McIntyre Chelsey
The Children's Hospital of Philadelphia, Philadelphia, PA, USA.
J Pharm Pract. 2014 Feb;27(1):101-5. doi: 10.1177/0897190013504958. Epub 2013 Oct 22.
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.
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.
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.
研究性药物服务（IDS）通常负责研究性产品的交付，无论是根据处方交付给研究参与者，还是批量交付给另一个研究性研究地点。这些交付往往需要跨越州界。对于未根据研究性新药申请进行的研究，这些运输受接收州立法的约束。
为了编制一份描述各州州际研究性产品运输法规的单一资源，我们联系了美国的每个州药房委员会。大多数州要求向其药房委员会注册才能将药品运入该州。一些州在某些情况下允许例外和/或豁免费用。受管制物质也属于药品执法管理局的管辖范围，并受到许多州对其运输的额外限制。
了解各州关于研究性产品州际运输的立法要求对于IDS维持所有法规的合规性至关重要。本文档为获取和解释此信息提供了一个重要框架。然而，由于立法经常变化，在开始州际运输之前应审查现行立法。
