There are scores of regulations and guidance both final and under review. The following is only a partial list of official documents that apply to good distribution practices.
21 Code of Federal Regulations Parts 210 and 211
- Part 210: Current Good Manufacturing Practice in Manufacturing, Processing, or holding of drugs
- Part 211: Current Good Manufacturing Practice for finished Pharmaceuticals
PDA Journal of Pharmaceutical Science and Technology Technical Report No. 39 Cold Chain Guidance for Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products Through the Transportation Environment Download PDF