; (ii) to remove a dead unborn child; or (iii) to treat an ectopic pregnancy. (B) The term adverse event includes each of the following: (i) A fatality. (ii) An ectopic pregnancy. (iii) A hospitalization. (iv) A blood loss requiring a transfusion. (v) An infection, including endometritis, pelvic inflammatory disease, and pelvic infections with sepsis. (vi) A severe infection. (C) The term gestation means the period of days beginning on the first day of the last menstrual period. (D) The term health care practitioner means any individual who is licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which the individual practices, to prescribe drugs subject to section 503(b)(1). (E) The term unborn child means an individual organism of the species homo sapiens , beginning at fertilization, until the point of being born alive as defined in section 8(b) of title 1, United States Code. . (b) Ongoing investigational use In the case of any investigational use of a drug pursuant to an investigational use exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(i) ) that was granted before the date of enactment of this Act, such exemption is deemed to be rescinded as of the day that is 3 years after the date of enactment of this Act if the Secretary would be prohibited by section 505(z)(1)(B) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), from granting such exemption as of such day.