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SENATE FLOOR VERSION
February 15, 2024
SENATE BILL NO. 1541 By: Garvin
An Act relating to the practice of pharmacy; allowing
pharmacist to test or screen for and initiate drug
therapy for minor, nonchronic health conditions;
specifying allowed tests ; allowing pharmacist to
dispense certain products under certain protocol;
directing promulgation of rules; amending 59 O.S.
2021, Section 353.1, as amended by Sect ion 6, Chapter
288, O.S.L. 2022 (59 O.S. Supp. 202 3, Section 353.1),
which relates to defini tions used in the Oklahoma
Pharmacy Act; modifying and adding definitions;
updating statutory language and references; providing
for codification; providing an effective date; and
declaring an emergency .
BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKL AHOMA:
SECTION 1. 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 initiate drug
therapy for minor, nonchronic health conditions as defined in
Section 353.1 of Title 59 of the Oklahoma Stat utes.
B. To test for minor, nonchronic he alth conditions under this
section, the pharmacist may use any test that may guide clinical
decision-making and that is:
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1. Approved by, cleared by, or authorized under an emergency
use authorization by the United States Food and Drug Administration;
and
2. Waived under the federal C linical Laboratory Improvement
Amendments of 1988 (CLIA) or deemed to be CLIA-waived for use in
patient care settings operating under a CLIA certificate.
C. A pharmacist may dispense self-administered hormonal
contraceptives under the protocol es tablished 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 by
January 1, 2025.
SECTION 2. AMENDATORY 59 O.S. 2021, Section 353.1, as
amended by Section 6 , Chapter 288, O.S.L. 2022 (5 9 O.S. Supp. 2023,
Section 353.1), is amended 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;
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 means, 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 thi s title and for the
purposes of the Okla homa 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 prescriptio n by a licensed pharmac ist 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 sta te 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 scien ce and art of
chemistry, whether of o rganic 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 anticip ation of prescription drug
orders based on routine, regularly observed prescribing patterns;
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9. “Continuing professional education” means professional,
pharmaceutical education in the general areas of the socioeco nomic
and legal aspects of health care; th e properties and actions of
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. 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 Boar d
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 delive ry of a drug or device to a
patient or a patient’s agent in a suitable container appr opriately
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 un der common ownership and control that do
not act as a wholesale distributor, or any other person authorized
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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” 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
engaged in dispensing, delivery, distribution, or storage of
dangerous drugs;
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17. “Drugs” means all medicinal substances and pre parations
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 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 an d responsibility of th e 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 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 o f 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 optometrist licensed to practice and authori zed to prescribe
dangerous drugs within the scope of practice of such practitioner;
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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 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
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
substances or labeling or relabeling of its container, and the
promotion and marketing of such drugs or devices. The term
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“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 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 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 m anaged with
noncontrolled drug therapies, min imal treatment, or sel f-care, and
is limited to the following:
a. influenzas,
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b. streptococcus,
c. SARS-CoV-2,
d. lice, and
e. 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.;
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 drugs,
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
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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 the 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
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 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;
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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 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 t he conduct,
operation, management, and control of a pharmacy, or
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g. the ordering, performing, and interpreting of tests
for minor, nonchronic health co nditions that meet the
requirements of Section 1 of this act and the
initiation of drug therapy for minor, nonchronic
health conditions,
h. the dispensing of se lf-administered hormonal
contraceptives as provided by Section 1 of this act,
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;
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 Oklahoma licensed
practitioner, an Oklahoma licensed advanced practice
registered nurse Advanced Practice Registered Nurse,
or an Oklahoma licensed physician assistant, or
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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 patien t without 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 establishment that repacks and
relabels a product or package for further sale or distribution
without further transaction;
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 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 Advanced Practice Registered
Nurse as defined in Section 567.3a of this title, and who is not in
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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 Osteopathic Examiners;
46. 47. “Supportive personnel” means technicians and auxil iary
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. 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
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;
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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 prisoner 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
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 3. This act shall become effective July 1, 2024.
SECTION 4. It being immediately necessary for the prese rvation
of the public peace, health or safety, an emergenc y 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 15, 2024 - DO PASS