; and (II) during such period of time, 1,000,000 retail packages of the drug, or an equivalent quantity of the active ingredient or ingredients of such drug as determined by the Secretary, were distributed for retail sale, as determined in such manner as the Secretary may require. (v) Rule of application If the Secretary refuses to file a request under this subparagraph, the requestor may not file over protest under subparagraph (A)(iii) unless the request involves a drug described in section 586(9) as in effect on January 1, 2017. (7) Treatment of final and tentative final monographs A final monograph or tentative final monograph establishing requirements of use for a drug described in subsection (b)(1) shall be deemed to be a final administrative order under this subsection and may be amended, revoked, or otherwise modified in accordance with the procedures of this subsection. (8) Packaging (A) In general An administrative order issued under paragraph (3), (5)(A), or (6) may include requirements for the packaging of a drug, such as to promote use in accordance with labeling, unit dose packaging, or requirements to prevent accidental overdose or ingestion, misuse, or abuse, including by pediatric populations. The Secretary shall consider, as appropriate, any such nonprescription drugs currently available, and the impact of the removal of such drugs without such packaging and the changing of such packaging on patients and manufacturers when establishing such requirements. (B) Effective date Requirements for packaging in an administrative order under paragraph (5)(B) shall not take effect earlier than the day after the date on which the comment period under paragraph (5)(B)(i)(III) ends. (C) Clarification This paragraph does not authorize the Secretary to require special packaging or child-resistant packaging under the Poison Prevention Packaging Act of 1970. (d) Procedure for minor changes (1) In general Minor changes in the dosage form of a drug that is described in clause (i)(I)(aa)(CC) or (ii) of subsection