---
kind: "section"
citation: "21 C.F.R. § 203.34"
title: "21"
number: "203.34"
heading: "Policies and procedures; administrative systems."
url: "https://uscodex.org/cfr/21/203.34"
---

# §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.**

## Notes

### 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.