§ 37:1226.2 — Prescription drug returns, exchanges, and redispensing; donation requirements;

Louisiana § 37:1226.2

• Jurisdiction: Louisiana
• Title 37: Professions and Occupations

Text

§1226.2. Prescription drug returns, exchanges, and redispensing; donation requirements;
authority to promulgate rules; limitation of liability
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.

Legislative History

Acts 2004, No. 811, §1; Acts 2006, No. 643, §1; Acts 2006, No. 797, §1; Acts 2018, No. 206, §3.