Stimuli Article Proposes Revision of USP Definition of Controlled Room Temperature (CRT)

In the current Pharmacopeial Forum, PF 51(3), a Stimuli article entitled "Aligning Room Temperature Standards for Pharmaceuticals—A Sustainable Approach" was published.

The article proposes a revision to the United States Pharmacopeia (USP) definition of controlled room temperature (CRT) to align with the room temperature ranges recommended by the Japanese Pharmacopoeia (JP), European Pharmacopoeia (EP), and World Health Organization (WHO).

Background

Currently, there is a discrepancy between the USP's CRT definition and the ranges defined for room temperature by the JP, EP, and WHO:

• USP: 20°–25°C (with excursions permitted within the range of 15°–30°C)
• JP, EP, and WHO: 15°–25°C

The authors of the article rightly point out that "this misalignment can lead to inconsistencies in drug storage practices and increased energy consumption."

Rationale

The Stimuli article discusses the potential benefits and implications of revising USP's CRT definition. After providing a brief overview of the history of USP's definition of CRT and an overview of current definitions and examples, the article addresses the following arguments:

• Energy costs and efficiency
• Environmental impact
• Global consistency
• Safety and stability
• Product wastage

Commenting and Feedback

USP invites industry stakeholders to engage in a discussion about the potential changes discussed in the article. Commenting is open until 31 July 2025.

The article can be viewed free of charge after registration on the Pharmacopeial Forum website.