38 | | - | (1) "donor" means a person who donates |
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39 | | - | unused prescription drugs to an eligible recipient for the |
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40 | | - | purpose of redistribution to patients; |
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41 | | - | (2) "eligible recipient" means a person who |
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42 | | - | registers with the board to participate in the collection of |
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43 | | - | donated drugs and is: |
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44 | | - | (a) licensed pursuant to |
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45 | | - | Section 61-11-14 NMSA 1978 to receive and distribute |
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46 | | - | prescription drugs; |
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47 | | - | (b) a health care facility licensed by |
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48 | | - | the health care authority pursuant to the Health Care Code; |
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49 | | - | or |
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50 | | - | (c) a practitioner licensed to |
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51 | | - | prescribe prescription drugs; SB 122 |
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52 | | - | Page 2 |
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| 44 | + | [(1) "clinic" means a facility licensed |
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| 45 | + | pursuant to Section 61-11-14 NMSA 1978 in which one or more |
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| 46 | + | licensed practitioners diagnose and treat patients and in which |
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| 47 | + | drugs are stored, dispensed or administered for the diagnosis |
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| 48 | + | and treatment of the facility's patients; provided that |
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| 49 | + | .229077.3 underscored material = new |
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| 50 | + | [bracketed material] = delete |
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78 | | - | (3) "patient" means an individual who |
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79 | | - | voluntarily receives donated prescription drugs; and |
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80 | | - | (4) "tamper-evident" means a device or |
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81 | | - | process that makes unauthorized access to protected |
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82 | | - | pharmaceutical packaging easily detected. |
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83 | | - | B. The board shall adopt and promulgate rules for |
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84 | | - | the donation of unused prescription drugs. Any person, |
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85 | | - | including persons from other states, may donate unexpired and |
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86 | | - | unused prescription drugs to an eligible recipient, and an |
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87 | | - | eligible recipient may accept and redistribute the donated |
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88 | | - | prescription drugs in accordance with rules promulgated |
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89 | | - | by the board. Donated prescription drugs shall only be |
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90 | | - | redistributed to a patient if the drugs will not expire |
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91 | | - | before the patient is able to completely use the drugs, based |
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92 | | - | on the directions for use given by the patient's prescribing |
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93 | | - | health care professional. |
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94 | | - | C. The board shall promulgate rules to establish: |
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95 | | - | (1) procedures to allow the donation and |
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96 | | - | redistribution of certain prescription drugs, including |
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97 | | - | refrigerated drugs, that: |
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98 | | - | (a) ensure that the redistribution |
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99 | | - | process is consistent with public health and safety |
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100 | | - | standards; |
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101 | | - | (b) exclude controlled substances; and |
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102 | | - | (c) allow in-state and out-of-state SB 122 |
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103 | | - | Page 3 |
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| 76 | + | "clinic" does not include the privately owned practice of a |
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| 77 | + | licensed practitioner or group of licensed practitioners exempt |
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| 78 | + | under Section 61-11-22 NMSA 1978; |
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| 79 | + | (2)] (1) "donor" means [an individual ] a |
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| 80 | + | person who donates unused prescription drugs to [a clinic or a |
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| 81 | + | participating practitioner for the purpose of redistribution to |
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| 82 | + | established patients of that clinic or practitioner; |
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| 83 | + | (3) "participating practitioner" means a |
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| 84 | + | licensed practitioner who is authorized to prescribe drugs and |
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| 85 | + | who registers with the board, and is subject to rules |
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| 86 | + | promulgated by the board, to participate in the collection of |
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| 87 | + | donated drugs, prescribed for use by established patients of |
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| 88 | + | that practitioner and donated for the purpose of redistribution |
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| 89 | + | to established patients of that practitioner ] an eligible |
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| 90 | + | recipient for the purpose of redistribution to patients; |
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| 91 | + | (2) "eligible recipient" means a person who |
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| 92 | + | registers with the board to participate in the collection of |
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| 93 | + | donated drugs and is: |
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| 94 | + | (a) licensed pursuant to Section |
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| 95 | + | 61-11-14 NMSA 1978 to receive and distribute prescription |
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| 96 | + | drugs; |
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| 97 | + | (b) a health care facility licensed by |
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| 98 | + | the health care authority pursuant to the Health Care Code; or |
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| 99 | + | (c) a practitioner licensed to prescribe |
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| 100 | + | prescription drugs; |
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| 101 | + | .229077.3 |
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| 102 | + | - 2 - underscored material = new |
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| 103 | + | [bracketed material] = delete |
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129 | | - | pharmacies that are experienced in managing donated |
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130 | | - | prescription drugs to distribute donated prescription drugs |
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131 | | - | to patients, either at a physical pharmacy location or |
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132 | | - | through a mail-order pharmacy; |
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133 | | - | (2) standards and procedures for accepting, |
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134 | | - | storing, labeling and redistributing donated prescription |
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135 | | - | drugs; |
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136 | | - | (3) standards and procedures for inspecting |
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137 | | - | donated prescription drugs to determine that the packaging is |
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138 | | - | tamper-evident and that the donated prescription drugs are |
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139 | | - | unadulterated, safe and suitable for redistribution; |
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140 | | - | (4) a form to be signed by the patient |
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141 | | - | specifying: |
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142 | | - | (a) knowledge that the donor took |
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143 | | - | reasonable care of the donated prescription drug; |
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144 | | - | (b) knowledge that the donated |
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145 | | - | prescription drugs have been inspected prior to being |
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146 | | - | dispensed and that there is no reason to believe that the |
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147 | | - | donated prescription drug was improperly handled or stored; |
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148 | | - | (c) that any person who exercises |
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149 | | - | reasonable care in donating, accepting or redistributing |
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150 | | - | pursuant to this section shall be immune from civil or |
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151 | | - | criminal liability or professional disciplinary action of any |
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152 | | - | kind for any related injury, death or loss; and |
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153 | | - | (d) that the immunity provided by this SB 122 |
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154 | | - | Page 4 |
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| 129 | + | [(4) "recipient"] (3) "patient" means an |
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| 130 | + | individual who voluntarily receives donated prescription drugs; |
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| 131 | + | and |
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| 132 | + | [(5)] (4) "tamper-evident" means a device or |
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| 133 | + | process that makes unauthorized access to protected |
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| 134 | + | pharmaceutical packaging easily detected. |
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| 135 | + | B. The board shall adopt and promulgate rules for |
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| 136 | + | the donation of unused prescription drugs. Any person, |
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| 137 | + | including persons from other states , may [be donated] donate |
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| 138 | + | unexpired and unused prescription drugs to [a clinic or a |
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| 139 | + | participating practitioner, and a clinic or a participating |
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| 140 | + | practitioner] an eligible recipient, and an eligible recipient |
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| 141 | + | may accept and redistribute the donated prescription drugs in |
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| 142 | + | accordance with rules promulgated by the board. Donated |
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| 143 | + | prescription drugs shall only be redistributed to a patient if |
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| 144 | + | the drugs will not expire before the patient is able to |
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| 145 | + | completely use the drugs, based on the directions for use given |
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| 146 | + | by the patient's prescribing health care professional. |
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| 147 | + | C. The board shall promulgate rules to establish: |
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| 148 | + | (1) procedures to allow the donation and |
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| 149 | + | redistribution of certain prescription drugs, including |
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| 150 | + | refrigerated drugs, that: |
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| 151 | + | (a) ensure that the redistribution |
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| 152 | + | process is consistent with public health and safety standards; |
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| 153 | + | [and] |
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| 154 | + | .229077.3 |
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| 155 | + | - 3 - underscored material = new |
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| 156 | + | [bracketed material] = delete |
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180 | | - | section shall not decrease or increase the civil or criminal |
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181 | | - | liability of a drug manufacturer, distributor or dispenser |
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182 | | - | that would have existed but for the donation; |
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183 | | - | (5) information required to be provided by |
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184 | | - | the donor verifying that: |
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185 | | - | (a) the donated prescription drug has |
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186 | | - | been properly stored and the container has not been opened or |
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187 | | - | tampered with; |
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188 | | - | (b) the donated prescription drug has |
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189 | | - | not been adulterated or misbranded; and |
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190 | | - | (c) the donor is voluntarily donating |
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191 | | - | the prescription drug; |
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192 | | - | (6) a handling fee not to exceed the |
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193 | | - | reasonable costs of participating in the collection of |
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194 | | - | donated prescription drugs that may be charged to the patient |
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195 | | - | by the eligible recipient to cover the costs of inspecting, |
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196 | | - | storing, labeling and redistributing the donated prescription |
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197 | | - | drug; and |
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198 | | - | (7) any other standards deemed necessary by |
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199 | | - | the board. |
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200 | | - | D. The board shall maintain and publish a current |
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201 | | - | listing of eligible recipients. |
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202 | | - | E. Before redistributing donated prescription |
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203 | | - | drugs, the eligible recipient shall: |
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204 | | - | (1) comply with all applicable federal laws SB 122 |
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205 | | - | Page 5 |
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| 182 | + | (b) exclude controlled substances; and |
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| 183 | + | (c) allow in-state and out-of-state |
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| 184 | + | pharmacies that are experienced in managing donated |
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| 185 | + | prescription drugs to distribute donated prescription drugs to |
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| 186 | + | patients, either at a physical pharmacy location or through a |
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| 187 | + | mail-order pharmacy; |
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| 188 | + | (2) standards and procedures for accepting, |
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| 189 | + | storing, labeling and redistributing donated prescription |
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| 190 | + | drugs; |
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| 191 | + | (3) standards and procedures for inspecting |
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| 192 | + | donated prescription drugs to determine that the packaging is |
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| 193 | + | tamper-evident and that the donated prescription drugs are |
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| 194 | + | unadulterated, safe and suitable for redistribution; |
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| 195 | + | (4) a form to be signed by the [recipient ] |
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| 196 | + | patient specifying: |
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| 197 | + | (a) knowledge that the donor [is not a |
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| 198 | + | pharmacist and] took reasonable care of the donated |
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| 199 | + | prescription drug; |
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| 200 | + | (b) knowledge that the [donor is known |
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| 201 | + | to the clinic or the participating practitioner ] donated |
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| 202 | + | prescription drugs have been inspected prior to being dispensed |
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| 203 | + | and that there is no reason to believe that the donated |
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| 204 | + | prescription drug was improperly handled or stored; |
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| 205 | + | (c) that any person who exercises |
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| 206 | + | reasonable care in donating, accepting or redistributing |
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| 207 | + | .229077.3 |
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| 208 | + | - 4 - underscored material = new |
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| 209 | + | [bracketed material] = delete |
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| 235 | + | pursuant to this section shall be immune from civil or criminal |
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| 236 | + | liability or professional disciplinary action of any kind for |
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| 237 | + | any related injury, death or loss; and |
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| 238 | + | (d) that the immunity provided by this |
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| 239 | + | section shall not decrease or increase the civil or criminal |
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| 240 | + | liability of a drug manufacturer, distributor or dispenser that |
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| 241 | + | would have existed but for the donation; |
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| 242 | + | (5) [a form to be signed ] information required |
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| 243 | + | to be provided by the donor verifying that: |
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| 244 | + | (a) the donated prescription drug has |
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| 245 | + | been properly stored and the container has not been opened or |
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| 246 | + | tampered with; |
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| 247 | + | (b) the donated prescription drug has |
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| 248 | + | not been adulterated or misbranded; and |
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| 249 | + | (c) the donor is voluntarily donating |
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| 250 | + | the prescription drug; |
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| 251 | + | (6) a handling fee not to exceed [twenty |
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| 252 | + | dollars ($20.00)] the reasonable costs of participating in the |
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| 253 | + | collection of donated prescription drugs that may be charged to |
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| 254 | + | the [recipient] patient by the [clinic or the participating |
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| 255 | + | practitioner] eligible recipient to cover the costs of |
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| 256 | + | inspecting, storing, labeling and redistributing the donated |
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| 257 | + | prescription drug; and |
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| 258 | + | (7) any other standards deemed necessary by |
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| 259 | + | the board. |
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| 260 | + | .229077.3 |
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| 261 | + | - 5 - underscored material = new |
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| 262 | + | [bracketed material] = delete |
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| 264 | + | 2 |
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| 265 | + | 3 |
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| 275 | + | 13 |
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| 276 | + | 14 |
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| 277 | + | 15 |
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| 279 | + | 17 |
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| 284 | + | 22 |
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| 285 | + | 23 |
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| 286 | + | 24 |
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| 287 | + | 25 |
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| 288 | + | D. The board shall maintain and publish a current |
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| 289 | + | listing of [clinics and participating practitioners ] eligible |
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| 290 | + | recipients. |
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| 291 | + | E. Before redistributing donated prescription |
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| 292 | + | drugs, the [clinic or the participating practitioner ] eligible |
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| 293 | + | recipient shall: |
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| 294 | + | (1) comply with all applicable federal laws |
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