# FDA Pharmaceutical Pilot: Proving Blockchain for Drug Traceability

**The Challenge:** The U.S. Drug Supply Chain Security Act (DSCSA) mandates unit-level track and traceability for pharmaceuticals. Traditional EDI systems handle document exchange but can't verify product authenticity or provide rapid traceability during recalls. Counterfeit drugs cost the pharmaceutical industry billions annually and threaten patient safety.

**The Solution:** In 2019, the [FDA launched a landmark pilot with IBM, KPMG, Merck, and Walmart](https://www.drugpatentwatch.com/blog/real-world-blockchain-uses-in-the-pharmaceutical-industry/) to test blockchain's viability for meeting DSCSA interoperability requirements. The collaboration connected disparate existing systems—manufacturer, distributor/dispenser, and technology providers—to create a common record of product movement while preserving EDI for routine transactions.

**The Results:**

* **Dramatic improvement in patient safety capabilities:** Proved drug provenance could be accurately captured on blockchain
* **Data privacy maintained:** "One up, one down" permissioned view protected sensitive information
* **Verified authenticity:** Every pharmaceutical unit tracked from manufacturing through delivery
* **EDI preserved:** Existing document exchange systems continued operating normally
* **Published findings:** February 2020 final report confirmed successful proof of concept

<figure><img src="/files/P5W3O1gXdtQuvZGxOA0W" alt=""><figcaption></figcaption></figure>

&#x20;


---

# Agent Instructions: Querying This Documentation

If you need additional information that is not directly available in this page, you can query the documentation dynamically by asking a question.

Perform an HTTP GET request on the current page URL with the `ask` query parameter:

```
GET https://hub.bsvblockchain.org/higher-learning/bsv-academy/the-business-case-for-blockchain-in-supply-chain/blockchain-vs.-traditional-edi/fda-pharmaceutical-pilot-proving-blockchain-for-drug-traceability.md?ask=<question>
```

The question should be specific, self-contained, and written in natural language.
The response will contain a direct answer to the question and relevant excerpts and sources from the documentation.

Use this mechanism when the answer is not explicitly present in the current page, you need clarification or additional context, or you want to retrieve related documentation sections.
