1 | 1 | | 86R11824 JSC-F |
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2 | 2 | | By: Kolkhorst S.B. No. 1233 |
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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 controlled substance prescriptions under the Texas |
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8 | 8 | | Controlled Substances Act; authorizing a fee. |
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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. Section 552.118, Government Code, is amended to |
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11 | 11 | | read as follows: |
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12 | 12 | | Sec. 552.118. EXCEPTION: CONFIDENTIALITY OF OFFICIAL |
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13 | 13 | | PRESCRIPTION PROGRAM INFORMATION. Information is excepted from the |
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14 | 14 | | requirements of Section 552.021 if it is: |
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15 | 15 | | (1) information on or derived from an official |
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16 | 16 | | prescription form filed with the Texas State Board of Pharmacy |
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17 | 17 | | under Section 481.0755, Health and Safety Code, or an electronic |
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18 | 18 | | prescription record filed with the Texas State Board of Pharmacy |
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19 | 19 | | under Section 481.075, Health and Safety Code; or |
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20 | 20 | | (2) other information collected under Section 481.075 |
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21 | 21 | | or 481.0755 of that code. |
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22 | 22 | | SECTION 2. Sections 481.002(10) and (47), Health and Safety |
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23 | 23 | | Code, are amended to read as follows: |
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24 | 24 | | (10) "Designated agent" means an individual |
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25 | 25 | | designated under Section 481.074(b-2) [481.073] to communicate a |
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26 | 26 | | practitioner's instructions to a pharmacist in an emergency. |
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27 | 27 | | (47) "Official prescription form" means a |
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28 | 28 | | prescription form that is used for a Schedule II controlled |
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29 | 29 | | substance under Section 481.0755 and contains the prescription |
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30 | 30 | | information required by Section 481.0755(e) [481.075]. |
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31 | 31 | | SECTION 3. Section 481.003(a), Health and Safety Code, is |
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32 | 32 | | amended to read as follows: |
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33 | 33 | | (a) The director may adopt rules to administer and enforce |
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34 | 34 | | this chapter, other than Sections [481.073,] 481.074, 481.075, |
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35 | 35 | | 481.0755, 481.0756, 481.076, 481.0761, 481.0762, 481.0763, |
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36 | 36 | | 481.07635, 481.07636, 481.0764, 481.0765, and 481.0766. The board |
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37 | 37 | | may adopt rules to administer Sections [481.073,] 481.074, 481.075, |
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38 | 38 | | 481.0755, 481.0756, 481.076, 481.0761, 481.0762, 481.0763, |
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39 | 39 | | 481.07635, 481.07636, 481.0764, 481.0765, and 481.0766. |
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40 | 40 | | SECTION 4. Section 481.074, Health and Safety Code, is |
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41 | 41 | | amended by amending Subsections (b), (c), (e), (f), (g), (h), (k), |
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42 | 42 | | and (q) and adding Subsections (b-1) and (b-2) to read as follows: |
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43 | 43 | | (b) Except in an emergency as defined by board rule under |
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44 | 44 | | Subsection (b-1) [of the board] or as otherwise provided by |
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45 | 45 | | [Subsection (o) or] Section 481.075(j) or (m) or 481.0755, a person |
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46 | 46 | | may not dispense or administer a controlled substance [listed in |
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47 | 47 | | Schedule II without a written prescription of a practitioner on an |
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48 | 48 | | official prescription form or] without an electronic prescription |
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49 | 49 | | that meets the requirements of and is completed by the practitioner |
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50 | 50 | | in accordance with Section 481.075. |
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51 | 51 | | (b-1) In an emergency as defined by board rule, a person may |
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52 | 52 | | dispense or administer a controlled substance [listed in Schedule |
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53 | 53 | | II] on the oral or telephonically communicated prescription of a |
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54 | 54 | | practitioner. The person who administers or dispenses the |
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55 | 55 | | substance shall: |
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56 | 56 | | (1) if the person is a prescribing practitioner or a |
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57 | 57 | | pharmacist, promptly comply with Subsection (c); or |
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58 | 58 | | (2) if the person is not a prescribing practitioner or |
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59 | 59 | | a pharmacist, promptly write the oral or telephonically |
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60 | 60 | | communicated prescription and include in the written record of the |
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61 | 61 | | prescription the name, address, and Federal Drug Enforcement |
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62 | 62 | | Administration number issued for prescribing a controlled |
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63 | 63 | | substance in this state of the prescribing practitioner, all |
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64 | 64 | | information required to be provided by a practitioner under Section |
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65 | 65 | | 481.075(e)(1), and all information required to be provided by a |
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66 | 66 | | dispensing pharmacist under Section 481.075(e)(2). |
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67 | 67 | | (b-2) In an emergency described by Subsection (b-1), an |
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68 | 68 | | agent designated in writing by a practitioner defined by Section |
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69 | 69 | | 481.002(39)(A) may communicate a prescription by telephone. A |
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70 | 70 | | practitioner who designates a different agent shall designate that |
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71 | 71 | | agent in writing and maintain the designation in the same manner in |
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72 | 72 | | which the practitioner initially designated an agent under this |
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73 | 73 | | subsection. On the request of a pharmacist, a practitioner shall |
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74 | 74 | | furnish a copy of the written designation. This subsection does not |
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75 | 75 | | relieve a practitioner or the practitioner's designated agent from |
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76 | 76 | | the requirement of Subchapter A, Chapter 562, Occupations Code. A |
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77 | 77 | | practitioner is personally responsible for the actions of the |
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78 | 78 | | designated agent in communicating a prescription to a pharmacist. |
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79 | 79 | | (c) Not later than the seventh day after the date a |
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80 | 80 | | prescribing practitioner authorizes an emergency oral or |
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81 | 81 | | telephonically communicated prescription, the prescribing |
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82 | 82 | | practitioner shall cause an [a written or] electronic prescription, |
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83 | 83 | | completed in the manner required by Section 481.075, to be |
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84 | 84 | | delivered to the dispensing pharmacist at the pharmacy where the |
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85 | 85 | | prescription was dispensed. [A written prescription may be |
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86 | 86 | | delivered in person or by mail. The envelope of a prescription |
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87 | 87 | | delivered by mail must be postmarked not later than the seventh day |
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88 | 88 | | after the date the prescription was authorized. On receipt of a |
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89 | 89 | | written prescription, the dispensing pharmacy shall file the |
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90 | 90 | | transcription of the telephonically communicated prescription and |
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91 | 91 | | the pharmacy copy and shall send information to the board as |
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92 | 92 | | required by Section 481.075.] On receipt of the [an] electronic |
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93 | 93 | | prescription, the pharmacist shall annotate the electronic |
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94 | 94 | | prescription record with the original authorization and date of the |
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95 | 95 | | emergency oral or telephonically communicated prescription. |
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96 | 96 | | (e) The partial filling of a prescription for a controlled |
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97 | 97 | | substance listed in Schedule II is permissible in accordance with |
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98 | 98 | | applicable federal law[, if the pharmacist is unable to supply the |
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99 | 99 | | full quantity called for in a written or electronic prescription or |
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100 | 100 | | emergency oral prescription and the pharmacist makes a notation of |
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101 | 101 | | the quantity supplied on the face of the written prescription, on |
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102 | 102 | | the written record of the emergency oral prescription, or in the |
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103 | 103 | | electronic prescription record. The remaining portion of the |
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104 | 104 | | prescription may be filled within 72 hours of the first partial |
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105 | 105 | | filling; however, if the remaining portion is not or cannot be |
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106 | 106 | | filled within the 72-hour period, the pharmacist shall so notify |
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107 | 107 | | the prescribing individual practitioner. No further quantity may |
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108 | 108 | | be supplied beyond 72 hours without a new prescription]. |
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109 | 109 | | (f) A prescription for a Schedule II controlled substance |
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110 | 110 | | for a patient in a long-term care facility (LTCF) or for a patient |
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111 | 111 | | with a medical diagnosis documenting a terminal illness may be |
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112 | 112 | | filled in partial quantities to include individual dosage units. |
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113 | 113 | | If there is any question about whether a patient may be classified |
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114 | 114 | | as having a terminal illness, the pharmacist must contact the |
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115 | 115 | | practitioner before partially filling the prescription. Both the |
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116 | 116 | | pharmacist and the practitioner have a corresponding |
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117 | 117 | | responsibility to assure that the controlled substance is for a |
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118 | 118 | | terminally ill patient. The pharmacist must record the |
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119 | 119 | | prescription [on an official prescription form or] in the |
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120 | 120 | | electronic prescription record and must indicate [on the official |
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121 | 121 | | prescription form or] in the electronic prescription record whether |
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122 | 122 | | the patient is "terminally ill" or an "LTCF patient." A |
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123 | 123 | | prescription that is partially filled and does not contain the |
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124 | 124 | | notation "terminally ill" or "LTCF patient" is considered to have |
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125 | 125 | | been filled in violation of this chapter. For each partial filling, |
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126 | 126 | | the dispensing pharmacist shall record [on the back of the official |
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127 | 127 | | prescription form or] in the electronic prescription record the |
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128 | 128 | | date of the partial filling, the quantity dispensed, the remaining |
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129 | 129 | | quantity authorized to be dispensed, and the identification of the |
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130 | 130 | | dispensing pharmacist. Before any subsequent partial filling, the |
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131 | 131 | | pharmacist must determine that the additional partial filling is |
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132 | 132 | | necessary. The total quantity of Schedule II controlled substances |
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133 | 133 | | dispensed in all partial fillings may not exceed the total quantity |
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134 | 134 | | prescribed. Schedule II prescriptions for patients in a long-term |
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135 | 135 | | care facility or patients with a medical diagnosis documenting a |
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136 | 136 | | terminal illness are valid for a period not to exceed 60 days |
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137 | 137 | | following the issue date unless sooner terminated by discontinuance |
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138 | 138 | | of the medication. |
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139 | 139 | | (g) A person may not dispense a controlled substance in |
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140 | 140 | | Schedule III or IV that is a prescription drug under the Federal |
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141 | 141 | | Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) without |
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142 | 142 | | a [written, electronic, oral, or telephonically communicated] |
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143 | 143 | | prescription of a practitioner defined by Section 481.002(39)(A) or |
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144 | 144 | | (D), except that the practitioner may dispense the substance |
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145 | 145 | | directly to an ultimate user. A prescription for a controlled |
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146 | 146 | | substance listed in Schedule III or IV may not be filled or refilled |
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147 | 147 | | later than six months after the date on which the prescription is |
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148 | 148 | | issued and may not be refilled more than five times, unless the |
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149 | 149 | | prescription is renewed by the practitioner. A prescription under |
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150 | 150 | | this subsection must comply with other applicable state and federal |
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151 | 151 | | laws. |
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152 | 152 | | (h) A pharmacist may dispense a controlled substance listed |
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153 | 153 | | in Schedule III, IV, or V under a [written, electronic, oral, or |
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154 | 154 | | telephonically communicated] prescription issued by a practitioner |
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155 | 155 | | defined by Section 481.002(39)(C) [and] only if the pharmacist |
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156 | 156 | | determines that the prescription was issued for a valid medical |
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157 | 157 | | purpose and in the course of professional practice. A prescription |
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158 | 158 | | described by [issued under] this subsection may not be filled or |
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159 | 159 | | refilled later than six months after the date the prescription is |
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160 | 160 | | issued and may not be refilled more than five times, unless the |
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161 | 161 | | prescription is renewed by the practitioner. |
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162 | 162 | | (k) A prescription for a controlled substance must show: |
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163 | 163 | | (1) the quantity of the substance prescribed: |
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164 | 164 | | (A) [numerically, followed by the number written |
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165 | 165 | | as a word, if the prescription is written; |
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166 | 166 | | [(B)] numerically, if the prescription is |
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167 | 167 | | electronic; or |
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168 | 168 | | (B) [(C)] if the prescription is communicated |
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169 | 169 | | orally or telephonically, as transcribed by the receiving |
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170 | 170 | | pharmacist; |
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171 | 171 | | (2) the date of issue; |
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172 | 172 | | (2-a) if the prescription is issued for a Schedule II |
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173 | 173 | | controlled substance to be filled at a later date under Subsection |
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174 | 174 | | (d-1), the earliest date on which a pharmacy may fill the |
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175 | 175 | | prescription; |
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176 | 176 | | (3) the name, address, and date of birth or age of the |
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177 | 177 | | patient or, if the controlled substance is prescribed for an |
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178 | 178 | | animal, the species of the animal and the name and address of its |
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179 | 179 | | owner; |
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180 | 180 | | (4) the name and strength of the controlled substance |
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181 | 181 | | prescribed; |
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182 | 182 | | (5) the directions for use of the controlled |
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183 | 183 | | substance; |
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184 | 184 | | (6) the intended use of the substance prescribed |
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185 | 185 | | unless the practitioner determines the furnishing of this |
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186 | 186 | | information is not in the best interest of the patient; and |
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187 | 187 | | (7) the name, address, Federal Drug Enforcement |
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188 | 188 | | Administration number, and telephone number of the practitioner at |
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189 | 189 | | the practitioner's usual place of business[, which must be legibly |
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190 | 190 | | printed or stamped on a written prescription; and |
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191 | 191 | | [(8) if the prescription is handwritten, the signature |
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192 | 192 | | of the prescribing practitioner]. |
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193 | 193 | | (q) Each dispensing pharmacist shall send all required |
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194 | 194 | | information[, including any information required to complete the |
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195 | 195 | | Schedule III through V prescription forms,] to the board by |
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196 | 196 | | electronic transfer or another form approved by the board not later |
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197 | 197 | | than the next business day after the date the prescription is |
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198 | 198 | | completely filled. |
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199 | 199 | | SECTION 5. The heading to Section 481.075, Health and |
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200 | 200 | | Safety Code, is amended to read as follows: |
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201 | 201 | | Sec. 481.075. SCHEDULE II PRESCRIPTIONS [OFFICIAL |
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202 | 202 | | PRESCRIPTION PROGRAM]. |
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203 | 203 | | SECTION 6. Sections 481.075(a), (e), (g), (h), (i), and |
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204 | 204 | | (j), Health and Safety Code, are amended to read as follows: |
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205 | 205 | | (a) A practitioner who prescribes a controlled substance |
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206 | 206 | | listed in Schedule II shall, except as provided by Section |
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207 | 207 | | 481.074(b-1) or 481.0755 or a rule adopted under Section 481.0761, |
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208 | 208 | | record the prescription [on an official prescription form or] in an |
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209 | 209 | | electronic prescription that includes the information required by |
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210 | 210 | | this section. |
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211 | 211 | | (e) Each [official prescription form or electronic] |
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212 | 212 | | prescription used to prescribe a Schedule II controlled substance |
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213 | 213 | | must contain: |
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214 | 214 | | (1) information provided by the prescribing |
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215 | 215 | | practitioner, including: |
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216 | 216 | | (A) the date the prescription is issued; |
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217 | 217 | | (B) the controlled substance prescribed; |
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218 | 218 | | (C) the quantity of controlled substance |
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219 | 219 | | prescribed, shown[: |
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220 | 220 | | [(i)] numerically[, followed by the number |
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221 | 221 | | written as a word, if the prescription is written; or |
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222 | 222 | | [(ii) numerically, if the prescription is |
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223 | 223 | | electronic]; |
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224 | 224 | | (D) the intended use of the controlled substance, |
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225 | 225 | | or the diagnosis for which the controlled substance [it] is |
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226 | 226 | | prescribed, and the instructions for use of the substance; |
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227 | 227 | | (E) the practitioner's name, address, and |
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228 | 228 | | Federal Drug Enforcement Administration number issued for |
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229 | 229 | | prescribing a controlled substance in this state; |
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230 | 230 | | (F) the name, address, and date of birth or age of |
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231 | 231 | | the person for whom the controlled substance is prescribed; and |
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232 | 232 | | (G) if the prescription is issued to be filled at |
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233 | 233 | | a later date under Section 481.074(d-1), the earliest date on which |
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234 | 234 | | a pharmacy may fill the prescription; |
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235 | 235 | | (2) information provided by the dispensing |
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236 | 236 | | pharmacist, including the date the prescription is filled; and |
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237 | 237 | | (3) [for a written prescription, the signatures of the |
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238 | 238 | | prescribing practitioner and the dispensing pharmacist or for an |
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239 | 239 | | electronic prescription,] the prescribing practitioner's |
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240 | 240 | | electronic signature or other secure method of validation |
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241 | 241 | | authorized by federal law. |
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242 | 242 | | (g) Except for an emergency oral or telephonically |
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243 | 243 | | communicated prescription described by [prescribed under] Section |
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244 | 244 | | 481.074(b-1) [481.074(b)], the prescribing practitioner shall: |
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245 | 245 | | (1) record [legibly fill in,] or direct a designated |
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246 | 246 | | agent to record [legibly fill in, on the official prescription form |
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247 | 247 | | or] in the electronic prescription[,] each item of information |
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248 | 248 | | required to be provided by the prescribing practitioner under |
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249 | 249 | | Subsection (e)(1), unless the practitioner determines that: |
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250 | 250 | | (A) under rule adopted by the board for this |
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251 | 251 | | purpose, it is unnecessary for the practitioner or the |
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252 | 252 | | practitioner's agent to provide the patient identification number; |
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253 | 253 | | or |
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254 | 254 | | (B) it is not in the best interest of the patient |
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255 | 255 | | for the practitioner or practitioner's agent to provide information |
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256 | 256 | | regarding the intended use of the controlled substance or the |
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257 | 257 | | diagnosis for which it is prescribed; and |
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258 | 258 | | (2) [sign the official prescription form and give the |
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259 | 259 | | form to the person authorized to receive the prescription or, in the |
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260 | 260 | | case of an electronic prescription,] electronically sign or |
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261 | 261 | | validate the electronic prescription as authorized by federal law |
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262 | 262 | | and transmit the prescription to the dispensing pharmacy. |
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263 | 263 | | (h) In the case of an emergency oral or telephonically |
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264 | 264 | | communicated prescription described by [prescribed under] Section |
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265 | 265 | | 481.074(b-1) [481.074(b)], the prescribing practitioner shall give |
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266 | 266 | | the dispensing pharmacy the information needed to complete the |
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267 | 267 | | [official prescription form or] electronic prescription record. |
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268 | 268 | | (i) Each dispensing pharmacist shall: |
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269 | 269 | | (1) [fill in on the official prescription form or] |
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270 | 270 | | note in the electronic prescription record each item of information |
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271 | 271 | | given orally to the dispensing pharmacy under Subsection (h) and |
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272 | 272 | | the date the prescription is filled[,] and[: |
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273 | 273 | | [(A) for a written prescription, fill in the |
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274 | 274 | | dispensing pharmacist's signature; or |
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275 | 275 | | [(B) for an electronic prescription,] |
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276 | 276 | | appropriately record the identity of the dispensing pharmacist in |
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277 | 277 | | the electronic prescription record; |
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278 | 278 | | (2) retain with the records of the pharmacy for at |
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279 | 279 | | least two years: |
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280 | 280 | | (A) [the official prescription form or] the |
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281 | 281 | | electronic prescription record[, as applicable]; and |
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282 | 282 | | (B) the name or other patient identification |
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283 | 283 | | required by Section 481.074(m) or (n); and |
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284 | 284 | | (3) send all required information, including any |
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285 | 285 | | information required to complete an [official prescription form or] |
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286 | 286 | | electronic prescription record, to the board by electronic transfer |
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287 | 287 | | or another form approved by the board not later than the next |
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288 | 288 | | business day after the date the prescription is completely filled. |
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289 | 289 | | (j) A medication order written for a patient who is admitted |
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290 | 290 | | to a hospital at the time the medication order is written and filled |
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291 | 291 | | is not required to be recorded [on an official prescription form or] |
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292 | 292 | | in an electronic prescription record that meets the requirements of |
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293 | 293 | | this section. |
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294 | 294 | | SECTION 7. Subchapter C, Chapter 481, Health and Safety |
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295 | 295 | | Code, is amended by adding Sections 481.0755 and 481.0756 to read as |
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296 | 296 | | follows: |
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297 | 297 | | Sec. 481.0755. WRITTEN, ORAL, AND TELEPHONICALLY |
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298 | 298 | | COMMUNICATED PRESCRIPTIONS. (a) Notwithstanding Sections 481.074 |
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299 | 299 | | and 481.075, a prescription for a controlled substance is not |
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300 | 300 | | required to be issued electronically and may be issued in writing if |
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301 | 301 | | the prescription is issued: |
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302 | 302 | | (1) by a veterinarian; |
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303 | 303 | | (2) in circumstances in which electronic prescribing |
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304 | 304 | | is not available due to temporary technological or electronic |
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305 | 305 | | failure, as prescribed by board rule; |
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306 | 306 | | (3) by a practitioner to be dispensed by a pharmacy |
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307 | 307 | | located outside this state, as prescribed by board rule; |
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308 | 308 | | (4) when the prescriber and dispenser are in the same |
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309 | 309 | | location or under the same license; |
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310 | 310 | | (5) in circumstances in which necessary elements are |
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311 | 311 | | not supported by the most recently implemented national data |
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312 | 312 | | standard that facilitates electronic prescribing; |
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313 | 313 | | (6) for a drug for which the United States Food and |
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314 | 314 | | Drug Administration requires additional information in the |
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315 | 315 | | prescription that is not possible with electronic prescribing; |
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316 | 316 | | (7) for a non-patient-specific prescription pursuant |
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317 | 317 | | to a standing order, approved protocol for drug therapy, |
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318 | 318 | | collaborative drug management, or comprehensive medication |
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319 | 319 | | management, in response to a public health emergency or in other |
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320 | 320 | | circumstances in which the practitioner may issue a |
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321 | 321 | | non-patient-specific prescription; |
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322 | 322 | | (8) for a drug under a research protocol; |
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323 | 323 | | (9) by a practitioner who has received a waiver under |
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324 | 324 | | Section 481.0756 from the requirement to use electronic |
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325 | 325 | | prescribing; |
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326 | 326 | | (10) under circumstances in which the practitioner has |
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327 | 327 | | the present ability to submit an electronic prescription but |
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328 | 328 | | reasonably determines that it would be impractical for the patient |
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329 | 329 | | to obtain the drugs prescribed under the electronic prescription in |
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330 | 330 | | a timely manner and that a delay would adversely impact the |
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331 | 331 | | patient's medical condition; or |
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332 | 332 | | (11) before January 1, 2021. |
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333 | 333 | | (b) A dispensing pharmacist who receives a controlled |
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334 | 334 | | substance prescription in a manner other than electronically is not |
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335 | 335 | | required to verify that the prescription is exempt from the |
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336 | 336 | | requirement that it be submitted electronically. The pharmacist |
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337 | 337 | | may dispense a controlled substance pursuant to an otherwise valid |
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338 | 338 | | written, oral, or telephonically communicated prescription |
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339 | 339 | | consistent with the requirements of this subchapter. |
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340 | 340 | | (c) Except in an emergency, a practitioner must use a |
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341 | 341 | | written prescription to submit a prescription described by |
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342 | 342 | | Subsection (a). In an emergency, the practitioner may submit an |
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343 | 343 | | oral or telephonically communicated prescription as authorized |
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344 | 344 | | under Section 481.074(b-1). |
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345 | 345 | | (d) A written prescription for a controlled substance other |
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346 | 346 | | than a Schedule II controlled substance must include the |
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347 | 347 | | information required under Section 481.074(k) and the signature of |
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348 | 348 | | the prescribing practitioner. |
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349 | 349 | | (e) A written prescription for a Schedule II controlled |
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350 | 350 | | substance must be on an official prescription form and include the |
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351 | 351 | | information required for an electronic prescription under Section |
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352 | 352 | | 481.075(e), the signature of the practitioner, and the signature of |
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353 | 353 | | the dispensing pharmacist after the prescription is filled. |
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354 | 354 | | (f) The board by rule shall authorize a practitioner to |
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355 | 355 | | determine whether it is necessary to obtain a particular patient |
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356 | 356 | | identification number and to provide that number on the official |
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357 | 357 | | prescription form. |
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358 | 358 | | (g) On request of a practitioner, the board shall issue |
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359 | 359 | | official prescription forms to the practitioner for a fee covering |
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360 | 360 | | the actual cost of printing, processing, and mailing the forms. |
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361 | 361 | | Before mailing or otherwise delivering prescription forms to a |
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362 | 362 | | practitioner, the board shall print on each form the number of the |
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363 | 363 | | form and any other information the board determines is necessary. |
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364 | 364 | | (h) Each official prescription form must be sequentially |
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365 | 365 | | numbered. |
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366 | 366 | | (i) A person may not obtain an official prescription form |
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367 | 367 | | unless the person is a practitioner as defined by Section |
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368 | 368 | | 481.002(39)(A) or an institutional practitioner. |
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369 | 369 | | (j) Not more than one Schedule II prescription may be |
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370 | 370 | | recorded on an official prescription form. |
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371 | 371 | | (k) Not later than the 30th day after the date a |
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372 | 372 | | practitioner's Federal Drug Enforcement Administration number or |
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373 | 373 | | license to practice has been denied, suspended, canceled, |
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374 | 374 | | surrendered, or revoked, the practitioner shall return to the board |
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375 | 375 | | all official prescription forms in the practitioner's possession |
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376 | 376 | | that have not been used for prescriptions. |
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377 | 377 | | (l) Each prescribing practitioner: |
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378 | 378 | | (1) may use an official prescription form only to |
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379 | 379 | | submit a prescription described by Subsection (a); |
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380 | 380 | | (2) shall date or sign an official prescription form |
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381 | 381 | | only on the date the prescription is issued; and |
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382 | 382 | | (3) shall take reasonable precautionary measures to |
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383 | 383 | | ensure that an official prescription form issued to the |
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384 | 384 | | practitioner is not used by another person to violate this |
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385 | 385 | | subchapter or a rule adopted under this subchapter. |
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386 | 386 | | (m) In the case of an emergency oral or telephonically |
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387 | 387 | | communicated prescription described by Section 481.074(b-1), the |
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388 | 388 | | prescribing practitioner shall give the dispensing pharmacy the |
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389 | 389 | | information needed to complete the official prescription form if |
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390 | 390 | | the pharmacy is not required to use the electronic prescription |
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391 | 391 | | record. |
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392 | 392 | | (n) Each dispensing pharmacist receiving an oral or |
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393 | 393 | | telephonically communicated prescription under Subsection (m) |
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394 | 394 | | shall: |
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395 | 395 | | (1) fill in on the official prescription form each |
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396 | 396 | | item of information given orally to the dispensing pharmacy under |
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397 | 397 | | Subsection (m) and the date the prescription is filled and fill in |
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398 | 398 | | the dispensing pharmacist's signature; |
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399 | 399 | | (2) retain with the records of the pharmacy for at |
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400 | 400 | | least two years: |
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401 | 401 | | (A) the official prescription form; and |
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402 | 402 | | (B) the name or other patient identification |
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403 | 403 | | required by Section 481.074(m) or (n); and |
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404 | 404 | | (3) send all required information, including any |
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405 | 405 | | information required to complete an official prescription form, to |
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406 | 406 | | the board by electronic transfer or another form approved by the |
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407 | 407 | | board not later than the next business day after the date the |
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408 | 408 | | prescription is completely filled. |
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409 | 409 | | Sec. 481.0756. WAIVERS FROM ELECTRONIC PRESCRIBING. (a) |
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410 | 410 | | The appropriate regulatory agency that issued the license, |
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411 | 411 | | certification, or registration to a prescriber is authorized to |
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412 | 412 | | grant a prescriber a waiver from the electronic prescribing |
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413 | 413 | | requirement under the provisions of this section. |
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414 | 414 | | (b) The board shall convene an interagency workgroup that |
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415 | 415 | | includes representatives of each regulatory agency that issues a |
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416 | 416 | | license, certification, or registration to a prescriber. |
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417 | 417 | | (c) The work group described by Subsection (b) shall |
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418 | 418 | | establish recommendations and standards for circumstances in which |
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419 | 419 | | a waiver from the electronic prescribing requirement is appropriate |
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420 | 420 | | and a process under which a prescriber may request and receive a |
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421 | 421 | | waiver. |
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422 | 422 | | (d) The board shall adopt rules establishing the |
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423 | 423 | | eligibility for a waiver, including: |
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424 | 424 | | (1) economic hardship; |
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425 | 425 | | (2) technological limitations not reasonably within |
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426 | 426 | | the control of the prescriber; or |
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427 | 427 | | (3) other exceptional circumstances demonstrated by |
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428 | 428 | | the prescriber. |
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429 | 429 | | (e) Each regulatory agency that issues a license, |
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430 | 430 | | certification, or registration to a prescriber shall adopt rules |
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431 | 431 | | for the granting of waivers consistent with the board rules adopted |
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432 | 432 | | under Subsection (d). |
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433 | 433 | | (f) A waiver may be issued to a prescriber for a period of |
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434 | 434 | | one year. On expiration of the waiver, the prescriber may reapply |
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435 | 435 | | for a waiver if the circumstances that necessitated the waiver |
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436 | 436 | | continue. |
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437 | 437 | | SECTION 8. Sections 481.0761(c) and (d), Health and Safety |
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438 | 438 | | Code, are amended to read as follows: |
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439 | 439 | | (c) The board by rule may: |
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440 | 440 | | (1) [permit more than one prescription to be |
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441 | 441 | | administered or dispensed and recorded on one prescription form for |
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442 | 442 | | a Schedule III through V controlled substance; |
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443 | 443 | | [(1-a)] establish a procedure for the issuance of |
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444 | 444 | | multiple prescriptions of a Schedule II controlled substance under |
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445 | 445 | | Section 481.074(d-1); |
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446 | 446 | | (2) remove from or return to the official prescription |
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447 | 447 | | program any aspect of a practitioner's or pharmacist's hospital |
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448 | 448 | | practice, including administering or dispensing; |
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449 | 449 | | (3) waive or delay any requirement relating to the |
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450 | 450 | | time or manner of reporting; |
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451 | 451 | | (4) establish compatibility protocols for electronic |
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452 | 452 | | data transfer hardware, software, or format, including any |
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453 | 453 | | necessary modifications for participation in a database described |
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454 | 454 | | by Section 481.076(j); |
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455 | 455 | | (5) establish a procedure to control the release of |
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456 | 456 | | information under Sections 481.074, 481.075, and 481.076; and |
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457 | 457 | | (6) establish a minimum level of prescription activity |
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458 | 458 | | below which a reporting activity may be modified or deleted. |
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459 | 459 | | (d) The board by rule shall authorize a practitioner to |
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460 | 460 | | determine whether it is necessary to obtain a particular patient |
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461 | 461 | | identification number and to provide that number [on the official |
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462 | 462 | | prescription form or] in the electronic prescription record. |
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463 | 463 | | SECTION 9. Subchapter C, Chapter 481, Health and Safety |
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464 | 464 | | Code, is amended by adding Sections 481.07635 and 481.07636 to read |
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465 | 465 | | as follows: |
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466 | 466 | | Sec. 481.07635. CONTINUING EDUCATION. (a) A person |
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467 | 467 | | authorized to receive information under Section 481.076(a)(5) |
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468 | 468 | | shall, not later than the first anniversary after the person is |
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469 | 469 | | issued a license, certification, or registration to prescribe or |
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470 | 470 | | dispense controlled substances under this chapter, complete two |
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471 | 471 | | hours of professional education related to approved procedures of |
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472 | 472 | | prescribing and monitoring controlled substances. |
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473 | 473 | | (b) A person authorized to receive information may annually |
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474 | 474 | | take the professional education course under this section to fulfil |
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475 | 475 | | hours toward the ethics education requirement of the person's |
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476 | 476 | | license, certification, or registration. |
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477 | 477 | | (c) The regulatory agency that issued the license, |
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478 | 478 | | certification, or registration to a person authorized to receive |
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479 | 479 | | information under Section 481.076(a)(5) shall approve professional |
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480 | 480 | | education to satisfy the requirements of this section. |
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481 | 481 | | Sec. 481.07636. OPIOID PRESCRIPTION LIMITS. (a) In this |
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482 | 482 | | section, "acute pain" means pain with abrupt onset that is caused by |
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483 | 483 | | an injury or other process that is not ongoing. The term does not |
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484 | 484 | | include: |
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485 | 485 | | (1) chronic pain; |
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486 | 486 | | (2) pain being treated as part of cancer care; |
---|
487 | 487 | | (3) pain being treated as part of hospice or other |
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488 | 488 | | end-of-life care; or |
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489 | 489 | | (4) pain being treated as part of palliative care. |
---|
490 | 490 | | (b) For the initial treatment of acute pain, a practitioner |
---|
491 | 491 | | may not: |
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492 | 492 | | (1) issue a prescription for an opioid in an amount |
---|
493 | 493 | | that exceeds a seven-day supply; or |
---|
494 | 494 | | (2) provide for a refill of an opioid. |
---|
495 | 495 | | (c) Subsection (b) does not apply to a prescription for an |
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496 | 496 | | opioid approved by the United States Food and Drug Administration |
---|
497 | 497 | | for the treatment of substance addiction that is issued by a |
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498 | 498 | | practitioner for the treatment of substance addiction. |
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499 | 499 | | (d) A dispenser is not subject to criminal, civil, or |
---|
500 | 500 | | administrative penalties for dispensing or refusing to dispense a |
---|
501 | 501 | | controlled substance under a prescription that exceeds the limits |
---|
502 | 502 | | provided by Subsection (b). |
---|
503 | 503 | | SECTION 10. Section 481.128(a), Health and Safety Code, is |
---|
504 | 504 | | amended to read as follows: |
---|
505 | 505 | | (a) A registrant or dispenser commits an offense if the |
---|
506 | 506 | | registrant or dispenser knowingly: |
---|
507 | 507 | | (1) distributes, delivers, administers, or dispenses |
---|
508 | 508 | | a controlled substance in violation of Subchapter C [Sections |
---|
509 | 509 | | 481.070-481.075]; |
---|
510 | 510 | | (2) manufactures a controlled substance not |
---|
511 | 511 | | authorized by the person's Federal Drug Enforcement Administration |
---|
512 | 512 | | registration or distributes or dispenses a controlled substance not |
---|
513 | 513 | | authorized by the person's registration to another registrant or |
---|
514 | 514 | | other person; |
---|
515 | 515 | | (3) refuses or fails to make, keep, or furnish a |
---|
516 | 516 | | record, report, notification, order form, statement, invoice, or |
---|
517 | 517 | | information required by this chapter; |
---|
518 | 518 | | (4) prints, manufactures, possesses, or produces an |
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519 | 519 | | official prescription form without the approval of the board; |
---|
520 | 520 | | (5) delivers or possesses a counterfeit official |
---|
521 | 521 | | prescription form; |
---|
522 | 522 | | (6) refuses an entry into a premise for an inspection |
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523 | 523 | | authorized by this chapter; |
---|
524 | 524 | | (7) refuses or fails to return an official |
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525 | 525 | | prescription form as required by Section 481.0755(k) [481.075(k)]; |
---|
526 | 526 | | (8) refuses or fails to make, keep, or furnish a |
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527 | 527 | | record, report, notification, order form, statement, invoice, or |
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528 | 528 | | information required by a rule adopted by the director or the board; |
---|
529 | 529 | | or |
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530 | 530 | | (9) refuses or fails to maintain security required by |
---|
531 | 531 | | this chapter or a rule adopted under this chapter. |
---|
532 | 532 | | SECTION 11. Section 481.129(a), Health and Safety Code, is |
---|
533 | 533 | | amended to read as follows: |
---|
534 | 534 | | (a) A person commits an offense if the person knowingly: |
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535 | 535 | | (1) distributes as a registrant or dispenser a |
---|
536 | 536 | | controlled substance listed in Schedule I or II, unless the person |
---|
537 | 537 | | distributes the controlled substance as authorized under the |
---|
538 | 538 | | federal Controlled Substances Act (21 U.S.C. Section 801 et seq.); |
---|
539 | 539 | | (2) uses in the course of manufacturing, prescribing, |
---|
540 | 540 | | or distributing a controlled substance a Federal Drug Enforcement |
---|
541 | 541 | | Administration registration number that is fictitious, revoked, |
---|
542 | 542 | | suspended, or issued to another person; |
---|
543 | 543 | | (3) issues a prescription bearing a forged or |
---|
544 | 544 | | fictitious signature; |
---|
545 | 545 | | (4) uses a prescription issued to another person to |
---|
546 | 546 | | prescribe a Schedule II controlled substance; |
---|
547 | 547 | | (5) possesses, obtains, or attempts to possess or |
---|
548 | 548 | | obtain a controlled substance or an increased quantity of a |
---|
549 | 549 | | controlled substance: |
---|
550 | 550 | | (A) by misrepresentation, fraud, forgery, |
---|
551 | 551 | | deception, or subterfuge; |
---|
552 | 552 | | (B) through use of a fraudulent prescription |
---|
553 | 553 | | form; [or] |
---|
554 | 554 | | (C) through use of a fraudulent oral or |
---|
555 | 555 | | telephonically communicated prescription; or |
---|
556 | 556 | | (D) through the use of a fraudulent electronic |
---|
557 | 557 | | prescription; or |
---|
558 | 558 | | (6) furnishes false or fraudulent material |
---|
559 | 559 | | information in or omits material information from an application, |
---|
560 | 560 | | report, record, or other document required to be kept or filed under |
---|
561 | 561 | | this chapter. |
---|
562 | 562 | | SECTION 12. Section 32.024, Human Resources Code, is |
---|
563 | 563 | | amended by adding Subsection (z-2) to read as follows: |
---|
564 | 564 | | (z-2) The limits on prescription drugs and medications |
---|
565 | 565 | | under the medical assistance program provided by Subsections (z) |
---|
566 | 566 | | and (z-1) do not apply to a prescription for an opioid for the |
---|
567 | 567 | | initial treatment of acute pain under Section 481.07636, Health and |
---|
568 | 568 | | Safety Code. |
---|
569 | 569 | | SECTION 13. Section 554.051(a-1), Occupations Code, is |
---|
570 | 570 | | amended to read as follows: |
---|
571 | 571 | | (a-1) The board may adopt rules to administer Sections |
---|
572 | 572 | | [481.073,] 481.074, 481.075, 481.0755, 481.0756, 481.076, |
---|
573 | 573 | | 481.0761, 481.0762, 481.0763, 481.07635, 481.07636, 481.0764, |
---|
574 | 574 | | 481.0765, and 481.0766, Health and Safety Code. |
---|
575 | 575 | | SECTION 14. Section 565.003, Occupations Code, is amended |
---|
576 | 576 | | to read as follows: |
---|
577 | 577 | | Sec. 565.003. ADDITIONAL GROUNDS FOR DISCIPLINE REGARDING |
---|
578 | 578 | | APPLICANT FOR OR HOLDER OF NONRESIDENT PHARMACY LICENSE. Unless |
---|
579 | 579 | | compliance would violate the pharmacy or drug statutes or rules in |
---|
580 | 580 | | the state in which the pharmacy is located, the board may discipline |
---|
581 | 581 | | an applicant for or the holder of a nonresident pharmacy license if |
---|
582 | 582 | | the board finds that the applicant or license holder has failed to |
---|
583 | 583 | | comply with: |
---|
584 | 584 | | (1) Section 481.074, [or] 481.075, 481.0755, |
---|
585 | 585 | | 481.0756, 481.076, 481.0761, 481.0762, 481.0763, 481.07635, |
---|
586 | 586 | | 481.07636, 481.0764, 481.0765, or 481.0766, Health and Safety Code; |
---|
587 | 587 | | (2) Texas substitution requirements regarding: |
---|
588 | 588 | | (A) the practitioner's directions concerning |
---|
589 | 589 | | generic substitution; |
---|
590 | 590 | | (B) the patient's right to refuse generic |
---|
591 | 591 | | substitution; or |
---|
592 | 592 | | (C) notification to the patient of the patient's |
---|
593 | 593 | | right to refuse substitution; |
---|
594 | 594 | | (3) any board rule relating to providing drug |
---|
595 | 595 | | information to the patient or the patient's agent in written form or |
---|
596 | 596 | | by telephone; or |
---|
597 | 597 | | (4) any board rule adopted under Section 554.051(a) |
---|
598 | 598 | | and determined by the board to be applicable under Section |
---|
599 | 599 | | 554.051(b). |
---|
600 | 600 | | SECTION 15. Sections 481.073, 481.074(o) and (p), and |
---|
601 | 601 | | 481.075(b), (c), (d), (f), (k), and (l), Health and Safety Code, are |
---|
602 | 602 | | repealed. |
---|
603 | 603 | | SECTION 16. A person who holds a license, certification, or |
---|
604 | 604 | | registration to prescribe or dispense a controlled substance issued |
---|
605 | 605 | | before September 1, 2020, is required to take the continuing |
---|
606 | 606 | | education course provided by Section 481.07635, Health and Safety |
---|
607 | 607 | | Code, as added by this Act, not later than September 1, 2021. |
---|
608 | 608 | | SECTION 17. This Act takes effect September 1, 2019. |
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