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STATE OF OKLAHOMA
1st Session of the 58th Legislature (2021)
SENATE BILL 638 By: Garvin
AS INTRODUCED
An Act relating to pharmacy; amending 59 O.S. 2011,
Section 367.3, as amended by Secti on 45, Chapter 475,
O.S.L. 2019 (59 O.S. Supp. 2020 , Section 367.3),
which relates to program for utilization of unused
prescription drugs; deleting procedure for transfer
of certain prescription drugs; providing for donation
or return of unused prescription medications for
credit or reimbursement; requiring certain credit or
reimbursement to state Medicaid program under certain
conditions; amending 59 O.S. 2011, Section 367.4,
which relates to criteria for accepting unused
prescription drugs; broadening criteria to apply to
returned drugs; amending 59 O.S. 2011, Section 367.5,
which relates to participation in program ; clarifying
inclusion of certain facilities; specifying ability
to refuse individual returns ; authorizing pharmacy to
restock and redistribute returned prescription drugs
after credit or reimbursement; excluding Medicaid
copayments from certain requirement ; amending 59 O.S.
2011, Section 367.6, which relates to l iability of
participating organization s and manufacturers;
broadening criteria to apply to returned drugs;
removing certain pharmacies from program; clarifying
inclusion of certain facilities; amending 59 O.S.
2011, Section 367.7, which relates to promulgation of
rules; directing promulgation of certain rules; and
providing an effective date.
BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
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SECTION 1. AMENDATORY 59 O.S. 2011, Section 367.3, as
amended by Section 45, Chapter 475, O.S.L. 2019 (59 O.S. Supp. 202 0,
Section 367.3), is amended to read as follows:
Section 367.3. A. The State Board of Pharmacy shall implement
statewide a program consistent with public health an d safety through
which unused prescription drugs, other than prescription drugs
defined as controlled dangerous substances in S ection 2-101 of Title
63 of the Oklahoma Statutes , may be transferred from residential
care homes, nursing facilities, assisted l iving centers, public
intermediate care facilities for individuals with intellectual
disabilities (ICFs/IID) or pharmaceutical manufacturers to
pharmacies operated by a county. If no county pharmacy exists, or
if a county pharmacy chooses not to participa te, such unused
prescription medications may be transferred to a pharmacy operated
by a city-county health department or a phar macy under contract with
a city-county health department, a pharmacy operated by the
Department of Mental Health and Substance Ab use Services or:
1. Donated by a residential care home, an assisted living
center, an intermediate care facility fo r individuals with
intellectual disabilities (ICF/IID) or a pharmaceutical manufacturer
to a charitable clinic for the purpose of distributing the unused
prescription medications to Oklahoma residents who are medically
indigent; or
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2. Returned by a residential care home, an assisted living
center or an intermediate care facility for individual s with
intellectual disabilities (ICF/IID) to the pharmacy where the unused
prescription medications were purchased in exchange for credit or
reimbursement. If the pharmacy accepts a return of unused
prescription medications that were purchased by the state Medicaid
program, the pharmacy shall credit or reimburse the state Medicaid
program for the medications; provided that, the pharmacy may keep
any dispensing fee paid to the pharmacy by the state Medicaid
program for dispensation of the medications.
B. The Board of Pharmacy shall promulgate rules and establish
procedures necessary to implement the program e stablished by the
Utilization of Unused Prescription Medications Act.
C. The Board of Pharmacy shall provide technical as sistance to
entities who may wish to participate in the program.
SECTION 2. AMENDATORY 59 O.S. 2011, Section 367.4, is
amended to read as follow s:
Section 367.4. The following criteria shall be used in
accepting unused prescription drugs for use under the Utilization of
Unused Prescription Medications Act:
1. Only prescription drugs i n their original sealed unit dose
packaging or unused injectables shall be accepted and dispensed
pursuant to the Utilization of Unused Prescription Medications Act;
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2. The packaging must be unopened, except that cancer drugs
packaged in single-unit doses may be accepted and dispensed when the
outside packaging is opened if the single -unit-dose packaging has
not been opened;
3. Expired prescription drugs shall not be accepted;
4. A prescription drug shall not be accepted or dispensed if
the person accepting or dispensing the drug has reason to believe
that the drug is adulterated;
5. No controlled dangerous substances shall be accepted; and
6. Subject to the limitation specified in this section, unused
prescription drugs dispensed for purposes of a medi cal assistance
program or drug product donation progra m, or unused prescription
drugs returned by a facility listed in Section 367.3 of this title
in exchange for credit or reimbursement, may be accepted and
dispensed under the Utilization of Unused Prescr iption Medications
Act.
SECTION 3. AMENDATORY 59 O.S. 2011, Section 367 .5, is
amended to read as follows:
Section 367.5. A. Participation in the Utilization of Unused
Prescription Medications Act by pharmacies, nursing homes, assisted
living centers, intermediate care facilities for individuals with
intellectual disabilities (ICF/IID), charitable clinics or
prescription drug manufacturers shall be voluntary. Nothing in the
Utilization of Unused Prescription Medications Act shall require any
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pharmacy, nursing home, assiste d living center, intermediate care
facility for individuals with intellectual disabilities (ICF/IID),
charitable clinic or pr escription drug manufacturer to participate
in the program. Furthermore, a pharmacy that participates in the
program shall have the right to refuse individual ret urns of unused
prescription medications including, but not limited to, medications
that were purchased by the state Medicaid program .
B. A pharmacy or charitable clinic which meets the eligibility
requirements established i n the Utilization of Unused Pres cription
Medications Act may:
1. Dispense dispense prescription drugs d onated under the
Utilization of Unused Prescription Medications Act to persons who
are medically indigent residents of Oklahoma as established in rules
by the State Board of Pharmacy; and
2. Charge. Such drugs shall not be resold . However, the
charitable clinic may charge persons receiving donated prescription
drugs a handling fee established by rule by the Board of Pharmacy.
C. A pharmacy which meets the eligibility requirements
established in the Utilization of Unused Prescription Medications
Act may restock and redistribute prescription drugs returned to the
pharmacy after the pharmacy has issue d the credit or reimbursement
to the facility or entity who purchased the prescription drugs. The
pharmacy shall not be required to reimburse Medicaid benefic iaries
for prescription copayments .
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D. A pharmacy or charitable clinic which meets the eligibility
requirements established and authorized by the Utili zation of Unused
Prescription Medications Act which accepts donated prescription
drugs shall:
1. Comply with all applicable federal and state laws related to
the storage and distribution of dangerous drugs;
2. Inspect all prescription drugs prior to disp ensing the
prescription drugs to determine that such drugs are not adulterated;
and
3. Dispense prescri ption drugs only pursuant to a prescription
issued by a health care professional .
D. Prescription drugs donated under the Utilization of Unused
Prescription Medications Act shall not be resold.
E. For purposes of the Utilization of Unused Prescription
Medications Act, reimbursement from governmental agencies to
charitable clinics shall not be considered resale of prescription
drugs.
SECTION 4. AMENDATORY 59 O.S. 2011, Section 367 .6, is
amended to read as follows:
Section 367.6. A. For matters related only to the lawful
donation, return, acceptance, or dispensing of prescription drugs
under the Utilization of Unused Prescription Medic ations Act, the
following persons and entities , in compliance with the Utilization
of Unused Prescription Medications Act, in the absence of bad faith
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or gross negligence, shall not be subject to criminal or civil
liability for injury other than death, or loss to person or
property, or professional di sciplinary action:
1. The State Board of Pharmacy;
2. The Department of Mental Health and Substance Abuse
Services;
3. Any prescription drug manufacturer, governmental entity,
nursing home, or assisted living cent er, intermediate care facility
for individuals with intellectual disabilities (ICF/IID) donating or
returning prescription drugs under the Utilization of Unused
Prescription Medications Act;
4. Any prescription drug manufacturer or its representative
that directly donates prescription drugs in professional samples to
a charitable clinic or a pharmacy under the Utilization of Unused
Prescription Medications Act;
5. Any pharmacy, charitable clinic or health care professional
that accepts or dispenses prescription drugs under the Utilization
of Unused Prescription Medications Act; a nd
6. Any pharmacy, or charitable clinic, city-county pharmacy or
other state-contracted pharmacy that employs a health care
professional who accepts or can legally dispense prescription drugs
under the Utilization of U nused Prescription Medications Act a nd the
Oklahoma Pharmacy Act.
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B. For matters related to the donation , return, acceptance, or
dispensing of a prescription drug manufactured by the prescription
drug manufacturer that is donated by any entity under the
Utilization of Unused Prescription Me dications Act, a prescription
drug manufacturer shall not, in the absence of bad faith or gross
negligence, be subject to criminal or civil liability for injury
other than for death, or loss to person or property includi ng, but
not limited to, liability fo r failure to transfer or communicate
product or consumer information or the expiration date of the
donated prescription drug.
SECTION 5. AMENDATORY 59 O.S. 2011, Secti on 367.7, is
amended to read as follows:
Section 367.7. A. The State Board of Pharmacy shall promulgate
emergency rules by December 1, 2004, to implement the Utilization of
Unused Prescription Medications Act. Permanent rules shall be
promulgated pursuant to the Administrative Pr ocedures Act. Such
rules shall include:
1. Eligibility criteria for pharmacies and charitable clinics
authorized to receive and dispense donated prescri ption drugs under
the Utilization of Unused Prescription Medic ations Act;
2. Establishment of a formu lary which shall include all
prescription drugs app roved by the federal Food and Drug
Administration;
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3. Standards and procedures for transfer, acceptanc e, safe
storage, security, and d ispensing of donated prescript ion drugs;
4. A process for seeking inp ut from the State Department of
Health in establishing provisions which affect nursing homes and
assisted living centers;
5. A process for seeking input from the Department of Mental
Health and Substance Abuse Servi ces in establishing provisions which
affect mental health and substance abuse clients;
6. Standards and procedures for inspecting donated prescription
drugs to ensure that the drugs are in comp liance with the
Utilization of Unused Prescription Medications Act and to ensure
that, in the professi onal judgment of the pharmacist, the
medications meet all federal and state standards for product
integrity;
7. Procedures for destruction of medications that are donated
which are controlled substances;
8. Procedures for verifying whether the pharmacy a nd
responsible pharmacist participating in the prog ram are licensed and
in good standing with the Board of Pharmacy;
9. Establishment of standards for ac ceptance of unused
prescription medications from assisted livi ng centers; and
10. Procedures for credit and reimbursement for returns of
unused prescription medications; and
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11. Any other standards and procedures the Board of Pharmacy
deems appropriate or necessary to implement the pro visions of the
Utilization of Unused Prescription Medications Act.
B. In accordance with the rules and procedures of the program
established pursuant to this section, a resident of a nursing
facility or assisted living cent er, or the representative or
guardian of a resident may donate unused prescription medications,
other than prescription drugs defined as controlled dange rous
substances by Section 2 -101 of Title 63 of the Oklahoma Statutes,
for dispensation to medically in digent persons.
SECTION 6. This act shall become effective November 1, 2021.
58-1-1557 DC 1/21/2021 9:33:59 AM