[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: 21CFR203.37]
[Page 108-109]
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. 203.37 Investigation and notification requirements.
(a) Investigation of falsification of drug sample records. A
manufacturer or authorized distributor of record that has reason to
believe that any person has falsified drug sample requests, receipts, or
records, or is diverting drug samples, shall:
(1) Notify FDA, by telephone or in writing, within 5 working days;
(2) Immediately initiate an investigation; and
(3) Provide FDA with a complete written report, including the reason
for and the results of the investigation, not later than 30 days after
the date of the initial notification in paragraph (a)(1) of this
section.
(b) Significant loss or known theft of drug samples. A manufacturer
or authorized distributor of record that distributes drug samples or a
charitable institution that receives donated drug samples from a
licensed practitioner shall:
(1) Notify FDA, by telephone or in writing, within 5 working days of
becoming aware of a significant loss or known theft;
(2) Immediately initiate an investigation into the significant loss
or known theft; and
(3) Provide FDA with a complete written report, including the reason
for and the results of the investigation, not later than 30 days after
the date of the initial notification in paragraph (b)(1) of this
section.
(c) Conviction of a representative. (1) A manufacturer or authorized
distributor of record that distributes drug samples shall notify FDA, by
telephone or in writing, within 30 days of becoming aware of the
conviction of one or more of its representatives for a violation of
section 503(c)(1) of the act or any State law involving the sale,
purchase, or trade of a drug sample or the offer to sell, purchase, or
trade a drug sample.
(2) A manufacturer or authorized distributor of record shall provide
FDA with a complete written report not later than 30 days after the date
of the initial notification.
(d) Selection of individual responsible for drug sample information.
A manufacturer or authorized distributor of record that distributes drug
samples shall inform FDA in writing within 30 days of selecting the
individual responsible for responding to a request for information about
drug samples of that individual's name, business address, and telephone
number.
(e) Whom to notify at FDA. Notifications and reports concerning
prescription human drugs and biological products regulated by the Center
for Drug Evaluation and Research shall be made to the Division of
Compliance Risk Management and Surveillance (HFD-330), Office of
Compliance, Center for Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers
[[Page 109]]
Lane, Rockville, MD 20857. Notifications and reports concerning
prescription human biological products regulated by the Center for
Biologics Evaluation and Research shall be made to the Division of
Inspections and Surveillance (HFM-650), Office of Compliance and
Biologics Quality, Center for Biologics Evaluation and Research, Food
and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD
20852.
[64 FR 67756, Dec. 3, 1999, as amended at 69 FR 48775, Aug. 11, 2004; 70
FR 14981, Mar. 24, 2005]
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