21 C.F.R. § 203.34

Current through September 30, 2021
Section 203.34 - 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.

21 C.F.R. § 203.34