SENATE FLOOR VERSION - SB1628 SFLR Page 1 (Bold face denotes Committee Amendments) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 SENATE FLOOR VERSION February 20, 2024 AS AMENDED SENATE BILL NO. 1628 By: Howard [ prescription drug pricing - pharmacy benefits manager - contracts - actions - codification - effective date ] BE IT ENACTED BY THE PEOPL E OF THE STATE OF OKLAHOM A: SECTION 1. AMENDATORY 36 O.S. 2021, Section 6960, as amended by Section 1, Chapter 38, O.S.L. 2022 (36 O.S. Supp. 2023, Section 6960), is amended to read as follows: Section 6960. For purposes of the Patient ’s Right to Pharmacy Choice Act: 1. “Health insurer” means any corporation, association, benefit society, exchange, partnership or individual licensed by the Oklahoma Insurance Code; 2. “Health insurer payor” means a health insurance company, health maintenance organizatio n, union, hospital and medical services organization or any entity providing or admin istering a self-funded health benefit plan; SENATE FLOOR VERSION - SB1628 SFLR Page 2 (Bold face denotes Committee Amendments) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 3. “Mail-order pharmacy” means a pharmacy licensed by this state that primarily dispenses and delivers covered drugs via commo n carrier; 4. “Pharmacy benefits manager ” or “PBM” means a person that performs pharmacy benefits man agement and any other person acting for such person under a contractual or employm ent relationship in the performance of pharmacy benefits management for a managed-care company, nonprofit hospital, medi cal service organization, insurance company, third-party payor or a health program administered by a department of this state; 5. “Provider” means a pharmacy, as defined in Section 353.1 of Title 59 of the Oklahoma Statutes or an agent or representative of a pharmacy; 6. “Retail pharmacy network ” means retail pharmacy providers contracted with a PBM in which the pharmacy primari ly fills and sells prescriptions via a retail, storefron t location; 7. “Rural service area” means a five-digit ZIP code in which the population density is less than one thousand (1,000) individu als per square mile; 8. “Spread pricing” means a prescription drug pricing model utilized by a pharmacy benefits manager in which the PBM cha rges a health benefit plan a contracted price for prescription drugs that differs from the amount the PBM directly or indirectly pays the pharmacy or pharmacist for pr oviding pharmacy services; SENATE FLOOR VERSION - SB1628 SFLR Page 3 (Bold face denotes Committee Amendments) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 9. “Suburban service area” means a five-digit ZIP code in whi ch the population density is between one thousan d (1,000) and three thousand (3,000) individuals per square mile ; and 10. “Urban service area” means a five-digit ZIP code in which the population density is greater than three thousand (3,000) individuals per square mile; 11. “340B drug pricing” means the pricing agreement established under Section 602 of the Veterans Health Care Act of 1992, Pub. L. No. 102-585; and 12. “340B entity” means a covered entity as that term is defined in 42 U.S.C., Section 256b. SECTION 2. AMENDATORY 36 O.S. 2021, Sect ion 6962, as last amended by Section 1, Chapter 293, O.S.L. 2023 (36 O.S. Supp. 2023, Section 6962), is amended to read as follows: Section 6962. A. The Attorney General shall review and approve retail pharmacy network access for all p harmacy benefits managers (PBMs) to ensure compliance with Sec tion 6961 of this title. B. A PBM, or an agent of a PBM, s hall not: 1. Cause or knowingly permit the use of advertisement, promotion, solicitation, representation, proposal or offer that is untrue, deceptive or misleading; 2. Charge a pharmacist or phar macy a fee related to the adjudication of a claim including without limitation a fee for: a. the submission of a claim, SENATE FLOOR VERSION - SB1628 SFLR Page 4 (Bold face denotes Committee Amendments) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 b. enrollment or partici pation in a retail pharmacy network, or c. the development or management of claims processing services or claims payment services related to participation in a retail pharmacy network; 3. Reimburse a pharmacy or pharmacist in the state an amount less than the amount that the PBM reimburses a pharm acy owned by or under common ownership with a PBM for providing the s ame covered services. The reimbursement amount paid to the pharmacy shall be equal to the reimbursement amount calculated on a per-unit basis using the same generic product identifier or generic code number paid to the PBM-owned or PBM-affiliated pharmacy; 4. Deny a provider the opportunity to participate in any pharmacy network at preferred participation status if the provider is willing to accept the terms and conditions that the PBM has established for other providers as a condition of preferred networ k participation status; 5. Deny, limit or terminate a provider’s contract based on employment status of a ny employee who has an active license to dispense, despite probation status, wi th the State Board of Pharmacy; 6. Retroactively deny or reduce reimbu rsement for a covered service claim after returning a paid claim response as part of the adjudication of the claim, unless: SENATE FLOOR VERSION - SB1628 SFLR Page 5 (Bold face denotes Committee Amendments) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 a. the original claim was submitted fraudulently, or b. to correct errors identified in an audit, so long as the audit was conducted in compliance with Sections 356.2 and 356.3 of Title 59 of the Oklahoma Statutes; 7. Fail to make any payment due to a pharmacy or pharmacist for covered services properly re ndered in the event a PBM terminates a provider from a pharmacy benefits manager network; 8. Conduct or practice spread pricing, as defined in Section 1 of this act, in this state; or 9. Charge a pharmacist or pharmacy a fee related to participation in a re tail pharmacy network including but not limited to the following: a. an application fee, b. an enrollment or participation fee, c. a credentialing or re-credentialing fee, d. a change of ownership fee, or e. a fee for the development or management of claims processing services or claims payment services; 10. Discriminate, offer lower reimbursement, or impose any separate terms upon a provider on the basis that a p rovider participates in 340B drug pricing; 11. Require a provider to reverse, resubmit, or clarify a 340B drug pricing claim after the initial adjudication unless these SENATE FLOOR VERSION - SB1628 SFLR Page 6 (Bold face denotes Committee Amendments) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 actions are in normal course of pharmacy business and not related to 340B drug pricing; 12. Require a billing modifier to indicate that the drug or claim is a 340B drug pricing claim, unless the drug or claim is being billed to the Oklahoma Medicaid Program; 13. Modify a patient copayment on the basis that the provider of the patient participates in 340B drug pricing; 14. Exclude a provider from a network on the basis that the provider participates in 340B drug pricing ; 15. Establish or set network adequacy req uirements based on 340B drug pricing participat ion by a provider; 16. Prohibit a 340B entity or a pharmacy under contract with a 340B entity from participating in the network of the PBM on the basis of participation in 340B drug pricing; or 17. Base the drug formulary or drug coverage decisions upon the 340B drug pricing status of a drug, including price or availability, or whether a dispensing pharmacy participates in 340B drug pricing. C. The prohibitions under this section shall apply to contracts between pharmacy benefits managers and providers for participation in retail pharmacy networks. 1. A PBM contract shall: a. not restrict, directly or indirectly, any pharmacy that dispenses a presc ription drug from informing, or penalize such pharmacy for informing, an indivi dual of SENATE FLOOR VERSION - SB1628 SFLR Page 7 (Bold face denotes Committee Amendments) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 any differential between the individual’s out-of- pocket cost or coverage with respect to acquisition of the drug and the amount an individual would pay to purchase the drug directly, and b. ensure that any entity that provides pharmacy benefits management services under a contract with any such health plan or health insurance coverage does not, with respect to such plan or coverage, restrict, directly or indirectly, a ph armacy that dispenses a prescription drug from inf orming, or penalize such pharmacy for informing, a covered individual of any differential between the individual’s out-of-pocket cost under the plan or coverage with respect to acquisition of the drug and t he amount an individual would pay for acquisition of the drug without using any health plan or health insurance coverag e, and c. eliminate discriminatory contracting as it relates to: (1) transferring the benefit of 340B drug pricing savings from a 340B entity to another entity, including without limitation pharmacy bene fits managers, private insurers, and managed care organizations, SENATE FLOOR VERSION - SB1628 SFLR Page 8 (Bold face denotes Committee Amendments) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 (2) offering a lower reimbursement rate for drugs purchased under 340B drug pricing than for the same drug not purchased under 340B d rug pricing, (3) refusal to cover drug purchases utilizing 340B drug pricing, (4) refusal to allow providers who utilize 340B drug pricing to participate in netwo rks, and (5) charging more than fair market value or seeking profit sharing in exchange for servi ces involving 340B drug pricing. 2. A pharmacy benefits manager ’s contract with a provider shall not prohibit, restrict or limit disclosure of information to the Attorney General, law enforcement or state and federal governmental officials investigating or examining a c omplaint or conducting a review of a pharmacy benefits manager ’s compliance with the requirements under the Patient’s Right to Pharmacy Choice Act. D. A pharmacy benefits m anager shall: 1. Establish and maintain an electronic claim inquiry processing system using the National Council for Prescription Drug Programs’ current standards to communicate information to pharmacies submitting claim inquiries ; 2. Fully disclose to insurers, self-funded employers, unions or other PBM clients the existence of the re spective aggregate SENATE FLOOR VERSION - SB1628 SFLR Page 9 (Bold face denotes Committee Amendments) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 prescription drug discounts, rebates rece ived from drug manufacturers and pharmacy audit recoupments; 3. Provide the Attorney General, insurers, self-funded employer plans and unions unrestricted audi t rights of and access to the respective PBM pharmaceutical manufacturer and provider contracts, plan utilization data, plan pricing data, pharmacy utilization data and pharmacy pricing data; 4. Maintain, for no less than three (3) years, documentation of all network development activities including but not limited to contract negotiations and any denials to providers to join networks. This documentation shall be made available to th e Attorney General upon request; 5. Report to the Attorney General, on a quarterly basis for each health insurer payor, on the following information: a. the aggregate amount of rebates received by t he PBM, b. the aggregate amount of rebates distributed to the appropriate health in surer payor, c. the aggregate amount of rebates passed on to the enrollees of each healt h insurer payor at the point of sale that reduced the applicable deductible, copayment, coinsure or other cost sharing amount of the enrollee, d. the individual and agg regate amount paid by t he health insurer payor to the PBM for pharmacy services SENATE FLOOR VERSION - SB1628 SFLR Page 10 (Bold face denotes Committee Amendments) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 itemized by pharmacy, drug product and service provided, and e. the individual and aggreg ate amount a PBM paid a provider for pharmacy services itemized by pharmacy, drug product and service provide d; and 6. Make drug formulary and coverage decisions based on the normal course of business of the PBM. SECTION 3. AMENDATORY Section 3, Chapter 38, O.S.L. 2022, as amended by Section 3, Chapter 293, O.S.L. 2023 (36 O.S. Supp. 2023, Section 6966.1), is am ended to read as fol lows: Section 6966.1. A. The Insurance Commissioner may censure, suspend, revoke or refuse to issue or renew a license of or levy a civil penalty against any person licensed under the insurance laws of this state for any violation of the Patient’s Right to Pharmacy Choice Act, Section 6958 et seq. o f this title. B. 1. If the Attorney General finds, after notice and opportunity for hearing, that a pharmacy benefits manager (PBM) violated one or more provisions of the Patient’s Right to Pharmacy Choice Act, the Pharmacy Audit Integrity Act or the provisions of Sections 357 through 360 of Title 59 of the Oklahoma Statues, the Attorney General may recommend the PBM be censured, his or her license may be suspended or rev oked and a penalty or remedy authorized by this act may be imposed. If the Attorney General SENATE FLOOR VERSION - SB1628 SFLR Page 11 (Bold face denotes Committee Amendments) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 makes such recommendation, the Commissioner shall take the recommended action. 2. In addition to or in lieu of any censure, suspension or revocation of a license, a PBM may be subject to a civil fine o f not less than One Hundred Dollars ($100.00) and not greater tha n Ten Thousand Dollars ($10,000.00) for each violation of the provisions of the Patient’s Right to Pharmacy Choice Act, the Pharmacy Audit Integrity Act or the provi sions of Sections 357 throug h 360 of Title 59 of the Oklahoma Statues, following notic e and an opportunity for a hearing. C. Notwithstanding whether the license of a PBM has been issued, suspended, revoke d, surrendered or lapsed by operation of law, the Attorney General is hereby authorized to enforce the provisions of the Patient ’s Right to Pharmacy Cho ice Act and impose any penalty or remedy authorized under the act against a PBM under investigation for or charg ed with a violation of the Pati ent’s Right to Pharmacy Choice Act, the Pharmacy Audit Integrity Act, the provisions of Sections 357 through 360 of Title 59 of the Oklahoma Statues or any provisi on of the insurance laws of this state. D. Each day that a PBM conducts business in this sta te without a license from the Insurance Department shall be deemed a violation of the Patient’s Right to Pharmacy Choice Act. SENATE FLOOR VERSION - SB1628 SFLR Page 12 (Bold face denotes Committee Amendments) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 E. 1. All hearings conducted by the Office of the Attorney General pursuant to this section shall be public and held in accordance with the Administrative Procedures Act. 2. Hearings shall be held at the office of the Attorney General or any other place the Attorney General may deem convenient. 3. The Attorney General, upon written request from a PBM affected by the hearing, shall cause a f ull stenographic record of the proceedings to be made by a competent court reporter . This record shall be at the expense of the PBM. 4. The ordinary fees and costs of the hearing examiner appointed pursuant to Section 319 of this title may be assessed by the hearing examiner against the respondent unless the respondent is the prevailing party. F. Any PBM whose license has been censured, susp ended, revoked or denied renewal or who has had a fine levied against him or her shall have the right of appeal from the final order of the Attorney General, pursuant to Section 318 et seq. of Title 75 of the Oklahoma Statutes. G. If the Attorney General determines, based upon an investigation of complaints, that a PBM has engaged in violations of the provisions of the Patient’s Right to Pharmacy Choice Act with such frequency as to indicate a general business practice, and that the PBM should be subjected to closer supervision with respect to those practices, the Attorney General may require the PBM to file a SENATE FLOOR VERSION - SB1628 SFLR Page 13 (Bold face denotes Committee Amendments) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 report at any periodic interval the Attorney General deems necessary. H. All claims processed by a PBM on behalf of a provider that participates in 340B drug pricing or on behalf of a 340B entity shall be deemed final at t he point of adjudication. SECTION 4. AMENDATORY 59 O.S. 2021, Section 353.1, as amended by Section 6, Chapter 288, O.S.L. 2022 (59 O.S. Supp. 2023, Section 353.1), is amended to read as follows: Section 353.1. For the purposes of the Oklahoma Pharmacy Act: 1. “Accredited program” means those seminars, classes, meetings, work projects, and oth er educational courses approved by the Board for purposes of continuing professional education; 2. “Act” means the Oklahoma Pharmacy Act; 3. “Administer” means the direct application of a drug, whether by injection, inhalation, ingestion or any other m eans, to the body of a patient; 4. “Assistant pharmacist” means any person presently licensed as an assistant pharmacist in the State of Okla homa by the Board pursuant to Section 353.10 of this title and for the purposes of the Oklahoma Pharmacy Act shal l be considered the same as a pharmacist, except where otherwise specified; 5. “Board” or “State Board” means the State Board of Pharmacy; 6. “Certify” or “certification of a prescription ” means the review of a filled prescription by a licensed pharmac ist or a SENATE FLOOR VERSION - SB1628 SFLR Page 14 (Bold face denotes Committee Amendments) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 licensed practitioner with dispensing authori ty to confirm that the medication, labeling an d packaging of the filled prescription are accurate and meet all requirem ents prescribed by state and federa l law. For the purposes of this paragraph, “licensed practitioner” shall not include optometrists wit h dispensing authority; 7. “Chemical” means any medicinal substance, whether simple or compound or obtained through the process of the science and art of chemistry, whether of organic or inorganic ori gin; 8. “Compounding” means the combining, admixing, m ixing, diluting, pooling, reconstituting or ot herwise altering of a drug or bulk drug substance to create a drug. Compounding includes the preparation of drugs or devices in anticipation of prescript ion drug orders based on routine, regularly observed pre scribing patterns; 9. “Continuing professional education” means professional, pharmaceutical education in the general areas of the socioeconomic and legal aspects of health care; the properties and actions of drugs and dosage forms; and the etiology, char acteristics and therapeutics of the diseased s tate; 10. “Dangerous drug”, “legend drug”, “prescription drug” or “Rx Only” means a drug: a. for human use subject to 21 U.S.C. 353(b)(1), or b. is labeled “Prescription Only”, or labeled with the following statement: “Caution: Federal law restricts SENATE FLOOR VERSION - SB1628 SFLR Page 15 (Bold face denotes Committee Amendments) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 this drug except for use by or on the order of a licensed veterinarian.”; 11. “Director” means the Executive Director of the State Board of Pharmacy unless context clearly indicates otherwise; 12. “Dispense” or “dispensing” means the interpretation, evaluation, and implementation of a prescription dru g order including the prepar ation and delivery of a drug or dev ice to a patient or a patient ’s agent in a suitable container appropria tely labeled for subsequent ad ministration to, or use by, a patient. Dispense includes sell, distribute, leave with, give away, dispose of, deliver or supply; 13. “Dispenser” means a retail pharmacy, hospital pharmacy, a group of chain pharmacies under c ommon ownership and control th at do not act as a wholesale distributor, or any other person authorized by law to dispense or administer prescription d rugs, and the affiliated warehouses or distributions of such entities und er common ownership and control t hat do not act as a wholesale distributor. For the purposes of this paragraph, “dispenser” does not mean a person who dispenses only products to be used in animals in accordance with 21 U.S.C. 360b(a)(5); 14. “Distribute” or “distribution” means the sale, purchase, trade, delivery, handling, storage, or receipt of a product, and does not include the dispensing of a product pursuant to a prescription executed in accordance with 21 U.S.C . 353(b)(1) or the SENATE FLOOR VERSION - SB1628 SFLR Page 16 (Bold face denotes Committee Amendments) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 dispensing of a product approved under 21 U.S.C. 360 b(b); provided, taking actual physical possession of a product or title shall not be required; 15. “Doctor of Pharmacy” means a person licensed by the Board to engage in the practice of pharmacy . The terms “pharmacist”, “D.Ph.”, and “Doctor of Pharmacy” shall be interchangeable and s hall have the same meaning wherever they a ppear in the Oklahoma Statutes and the rules promulgated by the Board; 16. “Drug outlet” means all manufacturers , repackagers, outsourcing faciliti es, wholesale distributors, third -party logistics providers, pharm acies, and all other facilities which are engaged in dispensing, delivery, distribution or s torage of dangerous drugs; 17. “Drugs” means all medicinal substances and preparations recognized by the United States Pharmacopoeia and National Formulary, or any revision thereof, and all substances an d preparations intended for external and/or internal use in the cure, diagnosis, mitigation, treatment or preventio n of disease in humans or animals and all substances and preparations, other than food, intended to affect the structure or any function of the body of a human or animals; 18. “Drug sample” means a unit of a prescription drug packaged under the authority and responsibility of the manufac turer that is SENATE FLOOR VERSION - SB1628 SFLR Page 17 (Bold face denotes Committee Amendments) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 not intended to be sold and is intended to promote the sale of the drug; 19. “Durable medical equipment” has the same meaning as provided by Section 2 of this act; 20. “Filled prescription” means a packaged prescription medication to which a label has been affixed which contain s such information as is requi red by the Oklahoma Pharmacy Act; 21. “Hospital” means any institution licensed as a hospit al by this state for the care and treatment of patients, or a pharmacy operated by the Oklahoma Department of Veterans Affairs; 22. “Licensed practitioner ” means an allopathic physician, osteopathic physician, podiatric physician, dentist, veterinarian or optometrist licensed to pra ctice and authorized to prescribe dangerous drugs within the scope of practice of such practitione r; 23. “Manufacturer” or “virtual manufacturer” means with respect to a product: a. a person that holds an application appr oved under 21 U.S.C. 355 or a license issued under 42 U.S.C. 262 for such product, or if such product is not the subject of an approved application or license , the person who manufactured the product, b. a co-licensed partner of the person described in subparagraph a that obtains the produ ct directly from SENATE FLOOR VERSION - SB1628 SFLR Page 18 (Bold face denotes Committee Amendments) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 a person described in this subparagraph or subparagraph a of this paragraph, c. an affiliate of a person described in subpara graph a or b who receives the product directly from a person described in this subpara graph or in subparagraph a or b of this paragraph, or d. a person who contracts with another to manufacture a product; 24. “Manufacturing” means the production, preparation, propagation, compounding, conversion or processing of a device or a drug, either directly or indirectly by extraction from substances of natural origin or independently by means of chemic al or biological synthesis and includes any pac kaging or repackaging of the substances or labeling or relabeling of its container, and the promotion and marketing of such drug s or devices. The term “manufacturing” also includes the preparation and promoti on of commercially available products from bulk compounds for resale by licensed pharmacies, licensed practitioners or other persons; 25. “Medical gas” means those gases including those in liquid state upon which the manufacturer or distributor has placed one of several cautions, such as “Rx Only”, in compliance with federal l aw; 26. “Medical gas order” means an order for medical gas issued by a licensed prescriber; SENATE FLOOR VERSION - SB1628 SFLR Page 19 (Bold face denotes Committee Amendments) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 27. “Medical gas distributor ” means a person licensed to distribute, transfer, wholesale, deliver or sell medical gases on drug orders to suppliers or oth er entities licensed to use, administer or distribute medical gas and may also includ e a patient or ultimate user; 28. “Medical gas supplier” means a person who dispenses medical gases on drug orders only to a patient or ultimate user; 29. “Medicine” means any drug or combination of drugs which has the property of curing, preventing, tre ating, diagnosing or mitigating diseases, or which is used for that purpose; 30. “Nonprescription drugs ” means medicines or drug s which are sold without a prescription and which are prepackaged for use by the consumer and labeled in accordance with the re quirements of the statutes and regulations of this state and th e federal government. Such items shall also include medical and d ental supplies and bottled or nonbulk chemicals which are sold or offered for sale to the general public if such articles or pr eparations meet the requirements of the Federal Food, Drug and Cosmetic Act, 21 U.S.C.A., Section 321 et seq.; 31. “Outsourcing facility” including “virtual outsourcing facility” means a facility at one geograp hic location or address that: a. is engaged in the compounding of sterile drugs, SENATE FLOOR VERSION - SB1628 SFLR Page 20 (Bold face denotes Committee Amendments) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 b. has elected to register as an outsourcing facility, and c. complies with all requirem ents of 21 U.S.C. 353b; 32. “Package” means the smallest individual saleable unit of product for distribution by a manufact urer or repackager that is intended by the manufacturer for ultimate s ale to the dispenser of such product. For the purposes of this paragraph, “individual saleable unit” means the smallest container of a product intro duced into commerce by the manufactur er or repackager that is intended by the manufacturer or repackager fo r individual sale to a dispenser; 33. “Person” means an individual, partnership, li mited liability company, corporation or association, unless the context otherwise requires; 34. “Pharmacist-in-charge” or “PIC” means the pharmacist licensed in this state responsible for th e management control of a pharmacy and all other aspects of t he practice of pharmacy in a licensed pharmacy as defined by Section 353.18 of this title; 35. “Pharmacy” means a place regularly licensed by the Board of Pharmacy in which prescriptions, drugs, medicines, chemicals and poisons are compounded or dispe nsed or such place where pharmacists practice the profession of pharmacy, or a pharmacy operated by the Oklahoma Department of Veterans Affairs; 36. “Pharmacy technician”, “technician”, “Rx tech”, or “tech” means a person issued a Technician permit by the State Board of SENATE FLOOR VERSION - SB1628 SFLR Page 21 (Bold face denotes Committee Amendments) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Pharmacy to assist the pharmacist and perform nonjudgment al, technical, manipulative, non-discretionary functions in the prescription department under the immediate and direct supervision of a pharmacist; 37. “Poison” means any substance which when introduced into the body, either directly or by abs orption, produces violent, morbid or fatal changes, or wh ich destroys living tissue with which such substance comes into contact; 38. “Practice of pharmacy” means: a. the interpretation and evaluation of prescription orders, b. the compounding, dispensing, administer ing and labeling of drugs and devices, except labeling by a manufacturer, repackager or distributor of nonprescription drugs and commercially packaged legend drugs and devices, c. the participation in drug selection and drug utilization reviews, d. the proper and safe storage of drugs and de vices and the maintenance of proper r ecords thereof, e. the responsibility for advising by counseling and providing information, where professionally necessary or where regulated, of therapeutic values, content, hazards and use of drugs and devices, SENATE FLOOR VERSION - SB1628 SFLR Page 22 (Bold face denotes Committee Amendments) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 f. the offering or performing of those ac ts, services, operations or transacti ons necessary in the conduct, operation, management and control of a pharmacy, or g. the provision of those acts or services that are necessary to provide pharmaceutical care; 39. “Preparation” means an article which may or may not contain sterile products compounded in a licensed pharmacy pursuant to the order of a licensed prescriber; 40. “Prescriber” means a person licensed in this state who is authorized to prescribe dangerous drugs within the scope of practice of the person’s profession; 41. “Prescription” means and includes any order for drug or medical supplies written or signed, or transmitted by word of mouth, telephone or other means of communication: a. by a licensed prescriber, b. under the supervision of an Oklahoma licensed practitioner, an Oklahoma licensed advanced practice registered nurse or an Oklahoma licensed physician assistant, or c. by an Oklahoma licensed wholesaler or distri butor as authorized in Section 353.29.1 of th is title; 42. “Product” means a prescription drug in a finishe d dosage form for administration to a patient w ithout substantial further manufacturing, such as ca psules, tablets, and lyophilized prod ucts SENATE FLOOR VERSION - SB1628 SFLR Page 23 (Bold face denotes Committee Amendments) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 before reconstitution. “Product” does not include blood components intended for transfusion, radioactive drugs or biologics and med ical gas; 43. “Repackager”, including “virtual repackager”, means a person who owns or operates an establishment that repac ks and relabels a product or package for further sale or distribution without further transaction; 44. “Sterile drug” means a drug that is intended for p arenteral administration, an ophthalmic or oral inhalation drug in aqueous format, or a drug that is required to be sterile under state and federal law; 45. “Supervising physician ” means an individual holding a current license to practice as a physician from the State Board of Medical Licensure and Supervision, pursuant to the provisions of the Oklahoma Allopathic Medical and Surgical Licensur e and Supervision Act, or the State Board of Osteopathic Examiners, pursuant to the provisions of the Oklahoma Osteopathic Medicine Act, who supervises an advanced practice registered nurse as defined in Secti on 567.3a of this title, and who is not in trai ning as an intern, resident, or fellow. To be eligible to supervise an advanced practice registered nurse, such physician shall remain in compliance with the rules promulgated by the State Board of Medical Li censure and Supervision or the State Board of O steopathic Examiners; SENATE FLOOR VERSION - SB1628 SFLR Page 24 (Bold face denotes Committee Amendments) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 46. “Supportive personnel” means technicians and auxi liary supportive persons who are regularly paid employees of a pharma cy who work and perform ta sks in the pharmacy as authorized by Section 353.18A of this title; 47. “Third-party logistics provider” including “virtual third- party logistics provider ” means an entity that provides or coordinates warehousing, or other logi stics services of a product in interstate commerce on beh alf of a manufacturer, wholesale distributor, or dispenser of a produ ct but does not take ownersh ip of the product, nor have res ponsibility to direct the sale or disposition of the product. For the purposes of this paragraph, “third-party logistics provid er” does not include shippers and the United States Postal Service; 48. “Wholesale distributor ” including “virtual wholesale distributor” means a person other than a manufacturer, a manufacturer’s co-licensed partner, a thir d-party logistics provider, or repackager engaged in wh olesale distribution as defined by 21 U.S.C. 353(e)(4) as amended by the Drug Supply Chain Security Act; 49. “County jail” means a facility operated by a county for the physical detention and correct ion of persons charged with, or convicted of, criminal offenses or ordinance violations or persons found guilty of civil or criminal contempt; SENATE FLOOR VERSION - SB1628 SFLR Page 25 (Bold face denotes Committee Amendments) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 50. “State correctional facility ” means a facility or institution that houses a p risoner population under the j urisdiction of the Department of Corrections; 51. “Unit dose package” means a package that contains a single dose drug with the n ame, strength, control number, and expiration date of that drug on the label; and 52. “Unit of issue package” means a package that provides multiple doses of the same dru g, but each drug is individually separated and includes t he name, lot number, and expiration da te; 53. “340B drug pricing” means the pricing agreement established under Section 602 of the Veterans Health Care Act of 1992, Pub. L. No. 102-585; and 54. “340B entity” means a covered entity as that term is defined in 42 U.S.C., Section 256b. SECTION 5. NEW LAW A new secti on of law to be codified in the Oklahoma Statutes as Section 355.5 of Title 59, unless there is created a duplicatio n in numbering, reads as follows: A manufacturer shall not: 1. Deny, prohibit, condition, discriminate against, refuse, or withhold 340B drug pricing for, or otherwise limit the dispensing , purchase, ordering, delivery , or receipt of, a drug purchased by a 340B entity, including, but not limited to, a drug purchased to be dispensed or administered under a contract pharmacy agreement; or SENATE FLOOR VERSION - SB1628 SFLR Page 26 (Bold face denotes Committee Amendments) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 2. Prohibit a pharmacy from contracting or participating with a 340B entity by denying 340B pricing on, or the pharmacy ’s access to, a drug that is manufactured by a manufacturer based on a pharmacy’s relationship with a 340B entity. SECTION 6. This act shall become effective November 1, 2024. COMMITTEE REPORT BY: COMMITTEE ON RETIREMENT AND INSURANCE February 20, 2024 - DO PASS AS AMENDED