18 Va. Admin. Code § 110-50-130

Current through Register Vol. 40, No. 22, June 17, 2024

Section 18VAC110-50-130 - Recordkeeping

A. All records and documentation required in this subsection shall be maintained and made available for inspection and photocopying upon request by an authorized agent of the board for a period of three years following the date the record was created or received by the wholesale distributor, nonresident wholesale distributor, third-party logistics provider, or nonresident third-party logistics provider. If records are not maintained onpremises at the address of record, they shall be made available within 48 hours of such request. A wholesale distributor, nonresident wholesale distributor, third-party logistics provider, or nonresident third party logistics provider shall establish and maintain the following:

1. Unless otherwise indicated in federal law, inventories and records of all transactions, including the dates of receipt and distribution or other disposition or provision, and records related to the federal requirements for an electronic, interoperable system to identify, trace, and verify prescription drugs as they are distributed;

2. Records documenting monitoring of environmental conditions to ensure compliance with the storage requirements as required in 18VAC110-50-50;

3. Documentation of visual inspection of drugs and accompanying documents required in 18VAC110-50-100, including the date of such inspection and the identity of the person conducting the inspection;

4. Documentation of quarantine of any product and steps taken for the proper reporting and disposition of the product , including the handling and disposition of all outdated, damaged, deteriorated, misbranded, or adulterated drugs;

5. An ongoing list of persons or entities from whom it receives prescription drugs and persons or entities to whom it distributes prescription drugs or provides prescription drugs as a third-party logistics provider or nonresident third-party logistics provider; and

6. Copies of the mandated report of thefts or unusual losses of Schedules II through V controlled substances in compliance with the requirements of § 54.1-3404 of the Code of Virginia.

B. Records shall either (i) be kept at the inspection site or immediately retrievable by computer or other electronic means and made readily available at the time of inspection or (ii) if kept at a central location and not electronically retrievable at the inspection site, be made available for inspection within 48 hours of a request by an authorized agent of the board.

C. All facilities shall have adequate backup systems to protect against the inadvertent loss or deliberate destruction of data.

18 Va. Admin. Code § 110-50-130

Derived from Virginia Register Volume 22, Issue 24, eff. September 6, 2006; Amended, Virginia Register Volume 33, Issue 19, eff. 6/29/2017; Amended, Virginia Register Volume 35, Issue 12, eff. 3/22/2019.

Statutory Authority: §§ 54.1-2400 and 54.1-3307 of the Code of Virginia.