Table 1.

Are You Ready for a Pharmacy Audit?

Are your NCI DARFs completely and correctly filled out? •There is a DARF for each investigational drug and dose strength. •All pertinent information has been completed on the DARF (i.e., no blanks). •No correction fluid (“white-out”) has been used, and all corrections are lined out and initialed. •The drug supply balance listed on the DARF matches the shelf stock. All DARFs are arranged in chronological order and by drug.

Are pharmacy satellite records available and properly maintained? •A DARF is completed at the satellite facility for any drug supplies stored for multiple therapy doses, and the incoming and outgoing supplies must match the main member DARFs.

Are all shipping invoices and transfer approvals available and in chronological order? •INDs cannot be transferred from one supply to another without NCI (or drug company, when relevant) approval. Documentation of transfer approval must be retained. •The invoices for all incoming and outgoing shipments must be available and in chronological order.

Have excess drug supplies been properly returned or destroyed? •Expired drug should be returned to the supplier in a timely interval. •When a study closes, excess IND supplies for the study should be transferred to another open study, if available, with NCI approval or returned to the supplier in a timely interval. •If a patient returns excess dispensed drug, it should be destroyed in accordance with NCI or drug company requirements. The drug amounts should not be re-entered on the DARF, as the DARF should denote only drug that can be dispensed to a patient.

Are INDs stored appropriately and securely? •INDs are stored separately by protocol and strength, with containers labeled properly. •INDs are stored separately from commercial supplies. •INDs are stored in an area accessible only to authorized personnel, or are kept in locked cabinets/refrigerators during times when the storage room itself can be accessed by unauthorized persons.

Abbreviations: NCI, National Cancer Institute; DARF, Drug Accountability Record Form; IND, investigational new drug.