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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 229FOOD AND DRUG
SUBCHAPTER BDONATION OF UNUSED DRUGS
RULE §229.21Definitions

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.


Source Note: The provisions of this §229.21 adopted to be effective May 29, 2003, 28 TexReg 4153; amended to be effective December 9, 2010, 35 TexReg 10755

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