Oklahoma 2023 Regular Session

Oklahoma Senate Bill SB931 Compare Versions

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28-ENGROSSED SENATE
29-BILL NO. 931 By: Garvin of the Senate
30-
31- and
32-
33- Marti of the House
29+SENATE FLOOR VERSION
30+February 9, 2023
3431
3532
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
5136
5237
5338
5439
5540
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+
5659 BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
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;
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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;
11395 2. “Act” means the Oklahoma Pharmacy Act;
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
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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
162145 preparation of drugs or devices in anticipation of prescript ion drug
163146 orders based on routine, regularly observed pre scribing patterns;
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;
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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;
211195 13. “Dispenser” means a retail pharmacy, hospital pharmacy, a
212196 group of chain pharmacies un der common ownership and control th at do
213197 not act as a wholesale distributor, or any other person authorized
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
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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
261246 engaged in dispensing, delivery, distribution or storage of
262247 dangerous drugs;
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
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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
311297 optometrist licensed to practice and authorize d to prescribe
312298 dangerous drugs within the scope of practice of such practitione r;
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
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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
361348 substances or labeling or relabeling of its container, and the
362349 promotion and marketing of such drug s or devices. The term
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
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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:
412400 a. influenzas,
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.;
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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.;
454447 31. 32. “Outsourcing facility” including “virtual outsourcing
455448 facility” means a facility at one geographic location or address
456449 that:
457450 a. is engaged in the compounding of sterile dru gs,
458451 b. has elected to register as an outsourcing facility,
459452 and
460453 c. complies with all requirem ents of 21 U.S.C. 353b;
461454 32. 33. “Package” means the smallest individual saleable unit
462455 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
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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
504498 where pharmacists practice the profession of pharmacy, or a pharmacy
505499 operated by the Oklahoma Department of Veterans Affairs;
506500 36. 37. “Pharmacy technician”, “technician”, “Rx tech”, or
507501 “tech” means a person issued a Technician permi t by the State Board
508502 of Pharmacy to assist the pharmacist and perform nonjudgmental,
509503 technical, manipulative, non-discretionary functions in the
510504 prescription department under the immediate and direct supervi sion
511505 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,
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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,
554549 e. the responsibility for advising by counseling and
555550 providing information, where professionally necessary
556551 or where regulated, of therapeutic values, content,
557552 hazards and use of drugs and devices,
558553 f. the offering or performing of those acts, services,
559554 operations or transactions necessary in t he conduct,
560555 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;
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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;
600598 40. 41. “Prescriber” means a person licensed in this state who
601599 is authorized to prescribe dangerous drugs within the scope of
602600 practice of the person’s profession;
603601 41. 42. “Prescription” means and includes any order for drug or
604602 medical supplies written or signed, or transmitted by word of mouth,
605603 telephone or other means of co mmunication:
606604 a. by a licensed prescriber,
607605 b. under the supervision of an Okla homa licensed
608606 practitioner, an Oklahoma licensed advanced practice
609607 registered nurse Advanced Practice Registered Nurse or
610608 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;
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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;
649648 44. 45. “Sterile drug” means a drug that is intended for
650649 parenteral administration, an ophthalmic or oral inhalation drug in
651650 aqueous format, or a drug that is required to be sterile under state
652651 and federal law;
653652 45. 46. “Supervising physician” means an individual holding a
654653 current license to practice as a physician from the State Board of
655654 Medical Licensure and Supervision, pursuant to the prov isions of the
656655 Oklahoma Allopathic Medical and Surgical Licensur e and Supervision
657656 Act, or the State Board of Osteopathic Examiners, pursuant to t he
658657 provisions of the Oklahoma Osteopathic Medicine Act, who supervises
659658 an advanced practice registered nurs e Advanced Practice Registered
660659 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
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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
699699 interstate commerce on behalf of a manufacturer, wholesale
700700 distributor, or dispenser of a product but does not take ownership
701701 of the product, nor have res ponsibility to direct the sale or
702702 disposition of the product. For the purposes of this paragraph,
703703 “third-party logistics provider” third-party logistics provider does
704704 not include shippers and the United States Postal Service;
705705 48. 49. “Wholesale distributor ” including “virtual wholesale
706706 distributor” means a person other than a manufacturer, a
707707 manufacturer’s co-licensed partner, a third-party logistics
708708 provider, or repackager engaged in wh olesale distribution as defined
709709 by 21 U.S.C. 353(e)(4) as amended by the Drug Supply Chain Security
710710 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
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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
747748 52. 53. “Unit of issue package” means a package that provides
748749 multiple doses of the same drug, but each drug is individually
749750 separated and includes the name, lot number, and expirat ion date.
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.
750770 SECTION 3. This act shall become effective July 1, 2023.
751-SECTION 4. It being immediately necessary for the prese rvation
752-of the public peace, health or safety, an emergency is hereby
753-declared to exist, by reason whereof this act shall t ake effect and
754-be in full force from and after its passage and approval.
755771
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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