2.6 Preparing Reserve Samples for Storage or Shipment

• 2.6.1 Reserve Samples
• 2.6.2 Sealing the Reserve Samples
• 2.6.3 Documenting the Reserve Samples

2.6.1 Reserve Samples

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 the following: the remaining FDA sample portion and any associated exhibits (e.g. investigator/inspector filth exhibits and isolated analyst filth analysis plates) and the 702(b) claimant's portion. (See Section 2.12 Definitions 702(b) portion). Section 702(b) of the Food Drug and Cosmetic (FD & C) Act [21 USC 3729(b)] requires FDA to furnish, upon request, a portion of the official sample for examination or analysis to any person, attorney or agent. An entire FDA sample may not be used for an analysis; an analyst is not authorized to use a 702(b) claimant's portion, or the remaining sample destroyed without approval from a supervisor.

Each portion of the reserve sample is placed in its original container (if possible), officially sealed using FDA-415a (if appropriate, see Section 2.12 Definitions Official Samples), and returned to the Sample Custodian. If a seal is placed on the reserve sample, the seal is quoted on the Analyst Worksheet, Item 11, Reserve Sample.

2.6.2 Sealing the Reserve Samples

The reserve portion of samples is officially sealed using FDA-415a (if appropriate, see Section 2.12 Definitions Official Samples) 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 defaced or hidden when resealing a sample. All seals must be visible to provide a continuity chain (i.e., the investigator's sealing the sample, the Analyst's breaking that seal, should the sample be introduced as a court exhibit).

2.6.3 Documenting the Reserve Samples

For accountability purposes, a clear description of the reserve sample, including the 702(b) claimants 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, Item 11, Reserve Sample, and, if applicable, documents the sample disposition in the FACTS "In-House Disposition" record. (See FACTS Manual and Section 2.5.1 for details). 
• Analyst attaches any broken official seals to the worksheet for a sample that was received with the FDA official seal.

Conditions where no reserve sample remains are usually confined to no action indicated (NAI) import and NAI perishable samples where the laboratory 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.