BRIEFING

 〈659〉 Packaging and Storage Requirements. This proposal is based on the version of the chapter official as of April 1, 2021. On the basis of comments received on the Stimuli article  Aligning Room Temperature Standards for Pharmaceuticals—a Sustainable Approach published in PF 51(5), the General Chapters—Packaging and Distribution Expert Committee is proposing to revise this USP compendial definition of Controlled room temperature (CRT) to align with that of the Japanese Pharmacopoeia (JP), European Pharmacopoeia (EP), and World Health Organization (WHO).

 Currently, USP defines CRT as 20°–25°, with excursions permitted from 15° and 30°. In contrast, JP, EP, and WHO define room temperature as 15°–25°. This discrepancy has led to inconsistencies in drug storage practices and increased energy consumption across the pharmaceutical industry.

 Rationale for revision:

• Global harmonization—Aligning USP’s CRT definition with JP, EP, and WHO standards will promote consistency in pharmaceutical storage practices worldwide.

• Environmental sustainability—Lowering the minimum CRT threshold to 15° can reduce HVAC energy demands, particularly in colder climates, leading to estimated energy savings of 10%–15%.

• Regulatory alignment—Harmonization will support international regulatory convergence and align with ICH principles, which emphasize stability and safety across global markets.

 The revised definition of CRT maintains the use of mean kinetic temperature (MKT) as the primary tool for evaluating short‑term temperature excursions beyond 25° (77 °F). Although the lower excursion limit is reduced from 20° to 15° (68° to 59  °F), this change does not alter the criteria for using MKT to assess CRT excursions.

 All temperature data and calculated MKT values must be documented. MKT should be calculated using all available temperature data during the observation period, defined as the product’s time in the holder’s possession or 30 days when the exact duration is unknown (e.g., warehouse storage). This recommendation is supported by temperature‑mapping data (1) and the typical 30‑day warehouse storage period observed in the United States.

 Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Products 〈1079.2〉 reinforces these limits, noting that the maximum allowable excursion duration is 24 hours and clarifying that storage time under controlled cold or cool conditions cannot be used to offset excursions outside CRT ranges.

 Stakeholders noted in their feedback to the Stimuli article (2) that ICH Q1A(R2) provides internationally harmonized stability conditions that support short‑term excursions, including intermediate (30 ± 2° / 65 ± 5% relative humidity) and accelerated (40 ± 2° / 75 ± 5% relative humidity) storage for 6 months. Although ICH Q1A(R2) does not specifically address MKT, the USP excursion limits align with the temperature ranges covered under intermediate and accelerated stability conditions.

 Additionally, minor editorial changes have been made to update the chapter to current USP style.

 (GCPD: D. Hunt)

 Case ID—SUB-2963