DNS and TLDs
Utilizing the Internet to Meet DSCSA Requirements
The internet is the world's largest informational resource. Reaching 5 Billion users; It offers individuals, governments, and companies the ability to communicate and share information on a scale never seen before. Trust.med leverages its role as an internet top-level domain(TLD) to bring the power of the Domain Name System (DNS) and resolvers to companies required to comply with the Drug Supply Chain Security Act (DSCSA).
2D Data Matrix:
The 2D Data Matrix is on the label of every DSCSA regulated Drug. Trust.med enhances the capabilities of this industry standard with its DSCSA compliance solutions.Protocol
Every domain and URL from Trust.med is secured with SSL certificates.GTIN
Trust.med identifies who to ask by using GS1 standardized identifiers as anchors. In this example we use the GTIN, the Global Trade Item Number. The GTIN is embedded within the 2D Data Matrix and identifies the product and product owner within Trust.med.rTLD
Restricted Top-Level Domain (rTLD):
.Med is a restricted top-level domain. As the Registry Operator of the rTLD we've set guidelines on the use of domain names and URL's. All .med domain names and URL's function as solutions for the healthcare supply chain and DSCSA compliance.
Know How to Ask
Trust.med pairs its standardized approach for identifying DSCSA data endpoints (using GTIN based .med domain names) with the Digital Link GS1 standard. After identifying the endpoint, the GTIN of a product, Trust.med formats your query using the Digital Link Standard. This standard organizes your request using the data elements embedded within a 2D Data Matrix and produces an easy to read response.
Trust.med provides a flexible and scalable solution for companies of any size. Requests to trading partners can be accomplished through the scanning of a 2D Data Matrix, manual entry of product information on the web, or an integration with Trust.med’s Application Programming Interface (API). This standardized approach for requesting information offsets concerns about technical aptitude, technology stacks, and tedious implementation. With just the product in your hand you can quickly and easily ask all of your DSCSA questions using the Trust.med registry.
Responding entities also gain from the use of the Trust.med registry. Organizations who are required by DSCSA to make data available can do so with a future proof mindset. Individual point to point connections for communicating and exchanging information regarding drug products is not required. This is especially impactful in regards to DSCSA which introduces compliance requirements between pharmaceutical manufacturers and pharmacies.
Know Who to Ask
Trading partners on the Drug Supply Chain are required by law to electronically exchange serialized data, make data available, and respond to certain requests for data. Trust.med uses .med domain names and resolvers to provide a universal method for identifying the source of regulated drug product data. If you know the Global Trade Item Number (GTIN, a GS1 standard) of a drug product, you know who to ask for more information via the Trust.med registry.
Trust.med has created a registry of serialized drug product GTIN’s in the form of domain names. The Trust.med registry gives trade partners the resource needed to identify the location of required DSCSA data on a per product basis. Knowing the GTIN of a product allows a requestor (e.g. trade partner, regulator, consumer) to visit the product specific domain and request product specific data (e.g. master data, tracing data, recall data).
The Domain Name System is the backbone of the internet. The DNS facilitates the simple navigation internet users experience today. Every device connected to the internet (e.g. phone, server, laptop) is assigned an Internet Protocol (IP) address such as 192. 168. 1.1. The DNS can translate words (e.g. amazon.com) or unique ID like GTIN’s (12345678901234.med) to IP addresses. This creates an easy to use system for identifying sources of information without complex lookups or syncing.
Top-level domains are the highest level in the hierarchical Domain Name System of the internet. As a top-level domain, .med restricts the use of .med domain names to the Drug Supply Chain. This is referred to as a restricted top-level domain. Other common restricted top-level domains include .gov, .edu, and .mil. Restricted top-level domains provide the trust and security required to keep bad actors out, without impacting useability.
Within the Trust.med Digital Link URL the GTIN specifies the product you need to ask a question about.
Within the Trust.med Digital Link URL the LOT specifies the LOT of the product you need to ask a question about.
Within the Trust.med Digital Link Serial Number specifies the product serial number you need to ask a question about.
Within the Trust.med Digital Link URL the Expiration Date specifies the expiration of the product you need to ask a question about.
Drug Manufacturers or their service providers simply set the endpoints of the data on a per product basis. These endpoints may vary based on the type of data being requested (e.g. Master Data vs EPCIS). These endpoints can be an API that facilitates querying of a repository or a webpage resolving in a browser. Trust.med utilizes GS1 compliant resolvers to facilitate the routing of requests based on request type and GTIN.
*Global Location Number (GLN) based requesting and responding is also available for organizations that require the need to identify who to ask based on location of facility.
Trust.med’s DSCSA compliance solutions are easy to implement, manage, and use regardless of technical aptitude. Contact our team to discuss your team’s specific needs or book a one-on-one demonstration.
|Manufacturers can make serialized data in EPCIS form available to their customers and recipients of their products via the Trust.med web dashboard, API, or integration by assigning a 'serialized data endpoint' to the GTIN based .med domain names.||Wholesale Distributors requiring a solution for EPCIS access and delivery to their customers can utilize Trust.med as a universal method for providing their clients serialized data.||Pharmacies are required to have access to serialized transaction data of product they receive. The Trust.med registry provides access to this DSCSA regulated data through its dashboard which is accessible on any device with an internet connection. Data can also be accessed through an integration with your existing software applications.|
|Manufacturers use the Trust.med registry to communication critical drug product notifications to the entire supply chain. Streamlining the delivery path of recall notification delivery and targeting notifications improves patient safety while reducing the noise of irrelevant notifications.||Wholesale Distributors can access recall notifications from their pharmaceutical drug manufacturer trading partners using the Trust.med Recall API. Cutting down the email, physical mail, and recall notification aggregation operations required with traditional recall notification solutions.||Pharmacies can access recall notifications from their email, Trust.med dashboard, or through an integration of their existing software platforms to the Trust.med API. Pharmacies receive recall notifications faster and improve patient safety with Trust.med.|
|Manufacturers can meet their DSCSA requirement of responding to product verification requests from dispensers by assigning endpoints to their GTIN based .med domain names in the Trust.med registry.||Pharmacies can make a product request by visiting any GTIN based .med domain name (i.e.12345678901234.com) and completing the product verification form. Alternatively, product verification requests can be made through the Trust.med API or through an integration with a Trust.med service provider.|
|Manufacturers needing to create a universal access method for their products Master Data utilize the Trust.med registry. After setting your Master Data endpoint on your products GTIN based .med domains, trading partners need simply access the endpoint through the GS1 standardized domain and resolver combination. Every trading partner can have the most up to date master data for your products without the need to sync.||Wholesale Distributors seeking a streamlined method to access up to date Master Data from their trading partner providers can call product based GTIN based .med domains and retrieve Master Data without the need to sync.|
|The Trust.med registry provides regulators and trading partners the ability to submit tracing requests on a per product basis by completing forms available on GTIN based .med domains or programmatically through the Trust.med API. Tracing requests are placed within a Trust.med waiting room, only accessible to the manufacturer. Allowing manufacturers to request additional information, approve the request for processing, or deny the request.||Tracing requests through Trust.med pass along key information including the SGLN (Serialized Global Location Number) to the requestor as part of the tracing report. GLN owners are identified and notified. Tracing requests can be processed by requestors based on GTIN and GLN.||Trust.med provides pharmacies and regulators the ability to process tracing requests by entering the application identifiers found on drug product labels (2D data matrix). Subsequent tracing inquiries can be done using the GLN of where the product exchanged ownership.|
|Manufacturers can purchase credentials through Trust.med or utilize Trust.med's License Verification Services to check the DSCSA required license standing of a trade partner at the time of shipping. DSCSA compliant logging is provided with the license check service and is accessible to Manufacturers for a minimum of 6 years.||Wholesale Distributors can purchase credentials through Trust.med or utilize Trust.med's License Verification Services to check the DSCSA required license standing of a trade partner at the time of shipping. DSCSA compliant logging is provided with the license check service and is accessible to Wholesale Distributors for a minimum of 6 years.||Pharmacies can utilize Trust.med's License Verification Services to check the DSCSA required license standing of a trade partner when required.|