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Oklahoma House Bill HB1655

Oklahoma 2023 Regular Session

Oklahoma House Bill HB1655 Compare Versions

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2828 STATE OF OKLAHOMA
2929
3030 1st Session of the 59th Legislature (2023)
3131
3232 HOUSE BILL 1655 By: McEntire
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3838 AS INTRODUCED
3939
4040 An Act relating to professions and occupations;
4141 amending 59 O.S. 2021, Section 353.1, as amended by
4242 Section 6, Chapter 288, O.S.L. 2022 (59 O.S. Supp.
4343 2022, Section 353.1), which relates to the Oklahoma
4444 Pharmacy Act, modifying definition; authorizing
4545 pharmacists to screen and test for certain
4646 conditions; providing for adoption of regulations;
4747 providing for codification; and providing an
4848 effective date.
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5454 BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
5555 SECTION 1. AMENDATORY 59 O.S. 2021, Section 353.1, as
5656 amended by Section 6, Chapter 288, O.S.L. 2022 (59 O.S. Supp . 2022,
5757 Section 353.1), is amended to read as follows:
5858 Section 353.1 For the purposes of the Ok lahoma Pharmacy Act:
5959 1. "Accredited program" means those seminars, classes,
6060 meetings, work projects, and oth er educational courses approved by
6161 the Board for purposes of continuing professional e ducation;
6262 2. "Act" means the Oklahoma Pharmacy Act;
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8989 3. "Administer" means the direct application of a drug, whether
9090 by injection, inhalation, ingestion or any other m eans, to the body
9191 of a patient;
9292 4. "Assistant pharmacist" means any person presently licensed
9393 as an assistant pharmacist in the State of Oklahoma by the Board
9494 pursuant to Section 353.10 of this title and for the purposes of the
9595 Oklahoma Pharmacy Act shal l be considered the same as a pharmacist,
9696 except where otherwise specified;
9797 5. "Board" or "State Board" means the State Board of Pharmacy;
9898 6. "Certify" or "certification of a prescription " means the
9999 review of a filled prescription by a licensed pharmac ist or a
100100 licensed practitioner with dispensing authori ty to confirm that the
101101 medication, labeling and packaging of the filled prescription are
102102 accurate and meet all requirements prescribed by state and federal
103103 law. For the purposes of this paragraph, "licensed practitioner"
104104 shall not include optometrists wit h dispensing authority;
105105 7. "Chemical" means any medicinal substance, whether simple or
106106 compound or obtained through the process of the science and art of
107107 chemistry, whether of organic or inorganic ori gin;
108108 8. "Compounding" means the combining, admixing, m ixing,
109109 diluting, pooling, reconstitut ing or otherwise altering of a drug or
110110 bulk drug substance to create a drug. Compounding includes the
111111 preparation of drugs or devices in anticipation of prescript ion drug
112112 orders based on routine, regularly observed pre scribing patterns;
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139139 9. "Continuing professional education" means professional,
140140 pharmaceutical education in the general areas of the socioeconomic
141141 and legal aspects of health care; the properties and actions of
142142 drugs and dosage forms; and the etiology, char acteristics and
143143 therapeutics of the d iseased state;
144144 10. "Dangerous drug", "legend drug", "prescription drug" or "Rx
145145 Only" means a drug:
146146 a. for human use subject to 21 U.S.C. 353(b)(1), or
147147 b. is labeled "Prescription Only", or labeled with the
148148 following statement: "Caution: Federal law restricts
149149 this drug except for use by or on the order of a
150150 licensed veterinarian.";
151151 11. "Director" means the Executive Director of the State Board
152152 of Pharmacy unless context clearly indicates otherwise;
153153 12. "Dispense" or "dispensing" means the interpretation ,
154154 evaluation, and implementation of a prescription drug order
155155 including the preparation and delivery of a drug or device to a
156156 patient or a patient 's agent in a suitable container appropria tely
157157 labeled for subsequent ad ministration to, or use by, a patient .
158158 Dispense includes sell, distribute, leave with, give away, dispose
159159 of, deliver or supply;
160160 13. "Dispenser" means a retail pharmacy, hospital pharmacy, a
161161 group of chain pharmacies under c ommon ownership and control th at do
162162 not act as a wholesale distribut or, or any other person authorized
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189189 by law to dispense or adm inister prescription drugs, and the
190190 affiliated warehouses or distributions of such entities und er common
191191 ownership and control t hat do not act as a wholesale distributor.
192192 For the purposes of this paragraph, "dispenser" does not mean a
193193 person who dispenses only products to be used in animals in
194194 accordance with 21 U.S.C. 360b(a)(5);
195195 14. "Distribute" or "distribution" means the sale, purchase,
196196 trade, delivery, handling, storage, or receipt of a prod uct, and
197197 does not include the dispensing of a product pursua nt to a
198198 prescription executed in accordance with 21 U.S.C. 353(b)(1) or the
199199 dispensing of a product approved under 21 U.S.C. 360 b(b); provided,
200200 taking actual physical possession of a product or ti tle shall not be
201201 required;
202202 15. "Doctor of Pharmacy" means a person licensed by the Board
203203 to engage in the practice of pharmacy . The terms "pharmacist",
204204 "D.Ph.", and "Doctor of Pharmacy" shall be interchangeable and s hall
205205 have the same meaning wherever th ey appear in the Oklahoma Statutes
206206 and the rules promulgated by the Board;
207207 16. "Drug outlet" means all manufacturers, repackagers,
208208 outsourcing faciliti es, wholesale distributors, third -party
209209 logistics providers, pharm acies, and all other facilities which are
210210 engaged in dispensing, delivery, distribution or storage of
211211 dangerous drugs;
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238238 17. "Drugs" means all medicinal substances and preparations
239239 recognized by the United States Pharmacopoeia and National
240240 Formulary, or any revision thereof, and all substances and
241241 preparations intended for external and/or internal use i n the cure,
242242 diagnosis, mitigation, treatment or prevention of disease in humans
243243 or animals and all substances and preparations, other than food,
244244 intended to affect the structure or any function of the body of a
245245 human or animals;
246246 18. "Drug sample" means a unit of a prescription drug packaged
247247 under the authority and responsibility of the manufac turer that is
248248 not intended to be sold and is intended to promote the sale of the
249249 drug;
250250 19. "Durable medical equipment" has the same meaning as
251251 provided by Section 2 375.2 of this act title;
252252 20. "Filled prescription" means a packaged prescription
253253 medication to which a label has been affixed which contain s such
254254 information as is required by the Oklahoma Pharmacy Act;
255255 21. "Hospital" means any institution licensed as a hospital by
256256 this state for the care and treatment of patients, or a pharmacy
257257 operated by the Oklahoma Department of Veterans Affairs;
258258 22. "Licensed practitioner" means an allopathic physician,
259259 osteopathic physician, podiatric physician, dentist, veterinarian or
260260 optometrist licensed to practice and authorize d to prescribe
261261 dangerous drugs within the scope of practice of such practitione r;
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288288 23. "Manufacturer" or "virtual manufacturer" means with respect
289289 to a product:
290290 a. a person that holds an application appr oved under 21
291291 U.S.C. 355 or a license issued under 42 U.S.C. 262 for
292292 such product, or if such product is not the subject of
293293 an approved application or license, the person who
294294 manufactured the prod uct,
295295 b. a co-licensed partner of the person described in
296296 subparagraph a that obtains the product directly from
297297 a person described in this subpa ragraph or
298298 subparagraph a of this paragraph,
299299 c. an affiliate of a person described in subparagraph a
300300 or b who receives the product directly from a person
301301 described in this subparagraph or in subparagraph a or
302302 b of this paragraph, or
303303 d. a person who contracts with another to manufacture a
304304 product;
305305 24. "Manufacturing" means the production, preparation,
306306 propagation, compounding, conversion or processing of a device or a
307307 drug, either directly or indirectly by extraction from substances of
308308 natural origin or independently by means of chemic al or biological
309309 synthesis and includes any packaging or repackaging of the
310310 substances or labeling or relabeling of its container, and the
311311 promotion and marketing of such drug s or devices. The term
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338338 "manufacturing" also includes the preparation and promoti on of
339339 commercially available produc ts from bulk compounds for resale by
340340 licensed pharmacies, licensed practitioners or other persons;
341341 25. "Medical gas" means those gases, including those in liquid
342342 state upon which the manufacturer or distributor has placed one of
343343 several cautions, such as "Rx Only", in compliance with federal law;
344344 26. "Medical gas order" means an order for medical gas issued
345345 by a licensed prescriber;
346346 27. "Medical gas distributor " means a person licensed to
347347 distribute, transfer, wholesale, deliver or sell medical gases on
348348 drug orders to suppliers or other entities licensed to use,
349349 administer or distribute medical gas and may also include a patient
350350 or ultimate user;
351351 28. "Medical gas supplier" means a person who dispe nses medical
352352 gases on drug orders only to a patient or ultimate user;
353353 29. "Medicine" means any drug or combination of drugs whic h has
354354 the property of curing, preventing, treating , diagnosing or
355355 mitigating diseases, or which is used for that purpose;
356356 30. "Nonprescription drugs " means medicines or drug s which are
357357 sold without a prescription and which are prepackaged for use by the
358358 consumer and labeled in accordance with the req uirements of the
359359 statutes and regulati ons of this state and the federal gov ernment.
360360 Such items shall also include medical and d ental supplies and
361361 bottled or nonbulk chemicals which are sold or offered for sale to
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388388 the general public if such articles or pre parations meet the
389389 requirements of the Federal Food, Drug and Cosmetic Act, 21
390390 U.S.C.A., Section 321 et seq.;
391391 31. "Outsourcing facility" including "virtual outsourcing
392392 facility" means a facility at one geograp hic location or address
393393 that:
394394 a. is engaged in the compounding of sterile dru gs,
395395 b. has elected to register as an outsourcing facility,
396396 and
397397 c. complies with all requirem ents of 21 U.S.C. 353b;
398398 32. "Package" means the smallest individual saleable unit of
399399 product for distribution by a manufact urer or repackager that is
400400 intended by the manufacturer for ultimate s ale to the dispenser of
401401 such product. For the purposes of this paragraph, "individual
402402 saleable unit" means the smallest container of a product intro duced
403403 into commerce by the manufactur er or repackager that is intended by
404404 the manufacturer or repackager fo r individual sale to a dispenser;
405405 33. "Person" means an individual, partnershi p, limited
406406 liability company, corporation or association, unless the c ontext
407407 otherwise requires;
408408 34. "Pharmacist-in-charge" or "PIC" means the pharmacist
409409 licensed in this state responsible for th e management control of a
410410 pharmacy and all other aspects of the practice of pharmacy in a
411411 licensed pharmacy as defined by Section 353.18 of this title;
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438438 35. "Pharmacy" means a place regularly licensed by the Board of
439439 Pharmacy in which prescriptions, drugs, medicines, chemicals and
440440 poisons are compounded or dispe nsed or such place where pharmacists
441441 practice the profession of pharmacy, or a pharmacy operated b y the
442442 Oklahoma Department of V eterans Affairs;
443443 36. "Pharmacy technician", "technician", "Rx tech", or "tech"
444444 means a person issued a Technician pharmacy technician permit by the
445445 State Board of Pharmacy to assist the pharmacist and perform
446446 nonjudgmental, technical, manipu lative, non-discretionary functions
447447 in the prescription department under the immediate and direct
448448 supervision of a pharmacist;
449449 37. "Poison" means any substance which when introduced into the
450450 body, either directly or by absorption, pro duces violent, morbid or
451451 fatal changes, or wh ich destroys living tissue with which such
452452 substance comes into contact;
453453 38. "Practice of pharmacy" means:
454454 a. the interpretation and evaluation of prescription
455455 orders,
456456 b. the compounding, dispensing, administer ing and
457457 labeling of drugs and devices, except labeling by a
458458 manufacturer, repackager or distributor of
459459 nonprescription drugs a nd commercially packaged legend
460460 drugs and devices,
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487487 c. the participation in drug selection and drug
488488 utilization reviews,
489489 d. the proper and safe storage of drugs and de vices and
490490 the maintenance of proper r ecords thereof,
491491 e. the responsibility for advising by counseling and
492492 providing information, where professionally necessary
493493 or where regulated, of therapeutic values, content,
494494 hazards and use of drugs and devices,
495495 f. the offering or performing of those ac ts, services,
496496 operations or transactions necessary in t he conduct,
497497 operation, management and control of a pharmacy, or
498498 g. ordering, performing, and interpreting tests
499499 authorized by the United States Food and Drug
500500 Administration and waived under the federal Clinical
501501 Laboratory Improvement Amendments of 1988 and
502502 initiating drug therapy for minor, nonch ronic health
503503 conditions,
504504 h. the dispensing of self-administered hormonal
505505 contraceptives and any nicotine replacement therapy
506506 product that is approved by the United States Food and
507507 Drug Administration, or
508508 i. the provision of those acts or services that are
509509 necessary to provide pharmaceutical care;
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536536 39. "Preparation" means an article which may or may not contain
537537 sterile products compounded in a licensed pharmacy pursuant to the
538538 order of a licensed prescriber;
539539 40. "Prescriber" means a person licensed in this state who is
540540 authorized to prescribe dangerous drugs within the scope of practice
541541 of the person's profession;
542542 41. "Prescription" means and includes any order for drug or
543543 medical supplies written or signed, or transmitted by word of mouth,
544544 telephone or other means of communication:
545545 a. by a licensed prescriber,
546546 b. under the supervision of an Oklahoma licensed
547547 practitioner, an Oklahoma licensed advanced practice
548548 registered nurse or an Oklahoma licensed physician
549549 assistant, or
550550 c. by an Oklahoma licensed wholesaler or dist ributor as
551551 authorized in Section 353.29.1 of this title;
552552 42. "Product" means a prescription drug in a finished dosage
553553 form for administration to a patient w ithout substantial further
554554 manufacturing, such as ca psules, tablets, and lyophilized products
555555 before reconstitution. "Product" does not include blood components
556556 intended for transfusion, radioactive drugs or biologics and med ical
557557 gas;
558558 43. "Repackager", including "virtual repackager", means a
559559 person who owns or operates an establishment that repac ks and
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586586 relabels a product or package for further sale or distribution
587587 without further transaction;
588588 44. "Sterile drug" means a drug that is intended for p arenteral
589589 administration, an ophthalmic or oral inhalation drug in aqueous
590590 format, or a drug that is required to be sterile under state and
591591 federal law;
592592 45. "Supervising physician " means an individual holding a
593593 current license to practice as a physician from the State Board of
594594 Medical Licensure and Supervision, pursuant to the provisions of the
595595 Oklahoma Allopathic Medical and Surgical Licensure and Supervision
596596 Act, or the State Board of Osteopathic Examiners, pursuant to t he
597597 provisions of the Oklahoma Osteopathic Medicine Act, who supervises
598598 an advanced practice registered nurse as defined in Secti on 567.3a
599599 of this title, and who is not in training as an intern, resident, or
600600 fellow. To be eligible to supervise an advanced practice registered
601601 nurse, such physician shall remain in compliance with the rules
602602 promulgated by the State Board of Medical Li censure and Supervision
603603 or the State Board of Osteopathic Examiners;
604604 46. "Supportive personnel " means technicians and auxil iary
605605 supportive persons who are regularly paid employees of a pharma cy
606606 who work and perform ta sks in the pharmacy as authorized by Section
607607 353.18A of this title;
608608 47. "Third-party logistics provider" including "virtual third-
609609 party logistics provider " means an entity that provides or
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636636 coordinates warehousing, or other logi stics services of a product in
637637 interstate commerce on beh alf of a manufacturer, wholesale
638638 distributor, or dispenser of a product but does not take ownership
639639 of the product, nor have res ponsibility to direct the sale or
640640 disposition of the product. For the purposes of this paragraph,
641641 "third-party logistics provid er" does not include shippers and the
642642 United States Postal Service;
643643 48. "Wholesale distributor " including "virtual wholesale
644644 distributor" means a person other than a manufacturer, a
645645 manufacturer's co-licensed partner, a thir d-party logistics
646646 provider, or repackager engaged in wholesale distribution as defined
647647 by 21 U.S.C. 353(e)(4) as amended by the Drug Supply Chain Security
648648 Act;
649649 49. "County jail" means a facility operated by a county for the
650650 physical detention and correct ion of persons charged with, or
651651 convicted of, criminal offenses or ordinance violations or persons
652652 found guilty of civil or criminal contempt;
653653 50. "State correctional facility " means a facility or
654654 institution that houses a p risoner population under the j urisdiction
655655 of the Department of Corrections;
656656 51. "Unit dose package" means a package that contains a single
657657 dose drug with the name, strength, control number, and expiratio n
658658 date of that drug on the label; and
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685685 52. "Unit of issue package" means a package that provides
686686 multiple doses of the same drug, but each drug is individually
687687 separated and includes the name, lot number, and expiration da te.
688688 SECTION 2. NEW LAW A new section of law to be codified
689689 in the Oklahoma Statutes as Section 353.31 of Title 59, unless there
690690 is created a duplication in numbering, reads as follow s:
691691 A. A pharmacist may test or screen for and administer tre atment
692692 for minor, nonchronic health conditions. For purposes of this
693693 section, a minor, nonchronic health condition i s typically a short-
694694 term health condition t hat is generally managed with non -controlled
695695 drug therapies, minimal treatment, or self -care and includes all of
696696 the following:
697697 1. Influenza;
698698 2. Streptococcus;
699699 3. SARS-COV-2 or other respiratory illness, conditio n, or
700700 disease;
701701 4. Lice;
702702 5. Urinary tract infection;
703703 6. Skin conditions, such as ringworm and athlete's foot; and
704704 7. Other emerging and exist ing public health threats identified
705705 by the State Department of Health if permitted by an order, rule, or
706706 regulation.
707707 B. A pharmacist who tests or scree ns for and treats minor,
708708 nonchronic health conditions under this section may use any test
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735735 that may guide clinical decision making which the Centers for
736736 Medicare and Medicaid Services has determined qualifies for a wa iver
737737 under the federal Clinical Laborato ry Improvement Amendments of
738738 1988, or the federal rules adopted thereunder, or any established
739739 screening procedures that can safely be performed by a pharmacist.
740740 A pharmacist may dispense self-administered hormonal contraceptives
741741 and nicotine replacement therapy products under the protoco l
742742 established pursuant to subsection C of this section, regardless of
743743 whether the patient has obtained a prescription.
744744 C. The Board of Pharmacy shall adopt regulations establishing a
745745 protocol for dispensing self -administered hormonal contraceptives
746746 and nicotine replacement therapy products by January 1, 2024.
747747 SECTION 3. This act shall become effective November 1, 2023.
748748
749749 59-1-5293 LRB 01/10/23