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    The advantages of unit dose dispensing are that the drug is fully identifiable and the integrity of the dosage form is protected until the actual moment of administration. If the drug is not used and the container is intact, the drug may be retrieved and redispensed without compromising its integrity. As a result of several recent regulatory actions emphasizing these inconsistencies, the regulations will be rewritten in the future to clarify the requirements. Because of the general lack of uniformity in the labeling for unit dose containers due to inconsistent interpretations of the regulations, or to a lack of knowledge of unit dose labeling requirements, we are issuing this Compliance Policy Guide CPG.

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    Beyond use dates are different from expiration dates. Expiration dates are required on commercially manufactured products and are determined after extensive study of the product's stability. Most expiration dates are given in years for commercial products. Beyond use dates are used for compounded preparations and are generally in days or months. The major problem for pharmacists is that the stability of compounded formulations often is not known.

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