ASHP Guidelines for the Management of Investigational Drug Products

Abstract

The purpose of these guidelines is to describe a standardized approach for the management of investigational drug products by the clinical research pharmacy, pharmaceutical industry, and cooperative and research network groups. The scope of these guidelines includes the receipt, accountability, storage, handling, preparation, dispensing, and final disposition of investigational drug products to ensure inspection readiness and compliance with regulations as provided in the Code of Federal Regulations (CFR), 21 CFR, Part 312,1 as well as International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E6 Good Clinical Practice2 (GCP) (described in 21 CFR Part 312, section 120) and Good Manufacturing Practice3 (GMP) (described in 21 CFR Part 211), and the approved clinical study protocols. These guidelines will facilitate the adoption of best practices by new and established clinical research pharmacies (e.g., investigational drug service [IDS]) in collaboration with the pharmaceutical industry for the optimal management of investigational drug products. The ultimate goals of standardizing the management of investigational drug products are to improve patient safety, improve efficiency, and provide robust clinical data that allow new and innovative medications to reach the patients who need them.