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The compounding pharmacy, not the FDA, assigns this date based on available stability data, USP guidelines, and the specific characteristics of their formulation
If batches drift, your data drifts with them
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Your laboratory equipment lacked sufficient controls to prevent and detect deletion or manipulation of your laboratory's electronic raw data." 8 Detailed Analysis of the Violation Spectroscopy Audit Trails: The FDA noted that "ultraviolet-visible (UV-vis) and infrared (IR) spectroscopy equipment was found to lack audit-trail functionality".8 Historically, regulatory focus has been on HPLC and GC data
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