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Expiration Dates for Solid Oral Drugs: FDA Revises Draft Guidance
Expiration Dates for Solid Oral Drugs: FDA Revises Draft Guidance | RAPS
The recommendations have been informally discussed by the FDA in various letters and other documents. However, expectations are different for repackagers, depending on the nature of how the product is packaged and what data is available to support the selected expiration date. With certain exceptions, and with the documentation of additional data on the protective nature of the proposed unit dose system, it is possible to have a longer expiration date. The guidance goes on to define the requirements of application of the USP standards, the moisture and light-resistant nature of the container if appropriate , as long as the original container is not opened and all the product in the container is packaged at the same time. The environmental conditions must be consistent with the labeled storage conditions of the original product and if there should not be a caution on the approved package warning against repackaging.
FDA Draft Guidance on Expiration Dating of Unit-Dose repackaged Solid Oral Dosage Forms
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The U. The FDA states that this action was taken in response to " an increasing demand in various health care settings for solid oral dosage form drug products repackaged into unit-dose containers, which hold a quantity of drug for administration as a single dose. The increase in unit-dose repackaging has led to questions regarding stability studies and appropriate expiration dates for these repackaged products ". Compliance Policy Guide In addition, once final, it will supersede Compliance Policy Guide