Texas Code § 549.0101

DEFINITIONS
Open in Lexace · Ask the AI about this section
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.

‹ Prev All Texas sections Next ›


Lexace provides legal information, not legal advice, and no attorney–client relationship is created. Statute text is provided for general information and may not reflect the most recent amendments; verify against the official state code.