22 Tex. Admin. Code § 291.52 - Definitions
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.
Notes
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