August 12 Webinar with Antares Vision: DSCSA Wholesaler Exemption & Authorized Trading Partners

The XATP Compliance Suite makes it easy for manufacturers and repackagers to manage verification requests from all trading partners, whether or not you make use of the Verification Router Service (VRS). Specifically, the XATP Credential plugs into your VRS to ensure that only Authorized Trading Partners (ATPs) can make requests, and the DSCSA Portal makes it easy for any ATP to make a request without needing to have a service.

Verification in the DSCSA

Under the DSCSA, the vast majority of human prescription drug saleable packages must have a unique product identifier with four data elements – NDC, lot, serial, and expiry date – in both human-readable and barcode form. The law also requires that manufacturers and repackagers have systems so that:

“upon receiving a request for verification from an authorized [manufacturer/repackager], wholesale distributor, or dispenser that is in possession or control of a product such person believes to be manufactured by such [manufacturer/repackager], a [manufacturer/repackager] shall, not later than 24 hours after receiving the request for verification or in other such reasonable time as determined by the Secretary, based on the circumstances of the request, notify the person making the request whether the product identifier, including the standardized numerical identifier, that is the subject of the request corresponds to the product identifier affixed or imprinted by the [manufacturer/repackager].”

The FDA in its guidance Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs calls on trading partners “to ensure that individual policies and procedures for verification of the product identifier are sufficient to satisfy the 2023 requirements for the interoperable, electronic tracing of product at the package level under section 582(g)(1) of the FD&C Act.”

Why Verification?

The vast majority of verification requests are related to saleable returns, as wholesalers are required to verify returned products before reintroducing them to the supply chain. Other reasons for verification include suspect & illegitimate product investigations, status checks, exceptions management, and compliance with state inspections.

It should be noted that verifications may be submitted by any Authorized Trading Partner

From the law:

> In the case of a manufacturer or repackager having a valid registration in accordance with section 510;
> in the case of a wholesale distributor, having a valid license under State law or section 583, in accordance with section 582(a)(6), and complying with the licensure reporting requirements under section503(e), as amended by the Drug Supply Chain Security Act.
> in the case of a third-party logistics provider, having a valid license under State law or section 584(a)(1), in accordance with section 582(a)(7), and complying with the licensure reporting requirements under section 584(b); and
> in the case of a dispenser, having a valid license under State law.

(ATP), including those who have no direct business relationship with the manufacturer or repackager.

Verification Router Service (VRS)

The Verification Router Service (VRS) is an interconnected network of vendor systems designed to automate verification requests and responses. Learn more.