Definitions

In this subpart: The term “affiliate” means a business entity that has a relationship with a second business entity if, directly or indirectly— The term “costs of resources allocated for OTC monograph drug activities” means the expenses in connection with OTC monograph drug activities for— The term “OTC monograph drug activities” means activities of the Secretary associated with OTC monograph drugs and inspection of facilities associated with such products, including the following activities: The activities necessary for review and evaluation of OTC monographs and OTC monograph order requests, including— Safety activities with respect to OTC monograph drugs, including— The term “Tier 2 OTC monograph order request” means, subject to subparagraph (B), an OTC monograph order request for— the addition or modification of a testing procedure applicable to one or more OTC monograph drugs, provided that such additional or modified testing procedure reflects a voluntary consensus standard with respect to pharmaceutical quality that is— The term “OTC monograph drug facility” means a foreign or domestic business or other entity that— is— For purposes of subparagraph (A)(i)(II), separate buildings or locations within close proximity are considered to be at one geographic location or address if the activities conducted in such buildings or locations are—