Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter B - DONATION OF UNUSED DRUGS › Section 229.21 - Definitions

Current through Reg. 49, No. 28; July 12, 2024
The following words and terms, when used in this
					 subchapter, must have the following meanings, unless the context clearly
					 indicates otherwise.
(1) Charitable
				  drug donor--A licensed convalescent or nursing home or related institution,
				  licensed hospice, hospital, physician, pharmacy, or a pharmaceutical seller or
				  manufacturer who donates drugs pursuant to a qualified patient assistance
				  program, or that donates drugs to a charitable medical clinic. A charitable
				  drug donor is a wholesale drug distributor.
(2) Charitable medical clinic--A clinic,
				  including a licensed pharmacy that is a community pharmaceutical access program
				  provider, that provides medical care or drugs without charge or for a
				  substantially reduced charge, complies with the insurance requirements of Civil
				  Practice and Remedies Code, Chapter 84, and is exempt from federal income tax
				  under Internal Revenue Code of 1986, §501(a) by being listed as an exempt
				  organization in §501(c)(3) or (4) of the Internal Revenue Code, and is
				  operated exclusively for the promotion of social welfare by being primarily
				  engaged in promoting the common good and general welfare of the people in a
				  community.
(3) Community
				  pharmaceutical access program--A program offered by a licensed pharmacy under
				  which the pharmacy assists financially disadvantaged persons to access
				  prescription drugs at no charge or at a substantially reduced charge.
(4) Department--The Department of State
				  Health Services.
(5) 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.
(6) Drug sample--A unit of a drug that is not
				  intended to be sold and is intended to promote the sale of the drug.
(7) Manufacture--The process of preparing,
				  propagating, compounding, processing, packaging, repackaging, labeling,
				  testing, or quality control of a drug or drug product, but does not include
				  compounding that is done within the practice of pharmacy and pursuant to a
				  prescription from a practitioner for a patient.
(8) Manufacturer--A person, other than a
				  charitable drug donor, as defined in Civil Practice and Remedies Code, Chapter
				  82.
(9) Patient assistance
				  program--A qualified program offered by a pharmaceutical manufacturer under
				  which the manufacturer provides drugs to financially disadvantaged persons at
				  no charge or at a substantially reduced cost. The term does not include the
				  provision of a drug as part of a clinical trial.
(10) Person--An individual, partnership,
				  corporation, or association.
(11)
				  Qualified program--Any program sponsored by a pharmaceutical
				  manufacturer.
(12) Seller--A
				  person, other than a charitable drug donor, as defined in Civil Practice and
				  Remedies Code, Chapter 82, who is engaged in the business of distributing or
				  otherwise placing, for any commercial purpose, in the stream of commerce for
				  use or consumption, a product or any component part thereof.
(13) Wholesale distribution--Distribution to
				  a person other than a consumer or patient including, but not limited to,
				  distribution to any person by a manufacturer, repacker, own-label distributor,
				  jobber, private label distributor, broker, manufacturer warehouse, distributor
				  warehouse, or other warehouse, manufacturer's exclusive distributor, drug
				  wholesaler or distributor, distributor, independent wholesale drug trader,
				  specialty wholesale distributor, third party logistics provider, retail
				  pharmacy that conducts wholesale distribution, and pharmacy warehouse that
				  conducts wholesale distribution.