§203.34. Policies and procedures; administrative systems.
21 C.F.R. § 203.34
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.
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 331, 333, 351, 352, 353, 360, 371, 374, 381.
Source
Source: 64 FR 67756, Dec. 3, 1999, unless otherwise noted.