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Current as of October 02, 2022 | Updated by FindLaw Staff
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.
Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.203.34 Policies and procedures; administrative systems - last updated October 02, 2022 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-203-34/
FindLaw Codes may not reflect the most recent version of the law in your jurisdiction. Please verify the status of the code you are researching with the state legislature or via Westlaw before relying on it for your legal needs.
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