A food for special dietary use means food that has been specially processed or formulated to meet the particular requirements of a person [B.24.001 These foods should not be eaten if the expiration date has passed as they have strict compositional and nutritional specifications which might not be met after the date.Generally, the expiration date may be shown on any label panel, except the bottom.
Product-specific, experimentally determined stability data evaluation protocols are preferable to published stability information.
It must be ascertained that CSPs will not be exposed to warm temperatures (see It should be recognized that the truly valid evidence of stability for predicting beyond-use dating can be obtained only through product-specific experimental studies.
Semi-quantitative procedures, such as thin-layer chromatography (TLC), may be acceptable for many CSPs.
However, quantitative stability-indicating assays, such as high performance liquid chromatographic (HPLC) assays, would be more appropriate for certain CSPs.
Examples include CSPs with a narrow therapeutic index, where close monitoring or dose titration is required to ensure therapeutic effectiveness and to avoid toxicity; where a theoretically established beyond-use dating period is supported by only marginal evidence; or where a significant margin of safety cannot be verified for the proposed beyond-use dating period.