What is the maximum BUD for a repackaged drug?

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The maximum beyond-use date (BUD) for a repackaged drug is established to ensure the safety and efficacy of the medication once it has been transferred from its original packaging. For repackaged medications, the guideline typically stipulates a BUD of six months or the original expiration date of the drug, whichever is shorter. This is founded on the principle of maintaining the integrity of the medication while accounting for factors such as potential degradation over time once a drug has been repackaged.

When repackaging, the stability of the drug can be affected, and thus shorter BUDs are recommended. This approach helps ensure that patients receive medications that are safe and effective. The original expiration date provides a frame of reference for how long the drug can be reasonably expected to maintain its potency, and the six-month guideline accounts for the additional variables introduced during repackaging.

In contrast, the other options suggest longer durations that could compromise the safety or efficacy of a repackaged drug, as they do not align with the standard practices established in pharmaceutical regulations regarding appropriate handling and storage of products post-packaging.

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