; and (ii) such drug is— (I) not classified in Category II for safety or effectiveness under a tentative final monograph; or (II) determined by the Secretary to be not safe and effective, in a final monograph or preamble to a rule that is the most recently applicable proposal or determination issued under part 330 of title 21, Code of Federal Regulations. (B) A nonprescription drug may be introduced into interstate commerce if such drug is— (i) (I) not classified in Category II for safety or effectiveness under a tentative final monograph; or (II) determined by the Secretary to be not safe and effective, in a final monograph or preamble to a rule that is the most recently applicable proposal or determination issued under part 330 of title 21, Code of Federal Regulations; and (ii) (I) (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; (bb) classified in category III for safety or effectiveness in the preamble of a proposed rule establishing such tentative final monograph; (cc) in conformity with the most recently proposed or final rule establishing or proposing conditions of nonprescription use published in the Federal Register related to such tentative final monograph and the general requirements for nonprescription drugs, including any modifications of those requirements under subsections (c) and (j); and (dd) 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) (aa) the subject of a proposed monograph or advance notice of proposed rulemaking that is the most recently applicable proposal or determination issued under part 330 of title 21, Code of Federal Regulations; (bb) classified in category I for safety and effectiveness under such proposed monograph or advance notice of proposed rulemaking