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What the paper covers- Everything drawn directly from USP ⟨1079.2⟩, including the August 2025 revisions, translated into guidance specialty pharmacy operations teams can act on.
MKT is a single calculated temperature representing the cumulative thermal stress a product has experienced. Unlike a simple average, MKT uses the Arrhenius equation to weight higher temperatures more heavily. The paper explains what MKT is not — including four specific misapplications identified in the chapter itself.
The August 2025 revision reinforces and clarifies requirements many operations teams are not yet implementing. The paper covers the critical compliance parameters every specialty pharmacy should have in their SOPs — including the 30-day rule for CRT products and the 24-hour rule for CCT excursions.
Using 52 weeks of historical data. Including post-excursion cooldown temperatures in the calculation. Treating MKT as the sole assessment tool. All three are called out by name in the chapter. This section walks through each one and explains the correct approach.
USP ⟨1079.2⟩ is clear that MKT is not appropriate for all products. Biologics, phase-change products, and products where clinical data indicate excursion risk regardless of MKT results require alternative assessment protocols — and that fact must be communicated to supply chain partners.
A 10-item checklist to evaluate whether your current temperature excursion SOP aligns with USP ⟨1079.2⟩ requirements — covering calculation windows, documentation, biologic carve-outs, packaging qualification data, and confirmation that the August 2025 revisions have been reviewed and SOPs updated.
Includes the complete chapter analysis, all three misapplication walkthroughs, guidance on when MKT cannot be used, and the full 10-item compliance checklist.
Efficient Solutions, Exceptional Results.
