; (bb) classified in category I for safety and effectiveness under such proposed monograph or advance notice of proposed rulemaking; (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 proposed monograph or advance notice of proposed rulemaking 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). (C) A nonprescription drug may be introduced into interstate commerce if— (i) such drug is classified in category II for safety or effectiveness under a tentative final monograph, or the Secretary has determined such drug not to be 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