Section 90. Minimum requirements for the storage, handling, transport, and shipment of prescription drugs

A. All locations where prescription drugs are received, stored, warehoused, handled, held, offered, marketed, displayed, or transported from shall:

1. Be of suitable construction to ensure that all drugs and devices in the facilities are maintained in accordance with the labeling of such drugs and devices or with official USP-NF compendium standards;

2. Be of suitable size and construction to facilitate cleaning, maintenance, and proper wholesale distribution operations;

3. Have adequate storage areas to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions;

4. Have a quarantine area for storage of drugs and devices that are outdated, damaged, deteriorated, misbranded, adulterated, counterfeit or suspected of being counterfeit, otherwise unfit for distribution, or that are in immediate or sealed secondary containers that have been opened;

5. Be maintained in a clean and orderly condition; and

6. Be free from infestation of any kind.

B. The facility shall provide for the secure and confidential storage of information with restricted access and policies and procedures to protect the integrity and confidentiality of the information.

C. The facility shall provide and maintain appropriate inventory controls in order to detect and document any theft, counterfeiting, or diversion of prescription drugs.

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.