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U.S. Department of Health and Human Services

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Volume III - 2.6 Reserve Samples

DFS Pyramid Logo

Other Laboratory Operations

Food and Drug Administration

DOCUMENT NO.:

III-2

VERSION NO.:1.9

Section 2 - Chain of Custody – Sample Handling

EFFECTIVE DATE: 04-17-2004 REVISED: 05-02-14

At the conclusion of the analysis, the analyst annotates the status of the reserve sample on the worksheet and prepares the reserve sample for storage or shipment.

The samples are returned to the Sample Custodians. Exceptions include the following circumstances:

  • analyst has received permission in advance from laboratory supervision to effect immediate In-House Disposition of the sample (see 2.9 Disposition of Samples),
  • entire sample has been consumed during analysis, and,
  • reserve sample needs special environmental storage or handling conditions not found in the sample storeroom.

The reserve sample consists of any remaining FDA portion and exhibits associated with an Official Sample (e.g. Investigator/Inspector filth exhibits and Analyst filth analysis plates), and the 702(b) claimant's portion. Section 702(b) of the FD&C Act requires '…upon request, provide a part of such official sample for examination or analysis by any person named on the label of the article, or the owner thereof, or his attorney or agent….' A domestic sample collected directly from a manufacturer may not be used in its entirety, as an analyst is not authorized to use a 702(b) claimant’s portion.

Each portion of the reserve sample should remain in its original container, if possible, and, if appropriate, officially sealed using FDA-415a. The sample is then returned to the Sample Custodian for storage until the sample is dispositioned. If a seal is placed on the reserve sample, the seal is quoted on the Analyst Worksheet, FDA 431, Reserve Sample.

 2.6.1 Sealing the Reserve Samples

The reserve portion of samples is officially sealed using FDA-415a prior to being returned to the Sample Custodian. The seal is affixed so that it actually seals the sample package and the sample package cannot be opened without any evidence of tampering. More than one seal may be needed. The original broken seal is not to be defaced or hidden when resealing a sample. All seals must be visible to provide a continuity chain. The Investigator’s seal on the sample, the Analyst’s information on the broken seal and the Analyst’s seal(s) on the sample should all be visible should the sample be introduced as a court exhibit

 2.6.2 Documenting the Reserve Samples

For accountability purposes, a clear description of the reserve sample, including the 702(b) claimant's portion (if present), is documented on the analyst worksheet. The amount of reserve sample remaining is compatible with the amount received and the amount used in the analysis; any discrepancies are explained on the analyst worksheet.

If no physical sample or exhibits remains:

  • Analyst records “NONE” or “NO RESERVE” on the Analyst Worksheet or electronic form, Item 11, Reserve Sample, and, if applicable, documents the sample disposition in the FACTS or LIMS “In-House Disposition” record.
  • If a sample is received with an official seal, and no reserve portion remains, the analyst must include the broken official seal in the worksheet package or electronic form.

Conditions where no reserve sample remains are usually confined to no action indicated (NAI) import and NAI perishable samples where the  supervisor has concurred in immediate destruction.

If the entire FDA portion of the sample has been used in the analysis, an analyst may be instructed by a supervisor to return the empty container(s) under an official seal to the Sample Custodian for possible use in court.