Definitions

For purposes of this subpart: The term “abbreviated new drug application”— does not include an application— The term “active pharmaceutical ingredient” means— a substance, or a mixture when the substance is unstable or cannot be transported on its own, intended— The term “affiliate” means a business entity that has a relationship with a second business entity if, directly or indirectly— The term “facility”— means a business or other entity— For purposes of subparagraph (A), separate buildings within close proximity are considered to be at one geographic location or address if the activities in them are— The term “finished dosage form” means— The term “human generic drug activities” means the following activities of the Secretary associated with generic drugs and inspection of facilities associated with generic drugs: The issuance of— The issuance of letters related to Type II active pharmaceutical drug master files which— Postmarket safety activities with respect to drugs approved under abbreviated new drug applications or supplements, including the following activities: The term “resources allocated for human generic drug activities” means the expenses for—