1 | 1 | | 81R9600 ALB-D |
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2 | 2 | | By: Cook H.B. No. 3156 |
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3 | 3 | | |
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4 | 4 | | |
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5 | 5 | | A BILL TO BE ENTITLED |
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6 | 6 | | AN ACT |
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7 | 7 | | relating to a drug donation program. |
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8 | 8 | | BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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9 | 9 | | SECTION 1. Subtitle A, Title 6, Health and Safety Code, is |
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10 | 10 | | amended by adding Chapter 442 to read as follows: |
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11 | 11 | | CHAPTER 442. DRUG DONATION PROGRAM |
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12 | 12 | | Sec. 442.001. DEFINITIONS. In this chapter: |
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13 | 13 | | (1) "Commission" means the Health and Human Services |
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14 | 14 | | Commission. |
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15 | 15 | | (2) "Department" means the Department of State Health |
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16 | 16 | | Services. |
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17 | 17 | | (3) "Executive commissioner" means the executive |
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18 | 18 | | commissioner of the Health and Human Services Commission. |
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19 | 19 | | (4) "Program" means the drug donation program. |
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20 | 20 | | Sec. 442.002. DRUG DONATION PROGRAM. The department shall |
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21 | 21 | | establish and maintain a drug donation program through which a |
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22 | 22 | | person may donate to a participating pharmacy or health care |
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23 | 23 | | facility an eligible drug for use by an individual who meets the |
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24 | 24 | | eligibility requirements under Section 442.008. |
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25 | 25 | | Sec. 442.003. DONATION. The following persons may donate |
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26 | 26 | | drugs at a pharmacy or health care facility that participates in the |
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27 | 27 | | program: |
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28 | 28 | | (1) an individual who is at least 18 years of age; or |
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29 | 29 | | (2) a pharmacy or health care facility or a |
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30 | 30 | | manufacturer or distributor of an eligible drug. |
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31 | 31 | | Sec. 442.004. DRUGS ELIGIBLE FOR PROGRAM. The Texas State |
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32 | 32 | | Board of Pharmacy and the Texas Medical Board shall adopt rules |
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33 | 33 | | regarding drugs that are eligible for the program, including rules |
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34 | 34 | | regarding: |
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35 | 35 | | (1) the inclusion of drugs used for the treatment of |
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36 | 36 | | cancer; |
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37 | 37 | | (2) the inclusion of non-cancer-related drugs that |
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38 | 38 | | cost more than $50; |
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39 | 39 | | (3) the prohibition of a controlled substance from |
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40 | 40 | | eligibility; and |
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41 | 41 | | (4) a list of eligible drugs. |
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42 | 42 | | Sec. 442.005. DISTRIBUTION OF DONATED DRUGS. A pharmacy or |
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43 | 43 | | health care facility that receives a donated drug through the |
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44 | 44 | | program may distribute the drug to an eligible pharmacy or health |
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45 | 45 | | care facility for use under the program. |
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46 | 46 | | Sec. 442.006. DISPENSATION OF DONATED DRUGS. (a) A |
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47 | 47 | | pharmacy or health care facility may accept and dispense a drug |
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48 | 48 | | through the program only if each of the following conditions is met: |
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49 | 49 | | (1) the drug must be in the drug's original, unopened, |
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50 | 50 | | sealed, and tamper-evident unit dose packaging and include the |
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51 | 51 | | drug's lot number and expiration date, or if packaged in single unit |
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52 | 52 | | doses, the single unit dose packaging must be unopened; |
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53 | 53 | | (2) the drug must have an expiration date later than |
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54 | 54 | | 120 days after the date the drug was donated; |
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55 | 55 | | (3) the drug must be unadulterated and correctly |
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56 | 56 | | branded; |
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57 | 57 | | (4) the drug must be accompanied by the signed donor |
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58 | 58 | | form under Section 442.009; and |
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59 | 59 | | (5) the drug must be inspected by a pharmacist to |
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60 | 60 | | ensure compliance with Subdivisions (1)-(4) before the pharmacist |
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61 | 61 | | may dispense the drug. |
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62 | 62 | | (b) A drug dispensed through the program must be prescribed |
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63 | 63 | | by a medical practitioner for use by an eligible individual and |
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64 | 64 | | dispensed by a pharmacist. |
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65 | 65 | | (c) A pharmacy or health care facility that dispenses a drug |
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66 | 66 | | through the program may charge an individual who receives the drug a |
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67 | 67 | | fee not to exceed the amount specified by executive commissioner |
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68 | 68 | | rule. |
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69 | 69 | | (d) A drug dispensed through the program may not be resold. |
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70 | 70 | | Sec. 442.007. RULES. The executive commissioner shall |
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71 | 71 | | adopt rules regarding the following: |
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72 | 72 | | (1) procedures regarding the storage of donated drugs, |
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73 | 73 | | including environmental conditions, separation of donated drugs |
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74 | 74 | | from non-donated drugs, and security; and |
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75 | 75 | | (2) recordkeeping of donor and recipient forms |
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76 | 76 | | required under Section 442.009. |
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77 | 77 | | Sec. 442.008. ELIGIBILITY REQUIREMENTS. (a) A person is |
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78 | 78 | | eligible to receive drugs through the program if the person is: |
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79 | 79 | | (1) uninsured, underinsured, or a recipient of |
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80 | 80 | | benefits through the medical assistance program under Chapter 32, |
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81 | 81 | | Human Resources Code, or Medicare; or |
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82 | 82 | | (2) a resident of this state who has been diagnosed |
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83 | 83 | | with cancer. |
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84 | 84 | | (b) The department shall prioritize dispensation to |
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85 | 85 | | individuals who are uninsured or indigent and shall permit |
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86 | 86 | | dispensation to other eligible individuals if an uninsured or |
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87 | 87 | | indigent individual is unavailable. |
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88 | 88 | | Sec. 442.009. DONOR FORM. (a) The department shall develop |
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89 | 89 | | forms for individuals who donate drugs to the program and for |
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90 | 90 | | recipients of drugs through the program. |
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91 | 91 | | (b) A person who donates a drug shall sign the donor form. |
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92 | 92 | | (c) A recipient of drugs through the program shall sign a |
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93 | 93 | | form that indicates the donated drug may have been previously |
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94 | 94 | | dispensed. |
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95 | 95 | | Sec. 442.010. REGISTRY FOR ELIGIBLE RECIPIENTS. The |
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96 | 96 | | department shall establish a voluntary registry for individuals who |
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97 | 97 | | are eligible to receive drugs through the program. |
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98 | 98 | | Sec. 442.011. REGISTRY OF PARTICIPATING PHARMACIES. The |
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99 | 99 | | department shall establish on the department's website a voluntary |
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100 | 100 | | registry for pharmacies and health care facilities participating in |
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101 | 101 | | the program. |
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102 | 102 | | Sec. 442.012. LIMITATION ON LIABILITY. (a) A pharmacy, |
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103 | 103 | | health care facility, physician, or pharmacist that participates in |
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104 | 104 | | the program under this chapter is not liable for harm caused by the |
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105 | 105 | | accepting, dispensing, or administering of drugs donated and |
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106 | 106 | | dispensed in substantial compliance with this chapter unless the |
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107 | 107 | | harm is caused by: |
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108 | 108 | | (1) wilful or wanton acts of negligence; |
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109 | 109 | | (2) conscious indifference or reckless disregard for |
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110 | 110 | | the safety of others; or |
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111 | 111 | | (3) intentional conduct. |
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112 | 112 | | (b) This section does not limit, or in any way affect or |
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113 | 113 | | diminish, the liability of a drug seller or manufacturer under |
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114 | 114 | | Chapter 82, Civil Practice and Remedies Code. |
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115 | 115 | | (c) This section does not apply if harm results from the |
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116 | 116 | | failure to fully and completely comply with the requirements of |
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117 | 117 | | Section 442.006 or rules adopted under this chapter. |
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118 | 118 | | (d) This section does not apply to a pharmacy, health care |
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119 | 119 | | facility, pharmacist, physician, or manufacturer that fails to |
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120 | 120 | | comply with the insurance provisions of Chapter 84, Civil Practice |
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121 | 121 | | and Remedies Code. |
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122 | 122 | | (e) Nothing in this chapter requires a pharmacy, |
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123 | 123 | | pharmacist, or medical practitioner to participate in the program. |
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124 | 124 | | Nothing in this chapter requires a person to donate drugs to the |
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125 | 125 | | program. |
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126 | 126 | | Sec. 442.013. OTHER LAW. The drug donation program |
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127 | 127 | | established under this chapter is in addition to the method for |
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128 | 128 | | redistribution of unused drugs established by Section 562.1085, |
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129 | 129 | | Occupations Code, and the drug donation program established under |
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130 | 130 | | Subchapter M, Chapter 431. |
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131 | 131 | | SECTION 2. If before implementing any provision of this Act |
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132 | 132 | | a state agency determines that a waiver or authorization from a |
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133 | 133 | | federal agency is necessary for implementation of that provision, |
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134 | 134 | | the agency affected by the provision shall request the waiver or |
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135 | 135 | | authorization and may delay implementing that provision until the |
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136 | 136 | | waiver or authorization is granted. |
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137 | 137 | | SECTION 3. This Act takes effect September 1, 2009. |
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