Withdrawal of approval of the drug mifepristone for termination of pregnancy

Effective upon the expiration of 14 days after the date of the enactment of this Act: (1) Approval of an application submitted under subsection (b) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) for the drug mifepristone (marketed as Mifeprex, and also known as RU–486) with an indication for the termination of intrauterine pregnancy, and of any application submitted under subsection (j) of such section for a drug with the same indication and for which mifepristone is the reference drug, is deemed to have been withdrawn under subsection (e) of such section. (2) For purposes of sections 301(d) and 304 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(d); 334), the introduction or delivery for introduction of a drug, the approval of which has been withdrawn as described in paragraph (1), into interstate commerce shall be considered a violation of section 505 of such Act (21 U.S.C. 355). (3) The drug mifepristone shall be considered misbranded for purposes of sections 301 and 304 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331; 334) if the drug bears labeling providing that the drug may be used for the termination of intrauterine pregnancy or that the drug may be used in conjunction with another drug for the termination of intrauterine pregnancy.