22 Tex. Admin. Code § 291.31 - Definitions
The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.
(1) Accurately as
prescribed--Dispensing, delivering, and/or distributing a 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
Chapter 562 of the Texas Pharmacy Act.
(2) Act--The Texas Pharmacy Act, Chapters 551
- 569, Occupations Code, as amended.
(3) Advanced practice registered nurse--A
registered nurse licensed by the Texas Board of Nursing to practice as an
advanced practice registered nurse on the basis of completion of an advanced
education program. The term includes nurse practitioner, nurse midwife, nurse
anesthetist, and clinical nurse specialist. The term is synonymous with
advanced nurse practitioner and advanced practice nurse.
(4) Automated checking device--A device that
confirms that the correct drug and strength has been labeled with the correct
label for the correct patient prior to delivery of the drug to the
patient.
(5) Automated counting
device--An automated device that is loaded with bulk drugs and counts and/or
packages (i.e., fills a vial or other container) a specified quantity of dosage
units of a designated drug product.
(6) Automated pharmacy dispensing system--A
system that automatically performs operations or activities, other than
compounding or administration, relative to the storage, packaging, counting,
and labeling for dispensing and delivery of medications, and that collects,
controls, and maintains all transaction information. "Automated pharmacy
dispensing system" does not mean "Automated compounding or counting device" or
"Automated medication supply device."
(7) Beyond use date--The date beyond which a
product should not be used.
(8)
Board--The Texas State Board of Pharmacy.
(9) Confidential record--Any health-related
record that contains information that identifies an individual and that is
maintained by a pharmacy or pharmacist, such as a patient medication record,
prescription drug order, or medication order.
(10) 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 (Chapter 481, Health and
Safety Code), or a drug, immediate precursor, or other substance included in
Schedules I, II, III, IV, or V of the Federal Comprehensive Drug Abuse
Prevention and Control Act of 1970, as amended ( Public Law 91-513).
(11) Dangerous drug--A drug or device that:
(A) is not included in Penalty Groups 1 - 4
of the Texas Controlled Substances Act, as amended, (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."
(12) 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).
(13) Deliver or delivery--The actual,
constructive, or attempted transfer of a prescription drug or device or
controlled substance from one person to another, whether or not for a
consideration.
(14) Designated
agent--
(A) a licensed nurse, physician
assistant, pharmacist, or other individual designated by a practitioner to
communicate prescription drug orders to a pharmacist;
(B) a licensed nurse, physician assistant, or
pharmacist employed in a health care facility to whom the practitioner
communicates a prescription drug order;
(C) an advanced practice registered nurse or
physician assistant authorized by a practitioner to prescribe or order drugs or
devices under Chapter 157 of the Medical Practice Act (Subtitle B, Occupations
Code); or
(D) a person who is a
licensed vocational nurse or has an education equivalent to or greater than
that required for a licensed vocational nurse designated by the practitioner to
communicate prescriptions for an advanced practice registered nurse or
physician assistant authorized by the practitioner to sign prescription drug
orders under Chapter 157 of the Medical Practice Act (Subtitle B, Occupations
Code).
(15)
Dispense--Preparing, packaging, compounding, or labeling for delivery a
prescription drug or device in the course of professional practice to an
ultimate user or his agent by or pursuant to the lawful order of a
practitioner.
(16) Dispensing
error--An action committed by a pharmacist or other pharmacy personnel that
causes the patient or patient's agent to take possession of a dispensed
prescription drug and an individual subsequently discovers that the patient has
received an incorrect drug product, which includes incorrect strength,
incorrect dosage form, and/or incorrect directions for use.
(17) Dispensing pharmacist--The pharmacist
responsible for the final check of the dispensed prescription before delivery
to the patient.
(18)
Distribute--The delivery of a prescription drug or device other than by
administering or dispensing.
(19)
Downtime--Period of time during which a data processing system is not
operable.
(20) Drug regimen
review--An evaluation of prescription drug orders and patient medication
records for:
(A) known allergies;
(B) rational
therapy-contraindications;
(C)
reasonable dose and route of administration;
(D) reasonable directions for use;
(E) duplication of therapy;
(F) drug-drug interactions;
(G) drug-food interactions;
(H) drug-disease interactions;
(I) adverse drug reactions; and
(J) proper utilization, including
overutilization or underutilization.
(21) Electronic prescription drug order--A
prescription drug order that is generated on an electronic application and
transmitted as an electronic data file.
(22) Electronic signature--A unique security
code or other identifier which specifically identifies the person entering
information into a data processing system. A facility which utilizes electronic
signatures must:
(A) maintain a permanent
list of the unique security codes assigned to persons authorized to use the
data processing system; and
(B)
have an ongoing security program which is capable of identifying misuse and/or
unauthorized use of electronic signatures.
(23) Electronic verification process--an
electronic verification, bar code verification, weight verification, radio
frequency identification (RFID), or similar electronic process or system that
accurately verifies that medication has been properly dispensed and labeled by,
or loaded into, an automated pharmacy dispensing system.
(24) Full-time pharmacist--A pharmacist who
works in a pharmacy from 30 to 40 hours per week or, if the pharmacy is open
less than 60 hours per week, one-half of the time the pharmacy is
open.
(25) Hard copy--A physical
document that is readable without the use of a special device.
(26) Hot water--The temperature of water from
the pharmacy's sink maintained at a minimum of 105 degrees F (41 degrees
C).
(27) Medical Practice Act--The
Texas Medical Practice Act, Subtitle B, Occupations Code, as amended.
(28) Medication order--A written order from a
practitioner or an oral order from a practitioner or his authorized agent for
administration of a drug or device.
(29) New prescription drug order--A
prescription drug order that has not been dispensed to the patient in the same
strength and dosage form by this pharmacy within the last year.
(30) Original prescription--The:
(A) original written prescription drug order;
or
(B) original oral or electronic
prescription drug order reduced to writing either manually or
electronically.
(31)
Part-time pharmacist--A pharmacist who works less than full-time.
(32) Patient counseling--Communication by the
pharmacist of information to the patient or patient's agent in order to improve
therapy by ensuring proper use of drugs and devices.
(33) Patient med-pak--A package prepared by a
pharmacist for a specific patient comprised of a series of containers and
containing two or more prescribed solid oral dosage forms. The patient med-pak
is so designed or each container is so labeled as to indicate the day and time,
or period of time, that the contents within each container are to be
taken.
(34) Pharmaceutical
care--The provision of drug therapy and other pharmaceutical services intended
to assist in the cure or prevention of a disease, elimination or reduction of a
patient's symptoms, or arresting or slowing of a disease process.
(35) 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.
(36)
Pharmacy technician--An individual who is registered with the board as a
pharmacy technician and 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.
(37) 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.
(38) Physician
assistant--A physician assistant recognized by the Texas Medical Board as
having the specialized education and training required under Subtitle B,
Chapter 157, Occupations Code, and issued an identification number by the Texas
Medical Board.
(39) 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, or veterinarian but excluding a person licensed under this
Act;
(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
prescribe or order drugs or devices under Chapter 157 of the Medical Practice
Act (Subtitle B, Occupations Code) or, for the purpose of this subchapter, a
pharmacist who practices in a hospital, hospital-based clinic, or an academic
health care institution and to whom a physician has delegated the authority to
sign a prescription for a dangerous drug under §
157.101, Occupations
Code.
(40)
Prepackaging--The act of repackaging and relabeling quantities of drug products
from a manufacturer's original commercial container into a prescription
container, unit-dose packaging, or multi-compartment container for dispensing
by a pharmacist to the ultimate consumer, including dispensing through the use
of an automated pharmacy dispensing system or automated checking
device.
(41) Prescription
department--The area of a pharmacy that contains prescription drugs.
(42) Prescription drug--
(A) a substance for which federal or state
law requires a prescription before the substance may be legally dispensed to
the public;
(B) a drug or device
that under federal law is required, before being dispensed or delivered, to be
labeled with the statement:
(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"; or
(C) a drug or device that is
required by federal or state statute or regulation to be dispensed on
prescription or that is restricted to use by a practitioner only.
(43) Prescription drug order--
(A) a written order from a practitioner or an
oral order from a practitioner or his authorized agent to a pharmacist for a
drug or device to be dispensed; or
(B) a written order or an oral order pursuant
to Subtitle B, Chapter 157, Occupations Code.
(44) Prospective drug use review--A review of
the patient's drug therapy and prescription drug order or medication order
prior to dispensing or distributing the drug.
(45) State--One of the 50 United States of
America, a U.S. territory, or the District of Columbia.
(46) Texas Controlled Substances Act--The
Texas Controlled Substances Act, Health and Safety Code, Chapter 481, as
amended.
(47) Written protocol--A
physician's order, standing medical order, standing delegation order, or other
order or protocol as defined by rule of the Texas Medical Board under the Texas
Medical Practice Act.
Notes
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