; or (4) a generic drug that is manufactured domestically, as described in subsection (b), is in shortage, as defined in section 506C(h)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356c(h)(2) ). (b) Generic drug manufactured domestically described In this section, a generic drug that is manufactured domestically— (1) is a drug— (A) that is approved under section 505(j) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j) ); and (B) for which there is at least one establishment registered under section 510(b)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(b)(1) ) engaged in the manufacture of the finished dosage form of the drug; and (2) excludes any authorized generic drug, as defined in section 505(t)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(t)(3) ). (c) Special rule concerning generic drugs in shortage A notification under subsection (a)(4) that a generic drug that is manufactured domestically, as described in subsection (b), is in shortage, shall apply only for— (1) an initial period of not more than 90 days; and (2) such additional 30-day renewal periods as the Secretary of Health and Human Services may indicate by— (A) submitting to Congress a notification of intent to renew the notification under subsection (a)(4)