Check out the following quoted passage from the June
1998 Draft Stability Guidance of Drug
Substances/Products, page 44: [Link =>
"The computation of the expiration dating period of
the drug product should begin no later than the time
of quality control release of that batch, and the date
of release should generally not exceed 30 days from
the production date, regardless of the packaging date.
The data generated in support of the assigned
expiration dating period should be from long-term
studies under the storage conditions recommended in
the labeling. If the expiration date includes only a
month and year, the product should meet specifications
through the last day of the month."
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