[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR58.195]
 
[Page 318-319]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
                                SERVICES
 
PART 58--GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES--Table of Contents
 
                     Subpart J--Records and Reports
 
Sec. 58.195  Retention of records.
 
    (a) Record retention requirements set forth in this section do not
supersede the record retention requirements of any other regulations in
this chapter.
 
[[Page 319]]
 
    (b) Except as provided in paragraph (c) of this section,
documentation records, raw data and specimens pertaining to a
nonclinical laboratory study and required to be made by this part shall
be retained in the archive(s) for whichever of the following periods is
shortest:
    (1) A period of at least 2 years following the date on which an
application for a research or marketing permit, in support of which the
results of the nonclinical laboratory study were submitted, is approved
by the Food and Drug Administration. This requirement does not apply to
studies supporting investigational new drug applications (IND's) or
applications for investigational device exemptions (IDE's), records of
which shall be governed by the provisions of paragraph (b)(2) of this
section.
    (2) A period of at least 5 years following the date on which the
results of the nonclinical laboratory study are submitted to the Food
and Drug Administration in support of an application for a research or
marketing permit.
    (3) In other situations (e.g., where the nonclinical laboratory
study does not result in the submission of the study in support of an
application for a research or marketing permit), a period of at least 2
years following the date on which the study is completed, terminated, or
discontinued.
    (c) Wet specimens (except those specimens obtained from mutagenicity
tests and wet specimens of blood, urine, feces, and biological fluids),
samples of test or control articles, and specially prepared material,
which are relatively fragile and differ markedly in stability and
quality during storage, shall be retained only as long as the quality of
the preparation affords evaluation. In no case shall retention be
required for longer periods than those set forth in paragraphs (a) and
(b) of this section.
    (d) The master schedule sheet, copies of protocols, and records of
quality assurance inspections, as required by Sec. 58.35(c) shall be
maintained by the quality assurance unit as an easily accessible system
of records for the period of time specified in paragraphs (a) and (b) of
this section.
    (e) Summaries of training and experience and job descriptions
required to be maintained by Sec. 58.29(b) may be retained along with
all other testing facility employment records for the length of time
specified in paragraphs (a) and (b) of this section.
    (f) Records and reports of the maintenance and calibration and
inspection of equipment, as required by Sec. 58.63(b) and (c), shall be
retained for the length of time specified in paragraph (b) of this
section.
    (g) Records required by this part may be retained either as original
records or as true copies such as photocopies, microfilm, microfiche, or
other accurate reproductions of the original records.
    (h) If a facility conducting nonclinical testing goes out of
business, all raw data, documentation, and other material specified in
this section shall be transferred to the archives of the sponsor of the
study. The Food and Drug Administration shall be notified in writing of
such a transfer.
 
[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33781, Sept. 4, 1987;
54 FR 9039, Mar. 3, 1989]