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97 | | - | application for a medical marijuana processing processor license. |
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98 | | - | The Department shall be authorized to issue two types of medical |
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99 | | - | marijuana processor licenses: |
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100 | | - | 1. Nonvolatile, which involves using any solvent in the |
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101 | | - | extraction process that is not a volatile solvent, including carbon |
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102 | | - | dioxide; and |
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103 | | - | 2. Volatile, which involves using any solvent that is or |
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104 | | - | produces a flammable gas or vapor that, when present in the air in |
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105 | | - | sufficient quantities, will create explosive or ignitable mixtures |
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106 | | - | and may also include extraction using nonvolatile solvents or no |
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107 | | - | solvents. |
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108 | | - | The application fee for a nonvolatile or volatile medical marijuana |
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109 | | - | processor license shall be Two Thousand Five Hundred Dollars |
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110 | | - | ($2,500.00) and methods. Methods of payment will shall be provided |
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111 | | - | on the website. The Oklahoma State Department of Health shall have |
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112 | | - | two (2) weeks to review the application, approve or reject the |
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113 | | - | application, and mail the approval/rejection letter (if rejected, |
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114 | | - | stating reasons for rejection) to the appli cant. |
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115 | | - | B. The Oklahoma State Department of Health must shall approve |
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116 | | - | all applications which meet the following criteria: |
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117 | | - | 1. Applicant must be age twenty -five (25) or older; |
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118 | | - | 2. Any applicant, applying as an individual, must show |
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119 | | - | residency in the State of Oklahoma; |
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121 | | - | HB2660 HFLR Page 3 |
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147 | | - | 3. All applying entities must show that all members, managers, |
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148 | | - | and board members are Oklahoma residents; |
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149 | | - | 4. An applying entity may show ownership of non -Oklahoma |
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150 | | - | residents, but that percentage ownership may not exceed twenty -five |
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151 | | - | percent (25%); |
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152 | | - | 5. All applying individuals or entities must be registered to |
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153 | | - | conduct business in the State of Oklahoma; and |
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154 | | - | 6. All applicants must disclose all ownership ;. |
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155 | | - | 7. Applicant(s) An applicant with only a nonviolent felony |
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156 | | - | conviction(s) in the last two (2) ye ars, or any other felony |
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157 | | - | conviction in five (5) years, inmates, or any person currently |
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158 | | - | incarcerated may not qualify for a medical marijuana processing |
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159 | | - | processor license. |
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160 | | - | C. A licensed medical marijuana processor may take marijuana |
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161 | | - | plants and distill or p rocess these plants into concentrates, |
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162 | | - | edibles, and other forms for consumption. As required by subsection |
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163 | | - | D of this section, the Oklahoma State Department of Health will |
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164 | | - | shall, within sixty (60) days of passage of this initiative, make |
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165 | | - | available a set of standards which will be used by licensed medical |
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166 | | - | marijuana processors in the preparation of edible marijuana |
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167 | | - | products. This should be in line with current food preparation |
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168 | | - | guidelines and no excessive or punitive rules may be established by |
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169 | | - | the Oklahoma State Department of Health. Once a year, the Oklahoma |
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170 | | - | State Department of Health may inspect a processing operation and |
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172 | | - | HB2660 HFLR Page 4 |
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198 | | - | determine its compliance with the preparation standards. If |
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199 | | - | deficiencies are found, a written report of deficiency will the |
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200 | | - | deficiencies shall be issued to the licensed medical marijuana |
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201 | | - | processor. The licensed medical marijuana processor will shall have |
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202 | | - | one (1) month to correct the deficiency or be subject to a fine of |
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203 | | - | Five Hundred Dollars ($500.00) for each deficiency. A licensed |
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204 | | - | medical marijuana processor may sell marijuana products it creates |
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205 | | - | to a licensed retailer, or any other licensed medical marijuana |
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206 | | - | processor. Further, these sales will shall be considered wholesale |
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207 | | - | sales and not subject to taxation. Under no circumstances ma y a |
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208 | | - | licensed medical marijuana processor sell marijuana, or any |
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209 | | - | marijuana product, directly to a medical marijuana license holder |
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210 | | - | patient licensee or caregiver licensee . However, a licensed medical |
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211 | | - | marijuana processor may process cannabis into a concentra ted form, |
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212 | | - | for a medical license holder, marijuana patient licensee for a fee. |
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213 | | - | Processors will Licensed medical marijuana processors shall be |
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214 | | - | required to complete a monthly yield and sales report to the |
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215 | | - | Oklahoma State Department of Health. This report will be due on the |
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216 | | - | 15th fifteenth of each month and provide reporting on the previous |
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217 | | - | month. This report will shall detail the amount of marijuana |
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218 | | - | purchased in pounds, the amount of marijuana cooked or processed in |
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219 | | - | pounds, and the amount of waste in pounds. Additionally, this |
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220 | | - | report will shall show total wholesale sales in dollars. The |
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221 | | - | Oklahoma State Department of Health will shall have oversight and |
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223 | | - | HB2660 HFLR Page 5 |
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248 | | - | |
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249 | | - | auditing responsibilities to ensure that all marijuana being grown |
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250 | | - | is accounted for. A licensed medical marijuana processor will shall |
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251 | | - | only be subject to a penalty if a gross discrepancy exists and |
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252 | | - | cannot be explained. Penalties for fraudulent reporting occurring |
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253 | | - | within any 2 year two-year time period will shall be an initial fine |
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254 | | - | of Five Thousand Dollars ($5, 000.00) (first) for a first offense and |
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255 | | - | revocation of licensing (second) the medial marijuana processor |
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256 | | - | license for a second offense . |
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257 | | - | D. The Department shall oversee inspection and compliance of |
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258 | | - | licensed medical marijuana processors producing products wit h |
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259 | | - | marijuana as an additive. The Oklahoma State Department of Health |
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260 | | - | will shall be compelled to, within thirty (30) days of passage of |
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261 | | - | this initiative, appoint a board of twelve (12) Oklahoma residents, |
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262 | | - | who are marijuana industry experts, to create a list of food safety |
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263 | | - | standards for processing and handling medical marijuana in Oklahoma. |
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264 | | - | These standards will shall be adopted by the agency Department and |
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265 | | - | the agency Department can enforce these standards for licensed |
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266 | | - | medical marijuana processors. The agency will Department shall |
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267 | | - | develop a standards review procedure and these standards can may be |
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268 | | - | altered by calling another board of twelve (12) Oklahoma marijuana |
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269 | | - | industry experts. A signed letter of twenty (20) operating licensed |
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270 | | - | medical marijuana processors would constitute a need for a new board |
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271 | | - | and standard standards review. |
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273 | | - | HB2660 HFLR Page 6 |
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299 | | - | E. If it becomes permissible , under federal law, marijuana may |
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300 | | - | be moved across state lines. |
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301 | | - | F. Any device used for the consumption of medical marijuana |
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302 | | - | shall be considered legal to be sold, manufactured, distributed, and |
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303 | | - | possessed. No merchant, wholesaler, manufacturer, or individual may |
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304 | | - | unduly be harassed or prosecuted for selling, manufacturing, or |
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305 | | - | possession of medical marijuana paraphernalia. |
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306 | | - | SECTION 2. AMENDATORY Section 17, Chapter 11, O.S.L. |
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307 | | - | 2019, as amended by Section 4, Chapter 312, O.S.L. 2019 (63 O.S. |
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308 | | - | Supp. 2020, Section 427.17), is amended to read as follows: |
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309 | | - | Section 427.17 A. There is hereby created a medical marijuana |
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310 | | - | testing laboratory license as a category of the medical marijuana |
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311 | | - | business license. The Authority is hereby enabled to monitor, |
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312 | | - | inspect and audit a licensed testing laboratory under this act. |
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313 | | - | B. The Authority is hereby authorized to contract with a |
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314 | | - | private laboratory for the purp ose of conducting compliance testing |
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315 | | - | of medical marijuana testing laboratories licensed in this state. |
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316 | | - | Any such laboratory under contract for compliance testing shall be |
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317 | | - | prohibited from conducting any other commercial medical marijuana |
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318 | | - | testing in this state. |
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319 | | - | C. The Authority shall have the authority to develop acceptable |
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320 | | - | testing and research practices, including but not limited to |
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321 | | - | testing, standards, quality control analysis, equipment |
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322 | | - | certification and calibration, and chemical identification and |
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324 | | - | HB2660 HFLR Page 7 |
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350 | | - | substances used in bona fide research methods so long as it complies |
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351 | | - | with this act. |
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352 | | - | D. A person who is a direct beneficial owner or an indirect |
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353 | | - | beneficial owner of a medical marijuana dispensary, medical |
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354 | | - | marijuana commercial grower, or medical marijuana processo r shall |
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355 | | - | not be an owner of a laboratory. |
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356 | | - | E. A laboratory and a laboratory applicant shall comply with |
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357 | | - | all applicable local ordinances, including but not limited to |
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358 | | - | zoning, occupancy, licensing and building codes. |
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359 | | - | F. A separate license shall be required f or each specific |
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360 | | - | laboratory. |
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361 | | - | G. A medical marijuana testing laboratory license may be issued |
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362 | | - | to a person who performs testing and research on medical marijuana |
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363 | | - | and medical marijuana products for medical marijuana businesses, |
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364 | | - | medical marijuana research fac ilities, medical marijuana education |
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365 | | - | facilities, and testing and research on marijuana and marijuana |
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366 | | - | products grown or produced by a patient or caregiver on behalf of a |
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367 | | - | patient, upon verification of registration. No state -approved |
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368 | | - | medical marijuana testin g facility shall operate unless a medical |
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369 | | - | laboratory director is on site during operational hours. |
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370 | | - | H. A laboratory applicant shall comply with the application |
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371 | | - | requirements of this section and shall submit such other information |
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372 | | - | as required for a medical m arijuana business applicant, in addition |
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374 | | - | HB2660 HFLR Page 8 |
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400 | | - | to any information the Authority may request for initial approval |
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401 | | - | and periodic evaluations during the approval period. |
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402 | | - | I. A medical marijuana testing laboratory may accept samples of |
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403 | | - | medical marijuana, medical mari juana concentrate or medical |
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404 | | - | marijuana product from a medical marijuana business for testing and |
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405 | | - | research purposes only, which purposes may include the provision of |
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406 | | - | testing services for samples submitted by a medical marijuana |
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407 | | - | business for product developm ent. The Department may require a |
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408 | | - | medical marijuana business to submit a sample of medical marijuana, |
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409 | | - | medical marijuana concentrate or medical marijuana product to a |
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410 | | - | medical marijuana testing laboratory upon demand. |
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411 | | - | J. A medical marijuana testing laborat ory may accept samples of |
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412 | | - | medical marijuana, medical marijuana concentrate or medical |
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413 | | - | marijuana product from an individual person for testing only under |
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414 | | - | the following conditions: |
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415 | | - | 1. The individual person is a patient or caregiver pursuant to |
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416 | | - | this act or is a participant in an approved clinical or |
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417 | | - | observational study conducted by a research facility; and |
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418 | | - | 2. The medical marijuana testing laboratory shall require the |
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419 | | - | patient or caregiver to produce a valid patient license and current |
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420 | | - | and valid photo identifi cation. |
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421 | | - | K. A medical marijuana testing laboratory may transfer samples |
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422 | | - | to another medical marijuana testing laboratory for testing. All |
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423 | | - | laboratory reports provided to or by a medical marijuana business or |
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424 | | - | |
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425 | | - | HB2660 HFLR Page 9 |
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451 | | - | to a patient or caregiver shall identify the medi cal marijuana |
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452 | | - | testing laboratory that actually conducted the test. |
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453 | | - | L. A medical marijuana testing laboratory may utilize a |
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454 | | - | licensed medical marijuana transporter to transport samples of |
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455 | | - | medical marijuana, medical marijuana concentrate and medical |
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456 | | - | marijuana product for testing, in accordance with this act and the |
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457 | | - | rules adopted pursuant thereto, between the originating medical |
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458 | | - | marijuana business requesting testing services and the destination |
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459 | | - | laboratory performing testing services. |
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460 | | - | M. The medical marijuana testing laboratory shall establish |
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461 | | - | policies to prevent the existence of or appearance of undue |
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462 | | - | commercial, financial or other influences that may diminish the |
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463 | | - | competency, impartiality and integrity of the testing processes or |
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464 | | - | results of the laboratory, or that may diminish public confidence in |
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465 | | - | the competency, impartiality and integrity of the testing processes |
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466 | | - | or results of the laboratory. At a minimum, employees, owners or |
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467 | | - | agents of a medical marijuana testing laboratory who participate in |
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468 | | - | any aspect of the analysis and results of a sample are prohibited |
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469 | | - | from improperly influencing the testing process, improperly |
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470 | | - | manipulating data, or improperly benefiting from any ongoing |
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471 | | - | financial, employment, personal or business relationship with the |
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472 | | - | medical marijuana business that provided the sample. |
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473 | | - | |
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474 | | - | HB2660 HFLR Page 10 |
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475 | | - | BOLD FACE denotes Committee Amendments. 1 |
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500 | | - | N. The Department, pursuant to rules promulgated by the State |
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501 | | - | Commissioner of Health, shall develop standards, policies and |
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502 | | - | procedures as necessary for: |
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503 | | - | 1. The cleanliness and orderliness of a laboratory premises and |
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504 | | - | the location of the laboratory in a secure location, and inspection, |
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505 | | - | cleaning and maintenance of any equipment or utensils used for the |
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506 | | - | analysis of test samples; |
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507 | | - | 2. Testing procedures, testing standards for cannabinoid and |
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508 | | - | terpenoid potency and safe levels of contaminants, and remediation |
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509 | | - | procedures; |
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510 | | - | 3. Controlled access areas for storage of medical marijuana and |
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511 | | - | medical marijuana product test samples, waste and reference |
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512 | | - | standards; |
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513 | | - | 4. Records to be retained and computer systems to be utilized |
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514 | | - | by the laboratory; |
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515 | | - | 5. The possession, storage and use by the laboratory of |
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516 | | - | reagents, solutions and reference standards; |
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517 | | - | 6. A certificate of analysis (COA) for each lot of reference |
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518 | | - | standard; |
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519 | | - | 7. The transport and disposal of unused marijuana, marijuana |
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520 | | - | products and waste; |
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521 | | - | 8. The mandatory use by a laboratory of an inventory tracking |
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522 | | - | system to ensure all test batches or samples containing medical |
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523 | | - | marijuana, medical marijuana concentrate or medical marijuana |
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524 | | - | |
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525 | | - | HB2660 HFLR Page 11 |
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526 | | - | BOLD FACE denotes Committee Amendments. 1 |
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551 | | - | products are identified and tracked from the point they are |
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552 | | - | transferred from a medical marijuana business, a patient or a |
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553 | | - | caregiver through the point of transfer, destruction or disposal. |
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554 | | - | The inventory tracking system reporting shall include the results of |
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555 | | - | any tests that are conducted on medical marijuana, medical marijuana |
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556 | | - | concentrate or medical marijuana product; |
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557 | | - | 9. Standards of performance; |
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558 | | - | 10. The employment of laboratory personnel; |
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559 | | - | 11. A written standard operating procedure manual to be |
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560 | | - | maintained and updated by the laboratory; |
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561 | | - | 12. The successful participa tion in a Department -approved |
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562 | | - | proficiency testing program for each testing category listed in this |
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563 | | - | section, in order to obtain and maintain certification; |
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564 | | - | 13. The establishment of and adherence to a quality assurance |
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565 | | - | and quality control program to ensure sufficient monitoring of |
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566 | | - | laboratory processes and quality of results reported; |
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567 | | - | 14. The establishment by the laboratory of a system to document |
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568 | | - | the complete chain of custody for samples from receipt through |
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569 | | - | disposal; |
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570 | | - | 15. The establishment by the laborator y of a system to retain |
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571 | | - | and maintain all required records, including business records, and |
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572 | | - | processes to ensure results are reported in a timely and accurate |
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573 | | - | manner; and |
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574 | | - | |
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575 | | - | HB2660 HFLR Page 12 |
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576 | | - | BOLD FACE denotes Committee Amendments. 1 |
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577 | | - | 2 |
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578 | | - | 3 |
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579 | | - | 4 |
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580 | | - | 5 |
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581 | | - | 6 |
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587 | | - | 12 |
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588 | | - | 13 |
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589 | | - | 14 |
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590 | | - | 15 |
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591 | | - | 16 |
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592 | | - | 17 |
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593 | | - | 18 |
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594 | | - | 19 |
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595 | | - | 20 |
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596 | | - | 21 |
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597 | | - | 22 |
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598 | | - | 23 |
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599 | | - | 24 |
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600 | | - | |
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601 | | - | 16. Any other aspect of laboratory testing of medical marijuana |
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602 | | - | or medical marijuana p roduct deemed necessary by the Department. |
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603 | | - | O. A medical marijuana testing laboratory shall promptly |
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604 | | - | provide the Department or designee of the Department access to a |
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605 | | - | report of a test and any underlying data that is conducted on a |
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606 | | - | sample at the request of a medical marijuana business or qualified |
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607 | | - | patient. A medical marijuana testing laboratory shall also provide |
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608 | | - | access to the Department or designee of the Department to laboratory |
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609 | | - | premises and to any material or information requested by the |
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610 | | - | Department to determine compliance with the requirements of this |
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611 | | - | section. |
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612 | | - | P. A medical marijuana testing laboratory shall retain all |
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613 | | - | results of laboratory tests conducted on marijuana or products for a |
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614 | | - | period of at least two (2) years and shall make them available to |
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615 | | - | the Department upon request. |
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616 | | - | Q. A medical marijuana testing laboratory shall test samples |
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617 | | - | from each harvest batch or product batch, as appropriate, of medical |
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618 | | - | marijuana, medical marijuana concentrate and medical marijuana |
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619 | | - | product for each of the following cat egories of testing, consistent |
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620 | | - | with standards developed by the Commissioner: |
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621 | | - | 1. Microbials; |
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622 | | - | 2. Mycotoxins; |
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623 | | - | 3. Residual solvents; |
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624 | | - | 4. Pesticides; |
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625 | | - | |
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626 | | - | HB2660 HFLR Page 13 |
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627 | | - | BOLD FACE denotes Committee Amendments. 1 |
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628 | | - | 2 |
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629 | | - | 3 |
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630 | | - | 4 |
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631 | | - | 5 |
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632 | | - | 6 |
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633 | | - | 7 |
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634 | | - | 8 |
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635 | | - | 9 |
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636 | | - | 10 |
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637 | | - | 11 |
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638 | | - | 12 |
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639 | | - | 13 |
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640 | | - | 14 |
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641 | | - | 15 |
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642 | | - | 16 |
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643 | | - | 17 |
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644 | | - | 18 |
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645 | | - | 19 |
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646 | | - | 20 |
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647 | | - | 21 |
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648 | | - | 22 |
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649 | | - | 23 |
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650 | | - | 24 |
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651 | | - | |
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652 | | - | 5. Tetrahydrocannabinol (THC) and other cannabinoid potency; |
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653 | | - | 6. Terpenoid potency; and |
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654 | | - | 7. Heavy metals. |
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655 | | - | R. A test batch shall not exceed ten (10) pounds of usable |
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656 | | - | marijuana or medical marijuana product, as appropriate. A grower |
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657 | | - | shall separate each harvest lot of usable marijuana into harvest |
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658 | | - | batches containing no more than ten (10) twenty-five (25) pounds. A |
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659 | | - | processor shall separate each medical marijuana production lot into |
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660 | | - | production batches containing no more than ten (10) pounds four (4) |
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661 | | - | liters of distillate and for final products, the Oklahoma Medical |
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662 | | - | Marijuana Authority shall be authorized to promulga te rules on final |
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663 | | - | products as necessary. Provided, however, the Authority shall not |
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664 | | - | require testing of final products more often than every two hundred |
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665 | | - | (200) grams of THC, unless the batch size processed is less than two |
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666 | | - | hundred (200) grams of THC. As us ed in this subsection, "final |
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667 | | - | products" shall include, but not be limited to, cookies, brownies, |
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668 | | - | candies, gummies and chocolates . |
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669 | | - | S. Medical marijuana testing laboratory licensure shall be |
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670 | | - | contingent upon successful on -site inspection, successful |
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671 | | - | participation in proficiency testing and ongoing compliance with the |
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672 | | - | applicable requirements in this section. |
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673 | | - | T. A medical marijuana testing laboratory shall be inspected |
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674 | | - | prior to initial licensure and annually thereafter by an inspector |
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675 | | - | approved by the Authority . |
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676 | | - | |
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677 | | - | HB2660 HFLR Page 14 |
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678 | | - | BOLD FACE denotes Committee Amendments. 1 |
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679 | | - | 2 |
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680 | | - | 3 |
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681 | | - | 4 |
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682 | | - | 5 |
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683 | | - | 6 |
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684 | | - | 7 |
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685 | | - | 8 |
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686 | | - | 9 |
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687 | | - | 10 |
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688 | | - | 11 |
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689 | | - | 12 |
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690 | | - | 13 |
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691 | | - | 14 |
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692 | | - | 15 |
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693 | | - | 16 |
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694 | | - | 17 |
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695 | | - | 18 |
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696 | | - | 19 |
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697 | | - | 20 |
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698 | | - | 21 |
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699 | | - | 22 |
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700 | | - | 23 |
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701 | | - | 24 |
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702 | | - | |
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703 | | - | U. Beginning on a date determined by the Commissioner, not |
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704 | | - | later than January 1, 2020, medical marijuana testing laboratory |
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705 | | - | licensure shall be contingent upon accreditation by the NELAC |
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706 | | - | Institute (TNI), ANSI/ASQ National Accreditation Board or another |
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707 | | - | accrediting body approved by the Commissioner, and any applicable |
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708 | | - | standards as determined by the Department. |
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709 | | - | V. A commercial grower shall not transfer or sell medical |
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710 | | - | marijuana and a processor shall not transfer, sell or process into a |
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711 | | - | concentrate or produ ct any medical marijuana, medical marijuana |
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712 | | - | concentrate or medical marijuana product unless samples from each |
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713 | | - | harvest batch or production batch from which that medical marijuana, |
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714 | | - | medical marijuana concentrate or medical marijuana product was |
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715 | | - | derived has been tested by a medical marijuana testing facility for |
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716 | | - | contaminants and passed all contaminant tests required by this act. |
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717 | | - | SECTION 3. This act shall become effective November 1, 2021. |
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718 | | - | |
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719 | | - | COMMITTEE REPORT BY: COMMITTEE ON ALCOHOL, TOBACCO AND CONTROLLED |
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720 | | - | SUBSTANCES, dated 03/01/2021 - DO PASS, As Amended. |
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| 55 | + | 58-1-6480 GRS 01/10/21 |
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