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STATE OF OKLAHOMA
2nd Session of the 59th Legislature (2024)
SENATE BILL 1628 By: Howard
AS INTRODUCED
An Act relating to prescription drug pricing;
amending 36 O.S. 2021, Section 6960, as amended by
Section 1, Chapter 38, O.S.L. 2022, 6962, as last
amended by Section 1, Chapter 293, O.S.L. 2023, and
Section 3, Chapter 38, O.S.L. 2022, as amended by
Section 3, Chapter 293, O.S.L. 2023 (36 O.S. Supp.
2023, Sections 6960, 6962, and 6966.1 ), which relate
to the Patient’s Right to Pharmacy Choi ce Act;
defining terms; increasing actions to be prohibited
by pharmacy benefits manager; adding requirements to
pharmacy benefits manager contracts; providing
certain claims be deemed final upon adjudication;
amending 59 O.S. 2021, Section 353.1, as amend ed by
Section 6, Chapter 288, O.S.L. 2022 (59 O.S. Supp.
2023, Section 353.1), which relates to the Oklahoma
Pharmacy Act; defining terms; prohibiting
prescription drug manufacturers from taking certain
actions against certain entities; providing for
codification; and providing an effective date .
BE IT ENACTED BY THE PEOPL E OF THE STATE OF OKLAHOMA:
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:
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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 organization, union, hospital and medical
services organization or any entity providing or admin istering a
self-funded health benefit plan;
3. “Mail-order pharmacy” means a pharmacy licensed by this
state that primarily dispenses and delivers covered drugs via common
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 whi ch the pharmacy primari ly fills and
sells prescriptions via a retail, storefron t location;
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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 charges 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 providing pharmacy services;
9. “Suburban service area ” means a five-digit ZIP code in which
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:
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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, shall not:
1. Cause or knowingly pe rmit 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,
b. enrollment or participation 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
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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:
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,
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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
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 o r
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 participation 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
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17. Base the drug formulary or drug coverage decisions upon the
340B drug pricing status of a drug, including price or availa bility,
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
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
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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 insure rs, and managed care
organizations,
(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.
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D. A pharmacy benefits manager 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 insurer s, self-funded employers, unions or
other PBM clients the existence of the re spective aggregate
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 dat a
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,
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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
itemized by pharmacy, drug product and service
provided, and
e. the individual and aggregate amount a PBM paid a
provider for pharmac y 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)
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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
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
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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.
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 cost s 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.
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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
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 the 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 Ok lahoma 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 Oklahoma by the Board
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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
licensed practitioner with dispensing authority 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 with 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, mixing,
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 prescribing patterns;
9. “Continuing professiona l 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, characteristics and
therapeutics of the diseased s tate;
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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
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 drug 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 administration 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 that do
not act as a wholesale distributor, or any other person authorized
by law to dispense or adm inister 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 parag raph, “dispenser” does not mean a
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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 pursua nt to a
prescription executed in accordance with 21 U.S.C . 353(b)(1) or the
dispensing of a product approved under 21 U.S.C. 360 b(b); provided,
taking actual physical possession of a product or title s hall 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 shall
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, pharmacies, and all other facilities which are
engaged in dispensing, delivery, distribution or storage 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 i n the cure,
diagnosis, mitigation, treatment or preventio n of disease in humans
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or animals and all substances and preparations, other than food,
intended to affect the structure or any function of t he 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
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 required by the Oklahoma Pharmacy Act;
21. “Hospital” means any institution licensed as a hospital 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 approved 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
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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
a person described in this subparagraph or
subparagraph a of this paragraph,
c. an affiliate of a person described in subparagraph a
or b who receives the product directly from a person
described in this subparagraph 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 pa ckaging 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 bul k compounds for resale by
licensed pharmacies, licensed practitioners or other persons;
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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;
27. “Medical gas distributor ” means a person licensed to
distribute, transfer, wholesale, deliver or sell medical gases on
drug orders to suppliers or other entities licensed to use,
administer or distribute medical gas and may also include 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 whic h has
the property of curing, preventing, treating , 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 req uirements 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 pre parations meet the
requirements of the Federal Food, Drug and Cosmetic Act, 21
U.S.C.A., Section 321 et seq.;
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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,
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 manufacturer 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 c ontext
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
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practice the profession of pharmacy, or a pharmacy operated by the
Oklahoma Department of V eterans Affairs;
36. “Pharmacy technician”, “technician”, “Rx tech”, or “tech”
means a person issued a Technician permit by the State Board of
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 absorption, pro duces 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 devices and
the maintenance of proper r ecords thereof,
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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,
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 p ractice
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 co mmunication:
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
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c. by an Oklahoma licensed wholesaler or distri butor as
authorized in Section 353.29.1 of this titl e;
42. “Product” means a prescription drug in a finishe d dosage
form for administration to a patient w ithout substantial further
manufacturing, such as capsules, tablets, and lyophilized products
before reconstitution. “Product” does not include blo od 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 training as an intern, resident, or
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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;
46. “Supportive personnel” means technicians and auxi liary
supportive persons who are regularly paid employees of a pharma cy
who work and perform tasks 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 pr oduct in
interstate commerce on beh alf of a manufacturer, wholesale
distributor, or dispenser of a product 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 parag raph,
“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 third-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;
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49. “County jail” means a facility operated by a county for the
physical detention and corr ection of persons charged with, or
convicted of, criminal o ffenses or ordinance violations or persons
found guilty of civil or criminal contempt;
50. “State correctional facility ” means a facility or
institution that houses a p risoner population under the jurisdiction
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 drug, but each drug is individually
separated and includes the 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 duplication 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 ,
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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
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.
59-2-3131 RD 1/12/2024 3:45:46 PM