CARO Documentation #

General Introduction #

CARO supports trading partners using a Verification Routing Service (VRS) for Product Identifier Verifications to comply with U.S. Drug Supply Chain Security Act (DSCSA) requirements for Authorized Trading Partners (ATP). To increase patient safety, the DSCSA postulates that pharmaceutical supply chain actors are only permitted to interact with trading partners that are authorized. Manufacturers and repackagers are authorized when they hold a valid FDA registration; wholesalers, third-party logistics providers (3PL), and dispensers require a State-issued license (refer to FDA guidance). Watch this FDA video for an introduction to the topic.

An ATP check on both sides is, for example, required for the verification of saleable returns or suspicious products. A wholesaler or dispenser would use their VRS to route the verification request to the original manufacturer. The manufacturer needs to identify the requester and verify the ATP status before sending a response with the product details. The identification and verification of the authorized status is also required when the requester receives a response from the manufacturer. Hence, both the requester and responder need mechanisms in place to ensure that the other side is an ATP.

How this documentation is organized #

• Essential Concepts provide some background knowledge on terminology used in our documentation and app.
• Tutorials take you through the CARO app and further relevant explanations.
• API Specification contains technical references for APIs and other aspects of CARO. They describe how it works and how to use it, but assume that you have a basic understanding of key concepts like REST, JSON and HTTP.

First steps for technical implementers #

1. Explore our CARO endpoints under API Specification.
2. Take a look at our Tutorials for VRS providers: VRS User Guide | VRS Testing Guide
3. Start implementing our API from scratch using the information provided in Concepts: Authentication | Errors

Getting help #

If you have already been invited to a dedicated Spherity Slack support channel, seeking assistance there will be the most straight-forward way for you to reach the CARO support team.

Otherwise please contact [email protected] for product-related questions or [email protected] for technical queries.