[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: 21CFR203.60]

[Page 97-98]
 
                        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 F_Request and Receipt Forms, Reports, and Records
 
Sec. 203.60  Request and receipt forms, reports, and records.


    (a)  Use of electronic records, electronic signatures, and 
handwritten signatures executed to electronic records. (1) Provided the 
requirements of part 11 of this chapter are met, electronic records, 
electronic signatures, and handwritten signatures executed to electronic 
records may be used as an alternative to paper records and handwritten 
signatures executed on paper to meet any of the record and signature 
requirements of PDMA, PDA, or this part.
    (2) Combinations of paper records and electronic records, electronic 
records and handwritten signatures executed on paper, or paper records 
and electronic signatures or handwritten signatures executed to 
electronic records, may be used to meet any of the record and signature 
requirements of PDMA, PDA, or this part, provided that:
    (i) The requirements of part 11 of this chapter are met for the 
electronic records, electronic signatures, or handwritten signatures 
executed to electronic records; and
    (ii) A reasonably secure link between the paper-based and electronic 
components exists such that the combined records and signatures are 
trustworthy and reliable, and to ensure that the signer cannot readily 
repudiate the signed records as not genuine.
    (3) For the purposes of this paragraph (a), the phrase ``record and 
signature requirements of PDMA, PDA, or this part'' includes drug sample 
request and receipt forms, reports, records, and other documents, and 
their associated signatures required by PDMA, PDA, and this part.
    (b) Maintenance of request and receipt forms, reports, records, and 
other documents created on paper. Request and receipt forms, reports, 
records, and other documents created on paper may be maintained on paper 
or by photographic imaging (i.e., photocopies or microfiche), provided 
that the security and authentication requirements described in paragraph 
(c) of this section

[[Page 98]]

are followed. Where a required document is created on paper and 
electronically scanned into a computer, the resulting record is an 
electronic record that must meet the requirements of part 11 of this 
chapter.
    (c) Security and authentication requirements for request and receipt 
forms, reports, records, and other documents created on paper. A request 
or receipt form, report, record, or other document, and any signature 
appearing thereon, that is created on paper and that is maintained by 
photographic imaging, or transmitted electronically (i.e., by facsimile) 
shall be maintained or transmitted in a form that provides reasonable 
assurance of being:
    (1) Resistant to tampering, revision, modification, fraud, 
unauthorized use, or alteration;
    (2) Preserved in accessible and retrievable fashion; and
    (3) Available to permit copying for purposes of review, analysis, 
verification, authentication, and reproduction by the person who 
executed the form or created the record, by the manufacturer or 
distributor, and by authorized personnel of FDA and other regulatory and 
law enforcement agencies.
    (d) Retention of request and receipt forms, reports, lists, records, 
and other documents. Any person required to create or maintain reports, 
lists, or other records under PDMA, PDA, or this part, including records 
relating to the distribution of drug samples, shall retain them for at 
least 3 years after the date of their creation.
    (e) Availability of request and receipt forms, reports, lists, and 
records. Any person required to create or maintain request and receipt 
forms, reports, lists, or other records under PDMA, PDA, or this part 
shall make them available, upon request, in a form that permits copying 
or other means of duplication, to FDA or other Federal, State, or local 
regulatory and law enforcement officials for review and reproduction. 
The records shall be made available within 2 business days of a request.