| Other Laboratory Operations Food and Drug Administration |
| DOCUMENT NO.: III-2 | VERSION NO.:1.2 | Section 2 - Chain of Custody – Sample Handling | EFFECTIVE DATE: 04/17/2004 | REVISED: 06/27/2008 |
2.7 Returning Samples to Custodial Storage
The laboratory reserve sample is kept until all legal or other action requiring
the sample is closed. The Reserve Sample consists of the remaining FDA portion,
and, if applicable, exhibits and the 702(b) claimant's portion. (See
Section 2.12 Definitions 702(b) portion)
Upon completion of the analysis, the Analyst returns any remaining sample reserve
to the Sample Custodian for storage, unless the reserve needs storage conditions
not under the control of the Sample Custodian. (e.g. storage in the laboratory).
2.7.1 Returning Samples to the Sample Custodian
For those samples returned to the Sample Custodian, the Sample Custodian
and the Analyst document the transfer of the sample in FACTS.
The Sample Custodian verifies that the physical sample received matches that
described in the FACTS "Sample Transfer" record. Any discrepancies
(e.g. quantity, unit) between the physical sample and the sample description
in the "Sample Transfer" record are immediately reported to the
Analyst. Discrepancies are reconciled and, if needed, the FACTS record is
corrected. The Sample Custodian updates the sample storage location in the
FACTS "Sample Transfer" record.
2.7.2 Returning Samples to Storage Areas not controlled by the Sample
Custodian
Special storage may call for all or a portion of the sample or exhibits
to be stored in areas not controlled by the Sample Custodian (e.g. the laboratory).
If the Reserve Sample is not returned to the Sample Custodian, the following
documentation is recorded on the Analyst Worksheet, Item 11, Reserve Sample:
- location and environmental conditions where the reserve is stored;
- an explanation why the sample was not returned to normal storage;
- amount sample stored; and
- if any of sample has been returned to the Sample Custodian, the information
is recorded in the FACTS "Sample Transfer" record.
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