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2018 SESSION
Be 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,
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.