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STATE OF OKLAHOMA
1st Session of the 59th Legislature (2023)
HOUSE BILL 1655 By: McEntire
AS INTRODUCED
An Act relating to professions and occupations;
amending 59 O.S. 2021, Section 353.1, as amended by
Section 6, Chapter 288, O.S.L. 2022 (59 O.S. Supp.
2022, Section 353.1), which relates to the Oklahoma
Pharmacy Act, modifying definition; authorizing
pharmacists to screen and test for certain
conditions; providing for adoption of regulations;
providing for codification; and providing an
effective date.
BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
SECTION 1. AMENDATORY 59 O.S. 2021, Section 353.1, as
amended by Section 6, Chapter 288, O.S.L. 2022 (59 O.S. Supp . 2022,
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 e ducation;
2. "Act" means the Oklahoma Pharmacy Act;
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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
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 authori ty 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 wit h dispensing authority;
7. "Chemical" means any medicinal substance, whether simple or
compound or obtained through the process of the science and art of
chemistry, whether of organic or inorganic ori gin;
8. "Compounding" means the combining, admixing, m ixing,
diluting, pooling, reconstitut ing 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 prescript ion drug
orders based on routine, regularly observed pre scribing patterns;
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9. "Continuing professional education" means professional,
pharmaceutical education in the general areas of the socioeconomic
and legal aspects of health care; the properties and actions of
drugs and dosage forms; and the etiology, char acteristics and
therapeutics of the d iseased state;
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 preparation and delivery of a drug or device to a
patient or a patient 's agent in a suitable container appropria tely
labeled for subsequent ad ministration to, or use by, a patient .
Dispense includes sell, distribute, leave with, give away, dispose
of, deliver or supply;
13. "Dispenser" means a retail pharmacy, hospital pharmacy, a
group of chain pharmacies under c ommon ownership and control th at do
not act as a wholesale distribut or, or any other person authorized
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by law to dispense or adm inister prescription drugs, and the
affiliated warehouses or distributions of such entities und er common
ownership and control t hat do not act as a wholesale distributor.
For the purposes of this paragraph, "dispenser" does not mean a
person who dispenses only products to be used in animals in
accordance with 21 U.S.C. 360b(a)(5);
14. "Distribute" or "distribution" means the sale, purchase,
trade, delivery, handling, storage, or receipt of a prod uct, 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 ti tle shall not be
required;
15. "Doctor of Pharmacy" means a person licensed by the Board
to engage in the practice of pharmacy . The terms "pharmacist",
"D.Ph.", and "Doctor of Pharmacy" shall be interchangeable and s hall
have the same meaning wherever th ey appear in the Oklahoma Statutes
and the rules promulgated by the Board;
16. "Drug outlet" means all manufacturers, repackagers,
outsourcing faciliti es, wholesale distributors, third -party
logistics providers, pharm acies, and all other facilities which are
engaged in dispensing, delivery, distribution or storage of
dangerous drugs;
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17. "Drugs" means all medicinal substances and preparations
recognized by the United States Pharmacopoeia and National
Formulary, or any revision thereof, and all substances and
preparations intended for external and/or internal use i n 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 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 2 375.2 of this act title;
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 practice and authorize d to prescribe
dangerous drugs within the scope of practice of such practitione r;
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23. "Manufacturer" or "virtual manufacturer" means with respect
to a product:
a. a person that holds an application appr oved under 21
U.S.C. 355 or a license issued under 42 U.S.C. 262 for
such product, or if such product is not the subject of
an approved application or license, the person who
manufactured the prod uct,
b. a co-licensed partner of the person described in
subparagraph a that obtains the product directly from
a person described in this subpa ragraph 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 packaging 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
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"manufacturing" also includes the preparation and promoti on of
commercially available produc ts 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 dispe nses 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 regulati ons of this state and the federal gov ernment.
Such items shall also include medical and d ental supplies and
bottled or nonbulk chemicals which are sold or offered for sale to
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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.;
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 dru gs,
b. has elected to register as an outsourcing facility,
and
c. complies with all requirem ents of 21 U.S.C. 353b;
32. "Package" means the smallest individual saleable unit of
product for distribution by a manufact urer or repackager that is
intended by the manufacturer for ultimate s ale to the dispenser of
such product. For the purposes of this paragraph, "individual
saleable unit" means the smallest container of a product intro duced
into commerce by the manufactur er or repackager that is intended by
the manufacturer or repackager fo r individual sale to a dispenser;
33. "Person" means an individual, partnershi p, limited
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 the practice of pharmacy in a
licensed pharmacy as defined by Section 353.18 of this title;
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35. "Pharmacy" means a place regularly licensed by the Board of
Pharmacy in which prescriptions, drugs, medicines, chemicals and
poisons are compounded or dispe nsed or such place where pharmacists
practice the profession of pharmacy, or a pharmacy operated b y the
Oklahoma Department of V eterans Affairs;
36. "Pharmacy technician", "technician", "Rx tech", or "tech"
means a person issued a Technician pharmacy technician permit by the
State Board of Pharmacy to assist the pharmacist and perform
nonjudgmental, technical, manipu lative, 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 a nd commercially packaged legend
drugs and devices,
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c. the participation in drug selection and drug
utilization reviews,
d. the proper and safe storage of drugs and de vices and
the maintenance of proper r ecords thereof,
e. the responsibility for advising by counseling and
providing information, where professionally necessary
or where regulated, of therapeutic values, content,
hazards and use of drugs and devices,
f. the offering or performing of those ac ts, services,
operations or transactions necessary in t he conduct,
operation, management and control of a pharmacy, or
g. ordering, performing, and interpreting tests
authorized by the United States Food and Drug
Administration and waived under the federal Clinical
Laboratory Improvement Amendments of 1988 and
initiating drug therapy for minor, nonch ronic health
conditions,
h. the dispensing of self-administered hormonal
contraceptives and any nicotine replacement therapy
product that is approved by the United States Food and
Drug Administration, or
i. the provision of those acts or services that are
necessary to provide pharmaceutical care;
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39. "Preparation" means an article which may or may not contain
sterile products compounded in a licensed pharmacy pursuant to the
order of a licensed prescriber;
40. "Prescriber" means a person licensed in this state who is
authorized to prescribe dangerous drugs within the scope of practice
of the person's profession;
41. "Prescription" means and includes any order for drug or
medical supplies written or signed, or transmitted by word of mouth,
telephone or other means of communication:
a. by a licensed prescriber,
b. under the supervision of an Oklahoma licensed
practitioner, an Oklahoma licensed advanced practice
registered nurse or an Oklahoma licensed physician
assistant, or
c. by an Oklahoma licensed wholesaler or dist ributor 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 w ithout substantial further
manufacturing, such as ca psules, tablets, and lyophilized products
before reconstitution. "Product" does not include blood components
intended for transfusion, radioactive drugs or biologics and med ical
gas;
43. "Repackager", including "virtual repackager", means a
person who owns or operates an establishment that repac ks and
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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 Licensure and Supervision
Act, or the State Board of Osteopathic Examiners, pursuant to t he
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
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 Osteopathic Examiners;
46. "Supportive personnel " means technicians and auxil iary
supportive persons who are regularly paid employees of a pharma cy
who work and perform ta sks in the pharmacy as authorized by Section
353.18A of this title;
47. "Third-party logistics provider" including "virtual third-
party logistics provider " means an entity that provides or
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coordinates warehousing, or other logi stics services of a product in
interstate commerce on beh alf of a manufacturer, wholesale
distributor, or dispenser of a product but does not take ownership
of the product, nor have res ponsibility to direct the sale or
disposition of the product. For the purposes of this paragraph,
"third-party logistics provid er" does not include shippers and the
United States Postal Service;
48. "Wholesale distributor " including "virtual wholesale
distributor" means a person other than a manufacturer, a
manufacturer's co-licensed partner, a thir d-party logistics
provider, or repackager engaged in wholesale distribution as defined
by 21 U.S.C. 353(e)(4) as amended by the Drug Supply Chain Security
Act;
49. "County jail" means a facility operated by a county for the
physical detention and correct ion of persons charged with, or
convicted of, criminal offenses or ordinance violations or persons
found guilty of civil or criminal contempt;
50. "State correctional facility " means a facility or
institution that houses a p risoner population under the j urisdiction
of the Department of Corrections;
51. "Unit dose package" means a package that contains a single
dose drug with the name, strength, control number, and expiratio n
date of that drug on the label; and
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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.
SECTION 2. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 353.31 of Title 59, unless there
is created a duplication in numbering, reads as follow s:
A. A pharmacist may test or screen for and administer tre atment
for minor, nonchronic health conditions. For purposes of this
section, a minor, nonchronic health condition i s typically a short-
term health condition t hat is generally managed with non -controlled
drug therapies, minimal treatment, or self -care and includes all of
the following:
1. Influenza;
2. Streptococcus;
3. SARS-COV-2 or other respiratory illness, conditio n, or
disease;
4. Lice;
5. Urinary tract infection;
6. Skin conditions, such as ringworm and athlete's foot; and
7. Other emerging and exist ing public health threats identified
by the State Department of Health if permitted by an order, rule, or
regulation.
B. A pharmacist who tests or scree ns for and treats minor,
nonchronic health conditions under this section may use any test
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that may guide clinical decision making which the Centers for
Medicare and Medicaid Services has determined qualifies for a wa iver
under the federal Clinical Laborato ry Improvement Amendments of
1988, or the federal rules adopted thereunder, or any established
screening procedures that can safely be performed by a pharmacist.
A pharmacist may dispense self-administered hormonal contraceptives
and nicotine replacement therapy products under the protoco l
established pursuant to subsection C of this section, regardless of
whether the patient has obtained a prescription.
C. The Board of Pharmacy shall adopt regulations establishing a
protocol for dispensing self -administered hormonal contraceptives
and nicotine replacement therapy products by January 1, 2024.
SECTION 3. This act shall become effective November 1, 2023.
59-1-5293 LRB 01/10/23