PDA TR 46

“Last mile” distribution is an often-used logistical term that refers to the transport of product from the manufacturing facility to the end user. For the purposes of this technical report, last mile is defined as the final transfer of a drug from the manufacturer or wholesaler to the end user which could be either the patient or the entity (e.g., pharmacy, hospital) that provides the drug to the patient. Transfers earlier in the distribution process involve organizations with greater knowledge of the product and the resources to ensure carefully controlled conditions of storage and transport compared to those available to the end user. As such, PDA Technical Report No. 46 (Revised 2024): Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to End User provides recommendations and tools based on current best practices to ensure that product quality is maintained until the final handoff.