Healthcare Providers with DSCSA Requirements

Let TraceLink shoulder your entire DSCSA workload.
From start to finish.

Working with more than 4,000 dispensing locations across the US has taught us
that handling DSCSA compliance effectively can get in the way of providing patient care.


With TraceLink, long DSCSA "to-do" lists for pharmacy buyers, technicians,
and administrators are a thing of the past – because we take care of it all.
Product, partner and company master data. Exceptions.
Paper-to-digital processing. Continuous quality control checks.
We even prepare documents in case of an audit.


Leave DSCSA compliance to the dedicated team of TraceLink service and
compliance experts used by the most US hospitals and pharmacies.
And we'll let you do what you do best: Deliver the highest quality care to your patients.

 

 


 

What is the Drug Supply Chain Security Act (DSCSA)?

DSCSA is a federal law. It stands for the
Drug Supply Chain Security Act, which is Title II of the Drug Quality and Security Act (DQSA).

Purpose of the Law. DSCSA mandates full supply chain traceability from pharmaceutical manufacturers to pharmacy dispensers for prescription drugs distributed in the United States. The law was signed by President Obama in November 2013, providing a national standard for drug security and replacing the patchwork of state-level Pedigree regulations that were previously being put into place.

Why DSCSA Is Important. The World Health Organization estimates that between 1% and 10% of drugs sold around the world are counterfeit, with that number reaching as high as 50% in some countries. DSCSA will help protect patient safety by enabling verification of products, improving the detection of suspect ones, and facilitating product recalls.

 

Understanding the Operational Impact of DSCSA Compliance

With DSCSA, you have to understand exactly where and how things happen in your operation. The time it takes to do so can negatively impact clinical productivity, operational cost, and patient outcomes.  

  • Did your suppliers send all the information you need for compliance?
  • What if National Drug Code (NDC) information is missing?
  • Do you receive product at multiple locations or distribution centers? 
  • How will you manage exceptions for units missing compliance info?
  • How will you save compliance documentation for the required 6 years?
  • Can you quickly locate any paper or digital compliance information during an audit in the required 2 business days?
  • How will your investments in lot-level compliance deliver incremental value for serialized products in the future?  

TraceLink answers these questions and more, managing every aspect of DSCSA compliance for your entire operation.

TraceLink Product Track with End-to-End Administration:
The Most Cost-Effective, Comprehensive DSCSA Healthcare Solution

TraceLink Product Track is used by more than 4,000 US hospital and pharmacy locations. Customers subscribe to software running on a platform that connects to thousands of prescription drug suppliers and processes all DSCSA compliance information.  Every Product Track subscription includes end-to-end administration services, providing a team of TraceLink compliance experts to manage all DSCSA compliance tasks, such as:

  • Adding and maintaining any missing product master data – for drug products that are purchased by a pharmacy.
  • Adding, removing, and maintaining any partners

    – 

    with whom an organization works to purchase drug products.
  • Adding or removing company locations – to cover all dispensing locations within the same operation.
  • Adding or removing new users, or changing user access permissions – as staffing needs evolve and new users need to use Product Track software.
  • Active maintenance and monitoring of exceptions

    – 

    due to receiving purchase orders or ASNs with missing information required by DSCSA.
  • Reprocessing any necessary transactions – after researching exceptions and validating that Product Track information is accurate and compliant.
  • Utilizing TraceLink’s unique “network-sourced” NDC database – to continuously update new NDCs that are discovered across the TraceLink network.
  • Manually entering required DSCSA data to create digital T3 from user scanned or uploaded paper documents – then appending the originally-scanned PO to ensure a fully-compliant, all-digital database of T3s.         
  • Actively monitoring data quality, and providing full customer support during inquiries – initiated by regulatory authorities, to ensure that customers can supply required compliance information within two business days. 

Member of a GPO?
Check Our List of Partners for Preferred Pricing

TraceLink has partnered with many of the largest Group Purchasing Organizations (GPOs), associations and cooperatives to establish preferred pricing and standardized terms of service for their members. These partnerships cover 90% of US hospital pharmacies. 

If your organization is a member of CHAMPS, CPS, FirstChoice Cooperative, GeriMed, GNYHA, Independent Pharmacy Cooperative, Innovatix, Intalere, MHA, MPhA, Pharmacy Systems, Premier, Vizient  or Yankee Alliance you can take advantage of discounted annual subscription rates for Product Track with end-to-end administration.

Get Preferred Pricing Info

Other DSCSA Solutions: What You Need to Know

Inaccurate T3 Creation. Many solutions generate DSCSA Transaction Histories (T3) for every product – even OTC products that don't require it. Be cautious of providers that create T3 for everything, because they mix large amounts of “junk” data with legitimate prescription drug data. Others place multi-field data strings into single data fields, making reconciliation during audits and serialization difficult.

Errors for Missing Info. Some compliance solutions generate “errors” for both OTC products and those that are missing NDC information. This creates large volumes of unresolved transactions. If your provider isn't handling this for you, you may have to reconcile these errors on your own – a manual, time consuming process.

Negligence Has an Impact. Without proper verification upon product receipt, it can be extremely difficult to respond to an FDA request for information in two business days. Auditors will question your Standard Operating Procedures (SOPs) for DSCSA compliance when T3 exists for products that don’t require it.

Serialization Ready? Or Not. Most DSCSA lot-level compliance solutions have not been developed to address serialization. This could require costly replacements of lot-level offerings – or the need to adopt a second solution – to meet your future serialization requirements. 


 

Investments in TraceLink form the Foundation
for Serialization and Longer-Term Business Value

Although US pharmacies aren't required to receive serialized product until 2020, TraceLink customers will be able to leverage the same serialization solutions currently used by hundreds of manufacturers, and extract valuable insights from serialized product data.

  • Buy and sell drug products with unique serial number identifiers on each package.
  • Verify suspect product at the package level through serial number identification and lot number. 
  • Utilize integrated dashboards that leverage serialized product information about expiry dates, dispensation trends, product inventory, and more.
  • Opt-in to receive additional product information from participating pharmaceutical manufacturers to improve real-time patient consultations. 

 

Stay Informed