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A BILL TO BE ENTITLED
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AN ACT
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relating to a drug donation program. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Subtitle A, Title 6, Health and Safety Code, is |
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amended by adding Chapter 442 to read as follows: |
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CHAPTER 442. DRUG DONATION PROGRAM |
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Sec. 442.001. DEFINITIONS. In this chapter: |
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(1) "Commission" means the Health and Human Services |
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Commission. |
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(2) "Department" means the Department of State Health |
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Services. |
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(3) "Executive commissioner" means the executive |
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commissioner of the Health and Human Services Commission. |
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(4) "Program" means the drug donation program. |
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Sec. 442.002. DRUG DONATION PROGRAM. The department shall |
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establish and maintain a drug donation program through which a |
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person may donate to a participating pharmacy or health care |
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facility an eligible drug for use by an individual who meets the |
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eligibility requirements under Section 442.008. |
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Sec. 442.003. DONATION. The following persons may donate |
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drugs at a pharmacy or health care facility that participates in the |
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program: |
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(1) an individual who is at least 18 years of age; or |
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(2) a pharmacy or health care facility or a |
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manufacturer or distributor of an eligible drug. |
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Sec. 442.004. DRUGS ELIGIBLE FOR PROGRAM. The Texas State |
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Board of Pharmacy and the Texas Medical Board shall adopt rules |
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regarding drugs that are eligible for the program, including rules |
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regarding: |
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(1) the inclusion of drugs used for the treatment of |
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cancer; |
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(2) the inclusion of non-cancer-related drugs that |
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cost more than $50; |
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(3) the prohibition of a controlled substance from |
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eligibility; and |
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(4) a list of eligible drugs. |
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Sec. 442.005. DISTRIBUTION OF DONATED DRUGS. A pharmacy or |
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health care facility that receives a donated drug through the |
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program may distribute the drug to an eligible pharmacy or health |
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care facility for use under the program. |
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Sec. 442.006. DISPENSATION OF DONATED DRUGS. (a) A |
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pharmacy or health care facility may accept and dispense a drug |
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through the program only if each of the following conditions is met: |
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(1) the drug must be in the drug's original, unopened, |
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sealed, and tamper-evident unit dose packaging and include the |
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drug's lot number and expiration date, or if packaged in single unit |
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doses, the single unit dose packaging must be unopened; |
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(2) the drug must have an expiration date later than |
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120 days after the date the drug was donated; |
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(3) the drug must be unadulterated and correctly |
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branded; |
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(4) the drug must be accompanied by the signed donor |
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form under Section 442.009; and |
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(5) the drug must be inspected by a pharmacist to |
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ensure compliance with Subdivisions (1)-(4) before the pharmacist |
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may dispense the drug. |
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(b) A drug dispensed through the program must be prescribed |
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by a medical practitioner for use by an eligible individual and |
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dispensed by a pharmacist. |
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(c) A pharmacy or health care facility that dispenses a drug |
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through the program may charge an individual who receives the drug a |
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fee not to exceed the amount specified by executive commissioner |
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rule. |
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(d) A drug dispensed through the program may not be resold. |
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Sec. 442.007. RULES. The executive commissioner shall |
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adopt rules regarding the following: |
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(1) procedures regarding the storage of donated drugs, |
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including environmental conditions, separation of donated drugs |
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from non-donated drugs, and security; and |
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(2) recordkeeping of donor and recipient forms |
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required under Section 442.009. |
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Sec. 442.008. ELIGIBILITY REQUIREMENTS. (a) A person is |
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eligible to receive drugs through the program if the person is: |
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(1) uninsured, underinsured, or a recipient of |
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benefits through the medical assistance program under Chapter 32, |
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Human Resources Code, or Medicare; or |
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(2) a resident of this state who has been diagnosed |
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with cancer. |
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(b) The department shall prioritize dispensation to |
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individuals who are uninsured or indigent and shall permit |
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dispensation to other eligible individuals if an uninsured or |
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indigent individual is unavailable. |
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Sec. 442.009. DONOR FORM. (a) The department shall develop |
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forms for individuals who donate drugs to the program and for |
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recipients of drugs through the program. |
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(b) A person who donates a drug shall sign the donor form. |
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(c) A recipient of drugs through the program shall sign a |
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form that indicates the donated drug may have been previously |
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dispensed. |
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Sec. 442.010. REGISTRY FOR ELIGIBLE RECIPIENTS. The |
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department shall establish a voluntary registry for individuals who |
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are eligible to receive drugs through the program. |
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Sec. 442.011. REGISTRY OF PARTICIPATING PHARMACIES. The |
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department shall establish on the department's website a voluntary |
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registry for pharmacies and health care facilities participating in |
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the program. |
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Sec. 442.012. LIMITATION ON LIABILITY. (a) A pharmacy, |
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health care facility, physician, or pharmacist that participates in |
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the program under this chapter is not liable for harm caused by the |
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accepting, dispensing, or administering of drugs donated and |
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dispensed in substantial compliance with this chapter unless the |
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harm is caused by: |
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(1) wilful or wanton acts of negligence; |
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(2) conscious indifference or reckless disregard for |
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the safety of others; or |
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(3) 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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Chapter 82, Civil Practice and Remedies Code. |
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(c) This section does not apply if harm results from the |
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failure to fully and completely comply with the requirements of |
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Section 442.006 or rules adopted under this chapter. |
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(d) This section does not apply to a pharmacy, health care |
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facility, pharmacist, physician, or manufacturer that fails to |
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comply with the insurance provisions of Chapter 84, Civil Practice |
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and Remedies Code. |
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(e) Nothing in this chapter requires a pharmacy, |
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pharmacist, or medical practitioner to participate in the program. |
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Nothing in this chapter requires a person to donate drugs to the |
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program. |
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Sec. 442.013. OTHER LAW. The drug donation program |
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established under this chapter is in addition to the method for |
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redistribution of unused drugs established by Section 562.1085, |
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Occupations Code, and the drug donation program established under |
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Subchapter M, Chapter 431. |
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SECTION 2. If before implementing any provision of this Act |
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a state agency determines that a waiver or authorization from a |
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federal agency is necessary for implementation of that provision, |
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the agency affected by the provision shall request the waiver or |
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authorization and may delay implementing that provision until the |
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waiver or authorization is granted. |
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SECTION 3. This Act takes effect September 1, 2011. |