; (BB) in conformity with the conditions for nonprescription use of such monograph and the general requirements specified for nonprescription drugs, including any modifications to those conditions made under subsections (c), (d), and (j); and (CC) except as permitted by an administrative order issued under subsection (c) or a minor change in the drug in conformity with subsection (d), is in a dosage form that has been used to a material extent and for a material time within the meaning of section 201(p)(2); or (bb) (AA) the subject of a tentative final monograph that is the most recently applicable proposal or determination issued under part 330 of title 21, Code of Federal Regulations, as of the date of enactment of the Over-the-Counter Drug Safety, Innovation, and Reform Act ; (BB) classified in category I for safety and effectiveness under such tentative final monograph; (CC) in conformity with the conditions for nonprescription use of such tentative final monograph, any subsequent determination by the Secretary, and the general conditions for nonprescription drugs, including any modifications of those conditions under subsections (c), (d), and (j); and (DD) except as permitted by an administrative order issued under subsection (c) or a minor change in the drug in conformity with subsection (d), is in a dosage form that has been used to a material extent and for a material time within the meaning of section 201(p)(2); or (II) the active ingredient in such drug is in conformity with— (aa) the requirements of a final administrative order issued under subsection (c) determining that such drug under the specific conditions of use is generally recognized as safe and effective within the meaning of section 201(p)(1); and (bb) the general requirements for nonprescription drugs, including any modifications of the requirements under subsections (c), (d), and (j); and (ii) such drug is— (I) not classified in Category II for safety or effectiveness under a tentative final monograph