The DSCSA, issued by the Food and Drug Administration (FDA)- World’s No 1 Health Department- outlines the steps necessary to build an electronic interoperable system that can track and trace types of prescription drugs as they are sold and distributed for community health care in United States. TrackTraceRx has developed the only health care solution that approaches traceability focusing on the following touch points:
Easily integrate with thousands of pharmaceutical companies, approved by the healthcare department, by simply joining our traceability network.
Our open API allows easy data exchange between the TrackTraceRx Cloud System and your internal systems.
Product Identification & ownership require keeping transaction records of the TH (Transaction History), TI (Transaction Information), and TS (Transaction Statement). These can later be shared with the health department for verification.
The DSCSA requires all health care units to verify returns using a VRS service to send queries between trading partners, directly or indirectly related to family and community health care. TrackTraceRx provides an easy to use Saleable Returns interface allowing you to manage connections and queries before issuing your return.
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Our VRS services allow your company to meet the DSCSA Saleable Returns requirements, which is an important step to ensure community health care is not compromised.
The Saleable Returns requirements mandates that all products be verified before returning them to their original "saleable" state. TrackTraceRx has been participating currently with the HDA VRS pilot and is up-to-date with all the requirements needed to make sure your organization is ready come November 2020. With the combination of the TrackTraceRx Traceability portal and the RapidRx Vision scanner, our VRS technology is unmatched within the health care industry.LEARN MORE
On November 27, 2013, President Obama signed into health care law -The Drug Quality and Security Act (DQSA). Title II of the Bill specifically dealt with the Drug Supply Chain Security Act (DSCSA). The DSCSA outlines the steps necessary to build an electronic interoperable pharmaceutical traceability system that can track and trace different types of prescription drugs as they are sold and distributed in the United States. The DSCSA mandates full supply chain traceability from pharmaceutical manufacturer to pharmacy dispenser.
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.
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.
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.
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.