The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise. Any term not defined in this section shall have the definition set out in the Act, §551.003 and Chapter 562.
(1) Act--The Texas Pharmacy Act, Occupations Code, Subtitle J, as amended.
(2) Biological product--A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.
(3) Biosimilar--A biological product that is highly similar to the reference product notwithstanding minor differences in clinically inactive components and there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.
(4) Data communication device--An electronic device that receives electronic information from one source and transmits or routes it to another (e.g., bridge, router, switch, or gateway).
(5) Electronic prescription drug order--A prescription drug order which is transmitted by an electronic device to the receiver (pharmacy).
(6) Generically equivalent--A drug that is pharmaceutically equivalent and therapeutically equivalent to the drug prescribed.
(7) Interchangeable--Referencing a biological product that is:
(8) Pharmaceutically equivalent--Drug products that have identical amounts of the same active chemical ingredients in the same dosage form and that meet the identical compendial or other applicable standards of strength, quality, and purity according to the United States Pharmacopoeia or another nationally recognized compendium.
(9) Reference product--A single biological product against which a biological product is evaluated and is found to be biosimilar.
(10) Therapeutically equivalent--Pharmaceutically equivalent drug products that, if administered in the same amounts, will provide the same therapeutic effect, identical in duration and intensity.
(11) Original prescription--The:
(12) Practitioner--
Source Note: The provisions of this §309.2 adopted to be effective June 1, 2002, 27 TexReg 1782; amended to be effective June 12, 2005, 30 TexReg 3210; amended to be effective December 6, 2015, 40 TexReg 8790; amended to be effective December 10, 2020, 45 TexReg 8866