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ENGROSSED HOUSE
BILL NO. 3497 By: McEntire of the House
and
Haste of the Senate
[ pharmacists - modifying pharmacists scope of
practice - effective date –
emergency ]
BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKL AHOMA:
SECTION 1. AMENDATORY 59 O.S. 2021, 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 other educational courses approved by
the Board for purposes of continuing professional ed ucation;
2. "Act" means the Oklahoma Pharmacy Act;
3. "Administer" means the direct application of a drug, whether
by injection, inhalation, ingestion or any ot her means, to the body
of a patient;
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4. "Assistant pharmacist" means any person presently lic ensed
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 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 pharm acist or a
licensed practitioner with dispensing aut hority 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 or igin;
8. "Compounding" means the combining, admixin g, mixing,
diluting, pooling, reconstituti ng 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 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 a ctions of
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drugs and dosage forms; and the etiology, characteristics and
therapeutics of the di seased 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 restr icts
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 appropriately
labeled for subseque nt 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 contr ol that do
not act as a wholesale distribu tor, or any other person authorized
by law to dispense or administer prescription drugs, and the
affiliated warehouses or distributions of such entities under com mon
ownership and control that do not act as a whole sale distributor.
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For the purposes of thi s 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 pro duct, 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 a pproved under 21 U.S.C. 360b(b); provided,
taking actual physical possession of a product or t itle 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 t hey appear in the Oklahoma Statutes
and the rules promulgated by the Board;
16. "Drug outlet" means all manufacturers, repackagers,
outsourcing facilities, whole sale 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 Pharmacopoeia and National
Formulary, or any revision thereof, and all substances and
preparations intended for external and/or internal use in the cure,
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diagnosis, mitigation, treatment or prevention of disease in humans
or animals and all su bstances and preparations, other than food,
intended to affect the structure or any function o f 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 promot e the sale of the
drug;
19. "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;
20. "Hospital" means any institution licensed as a h ospital by
this state for the care and tre atment of patients, or a pharmacy
operated by the Oklahoma Department of Veterans Affairs;
21. "Licensed practitioner " means an allopathic physician,
osteopathic physician, podiatric physician, dentist, veterinari an or
optometrist licensed to practice and authorized to prescribe
dangerous drugs within the scope of practice of such practitioner;
22. "Manufacturer" or "virtual manufacturer " means with respect
to a product:
a. a person that holds an application appro ved under 21
U.S.C. 355 or a license issue d under 42 U.S.C. 262 for
such product, or if such product is not the subject of
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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;
23. "Manufacturing" means the production, preparation,
propagation, compounding, conversion or pro cessing of a device or a
drug, either directly or indirectly by extra ction 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 d evices. The term
"manufacturing" also includes the preparation and promotion of
commercially available products from bulk compounds for resale by
licensed pharmacies, licensed practition ers or other persons;
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24. "Medical gas" means those gases including those in liquid
state upon which the manuf acturer or distributor has placed one of
several cautions, such as "Rx Only", in compliance with federal law;
25. "Medical gas order" means an order for medical gas issued
by a licensed prescriber;
26. "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;
27. "Medical gas supplier " means a person who dispenses medical
gases on drug orders only to a patient or ultimate user;
28. "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 purpo se;
29. "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 A ct, 21
U.S.C.A., Section 321 et seq.;
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30. "Outsourcing facility", including "virtual outsourcing
facility" means a facility at one geographic lo cation or address
that:
a. is engaged in the compounding of sterile d rugs,
b. has elected to register as an out sourcing facility,
and
c. complies with all requirements of 21 U.S.C. 353b;
31. "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 individu al sale to a dispenser;
32. "Person" means an individual, partnership, limited
liability company, corporatio n or association, unless the context
otherwise requires;
33. "Pharmacist-in-charge" or "PIC" means the pharmacist
licensed in this state responsib le 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;
34. "Pharmacy" means a place regularly licensed by t he Board of
Pharmacy in which prescription s, drugs, medicines, chemicals and
poisons are compounded or dispensed or such place where pharmacists
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practice the profession of pharmacy, or a pharmacy operated by the
Oklahoma Department of Veterans Affairs;
35. "Pharmacy technician", "technician", "Rx tech", or "tech"
means a person issued a Technician permit by the State Board of
Pharmacy to assist the phar macist and perform nonjudgmental,
technical, manipulative, non-discretionary functions in the
prescription department under the immediate and direc t supervision
of a pharmacist;
36. "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 wit h which such
substance comes into contact;
37. "Practice of pharmacy" means:
a. the interpretation and evaluation of prescription
orders,
b. the compounding, dispensing, administering an d
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 rec ords thereof,
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e. the responsibility for ad vising by counseling and
providing information, where professionally necessary
or where regulated, of therape utic values, content,
hazards and use of drugs and devices,
f. the offering or performing of those acts, services,
operations or transactions neces sary in the conduct,
operation, management and control of a pharmacy, or
g. the provision of those acts or se rvices that are
necessary to provide pharmaceutical care ordering,
performing, and evaluating laboratory and clinical
drug therapy related tests and initiating drug therapy
for minor, nonchronic health conditions, or
h. the provision of those acts or ser vices that are
necessary to provide ph armaceutical care;
38. "Preparation" means an article which may or may not contain
sterile products compounded in a licensed pharmacy pursuan t to the
order of a licensed prescriber;
39. "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;
40. "Prescription" means and includes any order for dr ug or
medical supplies written or signed, or transmitted by word of mouth,
telephone or other means of communicati on:
a. by a licensed prescriber,
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b. under the supervision of an Oklahoma licensed
practitioner, an Oklahoma licensed advanced practice
registered nurse or an Oklahoma licensed physicia n
assistant, or
c. by an Oklahoma licensed wholesaler or distributor as
authorized in Section 353.29.1 of thi s title;
41. "Product" means a prescription drug in a finished dosage
form for administration to a patie nt 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 medi cal
gas;
42. "Repackager", including "virtual repackager", means a
person who owns or operates an es tablishment that repacks and
relabels a product or package for further sale or distribution
without further transaction;
43. "Sterile drug" means a drug that is intended for paren teral
administration, an ophthalmic or ora l inhalation drug in aqueous
format, or a drug that is required to be st erile under state and
federal law;
44. "Supervising physician " means an individual holdin g a
current license to prac tice as a physician from the State Board of
Medical Licensure and S upervision, pursuant to the provis ions of the
Oklahoma Allopathic Medica l and Surgical Licensure and Supervis ion
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Act, or the State Board of Osteopathic Examiners, pursuant to the
provisions of the Oklahoma Osteopat hic Medicine Act, who supervises
an advanced practice registered nurse as de fined in Section 567.3a
of this title, and who is not in training as an int ern, resident, or
fellow. To be eligible to supervis e an advanced practice regi stered
nurse, such physician shall remain in compliance with the ru les
promulgated by the State Board of Medical Licensure and Supervision
or the State Board of Osteopathic Exa miners;
45. "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 a uthorized by Section
353.18A of this title;
46. "Third-party logistics provider", including "virtual third-
party logistics prov ider" 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 produ ct but does not take ownership
of the product, nor ha ve responsibility to direct the sale or
disposition of the product. For the purposes of this paragraph,
"third-party logistics provider" does not include shippers an d the
United States Postal Service;
47. "Wholesale distributor ", including "virtual wholesale
distributor" means a person other than a manufa cturer, a
manufacturer's co-licensed partner, a third-party logistics
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provider, or repackager engaged in wholesale distribution as defined
by 21 U.S.C. 353(e)(4) as amended by the Drug Supply Chain Securi ty
Act;
48. "County jail" means a facility operated by a county for the
physical detention an d correction of persons charged wi th, or
convicted of, criminal offenses or ordinance violations or persons
found guilty of civil or criminal contempt;
49. "State correctional facility " means a facility or
institution that houses a prisoner population und er the jurisdiction
of the Department of Corrections;
50. "Unit dose package" means a package that contains a single
dose drug with the name, strength, control n umber, and expiration
date of that drug on the label ; and
51. "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.
SECTION 2. NEW LAW A new section of la w to be codified
in the Oklahoma Statutes as Section 353.40 of Title 59, unless there
is created a duplication in numbering, reads as follows:
A. A pharmacist may test or screen for and treat minor,
nonchronic health conditions. For purposes of this sect ion, a
minor, nonchronic health condition is typically a short-term
condition that is generally managed with minim al treatment or self -
care, and includes:
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1. Influenza;
2. Streptococcus;
3. SARS-COV-2 or other respiratory ill ness, condition, or
disease;
4. Lice;
5. Urinary tract infection;
6. Skin conditions, such as ringworm and athlete's foot; and
7. Minor, uncomplicated infections.
B. A pharmacist who tests or screens for and treats minor,
nonchronic health conditions und er this section may use a ny 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 a dopted thereunder, or any established
screening procedures that can safely be performed by a pharmacist.
C. A pharmacist may dispense a self-administered hormonal
contraceptive and nicotine replacement therapy products under the
protocol established pursu ant to this section, regardless of whether
the patient has obtained a prescription.
D. The Board of Pharmacy shall adopt regulations establishing a
protocol for dispensing sel f-administered hormonal contraceptives
and nicotine replacement therapy products .
SECTION 3. This act shall become effective July 1, 2022.
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SECTION 4. It being immediately necessary for the preservation
of the public peace, health or safety, an emergency is hereby
declared to exist, by reason whereof t his act shall take effect and
be in full force from and after its p assage and approval.
Passed the House of Representatives the 23rd day of March, 2022.
Presiding Officer of the House
of Representatives
Passed the Senate the ___ day of __________, 2022.
Presiding Officer of the Senate