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ENGROSSED SENATE AMENDMENT
TO
ENGROSSED HOUSE
BILL NO. 2649 By: Echols of the House
and
Dugger of the Senate
An Act relating to durable medical equipment;
creating the Oklahoma Durable Medical Equipment
Licensing Act; defining terms; requiring a license;
providing for effective date of license; authorizing
certain inspections; requiring promulgation of rules;
construing provision ; providing for licensing
qualifications; providing for license revocation or
suspension; listing exceptions; providing for
codification; and providing an effective date .
AUTHOR: Remove as principal Senate author Dugger and substitute as
principal Senate autho r Garvin. Retain Dugger as Senate
coauthor
AUTHOR: Add the following Senate Coauthor: Stephens
AMENDMENT NO. 1. Page 1, strike the title, enacting clause and
entire bill and insert
“An Act relating to durable medical equipment;
creating the Oklahoma Durable Medical Equipment
Licensing Act; defining terms; requiring a license;
stipulating duration of license; aut horizing certain
inspections; requiring promulgation of rules;
construing provision; stating licensing
qualifications; requiring license for each individual
location; allowing licensing of out -of-state supplier
under certain condition and assessment of add itional
fee; requiring licensed supplier to meet established
safety standards; providing for license revocation or
suspension; listing exceptions; amending 59 O.S.
2021, Section 353.1, which relates to definitions
used in the Oklahoma Pharmacy Act; adding definition;
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amending 59 O.S. 2021, Section 353.7, which relates
to powers and duties of the State Board of Pharmacy;
broadening power to issue licenses; establishing
licensure fees for stated entities; providing for
codification; and providing an effective date.
BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
SECTION 1. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 375.1 of Title 59, unless there
is created a duplication in numbering, reads as follows:
Sections 2 through 5 of this act shall be known and may be cited
as the “Oklahoma Durable Medical Equipment Licensing Act ”.
SECTION 2. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 37 5.2 of Title 59, unless there
is created a duplication in numbering, reads as follows:
As used in the Oklahoma Durable Medical Equipment Licensing A ct:
1. “Board” means the State Board of Pharmacy;
2. a. “Durable medical equipment” means equipment for which
a prescription is required including for repair and
replacement parts, and that :
(1) can stand repeated use,
(2) has an expected useful life of at least t hree (3)
years,
(3) is primarily and customarily used to serve a
medical purpose,
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(4) is not generally useful to a person in the
absence of illness or injury,
(5) is appropriate for use in the home, and
(6) is intended for use by the consumer .
b. Durable medical equipment includes, but is not limited
to:
(1) ambulating assistance equipment,
(2) mobility equipment,
(3) rehabilitation seating,
(4) oxygen care and oxygen delivery systems,
(5) respiratory equipment and respiratory disease
management devices,
(6) rehabilitation environmental control equipment,
(7) ventilators,
(8) apnea monitors,
(9) diagnostic equipment,
(10) feeding pumps,
(11) beds prescribed by physicians to alleviate
medical conditions,
(12) transcutaneous electrical nerve stimulators, and
(13) sequential compression devices; and
3. “Supplier” means any person or entity that provides durabl e
medical equipment services or products and that currently bills or
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plans to bill a claim for reimbursement of services or products to a
third party.
SECTION 3. NEW LAW A new section of law to be codified
in the Oklahoma Statutes a s Section 375.3 of Title 59, unless there
is created a duplication in numbering, reads as follows:
A. Any supplier of durable medical equipment to a cons umer in
this state shall possess a durable medical equipment supplier
license issued by the State Board of Pharmacy pursuant to the
Oklahoma Durable Medical Equipment Licensing Act .
B. Licenses issued by the Board pursuant to the Oklahoma
Durable Medical Equipment Licensing Act shall be effective for
twelve (12) months from the date of issuance and shall not be
transferable or assignable.
C. The Board may initially and periodically inspect the
applicant’s office or place of business.
D. The Board shall promulgate rules necessary to implement the
provisions of the Oklahoma Durable Medical Equipment Licens ing Act.
Such rules shall prioritize patient safety and quality of durable
medical equipment. The Board may provide by rule that a ny person or
entity accredited by organizations recognized by the Centers for
Medicare and Medicaid Services is deemed to me et all or some of the
requirements of the Oklahoma Durable Medical Equipment Licensing
Act.
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E. Nothing in this section shall be construed to restrict or
prohibit private transactions between two parties.
SECTION 4. NEW LAW A new se ction of law to be codified
in the Oklahoma Statutes as Section 37 5.4 of Title 59, unless there
is created a duplication in numbering, reads as follows:
A. The State Board of Pharmacy may issue a license to an
applicant for licensure as a supplier of dura ble medical equipment
if the applicant pays the appropriate license fee established under
Section 8 of this act and submits in a form prescribed by the Bo ard
an application and proof that the applicant:
1. a. Maintains a physical office or place of busine ss
within this state, or
b. For a Medicare or Medicaid enrolled out-of-state
supplier, maintains a physical office or place of
business is within one hundred (100) miles of a
resident of this state being served by the supplier ;
2. Has obtained a state sales tax permit and any other
necessary license or permit as determined by the Board including but
not limited to any permit from the S tate Department of Health; and
3. Meets all state and federal accreditation requirements .
Each individual physical office o r place of business o wned or
operated by the supplier must be licen sed separately.
B. 1. The Board may issue a license to a Medicare or Medicaid
enrolled out-of-state supplier who has at least one accredited
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facility within one hundred (100) miles of any resident of this
state being served by the supplier.
2. The Board may assess a fee on out-of-state suppliers
necessary to cover the cost of inspect ion of those suppliers. The
inspection fee shall be in addition to the licensure fee.
C. A supplier licensed by the Board shall meet all safety
standards established by the Board, which shall include, but not be
limited to:
1. Ensuring that all personnel e ngaged in delivery, maintenance
and repair of durable medical equipment receive annual continuing
education;
2. Instructing the patient or patient ’s caregiver about how to
use the durable medical equipment provided ;
3. Receiving and responding to complaint s from patients;
4. Maintaining records of all patients receiving durable
medical equipment; and
5. Managing, maintaining , and servicing durable medical
equipment.
D. The Board may revoke or suspend a license for:
1. Violation of state or federal la w;
2. Violation of rules promulgated pursuant to the Oklahoma
Durable Medical Equipment Licensing Act ;
3. Permitting, aiding, or abetting any illegal act;
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4. Failing to meet the safety standards established by the
Board pursuant to the Oklahoma Durable Medical Equipment Licensing
Act;
5. Engaging in conduct or practices found by the Board to be
detrimental to the health, safety , or welfare of patients; or
6. Failing to renew a license.
SECTION 5. NEW LAW A new section of law to b e codified
in the Oklahoma Statutes as Section 37 5.5 of Title 59, unless there
is created a duplication in numbering, reads as follows:
The Oklahoma Durable Medical Equipment Licensing Act shall not
apply to:
1. Pharmacies and pharmacists;
2. Hospitals;
3. Ambulatory surgical centers;
4. Health care facilities owned or operated by the state or
federal government;
5. Skilled nursing facilities;
6. Assisted living facilities;
7. Prosthetic or orthotic practitioners;
8. Health care practitioners who are licensed to practice
health care in this state and who provide durable medical equipment
within the scope of their health care practice;
9. Manufacturers or wholesale distributors that do not sell or
rent durable medical equipment directly to consumers;
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10. Suppliers of insulin infusion pumps and related supplies or
services; or
11. Suppliers of medical devices approved by the Food and Drug
Administration that are used in the treatment of cancerous tumors .
SECTION 6. AMENDATORY 59 O.S. 2021, 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 other educational cou rses approved by
the Board 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 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 s ame 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 authori ty to confirm that the
medication, labeling an d packaging of the filled prescription are
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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 origin;
8. “Compounding” means the combining, admixing, m ixing,
diluting, pooling, reconstituting or ot herwise 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 pre scribing patterns;
9. “Continuing professiona l 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 s tate;
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”.;
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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 distributor, or an y other person authorized
by law to dispense or adm inister prescription drugs, and the
affiliated warehouses or distributions of such entities under common
ownership and control t hat do not act as a wholesale distributor.
For the purposes of this paragrap h, “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 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,
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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 facilities, wholesale distributors, third -party
logistics providers, pharm acies, 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 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 manufacturer that is
not intended to be sold and is intended to promote the sale of the
drug;
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19. “Durable medical equipment ” has the same meaning as
provided by Section 2 of this act;
20. “Filled prescription” means a packaged prescription
medication to which a label has been affixed which contain s such
information as is requi red by the Oklahoma Pharmacy Act;
20. 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;
21. 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;
22. 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 product,
b. a co-licensed partner of the person described in
subparagraph a that obtains the product directly from
a person described in this subparagraph or
subparagraph a,
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c. an affiliate of a person described in subpara graph a
or b who receives the product directly from a person
described in this subparagraph or in subparagraph a or
b;, or
d. a person who contracts wi th another to manufacture a
product;
23. 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 independ ently 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 drug s 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;
24. 25. “Medical gas” means those gases including those in
liquid state upon which the manufacturer o r distributor has placed
one of several cautions, such as “Rx Only”, in compliance with
federal law;
25. 26. “Medical gas order” means an order for medical gas
issued by a licensed prescriber;
26. 27. “Medical gas distributor ” means a person licensed to
distribute, transfer, wholesale, deliver or sell medical gases on
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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;
27. 28. “Medical gas supplier ” means a person who dispe nses
medical gases on drug orders only to a patient or ultimate user;
28. 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;
29. 30. “Nonprescription drugs ” means medicines or drug s which
are sold without a pre scription and which are prepackaged for use by
the consumer and labeled in accordance with the req uirements of the
statutes and regulations of this state and the federal governmen t.
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 pre parations meet the
requirements of the Federal Food, Drug and Cosmetic Act, 21
U.S.C.A., Section 321 et seq.;
30. 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 requirem ents of 21 U.S.C. 353b;
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31. 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 sale to the dispense r of
such product. For the purposes of this paragraph, “individual
saleable unit” means the smallest container of a product introduced
into commerce by the manufactur er or repackager that is intended by
the manufacturer or repackager for individual sale t o a dispenser;
32. 33. “Person” means an individual, partnership, li mited
liability company, corporation or association, unless the context
otherwise requires;
33. 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 t he practice of pharmacy in a
licensed pharmacy as defined by Section 353.18 of this title;
34. 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 by the Oklahoma Department of Veterans Affairs;
35. 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
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prescription department under the immediate and direct supervi sion
of a pharmacist;
36. 37. “Poison” means any substance which when introduced into
the body, either directly or by absorption, produces violent, mo rbid
or fatal changes, or which destroys living tissue with which such
substance comes into contact;
37. 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 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 dr ugs and devices,
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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 provision of those acts or services that are
necessary to provide pharma ceutical care;
38. 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;
39. 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;
40. 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 com munication:
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 distrib utor as
authorized in Section 353.29.1 of this title;
41. 42. “Product” means a prescription drug in a finished
dosage form for administration to a patient w ithout substantial
further manufacturing, such as capsules, tablets, and lyophilized
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products before reconstitution. “Product” does not include blood
components intended for transfusion, radioactive drugs or biologics
and medical gas;
42. 43. “Repackager”, including “virtual repackager”, means a
person who owns or operates an establishment that repac ks and
relabels a product or package for further sale or distribution
without further transaction;
43. 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;
44. 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;
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45. 46. “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;
46. 47. “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 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;
47. 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. 353(e)(4) as amended by the Drug Supply Chain Security
Act;
48. 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;
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49. 50. “State correctional facility ” means a facility or
institution that houses a prisoner population under the jurisdiction
of the Department of Corrections;
50. 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
51. 52. “Unit of issue package ” means a package that provid es
multiple doses of the same drug, but each drug is individually
separated and includes the name, lot number, and expiration da te.
SECTION 7. AMENDATORY 59 O.S. 2021, Section 353.7, is
amended to read as follows:
Section 353.7. The State Board of Pharmacy shall have the powe r
and duty to:
1. Regulate the practice of pharmacy;
2. Regulate the sale and distribution of drugs, medicine s,
chemicals and poisons;
3. Regulate the dispensing of drugs and medicines in all places
where drugs and medicines are compounded and/or dis pensed;
4. Examine and issue appropriate certificates of licensure as
Doctor of Pharmacy to all applicants whom t he Board deems qualified
under the provisions of the Oklahoma Pharmacy Act;
5. Issue licenses to manufacturers, repackagers, outsourcing
facilities, wholesale distri butors, third-party logistics providers,
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pharmacies and other dispensers, medical gas supp liers and, medical
gas distributors, and suppliers of durable medical equipment;
6. Issue sterile compounding and drug supplier permits for
pharmacies at the fee set by the Board, w ith the expiration date of
such permits to coincide with the pharmacy lice nse annual expiration
date;
7. Prescribe minimum standards with respect to floor space and
other physical characteristics of pharmacies and hospital dr ug rooms
as may be reasonably necessary for the maintenan ce of professional
surroundings and for the pro tection of the safety and welfare of the
public, and to refuse the issuance of new or re newal licenses for
failure to comply with such standards. Minim um standards for
hospital drug rooms shall be consistent with the State Department of
Health, Hospital Standards, as defined in OAC 310:667;
8. Authorize its inspectors, compliance officers and duly
authorized representatives to enter and inspect any and all places
including premises, vehicles, equipment, con tents and records, where
drugs, medicines, chemic als or poisons are stored, sold, vended,
given away, compounded, dispensed, manufactu red, repackaged or
transported;
9. Employ the number of inspect ors and pharmacist complian ce
officers necessary in the investigation of criminal activity or
preparation of administrative actions at an annual salary to be
fixed by the Board, and to authori ze necessary expenses. Any
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inspector certified as a peace offic er by the Council of Enforc ement
Education and Training shall have statewide jurisdiction to perform
the duties authorized by this section. In additio n, the inspectors
shall be considered pea ce officers and shall have the same powers
and authority as that granted to peace officers. In addition, such
inspectors or pharmacist compliance officers shall have the
authority to take and copy records and the d uty to confiscate all
drugs, medicines, chemicals or poisons found to be stored, sold,
vended, given away, compounded, dispensed or manufactured contrary
to the provisions of the Oklahoma Pharmacy Act;
10. Investigate complaints, subpoena witnesses and re cords,
initiate prosecution and hold hearings;
11. Administer oaths in all manners pertaining to the af fairs
of the Board and to take evidence and compel the attendance of
witnesses on questions pertaining to th e enforcement of the Oklahoma
Pharmacy Act;
12. Reprimand, place on probation, susp end, revoke permanently
and levy fines not to exceed Three Thous and Dollars ($3,000.00) for
each count for which any person charged with violating the Oklahoma
Pharmacy Act or Oklahoma Board of Pharmacy administrativ e rules has
been convicted in Board hear ings. The Board also may take other
disciplinary action. The B oard may impose as part of any
disciplinary action th e payment of costs expended by the Board for
any legal fees and costs including, but not limited to , staff time,
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salary and travel expense , witness fees and attorney fees. The
Board may also require ad ditional continuing educ ation including
attendance at a live continuing education program, and may require
participation in a rehabilitation program for the impaired. The
Board may take such actions singly or in combination, as the nature
of the violation requires;
13. Adopt and establish rules of profes sional conduct
appropriate to the establishment and mainte nance of a high standard
of integrity and dignity in the profession of pharmacy. Such rules
shall be subject to amendment or repeal by the Board as the need may
arise;
14. Make and publish rules such as may be necessary for
carrying out and enforcing the provisions of the Oklahoma Pharmacy
Act, Oklahoma drug laws and rules, federal dr ug laws and
regulations, and make such other rules as in its dis cretion may be
necessary to protect the health, saf ety and welfare of the public;
15. Establish and collect a ppropriate fees for licenses,
permits, inspections and services provided; and su ch fees shall be
nonrefundable. Such fees shall be promulgated to implement the
provisions of the Oklahoma Pharmacy Act and the Oklahoma Abortion -
Inducing Drug Certification P rogram Act under the provisions of the
Administrative Procedures Act ;
16. Regulate:
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a. personnel working in a pharmacy, such as interns and
supportive personnel including technicians, and issue
pharmacy technician permits and intern licenses,
b. interns, preceptors and training areas through whic h
the training of applicants occurs f or licensure as a
pharmacist, and
c. such persons regarding all aspects relating to the
handling of drugs, medicines, chemicals and poisons;
17. Acquire by purchase, lease, gif t, solicitation of gift or
by any other manner, and to maintain, use and opera te or to contract
for the maintenance, use and operation of or l ease of any and all
property of any kind, real, personal or mixed or any interest
therein unless otherwise provide d by the Oklahoma Pharmacy Act;
provided, all contracts for real property shal l be subject to the
provisions of Section 63 of Title 74 of the Oklahoma Statutes;
18. Perform other such duties, exercise other such powers and
employ such personnel as the pro visions and enforcement of the
Oklahoma Pharmacy Act may require; and
19. Approve pilot projects designed to utilize new or expanded
technology or processes and provide patients with better pharmacy
products or provide pharmacy services in a more safe and efficient
manner. Such approvals may in clude provisions granting exemptions
to any rule adopted by the Board.
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SECTION 8. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 353.7a of Title 59, unless th ere
is created a duplication in numbering, reads as follows:
The State Board of Pharmacy shall assess the following licensure
fees for the stated entities:
1. For a medical gas distributor , Four Hundred Dollars
($400.00) for an initial license and Two Hundred Dollars ($200.00)
for a license renewal;
2. For a supplier of durable medical equipment , Four Hundred
Dollars ($400.00) for an initial license and Two Hundred Dollars
($200.00) for a license renewal;
3. For a combined license for a medical gas distributor and
supplier of durable medical equipment , Six Hundred Dollars ($600.00)
for an initial license and Three Hundred Dollars ($300.00) for a
license renewal; and
4. For a medical gas supplier, an amount determined by the
Board in rule.
SECTION 9. This act shall become effective November 1, 2022. ”
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Passed the Senate the 28th day of April, 2022.
Presiding Officer of the Senate
Passed the House of Representatives the ____ day of __________,
2022.
Presiding Officer of the House
of Representatives
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ENGROSSED HOUSE
BILL NO. 2649 By: Echols of the House
and
Dugger of the Senate
An Act relating to durable medical equipment;
creating the Oklahoma Durable Medical Equipment
Licensing Act; defining terms; requiring a license;
providing for effective date of license; authorizing
certain inspections; requiring promul gation of rules;
construing provision ; providing for licensing
qualifications; providing for license revocation or
suspension; listing exceptions; providing for
codification; and providing an effective date .
BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
SECTION 10. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 375 of Title 59, unless there is
created a duplication in numbering, reads as follows:
This act shall be known and may be cited as the "Oklahoma
Durable Medical Equipment Licensing Act ".
SECTION 11. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 376 of T itle 59, unless there is
created a duplication in numbering, reads as follow s:
As used in the Oklahoma Durable Medical Equipment Licensing A ct:
1. "Board" means the State Board of Pharmacy;
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2. a. "Durable medical equipment" means equipment for which
a prescription is required, including for repair and
replacement parts, and tha t:
(1) can stand repeated use,
(2) has an expected useful life of at least three (3)
years,
(3) is primarily and customarily used to serve a
medical purpose,
(4) is not generally useful to a person in the
absence of illness or injury,
(5) is appropriate for use in the home, and
(6) is intended for use by the consumer .
b. Durable medical equipment includes, but is not limited
to:
(1) ambulating assistance equipment,
(2) mobility equipment,
(3) rehabilitation seating,
(4) oxygen care and oxygen delivery syste ms,
(5) respiratory equipment and respiratory disease
management devices,
(6) rehabilitation environmental control equipment,
(7) ventilators,
(8) apnea monitors,
(9) diagnostic equipment,
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(10) feeding pumps,
(11) beds prescribed by physicians to alleviate
medical conditions,
(12) transcutaneous electrical nerve stimulators, and
(13) sequential compression devices; and
3. "Supplier" means any person or entity that provides durable
medical equipment services or products and that currently bills or
plans to bill a claim for reimbursement of services or products to a
third party.
SECTION 12. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 377 of Title 59, unless there is
created a duplication in numbering, reads as follows:
A. Any supplier of durable medical equipment to a consumer in
Oklahoma shall possess a durable medical equipment supplier license
issued by the Board pursuant t o this act.
B. Licenses issued by the Board pursuant to this act shall be
effective for twelve (12) months from the date of issuance and shall
not be transferable or assignable.
C. The Board shall have the authority to initially and
periodically inspect the applicant's office or place of business.
D. The Board shall promulgate rules necessary to implement the
provisions of this act. Such rules shall prioritize patient safety
and quality of durable medical equipment. The Board may provide by
rule that any person or entity accredited by organizations
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recognized by the Centers fo r Medicare and Medicaid Services is
deemed to meet all or some of the requirements of this act.
E. Nothing in this section shall be construed to restrict or
prohibit private trans actions between two parties.
SECTION 13. NEW LAW A ne w section of law to be codified
in the Oklahoma Statutes as Section 378 of Title 59, unless there is
created a duplication in numbering, reads as follows:
A. The Board shall be au thorized to issue a license to an
applicant for licensure as a supplier of d urable medical equipment
if the applicant:
1. Submits an application in a form prescribed by the Board;
2. Maintains a physical office or place of business within this
state;
3. Pays a license fee established by the Board;
4. Meets all state and federa l accreditation requirements; and
5. Meets all safety standards established by the Board, which
shall include, but not be limited to:
a. ensuring that all personnel e ngaged in delivery,
maintenance and repair of durable medical equipment
receive annual continuing education,
b. instructing the patient or patient 's caregiver about
how to use the durable medical equipment provided ,
c. receiving and responding to complaints from patien ts,
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d. maintaining records of all patients receiving durable
medical equipment, and
e. managing, maintaining and servicing durable medical
equipment.
B. The Board may issue a license to a Medicare or Medicaid
enrolled out-of-state supplier who has at leas t one accredited
facility within one hundred (100) miles of any Oklahoma res ident
being served by the supplier.
C. The Board may revoke or suspend a license for:
1. Violation of state or federal law;
2. Violation of rules promulgated pursuant to this act;
3. Permitting, aiding or abetting any illegal act;
4. Failing to meet the safety standards established by the
Board pursuant to this act;
5. Engaging in conduct or practices found by the Board to be
detrimental to the health, safety or welfare of patients; or
6. Failing to renew a license.
SECTION 14. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 379 of Title 59, unless there is
created a duplication in numbering, reads as follows:
The Oklahoma Durable Medical Equipment Licensing Act shall not
apply to:
1. Pharmacies and pharmacists;
2. Hospitals;
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3. Ambulatory surgical centers;
4. Health care facilities owned or operated by the state or
federal government;
5. Skilled nursing facilities;
6. Assisted living facilities;
7. Prosthetic or orthotic practitioners;
8. Health care practitioners who are licensed to practice
health care in the State of Oklahoma and who provide durable medical
equipment within the scope of their health care practice;
9. Manufacturers or wholesale distributors that do not sell or
rent durable medical equipment directly to consumers; or
10. Suppliers of insulin infusion pumps and related supplies or
services.
SECTION 15. This act shall become effectiv e November 1, 2021.
Passed the House of Representatives the 9th day of March, 2021.
Presiding Officer of the House
of Representatives
Passed the Senate the ___ day of __________, 2021.
Presiding Officer of the Senate