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1 STATE OF OKLAHOMA
2 1st Session of the 60th Legislature (2025)
3 HOUSE BILL 1344 By: Humphrey
4
5
6 AS INTRODUCED
7 An Act relating to prescriptions for off-label
medications; defining terms; authorizing prescribing
8 off-label prescriptions; allowing for moral, ethical,
or religious exemptions; providing for immunity from
9 liability; providing for good-faith effort; providing
for temporary privileges; providing for at-home and
10 outpatient dispensing; prohibiting disciplinary
action; providing exceptions to disciplinary action;
11 proscribing the World Health Organization
jurisdiction in this state; providing for
12 codification; and providing an effective date.
13
14
15 BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
16 SECTION 1. NEW LAW A new section of law to be codified
17 in the Oklahoma Statutes as Section 355.7 of Title 59, unless there
18 is created a duplication in numbering, reads as follows:
19 A. As used in this section:
20 1. "Health-related licensing board" means a state board
21 authorized to issue a license to engage in the practice of a
22 licensed health professional authorized to prescribe drugs;
23 2. "Hospital" means an institution or facility that provides
24 inpatient medical or surgical services for a continuous period
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1 longer than twenty-four (24) hours and includes a hospital owned or
2 operated by the United States Department of Veterans Affairs;
3 3. "Identified" means that a hospital or inpatient facility
4 pharmacist has determined that the drug in question is the drug
5 prescribed by the patient's prescriber and that the patient's
6 prescribed drug is in the original manufacturer's packaging or is
7 labeled from an outpatient retail pharmacy, has been approved by the
8 prescriber for use, and is not outside of its beyond use date;
9 4. "Informed consent" means the communication between a
10 patient, patient's parent or guardian, or person holding a health
11 care power of attorney and a physician that results in the patient,
12 patient's parent or guardian, or person holding a health care power
13 of attorney authorizing, or agreeing to accept, a specific drug,
14 treatment, or intervention. The physician, as part of such
15 communication, shall provide all of the following information:
16 a. the patient's diagnosis, if known,
17 b. the nature and purpose of the recommended drug,
18 treatment, or intervention,
19 c. the burdens, risks, and expected benefits of all drug,
20 treatment, or intervention options, including the
21 option of forgoing treatment, and
22 d. any conflicts of interest the physician may have
23 regarding the recommended drug, treatment, or
24 intervention;
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1 5. "Inpatient facility" means either or both of the following:
2 a. a skilled nursing facility as defined in the Social
3 Security Act, Section 42 U.S.C., 1819(a), 1395i-3(a),
4 and
5 b. a freestanding inpatient rehabilitation facility;
6 6. "Off-label drug" means a drug that meets all of the
7 following:
8 a. the drug is approved by the United States Food and
9 Drug Administration to treat or prevent a disease,
10 illness, or infection, but prescribed for or used by a
11 patient to treat or prevent another disease, illness,
12 or infection,
13 b. the drug is legal for use in this state, and
14 c. the drug is not a controlled dangerous substance;
15 7. "Pharmacist" means an individual who holds a license issued
16 by the Board of Pharmacy authorizing the individual to practice
17 pharmacy;
18 8. "Political subdivision" means a county, township, municipal
19 corporation, school district, or other body corporate and politic
20 responsible for governmental activities in a geographic area smaller
21 than that of the state;
22 9. "Prescriber" has the same meaning as Section 353.1 of Title
23 59 of the Oklahoma Statutes;
24
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1 10. "Public official" means any officer, employee, or duly
2 authorized agent or representative of a state agency or political
3 subdivision; and
4 11. "State agency" means any organized agency, board, body,
5 commission, department, institution, office, or other entity
6 established by the laws of the state for the exercise of any
7 function of state government. State agency does not include a
8 court.
9 B. A prescriber may issue for a patient a prescription for any
10 drug, including an off-label drug, if the prescriber has obtained
11 the informed consent of any of the following:
12 1. The patient;
13 2. Patient's parent or guardian; or
14 3. Person holding the patient's health care power of attorney.
15 All of the following apply to the prescribing of an off-label
16 drug under this section:
17 1. The prescriber is not required to obtain or show a test
18 result for a particular disease, illness, or infection before
19 issuing the prescription for the patient's use of the drug at home
20 or for outpatient treatment or in a hospital or inpatient facility;
21 2. The patient is not required to have had a positive screen or
22 test result for a particular disease, illness, or infection before
23 the prescriber issues the prescription;
24
Req. No. 10748 Page 4
1 3. The patient is not required to have been exposed to a
2 disease, illness, or infection before the prescriber issues the
3 prescription for the patient's prophylactic use of the drug; and
4 4. In the case of a drug subject to a United States Food and
5 Drug Administration Risk Evaluation and Mitigation Strategy, the
6 usage of the drug for an off-label purpose must be consistent with
7 any requirements or recommendations the strategy establishes.
8 C. 1. A pharmacist shall dispense, and a hospital or inpatient
9 facility shall allow the dispensing of, an off-label drug to a
10 patient if a prescriber has issued for the patient a prescription
11 for the drug as described in subsection B of this section, except if
12 either of the following is the case:
13 a. the pharmacist, hospital, or inpatient facility has a
14 moral, ethical, or religious belief or conviction that
15 conflicts with the drug's dispensing, or
16 b. the pharmacist has documented that the patient has a
17 history of a life-threatening allergic reaction to the
18 prescribed off-label drug or there is a life-
19 threatening contraindication;
20 2. When a pharmacist shall dispense, or a hospital or inpatient
21 facility shall allow the dispensing of, an off-label drug for a
22 patient pursuant to this section, but the pharmacist, hospital, or
23 inpatient facility has an objective, good faith, and scientific
24 objection to the administration or dosage of the drug for that
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1 patient, the pharmacist, hospital, or inpatient facility shall be
2 immune from administrative or civil liability for any harm that may
3 arise from the dispensing or use of the off-label drug starting from
4 the date of dispensing, so long as, at the time of dispensing, the
5 pharmacist, hospital, or inpatient facility documents in the
6 patient's medical record the objective, good faith, and scientific
7 objection, by stating with particularity the basis of that
8 objection, which must be based on an individualized assessment of
9 the patient and the off-label drug;
10 3. a. In the case of a pharmacist who practices within a
11 hospital's or inpatient facility's pharmacy and where
12 an in-house treating prescriber issues for a hospital
13 or facility patient a prescription for an off-label
14 drug that is neither in stock nor listed on the
15 hospital's or facility's formulary, the pharmacist
16 shall document in the patient's medical record that a
17 good-faith effort was made to find out if the drug is
18 available from another hospital or inpatient facility
19 or another United States distributor. If available,
20 the drug shall be offered to the patient at an up-
21 front out-of-pocket cost. The hospital or inpatient
22 facility may require payment prior to ordering the
23 drug;
24
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1 b. If the hospital or inpatient facility pharmacist is
2 unable to obtain the off-label drug from another
3 hospital, inpatient facility, or distributor or if the
4 hospital, hospital pharmacist, inpatient facility, or
5 pharmacist declines to fill the prescription, and the
6 patient has access to the drug through a pharmacy
7 outside the hospital or inpatient facility or has the
8 drug available at home, then both of the following
9 apply:
10 (1) the hospital or inpatient facility shall permit
11 that drug to be brought into the hospital or
12 inpatient facility to be identified for the
13 patient's use. If identified, the drug will be
14 administered to the patient within the hospital
15 or inpatient facility, and
16 (2) when the hospital or inpatient facility or the
17 patient's in-house treating prescriber or other
18 in-house treating clinician is unwilling to
19 administer the identified drug to the patient,
20 then another prescriber or prescriber's delegate
21 may administer the drug;
22 4. When a patient's condition is so serious that the patient
23 cannot be safely transported out of a hospital or inpatient facility
24 and the patient, patient's parent or guardian, or person holding the
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1 patient's health care power of attorney wishes to try an off-label
2 drug to treat the patient's condition, but there is no in-house
3 prescriber willing to prescribe the drug, then the patient's
4 outpatient physician prescriber, after a prompt consultation with
5 the patient's hospital or inpatient facility care team and a review
6 of all of the patient's drugs, shall be allowed to immediately begin
7 applying for temporary privileges with oversight, based on criteria
8 within the hospital or inpatient facility medical staff bylaws used
9 to determine the issuance of temporary privileges. The temporary
10 privileges approval process is not to exceed five (5) days. If the
11 outpatient physician prescriber does not meet the hospital's or
12 facility's medical staff bylaw requirements and the outpatient
13 physician prescriber feels that temporary privileges were wrongfully
14 denied to the physician, then the physician may file a complaint
15 with the State Department of Health. The complaint shall include
16 the name of the hospital or facility, the hospital's or facility's
17 stated reason for the denial, and the name of the drug that the
18 outpatient physician prescriber was seeking temporary privileges in
19 order to prescribe. The Department shall keep a record of the
20 complaint, including the aforementioned information. The
21 complaint's information shall be kept on file with the Department
22 for seven (7) years and shall be made available to any citizen of
23 this state within ten (10) days of the citizen's written request.
24 If the outpatient physician prescriber meets the hospital's or
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1 facility's medical staff bylaw requirements for temporary
2 privileges, then he or she shall immediately be allowed to
3 participate in the patient's care in the narrowed scope of practice
4 regarding the administering and monitoring of the prescribed off-
5 label drug within the hospital or inpatient facility until the
6 patient is in a condition where the patient can be safely
7 transported to a hospital or inpatient facility where the outpatient
8 physician prescriber has privileges. In such a case, all of the
9 following apply:
10 a. the patient may be required to pay out-of-pocket for
11 the prescribed off-label drug before it is ordered,
12 b. if the hospital or inpatient facility cannot obtain
13 the off-label drug being prescribed by the outpatient
14 physician prescriber, then the requirements of
15 divisions (1) and (2) of subparagraph b of paragraph 3
16 of this subsection apply, and
17 c. the in-house pharmacist, hospital, or inpatient
18 facility and the in-house physician responsible for
19 the patient's care shall be immune from administrative
20 and civil liability for any harm that may arise from
21 the patient's use of the off-label drug prescribed by
22 the outpatient physician prescriber starting from the
23 date of dispensing;
24
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1 5. All of the following apply to the dispensing of an off-label
2 drug under paragraph 1 or 2 of this subsection:
3 a. the pharmacist is not required to obtain or show a
4 test result before dispensing the drug for the
5 patient's use at home or for other outpatient
6 treatment,
7 b. the patient is not required to have had a positive
8 screen or test result for a particular disease,
9 illness, or infection before the pharmacist dispenses
10 the drug, and
11 c. the patient is not required to have been exposed to a
12 disease, illness, or infection before the pharmacist
13 dispenses the drug for prophylactic use;
14 6. Nothing in this section prevents a pharmacist from
15 discussing a prescription with the prescriber who issued the
16 prescription. The ultimate decision to accept a drug prescribed by
17 the prescriber shall be made by one of the following who has given
18 informed consent: the patient, patient's parent or guardian, or
19 person holding the patient's health care power of attorney.
20 D. A health-related licensing board, department of health,
21 state board of pharmacy, or other state board or agency responsible
22 for the licensure or regulation of health care professionals shall
23 not consider any action taken by a prescriber or pharmacist or
24 hospital or inpatient facility under this section to be unlawful,
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1 unethical, unauthorized, or unprofessional conduct and shall not
2 pursue an administrative or disciplinary action against the
3 prescriber, pharmacist, hospital, or facility, except in cases of
4 recklessness or gross negligence. A health-related licensing board,
5 department of health, state board of pharmacy, or other state board
6 or agency responsible for the licensure or regulation of health care
7 professionals shall not pursue an administrative or disciplinary
8 action against a prescriber, pharmacist, or other licensed health
9 care professional or hospital or inpatient facility for publicly or
10 privately expressing a medical opinion that does not align with the
11 opinions of the board or agency, a board of health of a city or
12 county health district, or the department of health.
13 E. The World Health Organization shall have no jurisdiction in
14 this state. Therefore, no political subdivision, public official,
15 or state agency shall enforce or use any state funding to implement
16 any guideline, mandate, recommendation, or rule issued by the World
17 Health Organization that prohibits issuing a prescription for or
18 dispensing an off-label drug.
19 SECTION 2. This act shall become effective November 1, 2025.
20
21 60-1-10748 TJ 01/03/25
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