§ 203.34. Policies and procedures; administrative systems.

150 words·~1 min read·/us/cfr/t21/s§ 203.34·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

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.

Connections2 cite this

Cited by 2 sections

Citation graph

cites case law

§ 203.34

Policies and procedures; administrative systems.

Fed. Reg.×2

Cites 0Cited by 2 across 1 source