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ENGROSSED HOUSE AMENDME NT
TO
ENGROSSED SENATE BILL NO . 131 By: Garvin of the Senate
and
McEntire of the House
An Act relating to pharmacy; amending 59 O.S. 2011,
Section 353.18, as last amended by Section 4, Chapter
285, O.S.L. 2016 (59 O.S. Supp. 2020, Section
353.18), which relates to the sale, manufacturing or
packaging of dangerous drugs; providing licensure
exception; providing exception to pharmacy
requirements for facilities distributing or
dispensing dialysate or devices necessary for
peritoneal dialysis; amending 59 O.S. 2011, Section
353.24, as last amended by Section 6, Chapter 106,
O.S.L. 2018 (59 O.S. Supp. 2020, Section 353.24),
which relates to unlawful acts; providing certain
construction; providing certification exception; and
providing an effective date.
AUTHORS: Add the following House Coauthor s: Newton, Bush, Fugate,
Pae, McDugle, Roe, Moore, Talley, Cornwell, Marti,
Fetgatter, Culver, Lawson, Humphrey and Waldron
AMENDMENT NO. 1. Delete the title, enacting clause and entire bill
and replace with:
"An Act relating to public health; creating the
Oklahomans Caring for Oklahomans Act; directing the
Oklahoma Health Care Authority to develop a certain
program; providing for elements of the program;
requiring maximization of sharing certain
information; requiring data sharing programs to have
ability to screen for certain determinants;
requiring the Oklahoma Health Care Authority to
maintain and improve certain partnerships; directing
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the Oklahoma Health Care Authority to p romulgate
rules; and declaring an emergency.
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 1010.14 of Title 56, unless
there is created a duplication in numbering, reads as follows:
This act shall be known and may be cited as the "Oklahomans
Caring for Oklahomans Act".
SECTION 2. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 1010.15 of Title 56, unless
there is created a duplication in numbering, reads as follows:
A. The Oklahoma Health Care Authority shall implement the
Oklahomans Caring for Oklahomans Act by developing a program that
controls costs and improves health outc omes for Medicaid
beneficiaries. The plan shall contain new or improve upon existing
programs of the Authority and shall include, but not be limited to,
the following elements:
1. Prevention. Medicaid beneficiaries shall enroll in the
program and renew annually at their wellness visits to their primary
provider clinics. Enrollment and renewal shall include a standard
baseline risk assessment following the Centers for Medicare and
Medicaid Services' guidelines for substance abuse, mental health,
and physical health. The assessment shall identify social health
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risks including, but not limited to, smoking, sedentary lifestyle,
obesity, social factors such as domestic violence, and food
insecurity.
2. Chronic care management. The Authority shall develop a nd
carry out a plan for chronic care coordination that shall include,
but not be limited to, the following components:
a. medication therapy management,
b. patient education,
c. frequent interaction between the Authority and
beneficiaries to identify po tential health needs and
decrease emergency department and hospital
utilization, and
d. development of a long -term plan of wellness for each
beneficiary.
3. Payment reform. Building upon the success of primary care
medical homes, the Authority shall dev elop a transition care
management plan to incentivize compliance behaviors by patients
following inpatient treatment to decrease rehospitalizations and
emergency department utilization. The Authority shall establish
value-based payments for providers that incentivize providers with
improved quality metrics and health outcomes. If the Authority adds
to the covered benefit plan any new benefits that cost more than
Five Hundred Thousand Dollars ($500,000.00), the new benefits must
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be approved by the Legislat ure unless a corresponding budget offset
can be found within the Authority's existing agency budget.
B. Health information exchange. In order to reduce redundancy
for medical services, the Authority shall maximize the sharing of
health information amon g providers. Any program for sharing data
shall also have the ability to screen for social determinants of
health.
C. Partnerships with tribal nations shall be maintained and
enhanced by the Authority in implementation of the Oklahomans Caring
for Oklahomans Act.
D. The Oklahoma Health Care Authority shall promulgate rules as
necessary to implement this act.
SECTION 3. It being immediately necessary for the preservation
of the public peace, health or safety, an emergency is hereby
declared to exist, by reason whereof this act shall take effect and
be in full force from and after its passage and approval. "
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Passed the House of Representatives the 20th day of April, 2021.
Presiding Officer of the House of
Representatives
Passed the Senate the ____ day of __________, 2021.
Presiding Officer of the Senate
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ENGROSSED SENATE
BILL NO. 131 By: Garvin of the Senate
and
McEntire of the House
An Act relating to pharmacy; amending 59 O.S. 2011,
Section 353.18, as last amended b y Section 4, Chapter
285, O.S.L. 2016 (59 O.S. Supp. 2020, Section
353.18), which relates to the sale, manufacturing or
packaging of dangerous drugs; providing licensure
exception; providing exception to pharmacy
requirements for facilities distributing or
dispensing dialysate or devices necessary for
peritoneal dialysis; amending 59 O.S. 2011, Section
353.24, as last amended by Section 6, Chapter 106,
O.S.L. 2018 (59 O.S. Supp. 2020, Section 353.24),
which relates to unlawful acts; providing certain
construction; providing certification exception; and
providing an effective date.
BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
SECTION 4. AMENDATORY 59 O.S. 2011, Section 353.18, as
last amended by Section 4, Chapter 285, O .S.L. 2016 (59 O.S. Supp.
2020, Section 353.18), is amended to read as follows:
Section 353.18. A. 1. It shall be unlawful for any person,
including, but not limited to, Internet, website or online
pharmacies, to sell at retail or to offer for sale, dan gerous drugs,
medicines, chemicals or poisons for the treatment of disease,
excluding agricultural chemicals and drugs, or to accept
prescriptions for same, without first procuring a license from the
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State Board of Pharmacy. This licensure requirement app lies whether
such sale, offer for sale or acceptance of prescriptions occurs in
this state, or such sale, offer for sale, or acceptance of
prescription prescriptions occurs out of state and the dangerous
drug, medicine, chemical or poison is to be delivere d, distributed
or dispensed to patients or customers in this state. This licensure
requirement shall not apply to the distribution or dispensing of
dialysate or peritoneal dialysis devices to patients with end -stage
renal disease (ESRD) consistent with su bsection F of this section.
2. A pharmacy license shall be issued to such person as the
Board shall deem qualified upon evidence satisfactory to the Board
that:
a. the place for which the license is sought will be
conducted in full compliance with the law and the
rules of the Board,
b. the location and physical characteristics of the place
are reasonably consistent with the maintenance of
professional surroundings and constitute no known
danger to the public health and safety,
c. the place will be under th e management and control of
a licensed pharmacist or pharmacist -in-charge who
shall be licensed as a pharmacist in Oklahoma, and
d. a licensed pharmacist shall be present and on duty at
all business hours; provided, however, the provisions
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of this subparagraph shall not apply to hospital drug
rooms.
3. a. An application for an initial or renewal license
issued pursuant to the provisions of this subsection
shall:
(1) be submitted to the Board in writing,
(2) contain the name or names of persons owning the
pharmacy, and
(3) provide other such information deemed relevant by
the Board.
b. An application for an initial or renewal license shall
be accompanied by a licensing fee not to exceed Three
Hundred Dollars ($300.00) for each period of one (1)
year. Prior to opening for business, all applicants
for an initial license or permit shall be inspected.
An initial licensure applicant shall pay an inspection
fee not to exceed Two Hundred Dollars ($200.00);
provided, however, that no charge shall be made for
the licensing of any Federal Veterans Hospital in the
State of Oklahoma. Non -resident pharmacies shall
reimburse the Board for any actual expenses incurred
for inspections.
c. A license issued pursuant to the provisions of this
subsection shall be valid for a pe riod set by the
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Board and shall contain the name of the licensee and
the address of the place at which such business shall
be conducted.
4. A retail pharmacy that prepares sterile drugs shall obtain a
pharmacy license, and shall also obtain a sterile comp ounding permit
at a fee set by the Board, not to exceed Seventy -five Dollars
($75.00). Such pharmacy shall meet requirements set by the Board by
rule for sterile compounding permits.
5. An outsourcing facility desiring to dispense prescriptions
to patients must additionally license and meet the requirements of a
pharmacy.
B. 1. It shall be unlawful for any person to manufacture,
repackage, distribute, outsource, warehouse or be a third -party
logistics provider of any dangerous drugs, medicines, medical gases,
chemicals, or poisons for the treatment of disease, excluding
agricultural chemicals , without first procuring a license from the
Board. It shall be unlawful to sell or offer for sale at retail or
wholesale dangerous drugs, medicines, medical gases, chemicals or
poisons without first procuring a license from the Board. This
licensure requirement shall apply when the manufacturing,
repackaging, distributing, outsourcing, warehousing, or provision of
third-party logistics occurs in this state or out o f state for
delivery, distribution, or dispensing to patients or customers in
this state.
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2. A license shall be issued to such person as the Board shall
deem qualified upon satisfactory evidence to the Board that:
a. the place for which the license is sou ght will be
conducted in full compliance with the laws of this
state and the administrative rules of the Board,
b. the location and physical characteristics of the place
of business are reasonably consistent with the
maintenance of professional surrounding s and
constitute no known danger to public health and
safety,
c. the place shall be under the management and control of
such persons as may be approved by the Board after a
review and determination of the persons’
qualifications, and
d. an outsourcing facility shall designate in writing on
a Board-approved form a person to serve as the
pharmacist-in-charge who is a pharmacist licensed by
the Board.
3. a. An application for an initial or renewal license
issued pursuant to the provisions of this subsection
shall:
(1) be submitted to the Board in writing,
(2) contain the name or names of the owners or the
applicants, and
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(3) provide such other information deemed relevant by
the Board.
b. An application for an initial or renewal license shall
be accompanied by a licensing fee not to exceed Three
Hundred Dollars ($300.00) for each period of one (1)
year. Prior to opening for business, all applicants
for initial or renewal license shall be inspected. An
initial licensure applicant shall pay an inspection
fee not to exceed Two Hundred Dollars ($200.00). Non -
resident applicants shall reimburse the Board for any
actual expenses incurred for inspections.
c. A license issued pursuant to the provisions of this
subsection shall contain the name of the licensee and
the address of the place at which such business shall
be conducted and shall be valid for a period of time
set by the Board.
C. A licensee or permit holder who, pursuant to the provisions
of this section, fails to complete an application for a renewal
license or permit by the fifteenth day after the expiration of the
license or permit shall pay a late fee to be fixed by the Board.
D. 1. The Board shall promulgate rules regarding the issuance
and renewal of licenses and permits pursuant to the Oklahoma
Pharmacy Act which shall include, but need not be limited to ,
provisions for new or renewal application requirements for its
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licensees and permit holders. Requirements for new and renewal
applications may include, but need not be limited to, the following:
a. type of ownership, whether individual, partnership,
limited liability company or corporation,
b. names and addresses of principal owners or officers
and their Social Security numbers, including
applicant’s full name, all trade or business names
used, full business address, telephone numbers, and
email addresses,
c. names of designated representatives and facility
managers and their Social Security numbers and dates
of birth,
d. evidence of a criminal background check and
fingerprinting of the applicant, if a person, and all
of the applicant’s designated representatives and
facility managers,
e. a copy of the license from the applicant’s home state,
and if applicable, from the federal government,
f. bond requirements, and
g. any other information deemed by the Board to be
necessary to protect the public health and safety.
2. The Board shall be authorized to use an outside agency, such
as the National Association of Boards of Pharmacy (NABP) or the
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Verified-Accredited Wholesale Distributors (VAWD), to accredit
wholesale distributors and repackagers.
E. The Oklahoma Pharmacy Act shall not be construed to prevent
the sale of nonprescription drugs in original manufacturer packages
by any merchant or dealer.
F. The Oklahoma Pharmacy Act shall not be construed to ap ply to
a facility engaged in the distribution or dispensing to patients of
dialysate or peritoneal dialysis devices necessary to perform home
peritoneal dialysis, provided the following criteria are met:
1. The dialysate is comprised of dextrose or icodex trin;
2. The dialysate or peritoneal dialysis devices are approved or
cleared by the United States Food and Drug Administration;
3. The dialysate or peritoneal dialysis devices are lawfully
held by a manufacturer, or the manufacturer’s agent, who is prop erly
licensed by the Board as a manufacturer, wholesaler or distributor;
4. The dialysate or peritoneal dialysis devices are held and
delivered in their original, sealed packaging from the manufacturing
facility;
5. The dialysate or peritoneal dialysis d evices are delivered
only upon receipt of a physician’s prescription by a licensed
pharmacy, and the transmittal of an order from the licensed pharmacy
to the manufacturer or the manufacturer’s agent; and
6. The manufacturer or agent of the manufacturer d elivers the
dialysate or peritoneal dialysis devices directly to:
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a. a patient with ESRD or the patient’s designee for the
patient’s self-administration of the dialysis therapy,
or
b. a health care provider or institution for
administration or delivery of the dialysis therapy to
the patient with ESRD.
SECTION 5. AMENDATORY 59 O.S. 2011, Section 353.24, as
last amended by Section 6, Chapter 106, O.S.L. 2018 (59 O.S. Supp.
2020, Section 353.24), is amended to read as follows:
Section 353.24. A. It shall be unlawful for any licensee or
other person to:
1. Forge or increase the quantity of drug in any prescription,
or to present a prescription bearing forged, fictitious or altered
information or to possess any drug secured by such fo rged,
fictitious or altered prescription;
2. Sell, offer for sale, barter or give away any unused
quantity of drugs obtained by prescription, except through a program
pursuant to the Utilization of Unused Prescription Medications Act
or as otherwise provi ded by the State Board of Pharmacy;
3. Sell, offer for sale, barter or give away any drugs damaged
by fire, water, or other causes without first obtaining the written
approval of the Board or the State Department of Health;
4. No person, firm or business establishment shall offer to the
public, in any manner, their services as a “pick -up station” or
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intermediary for the purpose of having prescriptions filled or
delivered, whether for profit or gratuitously. Nor may the owner of
any pharmacy or drug store authorize any person, firm or business
establishment to act for them in this manner with these exceptions:
a. patient-specific filled prescriptions may be delivered
or shipped to a prescriber’s clinic for pick -up by
those patients whom the prescriber has individually
determined and documented do not have a permanent or
secure mailing address,
b. patient-specific filled prescriptions for drugs which
require special handling written by a prescriber may
be delivered or shipped to the prescriber’s clinic for
administration or pick -up at the prescriber’s office,
c. patient-specific filled prescriptions, including
sterile compounded drugs, may be delivered or shipped
to a prescriber’s clinic where they shall be
administered,
d. patient-specific filled prescriptio ns for patients
with End Stage Renal Disease end-stage renal disease
(ESRD) may be delivered or shipped to a prescriber’s
clinic for administration or final delivery to the
patient,
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e. patient-specific filled prescriptions for
radiopharmaceuticals may be d elivered or shipped to a
prescriber’s clinic for administration or pick -up, or
f. patient-specific filled prescriptions may be delivered
or shipped by an Indian Health Services (IHS) or
federally recognized tribal health organization
operating under the IH S in the delivery of the
prescriptions to a pharmacy operated by the IHS or a
federally recognized tribal health organization for
pick-up by an IHS or tribal patient.
However, nothing in this paragraph shall prevent a pharmacist or
an employee of the pharm acy from personally receiving a prescription
or delivering a legally filled prescription to a residence, office
or place of employment of the patient for whom the prescription was
written. Provided further, the provisions of this paragraph shall
not apply to any Department of Mental Health and Substance Abuse
Services employee or any person whose facility contracts with the
Department of Mental Health and Substance Abuse Services whose
possession of any dangerous drug, as defined in Section 353.1 of
this title, is for the purpose of delivery of a mental health
consumer’s medicine to the consumer’s home or residence. Nothing in
this paragraph shall prevent veterinary prescription drugs from
being shipped directly from an Oklahoma licensed wholesaler or
distributor registered with the Oklahoma Board of Veterinary Medical
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Examiners to a client; provided, such drugs may be dispensed only on
prescription of a licensed veterinarian and only when an existing
veterinary-client-patient relationship exists . Nothing in this
paragraph shall prevent dialysate and peritoneal dialysis devices
from being shipped directly from an Oklahoma licensed manufacturer,
wholesaler or distributor to an ESRD patient or patient’s designee,
consistent with subsection F of Section 353.18 of this title;
5. Sell, offer for sale or barter or buy any professional
samples except through a program pursuant to the Utilization of
Unused Prescription Medications Act;
6. Refuse to permit or otherwise prevent members of the Board
or such representatives thereof from entering and inspecting any and
all places, including premises, vehicles, equipment, contents, and
records, where drugs, medicine, chemicals or poisons are stored,
sold, vended, given away, compounded, dispensed, repackaged,
transported, or manufactured;
7. Interfere, refuse to participate in, impede or otherwise
obstruct any inspection, investigation or disciplinary proceeding
authorized by the Oklahoma Pharmacy Act;
8. Possess dangerous drugs without a valid prescription or a
valid license to possess such drugs; provided, however, this
provision shall not apply to any Department of Mental Health and
Substance Abuse Services employee or any person whose facility
contracts with the Department of Mental Health and Substance Abuse
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Services whose possession of any dangerous drug, as defined in
Section 353.1 of this title, is for the purpose of delivery of a
mental health consumer’s medicine to the consumer’s home or
residence;
9. Fail to establish and maintain effective controls against
the diversion of drugs for any other purpose than legitimate
medical, scientific or industrial uses as provided by state, federal
and local law;
10. Fail to have a written drug diversion detection and
prevention policy;
11. Possess, sell, offer for sale, b arter or give away any
quantity of dangerous drugs not listed as a scheduled drug pursuant
to Sections 2-201 through 2-212 of Title 63 of the Oklahoma Statutes
when obtained by prescription bearing forged, fictitious or altered
information.
a. A first violation of this section shall constitute a
misdemeanor and upon conviction shall be punishable by
imprisonment in the county jail for a term not more
than one (1) year and a fine in an amount not more
than One Thousand Dollars ($1,000.00).
b. A second violation of this section shall constitute a
felony and upon conviction shall be punishable by
imprisonment in the Department of Corrections for a
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term not exceeding five (5) years and a fine in an
amount not more than Two Thousand Dollars ($2,000.00);
12. Violate a Board order or agreed order;
13. Compromise the security of licensure examination materials;
or
14. Fail to notify the Board, in writing, within ten (10) days
of a licensee or permit holder’s address change.
B. 1. It shall be unlawful for any per son other than a
licensed pharmacist or physician to certify a prescription before
delivery to the patient or the patient’s representative or
caregiver. Dialysate and peritoneal dialysis devices supplied
pursuant to the provisions of subsection F of Secti on 353.18 of this
title shall not be required to be certified by a pharmacist prior to
being supplied by a manufacturer, wholesaler or distributor.
2. It shall be unlawful for any person to institute or manage a
pharmacy unless such person is a licensed p harmacist or has placed a
licensed pharmacist in charge of such pharmacy.
3. No licensed pharmacist shall manage, supervise or be in
charge of more than one pharmacy.
4. No pharmacist being requested to sell, furnish or compound
any drug, medicine, chemi cal or other pharmaceutical preparation, by
prescription or otherwise, shall substitute or cause to be
substituted for it, without authority of the prescriber or
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purchaser, any like drug, medicine, chemical or pharmaceutical
preparation.
5. No pharmacy, pharmacist-in-charge or other person shall
permit the practice of pharmacy except by a licensed pharmacist or
assistant pharmacist.
6. No person shall subvert the authority of the pharmacist -in-
charge of the pharmacy by impeding the management of the
prescription department to act in compliance with federal and state
law.
C. 1. It shall be unlawful for a pharmacy to resell dangerous
drugs to any wholesale distributor.
2. It shall be unlawful for a wholesale distributor to purchase
drugs from a pharmacy.
SECTION 6. This act shall become effective November 1, 2021.
Passed the Senate the 2nd day of March, 2021.
Presiding Officer of the Senate
Passed the House of Representatives the ____ day of __________,
2021.
Presiding Officer of the House
of Representatives
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