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2018 SESSION
18103199DBe it enacted by the General Assembly of Virginia:
1. That § 54.1-3411.1 of the Code of Virginia is amended and reenacted as follows:
§ 54.1-3411.1. Prohibition on returns, exchanges, or re-dispensing of drugs; exceptions.
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 of Pharmacy shall promulgate regulations to
establish a Prescription Drug
Donation Program 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, through
pharmacies, 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.
C. Such program shall accept eligible prescription drugs from individuals, manufacturers, nursing homes, assisted living facilities, 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.
D. Unused prescription drugs (i) dispensed for use by persons eligible for coverage under Title XIX or Title XXI of the Social Security Act, as amended, or (ii) dispensed through a prescription drug donation program may be donated pursuant to this section unless such donation is prohibited.
D. E. 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. F. 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.
G. In the absence of bad faith or gross negligence, no person who 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.