21 CFR § 203.34 - Policies and procedures; administrative systems.

---
identifier: "/us/cfr/t21/s203.34"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 203.34 - Policies and procedures; administrative systems."
title_number: 21
title_name: "Food and Drugs"
section_number: "203.34"
section_name: "Policies and procedures; administrative systems."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "C"
subchapter_name: "DRUGS: GENERAL"
part_number: "203"
part_name: "PRESCRIPTION DRUG MARKETING"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 331, 333, 351, 352, 353, 360, 371, 374, 381."
regulatory_source: "64 FR 67756, Dec. 3, 1999, unless otherwise noted."
cfr_part: "203"
---


# 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.