See also ColdChainInfo.com's exclusive article by cold chain expert Jeff Wodrich titled "Cold Chain Regulations, Guidances and Standards" for additional information.
ASTM’s (American Society for Testing and Materials) D3103 was issued in 2007 as a test method for evaluating the performance of thermal insulated packaging.
International Conference on Harmonization (ICH) - Guidance for Industry: Q1A(R2) Stability Testing of New Drug Substances and Products has significant application to cold chain distribution, particularly in relation to managing temperature excursions within the distribution environment.
PDA Technical Report No. 39 (PCCIGTR 39), Guidance for Temperature Controlled Medicinal Products, Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment - a comprehensive, guide on developing a cold chain management system.
PDA Technical Report No. 46 Last Mile - guidance on the proper handling of controlled-temperature medicinal products and devices along the final legs of the distribution chain.
Perishable Cargo Regulations (PCR) manual published by IATA, International Air Transport Association currently includes the suggested use of their time and temperature label to ensure proper handling of temperature sensitive healthcare products.
USP (United States Pharmacopeia) - The United States Pharmacopeia (USP) is the official standards setting authority for healthcare products manufactured, sold and distributed with in the United States. If you are involved in storing or transporting a healthcare product, you should be specifically aware of USP General Chapter <1079> Good Storage and Distribution Practices.
WHO (World Health Organization) - The WHO has issued a document that addresses cold chain distribution: working document QAS/04.068 on Good Distribution Practices.