; (II) marketed as category I in accordance with a tentative final monograph issued under part 330 of title 21, Code of Federal Regulations (including conditions of use and any applicable subsequent determinations under such part), as in effect on the day before the date of enactment of this section; or (III) marketed in accordance with a final order issued under this section. (iii) Sufficient information for a threshold demonstration of nonprescription marketing and use Information specified in this subparagraph, with respect to a request described in clause (i)(I), is— (I) information sufficient for a threshold demonstration that the drug subject to such request has a verifiable history of being marketed and safely used by consumers in the United States as a nonprescription drug under comparable conditions of use; (II) if the drug has not been previously marketed in the United States as a nonprescription drug, information sufficient for a threshold demonstration that the drug was marketed and safely used in a foreign country under conditions of marketing and use— (aa) for such period of time as needed to provide reasonable assurances concerning the safe nonprescription use of the drug; and (bb) during such period of time, was subject to sufficient monitoring by a regulatory body of any country listed in section 802(b)(1)(A) or any country designated by the Secretary in accordance with section 802(b)(1)(B)