21 C.F.R. § 203.34 Policies and procedures; administrative systems.
Title 21 - Food and Drugs
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.
Title 21: Food and Drugs
PART 203—PRESCRIPTION DRUG MARKETING
Subpart D—Samples
§ 203.34 Policies and procedures; administrative systems.
