; and (B) is not described in paragraphs (1), (2), (3), (4), or (5), or subsection (b)(1)(B). (b) Administrative orders (1) In general (A) Determination The Secretary may, on the initiative of the Secretary or at the request of one or more requestors, issue administrative orders determining whether there are conditions under which specific drugs, classes of such drugs, or combinations of such drugs are determined to be— (i) not subject to section 503(b)(1); and (ii) generally recognized as safe and effective within the meaning of section 201(p)(1). (B) Effect A drug or combination of drugs shall be deemed to not require approval under section 505 if such drug or combination of drugs— (i) is determined by the Secretary to meet the conditions specified in clauses (i) and (ii) of subparagraph (A); (ii) is marketed in conformity with an administrative order under this subsection; (iii) meets the general requirements for nonprescription drugs; and (iv) meets the requirements specified in subsections (c) and (k). (C) Standard The Secretary shall find that a drug is not generally recognized as safe and effective within the meaning of section 201(p)(1) if— (i) the evidence shows that the drug is not generally recognized as safe and effective within the meaning of section 201(p)(1); or (ii) the evidence is inadequate to show that the drug is generally recognized as safe and effective within the meaning of section 201(p)(1). (2) Administrative orders initiated by the secretary (A) In general In issuing an administrative order under paragraph (1) upon the Secretary’s initiative, the Secretary shall— (i) make reasonable efforts to notify informally, not later than 2 business days before the issuance of the proposed order, sponsors of drugs that will be subject to the administrative order; (ii) after any such reasonable efforts of notification— (I) issue a proposed administrative order by publishing it on the website of the Food and Drug Administration and include in such order the reasons for the issuance of such order