1 | 1 | | |
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2 | 2 | | |
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3 | 3 | | EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW. |
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4 | 4 | | [Brackets] indicate matter deleted from existing law. |
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5 | 5 | | *hb0536* |
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6 | 6 | | |
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7 | 7 | | HOUSE BILL 536 |
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8 | 8 | | J1, J2, F5 5lr1960 |
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9 | 9 | | |
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10 | 10 | | By: Delegates Guzzone, Boafo, Chisholm, Hill, Lopez, Martinez, and M. Morgan |
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11 | 11 | | Introduced and read first time: January 22, 2025 |
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12 | 12 | | Assigned to: Ways and Means and Health and Government Operations |
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13 | 13 | | |
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14 | 14 | | A BILL ENTITLED |
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15 | 15 | | |
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16 | 16 | | AN ACT concerning 1 |
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17 | 17 | | |
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18 | 18 | | Education and Health – Emergency Use Epinephrine – Alterations 2 |
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19 | 19 | | |
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20 | 20 | | FOR the purpose of altering the defined term “auto–injectable epinephrine” to be 3 |
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21 | 21 | | “emergency use epinephrine” and to include certain drug delivery devices and 4 |
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22 | 22 | | products; altering the name of the Emergency Use Auto–Injectable Epinephrine 5 |
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23 | 23 | | Program to be the Emergency Use Epinephrine Program; and generally relating to 6 |
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24 | 24 | | emergency use epinephrine. 7 |
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25 | 25 | | |
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26 | 26 | | BY repealing and reenacting, with amendments, 8 |
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27 | 27 | | Article – Education 9 |
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28 | 28 | | Section 7–426.2, 7–426.3, and 9.5–117(a)(3) and (f) 10 |
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29 | 29 | | Annotated Code of Maryland 11 |
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30 | 30 | | (2022 Replacement Volume and 2024 Supplement) 12 |
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31 | 31 | | |
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32 | 32 | | BY repealing and reenacting, without amendments, 13 |
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33 | 33 | | Article – Education 14 |
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34 | 34 | | Section 9.5–117(a)(1) 15 |
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35 | 35 | | Annotated Code of Maryland 16 |
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36 | 36 | | (2022 Replacement Volume and 2024 Supplement) 17 |
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37 | 37 | | |
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38 | 38 | | BY repealing and reenacting, with amendments, 18 |
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39 | 39 | | Article – Health – General 19 |
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40 | 40 | | Section 13–702, 13–704(e), 13–705, 13–706(a), 13–707(a) and (b), and 13–708(b); and 20 |
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41 | 41 | | 13–7A–01, 13–7A–02, 13–7A–03(a)(5), 13–7A–06, 13–7A–07(a) and (b), 21 |
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42 | 42 | | 13–7A–08(b), and 13–7A–09 to be under the amended subtitle “Subtitle 7A. 22 |
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43 | 43 | | Emergency Use Epinephrine Program” 23 |
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44 | 44 | | Annotated Code of Maryland 24 |
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45 | 45 | | (2023 Replacement Volume and 2024 Supplement) 25 |
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46 | 46 | | |
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47 | 47 | | BY repealing and reenacting, without amendments, 26 |
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48 | 48 | | Article – Health Occupations 27 2 HOUSE BILL 536 |
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49 | 49 | | |
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50 | 50 | | |
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51 | 51 | | Section 14–5F–01(a) and 14–5F–04.1(a)(1) 1 |
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52 | 52 | | Annotated Code of Maryland 2 |
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53 | 53 | | (2021 Replacement Volume and 2024 Supplement) 3 |
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54 | 54 | | |
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55 | 55 | | BY repealing 4 |
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56 | 56 | | Article – Health Occupations 5 |
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57 | 57 | | Section 14–5F–01(c) 6 |
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58 | 58 | | Annotated Code of Maryland 7 |
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59 | 59 | | (2021 Replacement Volume and 2024 Supplement) 8 |
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60 | 60 | | |
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61 | 61 | | BY repealing and reenacting, with amendments, 9 |
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62 | 62 | | Article – Health Occupations 10 |
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63 | 63 | | Section 14–5F–01(d) through (g), 14–5F–04.1(d)(1), and 14–5F–14(a)(5) 11 |
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64 | 64 | | Annotated Code of Maryland 12 |
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65 | 65 | | (2021 Replacement Volume and 2024 Supplement) 13 |
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66 | 66 | | |
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67 | 67 | | BY adding to 14 |
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68 | 68 | | Article – Health Occupations 15 |
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69 | 69 | | Section 14–5F–01(g) 16 |
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70 | 70 | | Annotated Code of Maryland 17 |
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71 | 71 | | (2021 Replacement Volume and 2024 Supplement) 18 |
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72 | 72 | | |
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73 | 73 | | SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 19 |
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74 | 74 | | That the Laws of Maryland read as follows: 20 |
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75 | 75 | | |
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76 | 76 | | Article – Education 21 |
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77 | 77 | | |
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78 | 78 | | 7–426.2. 22 |
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79 | 79 | | |
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80 | 80 | | (a) (1) In this section the following words have the meanings indicated. 23 |
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81 | 81 | | |
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82 | 82 | | (2) “Anaphylaxis” means a sudden, severe, and potentially life–threatening 24 |
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83 | 83 | | allergic reaction that occurs when an individual is exposed to an allergen. 25 |
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84 | 84 | | |
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85 | 85 | | (3) [“Auto–injectable] “EMERGENCY USE epinephrine” means a portable, 26 |
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86 | 86 | | disposable drug delivery device OR PRODUCT APPROVED BY THE FEDE RAL FOOD AND 27 |
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87 | 87 | | DRUG ADMINISTRATION that contains a premeasured single dose of epinephrine that is 28 |
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88 | 88 | | used to treat anaphylaxis in an emergency situation. 29 |
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89 | 89 | | |
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90 | 90 | | (b) Each county board shall establish a policy for public schools within its 30 |
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91 | 91 | | jurisdiction to authorize the school nurse and other school personnel to administer 31 |
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92 | 92 | | [auto–injectable] EMERGENCY USE epinephrine, if available, to a student who is 32 |
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93 | 93 | | determined to be or perceived to be in anaphylaxis, regardless of whether the student: 33 |
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94 | 94 | | |
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95 | 95 | | (1) Has been identified as having an anaphylactic allergy, as defined in § 34 |
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96 | 96 | | 7–426.1 of this subtitle; or 35 |
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97 | 97 | | HOUSE BILL 536 3 |
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98 | 98 | | |
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99 | 99 | | |
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100 | 100 | | (2) Has a prescription for epinephrine as prescribed by an authorized 1 |
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101 | 101 | | licensed health care practitioner under the Health Occupations Article. 2 |
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102 | 102 | | |
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103 | 103 | | (c) The policy established under subsection (b) of this section shall include: 3 |
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104 | 104 | | |
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105 | 105 | | (1) Training for school personnel on how to recognize the symptoms of 4 |
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106 | 106 | | anaphylaxis; 5 |
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107 | 107 | | |
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108 | 108 | | (2) Procedures for the emergency administration of [auto–injectable] 6 |
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109 | 109 | | EMERGENCY USE epinephrine; 7 |
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110 | 110 | | |
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111 | 111 | | (3) The proper follow–up emergency procedures; 8 |
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112 | 112 | | |
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113 | 113 | | (4) A provision authorizing a school nurse to obtain and store at a public 9 |
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114 | 114 | | school [auto–injectable] EMERGENCY USE epinephrine to be used in an emergency 10 |
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115 | 115 | | situation; and 11 |
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116 | 116 | | |
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117 | 117 | | (5) A requirement that each public school develop and implement a method 12 |
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118 | 118 | | for notifying the parents or guardians of students of the school’s policy under this section 13 |
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119 | 119 | | at the beginning of each school year. 14 |
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120 | 120 | | |
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121 | 121 | | (d) Except for any willful or grossly negligent act, a school nurse or other school 15 |
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122 | 122 | | personnel who respond in good faith to the anaphylactic reaction of a child in accordance 16 |
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123 | 123 | | with this section may not be held personally liable for any act or omission in the course of 17 |
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124 | 124 | | responding to the reaction. 18 |
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125 | 125 | | |
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126 | 126 | | (e) (1) Each public school shall submit, on the form that the Department 19 |
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127 | 127 | | requires, a report to the Department on each incident at the school or at a related school 20 |
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128 | 128 | | event that required the use of [auto–injectable] EMERGENCY USE epinephrine. 21 |
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129 | 129 | | |
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130 | 130 | | (2) The Department shall develop and disseminate a standard form to 22 |
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131 | 131 | | report each incident requiring the use of [auto–injectable] EMERGENCY USE epinephrine 23 |
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132 | 132 | | at a public school. 24 |
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133 | 133 | | |
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134 | 134 | | 7–426.3. 25 |
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135 | 135 | | |
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136 | 136 | | (a) (1) In this section the following words have the meanings indicated. 26 |
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137 | 137 | | |
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138 | 138 | | (2) “Anaphylaxis” means a sudden, severe, and potentially life–threatening 27 |
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139 | 139 | | allergic reaction that occurs when an individual is exposed to an allergen. 28 |
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140 | 140 | | |
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141 | 141 | | (3) [“Auto–injectable] “EMERGENCY USE epinephrine” means a portable, 29 |
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142 | 142 | | disposable drug delivery device OR PRODUCT APPROVED BY THE FEDE RAL FOOD AND 30 |
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143 | 143 | | DRUG ADMINISTRATION that contains a premeasured single dose of epinephrine that is 31 |
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144 | 144 | | used to treat anaphylaxis in an emergency situation. 32 |
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145 | 145 | | 4 HOUSE BILL 536 |
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146 | 146 | | |
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147 | 147 | | |
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148 | 148 | | (4) “School personnel” means individuals who are employed by a nonpublic 1 |
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149 | 149 | | school, including part–time employees, teachers and substitute teachers employed by the 2 |
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150 | 150 | | school for at least 7 days each school year, a school nurse, registered nurse case manager, 3 |
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151 | 151 | | delegating nurse, and administrative staff. 4 |
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152 | 152 | | |
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153 | 153 | | (b) Each nonpublic school in the State may establish a policy authorizing school 5 |
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154 | 154 | | personnel to administer [auto–injectable] EMERGENCY USE epinephrine, if available, to a 6 |
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155 | 155 | | student who is determined to be or perceived to be in anaphylaxis, regardless of whether 7 |
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156 | 156 | | the student: 8 |
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157 | 157 | | |
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158 | 158 | | (1) Has been identified as having an anaphylactic allergy, as defined in § 9 |
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159 | 159 | | 7–426.1 of this subtitle; or 10 |
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160 | 160 | | |
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161 | 161 | | (2) Has a prescription for epinephrine as prescribed by an authorized 11 |
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162 | 162 | | licensed health care practitioner under the Health Occupations Article. 12 |
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163 | 163 | | |
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164 | 164 | | (c) The policy established under subsection (b) of this section shall include: 13 |
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165 | 165 | | |
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166 | 166 | | (1) Training for school personnel on how to recognize the signs and 14 |
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167 | 167 | | symptoms of anaphylaxis by a licensed health care practitioner who is authorized to 15 |
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168 | 168 | | administer [auto–injectable] EMERGENCY USE epinephrine and who has been trained in 16 |
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169 | 169 | | an established protocol on how to recognize the signs and symptoms of anaphylaxis; 17 |
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170 | 170 | | |
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171 | 171 | | (2) Procedures for the emergency administration of [auto–injectable] 18 |
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172 | 172 | | EMERGENCY USE epinephrine; 19 |
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173 | 173 | | |
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174 | 174 | | (3) The proper follow–up emergency procedures; 20 |
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175 | 175 | | |
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176 | 176 | | (4) A provision authorizing a school nurse or other licensed health care 21 |
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177 | 177 | | practitioner to obtain, and[,] school personnel to store, at a nonpublic school 22 |
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178 | 178 | | [auto–injectable] EMERGENCY USE epinephrine to be used in an emergency situation; 23 |
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179 | 179 | | |
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180 | 180 | | (5) A requirement that the nonpublic school develop and implement a 24 |
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181 | 181 | | method for notifying the parents or guardians of students of the school’s policy under this 25 |
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182 | 182 | | section at the beginning of each school year; and 26 |
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183 | 183 | | |
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184 | 184 | | (6) An ongoing process for oversight and monitoring by a licensed health 27 |
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185 | 185 | | care practitioner of the implementation of the policy established under subsection (b) of this 28 |
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186 | 186 | | section. 29 |
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187 | 187 | | |
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188 | 188 | | (d) Except for any willful or grossly negligent act, school personnel who respond 30 |
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189 | 189 | | in good faith to the anaphylactic reaction of a child in accordance with this section may not 31 |
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190 | 190 | | be held personally liable for any act or omission in the course of responding to the reaction. 32 |
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191 | 191 | | |
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192 | 192 | | 9.5–117. 33 |
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193 | 193 | | HOUSE BILL 536 5 |
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194 | 194 | | |
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195 | 195 | | |
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196 | 196 | | (a) (1) In this section the following words have the meanings indicated. 1 |
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197 | 197 | | |
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198 | 198 | | (3) [“Auto–injectable] “EMERGENCY USE epinephrine” has the meaning 2 |
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199 | 199 | | stated in § 7–426.2 of this article. 3 |
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200 | 200 | | |
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201 | 201 | | (f) Except for any willfully or grossly negligent act, a child care provider or an 4 |
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202 | 202 | | employee of a child care provider who responds in good faith to the anaphylactic reaction 5 |
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203 | 203 | | of a child in accordance with the guidelines implemented under this section or by use of 6 |
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204 | 204 | | [auto–injectable] EMERGENCY USE epinephrine is immune from civil liability for any act 7 |
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205 | 205 | | or omission in the course of responding to the reaction. 8 |
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206 | 206 | | |
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207 | 207 | | Article – Health – General 9 |
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208 | 208 | | |
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209 | 209 | | 13–702. 10 |
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210 | 210 | | |
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211 | 211 | | (a) In this subtitle the following words have the meanings indicated. 11 |
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212 | 212 | | |
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213 | 213 | | (b) “Agent” means an individual who: 12 |
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214 | 214 | | |
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215 | 215 | | (1) Is at least 18 years of age; 13 |
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216 | 216 | | |
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217 | 217 | | (2) Has successfully completed, at the expense of an applicant, an 14 |
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218 | 218 | | educational training program approved by the Department; and 15 |
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219 | 219 | | |
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220 | 220 | | (3) Is appointed by a certificate holder to administer [auto–injectable] 16 |
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221 | 221 | | EMERGENCY USE epinephrine in accordance with the provisions of this subtitle. 17 |
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222 | 222 | | |
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223 | 223 | | (c) “Anaphylaxis” means a sudden, severe, and potentially life–threatening 18 |
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224 | 224 | | allergic reaction that occurs when an individual is exposed to an allergen. 19 |
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225 | 225 | | |
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226 | 226 | | [(d) “Auto–injectable epinephrine” means a portable, disposable drug delivery 20 |
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227 | 227 | | device that contains a premeasured single dose of epinephrine that is used to treat 21 |
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228 | 228 | | anaphylaxis in an emergency situation.] 22 |
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229 | 229 | | |
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230 | 230 | | [(e)] (D) “Certificate” means a certificate or an endorsement on the operating 23 |
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231 | 231 | | certificate of a youth camp issued by the Department to an individual who operates a youth 24 |
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232 | 232 | | camp under Title 14, Subtitle 4 of this article to obtain, store, and administer 25 |
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233 | 233 | | [auto–injectable] EMERGENCY USE epinephrine. 26 |
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234 | 234 | | |
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235 | 235 | | [(f)] (E) “Certificate holder” means an individual who is authorized by the 27 |
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236 | 236 | | Department to obtain, store, and administer [auto–injectable] EMERGENCY USE 28 |
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237 | 237 | | epinephrine to be used in an emergency situation. 29 |
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238 | 238 | | |
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239 | 239 | | (F) “EMERGENCY USE EPINEPH RINE” MEANS A PORTABLE , DISPOSABLE 30 |
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240 | 240 | | DRUG DELIVERY DEVICE OR PRODUCT APPROVED BY THE FEDE RAL FOOD AND 31 6 HOUSE BILL 536 |
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241 | 241 | | |
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242 | 242 | | |
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243 | 243 | | DRUG ADMINISTRATION THAT C ONTAINS A PREMEASURE D SINGLE DOSE OF 1 |
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244 | 244 | | EPINEPHRINE THAT IS USED TO TREAT ANAPHY LAXIS IN AN EMERGENC Y SITUATION. 2 |
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245 | 245 | | |
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246 | 246 | | (g) “Program” means the Emergency and Allergy Treatment Program. 3 |
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247 | 247 | | |
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248 | 248 | | (h) “Registered nurse practitioner” has the meaning stated in § 8–101 of the 4 |
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249 | 249 | | Health Occupations Article. 5 |
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250 | 250 | | |
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251 | 251 | | (i) “Youth camp” has the meaning stated in § 14–401 of this article. 6 |
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252 | 252 | | |
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253 | 253 | | 13–704. 7 |
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254 | 254 | | |
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255 | 255 | | (e) An applicant shall have a written policy that includes: 8 |
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256 | 256 | | |
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257 | 257 | | (1) Authorization for the certificate holder or agent to administer 9 |
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258 | 258 | | [auto–injectable] EMERGENCY USE epinephrine, if available, to an individual who has 10 |
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259 | 259 | | been determined to be or is believed to be experiencing anaphylaxis, whether or not the 11 |
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260 | 260 | | individual: 12 |
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261 | 261 | | |
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262 | 262 | | (i) Has previously been known to have experienced anaphylaxis; or 13 |
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263 | 263 | | |
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264 | 264 | | (ii) Has a prescription for epinephrine prescribed by an authorized 14 |
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265 | 265 | | health care practitioner licensed under the Health Occupations Article; 15 |
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266 | 266 | | |
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267 | 267 | | (2) A requirement that youth camp personnel complete training on how to 16 |
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268 | 268 | | recognize the symptoms of anaphylaxis; 17 |
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269 | 269 | | |
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270 | 270 | | (3) Procedures for the emergency administration of [auto–injectable] 18 |
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271 | 271 | | EMERGENCY USE epinephrine; 19 |
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272 | 272 | | |
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273 | 273 | | (4) Procedures for proper emergency follow–up; 20 |
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274 | 274 | | |
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275 | 275 | | (5) Authorization for a certificate holder to obtain and store 21 |
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276 | 276 | | [auto–injectable] EMERGENCY USE epinephrine to be used in an emergency; and 22 |
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277 | 277 | | |
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278 | 278 | | (6) A requirement that each certificate holder implement a method for 23 |
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279 | 279 | | notifying the parent or guardian of a camper of the youth camp’s policy under this section 24 |
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280 | 280 | | before the camper’s attendance. 25 |
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281 | 281 | | |
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282 | 282 | | 13–705. 26 |
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283 | 283 | | |
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284 | 284 | | (a) (1) A registered nurse practitioner or a physician licensed to practice 27 |
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285 | 285 | | medicine in the State may prescribe [auto–injectable] EMERGENCY USE epinephrine in 28 |
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286 | 286 | | the name of a certificate holder. 29 |
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287 | 287 | | HOUSE BILL 536 7 |
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288 | 288 | | |
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289 | 289 | | |
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290 | 290 | | (2) A registered nurse practitioner, a pharmacist licensed to practice 1 |
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291 | 291 | | pharmacy in the State, or a physician may dispense [auto–injectable] EMERGENCY USE 2 |
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292 | 292 | | epinephrine under a prescription issued to a certificate holder. 3 |
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293 | 293 | | |
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294 | 294 | | (b) A certificate holder may: 4 |
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295 | 295 | | |
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296 | 296 | | (1) On presentment of a certificate, receive from any registered nurse 5 |
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297 | 297 | | practitioner or any physician licensed to practice medicine in the State a prescription for 6 |
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298 | 298 | | [auto–injectable] EMERGENCY USE epinephrine and the necessary paraphernalia for the 7 |
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299 | 299 | | administration of [auto–injectable] EMERGENCY USE epinephrine; and 8 |
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300 | 300 | | |
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301 | 301 | | (2) Possess and store prescribed [auto–injectable] EMERGENCY USE 9 |
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302 | 302 | | epinephrine and the necessary paraphernalia for the administration of [auto–injectable] 10 |
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303 | 303 | | EMERGENCY USE epinephrine. 11 |
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304 | 304 | | |
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305 | 305 | | (c) In an emergency situation when registered nurse practitioner, physician, or 12 |
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306 | 306 | | emergency medical services are not immediately available, a certificate holder or agent may 13 |
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307 | 307 | | administer [auto–injectable] EMERGENCY USE epinephrine to an individual who is 14 |
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308 | 308 | | experiencing or believed in good faith by the certificate holder or agent to be experiencing 15 |
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309 | 309 | | anaphylaxis. 16 |
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310 | 310 | | |
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311 | 311 | | 13–706. 17 |
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312 | 312 | | |
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313 | 313 | | (a) A certificate holder shall submit to the Department, on a form required by the 18 |
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314 | 314 | | Department, a report of each incident that occurs while the youth camp is in session that 19 |
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315 | 315 | | required the administration of [auto–injectable] EMERGENCY USE epinephrine. 20 |
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316 | 316 | | |
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317 | 317 | | 13–707. 21 |
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318 | 318 | | |
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319 | 319 | | (a) A cause of action may not arise against a certificate holder or agent authorized 22 |
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320 | 320 | | under this subtitle for any act or omission when the certificate holder or agent is acting in 23 |
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321 | 321 | | good faith while administering [auto–injectable] EMERGENCY USE epinephrine to an 24 |
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322 | 322 | | individual experiencing or believed by the certificate holder or agent to be experiencing 25 |
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323 | 323 | | anaphylaxis, except where the conduct of the certificate holder or agent amounts to gross 26 |
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324 | 324 | | negligence, willful or wanton misconduct, or intentionally tortious conduct. 27 |
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325 | 325 | | |
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326 | 326 | | (b) (1) A cause of action may not arise against any physician for any act or 28 |
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327 | 327 | | omission when the physician in good faith prescribes or dispenses [auto–injectable] 29 |
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328 | 328 | | EMERGENCY USE epinephrine and the necessary paraphernalia for the administration of 30 |
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329 | 329 | | [auto–injectable] EMERGENCY USE epinephrine to a person certified by the Department 31 |
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330 | 330 | | under this subtitle. 32 |
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331 | 331 | | |
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332 | 332 | | (2) A cause of action may not arise against any pharmacist for any act or 33 |
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333 | 333 | | omission when the pharmacist in good faith dispenses [auto–injectable] EMERGENCY U SE 34 |
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334 | 334 | | epinephrine and the necessary paraphernalia for the administration of [auto–injectable] 35 |
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335 | 335 | | EMERGENCY USE epinephrine to a person certified by the Department under this subtitle. 36 8 HOUSE BILL 536 |
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336 | 336 | | |
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337 | 337 | | |
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338 | 338 | | |
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339 | 339 | | (3) A cause of action may not arise against any nurse practitioner for any 1 |
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340 | 340 | | act or omission when the nurse practitioner in good faith prescribes or dispenses 2 |
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341 | 341 | | [auto–injectable] EMERGENCY USE epinephrine and the necessary paraphernalia for the 3 |
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342 | 342 | | administration of [auto–injectable] EMERGENCY USE epinephrine to a person certified by 4 |
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343 | 343 | | the Department under this subtitle. 5 |
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344 | 344 | | |
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345 | 345 | | 13–708. 6 |
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346 | 346 | | |
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347 | 347 | | (b) An individual may not be held civilly liable in any action arising from or in 7 |
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348 | 348 | | connection with the administration of [auto–injectable] EMERGENCY USE epinephrine by 8 |
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349 | 349 | | the individual solely because the individual did not possess a certificate issued under this 9 |
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350 | 350 | | subtitle. 10 |
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351 | 351 | | |
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352 | 352 | | Subtitle 7A. Emergency Use [Auto–Injectable] Epinephrine Program. 11 |
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353 | 353 | | |
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354 | 354 | | 13–7A–01. 12 |
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355 | 355 | | |
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356 | 356 | | (a) In this subtitle the following words have the meanings indicated. 13 |
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357 | 357 | | |
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358 | 358 | | (b) “Agent” means an individual who: 14 |
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359 | 359 | | |
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360 | 360 | | (1) Is at least 18 years of age; 15 |
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361 | 361 | | |
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362 | 362 | | (2) Has successfully completed, at the expense of the participating facility, 16 |
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363 | 363 | | an educational training program approved by the Department under § 13–7A–03 of this 17 |
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364 | 364 | | subtitle; and 18 |
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365 | 365 | | |
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366 | 366 | | (3) Is designated by a certificate holder to administer [auto–injectable] 19 |
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367 | 367 | | EMERGENCY USE epinephrine in accordance with the provisions of this subtitle. 20 |
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368 | 368 | | |
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369 | 369 | | (c) “Anaphylaxis” means a sudden, severe, and potentially life–threatening 21 |
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370 | 370 | | allergic reaction that occurs when an individual is exposed to an allergen. 22 |
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371 | 371 | | |
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372 | 372 | | [(d) “Auto–injectable epinephrine” means a portable, disposable drug delivery 23 |
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373 | 373 | | device that contains a premeasured single dose of epinephrine that is used to treat 24 |
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374 | 374 | | anaphylaxis in an emergency situation.] 25 |
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375 | 375 | | |
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376 | 376 | | [(e)] (D) “Certificate” means a certificate issued by the Department to an 26 |
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377 | 377 | | individual to obtain, store, and administer [auto–injectable] EMERGENCY USE 27 |
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378 | 378 | | epinephrine. 28 |
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379 | 379 | | |
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380 | 380 | | [(f)] (E) “Certificate holder” means an individual who is authorized by the 29 |
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381 | 381 | | Department to obtain, store, and administer [auto–injectable] EMERGENCY USE 30 |
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382 | 382 | | epinephrine to be used in an emergency situation. 31 |
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383 | 383 | | HOUSE BILL 536 9 |
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384 | 384 | | |
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385 | 385 | | |
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386 | 386 | | [(g)] (F) “Eligible institution” means an institution of higher education that has 1 |
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387 | 387 | | a food service facility or a recreation and wellness facility on the premises and that is 2 |
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388 | 388 | | authorized under this subtitle to obtain and store [auto–injectable] EMERGENCY USE 3 |
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389 | 389 | | epinephrine. 4 |
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390 | 390 | | |
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391 | 391 | | (G) “EMERGENCY USE EPINEPH RINE” MEANS A PORTABLE , DISPOSABLE 5 |
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392 | 392 | | DRUG DELIVERY DEVICE OR PRODUCT APPROVED BY THE FEDE RAL FOOD AND 6 |
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393 | 393 | | DRUG ADMINISTRATION THAT C ONTAINS A PREMEASURE D SINGLE DOSE OF 7 |
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394 | 394 | | EPINEPHRINE THAT IS USED TO TREAT ANAPHY LAXIS IN AN EMERGENC Y SITUATION. 8 |
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395 | 395 | | |
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396 | 396 | | (h) “Food service facility” has the meaning indicated in § 21–301 of this article. 9 |
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397 | 397 | | |
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398 | 398 | | (i) “Participating facility” means a recreation or wellness facility at an eligible 10 |
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399 | 399 | | institution or a food service facility, including a food service facility at an eligible 11 |
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400 | 400 | | institution, in the State that voluntarily participates in the Program. 12 |
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401 | 401 | | |
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402 | 402 | | (j) “Program” means the Emergency Use [Auto–Injectable] Epinephrine 13 |
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403 | 403 | | Program established under § 13–7A–02 of this subtitle. 14 |
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404 | 404 | | |
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405 | 405 | | 13–7A–02. 15 |
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406 | 406 | | |
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407 | 407 | | (a) There is an Emergency Use [Auto–Injectable] Epinephrine Program. 16 |
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408 | 408 | | |
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409 | 409 | | (b) The purpose of the Program is to authorize individuals employed by a 17 |
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410 | 410 | | participating facility to obtain and store [auto–injectable] EMERGENCY USE epinephrine 18 |
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411 | 411 | | and administer [auto–injectable] EMERGENCY USE epinephrine to individuals who are 19 |
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412 | 412 | | experiencing or are believed to be experiencing anaphylaxis when a physician or emergency 20 |
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413 | 413 | | medical services are not immediately available. 21 |
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414 | 414 | | |
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415 | 415 | | (c) (1) Subject to paragraph (4) of this subsection, each participating facility 22 |
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416 | 416 | | may obtain: 23 |
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417 | 417 | | |
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418 | 418 | | (i) A prescription for a supply of [auto–injectable] EMERGENCY 24 |
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419 | 419 | | USE epinephrine from a licensed physician as provided in § 13–7A–06 of this subtitle; and 25 |
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420 | 420 | | |
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421 | 421 | | (ii) A supply of [auto–injectable] EMERGENCY USE epinephrine 26 |
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422 | 422 | | from a licensed pharmacist or a licensed physician as provided in § 13–7A–06 of this 27 |
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423 | 423 | | subtitle. 28 |
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424 | 424 | | |
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425 | 425 | | (2) Each participating facility shall store a supply of [auto–injectable] 29 |
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426 | 426 | | EMERGENCY USE epinephrine obtained under paragraph (1)(ii) of this subsection: 30 |
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427 | 427 | | |
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428 | 428 | | (i) In accordance with the manufacturer’s instructions; and 31 |
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429 | 429 | | |
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430 | 430 | | (ii) In a location that is readily accessible to employees or affiliated 32 |
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431 | 431 | | individuals in an emergency situation. 33 10 HOUSE BILL 536 |
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432 | 432 | | |
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433 | 433 | | |
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434 | 434 | | |
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435 | 435 | | (3) Each participating facility shall designate the employees who are 1 |
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436 | 436 | | certificate holders or designated affiliated individuals who are certificate holders who will 2 |
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437 | 437 | | be responsible for the storage, maintenance, and control of the supply of [auto–injectable] 3 |
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438 | 438 | | EMERGENCY USE epinephrine. 4 |
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439 | 439 | | |
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440 | 440 | | (4) A participating facility may not obtain or store [auto–injectable] 5 |
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441 | 441 | | EMERGENCY USE epinephrine unless the participating facility has at least two employees 6 |
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442 | 442 | | or designated affiliated individuals who are certificate holders. 7 |
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443 | 443 | | |
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444 | 444 | | (5) Each participating facility shall maintain a copy of the certificate issued 8 |
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445 | 445 | | to an employee or a designated affiliated individual under § 13–7A–05 of this subtitle. 9 |
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446 | 446 | | |
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447 | 447 | | 13–7A–03. 10 |
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448 | 448 | | |
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449 | 449 | | (a) The Department shall: 11 |
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450 | 450 | | |
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451 | 451 | | (5) Develop a method by which certificate holders may submit a report to 12 |
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452 | 452 | | the Department about each incident that occurred on the premises of a participating facility 13 |
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453 | 453 | | that involved the administration of [auto–injectable] EMERGENCY USE epinephrine by a 14 |
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454 | 454 | | certificate holder or an agent; and 15 |
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455 | 455 | | |
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456 | 456 | | 13–7A–06. 16 |
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457 | 457 | | |
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458 | 458 | | (a) (1) A physician licensed to practice medicine in the State may prescribe 17 |
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459 | 459 | | [auto–injectable] EMERGENCY USE epinephrine in the name of a certificate holder. 18 |
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460 | 460 | | |
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461 | 461 | | (2) A pharmacist licensed to practice pharmacy in the State or a physician 19 |
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462 | 462 | | may dispense [auto–injectable] EMERGENCY USE epinephrine under a prescription issued 20 |
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463 | 463 | | to a certificate holder. 21 |
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464 | 464 | | |
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465 | 465 | | (b) A certificate holder may: 22 |
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466 | 466 | | |
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467 | 467 | | (1) On presentment of a certificate, receive from any physician licensed to 23 |
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468 | 468 | | practice medicine in the State a prescription for [auto–injectable] EMERGENCY USE 24 |
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469 | 469 | | epinephrine and the necessary paraphernalia for the administration of [auto–injectable] 25 |
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470 | 470 | | EMERGENCY USE epinephrine; and 26 |
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471 | 471 | | |
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472 | 472 | | (2) Possess and store prescribed [auto–injectable] EMERGENCY USE 27 |
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473 | 473 | | epinephrine and the necessary paraphernalia for the administration of [auto–injectable] 28 |
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474 | 474 | | EMERGENCY USE epinephrine. 29 |
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475 | 475 | | |
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476 | 476 | | (c) In an emergency situation when a physician or emergency medical services 30 |
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477 | 477 | | are not immediately available, a certificate holder or an agent may administer 31 |
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478 | 478 | | [auto–injectable] EMERGENCY USE epinephrine to an individual who is experiencing or is 32 |
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479 | 479 | | believed in good faith by the certificate holder or agent to be experiencing anaphylaxis. 33 HOUSE BILL 536 11 |
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480 | 480 | | |
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481 | 481 | | |
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482 | 482 | | |
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483 | 483 | | 13–7A–07. 1 |
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484 | 484 | | |
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485 | 485 | | (a) (1) Except as provided in paragraph (2) of this subsection, a cause of action 2 |
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486 | 486 | | may not arise against a certificate holder for any act or omission if the certificate holder or 3 |
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487 | 487 | | agent is acting in good faith while administering [auto–injectable] EMERGENCY USE 4 |
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488 | 488 | | epinephrine to an individual who is experiencing or believed by the certificate holder or 5 |
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489 | 489 | | agent to be experiencing anaphylaxis except where the conduct of the certificate holder or 6 |
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490 | 490 | | agent amounts to gross negligence, willful or wanton misconduct, or intentionally tortious 7 |
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491 | 491 | | conduct. 8 |
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492 | 492 | | |
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493 | 493 | | (2) The provisions of paragraph (1) of this subsection do not apply if a 9 |
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494 | 494 | | certificate holder or participating facility that makes available, or a certificate holder who 10 |
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495 | 495 | | administers, [auto–injectable] EMERGENCY USE epinephrine to an individual who is 11 |
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496 | 496 | | experiencing or is believed by the certificate holder or participating facility to be 12 |
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497 | 497 | | experiencing anaphylaxis: 13 |
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498 | 498 | | |
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499 | 499 | | (i) Fails to follow standards and procedures for storage and 14 |
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500 | 500 | | administration of [auto–injectable] EMERGENCY USE epinephrine; or 15 |
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501 | 501 | | |
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502 | 502 | | (ii) Administers [auto–injectable] EMERGENCY USE epinephrine 16 |
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503 | 503 | | that is beyond the manufacturer’s expiration date. 17 |
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504 | 504 | | |
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505 | 505 | | (b) (1) A cause of action may not arise against any physician for any act or 18 |
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506 | 506 | | omission if the physician in good faith prescribes or dispenses [auto–injectable] 19 |
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507 | 507 | | EMERGENCY USE epinephrine and the necessary paraphernalia for the administration of 20 |
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508 | 508 | | [auto–injectable] EMERGENCY USE epinephrine to a certificate holder or participating 21 |
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509 | 509 | | facility under this subtitle. 22 |
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510 | 510 | | |
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511 | 511 | | (2) A cause of action may not arise against any pharmacist for any act or 23 |
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512 | 512 | | omission if the pharmacist in good faith dispenses [auto–injectable] EMERGENCY USE 24 |
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513 | 513 | | epinephrine and the necessary paraphernalia for the administration of [auto–injectable] 25 |
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514 | 514 | | EMERGENCY USE epinephrine to a certificate holder or a participating facility under this 26 |
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515 | 515 | | subtitle. 27 |
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516 | 516 | | |
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517 | 517 | | 13–7A–08. 28 |
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518 | 518 | | |
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519 | 519 | | (b) An individual may not be held civilly liable in any action arising from or in 29 |
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520 | 520 | | connection with the administration of [auto–injectable] EMERGENCY USE epinephrine by 30 |
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521 | 521 | | the individual solely because the individual did not possess a certificate issued under this 31 |
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522 | 522 | | subtitle. 32 |
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523 | 523 | | |
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524 | 524 | | 13–7A–09. 33 |
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525 | 525 | | |
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526 | 526 | | A certificate holder shall submit to the Department, in the manner required under § 34 |
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527 | 527 | | 13–7A–03 of this subtitle, a report of each incident that occurred on the premises of a 35 12 HOUSE BILL 536 |
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528 | 528 | | |
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529 | 529 | | |
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530 | 530 | | participating facility that involved the administration of [auto–injectable] EMERGENCY 1 |
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531 | 531 | | USE epinephrine by a certificate holder or an agent. 2 |
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532 | 532 | | |
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533 | 533 | | Article – Health Occupations 3 |
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534 | 534 | | |
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535 | 535 | | 14–5F–01. 4 |
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536 | 536 | | |
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537 | 537 | | (a) In this subtitle the following words have the meanings indicated. 5 |
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538 | 538 | | |
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539 | 539 | | [(c) “Auto–injectable epinephrine” means a portable, disposable drug delivery 6 |
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540 | 540 | | device that contains a premeasured single dose of epinephrine that is used to treat 7 |
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541 | 541 | | anaphylaxis in an emergency situation.] 8 |
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542 | 542 | | |
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543 | 543 | | [(d)] (C) “Board” means the State Board of Physicians. 9 |
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544 | 544 | | |
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545 | 545 | | [(e)] (D) “Committee” means the Naturopathic Medicine Advisory Committee. 10 |
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546 | 546 | | |
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547 | 547 | | [(f)] (E) “Council” means the Naturopathic Doctors Formulary Council. 11 |
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548 | 548 | | |
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549 | 549 | | [(g)] (F) (1) “Device” means a device used in the diagnosis, treatment, or 12 |
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550 | 550 | | prevention of disease. 13 |
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551 | 551 | | |
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552 | 552 | | (2) “Device” does not include: 14 |
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553 | 553 | | |
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554 | 554 | | (i) Any surgical or dental instrument; 15 |
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555 | 555 | | |
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556 | 556 | | (ii) Any physical therapy equipment; 16 |
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557 | 557 | | |
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558 | 558 | | (iii) Any X–ray apparatus; or 17 |
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559 | 559 | | |
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560 | 560 | | (iv) Any component part or accessory of any of the items listed in 18 |
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561 | 561 | | items (i) through (iii) of this paragraph. 19 |
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562 | 562 | | |
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563 | 563 | | (G) “EMERGENCY USE EPINEPH RINE” MEANS A PORTABLE , DISPOSABLE 20 |
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564 | 564 | | DRUG DELIVERY DEVICE OR PRODUCT APPROVED BY THE FEDE RAL FOOD AND 21 |
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565 | 565 | | DRUG ADMINISTRATION THAT C ONTAINS A PREMEASURE D SINGLE DOSE OF 22 |
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566 | 566 | | EPINEPHRINE THAT IS USED TO TREAT ANAPHY LAXIS IN AN EMERGENC Y SITUATION. 23 |
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567 | 567 | | |
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568 | 568 | | 14–5F–04.1. 24 |
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569 | 569 | | |
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570 | 570 | | (a) (1) There is a Naturopathic Doctors Formulary Council within the Board. 25 |
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571 | 571 | | |
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572 | 572 | | (d) (1) The formulary adopted by the Board shall include: 26 |
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573 | 573 | | |
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574 | 574 | | (i) Nonprescription drugs and devices; 27 |
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575 | 575 | | HOUSE BILL 536 13 |
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576 | 576 | | |
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577 | 577 | | |
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578 | 578 | | (ii) Prescription oxygen and [auto–injectable] EMERGENCY USE 1 |
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579 | 579 | | epinephrine; and 2 |
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580 | 580 | | |
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581 | 581 | | (iii) Prescription diaphragms and cervical caps for contraception. 3 |
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582 | 582 | | |
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583 | 583 | | 14–5F–14. 4 |
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584 | 584 | | |
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585 | 585 | | (a) A license authorizes a licensee, consistent with naturopathic education and 5 |
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586 | 586 | | training and competence demonstrated by passing the naturopathic physician licensing 6 |
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587 | 587 | | examination, to: 7 |
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588 | 588 | | |
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589 | 589 | | (5) Administer [auto–injectable] EMERGENCY USE epinephrine; 8 |
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590 | 590 | | |
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591 | 591 | | SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect July 9 |
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592 | 592 | | 1, 2025. 10 |
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593 | 593 | | |
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