25 Tex. Admin. Code § 95.2 - Definitions
The following words and terms, when used in this chapter, must have the following meanings, unless the context clearly indicates otherwise.
(1) Adulterated Drug or
Device--As defined in the Texas Food, Drug and Cosmetic Act, Health and Safety
Code, §
431.111.
(2) Controlled Substance--As
defined in the Health and Safety Code, §
481.002.
(3) Department--The Department of
State Health Services.
(4)
Dispense--To prepare, package, compound, or label in the course of professional
practice, a prescription drug or device for delivery to an ultimate user or the
user's agent under a practitioner's lawful order.
(5) Donor--An individual who donates unused,
unit-dose packaged prescription drugs under Health and Safety Code, Chapter
442, to a participating provider.
(6) Health Care Facility--A facility that
provides health care services to patients and maintains a pharmacy in the
facility. The term includes the following facilities if a pharmacy is
maintained in the facility:
(A) a general or
special hospital as defined by Health and Safety Code, Chapter 241;
(B) an ambulatory surgical center licensed
under Health and Safety Code, Chapter 243; and
(C) an institution licensed under Health and
Safety Code, Chapter 242.
(7) Health Care Professional--An individual
licensed, certified, or otherwise authorized to administer health care and
prescribe prescription drugs, for profit or otherwise, in the ordinary course
of business or professional practice. The term does not include a health care
facility.
(8) Manufacturer--A
person who is a designer, formulator, constructor, rebuilder, fabricator,
producer, compounder, processor, or assembler of any product or any component
part thereof and who places the product or any component part thereof in the
stream of commerce.
(9)
Participating Provider--A health care facility or pharmacy, or a pharmacist who
is an employee of the facility or pharmacy that elects to participate in the
collection and redistribution of donated prescription drugs under Health and
Safety Code, Chapter 442.
(10)
Pharmacist--A person licensed under Occupations Code, Chapter 558.
(11) Pharmacy--An entity licensed under
Occupations Code, Chapter 560.
(12) Prescription Drug--As defined under
Occupations Code, §
551.003.
(13) Program--Prescription Drug Donation
Program.
(14) Recipient--An
individual who voluntarily receives donated prescription drugs under Health and
Safety Code Chapter 442.
(15)
Tamper-Evident--Packaging that allows for detection of unauthorized access to a
prescription drug.
(16)
Unit-Dose--A dose of medicine prepared in an individual packet by a licensed
facility for convenience, safety, or monitoring.
Notes
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