; (ii) under the supervision of the same local management; and (iii) under a single firm establishment identifier and capable of being inspected by the Food and Drug Administration during a single inspection. (C) If a business or other entity would meet the definition of a facility under this paragraph but for being under multiple management, the business or other entity is deemed to constitute multiple facilities, one per management entity, for purposes of this paragraph. (8) The term monograph drug meeting means any meeting regarding the content of a proposed monograph drug order request. (9) The term monograph drug product means a monograph drug product that is marketed without an approved new drug application in accordance with section 505G. (10) The term monograph drug order request means a request for an order under section 505G for the issuance of an administrative order for a change to the monograph drug product. (11) The term monograph drug requestor means an entity submitting a monograph drug order request or a monograph drug meeting request or any other inquiry relating to a request for an order or development of a monograph drug order request. (12) The term person includes an affiliate thereof. (13) The term Tier 1 monograph drug order request means any monograph drug order request not determined to be a Tier 2 monograph drug order request. (14) (A) The term Tier 2 monograph drug order request means subject to subparagraph (B), a monograph drug order request for— (i) the reordering of existing information in the drug facts label of a monograph drug product; (ii) the addition of information to the other information section of the drug facts label of a nonprescription drug product, as limited by part 201.66(c)(7) of title 21, Code of Federal Regulations; (iii) modification to the directions for use section of the drug facts label of a nonprescription drug product, if such changes conform to changes made pursuant to section 505G(d)