1 STATE OF OKLAHOMA
2 1st Session of the 59th Legislature (2023)
3 HOUSE BILL 1655 By: McEntire
4
5
6 AS INTRODUCED
7 An Act relating to professions and occupations;
amending 59 O.S. 2021, Section 353.1, as amended by
8 Section 6, Chapter 288, O.S.L. 2022 (59 O.S. Supp.
2022, Section 353.1), which relates to the Oklahoma
9 Pharmacy Act, modifying definition; authorizing
pharmacists to screen and test for certain
10 conditions; providing for adoption of regulations;
providing for codification; and providing an
11 effective date.
12
13
14 BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
15 SECTION 1. AMENDATORY 59 O.S. 2021, Section 353.1, as
16 amended by Section 6, Chapter 288, O.S.L. 2022 (59 O.S. Supp. 2022,
17 Section 353.1), is amended to read as follows:
18 Section 353.1 For the purposes of the Oklahoma Pharmacy Act:
19 1. "Accredited program" means those seminars, classes,
20 meetings, work projects, and other educational courses approved by
21 the Board for purposes of continuing professional education;
22 2. "Act" means the Oklahoma Pharmacy Act;
23
24
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1 3. "Administer" means the direct application of a drug, whether
2 by injection, inhalation, ingestion or any other means, to the body
3 of a patient;
4 4. "Assistant pharmacist" means any person presently licensed
5 as an assistant pharmacist in the State of Oklahoma by the Board
6 pursuant to Section 353.10 of this title and for the purposes of the
7 Oklahoma Pharmacy Act shall be considered the same as a pharmacist,
8 except where otherwise specified;
9 5. "Board" or "State Board" means the State Board of Pharmacy;
10 6. "Certify" or "certification of a prescription" means the
11 review of a filled prescription by a licensed pharmacist or a
12 licensed practitioner with dispensing authority to confirm that the
13 medication, labeling and packaging of the filled prescription are
14 accurate and meet all requirements prescribed by state and federal
15 law. For the purposes of this paragraph, "licensed practitioner"
16 shall not include optometrists with dispensing authority;
17 7. "Chemical" means any medicinal substance, whether simple or
18 compound or obtained through the process of the science and art of
19 chemistry, whether of organic or inorganic origin;
20 8. "Compounding" means the combining, admixing, mixing,
21 diluting, pooling, reconstituting or otherwise altering of a drug or
22 bulk drug substance to create a drug. Compounding includes the
23 preparation of drugs or devices in anticipation of prescription drug
24 orders based on routine, regularly observed prescribing patterns;
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1 9. "Continuing professional education" means professional,
2 pharmaceutical education in the general areas of the socioeconomic
3 and legal aspects of health care; the properties and actions of
4 drugs and dosage forms; and the etiology, characteristics and
5 therapeutics of the diseased state;
6 10. "Dangerous drug", "legend drug", "prescription drug" or "Rx
7 Only" means a drug:
8 a. for human use subject to 21 U.S.C. 353(b)(1), or
9 b. is labeled "Prescription Only", or labeled with the
10 following statement: "Caution: Federal law restricts
11 this drug except for use by or on the order of a
12 licensed veterinarian.";
13 11. "Director" means the Executive Director of the State Board
14 of Pharmacy unless context clearly indicates otherwise;
15 12. "Dispense" or "dispensing" means the interpretation,
16 evaluation, and implementation of a prescription drug order
17 including the preparation and delivery of a drug or device to a
18 patient or a patient's agent in a suitable container appropriately
19 labeled for subsequent administration to, or use by, a patient.
20 Dispense includes sell, distribute, leave with, give away, dispose
21 of, deliver or supply;
22 13. "Dispenser" means a retail pharmacy, hospital pharmacy, a
23 group of chain pharmacies under common ownership and control that do
24 not act as a wholesale distributor, or any other person authorized
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1 by law to dispense or administer prescription drugs, and the
2 affiliated warehouses or distributions of such entities under common
3 ownership and control that do not act as a wholesale distributor.
4 For the purposes of this paragraph, "dispenser" does not mean a
5 person who dispenses only products to be used in animals in
6 accordance with 21 U.S.C. 360b(a)(5);
7 14. "Distribute" or "distribution" means the sale, purchase,
8 trade, delivery, handling, storage, or receipt of a product, and
9 does not include the dispensing of a product pursuant to a
10 prescription executed in accordance with 21 U.S.C. 353(b)(1) or the
11 dispensing of a product approved under 21 U.S.C. 360b(b); provided,
12 taking actual physical possession of a product or title shall not be
13 required;
14 15. "Doctor of Pharmacy" means a person licensed by the Board
15 to engage in the practice of pharmacy. The terms "pharmacist",
16 "D.Ph.", and "Doctor of Pharmacy" shall be interchangeable and shall
17 have the same meaning wherever they appear in the Oklahoma Statutes
18 and the rules promulgated by the Board;
19 16. "Drug outlet" means all manufacturers, repackagers,
20 outsourcing facilities, wholesale distributors, third-party
21 logistics providers, pharmacies, and all other facilities which are
22 engaged in dispensing, delivery, distribution or storage of
23 dangerous drugs;
24
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1 17. "Drugs" means all medicinal substances and preparations
2 recognized by the United States Pharmacopoeia and National
3 Formulary, or any revision thereof, and all substances and
4 preparations intended for external and/or internal use in the cure,
5 diagnosis, mitigation, treatment or prevention of disease in humans
6 or animals and all substances and preparations, other than food,
7 intended to affect the structure or any function of the body of a
8 human or animals;
9 18. "Drug sample" means a unit of a prescription drug packaged
10 under the authority and responsibility of the manufacturer that is
11 not intended to be sold and is intended to promote the sale of the
12 drug;
13 19. "Durable medical equipment" has the same meaning as
14 provided by Section 2 375.2 of this act title;
15 20. "Filled prescription" means a packaged prescription
16 medication to which a label has been affixed which contains such
17 information as is required by the Oklahoma Pharmacy Act;
18 21. "Hospital" means any institution licensed as a hospital by
19 this state for the care and treatment of patients, or a pharmacy
20 operated by the Oklahoma Department of Veterans Affairs;
21 22. "Licensed practitioner" means an allopathic physician,
22 osteopathic physician, podiatric physician, dentist, veterinarian or
23 optometrist licensed to practice and authorized to prescribe
24 dangerous drugs within the scope of practice of such practitioner;
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1 23. "Manufacturer" or "virtual manufacturer" means with respect
2 to a product:
3 a. a person that holds an application approved under 21
4 U.S.C. 355 or a license issued under 42 U.S.C. 262 for
5 such product, or if such product is not the subject of
6 an approved application or license, the person who
7 manufactured the product,
8 b. a co-licensed partner of the person described in
9 subparagraph a that obtains the product directly from
10 a person described in this subparagraph or
11 subparagraph a of this paragraph,
12 c. an affiliate of a person described in subparagraph a
13 or b who receives the product directly from a person
14 described in this subparagraph or in subparagraph a or
15 b of this paragraph, or
16 d. a person who contracts with another to manufacture a
17 product;
18 24. "Manufacturing" means the production, preparation,
19 propagation, compounding, conversion or processing of a device or a
20 drug, either directly or indirectly by extraction from substances of
21 natural origin or independently by means of chemical or biological
22 synthesis and includes any packaging or repackaging of the
23 substances or labeling or relabeling of its container, and the
24 promotion and marketing of such drugs or devices. The term
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1 "manufacturing" also includes the preparation and promotion of
2 commercially available products from bulk compounds for resale by
3 licensed pharmacies, licensed practitioners or other persons;
4 25. "Medical gas" means those gases, including those in liquid
5 state upon which the manufacturer or distributor has placed one of
6 several cautions, such as "Rx Only", in compliance with federal law;
7 26. "Medical gas order" means an order for medical gas issued
8 by a licensed prescriber;
9 27. "Medical gas distributor" means a person licensed to
10 distribute, transfer, wholesale, deliver or sell medical gases on
11 drug orders to suppliers or other entities licensed to use,
12 administer or distribute medical gas and may also include a patient
13 or ultimate user;
14 28. "Medical gas supplier" means a person who dispenses medical
15 gases on drug orders only to a patient or ultimate user;
16 29. "Medicine" means any drug or combination of drugs which has
17 the property of curing, preventing, treating, diagnosing or
18 mitigating diseases, or which is used for that purpose;
19 30. "Nonprescription drugs" means medicines or drugs which are
20 sold without a prescription and which are prepackaged for use by the
21 consumer and labeled in accordance with the requirements of the
22 statutes and regulations of this state and the federal government.
23 Such items shall also include medical and dental supplies and
24 bottled or nonbulk chemicals which are sold or offered for sale to
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1 the general public if such articles or preparations meet the
2 requirements of the Federal Food, Drug and Cosmetic Act, 21
3 U.S.C.A., Section 321 et seq.;
4 31. "Outsourcing facility" including "virtual outsourcing
5 facility" means a facility at one geographic location or address
6 that:
7 a. is engaged in the compounding of sterile drugs,
8 b. has elected to register as an outsourcing facility,
9 and
10 c. complies with all requirements of 21 U.S.C. 353b;
11 32. "Package" means the smallest individual saleable unit of
12 product for distribution by a manufacturer or repackager that is
13 intended by the manufacturer for ultimate sale to the dispenser of
14 such product. For the purposes of this paragraph, "individual
15 saleable unit" means the smallest container of a product introduced
16 into commerce by the manufacturer or repackager that is intended by
17 the manufacturer or repackager for individual sale to a dispenser;
18 33. "Person" means an individual, partnership, limited
19 liability company, corporation or association, unless the context
20 otherwise requires;
21 34. "Pharmacist-in-charge" or "PIC" means the pharmacist
22 licensed in this state responsible for the management control of a
23 pharmacy and all other aspects of the practice of pharmacy in a
24 licensed pharmacy as defined by Section 353.18 of this title;
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1 35. "Pharmacy" means a place regularly licensed by the Board of
2 Pharmacy in which prescriptions, drugs, medicines, chemicals and
3 poisons are compounded or dispensed or such place where pharmacists
4 practice the profession of pharmacy, or a pharmacy operated by the
5 Oklahoma Department of Veterans Affairs;
6 36. "Pharmacy technician", "technician", "Rx tech", or "tech"
7 means a person issued a Technician pharmacy technician permit by the
8 State Board of Pharmacy to assist the pharmacist and perform
9 nonjudgmental, technical, manipulative, non-discretionary functions
10 in the prescription department under the immediate and direct
11 supervision of a pharmacist;
12 37. "Poison" means any substance which when introduced into the
13 body, either directly or by absorption, produces violent, morbid or
14 fatal changes, or which destroys living tissue with which such
15 substance comes into contact;
16 38. "Practice of pharmacy" means:
17 a. the interpretation and evaluation of prescription
18 orders,
19 b. the compounding, dispensing, administering and
20 labeling of drugs and devices, except labeling by a
21 manufacturer, repackager or distributor of
22 nonprescription drugs and commercially packaged legend
23 drugs and devices,
24
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1 c. the participation in drug selection and drug
2 utilization reviews,
3 d. the proper and safe storage of drugs and devices and
4 the maintenance of proper records thereof,
5 e. the responsibility for advising by counseling and
6 providing information, where professionally necessary
7 or where regulated, of therapeutic values, content,
8 hazards and use of drugs and devices,
9 f. the offering or performing of those acts, services,
10 operations or transactions necessary in the conduct,
11 operation, management and control of a pharmacy, or
12 g. ordering, performing, and interpreting tests
13 authorized by the United States Food and Drug
14 Administration and waived under the federal Clinical
15 Laboratory Improvement Amendments of 1988 and
16 initiating drug therapy for minor, nonchronic health
17 conditions,
18 h. the dispensing of self-administered hormonal
19 contraceptives and any nicotine replacement therapy
20 product that is approved by the United States Food and
21 Drug Administration, or
22 i. the provision of those acts or services that are
23 necessary to provide pharmaceutical care;
24
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1 39. "Preparation" means an article which may or may not contain
2 sterile products compounded in a licensed pharmacy pursuant to the
3 order of a licensed prescriber;
4 40. "Prescriber" means a person licensed in this state who is
5 authorized to prescribe dangerous drugs within the scope of practice
6 of the person's profession;
7 41. "Prescription" means and includes any order for drug or
8 medical supplies written or signed, or transmitted by word of mouth,
9 telephone or other means of communication:
10 a. by a licensed prescriber,
11 b. under the supervision of an Oklahoma licensed
12 practitioner, an Oklahoma licensed advanced practice
13 registered nurse or an Oklahoma licensed physician
14 assistant, or
15 c. by an Oklahoma licensed wholesaler or distributor as
16 authorized in Section 353.29.1 of this title;
17 42. "Product" means a prescription drug in a finished dosage
18 form for administration to a patient without substantial further
19 manufacturing, such as capsules, tablets, and lyophilized products
20 before reconstitution. "Product" does not include blood components
21 intended for transfusion, radioactive drugs or biologics and medical
22 gas;
23 43. "Repackager", including "virtual repackager", means a
24 person who owns or operates an establishment that repacks and
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1 relabels a product or package for further sale or distribution
2 without further transaction;
3 44. "Sterile drug" means a drug that is intended for parenteral
4 administration, an ophthalmic or oral inhalation drug in aqueous
5 format, or a drug that is required to be sterile under state and
6 federal law;
7 45. "Supervising physician" means an individual holding a
8 current license to practice as a physician from the State Board of
9 Medical Licensure and Supervision, pursuant to the provisions of the
10 Oklahoma Allopathic Medical and Surgical Licensure and Supervision
11 Act, or the State Board of Osteopathic Examiners, pursuant to the
12 provisions of the Oklahoma Osteopathic Medicine Act, who supe