Old | New | Differences | |
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1 | - | An Act | |
2 | - | ENROLLED HOUSE | |
3 | - | BILL NO. 4056 By: Marti, Davis, Talley, and | |
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28 | + | STATE OF OKLAHOMA | |
29 | + | ||
30 | + | 2nd Session of the 58th Legislature (2022) | |
31 | + | ||
32 | + | CONFERENCE COMMITTEE | |
33 | + | SUBSTITUTE | |
34 | + | FOR ENGROSSED | |
35 | + | HOUSE BILL NO. 4056 By: Marti, Davis, Talley, and | |
4 | 36 | McDugle of the House | |
5 | 37 | ||
6 | 38 | and | |
7 | 39 | ||
8 | 40 | Paxton of the Senate | |
9 | 41 | ||
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11 | 43 | ||
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48 | + | CONFERENCE COMMITTEE SUBSTITUTE | |
12 | 49 | ||
13 | 50 | An Act relating to medical marijuana; amending 63 | |
14 | 51 | O.S. 2021, Section 427.17, as amended by Section 17 | |
15 | 52 | of Enrolled Senate Bill No. 1543 of the 2nd Session | |
16 | 53 | of the 58th Oklahoma Legislature, which relates to | |
17 | 54 | the Oklahoma Medical Marijuana and Patient Protection | |
18 | 55 | Act; directing certain entities to provide | |
19 | 56 | recommendations, standards and operating proce dures | |
20 | 57 | to the Oklahoma Medical Marijuana Authority; | |
21 | 58 | directing the Authority to promulgate rule s; | |
22 | 59 | requiring licensed medical marijuana testing | |
23 | 60 | laboratories to comply with rules; providing for | |
24 | 61 | license revocation; and declaring an emergency . | |
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26 | 63 | ||
27 | 64 | ||
28 | 65 | ||
29 | - | SUBJECT: Medical marijuana | |
30 | - | ||
31 | 66 | BE IT ENACTED BY THE PEOPLE OF THE S TATE OF OKLAHOMA: | |
32 | - | ||
33 | 67 | SECTION 1. AMENDATORY 63 O.S. 2021, Section 427.17, as | |
34 | 68 | amended by Section 17 of Enrolled Senate Bill No. 1543 of the 2nd | |
35 | 69 | Session of the 58th Oklahoma Legislature, is amended to read as | |
36 | 70 | follows: | |
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38 | 97 | Section 427.17 A. There is hereby created a medical marijuana | |
39 | 98 | testing laboratory licens e as a category of the medical marijuana | |
40 | 99 | business license. The Oklahoma Medical Marijuana Authority is | |
41 | 100 | hereby enabled to monitor, inspect and audit a licensed testing | |
42 | 101 | laboratory under the Oklahoma Medical Marijuana and Patient | |
43 | 102 | Protection Act. | |
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45 | 103 | B. 1. The Authority is hereby authorized to contract with a | |
46 | - | private laboratory for the purpose of conducting compliance testing | |
104 | + | private laboratory for the purpose of conducting compliance testing | |
47 | 105 | of medical marijuana testing laboratories licensed in th is state. | |
48 | 106 | Any such laboratory under contract for compliance t esting shall be | |
49 | 107 | prohibited from conducting any other commercial medical ma rijuana | |
50 | 108 | testing in this state. The laboratory the Authority contracts with | |
51 | 109 | for compliance testing shall not employ, or be owned by, the | |
52 | 110 | following: | |
111 | + | 1. Any | |
112 | + | a. any individual that has a direct or indirect interest in a | |
113 | + | licensed medical marijuana business; or | |
114 | + | 2. Any | |
115 | + | b. any individual or his or her spouse, parent, child, spouse | |
116 | + | of a child, sibling or spouse of a sibling that has an applica tion | |
117 | + | for a medical marijuana business license pending before the | |
118 | + | Authority or is a member of the board of directors of a medi cal | |
119 | + | marijuana business, or is an individual financially interested in | |
53 | 120 | ||
54 | - | 1. Any | |
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56 | - | a. any individual that has a direct or indirect interest | |
57 | - | in a licensed medical marijuana business ;, or | |
58 | - | ||
59 | - | 2. Any | |
60 | - | ||
61 | - | b. any individual or his or her spouse, parent, child, | |
62 | - | spouse of a child, sibling or spouse of a sibling that | |
63 | - | has an application for a medical marijuana business | |
64 | - | license pending before the Authority or is a member of | |
65 | - | the board of directors of a medi cal marijuana | |
66 | - | business, or is an individual financially interested | |
67 | - | in any licensee or medical marijuana business located | |
68 | - | within this state. | |
69 | - | ||
146 | + | any licensee or medical marijuana business located within this | |
147 | + | state. | |
70 | 148 | 2. The private laboratory under contract with the Authority for | |
71 | 149 | compliance testing and a board or committee comprised of licensed | |
72 | 150 | Oklahoma medical marijuana laboratories currently accredited by the | |
73 | 151 | International Organization for Standardizatio n (ISO) shall provide | |
74 | 152 | to the Authority its recommendations for all equipment and standards | |
75 | 153 | to be utilized by licensed medical marijuana testing laboratories | |
76 | 154 | when testing samples of medical marijuana, medical marijuana | |
77 | 155 | concentrate, and medical marijuana product s as well as standard | |
78 | 156 | operating procedures when extracting and testing medical marijuana, | |
79 | 157 | medical marijuana concentrate, and medical marijuana products. The | |
80 | 158 | recommendations shall be submitted to the Authority no later than | |
81 | 159 | June 1, 2023. The Authority shall have ninety (90) days from the | |
82 | 160 | date it receives the recommendations to promulgate new rules or | |
83 | 161 | modify its current rules for laboratory standards and testing. | |
84 | 162 | Beginning June 1, 2024, medical marijuana testing laboratories | |
85 | 163 | renewing their medical marijuana business license shall be subject | |
86 | 164 | to and comply with any new or modified rules relating to the testing | |
87 | 165 | of medical marijuana, medical marijuana concentrate, and medical | |
88 | 166 | marijuana products. The refusal or failure of a medical marijuana | |
89 | 167 | testing laboratory licensee to comply with new or modified rules | |
90 | - | relating to laboratory standards and testing procedures p romulgated ENR. H. B. NO. 4056 Page 3 | |
168 | + | relating to laboratory standards and testing procedures p romulgated | |
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91 | 195 | under the provisions of this paragraph shall result in the permanent | |
92 | 196 | revocation of the medical marijuana testing laboratory license. | |
93 | - | ||
94 | 197 | C. The Authority shall develop acceptable testin g practices | |
95 | 198 | including, but not limited to, testing, standards, qual ity control | |
96 | 199 | analysis, equipment certification and calibration, and chemical | |
97 | 200 | identification and substances used. | |
98 | - | ||
99 | 201 | D. A person who is a direct beneficial own er of a medical | |
100 | 202 | marijuana dispensary, m edical marijuana commercial grower or medical | |
101 | 203 | marijuana processor shall not be an owner of a laboratory. | |
102 | - | ||
103 | 204 | E. A laboratory and a laboratory applicant shall comply with | |
104 | 205 | all applicable local ordinances including , but not limited to, | |
105 | 206 | zoning, occupancy, licensi ng and building codes. | |
106 | - | ||
107 | 207 | F. A separate license shall be require d for each specific | |
108 | 208 | laboratory. | |
109 | - | ||
110 | 209 | G. A medical marijuana testing laboratory license may be issued | |
111 | 210 | to a person who perform s testing on medical marijuana a nd medical | |
112 | 211 | marijuana products for medical marijuana businesses, medical | |
113 | 212 | marijuana research facilities, m edical marijuana education | |
114 | 213 | facilities, and testing on marijuana and marijuana products grown or | |
115 | 214 | produced by a patient or caregiver on behalf of a patien t, upon | |
116 | 215 | verification of registration . A medical marijuana testing | |
117 | 216 | laboratory may also conduct research related to the development and | |
118 | 217 | improvement of its testing practices and procedures. No state- | |
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119 | 244 | approved medical marijuana testing facility shall operate unless a | |
120 | 245 | medical laboratory director is on site during operational hours. | |
121 | - | ||
122 | 246 | H. Laboratory applicants and licensees shall comply with the | |
123 | 247 | application requirements of this section and shall submit such other | |
124 | 248 | information as required for a medical marijuana bu siness applicant, | |
125 | 249 | in addition to any inform ation the Authority may request for initial | |
126 | 250 | approval and periodic evaluations during the approval period. | |
127 | - | ||
128 | 251 | I. A medical marijuana testing laboratory may accept samples of | |
129 | 252 | medical marijuana, medical marijuana conc entrate or medical | |
130 | 253 | marijuana product from a medical marijuana business, medical | |
131 | 254 | marijuana research facilit y or medical marijuana education facility | |
132 | 255 | for testing purposes only, which purposes may include the provision | |
133 | 256 | of testing services for samples submitte d by a medical marijuana | |
134 | 257 | business for product development. The Authority may require a | |
135 | - | medical marijuana business to submit a sample of medical marijuana, | |
258 | + | medical marijuana business to submit a sample of medical marijuana, | |
136 | 259 | medical marijuana concentrate or medical marijuana product to a | |
137 | 260 | medical marijuana testing or quality assurance laboratory upon | |
138 | 261 | demand. | |
139 | - | ||
140 | 262 | J. A medical marijuana testing laboratory may accept sample s of | |
141 | 263 | medical marijuana, medical marijuana concentrate or medical | |
142 | 264 | marijuana product from an individual person for testing only under | |
143 | 265 | the following conditions: | |
144 | - | ||
145 | 266 | 1. The individual person is a patient or careg iver pursuant to | |
146 | 267 | the Oklahoma Medical Marijuana and Patient Protection Act or is a | |
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147 | 294 | participant in an approved clinical or observational study conducted | |
148 | 295 | by a research facility; and | |
149 | - | ||
150 | 296 | 2. The medical marijuana tes ting laboratory shall require the | |
151 | 297 | patient or caregiver to produce a valid patient license and curr ent | |
152 | 298 | and valid photo identification. | |
153 | - | ||
154 | 299 | K. A medical marijuana testing laboratory may transfer samples | |
155 | 300 | to another medical m arijuana testing laboratory for testi ng. All | |
156 | 301 | laboratory reports provided to or by a medical marijuana business or | |
157 | 302 | to a patient or careg iver shall identify the medical marijuana | |
158 | 303 | testing laboratory that actually conducted the test. | |
159 | - | ||
160 | 304 | L. A medical marijuana t esting laboratory may utilize a | |
161 | 305 | licensed medical marijuana transporter to transport s amples of | |
162 | 306 | medical marijuana, medical marijuana conc entrate and medical | |
163 | 307 | marijuana product for testing, in accordance with the Oklahoma | |
164 | 308 | Medical Marijuana and Patient Protect ion Act and the rules adopted | |
165 | 309 | pursuant thereto, between the originating medical marij uana business | |
166 | 310 | requesting testing services and the d estination laboratory | |
167 | 311 | performing testing services. | |
168 | - | ||
169 | 312 | M. The medical marijuana testing laboratory shall establish | |
170 | 313 | policies to prevent the existence of or app earance of undue | |
171 | 314 | commercial, financial or other in fluences that may diminish the | |
172 | 315 | competency, impartia lity and integrity of the testing processes or | |
173 | 316 | results of the laboratory, or that may diminish public confidence in | |
174 | 317 | the competency, impartiality and integr ity of the testing processes | |
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175 | 344 | or results of the lab oratory. At a minimum, employees, owners or | |
176 | 345 | agents of a medical marijuana testing laboratory who participate in | |
177 | 346 | any aspect of the analysis and results of a sample are pro hibited | |
178 | 347 | from improperly influencing the testing process, improperly | |
179 | 348 | manipulating data or improperly benefiting from any ongoing | |
180 | - | financial, employment, personal or business relationship with the | |
349 | + | financial, employment, personal or business relationship with the | |
181 | 350 | medical marijuana business that provided the sample. A medical | |
182 | 351 | marijuana testing laboratory shal l not test samples for any medical | |
183 | 352 | marijuana business in which an owner, employee or agent of the | |
184 | 353 | medical marijuana testing laboratory has any form of ownership or | |
185 | 354 | financial interest in the medical marijuana business. | |
186 | - | ||
187 | 355 | N. The Authority, pursuant to rules promulgated by the | |
188 | 356 | Executive Director of the Authority, shall develop standards, | |
189 | 357 | policies and procedures as necessary for: | |
190 | - | ||
191 | 358 | 1. The cleanliness and orderliness of a laboratory premise s and | |
192 | 359 | the location of the laboratory in a secure location, and inspectio n, | |
193 | 360 | cleaning and maintenance of any equipment or utensils used for the | |
194 | 361 | analysis of test samples; | |
195 | - | ||
196 | 362 | 2. Testing procedures, testing standards for cannabinoid and | |
197 | 363 | terpenoid potency and safe levels of contaminants, and remediation | |
198 | 364 | procedures; | |
199 | - | ||
200 | 365 | 3. Controlled access areas for storage of medical marijuana and | |
201 | 366 | medical marijuana product test samples, waste and reference | |
202 | 367 | standards; | |
203 | 368 | ||
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204 | 394 | 4. Records to be retained and computer systems to be utilized | |
205 | 395 | by the laboratory; | |
206 | - | ||
207 | 396 | 5. The possession, storage and use by the laboratory of | |
208 | 397 | reagents, solutions and reference standards; | |
209 | - | ||
210 | 398 | 6. A certificate of analysis (COA) for each lot of reference | |
211 | 399 | standard; | |
212 | - | ||
213 | 400 | 7. The transport and disposal of unused marijuana, marijuana | |
214 | 401 | products and waste; | |
215 | - | ||
216 | 402 | 8. The mandatory use by a laboratory of an invent ory tracking | |
217 | 403 | system to ensure all harvest and production batches or samples | |
218 | 404 | containing medical marijuana, medical marijuana concentrate or | |
219 | 405 | medical marijuana products are identified and tracke d from the point | |
220 | 406 | they are transferred from a medical marijuana bu siness, a patient or | |
221 | 407 | a caregiver through the point of transfer, destruction or disposal. | |
222 | 408 | The inventory tracking system reporting shall include the results of | |
223 | 409 | any tests that are conducted on medical marijuana, medical marijuana | |
224 | 410 | concentrate or medical marij uana product; | |
225 | - | ENR. H. B. NO. 4056 Page 6 | |
226 | 411 | 9. Standards of performance; | |
227 | - | ||
228 | 412 | 10. The employment of laboratory personnel; | |
229 | - | ||
230 | 413 | 11. A written standard operating procedure manual to be | |
231 | 414 | maintained and updated by the laboratory; | |
232 | - | ||
233 | 415 | 12. The successful participation in a proficiency testing | |
234 | 416 | program approved by the Executive Director for each testing category | |
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235 | 443 | listed in this section, in order to obtain and maintain | |
236 | 444 | certification; | |
237 | - | ||
238 | 445 | 13. The establishment of and adherence to a quality assurance | |
239 | 446 | and quality control program to ensure sufficient monitori ng of | |
240 | 447 | laboratory processes and quality of results reported; | |
241 | - | ||
242 | 448 | 14. The immediate recall of medical marijuana or medical | |
243 | 449 | marijuana products that test above allowable thresholds or are | |
244 | 450 | otherwise determined to be unsa fe; | |
245 | - | ||
246 | 451 | 15. The establishment by the laborato ry of a system to document | |
247 | 452 | the complete chain of custody for samples from receipt through | |
248 | 453 | disposal; | |
249 | - | ||
250 | 454 | 16. The establishment by the laboratory of a system to retain | |
251 | - | and maintain all required records | |
455 | + | and maintain all required records including business records, and | |
252 | 456 | processes to ensure result s are reported in a timely and accurate | |
253 | 457 | manner; and | |
254 | - | ||
255 | 458 | 17. Any other aspect of laboratory testing of medical marijuana | |
256 | 459 | or medical marijuana product deemed necessary by the Executive | |
257 | 460 | Director. | |
258 | - | ||
259 | 461 | O. A medical marijuana test ing laboratory shall promptly | |
260 | 462 | provide the Authority or designee of the Authority access to a | |
261 | 463 | report of a test and any underlying data that is conducted on a | |
262 | 464 | sample at the request of a medical marijuana business or qualified | |
263 | 465 | patient. A medical marijuana testing laboratory shall also provide | |
264 | 466 | access to the Authority or designee of the Authority to laboratory | |
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265 | 493 | premises and to any material or information requested by t he | |
266 | 494 | Authority to determine compliance w ith the requirements of this | |
267 | 495 | section. | |
268 | - | ||
269 | 496 | P. A medical marijuana testing laboratory shall retain all | |
270 | - | results of laboratory tests conducted on marijuana or products for a | |
497 | + | results of laboratory tests conducted on marijuana or products for a | |
271 | 498 | period of at least seven (7) years and shall make them available to | |
272 | 499 | the Authority upon request. | |
273 | - | ||
274 | 500 | Q. A medical marijuana testing laboratory shall test samples | |
275 | 501 | from each harvest batch or product batch, as appropriate, of medical | |
276 | 502 | marijuana, medical marijuana concentrate and medical marij uana | |
277 | 503 | product for each of the following categories of testing , consistent | |
278 | 504 | with standards developed by the Executive Director: | |
279 | - | ||
280 | 505 | 1. Microbials; | |
281 | - | ||
282 | 506 | 2. Mycotoxins; | |
283 | - | ||
284 | 507 | 3. Residual solvents; | |
285 | - | ||
286 | 508 | 4. Pesticides; | |
287 | - | ||
288 | 509 | 5. Tetrahydrocannabinol (THC) and other cannab inoid potency; | |
289 | - | ||
290 | 510 | 6. Terpenoid type and concentration ; and | |
291 | - | ||
292 | 511 | 7. Heavy metals. | |
293 | - | ||
294 | 512 | R. A licensed medical marijuana testing laboratory shall test | |
295 | 513 | each individual harvest batch. A grower shall separate each harvest | |
296 | 514 | lot of usable marijuana into harvest batches cont aining no more than | |
297 | 515 | fifteen (15) pounds, with the exception of any plant material to be | |
298 | 516 | sold to a licensed processor for the purposes of turning the plant | |
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299 | 543 | material into concentrate which may be separated into harvest | |
300 | 544 | batches of no more than fifty (50) poun ds. A processor shall | |
301 | 545 | separate each medical marijuana production lot int o production | |
302 | 546 | batches containing no more than four (4) liters of concentrate or | |
303 | 547 | nine (9) pounds for nonliquid products, and for final products, the | |
304 | 548 | Oklahoma Medical Marijuana Authority shall be authorized to | |
305 | 549 | promulgate rules on final products as necessary . Provided, however, | |
306 | 550 | the Authority shall not require testing of final products less often | |
307 | 551 | than every one thousand (1,000) grams of THC. As used in this | |
308 | 552 | subsection, "final products" shall include, but not be limited to, | |
309 | 553 | cookies, brownies, candies, gummies, beverages and chocolates. | |
310 | - | ||
311 | 554 | S. Medical marijuana testing laboratory licensure shall be | |
312 | 555 | contingent upon successful on-site inspection, successful | |
313 | 556 | participation in proficiency testing an d ongoing compliance with the | |
314 | 557 | applicable requirements in this section. | |
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316 | 558 | T. A medical marijuana testing laboratory shall be inspected | |
317 | 559 | prior to initial licensure and up to two (2) times per year | |
318 | 560 | thereafter by an inspector approved by the Authority. The Authority | |
319 | 561 | may enter the licensed premises of a testing laboratory to conduct | |
320 | 562 | investigations and additional inspections when the Authority | |
321 | 563 | believes an investigation or additional inspection is necessary due | |
322 | 564 | to a possible violation of applicable laws, rules or r egulations. | |
323 | - | ||
324 | 565 | U. Medical marijuana testing laboratories shall obtain | |
325 | 566 | accreditation by an accrediting body approved by the Executive | |
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326 | 593 | Director within one (1) year of the date the initial license is | |
327 | 594 | issued. Renewal of any medical marijuana testing laboratory license | |
328 | 595 | shall be contingent upon accreditation in accordance with this | |
329 | 596 | subsection. All medical marijuana testing laboratories shall obtain | |
330 | 597 | accreditation prior to applying for and receiving a medical | |
331 | 598 | marijuana testing laboratory license. | |
332 | - | ||
333 | 599 | V. Unless authorized by the provisions of this section, a | |
334 | 600 | commercial grower shall not tran sfer or sell medical marijuana and a | |
335 | 601 | processor shall not transfer, sell or process into a concentrate or | |
336 | 602 | product any medical marijuana, medical marijuana concentrate or | |
337 | 603 | medical marijuana product unless samples from each harvest batch or | |
338 | 604 | production batch from which that medical marijuana, medical | |
339 | 605 | marijuana concentrate or medical marijuana product was derived has | |
340 | 606 | been tested by a medical marijuana testing laboratory and passed all | |
341 | 607 | contaminant tests required b y the Oklahoma Medical Marijuana and | |
342 | 608 | Patient Protection Act and applicable laws, rules and regulations. | |
343 | 609 | A licensed commercial grower may transfer medical marijuana that has | |
344 | 610 | failed testing to a licensed processor only for the purposes of | |
345 | 611 | decontamination or remediation and only in accordance with the | |
346 | 612 | provisions of the Oklahoma Medical Marijuana and Patient Protection | |
347 | 613 | Act and the rules and regulations promulgated by the Executive | |
348 | 614 | Director. Remediated and decontaminated medical marijuana may be | |
349 | 615 | returned only to the originating licensed comme rcial grower. | |
350 | 616 | ||
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351 | 642 | W. Kief shall not be transferred or sold except as authorized | |
352 | 643 | in the rules and regulations promulgated by the Executive Director. | |
353 | - | ||
354 | 644 | SECTION 2. It being immediately necessary for the preservation | |
355 | 645 | of the public peace, health or safety, an emergency is hereby | |
356 | 646 | declared to exist, by rea son whereof this act shall take effect and | |
357 | 647 | be in full force from and after its passage an d approval. | |
358 | 648 | ||
359 | - | ENR. H. B. NO. 4056 Page 9 | |
360 | - | ||
361 | - | Passed the House of Representatives the 18th day of May, 2022. | |
649 | + | 58-2-11561 GRS 05/16/22 | |
362 | 650 | ||
363 | 651 | ||
364 | - | ||
365 | - | ||
366 | - | Presiding Officer of the House | |
367 | - | of Representatives | |
368 | - | ||
369 | - | ||
370 | - | Passed the Senate the 19th day of May, 2022. | |
371 | - | ||
372 | - | ||
373 | - | ||
374 | - | ||
375 | - | Presiding Officer of the Senate | |
376 | - | ||
377 | - | ||
378 | - | ||
379 | - | OFFICE OF THE GOVERNOR | |
380 | - | Received by the Office of the Governor this ____________________ | |
381 | - | day of ___________________, 20_______, at _______ o'clock _______ M. | |
382 | - | By: _________________________________ | |
383 | - | Approved by the Governor of the State of Oklahoma this _____ ____ | |
384 | - | day of ___________________, 20_______, at _______ o'clock _______ M. | |
385 | - | ||
386 | - | ||
387 | - | _________________________________ | |
388 | - | Governor of the State of Oklahoma | |
389 | - | ||
390 | - | OFFICE OF THE SECRETARY OF STATE | |
391 | - | Received by the Office of the Secretary of State this __________ | |
392 | - | day of ___________________, 20_______, at _______ o'clock _______ M. | |
393 | - | By: _________________________________ |