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4 | 4 | | Req. No. 888 Page 1 1 |
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53 | 53 | | STATE OF OKLAHOMA |
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54 | 54 | | |
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55 | 55 | | 1st Session of the 60th Legislature (2025) |
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56 | 56 | | |
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57 | 57 | | SENATE BILL 907 By: Rosino |
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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 the practice of pharmacy; defining |
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66 | 66 | | terms; authorizing product fulfillment through |
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67 | 67 | | central fill pharmacies under certai n conditions; |
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68 | 68 | | listing powers and duties of pharmacist -in-charge; |
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69 | 69 | | providing certain limitations on filling of |
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70 | 70 | | prescriptions; requiring certain patient notification |
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71 | 71 | | by originating pharmacy; requiring provision of |
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72 | 72 | | certain information to patients; providing ex ception; |
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73 | 73 | | imposing certain duties on central fill pharmacy; |
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74 | 74 | | requiring maintenance of certain policy and procedure |
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75 | 75 | | manual; specifying certain product verification |
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76 | 76 | | responsibilities; requiring certain maintenance of |
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77 | 77 | | records; requiring certain application and f ee; |
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78 | 78 | | authorizing certain shared services; requiring |
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79 | 79 | | licensure; specifying qualifications for shared |
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80 | 80 | | services; imposing certain requirements on retail |
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81 | 81 | | pharmacy engaged in shared services; providing for |
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82 | 82 | | codification; and providing an effective date . |
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83 | 83 | | |
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84 | 84 | | |
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85 | 85 | | |
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86 | 86 | | |
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87 | 87 | | BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA: |
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88 | 88 | | SECTION 1. NEW LAW A new section of law to be codified |
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89 | 89 | | in the Oklahoma Statutes as Section 353.31 of Title 59, unless there |
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90 | 90 | | is created a duplication in numbering, reads as fol lows: |
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91 | 91 | | A. As used in this section: |
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142 | 142 | | |
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143 | 143 | | 1. “Central fill” means the filling of a prescription drug |
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144 | 144 | | order by a central fill pharmacy licensed by the State Board of |
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145 | 145 | | Pharmacy at the request of an originating pharmacy; |
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146 | 146 | | 2. “Central fill pharmacy ” means a licensed resident or non- |
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147 | 147 | | resident pharmacy facility that, upon the request of an origin ating |
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148 | 148 | | pharmacy, performs the product fulfillment of the drug order and |
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149 | 149 | | returns the filled prescription to the originating pharmacy for |
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150 | 150 | | delivery to the patient or patient ’s agent or sends it directly to |
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151 | 151 | | the patient for non-controlled substances. A central fill pharmacy |
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152 | 152 | | that returns filled prescriptions to an originating pharmacy shall |
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153 | 153 | | not be required to obtain a wholesale distributor license ; and |
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154 | 154 | | 3. “Originating pharmacy ” means a pharmacy located in this |
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155 | 155 | | state or out-of-state that is licensed or permitted by the state in |
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156 | 156 | | which it is located and, upon receipt of a prescription drug order, |
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157 | 157 | | requests a central fill pharmacy to perform the product fulfillment |
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158 | 158 | | of the order and upon rece ipt of the filled prescription drug order, |
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159 | 159 | | delivers the prescription to the patient or patient ’s agent. |
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160 | 160 | | B. 1. An originating pharmacy may engage in product |
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161 | 161 | | fulfillment with a central fill pharmacy if the pharmacies: |
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162 | 162 | | a. have the same owner or have entered into a written |
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163 | 163 | | contract or agreement that outlines the services to be |
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164 | 164 | | provided and the responsibilities and accountabilities |
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165 | 165 | | of each pharmacy in compliance with federal and state |
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166 | 166 | | laws and regulations , |
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217 | 217 | | |
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218 | 218 | | b. share a common electronic file or have appropriate |
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219 | 219 | | technology to allow access to sufficient information |
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220 | 220 | | necessary or required to dispense or process a |
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221 | 221 | | prescription drug order , |
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222 | 222 | | c. ensure all state and federal laws regarding patient |
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223 | 223 | | confidentiality, network security, and use of shared |
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224 | 224 | | databases are followed , and |
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225 | 225 | | d. maintain the prescription information in a readily |
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226 | 226 | | retrievable manner. |
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227 | 227 | | 2. The pharmacist-in-charge of a central fill pharmacy: |
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228 | 228 | | a. shall ensure that the pharmacy maintains and uses |
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229 | 229 | | adequate storage or shipment containers and shipping |
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230 | 230 | | processes to ensure drug stability and potency. Such |
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231 | 231 | | shipping processes shall include the use of |
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232 | 232 | | appropriate packaging material or devices, or both, to |
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233 | 233 | | ensure that the drug is maintained at an appropriate |
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234 | 234 | | temperature range to maintain the integrity of the |
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235 | 235 | | medication throughout the delivery process , |
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236 | 236 | | b. shall ensure that the filled prescriptions a re shipped |
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237 | 237 | | in containers that are sealed in a manner that would |
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238 | 238 | | show evidence of having been opened or tampered with , |
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239 | 239 | | and |
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240 | 240 | | c. may employ auxiliary supportive personnel to assist i n |
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241 | 241 | | non-dispensing functions such as inventory, delivery, |
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242 | 242 | | |
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243 | 243 | | |
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292 | 292 | | |
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293 | 293 | | receiving, or packing of completed prescription |
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294 | 294 | | orders. |
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295 | 295 | | 3. Controlled substance prescriptions filled by a central fill |
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296 | 296 | | pharmacy shall comply with both state and federal laws and |
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297 | 297 | | regulations. |
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298 | 298 | | 4. To the extent a pharmacy is acting as a central fill |
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299 | 299 | | pharmacy, the pharmacy shall not fill prescriptions provided |
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300 | 300 | | directly by a patient or an individual practitione r. |
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301 | 301 | | C. 1. An originating pharmacy that engages in prescription |
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302 | 302 | | filling by a central fill pharma cy shall, prior to the dispensing of |
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303 | 303 | | the prescription: |
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304 | 304 | | a. notify patients that their prescription may be filled |
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305 | 305 | | by another pharmacy, and |
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306 | 306 | | b. provide the name of that pharmacy or notify the |
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307 | 307 | | patient if the pharmacy is part of a network of |
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308 | 308 | | pharmacies under com mon ownership and that any of the |
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309 | 309 | | network pharmacies may fill the prescription . |
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310 | 310 | | 2. Patient notification may be provided through a one -time |
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311 | 311 | | written notice to the patient or through use of a sign in the |
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312 | 312 | | pharmacy. |
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313 | 313 | | D. 1. A central fill pharmacy that deliver s prescriptions |
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314 | 314 | | directly to a patient shall provide written information regarding |
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315 | 315 | | the prescription with the filled prescription. |
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316 | 316 | | |
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317 | 317 | | |
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366 | 366 | | |
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367 | 367 | | 2. A pharmacist at the originating pharmacy shall offer the |
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368 | 368 | | patient or the patient ’s agent information about the prescription |
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369 | 369 | | drug or device in accordance with Board rules. |
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370 | 370 | | 3. This subsection shall not apply to patients in facilities |
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371 | 371 | | including, but not limited to, hospitals or nursing facilities, |
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372 | 372 | | where drugs are administered to patients by a person authorized to |
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373 | 373 | | do so by law. |
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374 | 374 | | E. The central fill pharmacy shall: |
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375 | 375 | | 1. Place on the prescription label: |
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376 | 376 | | a. the name and address of the originating pharmacy which |
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377 | 377 | | receives the filled prescription for delivery to the |
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378 | 378 | | patient or the patient ’s agent, and |
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379 | 379 | | b. in some manner indicate which phar macy filled the |
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380 | 380 | | prescription; |
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381 | 381 | | 2. Comply with all other labeling requirements of federal and |
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382 | 382 | | state law; and |
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383 | 383 | | 3. Be exempt from signage requirements intended for patients. |
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384 | 384 | | F. A central fill policy and procedure manual shall be |
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385 | 385 | | maintained at both pharmacies and shall be available for inspection. |
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386 | 386 | | The originating and central fill pharmacies shall maintain only |
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387 | 387 | | those portions of the policy and procedure manual that relate to |
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388 | 388 | | that pharmacy’s operations. The manual shall at minimum contain: |
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389 | 389 | | 1. An outline of the responsibilities of the central fill |
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390 | 390 | | pharmacy and the originating pharmacy i ncluding, but not limited to: |
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391 | 391 | | |
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392 | 392 | | |
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441 | 441 | | |
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442 | 442 | | a. confidentiality and integrity of patient information |
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443 | 443 | | procedures, |
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444 | 444 | | b. drug utilization review , |
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445 | 445 | | c. counseling responsibilities , |
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446 | 446 | | d. policies for operating a continuous quality |
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447 | 447 | | improvement program for pharmacy services designed to |
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448 | 448 | | objectively and systematically monitor and evaluate |
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449 | 449 | | the quality and appropriateness of patient care, |
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450 | 450 | | pursue opportunities to improve patient care, and |
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451 | 451 | | resolve identified probl ems, |
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452 | 452 | | e. safe delivery of prescriptions to patients , |
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453 | 453 | | f. requirements for storag e and shipment of prescription |
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454 | 454 | | medication, and |
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455 | 455 | | g. procedures for conducting an annual review of written |
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456 | 456 | | policies and procedures and for documentation of this |
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457 | 457 | | review; and |
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458 | 458 | | 2. Other responsibilities regarding proper handling of a |
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459 | 459 | | prescription and delivery to a patient or a patient ’s agent pursuant |
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460 | 460 | | to federal and state controlled substances laws and regulations. |
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461 | 461 | | G. The pharmacist product verification responsibilities |
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462 | 462 | | provided by paragraph 2 of subsection B of this section shall be |
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463 | 463 | | deemed satisfied if: |
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464 | 464 | | 1. The pharmacy establishes and follows a policy and procedure |
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465 | 465 | | manual that complies with subsection F of this section ; or |
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466 | 466 | | |
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467 | 467 | | |
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516 | 516 | | |
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517 | 517 | | 2. The pharmacy uses an automated system, the system is fully |
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518 | 518 | | automated from the time the medication is stocked into the machine |
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519 | 519 | | until a completed, labeled, and sealed prescription is produced by |
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520 | 520 | | the system that is ready for dispensing to the patient. No manual |
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521 | 521 | | intervention with the medication may occur after the me dication is |
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522 | 522 | | stocked into the system. For purposes of this paragraph, manual |
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523 | 523 | | intervention shall not include preparing a finished prescription for |
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524 | 524 | | mailing, delivery, or storage . |
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525 | 525 | | H. 1. Records may be maintained in an alternative data |
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526 | 526 | | retention system inclu ding, but not limited to, a data processing |
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527 | 527 | | system or direct imaging system, if: |
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528 | 528 | | a. the records maintained in the alternative system |
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529 | 529 | | contain all of the information required on the manual |
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530 | 530 | | record, and |
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531 | 531 | | b. the data processing system is capable of producing a |
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532 | 532 | | hard copy of the record upon the request of the Board, |
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533 | 533 | | its representative, or o ther authorized local, state, |
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534 | 534 | | or federal law enforcement or regulatory agency. |
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535 | 535 | | 2. Each pharmacy shall maintain records in accordance with |
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536 | 536 | | federal and state laws and regulations and shall be able to produce |
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537 | 537 | | records as requested by the Board. |
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538 | 538 | | 3. The originating pharmacy records shall include the date the |
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539 | 539 | | request for filling was transmitted to the central fill pharmacy. |
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540 | 540 | | 4. The central fill pharmacy records shall include: |
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591 | 591 | | |
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592 | 592 | | a. the date the filled prescription was mailed or |
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593 | 593 | | delivered by the central fill pharmac y to the |
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594 | 594 | | originating pharmacy , and |
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595 | 595 | | b. if mailed or delivered to a patient, the name and |
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596 | 596 | | address to which the filled prescription was shipped. |
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597 | 597 | | I. A central fill pharmacy shall complete a pharmacy permit |
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598 | 598 | | application provided by the Board and shall: |
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599 | 599 | | 1. Provide the name of the owner, permit holder, and |
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600 | 600 | | pharmacist-in-charge of the pharmacy for service of process; and |
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601 | 601 | | 2. Pay the required fee as set by the Board through rule. |
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602 | 602 | | The Board shall develop and implement a central fill permit and |
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603 | 603 | | application under the authority granted by Section 353.18 of Title |
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604 | 604 | | 59 of the Oklahoma Statutes. |
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605 | 605 | | SECTION 2. NEW LAW A new section of law to be codified |
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606 | 606 | | in the Oklahoma Statutes as Section 353.32 of Title 59, unless there |
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607 | 607 | | is created a duplication in numbering, reads as follows: |
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608 | 608 | | A. A pharmacy may engage in shared services with another |
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609 | 609 | | pharmacy in accordance with this section and rules promulgated by |
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610 | 610 | | the State Board of Pharmacy inc luding data entry, interpretation of |
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611 | 611 | | a prescription or drug order, data entry verification, drug |
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612 | 612 | | utilization review, product verification , centralized fulfillment |
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613 | 613 | | under Section 1 of this act, or, when necessary, therapeutic |
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614 | 614 | | intervention. |
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615 | 615 | | |
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616 | 616 | | |
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617 | 617 | | Req. No. 888 Page 9 1 |
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666 | 666 | | B. Before participating in shared services, a pharmacy shall |
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667 | 667 | | have a current Board issued resident or non -resident retail pharmacy |
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668 | 668 | | license. |
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669 | 669 | | C. A pharmacy may provide or utilize shared services functions |
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670 | 670 | | only if the pharmacies involved: |
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671 | 671 | | 1. Either: |
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672 | 672 | | a. have the same owner, o r |
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673 | 673 | | b. have a written contract or agreement that outlines the |
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674 | 674 | | services provided and the shared responsibilities of |
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675 | 675 | | each party in complying with federal and state |
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676 | 676 | | pharmacy laws and rules; and |
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677 | 677 | | 2. Share a common electronic file or technology that allows |
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678 | 678 | | access to information necessary or required to perform shared |
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679 | 679 | | services in conformance with the Oklahoma Pharmacy Act and rules of |
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680 | 680 | | the Board. |
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681 | 681 | | D. A licensed retail pharmacy engaged in shared services shall : |
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682 | 682 | | 1. Maintain manual or electronic records that identify, |
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683 | 683 | | individually for each order processed, the name, initials, or |
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684 | 684 | | identification code of each pharmacist, intern, and pharmacy |
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685 | 685 | | technician who took part, as authorized by rules of the Board, in |
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686 | 686 | | the data entry, prescription or order interpretation, data entry |
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687 | 687 | | verification, drug utilization review, product verification , |
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688 | 688 | | centralized fulfillment, or necessary therapeutic intervention |
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689 | 689 | | performed at that pharmacy ; |
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690 | 690 | | |
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691 | 691 | | |
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692 | 692 | | Req. No. 888 Page 10 1 |
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741 | 741 | | 2. Report to the Board as soon as practical the results of any |
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742 | 742 | | disciplinary action taken by another stat e’s pharmacy regulatory |
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743 | 743 | | agency involving shared services; |
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744 | 744 | | 3. Provide adequate security to protect the confidentiality and |
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745 | 745 | | integrity of patient information; and |
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746 | 746 | | 4. Provide access for inspection of any required record or |
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747 | 747 | | information of any request by the B oard or its designee. |
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748 | 748 | | SECTION 3. This act shall become effective November 1, 2025. |
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749 | 749 | | |
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750 | 750 | | 60-1-888 DC 1/16/2025 11:03:10 AM |
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