Compendial activities relating to cold chain management issues: drug products and compounded preparations

The expansion of distibution pathways by emerging technologies has heightened the expectations of those involved in the area of drug storage and transportation. Medicines are now transported to remote areas of the world. Some of these medicines include HIV medications that may require refrigeration or special handling. Added to this, advances in healthcare treatment have allowed the use of complex biologics and proteins, as well as specialized compounded preparations such as biiodegradable hormone therapy that require special handling and specific storage methods. Because of these factors, the temperature and humidity to which these complex active medicines are exposed need to be critically studied and evluated because damage to these medicines could become irriversible and expensive. This article discusses the past and present activities of United States Pharmacopeia in the area of cold chain management with emphasis on appropriate methods of handling, storing, and shipping of these medicines.