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Temperature profiling for warehouses already in use should be done at known times of external temperature extremes, e.g., for a period of not less than 3 hours when air temperatures are higher than 25 or less than 15. The following factors, some of which may give rise to extreme temperatures, should be considered during the process of temperature profiling: the size of the space, location of space heaters, sun-facing walls, low ceilings or roofs, and geographic location of the warehouse. They should be placed throughout the warehouse in divided sections and should record the maximum and minimum temperatures during a 24-hour period for a total of three consecutive 24-hour periods. Temperature profiles can be compiled by using a suitable number of thermometers or other temperature recording instruments. Temperature- or humidity-sensitive articles are to be handled in accordance with General Notices. For a discussion of climates, stability, and mean kinetic temperature, see Pharmaceutical Stability 1150. These risks include exposure to temperature excursions, humidity, light, and oxygen. Figure 1 documents present-day routes and the associated risks. A Pharmacopeial preparation may follow several potential routes from the original manufacturer to the patient. This calibration should be based on NIST or international standards (see Monitoring Devices—Time, Temperature, and Humidity 1118 ). All equipment used for recording, monitoring, and maintaining temperatures and humidity conditions should be calibrated on a regular basis. The section Preservation, Packaging, Storage, and Labeling under General Notices and Requirements provides definitions for storage conditions. There is no change to any applicable requirements under Current Good Manufacturing Practices, approved labeling, state laws governing pharmacies, the USP General Notices and Requirements, or monographs. It describes procedures to maintain proper storage environments for individual articles and to ensure a preparation's integrity, including its appearance, until it reaches the user. This general information chapter is intended to provide general guidance concerning storing, distributing, and shipping of Pharmacopeial preparations.