[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: 21CFR203.36]
[Page 108]
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.
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