§ 106-145.8. Records of prescription drugs.
§ 106‑145.8. Records of prescription drugs.
(a) Records. A wholesale distributor shall establish andmaintain inventories and records of all transactions regarding the receipt anddistribution or other disposition of prescription drugs, including all storedprescription drugs, all incoming and outgoing prescription drugs, and alloutdated, damaged, deteriorated, misbranded, or adulterated prescriptiondrugs. A wholesale distributor is not required, however, to keep a record ofthe lot number or expiration date of a prescription drug disposed of ordistributed by the distributor.
A record of a prescription drug shall include all of the followinginformation:
(1) The source of the prescription drug, including the name andprincipal address of the seller or transferor and the address of the locationfrom which the drug was shipped.
(2) The identity and quantity of the prescription drug receivedand distributed or disposed of through another method.
(3) The date the wholesale distributor received the prescriptiondrug and the date the wholesale distributor distributed or otherwise disposedof the drug.
(4) Documentation of the proper storage of prescription drugs. Documentation may be by manual, electromechanical, or electronic temperatureand humidity recording equipment, devices, or logs.
A wholesale distributor shall keep a record of a prescription drug fortwo years after its disposition.
(b) Inspection. A wholesale distributor shall make inventoriesand records of prescription drugs available for inspection and photocopying byrepresentatives of the Department or authorized federal, State, or local lawenforcement officials. A wholesale drug distributor shall permit the Departmentor an authorized federal, State, or local law enforcement official to enter andinspect the distributor's premises and delivery vehicles and to audit thedistributor's records and written operating procedures at reasonable times andin a reasonable manner.
A record that is kept at the inspection site or is immediatelyretrievable by computer or other electronic means shall be readily availablefor authorized inspection during the two‑year retention period. A recordkept at a central location apart from the inspection site and notelectronically retrievable shall be made available for inspection within twoworking days of a request by an authorized official of a federal, State, orlocal law enforcement agency. (1991, c. 699, s. 2.)