[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR58.195]



[Page 311-312]

 

                        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.

    (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



[[Page 312]]



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]