36 | | - | |
---|
37 | | - | |
---|
38 | | - | An Act relating to the practice of pharmacy ; allowing |
---|
39 | | - | pharmacist to test or screen for and initiate drug |
---|
40 | | - | therapy for minor, nonchronic health conditions; |
---|
41 | | - | specifying allowed tests; allowing pharmacist to |
---|
42 | | - | dispense certain products under ce rtain protocol; |
---|
43 | | - | directing promulgation of rules ; amending 59 O.S. |
---|
44 | | - | 2021, Section 353.1, as amended by Section 6, Chapter |
---|
45 | | - | 288, O.S.L. 2022 (59 O.S. Supp. 2022, Section 353.1), |
---|
46 | | - | which relates to definitions used in the Oklahoma |
---|
47 | | - | Pharmacy Act; modifying and adding definitions ; |
---|
48 | | - | updating statutory lan guage and references; providing |
---|
49 | | - | for codification; providing an effective date; and |
---|
50 | | - | declaring an emergency. |
---|
| 33 | + | COMMITTEE SUBSTITUTE |
---|
| 34 | + | FOR |
---|
| 35 | + | SENATE BILL NO. 931 By: Garvin |
---|
| 41 | + | An Act relating to the practice of pharmacy ; amending |
---|
| 42 | + | 59 O.S. 2021, Section 353.1, as amended by Section 6, |
---|
| 43 | + | Chapter 288, O.S.L. 2022 (59 O.S. Supp. 2022, Section |
---|
| 44 | + | 353.1), which relates to definition s used in the |
---|
| 45 | + | Oklahoma Pharmacy Act; modifying and adding |
---|
| 46 | + | definitions; allowing pharmacist to test for, screen |
---|
| 47 | + | for, or treat minor, nonchronic health conditions; |
---|
| 48 | + | specifying permitted tests and screening pr ocedures; |
---|
| 49 | + | allowing pharmacist to dispense certain products |
---|
| 50 | + | under certain protocol; directing promulgation of |
---|
| 51 | + | rules; updating statutory lan guage; updating |
---|
| 52 | + | statutory reference; providing for codification; |
---|
| 53 | + | providing an effective date; and declaring an |
---|
| 54 | + | emergency. |
---|
| 55 | + | |
---|
| 56 | + | |
---|
| 57 | + | |
---|
| 58 | + | |
---|
57 | | - | SECTION 1. NEW LAW A new section of law to be codified |
---|
58 | | - | in the Oklahoma Statutes as Section 353.31 of Title 59, unless there |
---|
59 | | - | is created a duplication i n numbering, reads as follows : |
---|
60 | | - | A. A pharmacist may test or screen for and initiate drug |
---|
61 | | - | therapy for minor, nonchronic health conditions as defined in |
---|
62 | | - | Section 353.1 of Title 59 of the Oklahoma Stat utes. |
---|
63 | | - | B. To test for minor, nonchronic he alth conditions under this |
---|
64 | | - | section, the pharmacist may use any test that may guide clinical |
---|
65 | | - | decision-making and that is: |
---|
| 60 | + | SECTION 1. AMENDATORY 59 O.S. 2021, Section 353.1, as |
---|
| 61 | + | amended by Section 6, Chapter 288, O.S.L. 2022 (5 9 O.S. Supp. 2022, |
---|
| 62 | + | Section 353.1), is amen ded to read as follows: |
---|
| 63 | + | Section 353.1. For the purposes of the Oklahoma Pharmacy Act: |
---|
| 64 | + | 1. “Accredited program” means those seminars, classes, |
---|
| 65 | + | meetings, work projects, and oth er educational courses approved by |
---|
| 66 | + | the Board State Board of Pharmacy for purposes of continuing |
---|
| 67 | + | professional education; |
---|
92 | | - | 1. Approved by, cleared by, or authorized under an emergency |
---|
93 | | - | use authorization by the United States Food and Drug Administration; |
---|
94 | | - | and |
---|
95 | | - | 2. Waived under the federal C linical Laboratory Improvement |
---|
96 | | - | Amendments of 1988 (CLIA) or deemed to be CLIA-waived for use in |
---|
97 | | - | patient care settings operating under a CLIA certificate. |
---|
98 | | - | C. A pharmacist may dispense self-administered hormonal |
---|
99 | | - | contraceptives under the protocol es tablished pursuant to subsection |
---|
100 | | - | D of this section, regardless of whether the patient has obtained a |
---|
101 | | - | prescription. |
---|
102 | | - | D. The State Board of Pharmacy shall adopt rules establishing a |
---|
103 | | - | protocol for dispensing self-administered hormonal contraceptives by |
---|
104 | | - | January 1, 2024. |
---|
105 | | - | SECTION 2. AMENDATORY 59 O.S. 2021, Section 353.1, as |
---|
106 | | - | amended by Section 6 , Chapter 288, O.S.L. 2022 (5 9 O.S. Supp. 2022, |
---|
107 | | - | Section 353.1), is amended to read as follows: |
---|
108 | | - | Section 353.1. For the purposes of the Oklahoma Pharmacy Act: |
---|
109 | | - | 1. “Accredited program” means those seminars, classes, |
---|
110 | | - | meetings, work projects, and oth er educational courses approved by |
---|
111 | | - | the Board State Board of Pharmacy for purposes of continuing |
---|
112 | | - | professional education; |
---|
| 96 | + | 3. “Administer” means the direct application of a drug, whether |
---|
| 97 | + | by injection, inhalation, ingestion or any other m eans, to the body |
---|
| 98 | + | of a patient; |
---|
| 99 | + | 4. “Assistant pharmacist” means any person presently licensed |
---|
| 100 | + | as an assistant pharmacist in the State of Oklahom a this state by |
---|
| 101 | + | the Board pursuant to Section 353.10 of this title and for the |
---|
| 102 | + | purposes of the Oklahoma Pharmacy Act shal l be considered the same |
---|
| 103 | + | as a pharmacist, except whe re otherwise specified; |
---|
| 104 | + | 5. “Board” or “State Board” means the State Board of Pharmacy; |
---|
| 105 | + | 6. “Certify” or “certification of a prescription ” means the |
---|
| 106 | + | review of a filled prescription by a licensed pharmac ist or a |
---|
| 107 | + | licensed practitioner with dispensing authori ty to confirm that the |
---|
| 108 | + | medication, labeling and packaging of the filled prescription are |
---|
| 109 | + | accurate and meet all requirements prescribed by state and federal |
---|
| 110 | + | law. For the purposes of this paragraph, “licensed practitioner” |
---|
| 111 | + | shall not include optometrists wit h dispensing authority; |
---|
| 112 | + | 7. “Chemical” means any medicinal substance, whether simple or |
---|
| 113 | + | compound or obtained through the process of the science and art of |
---|
| 114 | + | chemistry, whether of organic or inorganic ori gin; |
---|
| 115 | + | 8. “Compounding” means the combining, admixing, m ixing, |
---|
| 116 | + | diluting, pooling, reconstituting or otherwise altering of a drug or |
---|
| 117 | + | bulk drug substance to create a drug. Compounding includes the |
---|
140 | | - | 3. “Administer” means the direct application of a drug, whether |
---|
141 | | - | by injection, inhalation, ingestion or any other means, to the body |
---|
142 | | - | of a patient; |
---|
143 | | - | 4. “Assistant pharmacist” means any person presently licensed |
---|
144 | | - | as an assistant pharmacist in the State of Oklahom a this state by |
---|
145 | | - | the Board pursuant to Section 353.10 of this title and for the |
---|
146 | | - | purposes of the Okla homa Pharmacy Act shal l be considered the same |
---|
147 | | - | as a pharmacist, except where otherwise specified; |
---|
148 | | - | 5. “Board” or “State Board” means the State Board of Pharmacy; |
---|
149 | | - | 6. “Certify” or “certification of a prescription” means the |
---|
150 | | - | review of a filled prescription b y a licensed pharmac ist or a |
---|
151 | | - | licensed practitioner with dispensing authority to confirm that the |
---|
152 | | - | medication, labeling and packaging of the filled prescription are |
---|
153 | | - | accurate and meet all requirements prescribed by state and federal |
---|
154 | | - | law. For the purposes of this paragraph, “licensed practitioner” |
---|
155 | | - | shall not include optometrists with dispensing authority; |
---|
156 | | - | 7. “Chemical” means any medicinal substance, whether simple or |
---|
157 | | - | compound or obtained through the process of the science and art of |
---|
158 | | - | chemistry, whether of organ ic or inorganic origin; |
---|
159 | | - | 8. “Compounding” means the combining, admixing, mixing, |
---|
160 | | - | diluting, pooling, reconstituting or otherwise altering of a drug or |
---|
161 | | - | bulk drug substance to create a drug. Compounding includes the |
---|
| 147 | + | 9. “Continuing professional education” means professional, |
---|
| 148 | + | pharmaceutical education in the general areas of the socioeconomic |
---|
| 149 | + | and legal aspects of health care; the properties and actions of |
---|
| 150 | + | drugs and dosage forms; and the etiology, char acteristics and |
---|
| 151 | + | therapeutics of the diseased state; |
---|
| 152 | + | 10. “Dangerous drug”, “legend drug”, “prescription drug” or “Rx |
---|
| 153 | + | Only” means a drug: |
---|
| 154 | + | a. for human use subject to 21 U.S.C. 353(b)(1), or |
---|
| 155 | + | b. is labeled “Prescription Only”, or labeled with the |
---|
| 156 | + | following statement: “Caution: Federal law restricts |
---|
| 157 | + | this drug except for to use by or on the order of a |
---|
| 158 | + | licensed veterinarian.”; |
---|
| 159 | + | 11. “Director” means the Executive Director of the State Board |
---|
| 160 | + | of Pharmacy unless context clearly indi cates otherwise; |
---|
| 161 | + | 12. “Dispense” or “dispensing” means the interpretation, |
---|
| 162 | + | evaluation, and implementation of a prescription drug order |
---|
| 163 | + | including the preparation and delivery of a drug or device to a |
---|
| 164 | + | patient or a patient ’s agent in a suitable container appr opriately |
---|
| 165 | + | labeled for subsequent ad ministration to, or use by, a patient. |
---|
| 166 | + | Dispense includes sell, distribute, leave with, give away, dispose |
---|
| 167 | + | of, deliver or supply; |
---|
190 | | - | 9. “Continuing professional education” means professional, |
---|
191 | | - | pharmaceutical education in the general areas of the socioeconomic |
---|
192 | | - | and legal aspects of health care; th e properties and actions of |
---|
193 | | - | drugs and dosage forms; and the etiology, characteristics and |
---|
194 | | - | therapeutics of the diseased state; |
---|
195 | | - | 10. “Dangerous drug”, “legend drug”, “prescription drug” or “Rx |
---|
196 | | - | Only” means a drug: |
---|
197 | | - | a. for human use subject to 21 U.S.C. 353(b)( 1), or |
---|
198 | | - | b. is labeled “Prescription Only”, or labeled with the |
---|
199 | | - | following statement: “Caution: Federal law restricts |
---|
200 | | - | this drug except for to use by or on the order of a |
---|
201 | | - | licensed veterinarian.”; |
---|
202 | | - | 11. “Director” means the Executive Director of the State Boar d |
---|
203 | | - | of Pharmacy unless context clearly indi cates otherwise; |
---|
204 | | - | 12. “Dispense” or “dispensing” means the interpretation, |
---|
205 | | - | evaluation, and implementation of a prescription drug order |
---|
206 | | - | including the preparation and delivery of a drug or device to a |
---|
207 | | - | patient or a patient’s agent in a suitable container appr opriately |
---|
208 | | - | labeled for subsequent administration to, or use by, a patient. |
---|
209 | | - | Dispense includes sell, distribute, leave with, give away, dispose |
---|
210 | | - | of, deliver or supply; |
---|
| 198 | + | by law to dispense or administer prescription drugs, and the |
---|
| 199 | + | affiliated warehouses or distributions of such entities und er common |
---|
| 200 | + | ownership and control that do not act as a wholesale distributor. |
---|
| 201 | + | For the purposes of this paragraph, “dispenser” dispenser does not |
---|
| 202 | + | mean a person who dispenses only products to be used in animals in |
---|
| 203 | + | accordance with 21 U.S.C. 360b(a)(5); |
---|
| 204 | + | 14. “Distribute” or “distribution” means the sale, purchase, |
---|
| 205 | + | trade, delivery, handling, storage, or receipt of a product, and |
---|
| 206 | + | does not include the dispensing of a product pursuant to a |
---|
| 207 | + | prescription executed in accordance with 21 U.S.C. 353(b)(1) or the |
---|
| 208 | + | dispensing of a product approved under 21 U.S.C. 360b(b); provided, |
---|
| 209 | + | taking actual physical possession of a product or title shall not be |
---|
| 210 | + | required; |
---|
| 211 | + | 15. “Doctor of Pharmacy” means a person licensed by the Board |
---|
| 212 | + | to engage in the practice of pharmacy . The terms “pharmacist”, |
---|
| 213 | + | “D.Ph.”, and “Doctor of Pharmacy” shall be interchangeable and s hall |
---|
| 214 | + | have the same meaning wherever they appear in the Oklahoma Statutes |
---|
| 215 | + | and the rules promulgated by the Board; |
---|
| 216 | + | 16. “Drug outlet” means all manufacturers, repackagers, |
---|
| 217 | + | outsourcing faciliti es, wholesale distributors, third-party |
---|
| 218 | + | logistics providers, pharm acies, and all other facilities which are |
---|
240 | | - | by law to dispense or administer prescription drugs, and the |
---|
241 | | - | affiliated warehouses or distributions of such entities under common |
---|
242 | | - | ownership and control that do not act as a wholesale distributor. |
---|
243 | | - | For the purposes of this paragraph, “dispenser” dispenser does not |
---|
244 | | - | mean a person who dispenses only products to be used in animals in |
---|
245 | | - | accordance with 21 U.S.C. 360b(a )(5); |
---|
246 | | - | 14. “Distribute” or “distribution” means the sale, purchase, |
---|
247 | | - | trade, delivery, handling, storage, or receipt of a product, and |
---|
248 | | - | does not include the dispensing of a product pursuant to a |
---|
249 | | - | prescription executed in accordance with 21 U.S.C. 353(b)(1) or the |
---|
250 | | - | dispensing of a product approved under 21 U.S.C. 360b(b); provided, |
---|
251 | | - | taking actual physical possession of a product or title shall not be |
---|
252 | | - | required; |
---|
253 | | - | 15. “Doctor of Pharmacy” means a person licensed by the Board |
---|
254 | | - | to engage in the practice of pharmacy . The terms “pharmacist”, |
---|
255 | | - | “D.Ph.”, and “Doctor of Pharmacy” shall be interchangeable and s hall |
---|
256 | | - | have the same meaning wherever they appear in the Oklahoma Statutes |
---|
257 | | - | and the rules promulgated by the Board; |
---|
258 | | - | 16. “Drug outlet” means all manufacturers, repackagers, |
---|
259 | | - | outsourcing faciliti es, wholesale distributors, third-party |
---|
260 | | - | logistics providers, pharm acies, and all other facilities which are |
---|
| 248 | + | 17. “Drugs” means all medicinal substances and preparations |
---|
| 249 | + | recognized by the United States Pharmacopoeia Pharmacopeia and |
---|
| 250 | + | National Formulary, or any revision thereof, and all substances and |
---|
| 251 | + | preparations intended for external and/or internal use in the cure, |
---|
| 252 | + | diagnosis, mitigation, treatment or prevention of disease in humans |
---|
| 253 | + | or animals and all substances and preparatio ns, other than food, |
---|
| 254 | + | intended to affect the structure or any function of the body of a |
---|
| 255 | + | human or animals; |
---|
| 256 | + | 18. “Drug sample” means a unit of a prescription drug packaged |
---|
| 257 | + | under the authority and responsibility of th e manufacturer that is |
---|
| 258 | + | not intended to be s old and is intended to promote the sale of the |
---|
| 259 | + | drug; |
---|
| 260 | + | 19. “Durable medical equipment” has the same meaning as |
---|
| 261 | + | provided by Section 2 of this act 375.2 of this title; |
---|
| 262 | + | 20. “Filled prescription” means a packaged pres cription |
---|
| 263 | + | medication to which a label has been affixed which con tains such |
---|
| 264 | + | information as is required by the Oklahoma Pharmacy Act; |
---|
| 265 | + | 21. “Hospital” means any institution licensed as a hospital by |
---|
| 266 | + | this state for the care and treatment of patients, or a pharm acy |
---|
| 267 | + | operated by the Oklahoma Department of Veterans Affairs; |
---|
| 268 | + | 22. “Licensed practitioner” means an allopathic physician, |
---|
| 269 | + | osteopathic physician, podiatric physician, dentist, veterinarian or |
---|
289 | | - | 17. “Drugs” means all medicinal substances and pre parations |
---|
290 | | - | recognized by the United States Pharmacopoeia Pharmacopeia and |
---|
291 | | - | National Formulary, or any revision thereof, and all substances and |
---|
292 | | - | preparations intended for external and/or internal use in the cure, |
---|
293 | | - | diagnosis, mitigation, treatment or prevention of disease in humans |
---|
294 | | - | or animals and all substances and preparations, other than food, |
---|
295 | | - | intended to affect the structure or any function of the body of a |
---|
296 | | - | human or animals; |
---|
297 | | - | 18. “Drug sample” means a unit of a prescription drug packaged |
---|
298 | | - | under the authority an d responsibility of th e manufacturer that is |
---|
299 | | - | not intended to be sold and is intended to promote the sale of the |
---|
300 | | - | drug; |
---|
301 | | - | 19. “Durable medical equipment” has the same meaning as |
---|
302 | | - | provided by Section 2 of this act 375.2 of this title; |
---|
303 | | - | 20. “Filled prescription” means a packaged pres cription |
---|
304 | | - | medication to which a label has been affixed which con tains such |
---|
305 | | - | information as is required by the Oklahoma Pharmacy Act; |
---|
306 | | - | 21. “Hospital” means any institution licensed as a hospital by |
---|
307 | | - | this state for the care and treatment o f patients, or a pharm acy |
---|
308 | | - | operated by the Oklahoma Department of Veterans Affairs; |
---|
309 | | - | 22. “Licensed practitioner” means an allopathic physician, |
---|
310 | | - | osteopathic physician, podiatric physician, dentist, veterinarian or |
---|
| 299 | + | 23. “Manufacturer” or “virtual manufacturer” means with respect |
---|
| 300 | + | to a product: |
---|
| 301 | + | a. a person that holds an application approved under 21 |
---|
| 302 | + | U.S.C. 355 or a license issued under 42 U.S.C. 262 for |
---|
| 303 | + | such product, or if such product is not the subject of |
---|
| 304 | + | an approved application or license, the person who |
---|
| 305 | + | manufactured the product, |
---|
| 306 | + | b. a co-licensed partner of the person described in |
---|
| 307 | + | subparagraph a of this paragraph that obtains the |
---|
| 308 | + | product directly from a person described in this |
---|
| 309 | + | subparagraph or subparagraph a of this paragraph, |
---|
| 310 | + | c. an affiliate of a person described in subpara graph a |
---|
| 311 | + | or b of this paragraph who receives the product |
---|
| 312 | + | directly from a person described in this subparagraph |
---|
| 313 | + | or in subparagraph a or b of this paragraph, or |
---|
| 314 | + | d. a person who contracts with another to manufacture a |
---|
| 315 | + | product; |
---|
| 316 | + | 24. “Manufacturing” means the production, preparation, |
---|
| 317 | + | propagation, compounding, conversion or processing of a device or a |
---|
| 318 | + | drug, either directly or indirectly by extraction from substances of |
---|
| 319 | + | natural origin or independently by means of chemical or biological |
---|
| 320 | + | synthesis and includes any pac kaging or repackaging of the |
---|
339 | | - | 23. “Manufacturer” or “virtual manufacturer” means with respect |
---|
340 | | - | to a product: |
---|
341 | | - | a. a person that holds an application approved under 21 |
---|
342 | | - | U.S.C. 355 or a license issued under 42 U.S.C. 262 for |
---|
343 | | - | such product, or if such product is not the subject of |
---|
344 | | - | an approved application or license, the person who |
---|
345 | | - | manufactured the product, |
---|
346 | | - | b. a co-licensed partner of the person described in |
---|
347 | | - | subparagraph a of this paragraph that obtains the |
---|
348 | | - | product directly from a person described in this |
---|
349 | | - | subparagraph or subparagraph a of this paragraph, |
---|
350 | | - | c. an affiliate of a person described in subpara graph a |
---|
351 | | - | or b of this paragraph who receives the product |
---|
352 | | - | directly from a person described in this subparagraph |
---|
353 | | - | or in subparagraph a or b of this paragraph, or |
---|
354 | | - | d. a person who contracts with another to manufacture a |
---|
355 | | - | product; |
---|
356 | | - | 24. “Manufacturing” means the production, preparation, |
---|
357 | | - | propagation, compounding, conversion or processing of a device or a |
---|
358 | | - | drug, either directly or indirectly by extraction from substances of |
---|
359 | | - | natural origin or independently by means of chemical or biological |
---|
360 | | - | synthesis and includes any pac kaging or repackaging of the |
---|
| 350 | + | “manufacturing” manufacturing also includes the preparation and |
---|
| 351 | + | promotion of commercially avail able products from bulk compounds for |
---|
| 352 | + | resale by licensed pharmacies, licensed practitioners or other |
---|
| 353 | + | persons; |
---|
| 354 | + | 25. “Medical gas” means those gases including those in liquid |
---|
| 355 | + | state upon which the manufacturer or distributor has placed one of |
---|
| 356 | + | several cautions, such as “Rx Only”, in compliance with federal l aw; |
---|
| 357 | + | 26. “Medical gas order” means an order for medical gas issued |
---|
| 358 | + | by a licensed prescriber; |
---|
| 359 | + | 27. “Medical gas distributor” means a person licensed to |
---|
| 360 | + | distribute, transfer, wholesale, deliver or sell medical gases on |
---|
| 361 | + | drug orders to suppliers or oth er entities licensed to use, |
---|
| 362 | + | administer or distribute medical gas and may also include a patient |
---|
| 363 | + | or ultimate user; |
---|
| 364 | + | 28. “Medical gas supplier” means a person who disp enses medical |
---|
| 365 | + | gases on drug orders only to a pati ent or ultimate user; |
---|
| 366 | + | 29. “Medicine” means any drug or combination of drugs which has |
---|
| 367 | + | the property of curing, preventing, treating, diagnosing or |
---|
| 368 | + | mitigating diseases, or which is used for that purpose; |
---|
| 369 | + | 30. “Minor, nonchronic health condition” means a typically |
---|
| 370 | + | short-term health condition that is generally managed with |
---|
389 | | - | “manufacturing” manufacturing also includes the preparation and |
---|
390 | | - | promotion of commercially avail able products from bulk compounds for |
---|
391 | | - | resale by licensed pharmacies, licensed practitioners or other |
---|
392 | | - | persons; |
---|
393 | | - | 25. “Medical gas” means those gases including those in liquid |
---|
394 | | - | state upon which the manufacturer or distributor has placed one of |
---|
395 | | - | several cautions, such as “Rx Only”, in compliance with federal l aw; |
---|
396 | | - | 26. “Medical gas order” means an order for medical gas issued |
---|
397 | | - | by a licensed prescriber; |
---|
398 | | - | 27. “Medical gas distributor” means a person licensed to |
---|
399 | | - | distribute, transfer, wholesale, deliver or sell medical gases on |
---|
400 | | - | drug orders to suppliers or oth er entities licensed to use, |
---|
401 | | - | administer or distribute medical gas and may also include a patient |
---|
402 | | - | or ultimate user; |
---|
403 | | - | 28. “Medical gas supplier” means a person who disp enses medical |
---|
404 | | - | gases on drug orders only to a pati ent or ultimate user; |
---|
405 | | - | 29. “Medicine” means any drug or combination of drugs which has |
---|
406 | | - | the property of curing, preventing, treating, diagnosing or |
---|
407 | | - | mitigating diseases, or which is used for that purpose; |
---|
408 | | - | 30. “Minor, nonchronic health condition” means a typically |
---|
409 | | - | short-term health condition that is generally m anaged with |
---|
410 | | - | noncontrolled drug therapies, min imal treatment, or sel f-care, and |
---|
411 | | - | is limited to the following: |
---|
| 398 | + | noncontrolled drug therapies, min imal treatment, or self -care, which |
---|
| 399 | + | includes the following: |
---|
| 401 | + | b. streptococcus, |
---|
| 402 | + | c. SARS-COV-2 or other respiratory illness, condition, or |
---|
| 403 | + | disease, |
---|
| 404 | + | d. lice, |
---|
| 405 | + | e. urinary tract infections , |
---|
| 406 | + | f. skin conditions, such as ringworm and athlete ’s foot, |
---|
| 407 | + | and |
---|
| 408 | + | g. other emerging and existing pub lic health threats |
---|
| 409 | + | identified by the State Department of Health if |
---|
| 410 | + | permitted by an order, rule, or regulation. |
---|
| 411 | + | 31. “Nonprescription drugs ” means medicines or drug s which are |
---|
| 412 | + | sold without a prescription and which are prepackaged for use by the |
---|
| 413 | + | consumer and labeled in accordance with the requirements of the |
---|
| 414 | + | statutes and regulations of this state and the federal gov ernment. |
---|
| 415 | + | Such items shall also include medical and d ental supplies and |
---|
| 416 | + | bottled or nonbulk chemicals which are sold or offered for sale to |
---|
| 417 | + | the general public if such articles or preparations meet the |
---|
| 418 | + | requirements of the Federal Food, Drug and Cosmetic Act, 21 |
---|
| 419 | + | U.S.C.A., Section 321 et seq.; |
---|
439 | | - | b. streptococcus, |
---|
440 | | - | c. SARS-CoV-2, |
---|
441 | | - | d. lice, and |
---|
442 | | - | e. other emerging and existing pub lic health threats |
---|
443 | | - | identified by the State Department of Health if |
---|
444 | | - | permitted by an order, rule, or regulation ; |
---|
445 | | - | 31. “Nonprescription drugs” means medicines or drug s which are |
---|
446 | | - | sold without a prescription and which are prepackaged for use by the |
---|
447 | | - | consumer and labeled in accordance with the requirements of the |
---|
448 | | - | statutes and regulations of this state and the federal gov ernment. |
---|
449 | | - | Such items shall also include medical and d ental supplies and |
---|
450 | | - | bottled or nonbulk chemicals which are sold or offered for sale to |
---|
451 | | - | the general public if such articles or preparations meet the |
---|
452 | | - | requirements of the Federal Food, Drug and Cosmetic Act, 21 |
---|
453 | | - | U.S.C.A., Section 321 et seq.; |
---|
454 | 447 | | 31. 32. “Outsourcing facility” including “virtual outsourcing |
---|
455 | 448 | | facility” means a facility at one geographic location or address |
---|
456 | 449 | | that: |
---|
457 | 450 | | a. is engaged in the compounding of sterile dru gs, |
---|
458 | 451 | | b. has elected to register as an outsourcing facility, |
---|
459 | 452 | | and |
---|
460 | 453 | | c. complies with all requirem ents of 21 U.S.C. 353b; |
---|
461 | 454 | | 32. 33. “Package” means the smallest individual saleable unit |
---|
462 | 455 | | of product for distribution by a manufacturer or repackager that is |
---|
| 456 | + | intended by the manufacturer for ultimate sale to the dispenser of |
---|
| 457 | + | such product. For the purposes of this paragraph, “individual |
---|
| 458 | + | saleable unit” means the smallest container of a product introduced |
---|
| 459 | + | into commerce by the manufacturer or repackager that is intended by |
---|
| 460 | + | the manufacturer or repackager for individual sale to a dispenser; |
---|
| 461 | + | 33. 34. “Person” means an individual, partnership, limited |
---|
| 462 | + | liability company, corporation or association, unless the context |
---|
| 463 | + | otherwise requires; |
---|
| 464 | + | 34. 35. “Pharmacist-in-charge” or “PIC” means the pharmacist |
---|
| 465 | + | licensed in this state responsible for th e management control of a |
---|
| 466 | + | pharmacy and all other aspects of the practice of pharmacy in a |
---|
| 467 | + | licensed pharmacy as defined by Section 353.18 of this title; |
---|
| 468 | + | 35. 36. “Pharmacy” means a place regularly licensed by the |
---|
| 469 | + | State Board of Pharmacy in which prescriptions, drugs, medicines, |
---|
| 470 | + | chemicals and poisons are compounded or dispensed or such place |
---|
489 | | - | intended by the manufacturer for ultimate sale to the dispenser of |
---|
490 | | - | such product. For the purposes of this paragraph, “individual |
---|
491 | | - | saleable unit” means the smallest container of a product introduced |
---|
492 | | - | into commerce by the manufacturer or repackager that is intended by |
---|
493 | | - | the manufacturer or repackager for individual sale to a dispenser; |
---|
494 | | - | 33. 34. “Person” means an individual, partnership, limited |
---|
495 | | - | liability company, corporation or association, unless the context |
---|
496 | | - | otherwise requires; |
---|
497 | | - | 34. 35. “Pharmacist-in-charge” or “PIC” means the pharmacist |
---|
498 | | - | licensed in this state responsible for the management control of a |
---|
499 | | - | pharmacy and all other aspects of the practice of pharmacy in a |
---|
500 | | - | licensed pharmacy as defined by Section 353.18 of this title; |
---|
501 | | - | 35. 36. “Pharmacy” means a place regularly licensed by the |
---|
502 | | - | State Board of Pharmacy in which prescriptions, drugs, medicines, |
---|
503 | | - | chemicals and poisons are compounded or dispensed or such place |
---|
504 | 498 | | where pharmacists practice the profession of pharmacy, or a pharmacy |
---|
505 | 499 | | operated by the Oklahoma Department of Veterans Affairs; |
---|
506 | 500 | | 36. 37. “Pharmacy technician”, “technician”, “Rx tech”, or |
---|
507 | 501 | | “tech” means a person issued a Technician permi t by the State Board |
---|
508 | 502 | | of Pharmacy to assist the pharmacist and perform nonjudgmental, |
---|
509 | 503 | | technical, manipulative, non-discretionary functions in the |
---|
510 | 504 | | prescription department under the immediate and direct supervi sion |
---|
511 | 505 | | of a pharmacist; |
---|
| 506 | + | 37. 38. “Poison” means any substance which when introduced into |
---|
| 507 | + | the body, either directly or by absorption, produces violent, morbid |
---|
| 508 | + | or fatal changes, or which destroys living tissue with which such |
---|
| 509 | + | substance comes into contact; |
---|
| 510 | + | 38. 39. “Practice of pharmacy” means: |
---|
| 511 | + | a. the interpretation and evaluation of prescription |
---|
| 512 | + | orders, |
---|
| 513 | + | b. the compounding, dispensing, administering and |
---|
| 514 | + | labeling of drugs and devices , except labeling by a |
---|
| 515 | + | manufacturer, repackager or distributor of |
---|
| 516 | + | nonprescription drugs a nd commercially packaged legend |
---|
| 517 | + | drugs and devices, |
---|
| 518 | + | c. the participation in drug selection and drug |
---|
| 519 | + | utilization reviews, |
---|
| 520 | + | d. the proper and safe storage of drugs and de vices and |
---|
| 521 | + | the maintenance of proper records thereof, |
---|
538 | | - | 37. 38. “Poison” means any substance which when introduced into |
---|
539 | | - | the body, either directly or by absorption, produces violent, morbid |
---|
540 | | - | or fatal changes, or which destroys living tissue with which such |
---|
541 | | - | substance comes into contact; |
---|
542 | | - | 38. 39. “Practice of pharmacy” means: |
---|
543 | | - | a. the interpretation and evaluation of prescription |
---|
544 | | - | orders, |
---|
545 | | - | b. the compounding, dispensing, administering and |
---|
546 | | - | labeling of drugs and devices, except labeling by a |
---|
547 | | - | manufacturer, repackager or distributor of |
---|
548 | | - | nonprescription drugs a nd commercially packaged legend |
---|
549 | | - | drugs and devices, |
---|
550 | | - | c. the participation in drug selection and drug |
---|
551 | | - | utilization reviews, |
---|
552 | | - | d. the proper and safe storage of drugs and devices and |
---|
553 | | - | the maintenance of proper records thereof, |
---|
554 | 549 | | e. the responsibility for advising by counseling and |
---|
555 | 550 | | providing information, where professionally necessary |
---|
556 | 551 | | or where regulated, of therapeutic values, content, |
---|
557 | 552 | | hazards and use of drugs and devices, |
---|
558 | 553 | | f. the offering or performing of those acts, services, |
---|
559 | 554 | | operations or transactions necessary in t he conduct, |
---|
560 | 555 | | operation, management and control of a pharmacy, or |
---|
| 556 | + | g. the ordering, performing, and interpreting of tests |
---|
| 557 | + | authorized by the United States Food and Drug |
---|
| 558 | + | Administration and waived under the federal Clinical |
---|
| 559 | + | Laboratory Improvement Amendments of 1988, and |
---|
| 560 | + | initiating drug therapy for minor, nonchronic health |
---|
| 561 | + | conditions, |
---|
| 562 | + | h. the dispensing of se lf-administered hormonal |
---|
| 563 | + | contraceptives and any nicotine replacement therapy |
---|
| 564 | + | product that is approved by the United States F ood and |
---|
| 565 | + | Drug Administration, or |
---|
| 566 | + | i. the provision of those acts or services that are |
---|
| 567 | + | necessary to provide pharmaceutical care; |
---|
| 568 | + | 39. 40. “Preparation” means an article which may or may not |
---|
| 569 | + | contain sterile produc ts compounded in a licensed pharmacy pursuant |
---|
| 570 | + | to the order of a licensed prescriber; |
---|
587 | | - | g. the ordering, performing, and interpreting of tests |
---|
588 | | - | for minor, nonchronic health conditio ns that meet the |
---|
589 | | - | requirements of Section 1 of this act and the |
---|
590 | | - | initiation of drug therapy for minor, nonchronic |
---|
591 | | - | health conditions, |
---|
592 | | - | h. the dispensing of se lf-administered hormonal |
---|
593 | | - | contraceptives as provided by Section 1 of this act, |
---|
594 | | - | or |
---|
595 | | - | i. the provision of those acts or services that are |
---|
596 | | - | necessary to provide pharmaceutical care; |
---|
597 | | - | 39. 40. “Preparation” means an article which may or may not |
---|
598 | | - | contain sterile produc ts compounded in a licensed pharmacy pursuant |
---|
599 | | - | to the order of a licensed prescriber; |
---|
600 | 598 | | 40. 41. “Prescriber” means a person licensed in this state who |
---|
601 | 599 | | is authorized to prescribe dangerous drugs within the scope of |
---|
602 | 600 | | practice of the person’s profession; |
---|
603 | 601 | | 41. 42. “Prescription” means and includes any order for drug or |
---|
604 | 602 | | medical supplies written or signed, or transmitted by word of mouth, |
---|
605 | 603 | | telephone or other means of co mmunication: |
---|
606 | 604 | | a. by a licensed prescriber, |
---|
607 | 605 | | b. under the supervision of an Okla homa licensed |
---|
608 | 606 | | practitioner, an Oklahoma licensed advanced practice |
---|
609 | 607 | | registered nurse Advanced Practice Registered Nurse or |
---|
610 | 608 | | an Oklahoma licensed physician assistant, or |
---|
| 609 | + | c. by an Oklahoma licensed wholesaler or distributor as |
---|
| 610 | + | authorized in Section 353.29.1 of this title; |
---|
| 611 | + | 42. 43. “Product” means a prescription drug in a finished |
---|
| 612 | + | dosage form for administration to a patient w ithout substantial |
---|
| 613 | + | further manufacturing, such as ca psules, tablets, and lyophilized |
---|
| 614 | + | products before reconstitution. “Product” Product does not include |
---|
| 615 | + | blood components intended for transfusion, radioactive drugs or |
---|
| 616 | + | biologics and medical gas; |
---|
| 617 | + | 43. 44. “Repackager”, including “virtual repackager”, means a |
---|
| 618 | + | person who owns or operates an establis hment that repacks and |
---|
| 619 | + | relabels a product or package for further sale or distribution |
---|
| 620 | + | without further transaction; |
---|
637 | | - | c. by an Oklahoma licensed wholesaler or distributor as |
---|
638 | | - | authorized in Section 353.29.1 of this title; |
---|
639 | | - | 42. 43. “Product” means a prescription drug in a finished |
---|
640 | | - | dosage form for administration to a patient w ithout substantial |
---|
641 | | - | further manufacturing, such as ca psules, tablets, and lyophilized |
---|
642 | | - | products before reconstitution. “Product” Product does not include |
---|
643 | | - | blood components intended for transfusion, radioactive drugs or |
---|
644 | | - | biologics and medical gas; |
---|
645 | | - | 43. 44. “Repackager”, including “virtual repackager”, means a |
---|
646 | | - | person who owns or operates an establishment that repacks and |
---|
647 | | - | relabels a product or package for further sale or distribution |
---|
648 | | - | without further transaction; |
---|
649 | 648 | | 44. 45. “Sterile drug” means a drug that is intended for |
---|
650 | 649 | | parenteral administration, an ophthalmic or oral inhalation drug in |
---|
651 | 650 | | aqueous format, or a drug that is required to be sterile under state |
---|
652 | 651 | | and federal law; |
---|
653 | 652 | | 45. 46. “Supervising physician” means an individual holding a |
---|
654 | 653 | | current license to practice as a physician from the State Board of |
---|
655 | 654 | | Medical Licensure and Supervision, pursuant to the prov isions of the |
---|
656 | 655 | | Oklahoma Allopathic Medical and Surgical Licensur e and Supervision |
---|
657 | 656 | | Act, or the State Board of Osteopathic Examiners, pursuant to t he |
---|
658 | 657 | | provisions of the Oklahoma Osteopathic Medicine Act, who supervises |
---|
659 | 658 | | an advanced practice registered nurs e Advanced Practice Registered |
---|
660 | 659 | | Nurse as defined in Section 567.3a of this title, and who is not in |
---|
| 660 | + | training as an intern, resident, or fellow . To be eligible to |
---|
| 661 | + | supervise an advanced practice registered nurs e Advanced Practice |
---|
| 662 | + | Registered Nurse, such physician shall remain in compliance with the |
---|
| 663 | + | rules promulgated by the State Boar d of Medical Licensure and |
---|
| 664 | + | Supervision or the State Board of O steopathic Examiners; |
---|
| 665 | + | 46. 47. “Supportive personnel” means technicians and auxil iary |
---|
| 666 | + | supportive persons who are regularly paid employees of a pharmacy |
---|
| 667 | + | who work and perform ta sks in the pharmacy as authorized by Section |
---|
| 668 | + | 353.18A of this title; |
---|
| 669 | + | 47. 48. “Third-party logistics provider” including “virtual |
---|
| 670 | + | third-party logistics provider ” means an entity that provides or |
---|
| 671 | + | coordinates warehousing, or other logistics services of a product in |
---|
687 | | - | training as an intern, resident, or fellow . To be eligible to |
---|
688 | | - | supervise an advanced practice registered nurse Advanced Practice |
---|
689 | | - | Registered Nurse, such physician shall remain in compliance with the |
---|
690 | | - | rules promulgated by the State Boar d of Medical Licensure and |
---|
691 | | - | Supervision or the State Board of O steopathic Examiners; |
---|
692 | | - | 46. 47. “Supportive personnel” means technicians and auxil iary |
---|
693 | | - | supportive persons who are regularly paid employees of a pharmacy |
---|
694 | | - | who work and perform tasks in the pharmacy as authorized by Section |
---|
695 | | - | 353.18A of this title; |
---|
696 | | - | 47. 48. “Third-party logistics provider” including “virtual |
---|
697 | | - | third-party logistics provider ” means an entity that provides or |
---|
698 | | - | coordinates warehousing, or other logistics services of a product in |
---|
699 | 699 | | interstate commerce on behalf of a manufacturer, wholesale |
---|
700 | 700 | | distributor, or dispenser of a product but does not take ownership |
---|
701 | 701 | | of the product, nor have res ponsibility to direct the sale or |
---|
702 | 702 | | disposition of the product. For the purposes of this paragraph, |
---|
703 | 703 | | “third-party logistics provider” third-party logistics provider does |
---|
704 | 704 | | not include shippers and the United States Postal Service; |
---|
705 | 705 | | 48. 49. “Wholesale distributor ” including “virtual wholesale |
---|
706 | 706 | | distributor” means a person other than a manufacturer, a |
---|
707 | 707 | | manufacturer’s co-licensed partner, a third-party logistics |
---|
708 | 708 | | provider, or repackager engaged in wh olesale distribution as defined |
---|
709 | 709 | | by 21 U.S.C. 353(e)(4) as amended by the Drug Supply Chain Security |
---|
710 | 710 | | Act; |
---|
| 711 | + | 49. 50. “County jail” means a facility operated by a county for |
---|
| 712 | + | the physical detention and correction of persons charged with, or |
---|
| 713 | + | convicted of, criminal o ffenses or ordinance violations or persons |
---|
| 714 | + | found guilty of civil or criminal contempt; |
---|
| 715 | + | 50. 51. “State correctional facility” means a facility or |
---|
| 716 | + | institution that houses a p risoner population under the jurisdiction |
---|
| 717 | + | of the Department of Corrections; |
---|
| 718 | + | 51. 52. “Unit dose package” means a package that contains a |
---|
| 719 | + | single dose drug with the name, strength, control number, and |
---|
| 720 | + | expiration date of that drug on the label; and |
---|
737 | | - | 49. 50. “County jail” means a facility operated by a county for |
---|
738 | | - | the physical detention and correction of persons charged with, or |
---|
739 | | - | convicted of, criminal o ffenses or ordinance violations or persons |
---|
740 | | - | found guilty of civil or criminal contempt; |
---|
741 | | - | 50. 51. “State correctional facility” means a facility or |
---|
742 | | - | institution that houses a p risoner population under the jurisdiction |
---|
743 | | - | of the Department of Corrections; |
---|
744 | | - | 51. 52. “Unit dose package” means a package that contains a |
---|
745 | | - | single dose drug with the name, strength, control number, and |
---|
746 | | - | expiration date of that drug on the label; and |
---|
| 751 | + | SECTION 2. NEW LAW A new section of law to be codified |
---|
| 752 | + | in the Oklahoma Statutes as Section 353.31 of Title 59, unless there |
---|
| 753 | + | is created a duplication i n numbering, reads as follows : |
---|
| 754 | + | A. A pharmacist may test or screen for a nd administer treatment |
---|
| 755 | + | for minor, nonchronic health conditions. |
---|
| 756 | + | B. A pharmacist who test s or screens for and treats minor, |
---|
| 757 | + | nonchronic health conditions provided by this secti on may use any |
---|
| 758 | + | test that may guide clinical decision-making, which the Centers for |
---|
| 759 | + | Medicare and Medicaid Services has determined qualifies for a waiver |
---|
| 760 | + | under the federal Clinical Laboratory Improvement Amendments of |
---|
| 761 | + | 1988, or the federal rules adopted there under, or any establish ed |
---|
| 762 | + | screening procedures that can safely be performed by a pharmacist. |
---|
| 763 | + | C. A pharmacist may dispense self-administered hormonal |
---|
| 764 | + | contraceptives and nicotine replacement therapy products under the |
---|
| 765 | + | protocol established pursuant to subsection D of this section, |
---|
| 766 | + | regardless of whether the patient has obtained a prescription. |
---|
| 767 | + | D. The State Board of Pharmacy shall adopt rules establishing a |
---|
| 768 | + | protocol for dispensing self-administered hormonal contraceptives |
---|
| 769 | + | and nicotine replacement therapy produc ts by January 1, 2024. |
---|
781 | | - | Passed the Senate the 22nd day of March, 2023. |
---|
782 | | - | |
---|
783 | | - | |
---|
784 | | - | |
---|
785 | | - | Presiding Officer of the Senate |
---|
786 | | - | |
---|
787 | | - | |
---|
788 | | - | Passed the House of Representatives the ____ day of __________, |
---|
789 | | - | 2023. |
---|
790 | | - | |
---|
791 | | - | |
---|
792 | | - | |
---|
793 | | - | Presiding Officer of the House |
---|
794 | | - | of Representatives |
---|
795 | | - | |
---|
| 798 | + | SECTION 4. It being immediately necessary for the prese rvation |
---|
| 799 | + | of the public peace, health or safety, an emergency is hereby |
---|
| 800 | + | declared to exist, by reason whereof this act shall t ake effect and |
---|
| 801 | + | be in full force from and after its passage and approval. |
---|
| 802 | + | COMMITTEE REPORT BY: COMMITTEE ON HEALTH AND HUMAN SERVICES |
---|
| 803 | + | February 9, 2023 - DO PASS AS AMENDED BY CS |
---|