Section 130. Recordkeeping

A. All records and documentation required in this subsection shall be maintained and made available for inspection and photocopying 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. A wholesale distributor shall establish and maintain the following:

1. Inventories and records of all transactions regarding the receipt and distribution, or other disposition of all prescription drugs, including the dates of receipt and distribution or other disposition;

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the proper reporting and disposition of the product shall be maintained, including the handling and disposition of all outdated, damaged, deteriorated, misbranded, or adulterated drugs;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; and

6. Copies of the mandated report of thefts or unusual losses of Schedule II—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.

Historical Notes

Derived from Volume 22, Issue 24, eff. September 6, 2006.

Statutory Authority

§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.