Okla. Stat. tit. 59, § 59-353.1v1

For the purposes of the Oklahoma Pharmacy Act:

1. “Accredited program” means those seminars, classes,

meetings, work projects, and other educational courses approved by

the State Board of Pharmacy 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 means, to the body

of a patient;

4. “Assistant pharmacist” means any person presently licensed

as an assistant pharmacist in this state by the Board pursuant to

Section 353.10 of this title and for the purposes of the Oklahoma

Pharmacy Act shall 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 pharmacist or a

licensed practitioner with dispensing authority to confirm that the

medication, labeling, and packaging of the filled prescription are

accurate and meet all requirements prescribed by state and federal

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 origin;

8. “Compounding” means the combining, admixing, mixing,

diluting, pooling, reconstituting, or otherwise altering of a drug

or bulk drug substance to create a drug. Compounding includes the

preparation of drugs or devices in anticipation of prescription drug

orders based on routine, regularly observed prescribing 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

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drugs and dosage forms; and the etiology, characteristics, and

therapeutics of the diseased state;

10. “Dangerous drug”, “legend drug”, “prescription drug”, or

“Rx Only” means a drug:

a. for human use subject to 21 U.S.C., Section 353(b)(1),

or

b. is labeled “Prescription Only”, or labeled with the

following statement: “Caution: Federal law restricts

this drug to 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 preparation and delivery of a drug or device to a

patient or a patient’s agent in a suitable container appropriately

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 common ownership and control that do

not act as a wholesale distributor, or any other person authorized

by law to dispense or administer prescription drugs, and the

affiliated warehouses or distributions of such entities under common

ownership and control that 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., Section 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., Section

353(b)(1) or the dispensing of a product approved under 21 U.S.C.,

Section 360b(b); provided, taking actual physical possession of a

product or title shall not be required;
stribution” 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., Section

353(b)(1) or the dispensing of a product approved under 21 U.S.C.,

Section 360b(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 shall

have the same meaning wherever they appear in the Oklahoma Statutes

and the rules promulgated by the Board;

16. “Drug outlet” means all manufacturers, repackagers,

outsourcing facilities, 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 Pharmacopeia and National Formulary,

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or any revision thereof, and all substances and preparations

intended for external and/or internal use in the cure, diagnosis,

mitigation, treatment, or prevention 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 manufacturer 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 375.2 of this title;

20. “Filled prescription” means a packaged prescription

medication to which a label has been affixed which contains 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:

a. an allopathic physician,

b. an osteopathic physician,

c. a podiatric physician,

d. a dentist,

e. a veterinarian,

f. an optometrist, or

g. a physician assistant,

licensed to practice and authorized to prescribe dangerous drugs

within the scope of practice of such practitioner;

23. “Manufacturer” or “virtual manufacturer” means with respect

to a product:

a. a person that holds an application approved under 21

U.S.C., Section 355 or a license issued under 42

U.S.C., Section 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 of this paragraph that obtains the

product 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 of this paragraph 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

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drug, either directly or indirectly by extraction from substances of

natural origin or independently by means of chemical or biological

synthesis and includes any packaging or repackaging of the

substances or labeling or relabeling of its container, and the

promotion and marketing of such drugs or devices. The term

manufacturing also includes the preparation and promotion of

commercially available products from bulk compounds for resale by
from substances of

natural origin or independently by means of chemical or biological

synthesis and includes any packaging or repackaging of the

substances or labeling or relabeling of its container, and the

promotion and marketing of such drugs or devices. The term

manufacturing also includes the preparation and promotion 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 law;

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 which has

the property of curing, preventing, treating, diagnosing, or

mitigating diseases, or which is used for that purpose;

30. “Nonprescription drugs” means medicines or drugs which are

sold without a prescription and which are prepackaged for use by the

consumer and labeled in accordance with the requirements of the

statutes and regulations of this state and the federal government.

Such items shall also include medical and dental supplies and

bottled or nonbulk chemicals which are sold or offered for sale to

the general public if such articles or preparations 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 geographic 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 requirements of 21 U.S.C., Section

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 sale to the dispenser of

such product. For the purposes of this paragraph, “individual

saleable unit” means the smallest container of a product introduced

into commerce by the manufacturer or repackager that is intended by

the manufacturer or repackager for individual sale to a dispenser;

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33. “Person” means an individual, partnership, limited

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 the management control of a

pharmacy and all other aspects of the practice of pharmacy in a

licensed pharmacy as provided by Section 353.18 of this title;

35. “Pharmacy” means a place regularly licensed by the State

Board of Pharmacy in which prescriptions, drugs, medicines,

chemicals, and poisons are compounded or dispensed 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

Pharmacy to assist the pharmacist and perform nonjudgmental,

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, produces violent, morbid, or

fatal changes, or which destroys living tissue with which such
cy to assist the pharmacist and perform nonjudgmental,

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, produces violent, morbid, or

fatal changes, or which 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, administering, 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 records 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,

f. the offering or performing of those acts, services,

operations, or transactions 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;

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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. (1) under the supervision of a supervising physician,

by an Oklahoma licensed advanced practice registered

nurse, or

(2) by an Oklahoma licensed physician assistant

pursuant to a practice agreement, or

c. by an Oklahoma licensed wholesaler or distributor as

authorized in Section 353.29.1 of this title;

42. “Product” means a prescription drug in a finished dosage

form for administration to a patient without substantial further

manufacturing, such as capsules, tablets, and lyophilized products

before reconstitution. Product does not include blood components

intended for transfusion, radioactive drugs or biologics and medical

gas;

43. “Repackager”, including “virtual repackager”, means a

person who owns or operates an establishment that repacks and

relabels a product or package for further sale or distribution

without further transaction;

44. “Sterile drug” means a drug that is intended for parenteral

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 Licensure 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 Section 567.3a

of this title,

and who is not in training 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 Licensure and Supervision or the State

Board of Osteopathic Examiners;

46. “Supportive personnel” means technicians and auxiliary

supportive persons who are regularly paid employees of a pharmacy
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 Licensure and Supervision or the State

Board of Osteopathic Examiners;

46. “Supportive personnel” means technicians and auxiliary

supportive persons who are regularly paid employees of a pharmacy

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

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coordinates warehousing, or other logistics services of a product in

interstate commerce on behalf of a manufacturer, wholesale

distributor, or dispenser of a product but does not take ownership

of the product, nor have responsibility to direct the sale or

disposition of the product. For the purposes of this paragraph,

third-party logistics provider 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 wholesale distribution as defined

by 21 U.S.C., Section 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 correction of persons charged with, or

convicted of, criminal offenses or ordinance violations or persons

found guilty of civil or criminal contempt;

50. “State correctional facility” means a facility or

institution that houses a prisoner population under the jurisdiction

of the Department of Corrections;

51. “Unit dose package” means a package that contains a single

dose drug with the name, 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 date.