The following words and terms, when used in this subchapter,
shall have the following meanings, unless the context clearly indicates
otherwise. Any term not defined in this section shall have the definition
set forth in the Act, §551.003.
(1) Accurately as prescribed--Dispensing, delivering,
and/or distributing a prescription drug order or radioactive prescription
drug order:
(A) to the correct patient (or agent of the patient)
for whom the drug or device was prescribed;
(B) with the correct drug in the correct strength,
quantity, and dosage form ordered by the practitioner; and
(C) with correct labeling (including directions for
use) as ordered by the practitioner. Provided, however, that nothing
herein shall prohibit pharmacist substitution if substitution is conducted
in strict accordance with applicable laws and rules, including Subchapter
A, Chapter 562 of the Act.
(2) ACPE--Accreditation Council for Pharmacy Education.
(3) Act--The Texas Pharmacy Act, Chapters 551 - 569,
Occupations Code, as amended.
(4) Administer--The direct application of a prescription
drug and/or radiopharmaceutical, by injection, inhalation, ingestion,
or any other means to the body of a patient by:
(A) a practitioner, an authorized agent under his supervision,
or other person authorized by law; or
(B) the patient at the direction of a practitioner.
(5) Authentication of product history--Identifying
the purchasing source, the intermediate handling, and the ultimate
disposition of any component of a radioactive drug.
(6) Authorized nuclear pharmacist--A pharmacist who:
(A) has completed the specialized training requirements
specified by this subchapter for the preparation and distribution
of radiopharmaceuticals; and
(B) is named on a Texas radioactive material license,
issued by the Texas Department of State Health Services, Radiation
Control Program.
(7) Authorized user--Any individual named on a Texas
radioactive material license, issued by the Texas Department of State
Health Services, Radiation Control Program.
(8) Board--The Texas State Board of Pharmacy.
(9) Component--Any ingredient intended for use in the
compounding of a drug preparation, including those that may not appear
in such preparation.
(10) Compounding--The preparation, mixing, assembling,
packaging, or labeling of a drug or device:
(A) as the result of a practitioner's prescription
drug or medication order based on the practitioner-patient-pharmacist
relationship in the course of professional practice;
(B) for administration to a patient by a practitioner
as the result of a practitioner's initiative based on the practitioner-patient-pharmacist
relationship in the course of professional practice;
(C) in anticipation of prescription drug or medication
orders based on routine, regularly observed prescribing patterns;
or
(D) for or as an incident to research, teaching, or
chemical analysis and not for sale or dispensing, except as allowed
under §562.154 or Chapter 563 of the Act.
(11) Controlled substance--A drug, immediate precursor,
or other substance listed in Schedules I - V or Penalty Groups 1-4
of the Texas Controlled Substances Act, as amended, or a drug, immediate
precursor, or other substance included in Schedule I, II, III, IV,
or V of the Federal Comprehensive Drug Abuse Prevention and Control
Act of 1970, as amended (Public Law 91-513).
(12) Dangerous drug--A drug or device that:
(A) is not included in Penalty Group 1, 2, 3, or 4,
Chapter 481, Health and Safety Code, and is unsafe for self-medication;
or
(B) bears or is required to bear the legend:
(i) "Caution: federal law prohibits dispensing without
prescription" or "Rx only" or another legend that complies with federal
law; or
(ii) "Caution: federal law restricts this drug to use
by or on the order of a licensed veterinarian."
(13) 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).
(14) Deliver or delivery--The actual, constructive,
or attempted transfer of a prescription drug or device, radiopharmaceutical,
or controlled substance from one person to another, whether or not
for a consideration.
(15) Designated agent--
(A) an individual, including a licensed nurse, physician
assistant, nuclear medicine technologist, or pharmacist:
(i) who is designated by a practitioner and authorized
to communicate a prescription drug order to a pharmacist; and
(ii) for whom the practitioner assumes legal responsibility;
(B) a licensed nurse, physician assistant, or pharmacist
employed in a health care facility to whom a practitioner communicates
a prescription drug order; or
(C) a registered nurse or physician assistant authorized
by a practitioner to administer a prescription drug order for a dangerous
drug under Subchapter B, Chapter 157 (Occupations Code).
(16) Device--An instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent, or other similar or related
articles, including any component parts or accessory that is required
under federal or state law to be ordered or prescribed by a practitioner.
(17) Diagnostic prescription drug order--A radioactive
prescription drug order issued for a diagnostic purpose.
(18) Dispense--Preparing, packaging, compounding, or
labeling for delivery a prescription drug or device, or a radiopharmaceutical
in the course of professional practice to an ultimate user or his
agent by or pursuant to the lawful order of a practitioner.
(19) Dispensing pharmacist--The authorized nuclear
pharmacist responsible for the final check of the dispensed prescription
before delivery to the patient.
(20) Distribute--The delivering of a prescription drug
or device, or a radiopharmaceutical other than by administering or
dispensing.
(21) Electronic radioactive prescription drug order--A
radioactive prescription drug order which is transmitted by an electronic
device to the receiver (pharmacy).
(22) Full-time pharmacist--A pharmacist who works in
a pharmacy at least 30 hours per week or, if the pharmacy is open
less than 60 hours per week, one-half of the time the pharmacy is
open.
(23) Hot water--The temperature of water from the pharmacy's
sink maintained at a minimum of 105 degrees F (41 degrees C).
(24) Nuclear pharmacy technique--The mechanical ability
required to perform the nonjudgmental, technical aspects of preparing
and dispensing radiopharmaceuticals.
(25) Original prescription--The:
(A) original written radioactive prescription drug
orders; or
(B) original oral or electronic radioactive prescription
drug orders maintained either manually or electronically.
(26) Pharmacist-in-charge--The pharmacist designated
on a pharmacy license as the pharmacist who has the authority or responsibility
for a pharmacy's compliance with laws and rules pertaining to the
practice of pharmacy.
(27) Pharmacy technician--An individual whose responsibility
in a pharmacy is to provide technical services that do not require
professional judgment regarding preparing and distributing drugs and
who works under the direct supervision of and is responsible to a
pharmacist.
(28) Pharmacy technician trainee--An individual who
is registered with the board as a pharmacy technician trainee and
is authorized to participate in a pharmacy's technician training program.
(29) Radioactive drug service--The act of distributing
radiopharmaceuticals; the participation in radiopharmaceutical selection
and the performance of radiopharmaceutical drug reviews.
(30) Radioactive prescription drug order--An order
from a practitioner or a practitioner's designated agent for a radiopharmaceutical
to be dispensed.
(31) Radiopharmaceutical--A prescription drug or device
that exhibits spontaneous disintegration of unstable nuclei with the
emission of a nuclear particle(s) or photon(s), including any nonradioactive
reagent kit or nuclide generator that is intended to be used in preparation
of any such substance.
(32) Sterile radiopharmaceutical--A dosage form of
a radiopharmaceutical free from living micro-organisms.
(33) Therapeutic prescription drug order--A radioactive
prescription drug order issued for a specific patient for a therapeutic
purpose.
(34) Ultimate user--A person who has obtained and possesses
a prescription drug or radiopharmaceutical for administration to a
patient by a practitioner.
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| Source Note: The provisions of this §291.52 adopted to be effective March 19, 1998, 23 TexReg 2815; amended to be effective September 16, 1999, 24 TexReg 7259; amended to be effective June 1, 2002, 27 TexReg 1781; amended to be effective March 4, 2004, 29 TexReg 1999; amended to be effective June 6, 2004, 29 TexReg 5362; amended to be effective September 14, 2010, 35 TexReg 8357; amended to be effective September 14, 2015, 40 TexReg 6110; amended to be effective June 11, 2017, 42 TexReg 2931; amended to be effective December 10, 2020, 45 TexReg 8852 |
