; and (B) is not described in paragraph (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 an administrative order determining whether there are conditions under which a specific drug, a class of drugs, or a combination of drugs, is determined to be— (i) not subject to section 503(b)(1); and (ii) generally recognized as safe and effective under 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 under subsections (c) and (k). (C) Standard The Secretary shall find that a drug is not generally recognized as safe and effective under section 201(p)(1) if— (i) the evidence shows that the drug is not generally recognized as safe and effective under section 201(p)(1); or (ii) the evidence is inadequate to show that the drug is generally recognized as safe and effective under 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, the sponsors of drugs who have a listing in effect under section 510(j) for the drugs or combination of drugs that will be subject to the administrative order