1 STATE OF OKLAHOMA
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2 1st Session of the 59th Legislature (2023)
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3 SENATE BILL 459 By: Stanley
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6 AS INTRODUCED
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7 An Act relating to the practice of nursing; amending
7 59 O.S. 2021, Section 353.1, as amended by Section 6,
8 Chapter 288, O.S.L. 2022 (59 O.S. Supp. 2022, Section
8 353.1), which relates to definitions used in the
9 Oklahoma Pharmacy Act; modifying definitions;
9 amending 59 O.S. 2021, Section 353.1a, which relates
10 to prescriptive authority of Advanced Practice
10 Registered Nurses; modifying prescriptive authority
11 of Certified Nurse-Midwives; amending 59 O.S. 2021,
11 Section 567.3a, which relates to definitions used in
12 the Oklahoma Nursing Practice Act; modifying
12 definitions; amending 59 O.S. 2021, Section 567.4a,
13 which relates to prescriptive authority; eliminating
13 supervision requirement for Certified Nurse-Midwife;
14 providing for independent practice; directing the
14 Oklahoma Board of Nursing to promulgate certain
15 rules; amending 59 O.S. 2021, Section 567.5a, which
15 relates to Advanced Practice Registered Nurse
16 license; providing for independent prescriptive
16 authority by endorsement for Certified Nurse-Midwife;
17 amending 63 O.S. 2021, Section 2-312, as amended by
17 Section 2, Chapter 184, O.S.L. 2022 (63 O.S. Supp.
18 2022, Section 2-312), which relates to controlled
18 dangerous substances; eliminating supervision
19 requirement for Certified Nurse-Midwife; and
19 providing an effective date.
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22 BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
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 1 SECTION 1. AMENDATORY 59 O.S. 2021, Section 353.1, as
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2 amended by Section 6, Chapter 288, O.S.L. 2022 (59 O.S. Supp. 2022,
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3 Section 353.1), is amended to read as follows:
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4 Section 353.1. For the purposes of the Oklahoma Pharmacy Act:
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5 1. “Accredited program” means those seminars, classes,
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6 meetings, work projects, and other educational courses approved by
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7 the Board State Board of Pharmacy for purposes of continuing
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8 professional education;
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9 2. “Act” means the Oklahoma Pharmacy Act;
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10 3. “Administer” means the direct application of a drug, whether
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11 by injection, inhalation, ingestion or any other means, to the body
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12 of a patient;
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13 4. “Assistant pharmacist” means any person presently licensed
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14 as an assistant pharmacist in the State of Oklahoma by the Board
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15 pursuant to Section 353.10 of this title and for the purposes of the
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16 Oklahoma Pharmacy Act shall be considered the same as a pharmacist,
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17 except where otherwise specified;
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18 5. “Board” or “State Board” means the State Board of Pharmacy;
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19 6. “Certify” or “certification of a prescription” means the
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20 review of a filled prescription by a licensed pharmacist or a
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21 licensed practitioner with dispensing authority to confirm that the
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22 medication, labeling and packaging of the filled prescription are
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23 accurate and meet all requirements prescribed by state and federal
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 1 law. For the purposes of this paragraph, “licensed practitioner”
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2 shall not include optometrists with dispensing authority;
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3 7. “Chemical” means any medicinal substance, whether simple or
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4 compound or obtained through the process of the science and art of
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5 chemistry, whether of organic or inorganic origin;
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6 8. “Compounding” means the combining, admixing, mixing,
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7 diluting, pooling, reconstituting or otherwise altering of a drug or
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8 bulk drug substance to create a drug. Compounding includes the
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9 preparation of drugs or devices in anticipation of prescription drug
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10 orders based on routine, regularly observed prescribing patterns;
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11 9. “Continuing professional education” means professional,
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12 pharmaceutical education in the general areas of the socioeconomic
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13 and legal aspects of health care; the properties and actions of
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14 drugs and dosage forms; and the etiology, characteristics and
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15 therapeutics of the diseased state;
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16 10. “Dangerous drug”, “legend drug”, “prescription drug” or “Rx
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17 Only” means a drug:
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18 a. for human use subject to 21 U.S.C. 353(b)(1), or
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19 b. is labeled “Prescription Only”, or labeled with the
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20 following statement: “Caution: Federal law restricts
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21 this drug except for use by or on the order of a
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22 licensed veterinarian.”;
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23 11. “Director” means the Executive Director of the State Board
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24 of Pharmacy unless context clearly indicates otherwise;
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 1 12. “Dispense” or “dispensing” means the interpretation,
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2 evaluation, and implementation of a prescription drug order
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3 including the preparation and delivery of a drug or device to a
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4 patient or a patient’s agent in a suitable container appropriately
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5 labeled for subsequent administration to, or use by, a patient.
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6 Dispense includes sell, distribute, leave with, give away, dispose
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7 of, deliver or supply;
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8 13. “Dispenser” means a retail pharmacy, hospital pharmacy, a
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9 group of chain pharmacies under common ownership and control that do
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10 not act as a wholesale distributor, or any other person authorized
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11 by law to dispense or administer prescription drugs, and the
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12 affiliated warehouses or distributions of such entities under common
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13 ownership and control that do not act as a wholesale distributor.
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14 For the purposes of this paragraph, “dispenser” does not mean a
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15 person who dispenses only products to be used in animals in
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16 accordance with 21 U.S.C. 360b(a)(5);
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17 14. “Distribute” or “distribution” means the sale, purchase,
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18 trade, delivery, handling, storage, or receipt of a product, and
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19 does not include the dispensing of a product pursuant to a
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20 prescription executed in accordance with 21 U.S.C. 353(b)(1) or the
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21 dispensing of a product approved under 21 U.S.C. 360b(b); provided,
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22 taking actual physical possession of a product or title shall not be
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23 required;
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 1 15. “Doctor of Pharmacy” means a person licensed by the Board
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2 to engage in the practice of pharmacy. The terms “pharmacist”,
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3 “D.Ph.”, and “Doctor of Pharmacy” shall be interchangeable and shall
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4 have the same meaning wherever they appear in the Oklahoma Statutes
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5 and the rules promulgated by the Board;
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6 16. “Drug outlet” means all manufacturers, repackagers,
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7 outsourcing facilities, wholesale distributors, third-party
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8 logistics providers, pharmacies, and all other facilities which are
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9 engaged in dispensing, delivery, distribution or storage of
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10 dangerous drugs;
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11 17. “Drugs” means all medicinal substances and preparations
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12 recognized by the United States Pharmacopoeia and National
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13 Formulary, or any revision thereof, and all substances and
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14 preparations intended for external and/or internal use in the cure,
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15 diagnosis, mitigation, treatment or prevention of disease in humans
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16 or animals and all substances and preparations, other than food,
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17 intended to affect the structure or any function of the body of a
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18 human or animals;
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19 18. “Drug sample” means a unit of a prescription drug packaged
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20 under the authority and responsibility of the manufacturer that is
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21 not intended to be sold and is intended to promote the sale of the
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22 drug;
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23 19. “Durable medical equipment” has the same meaning as
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24 provided by Section 2 of this act;
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 1 20. “Filled prescription” means a packaged prescription
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2 medication to which a label has been affixed which contains such
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3 information as is required by the Oklahoma Pharmacy Act;
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4 21. “Hospital” means any institution licensed as a hospital by
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5 this state for the care and treatment of patients, or a pharmacy
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6 operated by the Oklahoma Department of Veterans Affairs;
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7 22. “Licensed practitioner” means:
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8 a. an allopathic physician,
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9 b. an osteopathic physician,
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10 c. a podiatric physician,
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11 d. a dentist,
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12 e. a veterinarian or,
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13 f. an optometrist, or
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14 g. a Certified Nurse-Midwife,
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15 licensed to practice and authorized to prescribe dangerous drugs
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16 within the scope of practice of such practitioner;
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17 23. “Manufacturer” or “virtual manufacturer” means with respect
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18 to a product:
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19 a. a person that holds an application approved under 21
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20 U.S.C. 355 or a license issued under 42 U.S.C. 262 for
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21 such product, or if such product is not the subject of
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22 an approved application or license, the person who
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23 manufactured the product,
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 1 b. a co-licensed partner of the person described in
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2 subparagraph a that obtains the product directly from
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3 a person described in this subparagraph or
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4 subparagraph a of this paragraph,
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5 c. an affiliate of a person described in subparagraph a
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6 or b who receives the product directly from a person
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7 described in this subparagraph or in subparagraph a or
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8 b of this paragraph, or
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9 d. a person who contracts with another to manufacture a
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10 product;
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11 24. “Manufacturing” means the production, preparation,
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12 propagation, compounding, conversion or processing of a device or a
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13 drug, either directly or indirectly by extraction from substances of
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14 natural origin or independently by means of chemical or biological
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15 synthesis and includes any packaging or repackaging of the
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16 substances or labeling or relabeling of its container, and the
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17 promotion and marketing of such drugs or devices. The term
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18 “manufacturing” also includes the preparation and promotion of
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19 commercially available products from bulk compounds for resale by
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20 licensed pharmacies, licensed practitioners or other persons;
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21 25. “Medical gas” means those gases including those in liquid
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22 state upon which the manufacturer or distributor has placed one of
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23 several cautions, such as “Rx Only”, in compliance with federal law;
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 1 26. “Medical gas order” means an order for medical gas issued
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2 by a licensed prescriber;
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3 27. “Medical gas distributor” means a person licensed to
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4 distribute, transfer, wholesale, deliver or sell medical gases on
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5 drug orders to suppliers or other entities licensed to use,
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6 administer or distribute medical gas and may also include a patient
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7 or ultimate user;
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8 28. “Medical gas supplier” means a person who dispenses medical
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9 gases on drug orders only to a patient or ultimate user;
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10 29. “Medicine” means any drug or combination of drugs which has
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11 the property of curing, preventing, treating, diagnosing or
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12 mitigating diseases, or which is used for that purpose;
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13 30. “Nonprescription drugs” means medicines or drugs which are
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14 sold without a prescription and which are prepackaged for use by the
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15 consumer and labeled in accordance with the requirements of the
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16 statutes and regulations of this state and the federal government.
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17 Such items shall also include medical and dental supplies and
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18 bottled or nonbulk chemicals which are sold or offered for sale to
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19 the general public if such articles or preparations meet the
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20 requirements of the Federal Food, Drug and Cosmetic Act, 21
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21 U.S.C.A., Section 321 et seq.;
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22 31. “Outsourcing facility” including “virtual outsourcing
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23 facility” means a facility at one geographic location or address
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24 that:
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 1 a. is engaged in the compounding of sterile drugs,
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2 b. has elected to register as an outsourcing facility,
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3 and
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4 c. complies with all requirements of 21 U.S.C. 353b;
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5 32. “Package” means the smallest individual saleable unit of
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6 product for distribution by a manufacturer or repackager that is
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7 intended by the manufacturer for ultimate sale to the dispenser of
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8 such product. For the purposes of this paragraph, “individual
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9 saleable unit” means the smallest container of a product introduced
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10 into commerce by the manufacturer or repackager that is intended by
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11 the manufacturer or repackager for individual sale to a dispenser;
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12 33. “Person” means an individual, partnership, limited
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13 liability company, corporation or association, unless the context
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14 otherwise requires;
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15 34. “Pharmacist-in-charge” or “PIC” means the pharmacist
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16 licensed in this state responsible for the management control of a
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17 pharmacy and all other aspects of the practice of pharmacy in a
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18 licensed pharmacy as defined by Section 353.18 of this title;
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19 35. “Pharmacy” means a place regularly licensed by the Board of
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20 Pharmacy in which prescriptions, drugs, medicines, chemicals and
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21 poisons are compounded or dispensed or such place where pharmacists
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22 practice the profession of pharmacy, or a pharmacy operated by the
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23 Oklahoma Department of Veterans Affairs;
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 1 36. “Pharmacy technician”, “technician”, “Rx tech”, or “tech”
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2 means a person issued a Technician permit by the State Board of
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3 Pharmacy to assist the pharmacist and perform nonjudgmental,
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4 technical, manipulative, non-discretionary functions in the
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5 prescription department under the immediate and direct supervision
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6 of a pharmacist;
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7 37. “Poison” means any substance which when introduced into the
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8 body, either directly or by absorption, produces violent, morbid or
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9 fatal changes, or which destroys living tissue with which such
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10 substance comes into contact;
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11 38. “Practice of pharmacy” means:
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12 a. the interpretation and evaluation of prescription
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13 orders,
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14 b. the compounding, dispensing, administering and
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15 labeling of drugs and devices, except labeling by a
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16 manufacturer, repackager or distributor of
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17 nonprescription drugs and commercially packaged legend
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18 drugs and devices,
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19 c. the participation in drug selection and drug
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20 utilization reviews,
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21 d. the proper and safe storage of drugs and devices and
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22 the maintenance of proper records thereof,
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23 e. the responsibility for advising by counseling and
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24 providing information, where professionally necessary
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 1 or where regulated, of therapeutic values, content,
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2 hazards and use of drugs and devices,
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3 f. the offering or performing of those acts, services,
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4 operations or transactions necessary in the conduct,
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5 operation, management and control of a ph