[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR203.37]

[Page 90-91]
 
                        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 shall be made to the Division of Prescription 
Drug Compliance and Surveillance (HFD-330), Office of Compliance, Center 
for Drug Evaluation and Research, Food and Drug Administration, 7520 
Standish Pl., Rockville, MD 20855. Notifications and reports concerning 
prescription human biological products shall be made to the Division of 
Inspections and Surveillance (HFM-650), Office of Compliance,

[[Page 91]]

Center for Biologics Evaluation and Research, Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852.