Ohio Code 4729.89 – Investigational drugs
(A) As used in this section, “eligible patient,” “investigational drug, product, or device,” “terminal condition,” and “treating physician” have the same meanings as in section 4731.97 of the Revised Code.
Terms Used In Ohio Code 4729.89
- Damages: Money paid by defendants to successful plaintiffs in civil cases to compensate the plaintiffs for their injuries.
- Drug: means :
(1) Any article recognized in the United States pharmacopoeia and national formulary, or any supplement to them, intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals;
(2) Any other article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals;
(3) Any article, other than food, intended to affect the structure or any function of the body of humans or animals;
(4) Any article intended for use as a component of any article specified in division (E)(1), (2), or (3) of this section; but does not include devices or their components, parts, or accessories. See Ohio Code 4729.01
- manufacturer: means a person, other than a pharmacist or prescriber, who manufactures dangerous drugs and who is engaged in the sale of those dangerous drugs. See Ohio Code 4729.01
- Product: when used in reference to an investigational drug or product, means a biological product, other than a drug, that is made from a natural human, animal, or microorganism source and is intended to treat a disease or medical condition. See Ohio Code 4729.01
- Terminal distributor: includes pharmacies, hospitals, nursing homes, and laboratories and all other persons who procure dangerous drugs for sale or other distribution by or under the supervision of a pharmacist, licensed health professional authorized to prescribe drugs, or other person authorized by the state board of pharmacy. See Ohio Code 4729.01
(B) A manufacturer of dangerous drugs may, in accordance with section 4731.97 of the Revised Code, provide an investigational drug, product, or device for treatment of a terminal condition to an eligible patient or to the treating physician who is treating the eligible patient’s terminal condition. In doing so, the manufacturer may do all of the following:
(1) Provide the investigational drug, product, or device to the eligible patient or treating physician directly or through a terminal distributor of dangerous drugs;
(2) Provide the investigational drug, product, or device either with or without charge for the costs associated with manufacturing and providing the investigational drug, product, or device;
(3) Require the eligible patient to participate in data collection relating to use of the investigational drug, product, or device.
(C) Except for actions or omissions constituting willful or wanton misconduct, a manufacturer or terminal distributor of dangerous drugs that provides or distributes an investigational drug, product, or device pursuant to this section and section 4731.97 of the Revised Code is not liable for or subject to damages in any civil action or prosecution in any criminal proceeding for actions or omissions related to providing or distributing the investigational drug, product, or device.
(D) Nothing in this section shall be interpreted as requiring a manufacturer or terminal distributor to provide an investigational drug, product, or device to an eligible patient or the patient’s treating physician.