SECTION 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.

Source Note: The provisions of this §95.2 adopted to be effective March 1, 2018, 43 TexReg 872