{"data":{"id":"us/21-cfr-203.34","jurisdiction":"us","citation":"21 CFR 203.34","heading":"Policies and procedures; administrative systems.","body":"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:\n(a) Distributing drug samples by mail or common carrier, including methodology for reconciliation of requests and receipts;\n(b) Distributing drug samples by means other than mail or common carrier including the methodology for:\n(1) Reconciling requests and receipts, identifying patterns of nonresponse, and the manufacturer's or distributor's response when such patterns are found;\n(2) Conducting the annual physical inventory and preparation of the reconciliation report;\n(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\n(4) Storage of drug samples by representatives;\n(c) Identifying any significant loss of drug samples and notifying FDA of the loss; and\n(d) Monitoring any loss or theft of drug samples.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER C—DRUGS: GENERAL","PART 203—PRESCRIPTION DRUG MARKETING","Subpart D—Samples"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"6b3d6dffe25cc607ca80e281153a7a1cef919a3aac8df6e4ef494ae0b3b727fc","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-203.33","next":"us/21-cfr-203.35"},"notice":"GroundRules: Original legal text. Not legal advice."}