Regulations Guiding the Interstate Shipment of Investigational Product

Abstract

Purpose:

Investigational drug services (IDSs) are often responsible for delivery of investigational product, whether to a study participant pursuant to a prescription or in bulk to another investigational study site. These deliveries must often cross state borders. For situations in which the study is not conducted under an investigational new drug application, these shipments are subject to the legislation of the receiving state.

Summary:

Every state board of pharmacy in the United States was contacted in an effort to compile a single resource describing interstate investigational product shipping regulations for each state. The majority of the states require registration with their board of pharmacy for shipment of medication into the state. Some states will allow for exceptions and/or fee waiver in certain situations. Controlled substances also fall under the jurisdiction of the Drug Enforcement Administration, with additional constraints placed on their shipment by many states.

Conclusion:

Knowledge of state legislative requirements surrounding interstate shipment of investigational product is crucial for IDSs to maintain compliance with all regulations. This document provides an important framework for obtaining and interpreting this information. However, as legislation changes on a regular basis, current legislation should be reviewed prior to the commencement of interstate shipping.