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4 | 4 | | Req. No. 2763 Page 1 1 |
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52 | 52 | | |
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53 | 53 | | STATE OF OKLAHOMA |
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54 | 54 | | |
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55 | 55 | | 2nd Session of the 58th Legislature (2022) |
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56 | 56 | | |
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57 | 57 | | SENATE BILL 1847 By: Rogers |
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58 | 58 | | |
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59 | 59 | | |
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60 | 60 | | |
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61 | 61 | | |
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62 | 62 | | |
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63 | 63 | | AS INTRODUCED |
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64 | 64 | | |
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65 | 65 | | An Act relating to medical marijuana; amending 63 |
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66 | 66 | | O.S. 2021, Section 427.17, which rel ates to medical |
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67 | 67 | | marijuana testing laboratory license; allowing |
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68 | 68 | | process validation as an acceptable testing practi ce; |
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69 | 69 | | requiring process validation not to be mandatory by a |
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70 | 70 | | licensee; allowing for mi nimum testing once a |
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71 | 71 | | licensee achieves process v alidation; providing |
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72 | 72 | | retention policies for the validation process; |
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73 | 73 | | providing conditions to be maintained if significant |
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74 | 74 | | process changes are made by licensee; allowing for |
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75 | 75 | | inspection or audit by Authority; providing |
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76 | 76 | | punishment for violation; accessing a registration |
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77 | 77 | | fee; allowing for no law, rule , or regulation to |
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78 | 78 | | prohibit testing labs for offering services to |
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79 | 79 | | licensees; providing for samples consistent with |
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80 | 80 | | process validation rules; declaring an emergency. |
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81 | 81 | | |
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82 | 82 | | |
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83 | 83 | | |
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84 | 84 | | |
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85 | 85 | | BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHO MA: |
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86 | 86 | | SECTION 1. AMENDATORY 63 O.S. 2021, Section 427.17, is |
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87 | 87 | | amended to read as follows: |
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88 | 88 | | Section 427.17. A. There is hereby created a medical marijuana |
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89 | 89 | | testing laboratory license as a category of the medical marijuana |
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90 | 90 | | business license. The Oklahoma Medical Marijuana Authority is |
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91 | 91 | | hereby enabled to monitor, inspec t and audit a licensed testing |
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92 | 92 | | |
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142 | 142 | | |
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143 | 143 | | laboratory under the Oklahoma Medical Marijuana and Patient |
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144 | 144 | | Protection Act. |
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145 | 145 | | B. The Authority is hereby authorized to contract with a |
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146 | 146 | | private laboratory for the purpose of conducting complian ce testing |
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147 | 147 | | of medical marijuana t esting laboratories licensed in this state . |
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148 | 148 | | Any such laboratory under contract for compliance testing shall be |
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149 | 149 | | prohibited from conducting any other commercial medical marij uana |
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150 | 150 | | testing in this state . The laboratory the Au thority contracts with |
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151 | 151 | | for compliance testing shall not employ, or be owned by, the |
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152 | 152 | | following: |
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153 | 153 | | 1. Any individual that has a direct or indirect interest in a |
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154 | 154 | | licensed medical marijuana business; or |
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155 | 155 | | 2. Any individual or his or her spouse, parent, child, sp ouse |
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156 | 156 | | of a child, sibling or spo use of a sibling that has an application |
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157 | 157 | | for a medical marijuana business license pending before the |
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158 | 158 | | Department or is a member of the board of directors of a medical |
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159 | 159 | | marijuana business, or is an individual financially interes ted in |
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160 | 160 | | any licensee or medical marijuana business located within this |
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161 | 161 | | state. |
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162 | 162 | | C. The Authority shall develop acceptable testin g practices |
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163 | 163 | | including, but not limited to, testing, standards, quality control |
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164 | 164 | | analysis, equipment certification and calibration, process |
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165 | 165 | | validation, and chemical identification an d substances used. |
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216 | 216 | | |
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217 | 217 | | D. A person who is a direct beneficial owner of a medical |
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218 | 218 | | marijuana dispensary, medical marijuana commercial grower or medical |
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219 | 219 | | marijuana processor shall not be an owner of a laboratory. |
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220 | 220 | | E. A laboratory and a l aboratory applicant sha ll comply with |
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221 | 221 | | all applicable local or dinances including, but not limited to, |
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222 | 222 | | zoning, occupancy, licensing and building codes. |
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223 | 223 | | F. A separate license shall be required for each specific |
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224 | 224 | | laboratory. |
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225 | 225 | | G. A medical marijuana testing lab oratory license may b e issued |
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226 | 226 | | to a person who performs testin g on medical marijuana and medical |
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227 | 227 | | marijuana products for medical marijuana businesses, medical |
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228 | 228 | | marijuana research facili ties, medical marijuana education |
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229 | 229 | | facilities, and testing on marijuana and marijuana products g rown or |
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230 | 230 | | produced by a patient or caregiv er on behalf of a patient, upon |
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231 | 231 | | verification of registration . A medical marijuana testing |
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232 | 232 | | laboratory may also conduct re search related to the development and |
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233 | 233 | | improvement of its testing practices and procedures. No state- |
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234 | 234 | | approved medical marijuana testing facility shall operate unless a |
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235 | 235 | | medical laboratory director is on site during operational hours. |
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236 | 236 | | H. Laboratory applicants and licensees shall comply with the |
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237 | 237 | | application requirements of this se ction and shall submit such other |
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238 | 238 | | information as required for a medical marijuana business applicant, |
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239 | 239 | | in addition to any information the Authority may request for initial |
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240 | 240 | | approval and periodic evaluations during the approval period. |
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241 | 241 | | |
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242 | 242 | | |
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291 | 291 | | |
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292 | 292 | | I. A medical marijuana testing laboratory may accept samples of |
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293 | 293 | | medical marijuana, medical marijuana concentrate or medical |
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294 | 294 | | marijuana product from a medical marijuana business , medical |
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295 | 295 | | marijuana research facility or medical marijuana education facility |
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296 | 296 | | for testing purposes only, which purposes may include the provision |
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297 | 297 | | of testing services for samples submitted by a medical marijuana |
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298 | 298 | | business for product development . The Department may require a |
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299 | 299 | | medical marijuana business to submit a sample of medical mar ijuana, |
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300 | 300 | | medical marijuana concentrate or medical marijuana product to a |
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301 | 301 | | medical marijuana testing or quality assurance laboratory upon |
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302 | 302 | | demand. |
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303 | 303 | | J. A medical marijuana testing laboratory may accept samples o f |
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304 | 304 | | medical marijuana, medical marijuana concentrate or medical |
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305 | 305 | | marijuana product from an individual person for testing only under |
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306 | 306 | | the following conditions: |
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307 | 307 | | 1. The individual person is a patient or caregiver pursuant t o |
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308 | 308 | | the Oklahoma Medical Marijuana and Pa tient Protection Act or is a |
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309 | 309 | | participant in an app roved clinical or observ ational study conducted |
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310 | 310 | | by a research facility; and |
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311 | 311 | | 2. The medical marijuana testing laboratory shall require the |
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312 | 312 | | patient or caregiver to produce a valid patient license and current |
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313 | 313 | | and valid photo identification. |
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314 | 314 | | K. A medical marijuana testing laborator y may transfer samples |
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315 | 315 | | to another medical marijuana testing l aboratory for testing. All |
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316 | 316 | | |
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317 | 317 | | |
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367 | 367 | | laboratory reports provided to or by a medical marijuana business or |
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368 | 368 | | to a patient or caregive r shall identify the medical marijuana |
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369 | 369 | | testing laboratory that actually co nducted the test. |
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370 | 370 | | L. A medical marijuana testing laboratory may utilize a |
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371 | 371 | | licensed medical marijuana transporter to transport samples of |
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372 | 372 | | medical marijuana, medical marijuana concent rate and medical |
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373 | 373 | | marijuana product for testing, in accordance with the Oklahoma |
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374 | 374 | | Medical Marijuana and Patient Protection Act and the rules adopted |
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375 | 375 | | pursuant thereto, between the originating medical marijuana business |
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376 | 376 | | requesting testing services and the dest ination laboratory |
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377 | 377 | | performing testing services. |
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378 | 378 | | M. The medical marijuana testing laboratory shall establish |
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379 | 379 | | policies to prevent the ex istence of or appearance of undue |
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380 | 380 | | commercial, financial or other influences that may diminish the |
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381 | 381 | | competency, impartialit y and integrity of the testing processes or |
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382 | 382 | | results of the laboratory, or that may diminish public confidence in |
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383 | 383 | | the competency, impart iality and integrity of the testing processes |
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384 | 384 | | or results of the laboratory . At a minimum, employees, owners or |
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385 | 385 | | agents of a medical marijuana testing laboratory who partic ipate in |
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386 | 386 | | any aspect of the analysis and results of a sample are prohibited |
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387 | 387 | | from improperly influencing the testing process, improperly |
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388 | 388 | | manipulating data or improperly benefiting from any ongoing |
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389 | 389 | | financial, employment, personal or business relationship with the |
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390 | 390 | | medical marijuana business that provided the sample. A medical |
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441 | 441 | | |
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442 | 442 | | marijuana testing laboratory shall not test samples for any medical |
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443 | 443 | | marijuana business in which an owner, employee or agent of the |
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444 | 444 | | medical marijuana testing laboratory has any form of own ership or |
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445 | 445 | | financial interest in the medical marijuana business. |
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446 | 446 | | N. The Department, pursuant to rules promulgated by the State |
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447 | 447 | | Commissioner of Health, shall develop standards, policies and |
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448 | 448 | | procedures as necessary for: |
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449 | 449 | | 1. The cleanliness and orderliness of a laboratory premises a nd |
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450 | 450 | | the location of the laboratory in a secure location, and i nspection, |
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451 | 451 | | cleaning and maintenance of any equipment or utensils used for the |
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452 | 452 | | analysis of test samples; |
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453 | 453 | | 2. Testing procedures, testing standards for cannabinoid and |
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454 | 454 | | terpenoid potency and safe le vels of contaminants, process |
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455 | 455 | | validation, and remediation procedures. Process validation shall be |
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456 | 456 | | voluntary, and no licensee shall be required to validate their |
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457 | 457 | | process. The Department shall develop standards and requirements |
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458 | 458 | | for a licensee to achieve process validation. The standards, |
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459 | 459 | | policies, and procedures for process validation shall include, but |
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460 | 460 | | not be limited to: |
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461 | 461 | | a. initial requirements to achieve process validation and |
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462 | 462 | | ongoing minimum testing requirements once a licensee |
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463 | 463 | | has achieved process validation , |
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464 | 464 | | b. requiring licensees to track their marijuana and |
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465 | 465 | | marijuana product inventory with the Department's |
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466 | 466 | | |
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467 | 467 | | |
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516 | 516 | | |
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517 | 517 | | designated seed-to-sale system provided the Department |
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518 | 518 | | has selected a seed-to-sale system. This requirement |
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519 | 519 | | for compliance with the seed-to-sale system shall be |
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520 | 520 | | mandatory for licensees whether compliance with seed- |
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521 | 521 | | to-sale system is mandatory for all licensees , |
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522 | 522 | | c. record and document retention policies, which at a |
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523 | 523 | | minimum shall require licensees to retain all |
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524 | 524 | | documents and records related to process val idation. |
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525 | 525 | | Such records shall be main tained by the licensee for |
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526 | 526 | | as long as the licensee is continuing to operate under |
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527 | 527 | | that validated process. L icensees must retain all |
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528 | 528 | | such documents and records for at least four (4) years |
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529 | 529 | | after the licensee has stopped using the validated |
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530 | 530 | | process or after the licensee has made a significant |
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531 | 531 | | process change to a validated process change. Any |
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532 | 532 | | significant process to a licensee's validated |
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533 | 533 | | processes is subject to the same document retention |
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534 | 534 | | requirements and must be retained for as long as the |
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535 | 535 | | significant process change is part of an ongoing |
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536 | 536 | | validated process, and for at least four (4) years |
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537 | 537 | | after the licensee has stopped using the validated |
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538 | 538 | | process or after the licensee has made a subsequent |
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539 | 539 | | significant process change to the validated process , |
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540 | 540 | | |
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591 | 591 | | d. testing requirements to maintain process validation |
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592 | 592 | | when a licensee has made a significant process change |
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593 | 593 | | to a validated process, |
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594 | 594 | | e. requiring licensees to keep all records and documents |
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595 | 595 | | related to their pro cess validation read y and |
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596 | 596 | | accessible at the address listed on their marijuana |
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597 | 597 | | business license for inspection or audit by the |
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598 | 598 | | Authority without any notice from the Authority, |
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599 | 599 | | f. a process to revoke a lice nsee's authority to operate |
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600 | 600 | | under process validation, |
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601 | 601 | | g. punishment for willful violations of process |
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602 | 602 | | validation that, at a min imum, would prohibit a |
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603 | 603 | | licensee from operating under process validation for |
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604 | 604 | | five (5) years and the assessment of fine and fees by |
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605 | 605 | | the Authority as allowed by law, |
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606 | 606 | | h. an annual registration fee not to exceed Two Thousand |
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607 | 607 | | Five Hundred Dollars ($2,500.00) per licensee to be |
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608 | 608 | | deposited in the Oklahoma Medical Marijuana Revolving |
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609 | 609 | | Fund for the enforcement of law and regulation by the |
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610 | 610 | | Authority, and |
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611 | 611 | | i. provided no law, rule, or regulation sh all prohibit |
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612 | 612 | | medical marijuana testing labs from offering services |
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613 | 613 | | to licensees to achieve and manage pro cess validation |
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614 | 614 | | for consideration; |
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615 | 615 | | |
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616 | 616 | | |
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617 | 617 | | Req. No. 2763 Page 9 1 |
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665 | 665 | | |
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666 | 666 | | 3. Controlled access areas for storage of medical mariju ana and |
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667 | 667 | | medical marijuana product test samples, waste and r eference |
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668 | 668 | | standards; |
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669 | 669 | | 4. Records to be retained and computer systems to be utilized |
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670 | 670 | | by the laboratory; |
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671 | 671 | | 5. The possession, storage and use by the laborator y of |
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672 | 672 | | reagents, solutions and reference stan dards; |
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673 | 673 | | 6. A certificate of analysis (COA) for each lot of reference |
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674 | 674 | | standard; |
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675 | 675 | | 7. The transport and disposal of unused marijuana, marijuana |
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676 | 676 | | products and waste; |
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677 | 677 | | 8. The mandatory use by a laboratory of an inventor y tracking |
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678 | 678 | | system to ensure all harvest and production batches or samples |
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679 | 679 | | containing medical marijuana , medical marijuana concentrate or |
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680 | 680 | | medical marijuana products are identified and tracked f rom the point |
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681 | 681 | | they are transferred from a medical marijuana busi ness, a patient or |
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682 | 682 | | a caregiver through the point of transfer, destruction or disposal . |
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683 | 683 | | The inventory tracking system reporting shall include the results of |
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684 | 684 | | any tests that are conducted on med ical marijuana, medical marijuana |
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685 | 685 | | concentrate or medical marijua na product; |
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686 | 686 | | 9. Standards of performance; |
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687 | 687 | | 10. The employment of laboratory personnel; |
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688 | 688 | | 11. A written standard operating procedure manual to be |
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689 | 689 | | maintained and updated by the laboratory; |
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690 | 690 | | |
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691 | 691 | | |
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692 | 692 | | Req. No. 2763 Page 10 1 |
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740 | 740 | | |
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741 | 741 | | 12. The successful participation in a Department -approved |
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742 | 742 | | proficiency testing program for each testing category listed in this |
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743 | 743 | | section, in order to obtain and maintain cer tification; |
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744 | 744 | | 13. The establishment of and adherence to a quality assurance |
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745 | 745 | | and quality control program to ensure sufficient monitoring of |
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746 | 746 | | laboratory processes and quality of results reported; |
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747 | 747 | | 14. The immediate recall of medical marijuana or medical |
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748 | 748 | | marijuana products that test above allowable thresholds or are |
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749 | 749 | | otherwise determined to be unsa fe; |
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750 | 750 | | 15. The establishment by the laboratory of a system to docume nt |
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751 | 751 | | the complete chain of custody for sample s from receipt through |
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752 | 752 | | disposal; |
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753 | 753 | | 16. The establishment by the laboratory of a system to retain |
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754 | 754 | | and maintain all required records , including business records, and |
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755 | 755 | | processes to ensure results are reported in a time ly and accurate |
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756 | 756 | | manner; and |
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757 | 757 | | 17. Any other aspect of laboratory testing of medical marijuana |
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758 | 758 | | or medical marijuana product deemed necessary by the Department. |
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759 | 759 | | O. A medical marijuana test ing laboratory shall promptly |
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760 | 760 | | provide the Department or designee of th e Department access to a |
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761 | 761 | | report of a test and any underlying data that is conducted on a |
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762 | 762 | | sample at the request of a medical marijuana business or qualified |
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763 | 763 | | patient. A medical marijuana testing laboratory shall also provide |
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764 | 764 | | access to the Department or desi gnee of the Department to laboratory |
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765 | 765 | | |
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766 | 766 | | |
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767 | 767 | | Req. No. 2763 Page 11 1 |
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815 | 815 | | |
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816 | 816 | | premises and to any material or information requested by the |
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817 | 817 | | Department to determine compliance with the requirements of this |
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818 | 818 | | section. |
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819 | 819 | | P. A medical marijuana testing laboratory shall retain all |
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820 | 820 | | results of laboratory te sts conducted on marijuana or products for a |
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821 | 821 | | period of at least seven (7) years and shall make them av ailable to |
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822 | 822 | | the Department upon request. |
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823 | 823 | | Q. A medical marijuana testing laboratory shall test samples |
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824 | 824 | | from each harvest batch or, product batch, or samples consistent |
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825 | 825 | | with the promulgated rules fo r process validation, as appropriate, |
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826 | 826 | | of medical marijuana, medical marijuana concentrate and medical |
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827 | 827 | | marijuana product for each of the following categories of testi ng, |
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828 | 828 | | consistent with standards developed by the Co mmissioner: |
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829 | 829 | | 1. Microbials; |
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830 | 830 | | 2. Mycotoxins; |
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831 | 831 | | 3. Residual solvents; |
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832 | 832 | | 4. Pesticides; |
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833 | 833 | | 5. Tetrahydrocannabinol (THC) and other cannabinoid potency; |
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834 | 834 | | 6. Terpenoid type and concentration ; and |
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835 | 835 | | 7. Heavy metals. |
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836 | 836 | | R. A licensed medical marijuana testing laboratory shall test |
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837 | 837 | | each individual harvest batch . A grower shall separate each harvest |
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838 | 838 | | lot of usable marijua na into harvest batches containing no more tha n |
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839 | 839 | | fifteen (15) pounds, with the exception of any plant mate rial to be |
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840 | 840 | | |
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841 | 841 | | |
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842 | 842 | | Req. No. 2763 Page 12 1 |
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890 | 890 | | |
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891 | 891 | | sold to a licensed processor for the purposes of turning the plant |
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892 | 892 | | material into concentrate which may be separated into harvest |
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893 | 893 | | batches of no more than fifty (50) pounds . A processor shall |
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894 | 894 | | separate each medical marijuana production lot into pr oduction |
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895 | 895 | | batches containing no more tha n four (4) liters of concentrate or |
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896 | 896 | | nine (9) pounds for nonliquid products, and for final products, the |
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897 | 897 | | Oklahoma Medical Marijuana Authority shall be authorized to |
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898 | 898 | | promulgate rules on final products as necessary . Provided, however, |
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899 | 899 | | the Authority shall not req uire testing of final products less often |
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900 | 900 | | than every one thousand (1,000) grams of THC. As used in this |
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901 | 901 | | subsection, "final products" shall include, but not be limited to, |
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902 | 902 | | cookies, brownies, candies, gummies, beve rages and chocolates . |
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903 | 903 | | S. Medical marijuana testing laboratory licensure shall be |
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904 | 904 | | contingent upon successful on-site inspection, successful |
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905 | 905 | | participation in proficiency testing and ongoing compliance with the |
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906 | 906 | | applicable requirements in this section. |
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907 | 907 | | T. A medical marijuana testing laboratory shal l be inspected |
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908 | 908 | | prior to initial licensure and up to two (2) times per year |
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909 | 909 | | thereafter by an inspector approved by the Authority. The Authority |
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910 | 910 | | may enter the licensed premises of a testing laboratory to conduct |
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911 | 911 | | investigations and additional inspections whe n the Authority |
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912 | 912 | | believes an investigation or additi onal inspection is necessary due |
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913 | 913 | | to a possible violation of applicable laws, rules or regulations. |
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914 | 914 | | |
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915 | 915 | | |
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916 | 916 | | Req. No. 2763 Page 13 1 |
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964 | 964 | | |
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965 | 965 | | U. Medical marijuana testing laboratories shall obtain |
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966 | 966 | | accreditation by an accrediting body approved by the Commissioner |
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967 | 967 | | within one (1) year of the date the initial license is issued. |
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968 | 968 | | Renewal of any medical marijua na testing laboratory license shall be |
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969 | 969 | | contingent upon accreditation in accordance with this subsection . |
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970 | 970 | | All medical marijuana testing laborator ies shall obtain |
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971 | 971 | | accreditation prior to applying for and receiving a medical |
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972 | 972 | | marijuana testing laboratory licen se. |
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973 | 973 | | V. Unless authorized by the provisions of this section, a |
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974 | 974 | | commercial grower shall not transfer or se ll medical marijuana and a |
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975 | 975 | | processor shall not transfer, sell or process into a concentrate or |
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976 | 976 | | product any medical marijuana, medical marijuana concent rate or |
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977 | 977 | | medical marijuana product unless samples from each harvest batch or, |
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978 | 978 | | production batch, or samples consistent with the promulgated rules |
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979 | 979 | | for process validation from which that medical mariju ana, medical |
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980 | 980 | | marijuana concentrate or med ical marijuana product was derived has |
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981 | 981 | | been tested by a medical marijuana testin g laboratory and passed all |
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982 | 982 | | contaminant tests required by the Oklahoma Medical Marijuana and |
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983 | 983 | | Patient Protection Act and applicable laws , rules and regulations. |
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984 | 984 | | A licensed commercial grower may transfer medical marijuana that has |
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985 | 985 | | failed testing to a licensed processor only for the purposes of |
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986 | 986 | | decontamination or remediation and only in accordance with the |
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987 | 987 | | provisions of the Oklahoma Medical Marijuana and Patient Protection |
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988 | 988 | | Act and the rules and regulations of the Department . Remediated and |
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989 | 989 | | |
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990 | 990 | | |
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991 | 991 | | Req. No. 2763 Page 14 1 |
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1039 | 1039 | | |
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1040 | 1040 | | decontaminated medical marijuana may be returned only to the |
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1041 | 1041 | | originating licensed commercial grower. |
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1042 | 1042 | | W. Kief shall not be transferred or sold except as authorized |
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1043 | 1043 | | in the rules and regulations o f the Department. |
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1044 | 1044 | | SECTION 2. It being immediately neces sary for the preservation |
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1045 | 1045 | | of the public peace, health or safety, an emergency is hereby |
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1046 | 1046 | | declared to exist, by reason whereof this act shall take effec t and |
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1047 | 1047 | | be in full force from and after its passage an d approval. |
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1048 | 1048 | | |
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1049 | 1049 | | 58-2-2763 MR 1/20/2022 10:31:26 PM |
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