Reverse Distribution and the Drug Supply Chain Security Act (DSCSA)

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 3^rd Party logistics (3PL) companies.

Definition of a Reverse Distributor under the FDA

The 1^st 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 1^st 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.

The new draft states, “FDA previously considered returns processors and reverse logistics providers to be 3PLs because the definition at section 581(18) permitted these entities to handle the saleable product. FDA has received comments that some entities only handle products at the end of their lifecycle, either returning nonsaleable products to the manufacturer for credit or dispositioning products for destruction. FDA generally does not consider such entities to be 3PLs, as under these circumstances, these products will not re-enter the supply chain.”

Effect on GRx, Customers, and Unsalable Returns

None of the products that GRx processes on behalf of customers go back into the forward supply chain or are re-distributed for dispensing, as GRx returns non-saleable products to the manufacturer for credit or dispositions product for destruction. Therefore, we are not subject to the Drug Supply Chain Security Act (DSCSA) requirements, and GRx customers are not required to pass along TI (Transaction Information), TH (Transaction History), or TS (Transaction Statement) when returning the product to us.