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.
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| Source Note: The provisions of this §291.31 adopted to be effective November 5, 1982, 7 TexReg 3830; amended to be effective March 31, 1986, 11 TexReg 1349; amended to be effective September 14, 1988, 13 TexReg 4305; amended to be effective September 5, 1990, 15 TexReg 4807; amended to be effective March 18, 1991, 16 TexReg 1365; amended to be effective January 1, 1993, 17 TexReg 9116; amended to be effective June 1, 1994, 19 TexReg 3921; amended to be effective December 1, 1994, 19 TexReg 9179; amended to be effective March 21, 1996, 21 TexReg 2227; amended to be effective April 7, 1997, 22 TexReg 3106; amended to be effective September 16, 1999, 24 TexReg 7227; amended to beeffective March 29, 2000, 25 TexReg 2575; amended to be effective March 4, 2004, 29 TexReg 1951; amended to be effective June 6, 2004, 29 TexReg 5361; amended to be effective September 18, 2007, 32 TexReg 6319; amended to be effective September 7, 2008, 33 TexReg 7218; amended to be effective December 6, 2009, 34 TexReg 8691; amended to be effective March 17, 2013, 38 TexReg 1682; amended to be effective September 11, 2014, 39 TexReg 7094; amended to be effective December 7, 2014, 39 TexReg 9345; amended to be effective September 16, 2018, 43 TexReg 5783; amended to be effective March 12, 2019, 44 TexReg 1317; amended to be effective December 10, 2020, 45 TexReg 8851 |
