A. Drugs dispensed to persons pursuant to a prescription shall not be accepted for return or exchange for the purpose of re-dispensing by any pharmacist or pharmacy after such drugs have been removed from the pharmacy premises from which they were dispensed except:

1. In a hospital with an on-site hospital pharmacy wherein drugs may be returned to the pharmacy in accordance with practice standards;

2. In such cases where official compendium storage requirements are assured and the drugs are in manufacturers' original sealed containers or in sealed individual dose or unit dose packaging that meets official compendium class A or B container requirements, or better, and such return or exchange is consistent with federal law; or

3. When a dispensed drug has not been out of the possession of a delivery agent of the pharmacy.

B. The Board shall promulgate regulations to establish a prescription drug donation program for accepting unused previously dispensed prescription drugs that meet the criteria set forth in subdivision A 2, for the purpose of re-dispensing such drugs to indigent patients, either through hospitals or through clinics organized in whole or in part for the delivery of health care services to the indigent. Such program shall not authorize the donation of Schedule II-V controlled substances if so prohibited by federal law. No drugs shall be re-dispensed unless the integrity of the drug can be assured. Such program shall accept eligible prescription drugs from individuals, including those residing in nursing homes, assisted living facilities, or intermediate care facilities established for individuals with intellectual disability (ICF/IID), licensed hospitals, or any facility operated by the Department of Behavioral Health and Developmental Services. Additionally, such program shall accept eligible prescription drugs from an agent pursuant to a power of attorney, a decedent's personal representative, a legal guardian of an incapacitated person, or a guardian ad litem donated on behalf of the represented individual.

C. Unused prescription drugs dispensed for use by persons eligible for coverage under Title XIX or Title XXI of the Social Security Act, as amended, may be donated pursuant to this section unless such donation is prohibited.

D. A pharmaceutical manufacturer shall not be liable for any claim or injury arising from the storage, donation, acceptance, transfer, or dispensing of any drug provided to a patient or any other activity undertaken in accordance with a drug distribution program established pursuant to this section.

E. Nothing in this section shall be construed to create any new or additional liability, or to abrogate any liability that may exist, applicable to a pharmaceutical manufacturer for its products separately from the storage, donation, acceptance, transfer, or dispensing of any drug provided to a patient in accordance with a drug distribution program established pursuant to this section.

F. In the absence of bad faith or gross negligence, no person that donates, accepts, or dispenses unused prescription drugs in accordance with this section and Board regulations shall be subject to criminal or civil liability for matters arising from the donation, acceptance, or dispensing of such unused prescription drugs.

2002, c. 632; 2005, c. 68; 2008, c. 429; 2009, cc. 109, 114; 2018, c. 376.