[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR203.36]

[Page 94]
 
                        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. 203.36  Fulfillment houses, shipping and mailing services, comarketing 
agreements, and third-party recordkeeping.

    (a)  Responsibility for creating and maintaining forms, reports, and 
records. Any manufacturer or authorized distributor of record that uses 
a fulfillment house, shipping or mailing service, or other third party, 
or engages in a comarketing agreement with another manufacturer or 
distributor to distribute drug samples or to meet any of the 
requirements of PDMA, PDA, or this part, remains responsible for 
creating and maintaining all requests, receipts, forms, reports, and 
records required under PDMA, PDA, and this part.
    (b) Responsibility for producing requested forms, reports, or 
records. A manufacturer or authorized distributor of record that 
contracts with a third party to maintain some or all of its records 
shall produce requested forms, reports, records, or other required 
documents within 2 business days of a request by an authorized 
representative of FDA or another Federal, State, or local regulatory or 
law enforcement official.