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STATE OF OKLAHOMA
1st Session of the 60th Legislature (2025)
HOUSE BILL 1344 By: Humphrey
AS INTRODUCED
An Act relating to prescriptions for off-label
medications; defining terms; authorizing prescribing
off-label prescriptions; allowing for moral, ethical,
or religious exemptions; providing for immunity from
liability; providing for good-faith effort; providing
for temporary privileges; providing for at-home and
outpatient dispensing; prohibiting disciplinary
action; providing exceptions to disciplinary action;
proscribing the World Health Organization
jurisdiction in this state; 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 355.7 of Title 59, unless there
is created a duplication in numbering, reads as follows:
A. As used in this section:
1. "Health-related licensing board" means a state board
authorized to issue a license to engage in the practice of a
licensed health professional authorized to prescribe drugs;
2. "Hospital" means an institution or facility that provides
inpatient medical or surgical services for a continuous period
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longer than twenty-four (24) hours and includes a hospital owned or
operated by the United States Department of Veterans Affairs;
3. "Identified" means that a hospital or inpatient facility
pharmacist has determined that the drug in question is the drug
prescribed by the patient's prescriber and that the patient's
prescribed drug is in the original manufacturer's packaging or is
labeled from an outpatient retail pharmacy, has been approved by the
prescriber for use, and is not outside of its beyond use date;
4. "Informed consent" means the communication between a
patient, patient's parent or guardian, or person holding a health
care power of attorney and a physician that results in the patient,
patient's parent or guardian, or person holding a health care power
of attorney authorizing, or agreeing to accept, a specific drug,
treatment, or intervention. The physician, as part of such
communication, shall provide all of the following information:
a. the patient's diagnosis, if known,
b. the nature and purpose of the recommended drug,
treatment, or intervention,
c. the burdens, risks, and expected benefits of all drug,
treatment, or intervention options, including the
option of forgoing treatment, and
d. any conflicts of interest the physician may have
regarding the recommended drug, treatment, or
intervention;
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5. "Inpatient facility" means either or both of the following:
a. a skilled nursing facility as defined in the Social
Security Act, Section 42 U.S.C., 1819(a), 1395i-3(a),
and
b. a freestanding inpatient rehabilitation facility;
6. "Off-label drug" means a drug that meets all of the
following:
a. the drug is approved by the United States Food and
Drug Administration to treat or prevent a disease,
illness, or infection, but prescribed for or used by a
patient to treat or prevent another disease, illness,
or infection,
b. the drug is legal for use in this state, and
c. the drug is not a controlled dangerous substance;
7. "Pharmacist" means an individual who holds a license issued
by the Board of Pharmacy authorizing the individual to practice
pharmacy;
8. "Political subdivision" means a county, township, municipal
corporation, school district, or other body corporate and politic
responsible for governmental activities in a geographic area smaller
than that of the state;
9. "Prescriber" has the same meaning as Section 353.1 of Title
59 of the Oklahoma Statutes;
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10. "Public official" means any officer, employee, or duly
authorized agent or representative of a state agency or political
subdivision; and
11. "State agency" means any organized agency, board, body,
commission, department, institution, office, or other entity
established by the laws of the state for the exercise of any
function of state government. State agency does not include a
court.
B. A prescriber may issue for a patient a prescription for any
drug, including an off-label drug, if the prescriber has obtained
the informed consent of any of the following:
1. The patient;
2. Patient's parent or guardian; or
3. Person holding the patient's health care power of attorney.
All of the following apply to the prescribing of an off-label
drug under this section:
1. The prescriber is not required to obtain or show a test
result for a particular disease, illness, or infection before
issuing the prescription for the patient's use of the drug at home
or for outpatient treatment or in a hospital or inpatient facility;
2. The patient is not required to have had a positive screen or
test result for a particular disease, illness, or infection before
the prescriber issues the prescription;
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3. The patient is not required to have been exposed to a
disease, illness, or infection before the prescriber issues the
prescription for the patient's prophylactic use of the drug; and
4. In the case of a drug subject to a United States Food and
Drug Administration Risk Evaluation and Mitigation Strategy, the
usage of the drug for an off-label purpose must be consistent with
any requirements or recommendations the strategy establishes.
C. 1. A pharmacist shall dispense, and a hospital or inpatient
facility shall allow the dispensing of, an off-label drug to a
patient if a prescriber has issued for the patient a prescription
for the drug as described in subsection B of this section, except if
either of the following is the case:
a. the pharmacist, hospital, or inpatient facility has a
moral, ethical, or religious belief or conviction that
conflicts with the drug's dispensing, or
b. the pharmacist has documented that the patient has a
history of a life-threatening allergic reaction to the
prescribed off-label drug or there is a life-
threatening contraindication;
2. When a pharmacist shall dispense, or a hospital or inpatient
facility shall allow the dispensing of, an off-label drug for a
patient pursuant to this section, but the pharmacist, hospital, or
inpatient facility has an objective, good faith, and scientific
objection to the administration or dosage of the drug for that
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patient, the pharmacist, hospital, or inpatient facility shall be
immune from administrative or civil liability for any harm that may
arise from the dispensing or use of the off-label drug starting from
the date of dispensing, so long as, at the time of dispensing, the
pharmacist, hospital, or inpatient facility documents in the
patient's medical record the objective, good faith, and scientific
objection, by stating with particularity the basis of that
objection, which must be based on an individualized assessment of
the patient and the off-label drug;
3. a. In the case of a pharmacist who practices within a
hospital's or inpatient facility's pharmacy and where
an in-house treating prescriber issues for a hospital
or facility patient a prescription for an off-label
drug that is neither in stock nor listed on the
hospital's or facility's formulary, the pharmacist
shall document in the patient's medical record that a
good-faith effort was made to find out if the drug is
available from another hospital or inpatient facility
or another United States distributor. If available,
the drug shall be offered to the patient at an up-
front out-of-pocket cost. The hospital or inpatient
facility may require payment prior to ordering the
drug;
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b. If the hospital or inpatient facility pharmacist is
unable to obtain the off-label drug from another
hospital, inpatient facility, or distributor or if the
hospital, hospital pharmacist, inpatient facility, or
pharmacist declines to fill the prescription, and the
patient has access to the drug through a pharmacy
outside the hospital or inpatient facility or has the
drug available at home, then both of the following
apply:
(1) the hospital or inpatient facility shall permit
that drug to be brought into the hospital or
inpatient facility to be identified for the
patient's use. If identified, the drug will be
administered to the patient within the hospital
or inpatient facility, and
(2) when the hospital or inpatient facility or the
patient's in-house treating prescriber or other
in-house treating clinician is unwilling to
administer the identified drug to the patient,
then another prescriber or prescriber's delegate
may administer the drug;
4. When a patient's condition is so serious that the patient
cannot be safely transported out of a hospital or inpatient facility
and the patient, patient's parent or guardian, or person holding the
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patient's health care power of attorney wishes to try an off-label
drug to treat the patient's condition, but there is no in-house
prescriber willing to prescribe the drug, then the patient's
outpatient physician prescriber, after a prompt consultation with
the patient's hospital or inpatient facility care team and a review
of all of the patient's drugs, shall be allowed to immediately begin
applying for temporary privileges with oversight, based on criteria
within the hospital or inpatient facility medical staff bylaws used
to determine the issuance of temporary privileges. The temporary
privileges approval process is not to exceed five (5) days. If the
outpatient physician prescriber does not meet the hospital's or
facility's medical staff bylaw requirements and the outpatient
physician prescriber feels that temporary privileges were wrongfully
denied to the physician, then the physician may file a complaint
with the State Department of Health. The complaint shall include
the name of the hospital or facility, the hospital's or facility's
stated reason for the denial, and the name of the drug that the
outpatient physician prescriber was seeking temporary privileges in
order to prescribe. The Department shall keep a record of the
complaint, including the aforementioned information. The
complaint's information shall be kept on file with the Department
for seven (7) years and shall be made available to any citizen of
this state within ten (10) days of the citizen's written request.
If the outpatient physician prescriber meets the hospital's or
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facility's medical staff bylaw requirements for temporary
privileges, then he or she shall immediately be allowed to
participate in the patient's care in the narrowed scope of practice
regarding the administering and monitoring of the prescribed off-
label drug within the hospital or inpatient facility until the
patient is in a condition where the patient can be safely
transported to a hospital or inpatient facility where the outpatient
physician prescriber has privileges. In such a case, all of the
following apply:
a. the patient may be required to pay out-of-pocket for
the prescribed off-label drug before it is ordered,
b. if the hospital or inpatient facility cannot obtain
the off-label drug being prescribed by the outpatient
physician prescriber, then the requirements of
divisions (1) and (2) of subparagraph b of paragraph 3
of this subsection apply, and
c. the in-house pharmacist, hospital, or inpatient
facility and the in-house physician responsible for
the patient's care shall be immune from administrative
and civil liability for any harm that may arise from
the patient's use of the off-label drug prescribed by
the outpatient physician prescriber starting from the
date of dispensing;
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5. All of the following apply to the dispensing of an off-label
drug under paragraph 1 or 2 of this subsection:
a. the pharmacist is not required to obtain or show a
test result before dispensing the drug for the
patient's use at home or for other outpatient
treatment,
b. the patient is not required to have had a positive
screen or test result for a particular disease,
illness, or infection before the pharmacist dispenses
the drug, and
c. the patient is not required to have been exposed to a
disease, illness, or infection before the pharmacist
dispenses the drug for prophylactic use;
6. Nothing in this section prevents a pharmacist from
discussing a prescription with the prescriber who issued the
prescription. The ultimate decision to accept a drug prescribed by
the prescriber shall be made by one of the following who has given
informed consent: the patient, patient's parent or guardian, or
person holding the patient's health care power of attorney.
D. A health-related licensing board, department of health,
state board of pharmacy, or other state board or agency responsible
for the licensure or regulation of health care professionals shall
not consider any action taken by a prescriber or pharmacist or
hospital or inpatient facility under this section to be unlawful,
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unethical, unauthorized, or unprofessional conduct and shall not
pursue an administrative or disciplinary action against the
prescriber, pharmacist, hospital, or facility, except in cases of
recklessness or gross negligence. A health-related licensing board,
department of health, state board of pharmacy, or other state board
or agency responsible for the licensure or regulation of health care
professionals shall not pursue an administrative or disciplinary
action against a prescriber, pharmacist, or other licensed health
care professional or hospital or inpatient facility for publicly or
privately expressing a medical opinion that does not align with the
opinions of the board or agency, a board of health of a city or
county health district, or the department of health.
E. The World Health Organization shall have no jurisdiction in
this state. Therefore, no political subdivision, public official,
or state agency shall enforce or use any state funding to implement
any guideline, mandate, recommendation, or rule issued by the World
Health Organization that prohibits issuing a prescription for or
dispensing an off-label drug.
SECTION 2. This act shall become effective November 1, 2025.
60-1-10748 TJ 01/03/25