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U.S. Department of Health and Human Services

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Volume III - 2.7 Returning Samples to Custodial Storage

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Other Laboratory Operations

Food and Drug Administration

DOCUMENT NO.:

III-2

VERSION NO.:1.8

Section 2 - Chain of Custody – Sample Handling

EFFECTIVE DATE: 04-17-2004REVISED: 01-29-13

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. 

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, Block 11, Reserve Sample:

  • location and environmental conditions where the reserve is stored;
  • an explanation why the sample was not returned to the sample custodian for storage; and,
  • amount of sample stored.