Drug Supply Chain Security Act (DSCSA)

Supply chain compliance, consumer safety. The DSCSA dictates the steps for building an electronic system to identify and track medicines in the United States.


DSCSA is a priority of the Food and Drug Administration (FDA), the US drug regulatory agency. 

TrackTraceRX offers solutions that are DSCSA compliant by implementing an interoperable electronic system which tracks prescription drug sales and dispensing.

The TrackTraceRx Suite is revolutionary compared to other solutions on the market due to combining the TrackTraceRx Traceability Solution, a ERP, and a Commerce Platform completely integrated out of the box. This eliminates having to deal with multiple support, feature services and integration costs.

Additionally, TrackTraceRx’s VRS services will enable your company to meet the DSCSA’s saleable returns requirements ensuring company compliance and that patient safety is put first.

Contact sales
Integrated Network

Connect to our client network and easily integrate with thousands of pharmaceutical companies.

Software based on API-First

Quick and easy integration of internal or partner systems. Share data securely in the cloud.

T3 and serialisation management

Identifying product, ownership and custody requires storing records that can be shared for regulatory verification.

VRS - DSCSA compliance

The DSCSA requires you to verify returns through VRS. With our system you can manage connections and query in advance before issuing returns.


DSCSA Timeline

  • 2023
  • 2020
  • 2017
  • 2015

On November 2023, the DSCSA will turn into an electronic, serialized records retention serialization system. Item level products will need to be serialized and must be associated with its parent shipper case serial number and up to pallet serial number.

Saleable Returns Requirement

Companies must have a system in place to verify product returns.An essential process of the health care system, these products must be verified before they are put back in place for commercial redistribution.

One of the methods of doing this is to hire a third-party company such as TrackTraceRx to provide what is known as VRS (Verification Router Service). A Verification Router Service will already be integrated with the major VRS health care companies to easily be able to interexchange return verifications.

Lastly, dispensers will need to provide verification and tracking of serialized products.

Pharmaceutical Serialization Tracking

Manufacturers must add a "product identifier" to each individual package and homogeneous case of products. This product identifier is a standardized graphic (two-dimensional dot matrix) that carries the product's standardized numerical identifier (SNI), lot number, and expiration date in both human-readable and machine-readable format. The process helps in verifying the safety of health care products.

Serialization: All pharmaceutical manufacturers and repackaging companies are required to include unique serial numbers and expiration dates on prescription drug packaging.

Lot-level Health Care Shipment Track and Trace

Trading Partners must only purchase products from authorized trading partners, approved by the health department, and exchange transactional data on a lot batch level. Health care trading partners shall have a system or process in place to investigate and quarantine products that are "suspect" or "illegitimate", and notify the FDA and immediate trading partners.

Lot traceability: All pharmaceutical manufacturers are required to print lot/batch numbers on packaging for all prescription drugs.

Meet RapidRX: an extension of the Traceability Portal

Innovating the reading of standardized codes, RapidRx uses a mobile vision system integrated with Augmented Reality. A cost-effective and easy alternative to access real-time information.

  • Multiple Code Capture

    Multiple Code Capture

    Our vision system detects and scans multiple barcodes and Data Matrix codes at the same time. Unmatched scanning speed.

  • Augmented Reality (AR) RapidRX

    Augmented Reality (AR)

    Get real-time feedback such as expiry dates, sorting, inventory and even important instructions.

  • Mobile device compatible

    Mobile device compatible

    Leave your dedicated scanner by the wayside. Save money and use a smart mobile device. Faster and more practical.

  • Significant time saving

    Significant time saving

    Perform scanning checks 60% faster, reducing logistics operating costs and streamlining your supply chain.



Our VRS services enable your company to meet the DSCSA's saleable returns requirements, ensuring that patient healthcare is not compromised.

Let us Simplify your DSCSA Process!

Book demo