We’ve received some questions about the Drug Supply Chain Security Act (DSCSA) and a Reverse Distributor’s role in complying with the Act.

As you are probably aware, the DSCSA is being put in place to achieve interoperable, electronic tracing of products at the package level to identify and trace certain prescription drugs as they are distributed in the United States. Basically, an Act for better traceability of drugs. This act is being enforced on any entity/trading partner who operates within the forward supply chain. This includes 3rd Party logistics (3PL) companies.

Definition of a Reverse Distributor under the FDA

The 1st draft of the “Identifying Trading Partners Under the DSCSA” document, did not clearly define Reverse Distributors, and Reverse Distributors were lumped/categorized with 3PLs who operate within the forward supply chain.

After reviewing the 1st draft of “Identifying Trading Partners Under the DSCSA”, the FDA received many complaints about the categorization of Reverse Distribution as a 3PL and redefined their role within their most recent 2022 draft. Read more >