The Drug Supply Chain Security Act (DSCSA) contains a series of escalating mandates for companies in the pharmaceutical supply chain. Each deadline falls on the anniversary date of the law’s adoption on November 27, 2013. For 2019, one of the new requirements is for wholesale distributors to begin verifying saleable returns using the Standardized Numerical Identifier (SNI) before they can redistribute them.
The DSCSA verification requirement is an attempt to address a long-known weakness in the US drug distribution network where illegitimate drugs could potentially be introduced into the legitimate supply chain without detection. These might include counterfeit, stolen, or otherwise illegitimate drugs that are “returned” to the wholesaler by one customer (a criminal), and then sold by the wholesaler to another, unsuspecting customer. The criminal in this scenario would keep the original product they received from the wholesaler but would surreptitiously “return” the illegitimate drug—labeled to look the same—to the wholesaler. The second, unsuspecting customer would receive the illegitimate product. This adds a level of misdirection if someone later tries to figure out where the illegitimate drugs came from.
The original product would be sold within the supply chain or dispensed to patients by the criminal, and they would be credited by the wholesaler for the “return” of the illegitimate drugs. The criminal receives a normal profit from the original drugs, and the credit from the wholesaler would be close to 100 percent profit, since their costs would be considerably lower than that of the original manufacturer.
No one knows how often this weakness has been exploited by criminals over the years but wholesale distributors are not likely to make it publicly known whenever they stumble across something like this.
With the new requirement this year in November to verify saleable returns using the SNI before redistribution, Congress hopes legitimate wholesalers and manufacturers will have a better chance of detecting attempts to pass off illegitimate drugs as legitimate saleable returns. According to the DSCSA, a “verification” means the manufacturer verifies that they did produce a product matching the SNI in the request.
But How To Do It?
Several years ago, the Healthcare Distribution Alliance (HDA) recognized that the DSCSA language explaining verification of saleable returns did not include an explanation of exactly how to accomplish it efficiently. Because wholesale distributors receive millions of saleable returns nationwide every day, efficiency is paramount. Wholesalers must be able to fulfill the verification requirement in a sub-second per unit. One of the ways they came up with to meet the law, and quickly, is a Verification Router Service (VRS).
A VRS is an internet service that wholesalers can use to contact any participating original manufacturer of any serialized drug and submit a “verification request” electronically. Implemented correctly, the drug manufacturer can look up the labeling history of the requested SNI and respond automatically with a verification message within the required sub-second timeframe. Valid VRS responses include “yes, verified,” “no, not verified,” “an error occurred,” and some additional information for diagnosis and clarification purposes.
To participate in the VRS solution, drug manufacturers must implement a “VRS Responder” service with access to their serialization packaging history. The VRS Responder will receive DSCSA Verification Requests from authorized VRS solutions, perform the necessary lookups in the packaging history for that product and decide how to respond. The Responder will respond to the VRS and keep a history of the requests and its corresponding responses.
The deadline for saleable returns verification is this November 27, 2019 but an effort in the industry began in April to get the FDA to delay enforcement of the saleable returns mandate because of insufficient industry readiness. Several industry associations have written formal requests to the FDA asking for that discretion. It is impossible to predict whether the FDA will agree to such a delay or not. Companies should not be distracted by these efforts because there has been no hint that the FDA is even considering a delay.
Systech played a key role in the HDA VRS constorium and now offers a solution to help customers get in compliance with upcoming DSCSA regulations. It includes all of the necessary VRS functionalities such as:
- Master data management
- Trade partner management and whitelisting
- Verification responding
- Performing verification requests