Identifying Trading Partners Under the Drug Supply Chain Security Act; Revised Draft Guidance for Industry; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled "Identifying Trading Partners Under the Drug Supply Chain Security Act." FDA is issuing this guidance to assist industry and State and local governments in understanding how to categorize the entities in the drug supply chain in accordance with the Drug Supply Chain Security Act (DSCSA). The revised draft guidance explains how to determine when certain statutory requirements will apply to entities that are considered trading partners in the drug supply chain. It also discusses the activities of private-label distributors, salvagers, and returns processors and reverse logistics providers. Additionally, the revised draft guidance discusses the distribution of drugs for emergency medical reasons, office use, non-human research purposes, and research purposes in humans under an investigational new drug application. This guidance revises the August 2017 draft guidance entitled "Identifying Trading Partners Under the Drug Supply Chain Security Act."