22 Tex. Admin. Code § 291.72 - 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--Distributing and/or delivering a medication 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 as ordered by the
practitioner and required by rule.
(2) Act--The Texas Pharmacy Act, Chapters 551
- 566 and 568 - 569, Occupations Code, as amended.
(3) Administer--The direct application of a
prescription drug 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.
(4)
Automated compounding or counting device--An automated device that compounds,
measures, counts and/or packages a specified quantity of dosage units of a
designated drug product.
(5)
Automated medication supply system--A mechanical system that performs
operations or activities relative to the storage and distribution of
medications for administration and which collects, controls, and maintains all
transaction information.
(6)
Board--The State Board of Pharmacy.
(7) Clinical Pharmacy Program--An ongoing
program in which pharmacists are on duty during the time the pharmacy is open
for pharmacy services and pharmacists provide direct focused,
medication-related care for the purpose of optimizing patients' medication
therapy and achieving definite outcomes, which includes the following
activities:
(A) prospective medication
therapy consultation, selection, and adjustment;
(B) monitoring laboratory values and
therapeutic drug monitoring;
(C)
identifying and resolving medication-related problems; and
(D) disease state management.
(8) 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 drug order.
(9) Consultant pharmacist--A pharmacist
retained by a facility on a routine basis to consult with the facility in areas
that pertain to the practice of pharmacy.
(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, or a drug, immediate
precursor, or other substance included in Schedules I - 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 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."
(12) Device--An
instrument, apparatus, implement, machine, contrivance, implant, in vitro
reagent, or other similar or related article, including any component part or
accessory, that is required under federal or state law to be ordered or
prescribed by a practitioner.
(13)
Direct copy--Electronic copy or carbonized copy of a medication order,
including a facsimile (FAX) or digital image.
(14) 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.
(15) Distribute--The delivery of a
prescription drug or device other than by administering or
dispensing.
(16) Distributing
pharmacist--The pharmacist who checks the medication order prior to
distribution.
(17) Downtime--Period
of time during which a data processing system is not operable.
(18) Drug regimen review--
(A) An evaluation of medication orders and
patient medication records for:
(i) known
allergies;
(ii) rational
therapy--contraindications;
(iii)
reasonable dose and route of administration;
(iv) reasonable directions for use;
(v) duplication of therapy;
(vi) drug-drug interactions;
(vii) drug-food interactions;
(viii) drug-disease interactions;
(ix) adverse drug reactions; and
(x) proper utilization, including
overutilization or underutilization.
(B) The drug regimen review may be conducted
prior to administration of the first dose (prospective) or after administration
of the first dose (retrospective).
(19) 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.
(20) Expiration date--The date (and time,
when applicable) beyond which a product should not be used.
(21) Facility--
(A) a hospital or other patient facility that
is licensed under Chapter 241 or 577, Health and Safety Code;
(B) a hospice patient facility that is
licensed under Chapter 142, Health and Safety Code;
(C) an ambulatory surgical center licensed
under Chapter 243, Health and Safety Code; or
(D) a hospital maintained or operated by the
state.
(22) Floor
stock--Prescription drugs or devices not labeled for a specific patient and
maintained at a nursing station or other hospital department (excluding the
pharmacy) for the purpose of administration to a patient of the
facility.
(23) Formulary--List of
drugs approved for use in the facility by the committee which performs the
pharmacy and therapeutics function for the facility.
(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 (i.e., data
processing system, computer, etc).
(26) Hot water--The temperature of water from
the pharmacy's sink maintained at a minimum of 105 degrees F (41 degrees
C).
(27) Institutional
pharmacy--Area or areas in a facility where drugs are stored, bulk compounded,
delivered, compounded, dispensed, and distributed to other areas or departments
of the facility, or dispensed to an ultimate user or his or her
agent.
(28) Investigational new
drug--New drug intended for investigational use by experts qualified to
evaluate the safety and effectiveness of the drug as authorized by the Food and
Drug Administration.
(29) Medical
Practice Act--The Texas Medical Practice Act, Subtitle B, Occupations Code, as
amended.
(30) Medication order--A
written order from a practitioner or a verbal order from a practitioner or his
authorized agent for administration of a drug or device.
(31) Number of beds--The total number of beds
is determined by the:
(A) number of beds for
which the hospital is licensed by the Texas Department of State Health
Services; or
(B) average daily
census as calculated by dividing the total number of inpatients admitted during
the previous calendar year by 365 (or 366 if the previous calendar year is a
leap year).
(32)
Part-time pharmacist--A pharmacist either employed or under contract, who
routinely works less than full-time.
(33) Patient--A person who is receiving
services at the facility (including patients receiving ambulatory procedures
and patients conditionally admitted as observation patients), or who is
receiving long term care services or Medicare extended care services in a swing
bed on the hospital premise or an adjacent, readily accessible facility that is
under the authority of the hospital's governing body. For the purposes of this
definition, the term "long term care services" means those services received in
a skilled nursing facility which is a distinct part of the hospital and the
distinct part is not licensed separately or formally approved as a nursing home
by the state, even though it is designated or certified as a skilled nursing
facility. A patient includes a person confined in any correctional institution
operated by the state of Texas.
(34) Perpetual inventory--An inventory which
documents all receipts and distributions of a drug product, such that an
accurate, current balance of the amount of the drug product present in the
pharmacy is indicated.
(35)
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.
(36)
Pharmacist-in-charge--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.
(37) Pharmacy and therapeutics
function--Committee of the medical staff in the facility which assists in the
formulation of broad professional policies regarding the evaluation, selection,
distribution, handling, use, and administration, and all other matters relating
to the use of drugs and devices in the facility.
(38) 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.
(39) 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.
(40) Pre-packaging--The
act of re-packaging and re-labeling quantities of drug products from a
manufacturer's original container into unit-dose packaging or a multiple dose
container for distribution within the facility except as specified in §
291.74(f)(3)(B)
of this title (relating to Operational Standards).
(41) Prescription drug--
(A) A substance for which federal or state
law requires a prescription before it may be legally dispensed to the
public;
(B) A drug or device that
under federal law is required, prior to being dispensed or delivered, to be
labeled with either of the following statements:
(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 order of a licensed veterinarian;
or
(C) A drug or device
that is required by any applicable federal or state law or regulation to be
dispensed on prescription only or is restricted to use by a practitioner
only.
(42) Prescription
drug order--
(A) a written order from a
practitioner or a verbal 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 a verbal order
pursuant to Subtitle B, Chapter 157, Occupations Code.
(43) Rural hospital--A licensed hospital with
75 beds or fewer that:
(A) is located in a
county with a population of 50,000 or less as defined by the United States
Census Bureau in the most recent U.S. census; or
(B) has been designated by the Centers for
Medicare and Medicaid Services as a critical access hospital, rural referral
center, or sole community hospital.
(44) Sample--A prescription drug which is not
intended to be sold and is intended to promote the sale of the drug.
(45) Supervision--
(A) Physically present supervision--In a
Class C pharmacy, a pharmacist shall be physically present to directly
supervise pharmacy technicians or pharmacy technician trainees.
(B) Electronic supervision--In a Class C
pharmacy in a facility with 100 beds or less, a pharmacist licensed in Texas
may electronically supervise pharmacy technicians or pharmacy technician
trainees to perform the duties specified in §
291.73(e)(2) of
this title (relating to Personnel) provided:
(i) the pharmacy uses a system that monitors
the data entry of medication orders and the filling of such orders by an
electronic method that shall include the use of one or more the following types
of technology:
(I) digital interactive video,
audio, or data transmission;
(II)
data transmission using computer imaging by way of still-image capture and
store and forward; and
(III) other
technology that facilitates access to pharmacy services;
(ii) the pharmacy establishes controls to
protect the privacy and security of confidential records;
(iii) the pharmacist responsible for the
duties performed by a pharmacy technician or pharmacy technician trainee
verifies:
(I) the data entry; and
(II) the accuracy of the filled orders prior
to release of the order; and
(iv) the pharmacy keeps permanent digital
records of duties electronically supervised and data transmissions associated
with electronically supervised duties for a period of two years.
(C) If the conditions of
subparagraph (B) of this paragraph are met, electronic supervision shall be
considered the equivalent of direct supervision for the purposes of the
Act.
(46)
Tech-Check-Tech--Allowing a pharmacy technician to verify the accuracy of work
performed by another pharmacy technician relating to the filling of floor stock
and unit dose distribution systems for a patient admitted to the hospital if
the patient's orders have previously been reviewed and approved by a
pharmacist.
(47) Texas Controlled
Substances Act--The Texas Controlled Substances Act, the Health and Safety
Code, Chapter 481, as amended.
(48)
Unit-dose packaging--The ordered amount of drug in a dosage form ready for
administration to a particular patient, by the prescribed route at the
prescribed time, and properly labeled with name, strength, and expiration date
of the drug.
(49) Unusable
drugs--Drugs or devices that are unusable for reasons, such as they are
adulterated, misbranded, expired, defective, or recalled.
(50) 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 Subtitle B, Chapter 157, Occupations Code.
Notes
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