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A BILL TO BE ENTITLED
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AN ACT
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relating to the prescription drug donation program; authorizing |
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fees. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Subchapter M, Chapter 431, Health and Safety |
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Code, is amended to read as follows: |
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SUBCHAPTER M. PRESCRIPTION DRUG DONATION PROGRAM |
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Sec. 431.321. DEFINITIONS. In this subchapter: |
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(1) "Charitable drug donor" means: |
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(A) a licensed convalescent or nursing home or |
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related institution, licensed hospice, hospital, physician, or |
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pharmacy; or |
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(B) a pharmaceutical seller or manufacturer that |
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donates drugs under a qualified patient assistance program. |
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(2) [(a)] "Charitable medical clinic" means a clinic, |
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including a licensed pharmacy that is a community pharmaceutical |
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access program provider, that provides medical care or drugs |
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without charge or for a substantially reduced charge, complies with |
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the insurance requirements of Chapter 84, Civil Practice and |
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Remedies Code, and is exempt from federal income tax under Section |
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501(a) of the Internal Revenue Code of 1986 by being listed as an |
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exempt organization in Section 501(c)(3) or 501(c)(4) of the code |
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and is operated exclusively for the promotion of social welfare by |
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being primarily engaged in promoting the common good and general |
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welfare of the people in a community. |
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(3) "Community pharmaceutical access program" means a |
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program offered by a licensed pharmacy under which the pharmacy |
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assists financially disadvantaged persons by providing access to |
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prescription drugs at no charge or at a substantially reduced |
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charge. |
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(4) "Department" means the Department of State Health |
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Services. |
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(5) [(b)
"Seller" means a person, other than a
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charitable drug donor, as defined in Chapter 82, Civil Practice and
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Remedies Code.
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[(c)] "Manufacturer" means a person, other than a |
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charitable drug donor, as defined in Chapter 82, Civil Practice and |
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Remedies Code. |
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(6) "Patient [(d)
"Charitable drug donor" means a
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licensed convalescent or nursing home or related institution,
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licensed hospice, hospital, physician, pharmacy, or a
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pharmaceutical seller or manufacturer that donates drugs pursuant
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to a qualified patient assistance program, that donates drugs to a
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charitable medical clinic.
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[(d-1)
In this subchapter, "community pharmaceutical access
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program" means a program offered by a licensed pharmacy under which
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the pharmacy assists financially disadvantaged persons to access
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prescription drugs at no charge or at a substantially reduced
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charge.
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[(e) In this subchapter, "patient] assistance program" |
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means a qualified program offered by a pharmaceutical manufacturer |
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under which the manufacturer provides drugs to financially |
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disadvantaged persons at no charge or at a substantially reduced |
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cost. The term does not include the provision of a drug as part of a |
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clinical trial. |
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(7) "Prescription drug" has the meaning assigned by |
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Section 551.003, Occupations Code. |
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(8) "Program" means the prescription drug donation |
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program under this subchapter. |
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(9) "Seller" means a person, other than a charitable |
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drug donor, as defined in Chapter 82, Civil Practice and Remedies |
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Code. |
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Sec. 431.322. DONATION OF UNUSED DRUGS [TO CHARITABLE
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MEDICAL CLINIC]. (a) A charitable drug donor may donate certain |
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unused prescription drugs to the department for the program under |
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[a charitable medical clinic, and a charitable clinic may accept,
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dispense, or administer the donated drugs in accordance with] this |
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subchapter. |
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(b) A seller or manufacturer of a drug may not donate drugs |
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to the department [a charitable medical clinic] except under |
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[pursuant to] a qualified patient assistance program. A seller or |
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manufacturer of a drug that donates drugs through a qualified |
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patient assistance program is [shall be] considered a charitable |
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drug donor. |
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(c) A [The] charitable drug donor shall use appropriate |
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safeguards established by the department [board] to ensure that the |
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drugs are not compromised or illegally diverted while being stored |
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or transported [to the charitable medical clinic]. |
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(d) The department [charitable medical clinic] may not |
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accept the donated drugs unless: |
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(1) the charitable drug donor certifies that the drugs |
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have been properly stored while in the possession of the donor or of |
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the person for whom the drugs were originally dispensed; |
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(2) the charitable drug donor provides the department |
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[clinic] with a verifiable address and telephone number; and |
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(3) the person transferring possession of the drugs |
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presents [the charitable medical clinic with] photographic |
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identification. |
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Sec. 431.323. CIRCUMSTANCES UNDER WHICH DONATED DRUGS MAY |
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BE ACCEPTED [AND DISPENSED]. (a) The department [A charitable
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medical clinic] may accept [and dispense or administer] donated |
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drugs only in accordance with this subchapter. |
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(b) The donated drugs must be: |
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(1) [drugs that require a] prescription drugs; |
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(2) [. A donated drug may not be a controlled substance
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under Chapter 481.
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[(c) The donated drugs must be] approved by the federal Food |
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and Drug Administration and: |
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(A) [(1) be] sealed in the manufacturer's |
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unopened original tamper-evident packaging and either: |
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(i) [(A)] individually packaged; or |
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(ii) [(B)] packaged in unit-dose packaging; |
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(B) [(2)] be oral [or parenteral] medication in |
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sealed single-dose containers approved by the federal Food and Drug |
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Administration; or |
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(C) [(3)] be topical or inhalant drugs in sealed |
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units-of-use containers approved by the federal Food and Drug |
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Administration. |
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(c) Donated drugs may [; or
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[(4)
be parenteral medication in sealed multiple-dose
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containers approved by the federal Food and Drug Administration
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from which no doses have been withdrawn; and
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[(5) must] not: |
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(1) be the subject of a mandatory recall by a state or |
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federal agency or a voluntary recall by a drug seller or |
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manufacturer; |
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(2) be adulterated or misbranded; |
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(3) be a controlled substance under Chapter 481; |
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(4) be a parenteral or injectable medication; |
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(5) require refrigeration; or |
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(6) expire less than 60 days after the date of the |
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donation. |
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(d) The department [charitable medical clinic] may |
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distribute [dispense or administer] the donated drugs only[:
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[(1)
before the expiration date or within the
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recommended shelf life of the donated drugs, as applicable; and
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[(2)] after a licensed pharmacist has determined that |
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the drugs are of an acceptable integrity. |
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(e) The department may not charge a fee for the drugs |
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donated under the program other than a nominal handling fee to |
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defray the costs incurred in implementing the program under this |
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subchapter. |
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(f) The department may not resell the drugs donated under |
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the program. |
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Sec. 431.3231. DISPENSATION OF DONATED DRUGS. (a) |
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[(e)] The donated drugs may be accepted and dispensed or |
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administered only by: |
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(1) a [the] charitable medical clinic; or |
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(2) a physician's office using the drugs for patients |
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who receive assistance from the medical assistance program under |
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Chapter 32, Human Resources Code [only in accordance with rules
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adopted by the department]. |
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(b) A prescription drug dispensed or administered to a |
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patient under the program must be prescribed by a practitioner for |
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use by that patient. |
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(c) The clinic or physician dispensing or administering the |
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drug may charge a nominal handling fee in an amount prescribed by |
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department rule. |
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(d) A clinic or physician receiving donated drugs may not |
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resell the drugs. |
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Sec. 431.3232. CENTRAL DRUG REPOSITORY. The department |
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shall establish a location to centrally store drugs donated under |
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this subchapter for disbursement to qualifying recipients. |
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Sec. 431.3233. DATABASE OF DONATED DRUGS. The department |
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shall establish and maintain an electronic database in which: |
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(1) the department shall list the name and quantity of |
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each drug donated to the department under the program; and |
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(2) a charitable medical clinic or physician may |
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search for and request donated drugs. |
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Sec. 431.324. RULES. The executive commissioner of the |
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Health and Human Services Commission [department] shall adopt rules |
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to implement this subchapter that are designed to protect the |
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public health and safety, including: |
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(1) the maximum handling fee that may be imposed by a |
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clinic or physician dispensing or administering a donated drug; |
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(2) provisions for maintenance of the database of |
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donated drugs; and |
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(3) any necessary forms for the administration of the |
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program. |
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Sec. 431.325. LIMITATION ON CIVIL AND CRIMINAL LIABILITY. |
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(a) Charitable drug donors, charitable medical clinics, |
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physicians, and their employees are not civilly or criminally |
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liable or subject to professional disciplinary action for harm |
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caused by the [accepting,] dispensing[,] or administering of drugs |
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donated under [in strict compliance with] this subchapter unless |
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the harm is caused by: |
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(1) wilful [(i) willful] or wanton acts of |
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negligence; |
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(2) [(ii)] conscious indifference or reckless |
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disregard for the safety of others; or |
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(3) [(iii)] intentional conduct. |
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(b) This section does not limit, or in any way affect or |
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diminish, the liability of a drug seller or manufacturer under |
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[pursuant to] Chapter 82, Civil Practice and Remedies Code. |
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(c) This section does [shall] not apply if the [where] harm |
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results from the failure to [fully and completely] comply with the |
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requirements of this subchapter. |
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(d) This section does [shall] not apply to a charitable |
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medical clinic that fails to comply with the insurance provisions |
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of Chapter 84, Civil Practice and Remedies Code. |
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SECTION 2. Not later than December 1, 2015: |
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(1) the executive commissioner of the Health and Human |
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Services Commission shall adopt any rules necessary to implement |
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Subchapter M, Chapter 431, Health and Safety Code, as amended by |
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this Act; and |
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(2) the Department of State Health Services shall |
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establish the central repository and database required by |
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Subchapter M, Chapter 431, Health and Safety Code, as amended by |
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this Act. |
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SECTION 3. (a) The change in law made by this Act applies |
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only to a drug that is donated, accepted, dispensed, or |
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administered on or after January 1, 2016. |
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(b) Notwithstanding Subsection (a) of this section, a |
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charitable medical clinic that, on January 1, 2016, possesses drugs |
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donated under Subchapter M, Chapter 431, Health and Safety Code, as |
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it existed immediately before the effective date of this Act, may |
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dispense those remaining drugs in accordance with the former law. |
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SECTION 4. This Act takes effect September 1, 2015. |