[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR203.34]

[Page 90]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 203--PRESCRIPTION DRUG MARKETING--Table of Contents
 
                           Subpart D--Samples
 
Sec. 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.