§ 431.321 Definitions
§ 431.321. Definitions
(a) “Charitable medical clinic” means 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 Chapter 84, Civil Practice and Remedies Code, and is exempt from federal income tax under Section 501(a) of the Internal Revenue Code of 1986 by being listed as an exempt organization in Section 501(c)(3) or 501(c)(4) of the 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.
(b) “Seller” means a person, other than a charitable drug donor, as defined in Chapter 82, Civil Practice and Remedies Code.
(c) “Manufacturer” means a person, other than a charitable drug donor, as defined in Chapter 82, Civil Practice and Remedies Code.
(d) “Charitable drug donor” means a licensed convalescent or nursing home or related institution, licensed hospice, hospital, physician, pharmacy, or a pharmaceutical seller or manufacturer that donates drugs pursuant to a qualified patient assistance program, that donates drugs to a charitable medical clinic. (d-1) In this subchapter, “community pharmaceutical access program” means 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.
(e) In this subchapter, “patient assistance program” means 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.