DATABASE FOR AUTHORIZED GENERIC DRUGS.

SEC. 920. DATABASE FOR AUTHORIZED GENERIC DRUGS. Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), as amended by section 918, is further amended by adding at the end the following:“(t) Database for Authorized Generic Drugs.—“(1) In general.—“(A) Publication.—The Commissioner shall—“(i) not later than 9 months after the date of the enactment of the Food and Drug Administration Amendments Act of 2007, publish a complete list on the Internet Web site of the Food and Drug Administration of all authorized generic drugs (including drug trade name, brand company manufacturer, and the date the authorized generic drug entered the market); and“(ii) update the list quarterly to include each authorized generic drug included in an annual report submitted to the Secretary by the sponsor of a listed drug during the preceding 3-month period.“(B) Notification.—The Commissioner shall notify relevant Federal agencies, including the Centers for Medicare & Medicaid Services and the Federal Trade Commission, when the Commissioner first publishes the information described in subparagraph (A) that the information has been published and that the information will be updated quarterly.“(2) Inclusion.—The Commissioner shall include in the list described in paragraph (1) each authorized generic drug included in an annual report submitted to the Secretary by the sponsor of a listed drug after January 1, 1999.“(3) Authorized generic drug.—In this section, the term ‘authorized generic drug’ means a listed drug (as that term is used in subsection (j)) that—121 STAT. 962“(A) has been approved under subsection (c); and“(B) is marketed, sold, or distributed directly or indirectly to retail class of trade under a different labeling, packaging (other than repackaging as the listed drug in blister packs, unit doses, or similar packaging for use in institutions), product code, labeler code, trade name, or trade mark than the listed drug.”.