Blue Link’s Pharmaceutical Inventory Management Software provides functionality to manage all aspects of your pharmaceutical wholesale and distribution business. As an all-in-one pharmaceutical ERP system, Blue Link includes robust accounting and inventory management features and advanced functionality for regulatory compliance with the DEA, FDA and DSCSA, including Electronic Serialized File Management, Saleable Returns Verification, DEA and State License Management, Suspicious Order Monitoring, Suspect and Illegitimate Product Handling, EDI Integration, Barcode Scanning and Warehouse Management.
These features work together to automate processes and grow your business, increase transparency, and aid in regulatory compliance.
Pharmaceutical Distribution Software Functionality
|Electronic Serialized File Management||Saleable Returns – Verification Router Service||DEA & State License Expiry Date Management|
|Transaction History Management (T3) (to be updated for 2023 deadline)||Customer SKU Classification & Controlled Drug Scheduling||Suspicious Order Monitoring (SOM)|
|Identification of Product||Suspect & Illegitimate Product Handling||Controlled Substance Ordering System (CSOS)|
|Short Dated Drugs Management||Lot Tracking (Traceability)||Compliance Reporting|
|Accounting – A/R, A/P, GL, Bank Management, etc.||Order Entry & Invoicing||Purchase Orders|
|Warehouse Management & Shipping||Barcode Scanning||Serialized Equipment Tracking|
|Inventory Management||Pricing Rules||Reporting & Analytics|
|Contact Management & CRM||B2B Online Order Portal||Commission Management|
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DSCSA 2023 Interoperability Requirement – Now 2024
Blue Link ERP works with 3rd party applications that can read, decipher, store and transmit EPCIS file information for use in the receiving and shipping process.
When receiving inventory into your warehouse, you’re able to scan the product (largest unit size) and as part of the scan, Blue Link will automatically make a call to the 3rd party application to lookup the DTR information which is included in the EPCIS file to verify the product being received. The information is then passed into Blue Link and saved so it can be used in the outbound shipping process.
The Drug Supply Chain Security Act (DSCSA), signed into legislation by US President Barack Obama on November 27, 2013, ushered in a new age of transparency and accountability in the pharmaceutical industry. The DSCSA outlines several phases aimed at establishing an interconnected platform that will successfully identify and trace specific prescription drugs as they move through the supply chain. As of the end of 2023 and the completion of the ten-year implementation process, the resulting system in place will enable the communication of information at the individual package level identifying where a specific drug has been at different stages of the supply chain. The goal of this transition is to permit the verification of the legitimacy of the drug products, facilitate more efficient and timely recall procedures and protocols, and enhance the detection and notification of illegal products.
For wholesale distributors dealing with pharmaceuticals, Blue Link closely monitors FDA, DEA and the progression of DSCSA requirements and frequently consults with existing customers and industry experts to ensure the pharmaceutical specific functionality offered continues to meet the needs of the industry and new standards/regulations as they come into effect.
In August 2023, it was released by the FDA that they will be enforcing a ‘Stabilization Period‘ and will not be enforcing the DSCSA requirements until November 27th, 2024. The stabilization period is encouraged to be used to build and validate the systems and processes that require Pharmaceutical trading partners to be fully compliant with DSCSA requirements. Although the FDA will not be enforcing the law until 2024, it’s important that businesses do not stop or delay implementing these processes.
Read the FDA Guidance document:
Learn more about the Drug Supply Chain Security Act (DSCSA) and Pharmaceutical Distribution Software.
The NABP DDA program (VAWD) is an accreditation that is issued by the National Association of Boards of Pharmacy (NABP) to pharmaceutical wholesale drug distribution facilities. The accreditation verifies that distributing facilities are in compliance with state and federal laws which ultimately helps to prevent counterfeit drugs from entering the U.S. market. It is currently recognized by 21 states in the U.S., and is a requirement in Indiana, North Dakota, and Wyoming. Other states require NABP DDA as a condition of license renewal for disciplinary cases.
Over half of all Blue Link pharma customers have been able to achieve VAWD/NABP with the help of our pharma ERP software.
**To be updated for 2024 deadline (DSCSA 2024 Interoperability Requirement)
The DSCSA requires that all trading partners including manufacturers, repackagers, wholesale distributors, and dispensers not accept pharmaceutical products unless the trading partner they receive the product from can provide specific information about the product. This specific requirement dictates that every shipment moving through the supply chain include a Transaction Report or T3.
To meet these needs, Blue Link includes transaction history (product/lot tracing information) of a specific drug’s route and automatic tracking of information stored one level back and one level forward. The software includes the ability to enter complete transaction tracking for each product/lot back to the manufacturer and full Transaction Reporting (T3).
Blue Link ERP’s pharmaceutical classification capabilities enables you to restrict the type of controlled “scheduled” drugs any one of your customers can purchase. The software’s limit capabilities enable you to restrict the quantities of controlled drugs a customer can purchase and alerts you when customers exceed their quantity limits at the order level. Drug Family scheduling features enable you to restrict the total quantity of a “Family” of controlled drugs a customer can purchase per order or per month and includes features for managing ratios of controlled vs. non-controlled drug sales by customer on sales orders. In accordance with DEA standards, this feature can also be used to automatically generate ARCOS reports.
DSCSA 2024 Interoperability Requirement
Since 1971, the DEA has required pharmaceutical “registrants” to monitor sales orders and inform their DEA Field Division Office of any suspicious orders including unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency. Blue Link pharmaceutical inventory management software includes configurable SOM capabilities to monitor sales order activity in a number of areas including;
This functionality will automatically put a sales order “on hold” and send a notification to an authorized user within our customer’s business if certain criteria are met. Configuring the criteria and removing the “hold” status requires specific user permissions.
A Controlled Substance Ordering System (CSOS) allows distributors, pharmacies and manufacturers to transmit Schedule II (CII) orders electronically. This feature is certified by the DEA as an approved legal process based on industry regulations and streamlines the order and reporting process for Scheduled Drugs. Our CSOS DEA certified functionality allows trading partners in the supply chain to place orders online for Schedule II (C2) controlled substances. CSOS is built into Blue Link’s B2B Ordering Platform.
Short Dated Drugs functionality enables you to identify when a product should be considered “Short Dated” and allows you to associate a specific price to that products lot.
Lot tracking software, or batch tracking, allows for product traceability to keep track of which customers received specific groups (or shipments) of items and when they were received. The date these items were purchased and supplier they came from are also tracked, allowing you to monitor an individual group of products (or shipment) from the supplier to your own warehouse and ultimately to the customer. Strong lot tracking features will also allow users to print lot numbers on documents including invoices and packing slips. Lot tracking is especially important if any of the products you distribute are ever recalled – associating a specific lot number to products makes it much easier to handle recalls.
Blue Link ERP’s robust reporting functionality allows for the automatic printing and emailing of Transaction Reporting (T3), Customer License Expiry Report and allows you to automatically generate and upload ARCOS/CSOS reports to the DEA at a set scheduled date and time (as determined by you). Blue Link also has Lot Expiry Reports and Lot Recall Reports, in addition to standard financial reports, sales reports and inventory reports.
Below you will find some examples of Blue Link customers that are wholesale distributors in the Pharmaceutical and Medical industry. These customers have all benefited from Blue Link’s inventory and accounting ERP software with industry specific functionality to aid in DSCSA and FDA requirements such as our lot tracking, transaction reporting, CSOS and license management tools. As an expert in the pharmaceutical industry, Blue Link works with a variety of small-medium size pharmaceutical wholesale and distribution businesses across the USA.
Blue Link ERP maintains its strong presence in the pharmaceutical industry by keeping up-to-date on industry regulations and compliance as set out by the FDA, DEA, DSCSA and other affiliated governing bodies. For wholesale distributors, it is important to work with a software vendor like Blue Link that has a strong presence in the pharmaceutical world. Blue Link does this by maintaining a membership with the Healthcare Distribution Alliance (HDA), by forming partnerships with industry experts and by regularly participating in pharmaceutical conferences, seminars and tradeshows.
Headquartered in Washington, D.C., the Healthcare Distribution Alliance (HDA) is the national organization representing primary pharmaceutical distributors — the vital link between the nation’s pharmaceutical manufacturers and pharmacies, hospitals, long-term care facilities, clinics and others nationwide. The alliance represents 36 distribution companies — national, regional and specialty — as well as approximately 130 manufacturers and more than 50 service providers.
Since 1876, HDA has helped members navigate regulations and innovations to ensure efficient and reliable delivery of medicines and healthcare products. Throughout this period, the pharmaceutical distribution industry has undergone a rapid evolution as technology has advanced, the market has globalized and the supply chain has become more complex.
PDG is a collaborative forum dedicated to developing, advancing, and sustaining an effective and efficient model for interoperable tracing and verification of prescription pharmaceuticals in the United States. Through collaboration with industry stakeholders, PDG has developed a Foundational Blueprint for 2023 Interoperability, which provides a set of compliance and business requirements for DSCSA interoperability.
Gateway Tracker™, a product traceability platform, is completely integrated into Blue Link’s Pharmaceutical Distribution Software enabling item-level traceability functionality and DSCSA regulatory compliance. Goods receipt, reconciliation, inventory management, fulfillment, and reverse logistics are serialized-enabled through Gateway Tracker APIs. Direct access to serialization through the Blue Link interface means there is no need for costly configuration, complicated onboarding, or expensive integration services.
Gateway Checker Corporation develops pharmaceutical traceability software that enables conformance to GS1 application standards and DSCSA compliance. Gateway’s applications facilitate DSCSA traceability, drug transaction exchange, product verification, systems validation, conformance certification, and item-serialized, lifecycle management. Founded in 2019 based on 13 years’ experience establishing supply integrity and deploying serialization solutions to more than 50 companies. Gateway Checker Corporation is a GS1 Solution Provider, a GS1 Certified Conformance Testing Service, and a wholly owned subsidiary of BrandSure, LLC.
**Formerly Five Rivers RX and NavigateSOM
Blue Link works with Pharma Solutions to help pharmaceutical distribution businesses find and implement proper inventory and accounting pharmaceutical ERP software.
Pharma Solutions enables the drug supply chain to ensure quality and security through consulting and administrative solutions that leverage innovation, expertise, and technology. The company’s services span Federal and State requirements including State Licensing, NABP Accreditation, DEA Compliance and providing technological solutions to help pharmaceutical companies along the supply chain. Pharma Solutions are always hyper-focused on client care and meeting client objectives.
Powered by LSPedia, the verification router service in Blue Link ERP works to meet the November 27, 2019 DSCSA requirements and expands the capability to perform product verification in real time with sub-second response from anywhere, on any device, utilizing the unique product identifier.
LSPedia is a leading supply chain software provider for the pharmaceutical industry. LSPedia’s serialization solution RxChain enables pharmaceutical manufacturers, wholesale distributors, dispensers to manage data, distribute products, and track inventory at the serialized level. LSPedia’s Verification Router Service enables authorized trading partners to authenticate serialized products, verify returns, and deter counterfeiting.
Blue Link works with RxVirtual as an integration partner for eCommerce, EDI and integration with other third-party applications.
RxVirtual is a US based and operated IT company with focus in providing the most modern technology solutions, including EDI (Electronic Data Interchange) to allow businesses to streamline and automate their operations. Founded by a group of highly experienced IT specialists with years of collaboration in TOP enterprise level organizations.
Blue Link integrates with Trxade allowing for data to be electronically passed between Blue Link and the Trxade platform.
Founded by an independent pharmacist in 2010, the Trxade platform offers true price transparency to its over 7,500 Pharmacy members with industry-leading cost comparison tools and advanced search features that put Pharmacies in control of their Rx purchases like never before. They are the leading pharmaceuticals e-commerce marketplace featuring 30+ pedigree and NABP compliant wholesalers price competing in real time like Amazon and eBay.
Blue Link’s pharmaceutical inventory management software helps your business reduce manual work, automate processes and remain compliant with industry regulations so that you can focus on what really matters: growing your business. Let us help you with the hard work by providing an all-in-one pharmaceutical distribution system to manage your business operations.