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28 | 28 | | STATE OF OKLAHOMA |
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29 | 29 | | |
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30 | 30 | | 1st Session of the 59th Legislature (202 3) |
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31 | 31 | | |
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32 | 32 | | HOUSE BILL 1552 By: Moore |
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33 | 33 | | |
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34 | 34 | | |
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35 | 35 | | |
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36 | 36 | | |
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37 | 37 | | |
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38 | 38 | | AS INTRODUCED |
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39 | 39 | | |
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40 | 40 | | An Act relating to medical marijuana; amending 63 |
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41 | 41 | | O.S. 2021, Section 427.17, as last amended by Section |
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42 | 42 | | 1, Chapter 353, O.S.L. 2022 (63 O. S. Supp. 2022, |
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43 | 43 | | Section 427.17), which relates to the Oklahoma |
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44 | 44 | | Medical Marijuana and Patient Protection Act ; |
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45 | 45 | | directing employees of the Oklahoma Medical Marijuana |
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46 | 46 | | Authority to collect and submit samples; and |
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47 | 47 | | providing an effective date. |
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48 | 48 | | |
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49 | 49 | | |
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50 | 50 | | |
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51 | 51 | | |
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52 | 52 | | |
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53 | 53 | | |
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54 | 54 | | BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA: |
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55 | 55 | | SECTION 1. AMENDATORY 63 O.S. 2021, Section 427.17, as |
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56 | 56 | | last amended by Section 1, Chapter 353, O.S.L. 2022 (63 O.S. Supp. |
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57 | 57 | | 2022, Section 427.17), is a mended to read as follows: |
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58 | 58 | | Section 427.17 A. There is hereby created a medical marijuana |
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59 | 59 | | testing laboratory licens e as a category of the medical marijuana |
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60 | 60 | | business license. The Oklahoma Medical Marijuana Authority is |
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61 | 61 | | hereby enabled to monitor, inspect and audit a licensed testing |
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62 | 62 | | laboratory under the Oklahoma Medical Marijuana and Patient |
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63 | 63 | | Protection Act. |
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64 | 64 | | |
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90 | 90 | | B. 1. The Authority is hereby authorized to contract with a |
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91 | 91 | | private laboratory for the purpose of conducting compliance testing |
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92 | 92 | | of medical marijuana testing laboratories licensed in this state. |
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93 | 93 | | Any such laboratory under contract for compliance testing shall be |
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94 | 94 | | prohibited from conducting any other commercial medical ma rijuana |
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95 | 95 | | testing in this state. The laboratory the Authority contracts with |
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96 | 96 | | for compliance testing shall not employ, or be owned by, the |
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97 | 97 | | following: |
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98 | 98 | | a. any individual that has a direct or indirect interest |
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99 | 99 | | in a licensed medical marijuana business , or |
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100 | 100 | | b. any individual or his or her spouse, parent, child, |
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101 | 101 | | spouse of a child, sibling or spouse of a sibling that |
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102 | 102 | | has an application for a medical marijuana business |
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103 | 103 | | license pending before the Authority or is a member of |
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104 | 104 | | the board of directors of a medi cal marijuana |
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105 | 105 | | business, or is an individual financially interested |
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106 | 106 | | in any licensee or medical marijuana business located |
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107 | 107 | | within this state. |
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108 | 108 | | 2. The private laboratory under contract with the Authority for |
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109 | 109 | | compliance testing and a board or committee comprised of licensed |
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110 | 110 | | Oklahoma medical marijuana laboratories currently accredited by the |
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111 | 111 | | International Organization for Standardization (ISO) shall provide |
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112 | 112 | | to the Authority its recommendations for all equipment and standards |
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113 | 113 | | to be utilized by licensed medical marijuana testing laboratories |
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139 | 139 | | |
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140 | 140 | | when testing samples of medical marijuana, medical marijuana |
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141 | 141 | | concentrate, and medical marijuana products as well as standard |
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142 | 142 | | operating procedures when extracting and testing medical marijuana, |
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143 | 143 | | medical marijuana concentrate, and medical marijuana products. The |
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144 | 144 | | recommendations shall be submitted to the Authority no later tha n |
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145 | 145 | | June 1, 2023. The Authority shall have ninety (90) days from the |
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146 | 146 | | date it receives the recommendations to promulgate new rules or |
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147 | 147 | | modify its current rules for laboratory standards and testing. |
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148 | 148 | | Beginning June 1, 2024, medical marijuana testing laboratories |
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149 | 149 | | renewing their medical marijuana business license shall be subject |
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150 | 150 | | to and comply with any new or modified rules relating to the testing |
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151 | 151 | | of medical marijuana, medical marijuana concentrate, and medical |
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152 | 152 | | marijuana products. The refusal or failure of a med ical marijuana |
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153 | 153 | | testing laboratory licensee to comply with new or modified rules |
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154 | 154 | | relating to laboratory standards and testing procedures p romulgated |
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155 | 155 | | under the provisions of this paragraph shall result in the permanent |
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156 | 156 | | revocation of the medical marijuana tes ting laboratory license. |
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157 | 157 | | C. The Authority shall develop acceptable testin g practices |
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158 | 158 | | including, but not limited to, testing, standards, qual ity control |
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159 | 159 | | analysis, equipment certification and calibration, and chemical |
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160 | 160 | | identification and substances used. |
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161 | 161 | | D. A person who is a direct beneficial owner of a medical |
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162 | 162 | | marijuana dispensary, medical marij uana commercial grower or medical |
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163 | 163 | | marijuana processor shall not be an owner of a laboratory. |
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189 | 189 | | |
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190 | 190 | | E. A laboratory and a laboratory applicant shall comply with |
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191 | 191 | | all applicable local ordinances including, but not limited to, |
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192 | 192 | | zoning, occupancy, licensing and build ing codes. |
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193 | 193 | | F. A separate license shall be require d for each specific |
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194 | 194 | | laboratory. |
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195 | 195 | | G. A medical marijuana testing laboratory license may be issued |
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196 | 196 | | to a person who performs testing on medical marijuana and medical |
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197 | 197 | | marijuana products for medical marijuana bu sinesses, medical |
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198 | 198 | | marijuana research facilities, m edical marijuana education |
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199 | 199 | | facilities, and testing on marijuana and marijuana products grown or |
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200 | 200 | | produced by a patient or caregiver on behalf of a patient, upon |
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201 | 201 | | verification of registration . A medical marijuana testing |
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202 | 202 | | laboratory may also conduct research related to the development and |
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203 | 203 | | improvement of its testing practices and procedures. No state- |
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204 | 204 | | approved medical mari juana testing facility shall operate unless a |
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205 | 205 | | medical laboratory director is on site during operational hours. |
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206 | 206 | | H. Laboratory applicants and licensees shall comply with the |
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207 | 207 | | application requirements of this section and shall submit such other |
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208 | 208 | | information as required for a medical marijuana business applicant, |
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209 | 209 | | in addition to any information the Au thority may request for initial |
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210 | 210 | | approval and periodic evaluations during the approval period. |
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211 | 211 | | I. A 1. Except as provided in paragraph 2 of this subsection, |
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212 | 212 | | a medical marijuana testing laboratory may accept samples of medical |
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213 | 213 | | marijuana, medical marijuana concentrate or medical marijuana |
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240 | 240 | | product from a medical mari juana business, medical marijuana |
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241 | 241 | | research facility or medical marijuana education facility for |
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242 | 242 | | testing purposes only, which purposes may include the provision of |
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243 | 243 | | testing services for samples submitted by a medical marijuana |
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244 | 244 | | business for product developmen t. The Authority may require a |
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245 | 245 | | medical marijuana business to submit a sample of medical marijuana, |
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246 | 246 | | medical marijuana concentrate or medical marijuana product to a |
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247 | 247 | | medical marijuana testing or quality assurance laboratory upon |
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248 | 248 | | demand. |
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249 | 249 | | 2. A medical marijuana testing laborator y shall be prohibited |
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250 | 250 | | from accepting test samples of medical marijuana directly from a |
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251 | 251 | | medical marijuana commercial grower. A compliance officer of the |
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252 | 252 | | Authority shall be authorized to collect samples from the harvest |
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253 | 253 | | batch of the medical marijuana commercial grower and shall submit |
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254 | 254 | | such samples for testing to the medical marijuana testin g laboratory |
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255 | 255 | | on behalf of the medic al marijuana commercial grower and in |
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256 | 256 | | accordance with the provisions of this section. |
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257 | 257 | | J. A medical marijuana testing laboratory may accept sample s of |
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258 | 258 | | medical marijuana, medical marijuana concentrate or medical |
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259 | 259 | | marijuana product from an individual person for testing only under |
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260 | 260 | | the following conditions: |
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261 | 261 | | 1. The individual person is a patient or caregi ver pursuant to |
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262 | 262 | | the Oklahoma Medical Marijuana and Patient Protection Act or is a |
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288 | 288 | | |
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289 | 289 | | participant in an approved clinical or observational study conducted |
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290 | 290 | | by a research facility; and |
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291 | 291 | | 2. The medical marijuana testing laboratory shall require the |
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292 | 292 | | patient or caregiver to produce a valid patient license and curr ent |
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293 | 293 | | and valid photo identification. |
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294 | 294 | | K. A medical marijuana testing laboratory may transfer samples |
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295 | 295 | | to another medical marijuana testing laboratory for testing. All |
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296 | 296 | | laboratory reports provided to or by a m edical marijuana business or |
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297 | 297 | | to a patient or careg iver shall identify the medical marijuana |
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298 | 298 | | testing laboratory that actually conducted the test. |
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299 | 299 | | L. A medical marijuana testing laboratory may utilize a |
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300 | 300 | | licensed medical marijuana transporter to transport sa mples of |
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301 | 301 | | medical marijuana, medical marijuana conc entrate and medical |
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302 | 302 | | marijuana product for testing, in accordance with the Oklahoma |
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303 | 303 | | Medical Marijuana and Patient Protection Act and the rules adopted |
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304 | 304 | | pursuant thereto, between the originating medical mariju ana business |
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305 | 305 | | requesting testing services and the d estination laboratory |
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306 | 306 | | performing testing services. |
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307 | 307 | | M. The medical marijuana testing laboratory shall establish |
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308 | 308 | | policies to prevent the existence of or appearance of undue |
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309 | 309 | | commercial, financial or other inf luences that may diminish the |
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310 | 310 | | competency, impartia lity and integrity of the testing processes or |
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311 | 311 | | results of the laboratory, or that may diminish public confidence in |
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312 | 312 | | the competency, impartiality and integrity of the testing processes |
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338 | 338 | | |
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339 | 339 | | or results of the labo ratory. At a minimum, employees, owners or |
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340 | 340 | | agents of a medical marijuana testing laboratory who participate in |
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341 | 341 | | any aspect of the analysis and results of a sample are prohibited |
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342 | 342 | | from improperly influencing the testing process, improperly |
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343 | 343 | | manipulating data or improperly benefiting from any ongoing |
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344 | 344 | | financial, employment, personal or business relationship with the |
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345 | 345 | | medical marijuana business that provided the sample. A medical |
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346 | 346 | | marijuana testing laboratory shall not test samples for any medical |
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347 | 347 | | marijuana business in which an owner, employee or agent of the |
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348 | 348 | | medical marijuana testing laboratory has any form of ownership or |
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349 | 349 | | financial interest in the medical marijuana business. |
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350 | 350 | | N. The Authority, pursuant to rules promulgated by the |
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351 | 351 | | Executive Director of the Authority , shall develop standards, |
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352 | 352 | | policies and procedures as necessary for: |
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353 | 353 | | 1. The cleanliness and orderliness of a laboratory premises and |
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354 | 354 | | the location of the laboratory in a secure location, and inspection, |
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355 | 355 | | cleaning and maintenance of any equipment or utensils used f or the |
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356 | 356 | | analysis of test samples; |
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357 | 357 | | 2. Testing procedures, testing standards for cannabinoid and |
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358 | 358 | | terpenoid potency and safe levels of contaminants, and remediation |
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359 | 359 | | procedures; |
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360 | 360 | | 3. Controlled access areas for storage of medical marijuana and |
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361 | 361 | | medical marijuana product test samples, waste and reference |
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362 | 362 | | standards; |
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388 | 388 | | |
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389 | 389 | | 4. Records to be retained and computer systems to be utilized |
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390 | 390 | | by the laboratory; |
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391 | 391 | | 5. The possession, storage and use by the laboratory of |
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392 | 392 | | reagents, solutions and reference standards; |
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393 | 393 | | 6. A certificate of analysis (COA) for each lot of reference |
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394 | 394 | | standard; |
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395 | 395 | | 7. The transport and disposal of unused marijuana, marijuana |
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396 | 396 | | products and waste; |
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397 | 397 | | 8. The mandatory use by a laboratory of an inventory tracking |
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398 | 398 | | system to ensure all harvest and production batches or samples |
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399 | 399 | | containing medical marijuana, medical marijuana concentrate or |
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400 | 400 | | medical marijuana products are identified and tracked from the point |
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401 | 401 | | they are transferred from a medical marijuana business, a patient or |
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402 | 402 | | a caregiver through the point of transfer, destruction or disposal. |
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403 | 403 | | The inventory tracking system reporting shall include the results of |
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404 | 404 | | any tests that are conducted on medical marijuana, medical marijuana |
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405 | 405 | | concentrate or medical marijuana product; |
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406 | 406 | | 9. Standards of performance; |
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407 | 407 | | 10. The employment of laboratory personnel; |
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408 | 408 | | 11. A written standard operating procedure manual to be |
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409 | 409 | | maintained and updated by the laboratory; |
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410 | 410 | | 12. The successful participation in a proficiency testing |
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411 | 411 | | program approved by the Executive Director for each testing category |
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438 | 438 | | listed in this section, in order to obtain and maintain |
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439 | 439 | | certification; |
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440 | 440 | | 13. The establishment of and adherence to a quality assurance |
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441 | 441 | | and quality control program to ensure sufficient monitoring of |
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442 | 442 | | laboratory processes and quality of results reported; |
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443 | 443 | | 14. The immediate recall of medical marijuana or medical |
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444 | 444 | | marijuana products that test above allowable thresholds or are |
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445 | 445 | | otherwise determined to be unsafe; |
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446 | 446 | | 15. The establishment by the laboratory of a system to document |
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447 | 447 | | the complete chain of custody for samples from receipt through |
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448 | 448 | | disposal; |
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449 | 449 | | 16. The establishment by the laboratory of a system to retain |
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450 | 450 | | and maintain all required records, including business records, and |
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451 | 451 | | processes to ensure results are reported in a timely and accurate |
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452 | 452 | | manner; and |
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453 | 453 | | 17. Any other aspect of laboratory testing of medical marijuana |
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454 | 454 | | or medical marijuana product deemed necessary by the Executive |
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455 | 455 | | Director. |
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456 | 456 | | O. A medical marijuana testing laboratory shall promptly |
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457 | 457 | | provide the Authority or designee of the Authority access to a |
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458 | 458 | | report of a test and any underlying data that is conducted on a |
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459 | 459 | | sample at the request of a medical marijuana business or qualified |
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460 | 460 | | patient. A medical marijuana testing laboratory shall also provide |
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461 | 461 | | access to the Authority or designee of the Authority to laboratory |
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488 | 488 | | premises and to any material or information requested by t he |
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489 | 489 | | Authority to determine compliance w ith the requirements of this |
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490 | 490 | | section. |
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491 | 491 | | P. A medical marijuana testing laboratory shall retain all |
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492 | 492 | | results of laboratory tests conducted on marijuana or products for a |
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493 | 493 | | period of at least seven (7) years and shall make them available to |
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494 | 494 | | the Authority upon request. |
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495 | 495 | | Q. A medical marijuana testing laboratory shall test samples |
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496 | 496 | | from each harvest batch or product batch, as appropriate, of medical |
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497 | 497 | | marijuana, medical marijuana concentrate and medical marij uana |
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498 | 498 | | product for each of the following categories of testing , consistent |
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499 | 499 | | with standards developed by the Executive Director: |
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500 | 500 | | 1. Microbials; |
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501 | 501 | | 2. Mycotoxins; |
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502 | 502 | | 3. Residual solvents; |
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503 | 503 | | 4. Pesticides; |
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504 | 504 | | 5. Tetrahydrocannabinol (THC) and other cannab inoid potency; |
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505 | 505 | | 6. Terpenoid type and concentration ; and |
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506 | 506 | | 7. Heavy metals. |
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507 | 507 | | R. A licensed medical marijuana testing laboratory shall test |
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508 | 508 | | each individual harvest batch. A grower shall separate each harvest |
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509 | 509 | | lot of usable marijuana into harvest batches cont aining no more than |
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510 | 510 | | fifteen (15) pounds, with the exception of any plant material to be |
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511 | 511 | | sold to a licensed processor for the purposes of turning the plant |
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512 | 512 | | |
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538 | 538 | | material into concentrate which may be separated into harvest |
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539 | 539 | | batches of no more than fifty (50) poun ds. A processor shall |
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540 | 540 | | separate each medical marijuana production lot int o production |
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541 | 541 | | batches containing no more than four (4) liters of concentrate or |
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542 | 542 | | nine (9) pounds for nonliquid products, and for final products, the |
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543 | 543 | | Oklahoma Medical Marijuana Authority shall be authorized to |
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544 | 544 | | promulgate rules on final products as necessary . Provided, however, |
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545 | 545 | | the Authority shall not require testing of final products less often |
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546 | 546 | | than every one thousand (1,000) grams of THC. As used in this |
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547 | 547 | | subsection, "final products" shall include, but not be limited to, |
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548 | 548 | | cookies, brownies, candies, gummies, beverages and chocolates. |
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549 | 549 | | S. Medical marijuana testing laboratory licensure shall be |
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550 | 550 | | contingent upon successful on-site inspection, successful |
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551 | 551 | | participation in proficiency testing an d ongoing compliance with the |
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552 | 552 | | applicable requirements in this section. |
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553 | 553 | | T. A medical marijuana testing laboratory shall be inspected |
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554 | 554 | | prior to initial licensure and up to two (2) times per year |
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555 | 555 | | thereafter by an inspector approved by the Authority. The Authority |
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556 | 556 | | may enter the licensed premises of a testing laboratory to conduct |
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557 | 557 | | investigations and additional inspections when the Authority |
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558 | 558 | | believes an investigation or additional inspection is necessary due |
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559 | 559 | | to a possible violation of applicable laws, rules or r egulations. |
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560 | 560 | | U. Medical marijuana testing laboratories shall obtain |
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561 | 561 | | accreditation by an accrediting body approved by the Executive |
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562 | 562 | | |
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588 | 588 | | Director within one (1) year of the date the initial license is |
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589 | 589 | | issued. Renewal of any medical marijuana tes ting laboratory license |
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590 | 590 | | shall be contingent upon accreditation in accordance with this |
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591 | 591 | | subsection. All medical marijuana testing laboratories shall obtain |
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592 | 592 | | accreditation prior to applying for and receiving a medical |
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593 | 593 | | marijuana testing laboratory license. |
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594 | 594 | | V. Unless authorized by the provisions of this section, a |
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595 | 595 | | commercial grower shall not tran sfer or sell medical marijuana and a |
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596 | 596 | | processor shall not transfer, sell or process into a concentrate or |
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597 | 597 | | product any medical marijuana, medical marijuana concentrate o r |
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598 | 598 | | medical marijuana product unless samples from each harvest batch or |
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599 | 599 | | production batch from which that medical marijuana, medical |
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600 | 600 | | marijuana concentrate or medical marijuana product was derived has |
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601 | 601 | | been tested by a medical marijuana testing laboratory and passed all |
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602 | 602 | | contaminant tests required b y the Oklahoma Medical Marijuana and |
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603 | 603 | | Patient Protection Act and applicable laws, rules and regulations. |
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604 | 604 | | A licensed commercial grower may transfer medical marijuana that has |
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605 | 605 | | failed testing to a licensed processor only for the purposes of |
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606 | 606 | | decontamination or remediation and only in accordance with the |
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607 | 607 | | provisions of the Oklahoma Medical Marijuana and Patient Protection |
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608 | 608 | | Act and the rules and regulations promulgated by the Executive |
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609 | 609 | | Director. Remediated and decontaminated medical marijuana may be |
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610 | 610 | | returned only to the originating licensed comme rcial grower. |
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637 | 637 | | W. Kief shall not be transferred or sold except as authorized |
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638 | 638 | | in the rules and regulations promulgated by the Executive Director. |
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639 | 639 | | SECTION 2. This act shall become effective November 1, 2023. |
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640 | 640 | | |
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641 | 641 | | 59-1-5351 GRS 01/07/23 |
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