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SENATE FLOOR VERSION
February 9, 2023
COMMITTEE SUBSTITUTE
FOR
SENATE BILL NO. 931 By: Garvin
An Act relating to the practice of pharmacy ; 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 definition s used in the
Oklahoma Pharmacy Act; modifying and adding
definitions; allowing pharmacist to test for, screen
for, or treat minor, nonchronic health conditions;
specifying permitted tests and screening pr ocedures;
allowing pharmacist to dispense certain products
under certain protocol; directing promulgation of
rules; updating statutory lan guage; updating
statutory reference; providing for codification;
providing an effective date; and declaring an
emergency.
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 (5 9 O.S. Supp. 2022,
Section 353.1), is amen ded to read as follows:
Section 353.1. For the purposes of the Oklahoma Pharmacy Act:
1. “Accredited program” means those seminars, classes,
meetings, work projects, and oth er educational courses approved by
the Board State Board of Pharmacy for purposes of continuing
professional education;
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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 Oklahom a this state 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 whe re 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, reconstituting or otherwise altering of a drug or
bulk drug substance to create a drug. Compounding includes the
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preparation of drugs or devices in anticipation of prescript ion drug
orders based on routine, regularly observed pre scribing 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
drugs and dosage forms; and the etiology, char acteristics 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. 353(b)(1), or
b. is labeled “Prescription Only”, or labeled with the
following statement: “Caution: Federal law restricts
this drug except for 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 indi cates 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 appr opriately
labeled for subsequent ad ministration to, or use by, a patient.
Dispense includes sell, distribute, leave with, give away, dispose
of, deliver or supply;
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13. “Dispenser” means a retail pharmacy, hospital pharmacy, a
group of chain pharmacies un der common ownership and control th at 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 und er common
ownership and control that do not act as a wholesale distributor.
For the purposes of this paragraph, “dispenser” 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 product, and
does not include the dispensing of a product pursuant 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. 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 s hall
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 faciliti es, wholesale distributors, third-party
logistics providers, pharm acies, and all other facilities which are
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engaged in dispensing, delivery, distribution or storage of
dangerous drugs;
17. “Drugs” means all medicinal substances and preparations
recognized by the United States Pharmacopoeia Pharmacopeia and
National Formulary, 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 preparatio ns, 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 th e manufacturer that is
not intended to be s old 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 375.2 of this title;
20. “Filled prescription” means a packaged pres cription
medication to which a label has been affixed which con tains 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 pharm acy
operated by the Oklahoma Department of Veterans Affairs;
22. “Licensed practitioner” means an allopathic physician,
osteopathic physician, podiatric physician, dentist, veterinarian or
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optometrist licensed to practice and authorize d 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
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 subpara graph 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
drug, either directly or indirectly by extraction from substances of
natural origin or independently by means of chemical or biological
synthesis and includes any pac kaging or repackaging of the
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substances or labeling or relabeling of its container, and the
promotion and marketing of such drug s or devices. The term
“manufacturing” manufacturing also includes the preparation and
promotion of commercially avail able 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 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 oth er 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 disp enses medical
gases on drug orders only to a pati ent 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. “Minor, nonchronic health condition” means a typically
short-term health condition that is generally managed with
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noncontrolled drug therapies, min imal treatment, or self -care, which
includes the following:
a. influenzas,
b. streptococcus,
c. SARS-COV-2 or other respiratory illness, condition, or
disease,
d. lice,
e. urinary tract infections ,
f. skin conditions, such as ringworm and athlete ’s foot,
and
g. other emerging and existing pub lic health threats
identified by the State Department of Health if
permitted by an order, rule, or regulation.
31. “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 requirements of the
statutes and regulations 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
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.;
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31. 32. “Outsourcing facility” including “virtual outsourcing
facility” means a facility at one geographic 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. 33. “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;
33. 34. “Person” means an individual, partnership, limited
liability company, corporation or association, unless the context
otherwise requires;
34. 35. “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;
35. 36. “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
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where pharmacists practice the profession of pharmacy, or a pharmacy
operated by the Oklahoma Department of Veterans Affairs;
36. 37. “Pharmacy technician”, “technician”, “Rx tech”, or
“tech” means a person issued a Technician permi t 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 supervi sion
of a pharmacist;
37. 38. “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. 39. “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 a nd 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 de vices and
the maintenance of proper records 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 acts, services,
operations or transactions necessary in t he conduct,
operation, management and control of a pharmacy, or
g. the ordering, performing, and interpreting of 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, nonchronic health
conditions,
h. the dispensing of se lf-administered hormonal
contraceptives and any nicotine replacement therapy
product that is approved by the United States F ood and
Drug Administration, or
i. the provision of those acts or services that are
necessary to provide pharmaceutical care;
39. 40. “Preparation” means an article which may or may not
contain sterile produc ts compounded in a licensed pharmacy pursuant
to the order of a licensed prescriber;
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40. 41. “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. 42. “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 Okla homa licensed
practitioner, an Oklahoma licensed advanced practice
registered nurse Advanced Practice Registered Nurse or
an Oklahoma licensed physician assistant, or
c. by an Oklahoma licensed wholesaler or distributor as
authorized in Section 353.29.1 of this title;
42. 43. “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” Product does not include
blood components intended for transfusion, radioactive drugs or
biologics and medical gas;
43. 44. “Repackager”, including “virtual repackager”, means a
person who owns or operates an establis hment that repacks and
relabels a product or package for further sale or distribution
without further transaction;
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44. 45. “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. 46. “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 prov isions of the
Oklahoma Allopathic Medical and Surgical Licensur e 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 nurs e 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 nurs e Advanced Practice
Registered Nurse, such physician shall remain in compliance with the
rules promulgated by the State Boar d of Medical Licensure and
Supervision or the State Board of O steopathic Examiners;
46. 47. “Supportive personnel” means technicians and auxil iary
supportive persons who are regularly paid employees of a pharmacy
who work and perform ta sks in the pharmacy as authorized by Section
353.18A of this title;
47. 48. “Third-party logistics provider” including “virtual
third-party logistics provider ” means an entity that provides or
coordinates warehousing, or other logistics services of a product in
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interstate commerce on behalf 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 provider” third-party logistics provider does
not include shippers and the United States Postal Service;
48. 49. “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;
49. 50. “County jail” means a facility operated by a county for
the physical detention and correction of persons charged with, or
convicted of, criminal o ffenses or ordinance violations or persons
found guilty of civil or criminal contempt;
50. 51. “State correctional facility” means a facility or
institution that houses a p risoner population under the jurisdiction
of the Department of Corrections;
51. 52. “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
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52. 53. “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 expirat ion date.
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 i n numbering, reads as follows :
A. A pharmacist may test or screen for a nd administer treatment
for minor, nonchronic health conditions.
B. A pharmacist who test s or screens for and treats minor,
nonchronic health conditions provided by this secti on may use any
test that may guide clinical decision-making, which the Centers for
Medicare and Medicaid Services has determined qualifies for a waiver
under the federal Clinical Laboratory Improvement Amendments of
1988, or the federal rules adopted there under, or any establish ed
screening procedures that can safely be performed by a pharmacist.
C. A pharmacist may dispense self-administered hormonal
contraceptives and nicotine replacement therapy products under the
protocol established pursuant to subsection D of this section,
regardless of whether the patient has obtained a prescription.
D. The State Board of Pharmacy shall adopt rules establishing a
protocol for dispensing self-administered hormonal contraceptives
and nicotine replacement therapy produc ts by January 1, 2024.
SECTION 3. This act shall become effective July 1, 2023.
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SECTION 4. It being immediately necessary for the prese rvation
of the public peace, health or safety, an emergency is hereby
declared to exist, by reason whereof this act shall t ake effect and
be in full force from and after its passage and approval.
COMMITTEE REPORT BY: COMMITTEE ON HEALTH AND HUMAN SERVICES
February 9, 2023 - DO PASS AS AMENDED BY CS