[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1002.41]

[Page 605]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1002_RECORDS AND REPORTS--Table of Contents
 
                Subpart E_Dealer and Distributor Records
 
Sec. 1002.41  Disposition of records obtained by dealers and distributors.

    (a) Information obtained by dealers and distributors pursuant to 
Sec. 1002.40 shall immediately be forwarded to the appropriate 
manufacturer unless:
    (1) The dealer or distributor elects to hold and preserve such 
information and to immediately furnish it to the manufacturer when 
advised by the manufacturer or the Director, Center for Devices and 
Radiological Health, that such information is required for purposes of 
section 359 of the Act; and
    (2) The dealer or distributor, upon making the election under 
paragraph (a)(1) of this section, promptly notifies the manufacturer of 
such election; such notification shall be in writing and shall identify 
the dealer or distributor and the electronic product or products for 
which the information is being accumulated and preserved.
    (b) Every dealer or distributor who elects to hold and preserve 
information required pursuant to Sec. 1002.40 shall preserve the 
information for a period of 5 years from the date of the sale, award, or 
lease of the product, or until the dealer or distributor discontinues 
dealing in, or distributing the product, whichever is sooner. If the 
dealer or distributor discontinues dealing in, or distributing the 
product, such information as obtained pursuant to Sec. 1002.40 shall be 
furnished at that time, or before, to the manufacturer of the product.

[38 FR 28625, Oct. 15, 1973, as amended at 42 FR 18063, Apr. 5, 1977; 53 
FR 11254, Apr. 6, 1988]