Sec. 549.0101. DEFINITIONS. In this subchapter: (1) "Labeler" means a person that: (A) has a labeler code from the United States Food and Drug Administration under 21 C.F.R. Section 207.33; and (B) receives prescription drugs from a manufacturer or wholesaler and repackages those drugs for later retail sale. (2) "Manufacturer" means a manufacturer of prescription drugs as defined by 42 U.S.C. Section 1396r-8(k)(5), including a subsidiary or affiliate of a manufacturer. (3) "Supplemental rebate" means a cash rebate a manufacturer pays to this state: (A) on the basis of appropriate quarterly health and human services program utilization data relating to the manufacturer's products; and (B) in accordance with a state supplemental rebate agreement negotiated with the manufacturer and, if necessary, approved by the federal government under 42 U.S.C. Section 1396r-8. (4) "Wholesaler" means a person licensed under Subchapter I , Chapter 431 , Health and Safety Code.
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