6 | | - | ENROLLED |
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7 | | - | |
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8 | | - | AN ACT |
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9 | | - | |
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10 | | - | |
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11 | | - | ENTITLED An Act to prohibit pharmaceutical manufacturers from interfering in |
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12 | | - | contracts between 340B entities and pharmacies and to provide a penalty |
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13 | | - | therefor. |
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14 | | - | BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF SOUTH DAKOTA: |
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15 | | - | Section 1. That § 37-24-6 be AMENDED: |
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16 | | - | 37-24-6. It is a deceptive act or practice for any person to: |
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17 | | - | (1) Knowingly act, use, or employ any deceptive act or practice, fraud, false pretense, |
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18 | | - | false promises, or misrepresentation or to conceal, suppress, or omit any material |
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19 | | - | fact in connection with the sale or advertisement of any merchandise or the |
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20 | | - | solicitation of contributions for charitable purposes, regardless of whether any |
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21 | | - | person has in fact been misled, deceived, or damaged thereby; |
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22 | | - | (2) Advertise price reductions without satisfying one of the following: |
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23 | | - | (a) Including in the advertisement the specific basis for the claim of a price |
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24 | | - | reduction; or |
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25 | | - | (b) Offering the merchandise for sale at the higher price from which the |
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26 | | - | reduction is taken for at least seven consecutive business days during the |
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27 | | - | sixty-day period prior to the advertisement. |
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28 | | - | Any person advertising consumer property or services in this state, which |
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29 | | - | advertisements contain representations or statements as to any type of savings |
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30 | | - | claim, including reduced price claims and price comparison value claims, shall |
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31 | | - | maintain reasonable records for a period of two years from the date of sale and |
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32 | | - | advertisement, which records shall disclose the factual basis for such |
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33 | | - | representations or statements and from which the validity of any such claim be |
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34 | | - | established. However, these reasonable record provisions do not apply to the sale |
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35 | | - | of any merchandise that is of a class of merchandise that is routinely advertised |
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36 | | - | on at least a weekly basis in newspapers, shopping tabloids, or similar publications 25.627.15 2 154 |
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37 | | - | SB154 ENROLLED |
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38 | | - | and that has a sales price before price reduction that is less than fifteen dollars per |
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39 | | - | item; |
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40 | | - | (3) Represent a sale of merchandise at reduced rates due to the cessation of business |
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41 | | - | operations and after the date of the first advertisement remain in business under |
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42 | | - | the same, or substantially the same, ownership or trade name, or continue to offer |
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43 | | - | for sale the same type of merchandise at the same location for more than one |
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44 | | - | hundred twenty days; |
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45 | | - | (4) Give or offer a rebate, discount, or anything of value to a person as an inducement |
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46 | | - | for selling consumer property or services in consideration of giving the names of |
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47 | | - | prospective purchasers or otherwise aiding in making a sale to another person, if |
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48 | | - | the earning of the rebate, discount, or other thing of value is contingent upon the |
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49 | | - | occurrence of an event subsequent to the time the person agrees to the sale; |
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50 | | - | (5) Engage in any scheme or plan for disposal or distribution of merchandise whereby |
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51 | | - | a participant pays a valuable consideration for the chance to receive compensation |
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52 | | - | primarily for introducing one or more additional persons into participation in the |
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53 | | - | planner's scheme or for the chance to receive compensation when the person |
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54 | | - | introduced by the participant introduces a new participant; |
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55 | | - | (6) Send, deliver, provide, mail, or cause to be sent, delivered, provided, or mailed |
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56 | | - | any bill or invoice for unordered property or unordered service provided; |
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57 | | - | (7) Advertise a rate, price, or fee for a hotel, motel, campsite, or other lodging |
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58 | | - | accommodation which is not in fact available to the public under the terms |
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59 | | - | advertised. It is not a violation of this subdivision to establish contract rates which |
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60 | | - | are different than public rates; |
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61 | | - | (8) Charge a rate, price, or fee for a hotel, motel, campsite, or other lodging |
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62 | | - | accommodation which is different than the rate, price, or fee charged on the first |
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63 | | - | night of the guest's stay unless, at the initial registration of the guest, a written |
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64 | | - | notification of each price, rate, or fee to be charged during the guest's reserved |
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65 | | - | continuous stay is delivered to the guest and an acknowledgment of receipt of the |
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66 | | - | notice is signed by the guest and kept by the innkeeper for the same period of time |
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67 | | - | as is required by § 34-18-21; |
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68 | | - | (9) Knowingly fail to mail or to deliver by electronic means to a future guest a written |
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69 | | - | confirmation of the date and rates of reservations made for any accommodation at |
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70 | | - | a hotel, motel, campsite, or other lodging accommodation when a written request |
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71 | | - | for confirmation is received from the future guest; 25.627.15 3 154 |
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72 | | - | SB154 ENROLLED |
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73 | | - | (10) Require money in advance of arrival or a handling fee in the event of cancellation |
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74 | | - | of any hotel, motel, campsite, or other lodging accommodation unless the |
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75 | | - | innkeeper has a written policy or a separate contract with the guest stating so that |
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76 | | - | is mailed or delivered by electronic means to the guest at or near the making of |
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77 | | - | the reservation; |
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78 | | - | (11) Knowingly advertise or cause to be listed through the internet or in a telephone |
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79 | | - | directory a business address that misrepresents where the business is actually |
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80 | | - | located or that falsely states that the business is located in the same area covered |
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81 | | - | by the telephone directory. This subdivision does not apply to a telephone service |
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82 | | - | provider, an internet service provider, or a publisher or distributor of a telephone |
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83 | | - | directory, unless the conduct proscribed in this subdivision is on behalf of the |
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84 | | - | provider, publisher, or distributor; |
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85 | | - | (12) Sell, market, promote, advertise, or otherwise distribute any card or other |
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86 | | - | purchasing mechanism or device that is not insurance that purports to offer |
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87 | | - | discounts or access to discounts from pharmacies for prescription drug purchases |
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88 | | - | if: |
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89 | | - | (a) The card or other purchasing mechanism or device does not expressly state |
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90 | | - | in bold and prominent type, prevalently placed, that discounts are not |
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91 | | - | insurance; |
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92 | | - | (b) The discounts are not specifically authorized by a separate contract with |
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93 | | - | each pharmacy listed in conjunction with the card or other purchasing |
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94 | | - | mechanism or device; or |
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95 | | - | (c) The discount or access to discounts offered, or the range of discounts or |
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96 | | - | access to the range of discounts, is misleading, deceptive, or fraudulent, |
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97 | | - | regardless of the literal wording. |
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98 | | - | The provisions of this subdivision do not apply to a customer discount or |
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99 | | - | membership card issued by a store or buying club for use in that store or buying |
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100 | | - | club, or a patient access program voluntarily sponsored by a pharmaceutical |
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101 | | - | manufacturer, or a consortium of pharmaceutical manufacturers, that provide free |
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102 | | - | or discounted prescription drug products directly to low income or uninsured |
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103 | | - | individuals either through a discount card or direct shipment; |
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104 | | - | (13) Send or cause to be sent an unsolicited commercial electronic mail message that |
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105 | | - | does not include in the subject line of such message "ADV:" as the first four |
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106 | | - | characters. If the message contains information that consists of explicit sexual |
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107 | | - | material that may only be viewed, purchased, rented, leased, or held in possession 25.627.15 4 154 |
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108 | | - | SB154 ENROLLED |
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109 | | - | by an individual eighteen years of age and older, the subject line of each message |
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110 | | - | shall include "ADV:ADLT" as the first eight characters. An unsolicited commercial |
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111 | | - | electronic mail message does not include a message sent to a person with whom |
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112 | | - | the initiator has an existing personal or business relationship or a message sent at |
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113 | | - | the request or express consent of the recipient; |
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114 | | - | (14) Violate the provisions of § 22-25-52; |
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115 | | - | (15) Knowingly fail to disclose the amount of any mandatory fee when reservations are |
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116 | | - | made by a future guest at a hotel, motel, campsite, or other lodging |
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117 | | - | accommodations. A mandatory fee under this subdivision includes any resort fee |
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118 | | - | or parking fee charged by the lodging accommodations whether or not the guest |
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119 | | - | utilizes the amenities or the parking facility for which the fee is assessed; |
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120 | | - | (16) Cause misleading information to be transmitted to users of caller identification |
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121 | | - | technologies or otherwise block or misrepresent the origin of a telephone |
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122 | | - | solicitation. No provider of telephone caller identification services, |
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123 | | - | telecommunications, broadband, or voice over internet protocol service may be |
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124 | | - | held liable for violations of this subdivision committed by other individuals or |
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125 | | - | entities. It is not a violation of this subdivision: |
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126 | | - | (a) For a telephone solicitor to utilize the name and number of the entity the |
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127 | | - | solicitation is being made on behalf of rather than the name and number of |
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128 | | - | the telephone solicitor; |
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129 | | - | (b) If an authorized activity of a law enforcement agency; or |
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130 | | - | (c) If a court order specifically authorizes the use of caller identification |
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131 | | - | manipulation; or |
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132 | | - | (17) Violate section 3 or 4 of this Act. |
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133 | | - | Each act in violation of this section under one thousand dollars is a Class 1 |
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134 | | - | misdemeanor. Each act in violation of this statute over one thousand dollars but under |
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135 | | - | one hundred thousand dollars is a Class 6 felony. Each act in violation of this section over |
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136 | | - | one hundred thousand dollars is a Class 5 felony. |
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137 | | - | Section 2. That a NEW SECTION be added to a NEW CHAPTER in title 58: |
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138 | | - | Terms used in this chapter mean: |
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139 | | - | (1) "Pharmaceutical manufacturer," any person engaged in the business of preparing, |
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140 | | - | producing, converting, processing, packaging, labeling, or distributing a |
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141 | | - | prescription drug, but not including a wholesale distributor or dispenser; 25.627.15 5 154 |
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142 | | - | SB154 ENROLLED |
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143 | | - | (2) "Pharmacy," any place within or outside this state, licensed by the State Board of |
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144 | | - | Pharmacy, where drugs are dispensed, and pharmaceutical care is provided to |
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145 | | - | residents of this state; |
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146 | | - | (3) "340B drug," a drug purchased through the 340B drug discount program by a 340B |
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147 | | - | entity; |
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148 | | - | (4) "340B drug discount program," a program that imposes limitations on the prices |
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149 | | - | of drugs purchased by covered entities, in accordance with 42 U.S.C. § 256b |
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150 | | - | (January 1, 2025); and |
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151 | | - | (5) "340B entity," a covered entity as defined in 42 U.S.C. § 256b(a)(4) (January 1, |
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152 | | - | 2025). |
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153 | | - | Section 3. That a NEW SECTION be added to a new chapter in title 58: |
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154 | | - | A pharmaceutical manufacturer may not, directly or indirectly, deny, restrict, or |
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155 | | - | prohibit the acquisition of a 340B drug or the delivery of a 340B drug to a location that is |
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156 | | - | authorized to receive the drug by a 340B entity or pharmacy, unless receipt of the 340B |
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157 | | - | drug is prohibited by federal law. |
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158 | | - | Nothing in this section requires a pharmaceutical manufacturer to provide a 340B |
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159 | | - | drug price discount to a pharmacy. |
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160 | | - | Nothing in this section prohibits a pharmaceutical manufacturer from limiting |
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161 | | - | distribution of a drug in accordance with 21 U.S.C. § 355-1 (January 1, 2025). |
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162 | | - | Section 4. That a NEW SECTION be added to a new chapter in title 58: |
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163 | | - | A pharmaceutical manufacturer may not , directly or indirectly, require a 340B |
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164 | | - | entity or pharmacy to submit any claim or utilization data, as a condition for allowing the |
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165 | | - | acquisition of a 340B drug by, or delivery of a 340B drug to, a 340B entity, unless the |
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166 | | - | claim or utilization data sharing is required by federal law. |
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167 | | - | Nothing in this section prohibits a pharmaceutical manufacturer from conducting |
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168 | | - | an audit of a 340B entity, in accordance with 42 U.S.C. § 256b(a)(5)(C) (January 1, 2025). |
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169 | | - | Section 5. That a NEW SECTION be added to a new chapter in title 58: |
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170 | | - | In addition to any other remedy provided by law, a 340B entity or a pharmacy may |
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171 | | - | file a civil action against a pharmaceutical manufacturer for a violation of this Act, and |
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172 | | - | may request injunctive relief, actual and consequential damages, and reasonable |
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173 | | - | attorneys' fees and costs. 25.627.15 6 154 |
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174 | | - | SB154 ENROLLED |
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175 | | - | An Act to prohibit pharmaceutical manufacturers from interfering in contracts between 340B |
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176 | | - | entities and pharmacies and to provide a penalty therefor. |
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177 | | - | |
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178 | | - | |
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179 | | - | |
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180 | | - | |
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181 | | - | I certify that the attached Act originated in |
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182 | | - | the: |
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183 | | - | |
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184 | | - | Senate as Bill No. 154 |
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185 | | - | |
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186 | | - | |
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187 | | - | |
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188 | | - | Secretary of the Senate |
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189 | | - | |
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190 | | - | |
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191 | | - | |
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192 | | - | |
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193 | | - | President of the Senate |
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194 | | - | |
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195 | | - | Attest: |
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196 | | - | |
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197 | | - | |
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198 | | - | |
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199 | | - | |
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200 | | - | Secretary of the Senate |
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201 | | - | |
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202 | | - | |
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203 | | - | |
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204 | | - | |
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205 | | - | Speaker of the House |
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206 | | - | |
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207 | | - | Attest: |
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| 6 | + | SENATE HEALTH AND HUMAN SERVICES ENGROSSED |
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215 | | - | |
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216 | | - | |
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217 | | - | Senate Bill No. 154 |
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218 | | - | File No. ____ |
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219 | | - | Chapter No. ______ |
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220 | | - | |
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221 | | - | |
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222 | | - | |
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223 | | - | Received at this Executive Office |
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224 | | - | this _____ day of _____________, |
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225 | | - | |
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226 | | - | 2025 at ____________M. |
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227 | | - | |
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228 | | - | |
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229 | | - | |
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230 | | - | By |
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231 | | - | for the Governor |
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232 | | - | |
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233 | | - | |
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234 | | - | The attached Act is hereby |
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235 | | - | approved this ________ day of |
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236 | | - | ______________, A.D., 2025 |
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237 | | - | |
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238 | | - | |
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239 | | - | |
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240 | | - | |
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241 | | - | |
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242 | | - | Governor |
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243 | | - | |
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244 | | - | STATE OF SOUTH DAKOTA , |
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245 | | - | ss. |
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246 | | - | Office of the Secretary of State |
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247 | | - | |
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248 | | - | |
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249 | | - | Filed ____________, 2025 |
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250 | | - | at _________ o'clock __M. |
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251 | | - | |
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252 | | - | |
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253 | | - | |
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254 | | - | |
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255 | | - | |
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256 | | - | Secretary of State |
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257 | | - | |
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258 | | - | |
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259 | | - | |
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260 | | - | By |
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261 | | - | Asst. Secretary of State |
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262 | | - | |
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263 | | - | |
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| 14 | + | Underscores indicate new language. |
---|
| 15 | + | Overstrikes indicate deleted language. |
---|
| 16 | + | An Act to prohibit pharmaceutical manufacturers from interfering in contracts 1 |
---|
| 17 | + | between 340B entities and pharmacies and to provide a penalty therefor. 2 |
---|
| 18 | + | BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF SOUTH DAKOTA: 3 |
---|
| 19 | + | Section 1. That § 37-24-6 be AMENDED: 4 |
---|
| 20 | + | 37-24-6. It is a deceptive act or practice for any person to: 5 |
---|
| 21 | + | (1) Knowingly act, use, or employ any deceptive act or practice, fraud, false pretense, 6 |
---|
| 22 | + | false promises, or misrepresentation or to conceal, suppress, or omit any material 7 |
---|
| 23 | + | fact in connection with the sale or advertisement of any merchandise or the 8 |
---|
| 24 | + | solicitation of contributions for charitable purposes, regardless of whether any 9 |
---|
| 25 | + | person has in fact been misled, deceived, or damaged thereby; 10 |
---|
| 26 | + | (2) Advertise price reductions without satisfying one of the following: 11 |
---|
| 27 | + | (a) Including in the advertisement the specific basis for the claim of a price 12 |
---|
| 28 | + | reduction; or 13 |
---|
| 29 | + | (b) Offering the merchandise for sale at the higher price from which the 14 |
---|
| 30 | + | reduction is taken for at least seven consecutive business days during the 15 |
---|
| 31 | + | sixty-day period prior to the advertisement. 16 |
---|
| 32 | + | Any person advertising consumer property or services in this state, which 17 |
---|
| 33 | + | advertisements contain representations or statements as to any type of savings 18 |
---|
| 34 | + | claim, including reduced price claims and price comparison value claims, shall 19 |
---|
| 35 | + | maintain reasonable records for a period of two years from the date of sale and 20 |
---|
| 36 | + | advertisement, which records shall disclose the factual basis for such 21 |
---|
| 37 | + | representations or statements and from which the validity of any such claim be 22 |
---|
| 38 | + | established. However, these reasonable record provisions do not apply to the sale 23 |
---|
| 39 | + | of any merchandise that is of a class of merchandise that is routinely advertised 24 |
---|
| 40 | + | on at least a weekly basis in newspapers, shopping tabloids, or similar publications 25 25.627.14 2 154 |
---|
| 41 | + | Underscores indicate new language. |
---|
| 42 | + | Overstrikes indicate deleted language. |
---|
| 43 | + | and that has a sales price before price reduction that is less than fifteen dollars per 1 |
---|
| 44 | + | item; 2 |
---|
| 45 | + | (3) Represent a sale of merchandise at reduced rates due to the cessation of business 3 |
---|
| 46 | + | operations and after the date of the first advertisement remain in business under 4 |
---|
| 47 | + | the same, or substantially the same, ownership or trade name, or continue to offer 5 |
---|
| 48 | + | for sale the same type of merchandise at the same location for more than one 6 |
---|
| 49 | + | hundred twenty days; 7 |
---|
| 50 | + | (4) Give or offer a rebate, discount, or anything of value to a person as an inducement 8 |
---|
| 51 | + | for selling consumer property or services in consideration of giving the names of 9 |
---|
| 52 | + | prospective purchasers or otherwise aiding in making a sale to another person, if 10 |
---|
| 53 | + | the earning of the rebate, discount, or other thing of value is contingent upon the 11 |
---|
| 54 | + | occurrence of an event subsequent to the time the person agrees to the sale; 12 |
---|
| 55 | + | (5) Engage in any scheme or plan for disposal or distribution of merchandise whereby 13 |
---|
| 56 | + | a participant pays a valuable consideration for the chance to receive compensation 14 |
---|
| 57 | + | primarily for introducing one or more additional persons into participation in the 15 |
---|
| 58 | + | planner's scheme or for the chance to receive compensation when the person 16 |
---|
| 59 | + | introduced by the participant introduces a new participant; 17 |
---|
| 60 | + | (6) Send, deliver, provide, mail, or cause to be sent, delivered, provided, or mailed 18 |
---|
| 61 | + | any bill or invoice for unordered property or unordered service provided; 19 |
---|
| 62 | + | (7) Advertise a rate, price, or fee for a hotel, motel, campsite, or other lodging 20 |
---|
| 63 | + | accommodation which is not in fact available to the public under the terms 21 |
---|
| 64 | + | advertised. It is not a violation of this subdivision to establish contract rates which 22 |
---|
| 65 | + | are different than public rates; 23 |
---|
| 66 | + | (8) Charge a rate, price, or fee for a hotel, motel, campsite, or other lodging 24 |
---|
| 67 | + | accommodation which is different than the rate, price, or fee charged on the first 25 |
---|
| 68 | + | night of the guest's stay unless, at the initial registration of the guest, a written 26 |
---|
| 69 | + | notification of each price, rate, or fee to be charged during the guest's reserved 27 |
---|
| 70 | + | continuous stay is delivered to the guest and an acknowledgment of receipt of the 28 |
---|
| 71 | + | notice is signed by the guest and kept by the innkeeper for the same period of time 29 |
---|
| 72 | + | as is required by § 34-18-21; 30 |
---|
| 73 | + | (9) Knowingly fail to mail or to deliver by electronic means to a future guest a written 31 |
---|
| 74 | + | confirmation of the date and rates of reservations made for any accommodation at 32 |
---|
| 75 | + | a hotel, motel, campsite, or other lodging accommodation when a written request 33 |
---|
| 76 | + | for confirmation is received from the future guest; 34 25.627.14 3 154 |
---|
| 77 | + | Underscores indicate new language. |
---|
| 78 | + | Overstrikes indicate deleted language. |
---|
| 79 | + | (10) Require money in advance of arrival or a handling fee in the event of cancellation 1 |
---|
| 80 | + | of any hotel, motel, campsite, or other lodging accommodation unless the 2 |
---|
| 81 | + | innkeeper has a written policy or a separate contract with the guest stating so that 3 |
---|
| 82 | + | is mailed or delivered by electronic means to the guest at or near the making of 4 |
---|
| 83 | + | the reservation; 5 |
---|
| 84 | + | (11) Knowingly advertise or cause to be listed through the internet or in a telephone 6 |
---|
| 85 | + | directory a business address that misrepresents where the business is actually 7 |
---|
| 86 | + | located or that falsely states that the business is located in the same area covered 8 |
---|
| 87 | + | by the telephone directory. This subdivision does not apply to a telephone service 9 |
---|
| 88 | + | provider, an internet service provider, or a publisher or distributor of a telephone 10 |
---|
| 89 | + | directory, unless the conduct proscribed in this subdivision is on behalf of the 11 |
---|
| 90 | + | provider, publisher, or distributor; 12 |
---|
| 91 | + | (12) Sell, market, promote, advertise, or otherwise distribute any card or other 13 |
---|
| 92 | + | purchasing mechanism or device that is not insurance that purports to offer 14 |
---|
| 93 | + | discounts or access to discounts from pharmacies for prescription drug purchases 15 |
---|
| 94 | + | if: 16 |
---|
| 95 | + | (a) The card or other purchasing mechanism or device does not expressly state 17 |
---|
| 96 | + | in bold and prominent type, prevalently placed, that discounts are not 18 |
---|
| 97 | + | insurance; 19 |
---|
| 98 | + | (b) The discounts are not specifically authorized by a separate contract with 20 |
---|
| 99 | + | each pharmacy listed in conjunction with the card or other purchasing 21 |
---|
| 100 | + | mechanism or device; or 22 |
---|
| 101 | + | (c) The discount or access to discounts offered, or the range of discounts or 23 |
---|
| 102 | + | access to the range of discounts, is misleading, deceptive, or fraudulent, 24 |
---|
| 103 | + | regardless of the literal wording. 25 |
---|
| 104 | + | The provisions of this subdivision do not apply to a customer discount or 26 |
---|
| 105 | + | membership card issued by a store or buying club for use in that store or buying 27 |
---|
| 106 | + | club, or a patient access program voluntarily sponsored by a pharmaceutical 28 |
---|
| 107 | + | manufacturer, or a consortium of pharmaceutical manufacturers, that provide free 29 |
---|
| 108 | + | or discounted prescription drug products directly to low income or uninsured 30 |
---|
| 109 | + | individuals either through a discount card or direct shipment; 31 |
---|
| 110 | + | (13) Send or cause to be sent an unsolicited commercial electronic mail message that 32 |
---|
| 111 | + | does not include in the subject line of such message "ADV:" as the first four 33 |
---|
| 112 | + | characters. If the message contains information that consists of explicit sexual 34 |
---|
| 113 | + | material that may only be viewed, purchased, rented, leased, or held in possession 35 25.627.14 4 154 |
---|
| 114 | + | Underscores indicate new language. |
---|
| 115 | + | Overstrikes indicate deleted language. |
---|
| 116 | + | by an individual eighteen years of age and older, the subject line of each message 1 |
---|
| 117 | + | shall include "ADV:ADLT" as the first eight characters. An unsolicited commercial 2 |
---|
| 118 | + | electronic mail message does not include a message sent to a person with whom 3 |
---|
| 119 | + | the initiator has an existing personal or business relationship or a message sent at 4 |
---|
| 120 | + | the request or express consent of the recipient; 5 |
---|
| 121 | + | (14) Violate the provisions of § 22-25-52; 6 |
---|
| 122 | + | (15) Knowingly fail to disclose the amount of any mandatory fee when reservations are 7 |
---|
| 123 | + | made by a future guest at a hotel, motel, campsite, or other lodging 8 |
---|
| 124 | + | accommodations. A mandatory fee under this subdivision includes any resort fee 9 |
---|
| 125 | + | or parking fee charged by the lodging accommodations whether or not the guest 10 |
---|
| 126 | + | utilizes the amenities or the parking facility for which the fee is assessed; or 11 |
---|
| 127 | + | (16) Cause misleading information to be transmitted to users of caller identification 12 |
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| 128 | + | technologies or otherwise block or misrepresent the origin of a telephone 13 |
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| 129 | + | solicitation. No provider of telephone caller identification services, 14 |
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| 130 | + | telecommunications, broadband, or voice over internet protocol service may be 15 |
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| 131 | + | held liable for violations of this subdivision committed by other individuals or 16 |
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| 132 | + | entities. It is not a violation of this subdivision: 17 |
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| 133 | + | (a) For a telephone solicitor to utilize the name and number of the entity the 18 |
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| 134 | + | solicitation is being made on behalf of rather than the name and number of 19 |
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| 135 | + | the telephone solicitor; 20 |
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| 136 | + | (b) If an authorized activity of a law enforcement agency; or 21 |
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| 137 | + | (c) If a court order specifically authorizes the use of caller identification 22 |
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| 138 | + | manipulation; or 23 |
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| 139 | + | (17) Violate section 3 or 4 of this Act. 24 |
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| 140 | + | Each act in violation of this section under one thousand dollars is a Class 1 25 |
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| 141 | + | misdemeanor. Each act in violation of this statute over one thousand dollars but under 26 |
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| 142 | + | one hundred thousand dollars is a Class 6 felony. Each act in violation of this section over 27 |
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| 143 | + | one hundred thousand dollars is a Class 5 felony. 28 |
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| 144 | + | Section 2. That a NEW SECTION be added to a NEW CHAPTER in title 58: 29 |
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| 145 | + | Terms used in this chapter mean: 30 |
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| 146 | + | (1) "Pharmaceutical manufacturer," any person engaged in the business of preparing, 31 |
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| 147 | + | producing, converting, processing, packaging, labeling, or distributing a 32 |
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| 148 | + | prescription drug, but not including a wholesale distributor or dispenser; 33 25.627.14 5 154 |
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| 149 | + | Underscores indicate new language. |
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| 150 | + | Overstrikes indicate deleted language. |
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| 151 | + | (2) "Pharmacy," any place within or outside this state, licensed by the State Board of 1 |
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| 152 | + | Pharmacy, where drugs are dispensed, and pharmaceutical care is provided to 2 |
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| 153 | + | residents of this state; 3 |
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| 154 | + | (3) "340B drug," a drug purchased through the 340B drug discount program by a 340B 4 |
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| 155 | + | entity; 5 |
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| 156 | + | (4) "340B drug discount program," a program that imposes limitations on the prices 6 |
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| 157 | + | of drugs purchased by covered entities, in accordance with 42 U.S.C. § 256b 7 |
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| 158 | + | (January 1, 2025); and 8 |
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| 159 | + | (5) "340B entity," a covered entity as defined in 42 U.S.C. § 256b(a)(4) (January 1, 9 |
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| 160 | + | 2025). 10 |
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| 161 | + | Section 3. That a NEW SECTION be added to a new chapter in title 58: 11 |
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| 162 | + | A pharmaceutical manufacturer may not, directly or indirectly, deny, restrict, or 12 |
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| 163 | + | prohibit the acquisition of a 340B drug or the delivery of a 340B drug to a location that is 13 |
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| 164 | + | authorized to receive the drug by a 340B entity or pharmacy, unless receipt of the 340B 14 |
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| 165 | + | drug is prohibited by federal law. 15 |
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| 166 | + | Nothing in this section requires a pharmaceutical manufacturer to provide a 340B 16 |
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| 167 | + | drug price discount to a pharmacy. 17 |
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| 168 | + | Nothing in this section prohibits a pharmaceutical manufacturer from limiting 18 |
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| 169 | + | distribution of a drug in accordance with 21 U.S.C. § 355-1 (January 1, 2025). 19 |
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| 170 | + | Section 4. That a NEW SECTION be added to a new chapter in title 58: 20 |
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| 171 | + | A pharmaceutical manufacturer may not , directly or indirectly, require a 340B 21 |
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| 172 | + | entity or pharmacy to submit any claim or utilization data, as a condition for allowing the 22 |
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| 173 | + | acquisition of a 340B drug by, or delivery of a 340B drug to, a 340B entity, unless the 23 |
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| 174 | + | claim or utilization data sharing is required by federal law. 24 |
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| 175 | + | Nothing in this section prohibits a pharmaceutical manufacturer from conducting 25 |
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| 176 | + | an audit of a 340B entity, in accordance with 42 U.S.C. § 256b(a)(5)(C) (January 1, 2025). 26 |
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| 177 | + | Section 5. That a NEW SECTION be added to a new chapter in title 58: 27 |
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| 178 | + | In addition to any other remedy provided by law, a 340B entity or a pharmacy may 28 |
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| 179 | + | file a civil action against a pharmaceutical manufacturer for a violation of this Act, and 29 |
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| 180 | + | may request injunctive relief, actual and consequential damages, and reasonable 30 |
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| 181 | + | attorneys' fees and costs. 31 |
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