Oklahoma 2022 Regular Session

Oklahoma House Bill HB3497 Compare Versions

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28-ENGROSSED HOUSE
29-BILL NO. 3497 By: McEntire of the House
29+HOUSE OF REPRESENTATIVES - FLOOR VERSION
3030
31- and
31+STATE OF OKLAHOMA
3232
33- Haste of the Senate
33+2nd Session of the 58th Legislature (2022)
34+
35+COMMITTEE SUBSTITUTE
36+FOR
37+HOUSE BILL NO. 3497 By: McEntire
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43+COMMITTEE SUBSTITUTE
3944
40-
41-
42-[ pharmacists - modifying pharmacists scope of
43-practice - effective date –
44- emergency ]
45+An Act relating to pharmacists; amending 59 O.S.
46+2021, Section 353.1, which relates to definitions;
47+modifying definitions; modifying pharmacists scope of
48+practice; allowing for testing or screening of
49+certain medical conditions; providing conditions;
50+providing guidelines; allowing for dispensing certain
51+drugs; directing the Board of Pharmacy to adopt
52+certain regulations; providing for codification;
53+providing an effective date ; and declaring an
54+emergency.
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4959 BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKL AHOMA:
5060 SECTION 1. AMENDATORY 59 O.S. 2021, Section 353.1, is
5161 amended to read as follows:
5262 Section 353.1 For the purposes of the Oklahoma Pharmacy Act:
5363 1. "Accredited program" means those seminars, classes,
5464 meetings, work projects, and other educational courses approved by
5565 the Board for purposes of continuing professional ed ucation;
5666 2. "Act" means the Oklahoma Pharmacy Act;
57-3. "Administer" means the direct application of a drug, whether
58-by injection, inhalation, ingestion or any ot her means, to the body
59-of a patient;
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94+3. "Administer" means the direct application of a drug, whether
95+by injection, inhalation, ingestion or any ot her means, to the body
96+of a patient;
8697 4. "Assistant pharmacist" means any person presently lic ensed
8798 as an assistant pharmacist in the State of Oklahoma by the Board
8899 pursuant to Section 353.10 of this title and for the purposes of the
89100 Oklahoma Pharmacy Act shall be considered the same as a pharmacist,
90101 except where otherwise specified;
91102 5. "Board" or "State Board" means the State Board of Pharmacy;
92103 6. "Certify" or "certification of a prescription " means the
93104 review of a filled prescription by a licensed pharm acist or a
94105 licensed practitioner with dispensing aut hority to confirm that the
95106 medication, labeling and packaging of the filled prescription are
96107 accurate and meet all requirements prescribed by state and federal
97108 law. For the purposes of this paragraph, "licensed practitioner"
98109 shall not include optometrists with dispensing authority;
99110 7. "Chemical" means any medicinal substance, whether simple or
100111 compound or obtained through the process of the science and art of
101112 chemistry, whether of organic or inorganic or igin;
102113 8. "Compounding" means the combining, admixin g, mixing,
103114 diluting, pooling, reconstituti ng or otherwise altering of a drug or
104115 bulk drug substance to create a drug. Compounding includes the
105116 preparation of drugs or devices in anticipation of prescript ion drug
106117 orders based on routine, regularly observed prescribing patterns;
107-9. "Continuing professional education" means professional,
108-pharmaceutical education in the general areas of the socioeconomic
109-and legal aspects of health care; the properties and a ctions of
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145+9. "Continuing professional education" means professional,
146+pharmaceutical education in the general areas of the socioeconomic
147+and legal aspects of health care; the properties and a ctions of
136148 drugs and dosage forms; and the etiology, characteristics and
137149 therapeutics of the di seased state;
138150 10. "Dangerous drug", "legend drug", "prescription drug" or "Rx
139151 Only" means a drug:
140152 a. for human use subject to 21 U.S.C. 353(b)(1), or
141153 b. is labeled "Prescription Only", or labeled with the
142154 following statement: "Caution: Federal law restr icts
143155 this drug except for use by or on the order of a
144156 licensed veterinarian ".";
145157 11. "Director" means the Executive Director of the State Board
146158 of Pharmacy unless context clearly indicates otherwise;
147159 12. "Dispense" or "dispensing" means the interpretation ,
148160 evaluation, and implementation of a prescription drug order,
149161 including the preparation and delivery of a drug or device to a
150162 patient or a patient 's agent in a suitable container appropriately
151163 labeled for subseque nt administration to, or use by, a patient .
152164 Dispense includes sell, distribute, leave with, give away, dispose
153165 of, deliver or supply;
154166 13. "Dispenser" means a retail pharmacy, hospital pharmacy, a
155167 group of chain pharmacies under common ownership and contr ol that do
156168 not act as a wholesale distribu tor, or any other person authorized
157-by law to dispense or administer prescription drugs, and the
158-affiliated warehouses or distributions of such entities under com mon
159-ownership and control that do not act as a whole sale distributor.
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196+by law to dispense or administer prescription drugs, and the
197+affiliated warehouses or distributions of such entities under com mon
198+ownership and control that do not act as a whole sale distributor.
186199 For the purposes of thi s paragraph, "dispenser" does not mean a
187200 person who dispenses only products to be used in animals in
188201 accordance with 21 U.S.C. 360b(a)(5);
189202 14. "Distribute" or "distribution" means the sale, purchase,
190203 trade, delivery, handling, storage, or receipt of a pro duct, and
191204 does not include the dispensing of a product pursuant to a
192205 prescription executed in accordance with 21 U.S.C. 353(b)(1) or the
193206 dispensing of a product a pproved under 21 U.S.C. 360b(b); provided,
194207 taking actual physical possession of a product or t itle shall not be
195208 required;
196209 15. "Doctor of Pharmacy" means a person licensed by the Board
197210 to engage in the practice of pharmacy. The terms "pharmacist",
198211 "D.Ph.", and "Doctor of Pharmacy" shall be interchangeable and shall
199212 have the same meaning wherever t hey appear in the Oklahoma Statutes
200213 and the rules promulgated by the Board;
201214 16. "Drug outlet" means all manufacturers, repackagers,
202215 outsourcing facilities, whole sale distributors, third -party
203216 logistics providers, pharmacies, and all other facilities which are
204217 engaged in dispensing, delivery, distribution or storage of
205218 dangerous drugs;
206-17. "Drugs" means all medicinal substances and preparations
207-recognized by the United States Pharmacopoeia and National
208-Formulary, or any revision thereof, and all substances and
209-preparations intended for external and/or internal use in the cure,
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246+17. "Drugs" means all medicinal substances and preparations
247+recognized by the United States Pharmacopoeia and National
248+Formulary, or any revision thereof, and all substances and
249+preparations intended for external and/or internal use in the cure,
236250 diagnosis, mitigation, treatment or prevention of disease in humans
237251 or animals and all su bstances and preparations, other than food,
238252 intended to affect the structure or any function o f the body of a
239253 human or animals;
240254 18. "Drug sample" means a unit of a prescription drug packaged
241255 under the authority and responsibility of the manufacturer that is
242256 not intended to be sold and is intended to promot e the sale of the
243257 drug;
244258 19. "Filled prescription" means a packaged prescription
245259 medication to which a label has been affixed which contains such
246260 information as is required by the Oklahoma Pharmacy Act;
247261 20. "Hospital" means any institution licensed as a h ospital by
248262 this state for the care and tre atment of patients, or a pharmacy
249263 operated by the Oklahoma Department of Veterans Affairs;
250264 21. "Licensed practitioner " means an allopathic physician,
251265 osteopathic physician, podiatric physician, dentist, veterinari an or
252266 optometrist licensed to practice and authorized to prescribe
253267 dangerous drugs within the scope of practice of such practitioner;
254268 22. "Manufacturer" or "virtual manufacturer " means with respect
255269 to a product:
256-a. a person that holds an application appro ved under 21
257-U.S.C. 355 or a license issue d under 42 U.S.C. 262 for
258-such product, or if such product is not the subject of
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297+a. a person that holds an application appro ved under 21
298+U.S.C. 355 or a license issue d under 42 U.S.C. 262 for
299+such product, or if such product is not the subject of
285300 an approved application or license, the person who
286301 manufactured the product,
287302 b. a co-licensed partner of the person described in
288-subparagraph a of this paragraph that obtains the
289-product directly from a person described in this
290-subparagraph or subparagraph a of this paragraph,
303+subparagraph a that obtains the product direct ly from
304+a person described in this subparagraph or
305+subparagraph a,
291306 c. an affiliate of a person described in subparagraph a
292-or b of this paragraph who receives the product
293-directly from a person described in this subparagraph
294-or in subparagraph a or b; of this paragraph, or
307+or b who receives the product directly from a person
308+described in this subparagraph or in s ubparagraph a or
309+b; or
295310 d. a person who contracts with another to manufacture a
296311 product;
297312 23. "Manufacturing" means the production, preparation,
298313 propagation, compounding, conversion or processing of a devi ce or a
299314 drug, either directly or indirectly by extra ction from substances of
300315 natural origin or independently by means of chemical or biological
301316 synthesis and includes any packaging or repackaging of the
302317 substances or labeling or relabeling of its container , and the
303318 promotion and marketing of such drugs or d evices. The term
304319 "manufacturing" also includes the preparation and promotion of
305-commercially available products from bulk compounds for resale by
306-licensed pharmacies, licensed practition ers or other persons;
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347+commercially available products from bulk compounds for resale by
348+licensed pharmacies, licensed practitioners or other pers ons;
333349 24. "Medical gas" means those gases including those in liquid
334350 state upon which the manuf acturer or distributor has placed one of
335351 several cautions, such as "Rx Only", in compliance with federal law;
336352 25. "Medical gas order" means an order for medical gas issued
337353 by a licensed prescriber;
338354 26. "Medical gas distributor" means a person licensed to
339355 distribute, transfer, wholesale, deliver or sell medical gases on
340356 drug orders to suppliers or other entities licensed to use,
341357 administer or distribute medical ga s and may also include a patient
342358 or ultimate user;
343359 27. "Medical gas supplier " means a person who dispenses medical
344360 gases on drug orders only to a patient or ultimate user;
345361 28. "Medicine" means any drug or combination of drugs which has
346362 the property of curing, preventing, treating, diagnosing or
347363 mitigating diseases, or which is used for that purpo se;
348364 29. "Nonprescription drugs" means medicines or drugs which are
349365 sold without a prescription and which are prepackaged for use by the
350366 consumer and labeled in a ccordance with the requirements of the
351367 statutes and regulations of this state and the federal government.
352368 Such items shall also include medical and dental supplies and
353369 bottled or nonbulk chemicals which are sold or offered for sale to
354370 the general public i f such articles or preparations meet the
355-requirements of the Federal Food, Drug and Cosmetic A ct, 21
356-U.S.C.A., Section 321 et seq.;
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398+requirements of the Federal Food, Drug and Cosmetic A ct, 21
399+U.S.C.A., Section 321 et seq.;
383400 30. "Outsourcing facility", including "virtual outsourcing
384401 facility" means a facility at one geographic location or address
385402 that:
386403 a. is engaged in the compounding of sterile d rugs,
387404 b. has elected to register as an out sourcing facility,
388405 and
389406 c. complies with all requirements of 21 U.S.C. 353b;
390407 31. "Package" means the smallest individual saleable unit of
391408 product for distribution by a manufacturer or repackager that is
392409 intended by the manufacturer for ultimate sale to the dispenser of
393410 such product. For the purposes of this paragraph, "individual
394411 saleable unit" means the smallest container of a product introduced
395412 into commerce by the manufacturer or repackager that is intended by
396413 the manufacturer or repackager for individu al sale to a dispenser;
397414 32. "Person" means an individual, partnership, limited
398415 liability company, corporation or association, unless the context
399416 otherwise requires;
400417 33. "Pharmacist-in-charge" or "PIC" means the pharmacist
401418 licensed in this state responsib le for the management control of a
402419 pharmacy and all other aspects of the practice of pharmacy in a
403420 licensed pharmacy as defined by Section 353.18 of this title;
404-34. "Pharmacy" means a place regularly licensed by t he Board of
405-Pharmacy in which prescription s, drugs, medicines, chemicals and
406-poisons are compounded or dispensed or such place where pharmacists
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448+34. "Pharmacy" means a place regularly licensed by t he Board of
449+Pharmacy in which prescription s, drugs, medicines, chemicals and
450+poisons are compounded or dispensed or such place where pharmacists
433451 practice the profession of pharmacy, or a pharmacy operated by the
434452 Oklahoma Department of Veterans Affairs;
435453 35. "Pharmacy technician", "technician", "Rx tech", or "tech"
436454 means a person issued a Technician permit by the State Board of
437455 Pharmacy to assist the pharmacist and perform nonjudgmental,
438456 technical, manipulative, non-discretionary functions in the
439457 prescription department under the immediate and direc t supervision
440458 of a pharmacist;
441459 36. "Poison" means any substance which when introduced into the
442460 body, either directly or by absorption, produces violent, morbid o r
443461 fatal changes, or which destroys living tissue wit h which such
444462 substance comes into contact;
445463 37. "Practice of pharmacy" means:
446464 a. the interpretation and evaluation of prescription
447465 orders,
448466 b. the compounding, dispensing, administering and
449467 labeling of drugs and devices, except labeling by a
450468 manufacturer, repackager or distributor of
451469 nonprescription drugs and commercially packaged legend
452470 drugs and devices,
453-c. the participation in drug selection and drug
454-utilization reviews,
455-d. the proper and safe storage of drugs and devices and
456-the maintenance of proper rec ords thereof,
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498+c. the participation in drug selection and drug
499+utilization reviews,
500+d. the proper and safe storage of drugs and devices and
501+the maintenance of proper rec ords thereof,
483502 e. the responsibility for ad vising by counseling and
484503 providing information, where professionally necessary
485504 or where regulated, of therapeutic values, content,
486505 hazards and use of drugs and de vices,
487506 f. the offering or performing of those acts, services,
488507 operations or transactions neces sary in the conduct,
489508 operation, management and control of a pharmacy, or
490509 g. the provision of those acts or services that are
491510 necessary to provide pharmaceutical c are ordering,
492511 performing, and evaluating laboratory and clinical
493512 drug therapy related tests and initiating drug therapy
494-for minor, nonchronic health conditions, or
495-h. the provision of those acts or ser vices that are
513+for minor, nonchronic health conditions,
514+h. the prescribing and dispensing of self-administered
515+hormonal contraceptives and any nicotine replacement
516+therapy product that is approved by the U.S. Food and
517+Drug Administration, or
518+i. the provision of those acts or ser vices that are
496519 necessary to provide pharmaceutical ca re;
497-38. "Preparation" means an article which may or may not contain
498-sterile products compounded in a licensed pharmacy pursuan t to the
499-order of a licensed prescriber;
500-39. "Prescriber" means a person licensed in this state who is
501-authorized to prescribe dangerous drugs within the scope of practice
502-of the person's profession;
503-40. "Prescription" means and includes any order for dr ug or
504-medical supplies written or signed, or transmitted by word of mouth,
505-telephone or other means of communicati on:
506-a. by a licensed prescriber,
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547+38. "Preparation" means an article which may or may not contain
548+sterile products compounded in a licensed pharmacy pursuan t to the
549+order of a licensed prescriber;
550+39. "Prescriber" means a person licensed in this state who is
551+authorized to prescribe dangerous drugs within the scope of practice
552+of the person's profession;
553+40. "Prescription" means and includes any order for dr ug or
554+medical supplies written or signed, or transmitted by word of mouth,
555+telephone or other means of communication:
556+a. by a licensed prescriber,
533557 b. under the supervision of an Oklahoma licensed
534558 practitioner, an Oklahoma licensed advanced practice
535559 registered nurse or an Oklahoma licensed physicia n
536560 assistant, or
537561 c. by an Oklahoma licensed wholesaler or distributor as
538562 authorized in Section 353.29.1 of this title;
539563 41. "Product" means a prescription drug in a finished dosage
540564 form for administration to a patie nt without substantial further
541565 manufacturing, such as capsules, tablets, and lyophilized products
542566 before reconstitution. "Product" does not include blood components
543567 intended for transfusion, radioactive drugs or biologics and medi cal
544568 gas;
545569 42. "Repackager", including "virtual repackager", means a
546570 person who owns or operates an es tablishment that repacks and
547-relabels a product or package for further sale or distribution
548-without further transaction;
549-43. "Sterile drug" means a drug that is intended for paren teral
550-administration, an ophthalmic or ora l inhalation drug in aqueous
551-format, or a drug that is required to be st erile under state and
552-federal law;
553-44. "Supervising physician " means an individual holdin g a
554-current license to prac tice as a physician from the State Board of
555-Medical Licensure and S upervision, pursuant to the provis ions of the
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
599+without further transaction;
600+43. "Sterile drug" means a drug that is intended for paren teral
601+administration, an ophthalmic or ora l inhalation drug in aqueous
602+format, or a drug that is required to be sterile under state and
603+federal law;
604+44. "Supervising physician " means an individual holdin g a
605+current license to prac tice as a physician from the State Board of
606+Medical Licensure and S upervision, pursuant to the provis ions of the
607+Oklahoma Allopathic Medical and Surgical Licensure and Supervision
583608 Act, or the State Board of Osteopathic Examiners, pursuant to the
584609 provisions of the Oklahoma Osteopat hic Medicine Act, who supervises
585610 an advanced practice registered nurse as de fined in Section 567.3a
586611 of this title, and who is not in training as an intern, resident, or
587612 fellow. To be eligible to supervis e an advanced practice regi stered
588613 nurse, such physician shall remain in compliance with the ru les
589614 promulgated by the State Board of Medical Licensure and Supervision
590615 or the State Board of Osteopathic Examiners;
591616 45. "Supportive personnel " means technicians and auxiliary
592617 supportive persons who are regularly paid employees of a pharmacy
593618 who work and perform tasks in the pharmacy as a uthorized by Section
594619 353.18A of this title;
595620 46. "Third-party logistics provider ", including "virtual third-
596621 party logistics prov ider" means an entity that provides or
597-coordinates warehousing, or other logistics services of a product in
598-interstate commerce on behalf of a manufacturer, wholesale
599-distributor, or dispenser of a produ ct but does not take ownership
600-of the product, nor ha ve responsibility to direct the sale or
601-disposition of the product. For the purposes of this paragraph,
602-"third-party logistics provider" does not include shippers an d the
603-United States Postal Service;
604-47. "Wholesale distributor ", including "virtual wholesale
605-distributor" means a person other than a manufa cturer, a
606-manufacturer's co-licensed partner, a third-party logistics
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649+coordinates warehousing, or other logistics services of a product in
650+interstate commerce on behalf of a manufacturer, wholesale
651+distributor, or dispenser of a product but does not take ownership
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
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
633659 provider, or repackager engaged in wholesale distribution as defined
634660 by 21 U.S.C. 353(e)(4) as amended by the Drug Supply Chain Securi ty
635661 Act;
636662 48. "County jail" means a facility operated by a county for the
637663 physical detention an d correction of persons charged wi th, or
638664 convicted of, criminal offenses or ordinance violations or persons
639665 found guilty of civil or criminal contempt;
640666 49. "State correctional facility " means a facility or
641667 institution that houses a prisoner population und er the jurisdiction
642668 of the Department of Corrections;
643669 50. "Unit dose package" means a package that contains a single
644670 dose drug with the name, strength, control n umber, and expiration
645671 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
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:
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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:
683710 1. Influenza;
684711 2. Streptococcus;
685712 3. SARS-COV-2 or other respiratory ill ness, condition, or
686713 disease;
687714 4. Lice;
688715 5. Urinary tract infection;
689716 6. Skin conditions, such as ringworm and athlete's foot; and
690717 7. Minor, uncomplicated inf ections.
691718 B. A pharmacist who tests or screens for and treats minor,
692719 nonchronic health conditions under this section may use a ny test
693720 that may guide clinical decision making which the Centers for
694721 Medicare and Medicaid Services has determined qualifies for a waiver
695722 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.
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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.
732760 SECTION 4. It being immediately necessary for the preservation
733761 of the public peace, health or safety, an emergency is hereby
734762 declared to exist, by reason whereof thi s act shall take effect and
735763 be in full force from and after its p assage and approval.
736-Passed the House of Representatives the 23rd day of March, 2022.
737764
738-
739-
740-
741- Presiding Officer of the House
742- of Representatives
743-
744-
745-Passed the Senate the ___ day of __________, 2022.
746-
747-
748-
749-
750- Presiding Officer of the Senate
751-
752-
765+COMMITTEE REPORT BY: COMMITTEE ON PUBLIC HEALTH, dated 03/02/2022 -
766+DO PASS, As Amended.