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 | | *sb0161* |
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6 | 6 | | |
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7 | 7 | | SENATE BILL 161 |
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8 | 8 | | J2 3lr1325 |
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9 | 9 | | HB 260/22 – HGO CF 3lr1831 |
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10 | 10 | | By: Senator Lam (By Request – State Board of Physicians) |
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11 | 11 | | Introduced and read first time: January 18, 2023 |
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12 | 12 | | Assigned to: Finance |
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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 | | State Board of Physicians – Dispensing Permits 2 |
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19 | 19 | | |
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20 | 20 | | FOR the purpose of transferring oversight of the inspection of the offices of dispensing 3 |
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21 | 21 | | physicians from the Office of Controlled Substances Administration to the State 4 |
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22 | 22 | | Board of Physicians; altering the circumstances under which a physician may 5 |
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23 | 23 | | dispense drugs or devices; requiring that certain appropriations be transferred to the 6 |
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24 | 24 | | Board on a certain date; providing for the transfer of certain functions, powers, 7 |
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25 | 25 | | duties, property, records, fixtures, credits, assets, liability, obligations, rights, and 8 |
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26 | 26 | | privileges; requiring that certain employees of the Office be transferred to the Board 9 |
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27 | 27 | | without diminution of their rights, benefits, employment, or retirement status; 10 |
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28 | 28 | | requiring that certain positions at the Office be transferred to the Board; providing 11 |
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29 | 29 | | for the continuity of certain transactions affected by or flowing from this Act; 12 |
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30 | 30 | | providing for the continuity of certain laws, regulations, standards and guidelines, 13 |
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31 | 31 | | policies, orders and other directives, forms, plans, membership, contracts, property, 14 |
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32 | 32 | | investigations, administrative and judicial responsibilities, rights, and other duties 15 |
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33 | 33 | | and responsibilities; and generally relating to the dispensing of drugs or devices by 16 |
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34 | 34 | | licensed physicians. 17 |
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35 | 35 | | |
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36 | 36 | | BY repealing and reenacting, with amendments, 18 |
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37 | 37 | | Article – Health Occupations 19 |
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38 | 38 | | Section 12–102(a) and (c), 12–102.1, 12–102.2, and 14–509 20 |
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39 | 39 | | Annotated Code of Maryland 21 |
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40 | 40 | | (2021 Replacement Volume and 2022 Supplement) 22 |
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41 | 41 | | |
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42 | 42 | | SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 23 |
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43 | 43 | | That the Laws of Maryland read as follows: 24 |
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44 | 44 | | |
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45 | 45 | | Article – Health Occupations 25 |
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46 | 46 | | |
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47 | 47 | | 12–102. 26 |
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48 | 48 | | 2 SENATE BILL 161 |
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49 | 49 | | |
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50 | 50 | | |
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51 | 51 | | (a) (1) In this section the following [terms] WORDS have the meanings 1 |
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52 | 52 | | indicated. 2 |
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53 | 53 | | |
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54 | 54 | | (2) “In the public interest” means the dispensing of drugs or devices by a 3 |
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55 | 55 | | licensed dentist[, physician,] or podiatrist to a patient when a pharmacy is not conveniently 4 |
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56 | 56 | | available to the patient. 5 |
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57 | 57 | | |
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58 | 58 | | (3) “Personally preparing and dispensing” means that the license d 6 |
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59 | 59 | | dentist[, physician,] or podiatrist: 7 |
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60 | 60 | | |
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61 | 61 | | (i) Is physically present on the premises where the prescription is 8 |
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62 | 62 | | filled; and 9 |
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63 | 63 | | |
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64 | 64 | | (ii) Performs a final check of the prescription before it is provided to 10 |
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65 | 65 | | the patient. 11 |
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66 | 66 | | |
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67 | 67 | | (c) (1) This subsection does not apply to a licensed dentist who obtains a 12 |
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68 | 68 | | permit from the State Board of Dental Examiners under subsection (h) of this section. 13 |
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69 | 69 | | |
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70 | 70 | | (2) This title does not prohibit: 14 |
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71 | 71 | | |
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72 | 72 | | (i) A licensed veterinarian from: 15 |
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73 | 73 | | |
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74 | 74 | | 1. Personally preparing and dispensing the veterinarian’s 16 |
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75 | 75 | | prescriptions; or 17 |
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76 | 76 | | |
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77 | 77 | | 2. Dispensing, in accordance with § 2 –313(c) of the 18 |
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78 | 78 | | Agriculture Article, compounded nonsterile preparations or compounded sterile 19 |
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79 | 79 | | preparations provided by a pharmacy; 20 |
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80 | 80 | | |
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81 | 81 | | (II) A LICENSED PHYSICIAN F ROM PERSONALLY PREPA RING 21 |
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82 | 82 | | AND DISPENSING PRESC RIPTIONS IF THE PHYS ICIAN HAS OBTAINED A PERMIT 22 |
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83 | 83 | | UNDER § 14–509 OF THIS ARTICLE; 23 |
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84 | 84 | | |
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85 | 85 | | [(ii)] (III) A licensed dentist[, physician,] or podiatrist from 24 |
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86 | 86 | | personally preparing and dispensing the dentist’s[, physician’s,] or podiatrist’s 25 |
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87 | 87 | | prescriptions when: 26 |
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88 | 88 | | |
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89 | 89 | | 1. The dentist[, physician,] or podiatrist: 27 |
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90 | 90 | | |
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91 | 91 | | A. Has applied to the board of licensure in this State which 28 |
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92 | 92 | | licensed the dentist[, physician,] or podiatrist; 29 |
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93 | 93 | | |
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94 | 94 | | B. Has demonstrated to the satisfaction of that board that the 30 |
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95 | 95 | | dispensing of prescription drugs or devices by the dentist[, physician,] or podiatrist is in 31 |
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96 | 96 | | the public interest; 32 SENATE BILL 161 3 |
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97 | 97 | | |
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98 | 98 | | |
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99 | 99 | | |
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100 | 100 | | C. Has received a written permit from that board to dispense 1 |
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101 | 101 | | prescription drugs or devices except that a written permit is not required in order to 2 |
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102 | 102 | | dispense starter dosages or samples without charge; and 3 |
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103 | 103 | | |
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104 | 104 | | D. Posts a sign conspicuously positioned and readable 4 |
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105 | 105 | | regarding the process for resolving incorrectly filled prescriptions or includes written 5 |
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106 | 106 | | information regarding the process with each prescription dispensed; 6 |
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107 | 107 | | |
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108 | 108 | | 2. The person for whom the drugs or devices are prescribed 7 |
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109 | 109 | | is a patient of the prescribing dentist[, physician,] or podiatrist; 8 |
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110 | 110 | | |
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111 | 111 | | 3. The dentist[, physician,] or podiatrist does not have a 9 |
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112 | 112 | | substantial financial interest in a pharmacy; and 10 |
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113 | 113 | | |
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114 | 114 | | 4. The dentist[, physician,] or podiatrist: 11 |
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115 | 115 | | |
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116 | 116 | | A. Complies with the dispensing and labeling requirements 12 |
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117 | 117 | | of this title; 13 |
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118 | 118 | | |
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119 | 119 | | B. Records the dispensing of the prescription drug or device 14 |
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120 | 120 | | on the patient’s chart; 15 |
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121 | 121 | | |
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122 | 122 | | C. Allows the Office of Controlled Substances Administration 16 |
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123 | 123 | | to enter and inspect the dentist’s[, physician’s,] or podiatrist’s office at all reasonable hours 17 |
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124 | 124 | | and in accordance with § 12–102.1 of this subtitle; 18 |
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125 | 125 | | |
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126 | 126 | | D. On inspection by the Office of Controlled Substances 19 |
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127 | 127 | | Administration, signs and dates an acknowledgment form provided by the Office of 20 |
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128 | 128 | | Controlled Substances Administration relating to the requirements of this section; 21 |
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129 | 129 | | |
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130 | 130 | | E. Except for starter dosages or samples without charge, 22 |
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131 | 131 | | provides the patient with a written prescription, maintains prescription files in accordance 23 |
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132 | 132 | | with § 12–403(c)(13) of this title, and maintains a separate file for Schedule II prescriptions; 24 |
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133 | 133 | | |
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134 | 134 | | F. Does not direct patients to a single pharmacist or 25 |
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135 | 135 | | pharmacy in accordance with § 12–403(c)(8) of this title; 26 |
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136 | 136 | | |
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137 | 137 | | G. Does not receive remuneration for referring patients to a 27 |
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138 | 138 | | pharmacist or pharmacy; 28 |
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139 | 139 | | |
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140 | 140 | | H. Complies with the child resistant packaging requirements 29 |
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141 | 141 | | regarding prescription drugs under Title 22, Subtitle 3 of the Health – General Article; 30 |
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142 | 142 | | |
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143 | 143 | | I. Complies with drug recalls; 31 |
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144 | 144 | | 4 SENATE BILL 161 |
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145 | 145 | | |
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146 | 146 | | |
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147 | 147 | | J. Maintains biennial inventories and complies with any 1 |
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148 | 148 | | other federal and State record–keeping requirements relating to controlled dangerous 2 |
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149 | 149 | | substances; 3 |
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150 | 150 | | |
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151 | 151 | | K. Purchases prescription drugs from a pharmacy or 4 |
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152 | 152 | | wholesale distributor who holds a permit issued by the Board of Pharmacy, as verified by 5 |
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153 | 153 | | the Board of Pharmacy; 6 |
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154 | 154 | | |
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155 | 155 | | L. Annually reports to the respective board of licensure 7 |
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156 | 156 | | whether the dentist[, physician,] or podiatrist has personally prepared and dispensed 8 |
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157 | 157 | | prescription drugs within the previous year; and 9 |
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158 | 158 | | |
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159 | 159 | | M. Completes ten continuing education credits over a 5–year 10 |
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160 | 160 | | period relating to the preparing and dispensing of prescription drugs, offered by the 11 |
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161 | 161 | | Accreditation Council for Pharmacy Education (ACPE) or as approved by the Secretary, in 12 |
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162 | 162 | | consultation with each respective board of licensure, as a condition of permit renewal; OR 13 |
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163 | 163 | | |
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164 | 164 | | [(iii) A licensed physician from dispensing a topical medication 14 |
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165 | 165 | | without obtaining the permit required under item (ii)1C of this paragraph or completing 15 |
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166 | 166 | | the continuing education required under item (ii)4M of this paragraph when the physician: 16 |
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167 | 167 | | |
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168 | 168 | | 1. Otherwise complies with item (ii) of this paragraph; and 17 |
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169 | 169 | | |
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170 | 170 | | 2. Has obtained a special written permit under § 14–509 of 18 |
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171 | 171 | | this article; 19 |
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172 | 172 | | |
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173 | 173 | | (iv) A licensed physician who complies with the requirements of item 20 |
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174 | 174 | | (ii) of this paragraph from personally preparing and dispensing a prescription written by: 21 |
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175 | 175 | | |
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176 | 176 | | 1. A physician assistant in accordance with a delegation 22 |
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177 | 177 | | agreement that complies with Title 15, Subtitle 3 of this article; or 23 |
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178 | 178 | | |
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179 | 179 | | 2. A nurse practitioner who is authorized to practice under 24 |
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180 | 180 | | Title 8, Subtitle 3 of this article and is working with the physician in the same office setting; 25 |
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181 | 181 | | or] 26 |
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182 | 182 | | |
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183 | 183 | | [(v)] (IV) A hospital–based clinic from dispensing prescriptions to 27 |
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184 | 184 | | its patients. 28 |
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185 | 185 | | |
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186 | 186 | | 12–102.1. 29 |
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187 | 187 | | |
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188 | 188 | | (a) This section does not apply to [a]: 30 |
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189 | 189 | | |
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190 | 190 | | (1) A licensed dentist who obtains a permit from the State Board of Dental 31 |
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191 | 191 | | Examiners under § 12–102(h) of this subtitle; OR 32 |
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192 | 192 | | SENATE BILL 161 5 |
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193 | 193 | | |
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194 | 194 | | |
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195 | 195 | | (2) A LICENSED PHYSICIAN W HO OBTAINS A PERMIT FROM THE 1 |
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196 | 196 | | STATE BOARD OF PHYSICIANS UNDE R § 14–509 OF THIS ARTICLE . 2 |
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197 | 197 | | |
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198 | 198 | | (b) The Office of Controlled Substances Administration shall enter and inspect 3 |
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199 | 199 | | the office of a dentist[, physician,] or podiatrist who holds: 4 |
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200 | 200 | | |
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201 | 201 | | (1) An initial dispensing permit: 5 |
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202 | 202 | | |
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203 | 203 | | (i) Within 6 months after receiving the report required under § 6 |
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204 | 204 | | 12–102(l)(1) of this subtitle; and 7 |
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205 | 205 | | |
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206 | 206 | | (ii) At least one more time during the duration of the permit; and 8 |
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207 | 207 | | |
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208 | 208 | | (2) A renewed dispensing permit at least two times during the duration of 9 |
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209 | 209 | | the permit. 10 |
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210 | 210 | | |
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211 | 211 | | (c) The Office of Controlled Substances Administration promptly shall report the 11 |
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212 | 212 | | results of the inspections required under subsection (b) of this section to the respective 12 |
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213 | 213 | | board of licensure. 13 |
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214 | 214 | | |
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215 | 215 | | 12–102.2. 14 |
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216 | 216 | | |
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217 | 217 | | (a) This section does not apply to [a]: 15 |
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218 | 218 | | |
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219 | 219 | | (1) A licensed dentist who obtains a permit from the State Board of Dental 16 |
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220 | 220 | | Examiners under § 12–102(h) of this subtitle; OR 17 |
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221 | 221 | | |
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222 | 222 | | (2) A LICENSED PHYSICIAN W HO OBTAINS A PER MIT FROM THE 18 |
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223 | 223 | | STATE BOARD OF PHYSICIANS UNDER § 14–509 OF THIS ARTICLE . 19 |
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224 | 224 | | |
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225 | 225 | | (b) The Board of Dental Examiners[, the Board of Physicians,] and the Board of 20 |
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226 | 226 | | Podiatric Medical Examiners shall charge a fee to a dentist[, physician,] or podiatrist who 21 |
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227 | 227 | | holds a dispensing permit in an amount that will produce funds to approximate but not 22 |
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228 | 228 | | exceed the documented costs to the Office of Controlled Substances Administration for 23 |
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229 | 229 | | inspection of dispensing permit holders. 24 |
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230 | 230 | | |
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231 | 231 | | (c) Revenues collected by the Board of Dental Examiners[, the Board of 25 |
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232 | 232 | | Physicians,] and the Board of Podiatric Medical Examiners under this section shall be paid 26 |
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233 | 233 | | into the General Fund of the State. 27 |
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234 | 234 | | |
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235 | 235 | | 14–509. 28 |
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236 | 236 | | |
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237 | 237 | | (a) (1) In this section[,] THE FOLLOWING WORDS HAVE THE MEANINGS 29 |
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238 | 238 | | INDICATED. 30 |
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239 | 239 | | 6 SENATE BILL 161 |
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240 | 240 | | |
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241 | 241 | | |
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242 | 242 | | (2) “ACCME” means the Accrediting Council for Continuing Medical 1 |
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243 | 243 | | Education. 2 |
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244 | 244 | | |
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245 | 245 | | (3) “ADMINISTERING ” MEANS THE DIRECT INT RODUCTION OF A 3 |
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246 | 246 | | SINGLE DOSAGE OF A D RUG OR DEVICE AT A G IVEN TIME, WHETHER BY INJECTION 4 |
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247 | 247 | | OR OTHER MEANS , AND WHETHER IN LIQUI D, TABLET, CAPSULE, OR OTHER FORM . 5 |
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248 | 248 | | |
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249 | 249 | | (4) “DISPENSING PERMIT ” MEANS A WRITTEN PERM IT ISSUED BY THE 6 |
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250 | 250 | | BOARD TO A LICENSED P HYSICIAN TO PERSONAL LY PREPARE AND DISPE NSE DRUGS 7 |
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251 | 251 | | OR DEVICES TO A PATI ENT. 8 |
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252 | 252 | | |
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253 | 253 | | (5) “IN THE PUBLIC INTERES T” MEANS THE DISPENSING OF DRUGS 9 |
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254 | 254 | | OR DEVICES BY A LICENSED PHYSICIAN TO A PATIENT WHEN A PHARMACY IS NOT 10 |
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255 | 255 | | CONVENIENTLY AVAILAB LE TO THE PATIENT . 11 |
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256 | 256 | | |
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257 | 257 | | (6) “PERSONALLY PREPARING AND DISPENSING ” MEANS THAT THE 12 |
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258 | 258 | | LICENSED PHYSICIAN : 13 |
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259 | 259 | | |
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260 | 260 | | (I) IS PHYSICALLY PRESENT ON THE PREMISES WHER E THE 14 |
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261 | 261 | | PRESCRIPTION IS FILL ED; AND 15 |
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262 | 262 | | |
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263 | 263 | | (II) PERFORMS A FINAL CHEC K OF THE PRESCRIPTIO N BEFORE 16 |
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264 | 264 | | IT IS PROVIDED TO TH E PATIENT. 17 |
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265 | 265 | | |
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266 | 266 | | (7) “SAMPLE UNIT ” HAS THE MEANING STAT ED IN 21 C.F.R. § 18 |
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267 | 267 | | 203.3(AA). 19 |
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268 | 268 | | |
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269 | 269 | | (8) “STARTER DOSAGE” MEANS AN AMOUNT OF A DRUG OR A DEVICE 20 |
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270 | 270 | | SUFFICIENT TO BEGIN THERAPY: 21 |
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271 | 271 | | |
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272 | 272 | | (I) FOR A DURATION OF 72 HOURS OR LESS ; OR 22 |
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273 | 273 | | |
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274 | 274 | | (II) PRIOR TO OBTAINING A LARGER QUANTITY OF T HE DRUG 23 |
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275 | 275 | | OR DEVICE TO COMPLET E THE THERAPY . 24 |
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276 | 276 | | |
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277 | 277 | | (9) “TOPICAL MEDICATION PE RMIT” MEANS A WRITTEN PERM IT 25 |
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278 | 278 | | ISSUED BY THE BOARD TO A LICENSED P HYSICIAN TO DISPENSE TOPICAL 26 |
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279 | 279 | | MEDICATIONS THAT ARE APPROVED BY THE FEDE RAL FOOD AND DRUG 27 |
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280 | 280 | | ADMINISTRATION FOR TH E TREATMENT OF HYPOT RICHOSIS. 28 |
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281 | 281 | | |
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282 | 282 | | (b) [A physician may dispense a topical medication that is approved by the federal 29 |
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283 | 283 | | Food and Drug Administration for the treatment of hypotrichosis without obtaining a 30 |
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284 | 284 | | dispensing permit or completing the continuing education required under § 12–102(c)(2)(ii) 31 |
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285 | 285 | | of this article if the physician: 32 |
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286 | 286 | | SENATE BILL 161 7 |
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287 | 287 | | |
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288 | 288 | | |
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289 | 289 | | (1) Otherwise complies with the requirements of § 12–102(c)(2)(ii) of this 1 |
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290 | 290 | | article; and 2 |
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291 | 291 | | |
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292 | 292 | | (2)] THIS SECTION DOES NOT APPLY TO A PHYSICIAN WHO: 3 |
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293 | 293 | | |
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294 | 294 | | (1) (I) Has received a [special class of written] TOPICAL MEDICATION 4 |
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295 | 295 | | permit from the Board[.]; 5 |
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296 | 296 | | |
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297 | 297 | | [(c) The Board may issue a special class of written permit to a physician under 6 |
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298 | 298 | | subsection (b) of this section if the physician: 7 |
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299 | 299 | | |
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300 | 300 | | (1)] (II) DISPENSES ONLY A TOPI CAL MEDICATION THAT IS 8 |
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301 | 301 | | APPROVED BY THE FEDE RAL FOOD AND DRUG ADMINISTRATION FOR TH E 9 |
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302 | 302 | | TREATMENT OF HYPOTRICHOSIS ; 10 |
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303 | 303 | | |
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304 | 304 | | (III) Completes 1 hour of continuing medical education per year on 11 |
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305 | 305 | | the dispensing of topical medications developed by an ACCME–accredited Maryland 12 |
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306 | 306 | | nonprofit or governmental entity; and 13 |
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307 | 307 | | |
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308 | 308 | | [(2)] (IV) Pays to the Board a $100 permit fee; 14 |
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309 | 309 | | |
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310 | 310 | | (2) PERSONALLY DISPENSES A DRUG OR DEVICE SAM PLE TO A 15 |
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311 | 311 | | PATIENT IF: 16 |
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312 | 312 | | |
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313 | 313 | | (I) THE SAMPLE COMPLIES W ITH THE LABELING 17 |
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314 | 314 | | REQUIREMENTS OF § 12–505 OF THIS ARTICLE; 18 |
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315 | 315 | | |
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316 | 316 | | (II) NO CHARGE IS MADE FOR THE SAMPLE; AND 19 |
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317 | 317 | | |
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318 | 318 | | (III) THE AUTHORIZED PRESCR IBER ENTERS AN APPROPRIATE 20 |
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319 | 319 | | RECORD IN THE PATIEN T’S CHART; 21 |
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320 | 320 | | |
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321 | 321 | | (3) ADMINISTERS A PRESCRI PTION DRUG OR DEVICE IN THE COURSE 22 |
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322 | 322 | | OF TREATING A PATIEN T; 23 |
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323 | 323 | | |
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324 | 324 | | (4) PERSONALLY DISPENSES A STARTER DOSAGE OF A PRESCRIPTION 24 |
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325 | 325 | | DRUG OR DEVICE TO A PATIENT IF: 25 |
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326 | 326 | | |
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327 | 327 | | (I) THE STARTER DOSAGE CO MPLIES WITH THE LABELIN G 26 |
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328 | 328 | | REQUIREMENTS OF § 12–505 OF THIS ARTICLE; 27 |
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329 | 329 | | |
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330 | 330 | | (II) NO CHARGE IS MADE FOR THE STARTER DOSAGE ; AND 28 |
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331 | 331 | | |
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332 | 332 | | (III) THE LICENSED PHYSICIA N ENTERS AN APPROPRI ATE 29 |
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333 | 333 | | RECORD ON THE PATIEN T’S CHART; OR 30 8 SENATE BILL 161 |
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334 | 334 | | |
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335 | 335 | | |
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336 | 336 | | |
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337 | 337 | | (5) DISPENSES A PRESCRIPT ION DRUG OR DEVICE IN THE COURSE OF 1 |
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338 | 338 | | TREATING A PATIENT A T: 2 |
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339 | 339 | | |
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340 | 340 | | (I) A MEDICAL FACILITY OR CLINIC THAT IS OPERA TED ON A 3 |
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341 | 341 | | NONPROFIT BASIS ; 4 |
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342 | 342 | | |
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343 | 343 | | (II) A HEALTH CENTER THAT O PERATES ON A CAMPUS OF AN 5 |
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344 | 344 | | INSTITUTION OF HIGHE R EDUCATION; OR 6 |
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345 | 345 | | |
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346 | 346 | | (III) A PUBLIC HEALTH FACILI TY, A MEDICAL F ACILITY UNDER 7 |
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347 | 347 | | CONTRACT WITH A STATE OR LOCAL HEALTH DEPARTMENT , OR A FACILITY FUNDED 8 |
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348 | 348 | | WITH PUBLIC FUNDS . 9 |
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349 | 349 | | |
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350 | 350 | | (C) A LICENSED PHYSICIAN M AY PERSONALLY PREPAR E AND DISPENSE 10 |
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351 | 351 | | PRESCRIPTIONS ONLY I F: 11 |
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352 | 352 | | |
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353 | 353 | | (1) THE PHYSICIAN: 12 |
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354 | 354 | | |
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355 | 355 | | (I) HAS AN ACTIVE LICENSE IN GOOD STANDING ; 13 |
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356 | 356 | | |
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357 | 357 | | (II) HAS APPLIED TO THE BOARD FOR A DISPENSIN G PERMIT; 14 |
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358 | 358 | | |
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359 | 359 | | (III) HAS PAID A FEE DETERM INED BY THE BOARD TO PRODUCE 15 |
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360 | 360 | | FUNDS TO APPROXIMATE BUT NOT EXCEED THE D OCUMENTED COSTS TO T HE 16 |
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361 | 361 | | BOARD FOR CONDUCTING INSPECTION S OF DISPENSING PERM IT HOLDERS; 17 |
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362 | 362 | | |
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363 | 363 | | (IV) HAS DEMONSTRATED TO T HE SATISFACTION OF T HE BOARD 18 |
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364 | 364 | | THAT THE DISPENSING OF PRESCRIPTION DRUG S OR DEVICES BY THE PHYSICIAN IS 19 |
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365 | 365 | | IN THE PUBLIC INTERE ST; 20 |
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366 | 366 | | |
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367 | 367 | | (V) HAS RECEIVED A DISPEN SING PERMIT FROM THE BOARD; 21 |
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368 | 368 | | AND 22 |
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369 | 369 | | |
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370 | 370 | | (VI) HAS A SIGN CONSPICUOU SLY POSITIONED AND R EADABLE 23 |
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371 | 371 | | REGARDING THE PROCES S FOR RESOLVING INCO RRECTLY FILLED PRESC RIPTIONS 24 |
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372 | 372 | | OR INCLUDES WRITTEN INFORMATION REGARDIN G THE PROCESS WITH E ACH 25 |
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373 | 373 | | PRESCRIPTION DISPENS ED; 26 |
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374 | 374 | | |
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375 | 375 | | (2) THE INDIVIDUAL FOR WH OM THE DRUG OR DEVICE IS 27 |
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376 | 376 | | PRESCRIBED IS A PATI ENT OF: 28 |
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377 | 377 | | |
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378 | 378 | | (I) THE PRESCRIBING PHYSI CIAN; 29 |
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379 | 379 | | SENATE BILL 161 9 |
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380 | 380 | | |
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381 | 381 | | |
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382 | 382 | | (II) A PHYSICIAN ASSISTANT IN ACCORDANCE WITH A 1 |
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383 | 383 | | DELEGATION AGREEMENT THAT COMPLIES WITH TITLE 15, SUBTITLE 3 OF THIS 2 |
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384 | 384 | | ARTICLE; OR 3 |
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385 | 385 | | |
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386 | 386 | | (III) A NURSE PRACTITIONER W HO IS AUTHORIZE D TO PRACTICE 4 |
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387 | 387 | | UNDER TITLE 8, SUBTITLE 3 OF THIS ARTICLE AND IS WORKING WITH THE 5 |
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388 | 388 | | PHYSICIAN IN THE SAM E OFFICE SETTING ; 6 |
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389 | 389 | | |
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390 | 390 | | (3) THE PHYSICIAN DOES NO T HAVE A SUBSTANTIAL FINANCIAL 7 |
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391 | 391 | | INTEREST IN A PHARMA CY; AND 8 |
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392 | 392 | | |
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393 | 393 | | (4) THE PHYSICIAN: 9 |
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394 | 394 | | |
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395 | 395 | | (I) COMPLIES WITH THE DIS PENSING AND LABELING 10 |
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396 | 396 | | REQUIREMENTS OF THIS TITLE, TITLE 12 OF THIS ARTICLE , AND THE BOARD’S 11 |
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397 | 397 | | REGULATIONS ; 12 |
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398 | 398 | | |
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399 | 399 | | (II) RECORDS THE DISPENSIN G OF THE PRESCRIPTIO N DRUG 13 |
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400 | 400 | | OR DEVICE ON THE PAT IENT’S CHART; 14 |
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401 | 401 | | |
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402 | 402 | | (III) PROVIDES THE PATIENT WITH A WRITTEN PRESCRIPTION , 15 |
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403 | 403 | | MAINTAINS PRESCRIPTI ON FILES IN ACCORDAN CE WITH § 12–403(C)(13) OF THIS 16 |
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404 | 404 | | ARTICLE, AND MAINTAINS A SEPA RATE FILE FOR SCHEDULE II PRESCRIPTIONS ; 17 |
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405 | 405 | | |
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406 | 406 | | (IV) DOES NOT DIRECT PATIE NTS TO A SINGLE PHAR MACIST OR 18 |
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407 | 407 | | PHARMACY IN ACCORDAN CE WITH § 12–403(C)(8) OF THIS ARTICLE; 19 |
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408 | 408 | | |
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409 | 409 | | (V) DOES NOT RECEIVE REMU NERATION FOR REFERRI NG 20 |
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410 | 410 | | PATIENTS TO A PHARMA CIST OR PHARMACY ; 21 |
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411 | 411 | | |
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412 | 412 | | (VI) COMPLIES WITH THE CHI LD RESISTANT PACKAGI NG 22 |
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413 | 413 | | REQUIREMENTS REGARDI NG PRESCRIPTION DRUG S UNDER TITLE 22, SUBTITLE 3 23 |
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414 | 414 | | OF THE HEALTH – GENERAL ARTICLE; 24 |
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415 | 415 | | |
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416 | 416 | | (VII) COMPLIES WITH DRUG RE CALLS; 25 |
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417 | 417 | | |
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418 | 418 | | (VIII) MAINTAINS BIENNIAL IN VENTORIES AND COMPLI ES WITH 26 |
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419 | 419 | | ANY OTHER FEDERAL AN D STATE RECORD –KEEPING REQUIREMENTS RELATING TO 27 |
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420 | 420 | | CONTROLLED DANGEROUS SUBSTANCES; 28 |
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421 | 421 | | |
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422 | 422 | | (IX) PURCHASES PRESCRIPTIO N DRUGS FROM A PHARMACY OR 29 |
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423 | 423 | | WHOLESALE DISTRIBUTO R THAT HOLDS A PERMI T ISSUED BY THE STATE BOARD OF 30 |
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424 | 424 | | PHARMACY, AS VERIFIED BY THE STATE BOARD OF PHARMACY; AND 31 |
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425 | 425 | | 10 SENATE BILL 161 |
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426 | 426 | | |
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427 | 427 | | |
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428 | 428 | | (X) COMPLIES WITH CONTINU ING EDUCATION REQUIR EMENTS 1 |
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429 | 429 | | RELATING TO THE PREP ARING AND DISPENSING OF PRESCRIPTION DRUGS AS 2 |
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430 | 430 | | PROVIDED FOR IN REGU LATIONS ADOPTED BY T HE BOARD. 3 |
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431 | 431 | | |
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432 | 432 | | (D) A PHYSICIAN WHO FAILS TO COMPLY WITH THE P ROVISIONS OF THIS 4 |
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433 | 433 | | SECTION GOVERNING TH E DISPENSING OF PRES CRIPTION DRUGS OR DE VICES 5 |
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434 | 434 | | SHALL: 6 |
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435 | 435 | | |
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436 | 436 | | (1) HAVE THE DISPENSING P ERMIT REVOKED ; AND 7 |
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437 | 437 | | |
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438 | 438 | | (2) BE SUBJECT TO DISCIPL INARY ACTION BY THE BOARD. 8 |
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439 | 439 | | |
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440 | 440 | | (E) (1) (I) WITHIN 6 MONTHS AFTER THE BOARD ISSUES AN INITI AL 9 |
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441 | 441 | | DISPENSING PERMIT TO A LICENSED PHYSICIAN , THE BOARD SHALL ENTER AND 10 |
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442 | 442 | | INSPECT THE OFFICE O F THE PHYSICIAN. 11 |
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443 | 443 | | |
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444 | 444 | | (II) IF THE BOARD RENEWS A DISPEN SING PERMIT TO A 12 |
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445 | 445 | | LICENSED PHYSICIAN , THE BOARD SHALL ENTER AND INSPECT THE OFFICE O F THE 13 |
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446 | 446 | | PHYSICIAN AT LEAST O NE TIME DURING THE D URATION OF THE RENEW ED PERMIT. 14 |
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447 | 447 | | |
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448 | 448 | | (2) THE BOARD SHALL REPORT TO THE OFFICE OF CONTROLLED 15 |
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449 | 449 | | SUBSTANCES ADMINISTRATION ANY VI OLATION RELATED TO C ONTROLLED 16 |
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450 | 450 | | DANGEROUS SUBSTANCES FOUND DURING AN INSP ECTION REQUIRED UNDE R 17 |
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451 | 451 | | PARAGRAPH (1) OF THIS SUBSECTION . 18 |
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452 | 452 | | |
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453 | 453 | | SECTION 2. AND BE IT FURTHER ENACTED, That, on the effective date of this 19 |
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454 | 454 | | Act, the following shall be transferred to the State Board of Physicians: 20 |
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455 | 455 | | |
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456 | 456 | | (1) all appropriations, including State and federal funds, held by the Office 21 |
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457 | 457 | | of Controlled Substances Administration for the purposes of conducting inspections of 22 |
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458 | 458 | | offices of physicians who hold dispensing permits under § 14–509 of the Health Occupations 23 |
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459 | 459 | | Article on the effective date of this Act; and 24 |
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460 | 460 | | |
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461 | 461 | | (2) all books and records including electronic records, real and personal 25 |
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462 | 462 | | property, equipment, fixtures, assets, liabilities, obligations, credits, rights, and privileges 26 |
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463 | 463 | | held by the Office of Controlled Substances Administration for the purposes of conducting 27 |
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464 | 464 | | inspections of offices of physicians who hold dispensing permits under § 14–509 of the 28 |
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465 | 465 | | Health Occupations Article on the effective date of this Act. 29 |
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466 | 466 | | |
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467 | 467 | | SECTION 3. AND BE IT FURTHER ENACTED, That all employees of the Office of 30 |
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468 | 468 | | Controlled Substances Administration who are assigned more than 50% of the time to a 31 |
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469 | 469 | | function related to conducting inspections of offices of physicians who hold dispensing 32 |
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470 | 470 | | permits under § 14–509 of the Health Occupations Article on the effective date of this Act 33 |
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471 | 471 | | shall be transferred to the State Board of Physicians without diminution of their rights, 34 |
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472 | 472 | | benefits, employment, or retirement status. 35 SENATE BILL 161 11 |
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473 | 473 | | |
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474 | 474 | | |
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475 | 475 | | |
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476 | 476 | | SECTION 4. AND BE IT FURTHER ENACTED, That all positions of the Office of 1 |
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477 | 477 | | Controlled Substances Administration who are assigned more than 50% of the time to a 2 |
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478 | 478 | | function related to conducting inspections of offices of physicians who hold dispensing 3 |
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479 | 479 | | permits under § 14–509 of the Health Occupations Article on the effective date of this Act 4 |
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480 | 480 | | shall be transferred to the State Board of Physicians. 5 |
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481 | 481 | | |
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482 | 482 | | SECTION 5. AND BE IT FURTHER ENACTED, That any transaction affected by 6 |
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483 | 483 | | the transfer of oversight of the conducting of inspections of offices of physicians who hold 7 |
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484 | 484 | | dispensing permits under § 14–509 of the Health Occupations Article and validly entered 8 |
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485 | 485 | | into before the effective date of this Act, and every right, duty, or interest flowing from it 9 |
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486 | 486 | | remains valid after the effective date of this Act and may be terminated, completed, 10 |
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487 | 487 | | consummated, or enforced under the law. 11 |
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488 | 488 | | |
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489 | 489 | | SECTION 6. AND BE IT FURTHER ENACTED, That all existing laws, regulations, 12 |
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490 | 490 | | proposed regulations, standards and guidelines, policies, orders and other directives, forms, 13 |
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491 | 491 | | plans, memberships, contracts, property, investigations, administrative and judicial 14 |
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492 | 492 | | responsibilities, rights to sue and be sued, and all other duties and responsibilities 15 |
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493 | 493 | | associated with the oversight of the conducting of inspections of offices of physicians who 16 |
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494 | 494 | | hold dispensing permits under § 14–509 of the Health Occupations Article prior to the 17 |
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495 | 495 | | effective date of this Act shall continue and, as appropriate, are legal and binding on the 18 |
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496 | 496 | | State Board of Physicians until completed, withdrawn, canceled, modified, or otherwise 19 |
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497 | 497 | | changed under the law. 20 |
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498 | 498 | | |
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499 | 499 | | SECTION 7. AND BE IT FURTHER ENACTED, That this Act shall take effect 21 |
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500 | 500 | | October 1, 2023. 22 |
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501 | 501 | | |
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