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).
Verification Under 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.”
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 (ATP), including those who have no direct business relationship with the manufacturer or repackager.
This article covers the verification workflows available via the DSCSA Portal. For more general information about verification and the VRS, see our introductory article.
DSCSA Portal Roles #
The XATP Magic Portal makes it easy for manufacturers to receive and manage requests and reports from direct and indirect ATPs including pharmacies, wholesalers, and third-party logistics providers. It includes two roles:
- Host: The portal owner, such as a manufacturer. The Host has access to the XATP Dashboard, which includes ticket views for all Portal workflows.
- Guest: External users such as pharmacists and wholesalers. Guests can submit requests and reports in the Portal.
Verification Workflow Overview #
At a high level, a standard verification workflow through the portal is as follows:
- Guest enters the portal. (More information about Portal invites and registration can be found here.)
- Guest submits a Verification Request. (The Guest must be a validated ATP in order to submit a request through the Portal. More information about ATP validation can be found here.)
- Host receives a notification email.
- Host reviews Verification Request.
- Host submits Verification Response.
- Guest receives a notification email.
VRS Integration #
Standard Workflows #
Happy Path #
A trading partner submits a verification request for a valid package that the VRS finds to be valid.
| User | Action(s) | Result |
| Guest | 1. Access the portal 2. Hit New Request 3. Select verification 4. Fill out form based on happy path test products (available separately) 5. Hit Submit 6. Wait up to 30 seconds | Verification request received; response received |
| Guest | Access email account | Successful verification email received >1 min of submission |
| Host | 1. Login to the portal 2. Go to Partner Requests | Request is logged as verified |
Sad Path: Verified #
A trading partner submits a verification request for a package that is rejected by the VRS (e.g. unlisted or endpoint issue), but turns out to be a valid package.
| User | Action(s) | Result |
| Guest | 1. Access the portal 2. Hit New Request 3. Select verification 4. Fill out form based on happy path test products (available separately) 5. Hit Submit | Verification request received; response pending |
| Host | 1. Login to the portal 2. Go to Partner Requests | Package appears as pending review in Partner Requests |
| Host | 1. Click into ticket and review response from VRS (if applicable) 2. Select “Verified” 3. Hit Submit | Package appears as verified in Partner Requests |
| Guest | Access email account | Successful verification email received >1 min of manufacturer submission |
Sad Path: Not Verified #
A trading partner submits a verification request for an invalid package.
| User | Action(s) | Result |
| Guest | 1. Access the portal 2. Hit New Request 3. Select verification 4. Fill out form based on happy path test products (available separately) 5. Hit Submit | Verification request received; response pending |
| Host | 1. Login to the portal 2. Go to Partner Requests | Package appears as pending review in Partner Requests |
| Host | 1. Click into ticket and review response from VRS 2. Select “Not Verified” 3. Add/confirm failure reason 4. Add optional comment 5. Hit Submit | Package appears as not verified in Partner Requests |
| Guest | Access email account | Failed verification email received >1 min of manufacturer submission |
Sad Path: More Information Needed #
A trading partner submits a verification request for a package for which more information is needed. In this test case, it turns out to be Not Verified.
| User | Action(s) | Result |
| Guest | 1. Access the portal 2. Hit New Request 3. Select verification 4. Fill out form based on happy path test products (available separately) 5. Hit Submit | Verification request received; response pending |
| Host | 1. Login to the portal 2. Go to Partner Requests | Package appears as pending review in Partner Requests |
| Host | 1. Click into ticket and review response from VRS 2. Select “More Information Needed” 3. Add optional comment 4. Hit Submit | Package appears as Information Requested in Partner Requests |
| Guest | Access the portal | Ticket appears as information requested |
| Guest | 1. Access ticket 2. Add a comment 3. Hit Submit | Comment submitted; ticket still appears as information requested |
| Host | 1. Click into ticket and review response from requester 2. Select “Not Verified” 3. Add optional comment 4. Hit Submit | Package appears as Not Verified in Partner Requests |
| Guest | Access email account | Failed verification email received >1 min of manufacturer submission |
Test Products #
For the purposes of Interoperability testing, ask your serialization provider for test data that can be submitted
