40 | | - | |
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41 | | - | |
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42 | | - | [ pharmacists - modifying pharmacists scope of |
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43 | | - | practice - effective date – |
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44 | | - | emergency ] |
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| 45 | + | An Act relating to pharmacists; amending 59 O.S. |
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| 46 | + | 2021, Section 353.1, which relates to definitions; |
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| 47 | + | modifying definitions; modifying pharmacists scope of |
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| 48 | + | practice; allowing for testing or screening of |
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| 49 | + | certain medical conditions; providing conditions; |
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| 50 | + | providing guidelines; allowing for dispensing certain |
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| 51 | + | drugs; directing the Board of Pharmacy to adopt |
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| 52 | + | certain regulations; providing for codification; |
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| 53 | + | providing an effective date ; and declaring an |
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| 54 | + | emergency. |
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45 | 55 | | |
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46 | 56 | | |
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47 | 57 | | |
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48 | 58 | | |
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49 | 59 | | BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKL AHOMA: |
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50 | 60 | | SECTION 1. AMENDATORY 59 O.S. 2021, Section 353.1, is |
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51 | 61 | | amended to read as follows: |
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52 | 62 | | Section 353.1 For the purposes of the Oklahoma Pharmacy Act: |
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53 | 63 | | 1. "Accredited program" means those seminars, classes, |
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54 | 64 | | meetings, work projects, and other educational courses approved by |
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55 | 65 | | the Board for purposes of continuing professional ed ucation; |
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56 | 66 | | 2. "Act" means the Oklahoma Pharmacy Act; |
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86 | 97 | | 4. "Assistant pharmacist" means any person presently lic ensed |
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87 | 98 | | as an assistant pharmacist in the State of Oklahoma by the Board |
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88 | 99 | | pursuant to Section 353.10 of this title and for the purposes of the |
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89 | 100 | | Oklahoma Pharmacy Act shall be considered the same as a pharmacist, |
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90 | 101 | | except where otherwise specified; |
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91 | 102 | | 5. "Board" or "State Board" means the State Board of Pharmacy; |
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92 | 103 | | 6. "Certify" or "certification of a prescription " means the |
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93 | 104 | | review of a filled prescription by a licensed pharm acist or a |
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94 | 105 | | licensed practitioner with dispensing aut hority to confirm that the |
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95 | 106 | | medication, labeling and packaging of the filled prescription are |
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96 | 107 | | accurate and meet all requirements prescribed by state and federal |
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97 | 108 | | law. For the purposes of this paragraph, "licensed practitioner" |
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98 | 109 | | shall not include optometrists with dispensing authority; |
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99 | 110 | | 7. "Chemical" means any medicinal substance, whether simple or |
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100 | 111 | | compound or obtained through the process of the science and art of |
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101 | 112 | | chemistry, whether of organic or inorganic or igin; |
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102 | 113 | | 8. "Compounding" means the combining, admixin g, mixing, |
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103 | 114 | | diluting, pooling, reconstituti ng or otherwise altering of a drug or |
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104 | 115 | | bulk drug substance to create a drug. Compounding includes the |
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105 | 116 | | preparation of drugs or devices in anticipation of prescript ion drug |
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106 | 117 | | orders based on routine, regularly observed prescribing patterns; |
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136 | 148 | | drugs and dosage forms; and the etiology, characteristics and |
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137 | 149 | | therapeutics of the di seased state; |
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138 | 150 | | 10. "Dangerous drug", "legend drug", "prescription drug" or "Rx |
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139 | 151 | | Only" means a drug: |
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140 | 152 | | a. for human use subject to 21 U.S.C. 353(b)(1), or |
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141 | 153 | | b. is labeled "Prescription Only", or labeled with the |
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142 | 154 | | following statement: "Caution: Federal law restr icts |
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143 | 155 | | this drug except for use by or on the order of a |
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144 | 156 | | licensed veterinarian "."; |
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145 | 157 | | 11. "Director" means the Executive Director of the State Board |
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146 | 158 | | of Pharmacy unless context clearly indicates otherwise; |
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147 | 159 | | 12. "Dispense" or "dispensing" means the interpretation , |
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148 | 160 | | evaluation, and implementation of a prescription drug order, |
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149 | 161 | | including the preparation and delivery of a drug or device to a |
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150 | 162 | | patient or a patient 's agent in a suitable container appropriately |
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151 | 163 | | labeled for subseque nt administration to, or use by, a patient . |
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152 | 164 | | Dispense includes sell, distribute, leave with, give away, dispose |
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153 | 165 | | of, deliver or supply; |
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154 | 166 | | 13. "Dispenser" means a retail pharmacy, hospital pharmacy, a |
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155 | 167 | | group of chain pharmacies under common ownership and contr ol that do |
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156 | 168 | | not act as a wholesale distribu tor, or any other person authorized |
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186 | 199 | | For the purposes of thi s paragraph, "dispenser" does not mean a |
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187 | 200 | | person who dispenses only products to be used in animals in |
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188 | 201 | | accordance with 21 U.S.C. 360b(a)(5); |
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189 | 202 | | 14. "Distribute" or "distribution" means the sale, purchase, |
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190 | 203 | | trade, delivery, handling, storage, or receipt of a pro duct, and |
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191 | 204 | | does not include the dispensing of a product pursuant to a |
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192 | 205 | | prescription executed in accordance with 21 U.S.C. 353(b)(1) or the |
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193 | 206 | | dispensing of a product a pproved under 21 U.S.C. 360b(b); provided, |
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194 | 207 | | taking actual physical possession of a product or t itle shall not be |
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195 | 208 | | required; |
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196 | 209 | | 15. "Doctor of Pharmacy" means a person licensed by the Board |
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197 | 210 | | to engage in the practice of pharmacy. The terms "pharmacist", |
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198 | 211 | | "D.Ph.", and "Doctor of Pharmacy" shall be interchangeable and shall |
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199 | 212 | | have the same meaning wherever t hey appear in the Oklahoma Statutes |
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200 | 213 | | and the rules promulgated by the Board; |
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201 | 214 | | 16. "Drug outlet" means all manufacturers, repackagers, |
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202 | 215 | | outsourcing facilities, whole sale distributors, third -party |
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203 | 216 | | logistics providers, pharmacies, and all other facilities which are |
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204 | 217 | | engaged in dispensing, delivery, distribution or storage of |
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205 | 218 | | dangerous drugs; |
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236 | 250 | | diagnosis, mitigation, treatment or prevention of disease in humans |
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237 | 251 | | or animals and all su bstances and preparations, other than food, |
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238 | 252 | | intended to affect the structure or any function o f the body of a |
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239 | 253 | | human or animals; |
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240 | 254 | | 18. "Drug sample" means a unit of a prescription drug packaged |
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241 | 255 | | under the authority and responsibility of the manufacturer that is |
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242 | 256 | | not intended to be sold and is intended to promot e the sale of the |
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243 | 257 | | drug; |
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244 | 258 | | 19. "Filled prescription" means a packaged prescription |
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245 | 259 | | medication to which a label has been affixed which contains such |
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246 | 260 | | information as is required by the Oklahoma Pharmacy Act; |
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247 | 261 | | 20. "Hospital" means any institution licensed as a h ospital by |
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248 | 262 | | this state for the care and tre atment of patients, or a pharmacy |
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249 | 263 | | operated by the Oklahoma Department of Veterans Affairs; |
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250 | 264 | | 21. "Licensed practitioner " means an allopathic physician, |
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251 | 265 | | osteopathic physician, podiatric physician, dentist, veterinari an or |
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252 | 266 | | optometrist licensed to practice and authorized to prescribe |
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253 | 267 | | dangerous drugs within the scope of practice of such practitioner; |
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254 | 268 | | 22. "Manufacturer" or "virtual manufacturer " means with respect |
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255 | 269 | | to a product: |
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295 | 310 | | d. a person who contracts with another to manufacture a |
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296 | 311 | | product; |
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297 | 312 | | 23. "Manufacturing" means the production, preparation, |
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298 | 313 | | propagation, compounding, conversion or processing of a devi ce or a |
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299 | 314 | | drug, either directly or indirectly by extra ction from substances of |
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300 | 315 | | natural origin or independently by means of chemical or biological |
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301 | 316 | | synthesis and includes any packaging or repackaging of the |
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302 | 317 | | substances or labeling or relabeling of its container , and the |
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303 | 318 | | promotion and marketing of such drugs or d evices. The term |
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304 | 319 | | "manufacturing" also includes the preparation and promotion of |
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333 | 349 | | 24. "Medical gas" means those gases including those in liquid |
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334 | 350 | | state upon which the manuf acturer or distributor has placed one of |
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335 | 351 | | several cautions, such as "Rx Only", in compliance with federal law; |
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336 | 352 | | 25. "Medical gas order" means an order for medical gas issued |
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337 | 353 | | by a licensed prescriber; |
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338 | 354 | | 26. "Medical gas distributor" means a person licensed to |
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339 | 355 | | distribute, transfer, wholesale, deliver or sell medical gases on |
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340 | 356 | | drug orders to suppliers or other entities licensed to use, |
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341 | 357 | | administer or distribute medical ga s and may also include a patient |
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342 | 358 | | or ultimate user; |
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343 | 359 | | 27. "Medical gas supplier " means a person who dispenses medical |
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344 | 360 | | gases on drug orders only to a patient or ultimate user; |
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345 | 361 | | 28. "Medicine" means any drug or combination of drugs which has |
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346 | 362 | | the property of curing, preventing, treating, diagnosing or |
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347 | 363 | | mitigating diseases, or which is used for that purpo se; |
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348 | 364 | | 29. "Nonprescription drugs" means medicines or drugs which are |
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349 | 365 | | sold without a prescription and which are prepackaged for use by the |
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350 | 366 | | consumer and labeled in a ccordance with the requirements of the |
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351 | 367 | | statutes and regulations of this state and the federal government. |
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352 | 368 | | Such items shall also include medical and dental supplies and |
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353 | 369 | | bottled or nonbulk chemicals which are sold or offered for sale to |
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354 | 370 | | the general public i f such articles or preparations meet the |
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383 | 400 | | 30. "Outsourcing facility", including "virtual outsourcing |
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384 | 401 | | facility" means a facility at one geographic location or address |
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385 | 402 | | that: |
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386 | 403 | | a. is engaged in the compounding of sterile d rugs, |
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387 | 404 | | b. has elected to register as an out sourcing facility, |
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388 | 405 | | and |
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389 | 406 | | c. complies with all requirements of 21 U.S.C. 353b; |
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390 | 407 | | 31. "Package" means the smallest individual saleable unit of |
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391 | 408 | | product for distribution by a manufacturer or repackager that is |
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392 | 409 | | intended by the manufacturer for ultimate sale to the dispenser of |
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393 | 410 | | such product. For the purposes of this paragraph, "individual |
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394 | 411 | | saleable unit" means the smallest container of a product introduced |
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395 | 412 | | into commerce by the manufacturer or repackager that is intended by |
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396 | 413 | | the manufacturer or repackager for individu al sale to a dispenser; |
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397 | 414 | | 32. "Person" means an individual, partnership, limited |
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398 | 415 | | liability company, corporation or association, unless the context |
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399 | 416 | | otherwise requires; |
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400 | 417 | | 33. "Pharmacist-in-charge" or "PIC" means the pharmacist |
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401 | 418 | | licensed in this state responsib le for the management control of a |
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402 | 419 | | pharmacy and all other aspects of the practice of pharmacy in a |
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403 | 420 | | licensed pharmacy as defined by Section 353.18 of this title; |
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433 | 451 | | practice the profession of pharmacy, or a pharmacy operated by the |
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434 | 452 | | Oklahoma Department of Veterans Affairs; |
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435 | 453 | | 35. "Pharmacy technician", "technician", "Rx tech", or "tech" |
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436 | 454 | | means a person issued a Technician permit by the State Board of |
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437 | 455 | | Pharmacy to assist the pharmacist and perform nonjudgmental, |
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438 | 456 | | technical, manipulative, non-discretionary functions in the |
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439 | 457 | | prescription department under the immediate and direc t supervision |
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440 | 458 | | of a pharmacist; |
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441 | 459 | | 36. "Poison" means any substance which when introduced into the |
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442 | 460 | | body, either directly or by absorption, produces violent, morbid o r |
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443 | 461 | | fatal changes, or which destroys living tissue wit h which such |
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444 | 462 | | substance comes into contact; |
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445 | 463 | | 37. "Practice of pharmacy" means: |
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446 | 464 | | a. the interpretation and evaluation of prescription |
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447 | 465 | | orders, |
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448 | 466 | | b. the compounding, dispensing, administering and |
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449 | 467 | | labeling of drugs and devices, except labeling by a |
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450 | 468 | | manufacturer, repackager or distributor of |
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451 | 469 | | nonprescription drugs and commercially packaged legend |
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452 | 470 | | drugs and devices, |
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483 | 502 | | e. the responsibility for ad vising by counseling and |
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484 | 503 | | providing information, where professionally necessary |
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485 | 504 | | or where regulated, of therapeutic values, content, |
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486 | 505 | | hazards and use of drugs and de vices, |
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487 | 506 | | f. the offering or performing of those acts, services, |
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488 | 507 | | operations or transactions neces sary in the conduct, |
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489 | 508 | | operation, management and control of a pharmacy, or |
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490 | 509 | | g. the provision of those acts or services that are |
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491 | 510 | | necessary to provide pharmaceutical c are ordering, |
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492 | 511 | | performing, and evaluating laboratory and clinical |
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493 | 512 | | drug therapy related tests and initiating drug therapy |
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494 | | - | for minor, nonchronic health conditions, or |
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495 | | - | h. the provision of those acts or ser vices that are |
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| 513 | + | for minor, nonchronic health conditions, |
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| 514 | + | h. the prescribing and dispensing of self-administered |
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| 515 | + | hormonal contraceptives and any nicotine replacement |
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| 516 | + | therapy product that is approved by the U.S. Food and |
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| 517 | + | Drug Administration, or |
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| 518 | + | i. the provision of those acts or ser vices that are |
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497 | | - | 38. "Preparation" means an article which may or may not contain |
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498 | | - | sterile products compounded in a licensed pharmacy pursuan t to the |
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499 | | - | order of a licensed prescriber; |
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500 | | - | 39. "Prescriber" means a person licensed in this state who is |
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501 | | - | authorized to prescribe dangerous drugs within the scope of practice |
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502 | | - | of the person's profession; |
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503 | | - | 40. "Prescription" means and includes any order for dr ug or |
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504 | | - | medical supplies written or signed, or transmitted by word of mouth, |
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505 | | - | telephone or other means of communicati on: |
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506 | | - | a. by a licensed prescriber, |
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| 547 | + | 38. "Preparation" means an article which may or may not contain |
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| 548 | + | sterile products compounded in a licensed pharmacy pursuan t to the |
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| 549 | + | order of a licensed prescriber; |
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| 550 | + | 39. "Prescriber" means a person licensed in this state who is |
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| 551 | + | authorized to prescribe dangerous drugs within the scope of practice |
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| 552 | + | of the person's profession; |
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| 553 | + | 40. "Prescription" means and includes any order for dr ug or |
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| 554 | + | medical supplies written or signed, or transmitted by word of mouth, |
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| 555 | + | telephone or other means of communication: |
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| 556 | + | a. by a licensed prescriber, |
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533 | 557 | | b. under the supervision of an Oklahoma licensed |
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534 | 558 | | practitioner, an Oklahoma licensed advanced practice |
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535 | 559 | | registered nurse or an Oklahoma licensed physicia n |
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536 | 560 | | assistant, or |
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537 | 561 | | c. by an Oklahoma licensed wholesaler or distributor as |
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538 | 562 | | authorized in Section 353.29.1 of this title; |
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539 | 563 | | 41. "Product" means a prescription drug in a finished dosage |
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540 | 564 | | form for administration to a patie nt without substantial further |
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541 | 565 | | manufacturing, such as capsules, tablets, and lyophilized products |
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542 | 566 | | before reconstitution. "Product" does not include blood components |
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543 | 567 | | intended for transfusion, radioactive drugs or biologics and medi cal |
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544 | 568 | | gas; |
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545 | 569 | | 42. "Repackager", including "virtual repackager", means a |
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546 | 570 | | person who owns or operates an es tablishment that repacks and |
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547 | | - | relabels a product or package for further sale or distribution |
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548 | | - | without further transaction; |
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549 | | - | 43. "Sterile drug" means a drug that is intended for paren teral |
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550 | | - | administration, an ophthalmic or ora l inhalation drug in aqueous |
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551 | | - | format, or a drug that is required to be st erile under state and |
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552 | | - | federal law; |
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553 | | - | 44. "Supervising physician " means an individual holdin g a |
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554 | | - | current license to prac tice as a physician from the State Board of |
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555 | | - | Medical Licensure and S upervision, pursuant to the provis ions of the |
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556 | | - | Oklahoma Allopathic Medica l and Surgical Licensure and Supervis ion |
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| 598 | + | relabels a product or package for further sale or distribution |
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| 599 | + | without further transaction; |
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| 600 | + | 43. "Sterile drug" means a drug that is intended for paren teral |
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| 601 | + | administration, an ophthalmic or ora l inhalation drug in aqueous |
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| 602 | + | format, or a drug that is required to be sterile under state and |
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| 603 | + | federal law; |
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| 604 | + | 44. "Supervising physician " means an individual holdin g a |
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| 605 | + | current license to prac tice as a physician from the State Board of |
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| 606 | + | Medical Licensure and S upervision, pursuant to the provis ions of the |
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| 607 | + | Oklahoma Allopathic Medical and Surgical Licensure and Supervision |
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583 | 608 | | Act, or the State Board of Osteopathic Examiners, pursuant to the |
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584 | 609 | | provisions of the Oklahoma Osteopat hic Medicine Act, who supervises |
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585 | 610 | | an advanced practice registered nurse as de fined in Section 567.3a |
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586 | 611 | | of this title, and who is not in training as an intern, resident, or |
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587 | 612 | | fellow. To be eligible to supervis e an advanced practice regi stered |
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588 | 613 | | nurse, such physician shall remain in compliance with the ru les |
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589 | 614 | | promulgated by the State Board of Medical Licensure and Supervision |
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590 | 615 | | or the State Board of Osteopathic Examiners; |
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591 | 616 | | 45. "Supportive personnel " means technicians and auxiliary |
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592 | 617 | | supportive persons who are regularly paid employees of a pharmacy |
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593 | 618 | | who work and perform tasks in the pharmacy as a uthorized by Section |
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594 | 619 | | 353.18A of this title; |
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595 | 620 | | 46. "Third-party logistics provider ", including "virtual third- |
---|
596 | 621 | | party logistics prov ider" means an entity that provides or |
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597 | | - | coordinates warehousing, or other logistics services of a product in |
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598 | | - | interstate commerce on behalf of a manufacturer, wholesale |
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599 | | - | distributor, or dispenser of a produ ct but does not take ownership |
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600 | | - | of the product, nor ha ve responsibility to direct the sale or |
---|
601 | | - | disposition of the product. For the purposes of this paragraph, |
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602 | | - | "third-party logistics provider" does not include shippers an d the |
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603 | | - | United States Postal Service; |
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604 | | - | 47. "Wholesale distributor ", including "virtual wholesale |
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605 | | - | distributor" means a person other than a manufa cturer, a |
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606 | | - | manufacturer's co-licensed partner, a third-party logistics |
---|
| 649 | + | coordinates warehousing, or other logistics services of a product in |
---|
| 650 | + | interstate commerce on behalf of a manufacturer, wholesale |
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| 651 | + | distributor, or dispenser of a product but does not take ownership |
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| 652 | + | of the product, nor ha ve responsibility to direct the sale or |
---|
| 653 | + | disposition of the product. For the purposes of this paragraph, |
---|
| 654 | + | "third-party logistics provider" does not include shippers and the |
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| 655 | + | United States Postal Service; |
---|
| 656 | + | 47. "Wholesale distributor ", including "virtual wholesale |
---|
| 657 | + | distributor" means a person other than a manufa cturer, a |
---|
| 658 | + | manufacturer's co-licensed partner, a third-party logistics |
---|
633 | 659 | | provider, or repackager engaged in wholesale distribution as defined |
---|
634 | 660 | | by 21 U.S.C. 353(e)(4) as amended by the Drug Supply Chain Securi ty |
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635 | 661 | | Act; |
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636 | 662 | | 48. "County jail" means a facility operated by a county for the |
---|
637 | 663 | | physical detention an d correction of persons charged wi th, or |
---|
638 | 664 | | convicted of, criminal offenses or ordinance violations or persons |
---|
639 | 665 | | found guilty of civil or criminal contempt; |
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640 | 666 | | 49. "State correctional facility " means a facility or |
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641 | 667 | | institution that houses a prisoner population und er the jurisdiction |
---|
642 | 668 | | of the Department of Corrections; |
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643 | 669 | | 50. "Unit dose package" means a package that contains a single |
---|
644 | 670 | | dose drug with the name, strength, control n umber, and expiration |
---|
645 | 671 | | date of that drug on the label ; and |
---|
646 | | - | 51. "Unit of issue package " means a package that provides |
---|
647 | | - | multiple doses of the same drug, but each drug is individually |
---|
648 | | - | separated and includes the name, lot number, and expiration date. |
---|
649 | | - | SECTION 2. NEW LAW A new section of la w to be codified |
---|
650 | | - | in the Oklahoma Statutes as Section 353.40 of Title 59, unless there |
---|
651 | | - | is created a duplication in numbering, reads as follows: |
---|
652 | | - | A. A pharmacist may test or screen for and treat minor, |
---|
653 | | - | nonchronic health conditions. For purposes of this sect ion, a |
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654 | | - | minor, nonchronic health condition is typically a short-term |
---|
655 | | - | condition that is generally managed with minim al treatment or self - |
---|
656 | | - | care, and includes: |
---|
| 699 | + | 51. "Unit of issue package " means a package that provides |
---|
| 700 | + | multiple doses of the same drug, but each drug is individually |
---|
| 701 | + | separated and includes the name, lot number, and expiration date. |
---|
| 702 | + | SECTION 2. NEW LAW A new section of la w to be codified |
---|
| 703 | + | in the Oklahoma Statutes as Section 353.40 of Title 59, unless there |
---|
| 704 | + | is created a duplication in numbering, reads as follows: |
---|
| 705 | + | A. A pharmacist may test or screen for and treat minor, |
---|
| 706 | + | nonchronic health conditions. For purposes of this sect ion, a |
---|
| 707 | + | minor, nonchronic health condition is typically a short-term |
---|
| 708 | + | condition that is generally managed with minimal treatment or self - |
---|
| 709 | + | care, and includes: |
---|
683 | 710 | | 1. Influenza; |
---|
684 | 711 | | 2. Streptococcus; |
---|
685 | 712 | | 3. SARS-COV-2 or other respiratory ill ness, condition, or |
---|
686 | 713 | | disease; |
---|
687 | 714 | | 4. Lice; |
---|
688 | 715 | | 5. Urinary tract infection; |
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689 | 716 | | 6. Skin conditions, such as ringworm and athlete's foot; and |
---|
690 | 717 | | 7. Minor, uncomplicated inf ections. |
---|
691 | 718 | | B. A pharmacist who tests or screens for and treats minor, |
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692 | 719 | | nonchronic health conditions under this section may use a ny test |
---|
693 | 720 | | that may guide clinical decision making which the Centers for |
---|
694 | 721 | | Medicare and Medicaid Services has determined qualifies for a waiver |
---|
695 | 722 | | under the federal Clinical Laboratory Improvement Amendments of |
---|
696 | | - | 1988, or the federal rules a dopted thereunder, or any established |
---|
697 | | - | screening procedures that can safely be performed by a pharmacist. |
---|
698 | | - | C. A pharmacist may dispense a self-administered hormonal |
---|
699 | | - | contraceptive and nicotine replacement therapy products under the |
---|
700 | | - | protocol established pursu ant to this section, regardless of whether |
---|
701 | | - | the patient has obtained a prescription. |
---|
702 | | - | D. The Board of Pharmacy shall adopt regulations establishing a |
---|
703 | | - | protocol for dispensing sel f-administered hormonal contraceptives |
---|
704 | | - | and nicotine replacement therapy products . |
---|
705 | | - | SECTION 3. This act shall become effective July 1, 2022. |
---|
| 750 | + | 1988, or the federal rules adopted thereunder, or any established |
---|
| 751 | + | screening procedures that can safely be performed by a pharmacist. |
---|
| 752 | + | C. A pharmacist may dispense a self-administered hormonal |
---|
| 753 | + | contraceptive and nicotine replacement therapy products under the |
---|
| 754 | + | protocol established pursuant to th is section, regardless of whether |
---|
| 755 | + | the patient has obtained a prescription. |
---|
| 756 | + | D. The Board of Pharmacy shall adopt regulations establishing a |
---|
| 757 | + | protocol for dispensing self -administered hormonal contraceptives |
---|
| 758 | + | and nicotine replacement therapy products. |
---|
| 759 | + | SECTION 3. This act shall become effective July 1, 2022. |
---|