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:
(A) biosimilar to the reference product and can be
expected to produce the same clinical result as the reference product
in any given patient; and if the biological product is administered
more than once to an individual, the risk in terms of safety or diminished
efficacy of alternating or switching between use of the biological
product and the reference product is not greater than the risk of
using the reference product without such alternation or switch may
be substituted for the reference product without the intervention
of the health care provider who prescribed the reference product;
or
(B) designated as therapeutically equivalent to another
product by the United States Food and Drug Administration in the most
recent edition or supplement of the United States Food and Drug Administration's
references.
(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:
(A) original written prescription drug orders; or
(B) original oral or electronic prescription drug orders
reduced to writing either manually or electronically.
(12) Practitioner--
(A) A person licensed or registered to prescribe, distribute,
administer, or dispense a prescription drug or device in the course
of professional practice in this state, including a physician, dentist,
podiatrist, therapeutic optometrist, or veterinarian but excluding
a person licensed under this subtitle;
(B) A person licensed by another state, Canada, or
the United Mexican States in a health field in which, under the law
of this state, a license holder in this state may legally prescribe
a dangerous drug;
(C) A person practicing in another state and licensed
by another state as a physician, dentist, veterinarian, or podiatrist,
who has a current federal Drug Enforcement Administration registration
number and who may legally prescribe a Schedule II, III, IV, or V
controlled substance, as specified under Chapter 481, Health and Safety
Code, in that other state; or
(D) An advanced practice registered nurse or physician
assistant to whom a physician has delegated the authority to carry
out or sign prescription drug orders under §§157.0511, 157.0512,
or 157.054, Occupations Code.
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| 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 |
