39 | | - | [ practice of pharmacy - drug therapy - tests - |
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40 | | - | codification - effective date ] |
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| 63 | + | AS INTRODUCED |
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| 64 | + | |
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| 65 | + | An Act relating to the practice of pharmacy; allowing |
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| 66 | + | pharmacist to test or screen for and initiate drug |
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| 67 | + | therapy for minor, nonchronic health conditions; |
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| 68 | + | specifying allowed tests; prohibiting certain test, |
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| 69 | + | screening, and treatment ; amending 59 O.S. 2021, |
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| 70 | + | Section 353.1, as amended by Section 6, Chapter 288, |
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| 71 | + | O.S.L. 2022 (59 O.S. Supp. 202 4, Section 353.1), |
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| 72 | + | which relates to definitions used in the Oklahoma |
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| 73 | + | Pharmacy Act; modifying and adding definitions; |
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| 74 | + | updating statutory language and references; providing |
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| 75 | + | for codification; and providing an effective date . |
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| 76 | + | |
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41 | 77 | | |
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42 | 78 | | |
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43 | 79 | | |
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44 | 80 | | |
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45 | 81 | | BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA: |
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46 | 82 | | SECTION 1. NEW LAW A new section of law to be codified |
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47 | 83 | | in the Oklahoma Statutes as Section 353.31 of Title 59, unless there |
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48 | 84 | | is created a duplication in numbering, reads as follows: |
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49 | 85 | | A. In accordance with a standing order issued by a licensed |
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50 | 86 | | allopathic or osteopathic physician or by the medical director of a |
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51 | 87 | | county or local health department, a pharmacist may test or screen |
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52 | 88 | | for and initiate drug therapy for minor, nonchronic health |
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53 | 89 | | conditions as defined in Section 353.1 of Title 59 of the Oklahoma |
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54 | 90 | | Statutes. |
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88 | 148 | | 2. Waived under the federal Clinica l Laboratory Improvement |
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89 | 149 | | Amendments of 1988 (CLIA) or deemed to be CLIA -waived for use in |
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90 | 150 | | patient care settings operating under a CLIA certificate. |
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91 | 151 | | C. A pharmacist shall not tes t or screen for streptococcus or |
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92 | 152 | | initiate drug therapy for streptococcus to individuals under six (6) |
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93 | 153 | | years of age. |
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94 | 154 | | SECTION 2. AMENDATORY 59 O.S. 2021, Section 353.1, as |
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95 | 155 | | amended by Section 6, Chapter 288, O.S.L. 2022 (59 O.S. Supp . 2024, |
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96 | 156 | | Section 353.1), is amended to read as follows: |
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97 | 157 | | Section 353.1. For the purposes of the Oklahoma Pharmacy Act: |
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98 | 158 | | 1. “Accredited program” means those seminars, classes, |
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99 | 159 | | meetings, work projects, and other educational courses approved by |
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100 | 160 | | the Board State Board of Pharmacy for purposes of continuing |
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101 | 161 | | professional education; |
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102 | 162 | | 2. “Act” means the Oklahoma Pharmacy Act; |
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103 | 163 | | 3. “Administer” means the direct application of a drug, whether |
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104 | 164 | | by injection, inhalation, ingestion , or any other means, to the body |
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105 | 165 | | of a patient; |
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139 | 223 | | 6. “Certify” or “certification of a prescription ” means the |
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140 | 224 | | review of a filled prescription by a licensed pharmacist or a |
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141 | 225 | | licensed practitioner with dispensing authority to confirm that the |
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142 | 226 | | medication, labeling , and packaging of the filled prescription are |
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143 | 227 | | accurate and meet all requirements prescribed by state and federal |
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144 | 228 | | law. For the purposes of this paragraph, “licensed practitioner ” |
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145 | 229 | | shall not include optometrists with dispensing authority; |
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146 | 230 | | 7. “Chemical” means any medicinal substance, whether simple or |
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147 | 231 | | compound or obtained through the process of the science and art of |
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148 | 232 | | chemistry, whether of organic or inorganic origin; |
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149 | 233 | | 8. “Compounding” means the combining, admixing, mixing, |
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150 | 234 | | diluting, pooling, reconstituting , or otherwise altering of a drug |
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151 | 235 | | or bulk drug substance to create a drug. Compounding includes the |
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152 | 236 | | preparation of drugs or devices in anticipation of prescription drug |
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153 | 237 | | orders based on routine, regularly observed prescribing patterns; |
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154 | 238 | | 9. “Continuing professional education ” means professional, |
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155 | 239 | | pharmaceutical education in the general areas of the socioeconomic |
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156 | 240 | | and legal aspects of health care; the properties and actions of |
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189 | 297 | | b. is labeled “Prescription Only”, or labeled with the |
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190 | 298 | | following statement: “Caution: Federal law restricts |
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191 | 299 | | this drug except for to use by or on the order of a |
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192 | 300 | | licensed veterinarian. ”; |
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193 | 301 | | 11. “Director” means the Executive Director of the State Board |
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194 | 302 | | of Pharmacy unless context clearl y indicates otherwise; |
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195 | 303 | | 12. “Dispense” or “dispensing” means the interpretatio n, |
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196 | 304 | | evaluation, and implementation of a prescription drug order |
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197 | 305 | | including the preparation and delivery of a drug or device to a |
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198 | 306 | | patient or a patient ’s agent in a suitable containe r appropriately |
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199 | 307 | | labeled for subsequent administration to, or use by, a patient. |
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200 | 308 | | Dispense includes sell, distribute, leave with, give away, dispose |
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201 | 309 | | of, deliver, or supply; |
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202 | 310 | | 13. “Dispenser” means a retail pharmacy, hospital pharmacy, a |
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203 | 311 | | group of chain pharma cies under common ownership and control that do |
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204 | 312 | | not act as a wholesale distrib utor, or any other person authorized |
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205 | 313 | | by law to dispense or administer prescription drugs, and the |
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206 | 314 | | affiliated warehouses or distributions of such entities under common |
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207 | 315 | | ownership and control that do not act as a wholesale distributor. |
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208 | | - | For the purposes of this paragraph, “dispenser” dispenser does not |
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209 | | - | mean a person who dispenses only products to be used in animals in |
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210 | | - | accordance with 21 U.S.C. 360b(a)(5); |
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211 | | - | 14. “Distribute” or “distribution” means the sale, purchase, |
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212 | | - | trade, delivery, handling, storage, or receipt of a product, and |
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| 367 | + | For the purposes of this paragraph, “dispenser” dispenser does not |
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| 368 | + | mean a person who dispenses only products to be used in animals in |
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| 369 | + | accordance with 21 U.S.C. 360b(a)(5); |
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| 370 | + | 14. “Distribute” or “distribution” means the sale, purchase, |
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| 371 | + | trade, delivery, handling, storage, or recei pt of a product, and |
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240 | 372 | | does not include the dispensing of a product pursuant to a |
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241 | 373 | | prescription executed in accordance with 21 U.S.C. 353(b)(1) or the |
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242 | 374 | | dispensing of a product approv ed under 21 U.S.C. 360b(b); provided, |
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243 | 375 | | taking actual physical possession of a product or title shall not be |
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244 | 376 | | required; |
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245 | 377 | | 15. “Doctor of Pharmacy” means a person licensed by the Board |
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246 | 378 | | to engage in the practice of pharmacy. The terms “pharmacist”, |
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247 | 379 | | “D.Ph.”, and “Doctor of Pharmacy” shall be interchangeable and shall |
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248 | 380 | | have the same meaning wherever they appear in the Oklahoma Statutes |
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249 | 381 | | and the rules promulgated by the Board; |
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250 | 382 | | 16. “Drug outlet” means all manufacturers, repackagers, |
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251 | 383 | | outsourcing facilities, wholesale distributors, third-party |
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252 | 384 | | logistics providers, pharmacies, and all other facilities which are |
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253 | 385 | | engaged in dispensing, delivery, distribution , or storage of |
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254 | 386 | | dangerous drugs; |
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255 | 387 | | 17. “Drugs” means all medicinal substances and preparations |
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256 | 388 | | recognized by the Unite d States Pharmacopoeia Pharmacopeia and |
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257 | 389 | | National Formulary, or any revision th ereof, and all substances and |
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258 | 390 | | preparations intended for external and/or internal use in the cure, |
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290 | 446 | | 18. “Drug sample” means a unit of a prescription drug packaged |
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291 | 447 | | under the authority and responsibility of the manufact urer that is |
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292 | 448 | | not intended to be sold and is intended to promote the sale of th e |
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293 | 449 | | drug; |
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294 | 450 | | 19. “Durable medical equipment ” has the same meaning as |
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295 | 451 | | provided by Section 2 of this act 375.2 of this title; |
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296 | 452 | | 20. “Filled prescription” means a packaged prescription |
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297 | 453 | | medication to which a label has been affixed which contains such |
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298 | 454 | | information as is required by the Oklahoma Pharmacy Act; |
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299 | 455 | | 21. “Hospital” means any institution licensed as a hospital by |
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300 | 456 | | this state for the care and treatment of patients, or a pharmacy |
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301 | 457 | | operated by the Oklahoma Department of Veterans Affairs; |
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302 | 458 | | 22. “Licensed practitioner ” means an allopathic physician, |
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303 | 459 | | osteopathic physician, podiatric physician, dentist, veterinarian , |
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304 | 460 | | or optometrist licensed to practice and authorized to prescribe |
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305 | 461 | | dangerous drugs within the scope of practice of such practitioner; |
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306 | 462 | | 23. “Manufacturer” or “virtual manufacturer ” means with respect |
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307 | 463 | | to a product: |
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308 | 464 | | a. a person that holds an application approved under 21 |
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309 | 465 | | U.S.C. 355 or a license issued under 42 U.S.C. 262 for |
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340 | 520 | | b. a co-licensed partner of the person described in |
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341 | 521 | | subparagraph a of this paragraph that obtains the |
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342 | 522 | | product directly from a person desc ribed in this |
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343 | 523 | | subparagraph or subparagraph a of this paragraph, |
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344 | 524 | | c. an affiliate of a person described in subparagraph a |
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345 | 525 | | or b of this paragraph who receives the product |
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346 | 526 | | directly from a person described in this subparagraph |
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347 | 527 | | or in subparagraph a or b of this paragraph, or |
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348 | 528 | | d. a person who contracts with another to manufacture a |
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349 | 529 | | product; |
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350 | 530 | | 24. “Manufacturing” means the production, preparation, |
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351 | 531 | | propagation, compounding, conversion , or processing of a device or a |
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352 | 532 | | drug, either directly or indirectly by extraction fr om substances of |
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353 | 533 | | natural origin or independently by means of chemical or biological |
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354 | 534 | | synthesis and includes any packaging or repackaging of the |
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355 | 535 | | substances or labeling or relabeling of its container, and the |
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356 | 536 | | promotion and marketing of such drugs or devices. The term |
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357 | 537 | | “manufacturing” manufacturing also includes the preparation and |
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358 | 538 | | promotion of commercially available products from bulk compounds for |
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359 | 539 | | resale by licensed pharmacies, licensed practitioners , or other |
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360 | 540 | | persons; |
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391 | 595 | | 26. “Medical gas order” means an order for medical gas issued |
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392 | 596 | | by a licensed prescriber; |
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393 | 597 | | 27. “Medical gas distributor ” means a person licensed to |
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394 | 598 | | distribute, transfer, wholes ale, deliver, or sell medical gases on |
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395 | 599 | | drug orders to suppliers or other entities licensed to use, |
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396 | 600 | | administer, or distribute medical gas and may also include a patient |
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397 | 601 | | or ultimate user; |
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398 | 602 | | 28. “Medical gas supplier ” means a person who dispenses medical |
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399 | 603 | | gases on drug orders only to a patient or ultimate user; |
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400 | 604 | | 29. “Medicine” means any drug or combination of drugs which has |
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401 | 605 | | the property of curing, preventing, treating, diagnosing , or |
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402 | 606 | | mitigating diseases, or which is used for that purpose; |
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403 | 607 | | 30. “Minor, nonchronic health condition” means a typically |
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404 | 608 | | short-term health condition that is generally managed with |
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405 | 609 | | noncontrolled drug therapies, minimal treatment, or self -care, and |
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406 | 610 | | is limited to the following: |
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407 | 611 | | a. influenzas, |
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408 | 612 | | b. streptococcus, |
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409 | 613 | | c. SARS-CoV-2, |
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410 | 614 | | d. lice, and |
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441 | 669 | | 31. “Nonprescription drugs ” means medicines or drugs which are |
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442 | 670 | | sold without a prescription and which are prepa ckaged for use by the |
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443 | 671 | | consumer and labeled in accordance with the requirements of the |
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444 | 672 | | statutes and regulations of this state and the federal government. |
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445 | 673 | | Such items shall also in clude medical and dental supplies and |
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446 | 674 | | bottled or nonbulk chemicals which are sold or offered for sale to |
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447 | 675 | | the general public if such articles or preparations meet the |
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448 | 676 | | requirements of the Federal Food, Drug , and Cosmetic Act, 21 |
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449 | 677 | | U.S.C.A., Section 321 et seq. ; |
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450 | 678 | | 31. 32. “Outsourcing facility ” including “virtual outsourcing |
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451 | 679 | | facility” means a facility at one geographic location or address |
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452 | 680 | | that: |
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453 | 681 | | a. is engaged in the compounding of sterile drugs, |
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454 | 682 | | b. has elected to register as an outsourcing facility, |
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455 | 683 | | and |
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456 | 684 | | c. complies with all requirements of 21 U.S.C. 353b; |
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457 | 685 | | 32. 33. “Package” means the smallest individual saleable unit |
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458 | 686 | | of product for distribution by a manufacturer or repackager that is |
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459 | 687 | | intended by the manufacturer for ultimate sale to the dispenser of |
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460 | 688 | | such product. For the purposes of this paragraph, “individual |
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461 | 689 | | saleable unit” means the smallest container of a product introduced |
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491 | 743 | | 33. 34. “Person” means an individual, partnership, limited |
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492 | 744 | | liability company, corporation , or association, unless the context |
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493 | 745 | | otherwise requires; |
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494 | 746 | | 34. 35. “Pharmacist-in-charge” or “PIC” means the pharmacist |
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495 | 747 | | licensed in this state responsible for the managemen t control of a |
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496 | 748 | | pharmacy and all other aspects of the practice of pharmacy in a |
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497 | 749 | | licensed pharmacy as defined by Section 353.18 of this title; |
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498 | 750 | | 35. 36. “Pharmacy” means a place regularly licensed by the |
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499 | 751 | | State Board of Pharmacy in which prescriptions, drugs, medicines, |
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500 | 752 | | chemicals, and poisons are compounded or dispensed or such place |
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501 | 753 | | where pharmacists practice the profession of pharmacy, or a pharmacy |
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502 | 754 | | operated by the Oklahoma Department of Veterans Affairs; |
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503 | 755 | | 36. 37. “Pharmacy technician”, “technician”, “Rx tech”, or |
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504 | 756 | | “tech” means a person issued a Technician technician permit by the |
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505 | 757 | | State Board of Pharmacy to assist the pharmacist and perform |
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506 | 758 | | nonjudgmental, technical, manipulative, non -discretionary functions |
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507 | 759 | | in the prescription department under the immediate and direct |
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508 | 760 | | supervision of a pharmacist; |
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509 | 761 | | 37. 38. “Poison” means any substance which when introduced into |
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510 | 762 | | the body, either directly or by absorption, produces violent, |
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511 | 763 | | morbid, or fatal changes, or which destroys living tissue with which |
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512 | 764 | | such substance comes in to contact; |
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541 | 817 | | a. the interpretation and e valuation of prescription |
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542 | 818 | | orders, |
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543 | 819 | | b. the compounding, dispensing, administering , and |
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544 | 820 | | labeling of drugs and devices, except labeling by a |
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545 | 821 | | manufacturer, repackager , or distributor of |
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546 | 822 | | nonprescription drugs and commercially packaged legend |
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547 | 823 | | drugs and devices, |
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548 | 824 | | c. the participation in drug selection and drug |
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549 | 825 | | utilization reviews, |
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550 | 826 | | d. the proper and safe storage of drugs and devices and |
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551 | 827 | | the maintenance of proper records thereof, |
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552 | 828 | | e. the responsibility for advising by counseling and |
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553 | 829 | | providing information, where profess ionally necessary |
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554 | 830 | | or where regulated, of therapeutic values, content, |
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555 | 831 | | hazards, and use of drugs and devices, |
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556 | 832 | | f. the offering or performing of those acts, services, |
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557 | 833 | | operations, or transactions necessary in the conduct, |
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558 | 834 | | operation, management , and control of a pharmacy, or |
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559 | 835 | | g. the ordering, performing, and interpreting of tests |
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560 | 836 | | for minor, nonchronic health conditions that meet the |
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561 | 837 | | requirements of Section 1 of this act and the |
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562 | 838 | | initiation of drug therapy for minor, nonchronic |
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563 | 839 | | health conditions, or |
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590 | 890 | | |
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591 | 891 | | h. the provision of those acts or services that are |
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592 | 892 | | necessary to provide pharmaceutical care; |
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593 | 893 | | 39. 40. “Preparation” means an article which may or may not |
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594 | 894 | | contain sterile products compounded in a licensed pharmacy pursuant |
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595 | 895 | | to the order of a licensed prescriber; |
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596 | 896 | | 40. 41. “Prescriber” means a person licensed in this state who |
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597 | 897 | | is authorized to prescribe dangerous drugs within the scope of |
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598 | 898 | | practice of the person ’s profession; |
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599 | 899 | | 41. 42. “Prescription” means and includes any order for drug or |
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600 | 900 | | medical supplies written or signed, or transmitted by word of mouth, |
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601 | 901 | | telephone, or other means of communication: |
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602 | 902 | | a. by a licensed prescriber, |
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603 | 903 | | b. under the supervision of an Oklahoma licensed |
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604 | 904 | | practitioner, an Oklaho ma licensed advanced practice |
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605 | 905 | | registered nurse Advanced Practice Registered Nurse, |
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606 | 906 | | or an Oklahoma licensed physician assistant, or |
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607 | 907 | | c. by an Oklahoma licensed wholesaler or distributor as |
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608 | 908 | | authorized in Section 353.29.1 of this title; |
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609 | 909 | | 42. 43. “Product” means a prescription drug in a finished |
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610 | 910 | | dosage form for administration to a patien t without substantial |
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611 | 911 | | further manufacturing, such as capsules, tablets, and lyophilized |
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612 | 912 | | products before reconstitution. “Product” Product does not include |
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613 | 913 | | blood components inten ded for transfusion, radioactive drugs or |
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614 | 914 | | biologics and medical gas; |
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641 | 965 | | |
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642 | 966 | | 43. 44. “Repackager”, including “virtual repackager”, means a |
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643 | 967 | | person who owns or operates an establishment that repacks and |
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644 | 968 | | relabels a product or package for further sale or distribution |
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645 | 969 | | without further transaction; |
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646 | 970 | | 44. 45. “Sterile drug” means a drug that is int ended for |
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647 | 971 | | parenteral administration, an ophthalmic or oral inhalation drug in |
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648 | 972 | | aqueous format, or a drug that is required to be sterile under state |
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649 | 973 | | and federal law; |
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650 | 974 | | 45. 46. “Supervising physician” means an individual holding a |
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651 | 975 | | current license to practice as a physician from the State Board of |
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652 | 976 | | Medical Licensure and Supervision, pursuant to the provisions of the |
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653 | 977 | | Oklahoma Allopathic Medical and Surgical Licensure and Supervision |
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654 | 978 | | Act, or the State Board of Osteopathic Examiners, pursuant to the |
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655 | 979 | | provisions of the Oklahoma Osteopathic Medicine Act, who supervises |
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656 | 980 | | an advanced practice registered nurse Advanced Practice Registered |
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657 | 981 | | Nurse as defined in Section 567.3a of this title, and who i s not in |
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658 | 982 | | training as an intern, resident, or fellow. To be eligible to |
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659 | 983 | | supervise an advanced practice registered nurse Advanced Practice |
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660 | 984 | | Registered Nurse, such physician shall remain in compliance with the |
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661 | 985 | | rules promulgated by the State Board of Medical L icensure and |
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662 | 986 | | Supervision or the State Board of Osteopathic Examiners; |
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663 | 987 | | 46. 47. “Supportive personnel ” means technicians and auxiliary |
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664 | 988 | | supportive persons who are regularly paid employees of a pharmacy |
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691 | 1039 | | |
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692 | 1040 | | who work and perform tasks in the pharmacy as authorized by Section |
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693 | 1041 | | 353.18A of this title; |
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694 | 1042 | | 47. 48. “Third-party logistics provider ” including “virtual |
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695 | 1043 | | third-party logistics provider ” means an entity that provides or |
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696 | 1044 | | coordinates warehousing, or other logistics services of a product in |
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697 | 1045 | | interstate commerce on beh alf of a manufacturer, wholesale |
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698 | 1046 | | distributor, or dispenser of a product but do es not take ownership |
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699 | 1047 | | of the product, nor have responsibility to direct the sale or |
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700 | 1048 | | disposition of the product. For the purposes of this paragraph, |
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701 | 1049 | | “third-party logistics provid er” third-party logistics provider does |
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702 | 1050 | | not include shippers and the United States Postal Service; |
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703 | 1051 | | 48. 49. “Wholesale distributor ” including “virtual wholesale |
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704 | 1052 | | distributor” means a person other than a manufacturer, a |
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705 | 1053 | | manufacturer’s co-licensed partner, a third-party logistics |
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706 | 1054 | | provider, or repackager engaged in wholesale distributio n as defined |
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707 | 1055 | | by 21 U.S.C. 353(e)(4) as amended by the Drug Supply Chain Security |
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708 | 1056 | | Act; |
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709 | 1057 | | 49. 50. “County jail” means a facility operated by a county for |
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710 | 1058 | | the physical detention and correction of persons charged with, or |
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711 | 1059 | | convicted of, criminal offenses or ordinance violations or persons |
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712 | 1060 | | found guilty of civil or criminal contempt; |
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713 | 1061 | | 50. 51. “State correctional facility ” means a facility or |
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714 | 1062 | | institution that houses a prisoner population u nder the jurisdiction |
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715 | 1063 | | of the Department of Corrections; |
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716 | 1064 | | |
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722 | 1094 | | 5 |
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723 | 1095 | | 6 |
---|
724 | 1096 | | 7 |
---|
725 | 1097 | | 8 |
---|
726 | 1098 | | 9 |
---|
727 | 1099 | | 10 |
---|
728 | 1100 | | 11 |
---|
729 | 1101 | | 12 |
---|
730 | 1102 | | 13 |
---|
731 | 1103 | | 14 |
---|
732 | 1104 | | 15 |
---|
733 | 1105 | | 16 |
---|
734 | 1106 | | 17 |
---|
735 | 1107 | | 18 |
---|
736 | 1108 | | 19 |
---|
737 | 1109 | | 20 |
---|
738 | 1110 | | 21 |
---|
739 | 1111 | | 22 |
---|
740 | 1112 | | 23 |
---|
741 | 1113 | | 24 |
---|
742 | 1114 | | |
---|
743 | 1115 | | 51. 52. “Unit dose package” means a package that contains a |
---|
744 | 1116 | | single dose drug with the name, strength, control number, and |
---|
745 | 1117 | | expiration date of that drug on the label; and |
---|
746 | 1118 | | 52. 53. “Unit of issue packag e” means a package that provides |
---|
747 | 1119 | | multiple doses of the same drug, but each drug is individually |
---|
748 | 1120 | | separated and includes the name, lot number, and expiration date. |
---|
749 | 1121 | | SECTION 3. This act shall become effective November 1, 2025. |
---|