นิยาม “counterfeit drug” ของสหรัฐอเมริกาตามกฎหมาย 21 U.S.C. section 321 (2) คำว่า “counterfeit” ในความหมายที่แปลว่า “ปลอม” ไม่ใช่คำที่กล่าวถึงเรื่องคุณภา
(2) The term “counterfeit drug” means a drug which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a drug manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such drug and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other drug manufacturer, processor, packer, or distributor.