1 | 1 | | 88R1980 KKR-D |
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2 | 2 | | By: Dean H.B. No. 1373 |
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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 pilot program for the safe disposal of controlled |
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8 | 8 | | substance prescription drugs. |
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9 | 9 | | BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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10 | 10 | | SECTION 1. Subtitle A, Title 6, Health and Safety Code, is |
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11 | 11 | | amended by adding Chapter 442A to read as follows: |
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12 | 12 | | CHAPTER 442A. CONTROLLED SUBSTANCE PRESCRIPTION DRUG SAFE DISPOSAL |
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13 | 13 | | PILOT PROGRAM |
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14 | 14 | | SUBCHAPTER A. GENERAL PROVISIONS |
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15 | 15 | | Sec. 442A.001. DEFINITIONS. In this chapter: |
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16 | 16 | | (1) "Board" means the Texas State Board of Pharmacy. |
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17 | 17 | | (2) "Controlled substance" has the meaning assigned by |
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18 | 18 | | Section 481.002. |
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19 | 19 | | (3) "Pharmacy" means a facility licensed under Chapter |
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20 | 20 | | 560, Occupations Code. |
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21 | 21 | | (4) "Pilot program" means the controlled substance |
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22 | 22 | | prescription drug safe disposal pilot program established under |
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23 | 23 | | this chapter. |
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24 | 24 | | (5) "Prescription drug" has the meaning assigned by |
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25 | 25 | | Section 551.003, Occupations Code. |
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26 | 26 | | Sec. 442A.002. CONTROLLED SUBSTANCE PRESCRIPTION DRUG SAFE |
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27 | 27 | | DISPOSAL PILOT PROGRAM. The board by rule shall develop and |
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28 | 28 | | implement a controlled substance prescription drug safe disposal |
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29 | 29 | | pilot program to increase the number of locations in this state in |
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30 | 30 | | which unused controlled substance prescription drugs are collected |
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31 | 31 | | from the public for safe disposal. |
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32 | 32 | | SUBCHAPTER B. PHARMACY PARTICIPATION |
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33 | 33 | | Sec. 442A.051. PHARMACY ELIGIBILITY. A pharmacy operating |
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34 | 34 | | in this state may apply to the board to participate in the pilot |
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35 | 35 | | program if the pharmacy: |
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36 | 36 | | (1) is registered with the United States Drug |
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37 | 37 | | Enforcement Administration; |
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38 | 38 | | (2) is not the subject of state or federal opioid |
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39 | 39 | | litigation; and |
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40 | 40 | | (3) meets the eligibility requirements established by |
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41 | 41 | | board rules. |
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42 | 42 | | Sec. 442A.052. APPLICATION AND SELECTION PROCESSES. (a) |
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43 | 43 | | The board shall adopt rules prescribing: |
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44 | 44 | | (1) the form and manner for a pharmacy to apply for |
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45 | 45 | | participation in the pilot program; and |
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46 | 46 | | (2) evaluation and selection criteria and processes. |
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47 | 47 | | (b) The board shall give priority to a pharmacy applicant |
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48 | 48 | | that: |
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49 | 49 | | (1) does not collect unused controlled substance |
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50 | 50 | | prescription drugs at the time the applicant submits the |
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51 | 51 | | application; or |
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52 | 52 | | (2) is located in a rural or underserved area the board |
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53 | 53 | | designates. |
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54 | 54 | | (c) A pharmacy that operates multiple locations must submit |
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55 | 55 | | an application for each location. |
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56 | 56 | | Sec. 442A.053. COLLECTION RECEPTACLE REQUIREMENTS. A |
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57 | 57 | | participating pharmacy that provides a collection receptacle for |
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58 | 58 | | the safe disposal of controlled substance prescription drugs shall |
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59 | 59 | | ensure the receptacle: |
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60 | 60 | | (1) meets the requirements of 21 C.F.R. Section |
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61 | 61 | | 1317.75; |
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62 | 62 | | (2) is accessible during the pharmacy's regular hours |
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63 | 63 | | of operation; |
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64 | 64 | | (3) allows anonymous returns of unused controlled |
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65 | 65 | | substance prescription drugs; and |
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66 | 66 | | (4) provides disposal of unused controlled substance |
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67 | 67 | | prescription drugs at no cost to the person returning the drugs. |
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68 | 68 | | Sec. 442A.054. MAIL-BACK REQUIREMENTS. A participating |
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69 | 69 | | pharmacy that provides a mail-back program for the safe disposal of |
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70 | 70 | | controlled substance prescription drugs shall: |
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71 | 71 | | (1) ensure the program meets the requirements of 21 |
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72 | 72 | | C.F.R. Section 1317.70; and |
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73 | 73 | | (2) provide at the time the pharmacy dispenses a |
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74 | 74 | | controlled substance prescription drug, at no cost to the person to |
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75 | 75 | | whom the drug is prescribed, a mail-in pouch for the person to |
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76 | 76 | | surrender any unused drugs by mail. |
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77 | 77 | | Sec. 442A.055. PHARMACY MANAGEMENT; RECORDS. A |
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78 | 78 | | participating pharmacy is responsible for the daily management and |
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79 | 79 | | recordkeeping of the pharmacy's controlled substance prescription |
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80 | 80 | | drug safe disposal program in accordance with the pharmacy's United |
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81 | 81 | | States Drug Enforcement Administration registration. |
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82 | 82 | | Sec. 442A.056. TEXAS PREMIER PHARMACY DESIGNATION. (a) |
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83 | 83 | | The board shall designate each pharmacy participating in the pilot |
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84 | 84 | | program as a Texas premier pharmacy provider committed to safe |
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85 | 85 | | opioid disposal. |
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86 | 86 | | (b) A participating pharmacy may use the designation for |
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87 | 87 | | marketing purposes. |
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88 | 88 | | SUBCHAPTER C. BOARD DUTIES |
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89 | 89 | | Sec. 442A.101. PILOT PROGRAM INCENTIVES. (a) The board |
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90 | 90 | | shall assist each pharmacy participating in the pilot program with |
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91 | 91 | | establishing and operating a plan for the safe return of controlled |
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92 | 92 | | substance prescription drugs under the pilot program, including by |
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93 | 93 | | paying the costs of: |
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94 | 94 | | (1) one collection receptacle for each pharmacy |
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95 | 95 | | location; |
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96 | 96 | | (2) supplies necessary for a mail-back program, |
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97 | 97 | | including envelopes and shipping costs; |
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98 | 98 | | (3) destruction of collected drugs through |
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99 | 99 | | incineration; and |
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100 | 100 | | (4) other operational needs as the board determines |
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101 | 101 | | appropriate. |
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102 | 102 | | (b) The board may: |
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103 | 103 | | (1) provide reimbursement costs directly to a |
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104 | 104 | | participating pharmacy for the costs the pharmacy incurs in |
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105 | 105 | | establishing and operating the plan under Subsection (a); or |
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106 | 106 | | (2) contract with a vendor to provide directly to the |
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107 | 107 | | participating pharmacy the supplies and services necessary to |
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108 | 108 | | implement the plan and reimburse the vendor for providing the |
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109 | 109 | | supplies and services. |
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110 | 110 | | (c) Subject to money available for purposes of this chapter, |
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111 | 111 | | the board may provide financial incentives to a pharmacy that is |
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112 | 112 | | providing drug collection services to continue providing those |
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113 | 113 | | services or expand those services to accommodate controlled |
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114 | 114 | | substance prescriptions. The board may provide incentives to a |
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115 | 115 | | chain retail pharmacy for not more than 15 locations. |
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116 | 116 | | Sec. 442A.102. COMMUNITY OUTREACH. (a) The board shall: |
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117 | 117 | | (1) develop and distribute educational outreach |
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118 | 118 | | materials for the public about the availability of safe controlled |
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119 | 119 | | substance prescription drug disposal in this state; |
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120 | 120 | | (2) post the materials on the board's Internet |
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121 | 121 | | website; and |
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122 | 122 | | (3) provide the materials to other state agencies for |
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123 | 123 | | those agencies to conduct the community outreach. |
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124 | 124 | | (b) The educational outreach materials must be in English, |
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125 | 125 | | Spanish, and, if applicable, another language spoken by a |
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126 | 126 | | substantial portion of the residents in a specific area of this |
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127 | 127 | | state. |
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128 | 128 | | Sec. 442A.103. REPORT. Not later than December 1 of each |
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129 | 129 | | even-numbered year, the board shall submit to the governor, the |
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130 | 130 | | lieutenant governor, and the legislature a report that: |
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131 | 131 | | (1) summarizes the results of the pilot program, |
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132 | 132 | | including: |
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133 | 133 | | (A) the number and geographic distribution of |
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134 | 134 | | collection receptacles; |
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135 | 135 | | (B) the amount of controlled substance |
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136 | 136 | | prescription drugs disposed by pharmacies under the pilot program; |
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137 | 137 | | (C) the amount and recipient of money distributed |
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138 | 138 | | under the pilot program; and |
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139 | 139 | | (D) a description of the board's educational |
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140 | 140 | | efforts and outcomes; and |
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141 | 141 | | (2) recommends whether the pilot program should |
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142 | 142 | | continue, be expanded, or terminate or whether the board should |
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143 | 143 | | permanently implement a controlled substance prescription drug |
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144 | 144 | | safe disposal program. |
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145 | 145 | | SUBCHAPTER D. FUNDING |
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146 | 146 | | Sec. 442A.151. FUNDING. (a) Money contained in the opioid |
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147 | 147 | | abatement account established under Section 403.505, Government |
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148 | 148 | | Code, as added by Chapter 781 (S.B. 1827), Acts of the 87th |
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149 | 149 | | Legislature, Regular Session, 2021, may be appropriated to the |
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150 | 150 | | board to fund the pilot program established under this chapter. |
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151 | 151 | | (b) The board may collect gifts, grants, and donations to |
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152 | 152 | | fund the program. |
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153 | 153 | | SUBCHAPTER E. EXPIRATION |
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154 | 154 | | Sec. 442A.201. EXPIRATION. This chapter expires September |
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155 | 155 | | 1, 2029. |
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156 | 156 | | SECTION 2. As soon as practicable after the effective date |
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157 | 157 | | of this Act, the Texas State Board of Pharmacy shall implement the |
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158 | 158 | | controlled substance prescription drug safe disposal pilot program |
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159 | 159 | | developed under Chapter 442A, Health and Safety Code, as added by |
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160 | 160 | | this Act. |
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161 | 161 | | SECTION 3. This Act takes effect September 1, 2023. |
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