Policies and procedures; administrative systems.

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: (a) Distributing drug samples by mail or common carrier, including methodology for reconciliation of requests and receipts; (b) Distributing drug samples by means other than mail or common carrier including the methodology for: (1) Reconciling requests and receipts, identifying patterns of nonresponse, and the manufacturer's or distributor's response when such patterns are found; (2) Conducting the annual physical inventory and preparation of the reconciliation report; (3) 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 (4) Storage of drug samples by representatives; (c) Identifying any significant loss of drug samples and notifying FDA of the loss; and (d) Monitoring any loss or theft of drug samples.