(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.
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Source Note: The provisions of this §291.72 adopted to be effective April 23, 1982, 7 TexReg 1469; amended to be effective December 18, 1985, 10 TexReg 4694; amended to be effective May 27, 1988, 13 TexReg 2251; amended to be effective February 1, 1989, 14 TexReg 453; amended to be effective October 27, 1989, 14 TexReg 5494; amended to be effective September 5, 1990, 15 TexReg 4810; amended to be effective September 30, 1993, 18 TexReg 6460; amended to be effective March 16, 1995, 20 TexReg 1543; amended to be effective March 21, 1996, 21 TexReg 2242; amended to be effective April 7, 1997, 22 TexReg 3106; amended to be effective September 16, 1999, 24 TexReg 7265; amended to beeffective June 4, 2000, 25 TexReg 4816; amended to be effective August 31, 2000, 25 TexReg 8406; amended to be effective March 7, 2001, 26 TexReg 1865; amended to be effective March 4, 2004, 29 TexReg 2000; amended to be effective June 6, 2004, 29 TexReg 5376; amended to be effective September 18, 2007, 32 TexReg 6333; amended to be effective September 7, 2008, 33 TexReg 7241; amended to be effective September 20, 2009, 34 TexReg 6323; amended to be effective March 11, 2010, 35 TexReg 2005; amended to be effective May 30, 2010, 35 TexReg 4177; amended to be effective December 7, 2010, 35 TexReg 10693; amended to be effective December 7, 2014, 39 TexReg 9355 |