Identifying Trading Partners Under the Drug Supply Chain Security Act Guidance for Industry

Entity responsible for submitting NDINs

Entities that do not take ownership and are included under 3PL category.

Trading partner required to have verification systems; Trading partner required to have verification systems in place.; Trading partner required to validate transaction history and verify product identifiers; must quarantine illegitimate product; receives returned product that it intends to further distribute

Trading partner required to have verification systems; Trading partner required to have verification systems in place.; Trading partner required to verify product identifiers with manufacturers; must maintain systems for disposition; must first verify that the product identifier imprinted upon or affixed to the package

Trading partner required to have verification systems; Trading partner required to have verification systems in place.; Trading partner such as a pharmacy required to verify at least 3 packages or 10 percent of suspect product; must identify and quarantine illegitimate product; may return product, saleable and non-saleable, to the trading partner

Entity that provides resources for the distribution of a product but does not take ownership.; Entity providing warehousing or logistics services without taking ownership of the product.; Entity providing logistics services without taking ownership of product; Defined as entities providing warehousing or logistics services; Provides warehousing or logistics services without taking ownership

Entities involved in reverse logistics; Entities that do not take ownership and are included under 3PL category.

Entities that warehouse but do not own product

Entity that controls or is controlled by the applicant; Business entities related to the applicant

entity sharing a drug application