation, and not based on the specific formulation or package size or package type of the drug. ‘‘(e) QUALIFYING SINGLE SOURCE DRUG.— ‘‘(1) IN GENERAL.—For purposes of this part, the term ‘quali- fying single source drug’ means, with respect to an initial price applicability year, subject to paragraphs (2) and (3), a covered part D drug (as defined in section 1860D–2(e)) that is described in any of the following or a drug or biological product for which payment may be made under part B of title XVIII that is described in any of the following: ‘‘(A) DRUG PRODUCTS.—A drug— ‘‘(i) that is approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act and is marketed pursuant to such approval; ‘‘(ii) for which, as of the selected drug publication date with respect to such initial price applicability year, at least 7 years will have elapsed since the date of such approval; and ‘‘(iii) that is not the listed drug for any drug that is approved and marketed under section 505(j) of such Act. ‘‘(B) BIOLOGICAL PRODUCTS.—A biological product— ‘‘(i) that is licensed under section 351(a) of the Public Health Service Act and is marketed under sec- tion 351 of such Act; ‘‘(ii) for which, as of the selected drug publication date with respect to such initial price applicability year, at least 11 years will have elapsed since the date of such licensure; and ‘‘(iii) that is not the reference product for any biological product that is licensed and marketed under section 351(k) of such Act. ‘‘(2) TREATMENT OF AUTHORIZED GENERIC DRUGS.— ‘‘(A) IN GENERAL.—In the case of a qualifying single source drug described in subparagraph (A) or (B) of para- graph (1) that is the listed drug (as such term is used in section 505(j) of the Federal Food, Drug, and Cosmetic Act) or a product described in clause (ii) of subparagraph Time periods. Definition. VerDate Sep 11 2014 13:57 Oct 25, 2022 Jkt 029139 PO 00169 Frm 00023 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL169.117 PUBL169 jmbennett on LAP3P8D0R2PROD with Publaw