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.
Structure Code of Virginia
Title 54.1 - Professions and Occupations
§ 54.1-3403. Chapter not applicable to economic poisons
§ 54.1-3405. Access to and copies of records; inspections
§ 54.1-3406. Records confidential; disclosure of information about violations of federal law
§ 54.1-3407. Analysis of controlled substances
§ 54.1-3408. Professional use by practitioners
§ 54.1-3408.01. Requirements for prescriptions
§ 54.1-3408.02. Transmission of prescriptions
§ 54.1-3408.03. Dispensing of therapeutically equivalent drug product permitted
§ 54.1-3408.04. Dispensing of interchangeable biosimilars permitted
§ 54.1-3408.05. Use of FDA-approved substance upon publication of final rule
§ 54.1-3408.1. Prescription in excess of recommended dosage in certain cases
§ 54.1-3408.3. Certification for use of cannabis oil for treatment
§ 54.1-3408.5. Epinephrine required in certain public places
§ 54.1-3409. Professional use by veterinarians
§ 54.1-3410. When pharmacist may sell and dispense drugs
§ 54.1-3410.1. Requirements for radiopharmaceuticals
§ 54.1-3411. When prescriptions may be refilled
§ 54.1-3411.1. Prohibition on returns, exchanges, or re-dispensing of drugs; exceptions
§ 54.1-3411.2. Prescription drug disposal programs
§ 54.1-3411.2:1. Guidelines for disposal of unused drugs
§ 54.1-3412. Date of dispensing; initials of pharmacist; automated data processing system
§ 54.1-3413. Manufacturing and administering Schedule I drugs
§ 54.1-3414. Official orders for Schedule II drugs
§ 54.1-3415. Distribution of drugs in Schedules II through VI by manufacturers and wholesalers
§ 54.1-3415.1. Delivery of medical devices on behalf of a medical equipment supplier
§ 54.1-3416. No prescription for preparations listed pursuant to Schedule V
§ 54.1-3417. Disposing of stocks of Schedules II through V drugs
§ 54.1-3418. Sale of aqueous or oleaginous solutions
§ 54.1-3419. Dispensing of insulin preparations
§ 54.1-3420. Distribution of certain drugs; written request or confirmation of receipt
§ 54.1-3420.1. Identification required for filling prescriptions
§ 54.1-3420.2. Delivery of prescription drug order
§ 54.1-3426. Regulations for special packaging
§ 54.1-3427. Dispensing drugs without safety closure container
§ 54.1-3428. Dissemination of information
§ 54.1-3429. Revocation of permit issued to manufacturer, wholesaler or distributor
§ 54.1-3430. Display of permit; permits nontransferable; renewal
§ 54.1-3431. Admission into evidence of certain certificates of analysis
§ 54.1-3432. Supervision by pharmacist
§ 54.1-3433. Certain advertising and signs unlawful
§ 54.1-3434. Permit to conduct pharmacy
§ 54.1-3434.01. Notice of pharmacy closing; change of ownership; penalty
§ 54.1-3434.02. Automated drug dispensing systems
§ 54.1-3434.03. Continuous quality improvement program
§ 54.1-3434.04. Automatic review of certain case decisions
§ 54.1-3434.05. Permit to act as an outsourcing facility
§ 54.1-3434.1. Nonresident pharmacies to register with Board
§ 54.1-3434.2. Permit to be issued
§ 54.1-3434.3. Denial, revocation, suspension of registration, summary proceedings
§ 54.1-3434.4. Prohibited acts
§ 54.1-3434.5. Nonresident outsourcing facilities to register with the Board
§ 54.1-3435. License to act as wholesale distributor; renewal; fee
§ 54.1-3435.01. Registration of nonresident wholesale distributors; renewal; fee
§ 54.1-3435.02. Certain permitted pharmacies and medical equipment suppliers exempted
§ 54.1-3435.2. Permit to act as medical equipment supplier; storage; limitation; regulations
§ 54.1-3435.3. Inspection and audit
§ 54.1-3435.3:1. Registration of nonresident medical equipment suppliers; renewal; fee
§ 54.1-3435.4. Permit to act as warehouser; regulations
§ 54.1-3435.4:01. Registration to act as a nonresident warehouser; regulations
§ 54.1-3435.4:1. Permitting of third-party logistics provider; renewal
§ 54.1-3435.4:2. Registration of nonresident third-party logistics provider; renewal
§ 54.1-3436.1. Prescription drug price transparency
§ 54.1-3437. Permit to manufacture drugs
§ 54.1-3437.1. Limited permit for repackaging drugs
§ 54.1-3438. Manufacturing, etc., of drugs or proprietary medicines, to be supervised by pharmacist
§ 54.1-3439. Application for nonrestricted manufacturing permit; fee
§ 54.1-3440. Persons to whom nonrestricted permit is granted
§ 54.1-3442. When permit not to be granted; regulations
§ 54.1-3442.01. Registration of nonresident manufacturer; renewal
§ 54.1-3442.02. Prescription drug price transparency
§ 54.1-3442.4. Limitation of liability
§ 54.1-3442.6. Permit to operate pharmaceutical processor or cannabis dispensing facility
§ 54.1-3442.7. Dispensing cannabis products; report
§ 54.1-3442.8. Criminal liability; exceptions
§ 54.1-3443. Board to administer article
§ 54.1-3444. Controlled substances included by whatever name designated
§ 54.1-3445. Placement of substance in Schedule I
§ 54.1-3447. Placement of substance in Schedule II
§ 54.1-3449. Placement of substance in Schedule III
§ 54.1-3451. Placement of substance in Schedule IV
§ 54.1-3453. Placement of substance in Schedule V
§ 54.1-3456. Controlled substance analog
§ 54.1-3456.1. Drugs of concern
§ 54.1-3460. Poisonous or deleterious substance, or color additive
§ 54.1-3461. Adulterated drug or device
§ 54.1-3462. Misbranded drug or device
§ 54.1-3463. Exemption of drugs dispensed by filling or refilling prescription
§ 54.1-3464. Adulterated cosmetics
§ 54.1-3465. Misbranded cosmetics
§ 54.1-3468. Conditions to dispensing device, item, or substance; records
§ 54.1-3469. Storage, usage, and disposition of controlled paraphernalia
§ 54.1-3470. Obtaining controlled paraphernalia by fraud, etc.
§ 54.1-3471. Issuance of permits to certain persons other than registered pharmacists