[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR203.34]
[Page 107]
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.
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