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:
Cont'd...
