Revision of the USP Chapter on Packaging and Storage Requirements

In the Pharmacopeial Forum No 39(4), the USP has published a proposal for the revision of Chapter <659> on "Packaging and Storage Requirements". The revision particularly points out the "single-dose container" definition which means that a medicinal product is intended for one-time use in one single patient. This is the result of drug incidents caused by improper handling in the past. 

Chapter <659> provides definitions for the different types of packaging as well as storage conditions.

Storage conditions are defined by the following terms:

  • Freezer (-25° to -10°C)
  • Refrigerator (2 - 8°C)
  • Cold (not more than 8°C)
  • Cool (8 - 15°C)
  • Room temperature
  • Controlled room temperature (considering the mean kinetic temperature)
  • Warm (30°C - 40°C)
  • Excessive heat (above 40°C)
  • Dry place (under 40% average relative humidity at 20°C)
  • Protection from freezing
  • Protection from light

Comments to the proposed revision of this chapter can be sent until 30 September 2013. The document can be found on the Pharmacopeial Forum of the USP website.

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