FDA Updates Registration Requirements For Everybody Involved in Drug Distribution

In a new guidance document released by FDA practically every party that is involved in any aspect of the manufacture, distribution, shipping and handling of drugs and biologics will be required to register either with the FDA directly or with a state regulators where they operate. Several new parties are added to the registration requirements such as third-party logistics providers and wholesale distributors that previously did not need to register. The retailers still do not need to register with the FDA but manufacturers, license-holders, distributors, shippers, warehouse owners, return handling groups, and miscellaneous third-party logistics providers, all have to register with the FDA. The registrations are not product specific but company specific, meaning that each company will register annually for all its activities and do not need to individually register for each product they handle. Also, almost all registrations will be online on FDA’s web-site. The goal of these registrations is to control the drug supply chain by requiring every party to be fully aware of their responsibilities to assure the control of the drug supply chain. These rules should greatly increase the transparency of the drug supply chain. This is a must read guidance for anyone involved in handling of all kinds of drugs and biologics.