StacksVerified U.S. regulatory reference

21 CFR §203.34

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
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:
  1. (a)Distributing drug samples by mail or common carrier, including methodology for reconciliation of requests and receipts;
  2. (b)Distributing drug samples by means other than mail or common carrier including the methodology for:
    1. (1)Reconciling requests and receipts, identifying patterns of nonresponse, and the manufacturer's or distributor's response when such patterns are found;
    2. (2)Conducting the annual physical inventory and preparation of the reconciliation report;
    3. (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. (4)Storage of drug samples by representatives;
  3. (c)Identifying any significant loss of drug samples and notifying FDA of the loss; and
  4. (d)Monitoring any loss or theft of drug samples.