Each manufacturer or authorized distributor of record that distributes drug samples shall establish, maintain, and adhere to written policies and procedures describing its administrative systems for the following:
Distributing drug samples by mail or common carrier, including methodology for reconciliation of requests and receipts;
Distributing drug samples by means other than mail or common carrier including the methodology for:
Reconciling requests and receipts, identifying patterns of nonresponse, and the manufacturer's or distributor's response when such patterns are found;
Conducting the annual physical inventory and preparation of the reconciliation report;
Implementing a sample distribution security and audit system, including conducting random and for-cause audits of sales representatives by personnel independent of the sales force; and
Storage of drug samples by representatives;
Identifying any significant loss of drug samples and notifying FDA of the loss; and
Monitoring any loss or theft of drug samples.
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