Louisiana Revised Statutes 37:1226.2 – Prescription drug returns, exchanges, and redispensing; donation requirements; authority to promulgate rules; limitation of liability
Terms Used In Louisiana Revised Statutes 37:1226.2
- Board: means the Louisiana Board of Pharmacy. See Louisiana Revised Statutes 37:1164
- dispensing: means the interpretation, evaluation, and implementation of a prescription drug order, including the preparation and delivery of a drug or device to a patient or patient's agent in a suitable container appropriately labeled for subsequent administration to, or use by, a patient. See Louisiana Revised Statutes 37:1164
- distribution: means the delivery of a drug or device other than by administering or dispensing. See Louisiana Revised Statutes 37:1164
- Donor: The person who makes a gift.
- Drug: means :
(a) Any substance recognized as a drug in the official compendium, or supplement thereto, designated by the board for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases in humans or other animals. See Louisiana Revised Statutes 37:1164
- Hospital pharmacy: means a pharmacy department located in a hospital licensed under Louisiana Revised Statutes 37:1164
- Manufacturer: means a person who manufactures drugs and includes a labeler, primary distributor, or person who prepares drugs in dosage form by mixing. See Louisiana Revised Statutes 37:1164
- Obligation: An order placed, contract awarded, service received, or similar transaction during a given period that will require payments during the same or a future period.
- Person: means an individual, corporation, partnership, association, or any other legal entity, including government. See Louisiana Revised Statutes 37:1164
- Pharmacist: means an individual currently licensed by the board to engage in the practice of pharmacy in the state. See Louisiana Revised Statutes 37:1164
- Pharmacy: means any place located within this state where drugs are dispensed and pharmacy primary care is provided, and any place outside of this state where drugs are dispensed and pharmacy primary care is provided to residents of this state. See Louisiana Revised Statutes 37:1164
- Tort: A civil wrong or breach of a duty to another person, as outlined by law. A very common tort is negligent operation of a motor vehicle that results in property damage and personal injury in an automobile accident.
A. All drugs dispensed on prescription to a patient shall be accepted for return, exchange, or redispensing by a charitable pharmacy after such drugs have been removed from the pharmacy premises where they were dispensed including but not limited to:
(1) In a hospital with a permitted hospital pharmacy on site, drugs may be returned to the pharmacy in accordance with good professional practice standards.
(2) Any person, including a drug manufacturer, hospital, health care facility, or governmental entity may donate prescription drugs to a charitable pharmacy for relabeling and dispensing to the indigent, free of charge, pursuant to a valid prescription order.
B. Donations of prescription drugs to a charitable pharmacy are subject to the following requirements:
(1) The charitable pharmacy may accept drugs in their original sealed and tamper-evident packaging, including drugs packaged in single-unit doses, including blister packs. These drugs may be dispensed when the outside packaging is opened if the single-unit dose packaging is intact, subject to the provisions of Paragraph (B)(2) of this Section.
(2) The pharmacist in charge of the charitable pharmacy shall determine if the drug is not adulterated or misbranded and is safe to dispense. No product where the integrity of the medication cannot be assured shall be redispensed by the pharmacist of the charitable pharmacy.
(3) The donor shall execute a form stating the donation of the drugs. The pharmacy shall retain that form along with other acquisition records.
(4) The patient’s name, prescription number, and any other identifying marks shall be obliterated from the packaging prior to redispensing the medication to another patient.
(5) The drug name, strength, and expiration date shall remain on the medication package label. The redispensed medication shall be assigned the expiration date stated on the package.
(6) Expired drugs accepted by a charitable pharmacy shall not be redispensed.
(7) The charitable pharmacy shall comply with all state and federal laws regarding controlled dangerous substances.
(8) No drug dispensed through a charitable pharmacy shall be eligible for reimbursement from the Medicaid Pharmacy Program.
(9) In the event that a charitable pharmacy in the closest proximity to the donor refuses the donation, such refusal shall be documented by the donor, who then may make the donation to the Department of Public Safety and Corrections-Corrections Services for distribution to the penal institution pharmacies under its authority.
C. The board shall have the authority to promulgate rules and regulations in accordance with the Administrative Procedure Act for the purpose of administering the provisions of this Section.
D.(1) No person, including a drug manufacturer, healthcare facility, or governmental agency who donates prescription drugs to a charitable pharmacy, as well as the charitable pharmacy, any pharmacist who originally dispensed the donated prescription drugs, any pharmacist dispensing donated prescription drugs, or the Louisiana Board of Pharmacy shall be subject to any professional disciplinary action, criminal prosecution, liability in tort or other civil action for injury, death, or loss to person or property related to the donating, accepting, or dispensing of donated prescription drugs.
(2) No pharmaceutical manufacturer shall be liable for any claim or injury arising from the transfer of any prescription drug pursuant to the provisions of this Section, including but not limited to liability for failure to transfer or communicate product or consumer information regarding the transferred drug, as well as the expiration date of the transferred drug.
E. For purposes of this Section “charitable pharmacy” means the practice of a pharmacy at a site where prescriptions are dispensed by a charitable organization free of charge to appropriately screened and qualified patients.
F. A hospital, health care facility, or governmental entity enrolled in the Medicaid program shall attempt to donate all unused or surplus prescription drugs meeting the criteria in Subsections A and B of this Section to charitable pharmacies. The provisions of this Subsection shall not apply to any hospital, health care facility, or governmental entity owned by or operated by an agency or department of the executive branch of the state.
G. In the event such hospital, health care facility or governmental entity does not have a charitable pharmacy within twenty miles of its location, the charitable pharmacy shall have the obligation to obtain those prescription drugs. In the event the charitable pharmacy is unable to make such arrangements, there shall be no requirement on the part of the hospital, health care facility or governmental entity to donate the drugs.
H. Notwithstanding any other provision of law to the contrary, a faith-based charitable pharmacy shall not be required to accept any prescription drugs it deems to conflict with its faith values.
I. For the purpose of this Section, “governmental entity” shall mean a health care facility owned and operated by a political subdivision of the state.
Acts 2004, No. 811, §1; Acts 2006, No. 643, §1; Acts 2006, No. 797, §1; Acts 2018, No. 206, §3.