Is your company prepared for
Drug Supply Chain Security Act
(DSCSA) Compliance?

Deadlines are right around the corner and many organizations are not yet ready for serialization. Net@Work offers solutions and resources that prepare Drug Supply Chain Manufacturers, Distributors and Retailers to be ready for the fast-approaching regulations coming in 2017 and beyond.

Contact a DSCSA Compliance Expert

What are the DSCSA requirements for Manufacturers and Distributors?

The DSCSA creates a complex web of compliance issues around tracing and verification of drug product transactions between suppliers and their trading partners. To minimize risks and costs associated with DSCSA compliance, businesses may need to put new IT resources in place, perform due diligence on logistics partners and other third parties, and document and address any gaps in their overall compliance strategy.

A recent poll by TraceLink, indicated that Warehouses are not yet ready for serialization. Respondents overwhelmingly indicated they are not yet equipped to handle serialized product in their warehouses, or have they begun to implement serialization with their manufacturing partners. Only 38% of respondents said they were confident their ERP or WMS systems will be able to handle all their serialized distribution needs.

Timeline of DSCSA Requirements

November 2017
Manufacturers serialize product

November 2018
Repackagers serialize product

November 2019
Distributors transact only serialized product

November 2020
Dispensers transact only serialized product

How Will the DSCSA Impact My Business?
 Get In-depth DSCSA Info
What Steps do I Need to Take to Comply with DSCSA?
 Watch our DSCSA Video
Do I meet DSCSA requirements? Take this Self-Assessment.
 Launch DSCSA Assessment

Recommended software solution(s) to meet DSCSA requirements

As your trusted advisor, Net@Work recommends TrueCommerce EDI along with AccellosOne WMS as integrated solutions that work with both Sage and NetSuite Solutions.

What additional benefits do I get as a result of being compliant?

  • 4D labeling: ensures you meet the DSCSA requirements
  • Seamless integration with Sage 300 and NetSuite to your WMS and EDI solutions
  • Order accuracy: Achieve over 99%+ accuracy
  • Outbound shipments: Volume increases 15%, double your orders per day
  • Employee productivity: Improve productivity and keep personnel costs low
  • Inventory accuracy: Over 99% and 80-85% less inventory loss
  • Picking times & lines: reduced time 20% and triple number of lines picked
  • Directed putaway: Replenishment accuracy over 99%
  • Increased speed of warehouse operations
  • Easy and fast implementation: 90 day implementation and no interruption in business

Recommended Solution: AccellosOne WMS

  • Reduces or eliminates manual data-entry errors, saving charge-back penalties
  • Streamlines inventory management, speeding time-to-market delivery
  • Increases productivity without increasing staff, saving labor costs

Recommended Solution: TrueCommerce EDI

DSCSA FAQ & External Resources

DSCSA Frequently Asked Questions:

To ensure all 2017 compliance requirements are met manufacturers and distributors should allow 6 months to fully implement compliant solutions.

DSCSA requires each supply chain member to ensure that it buys products from and sells products to only “authorized trading partners.” A manufacturer is considered authorized if it is registered with the FDA as a drug establishment. FDA maintains a searchable database that can be checked to confirm a drug manufacturer’s registration status. More information.

The 856 Advance Ship Notice (ASN) is a notification of pending deliveries, similar to a packing list but it is sent electronically via Electronic Data Interchange (EDI). The ASN is formatted to include additional fields so it could be used to transmit all of the DSCSA TI/TH/TS information required.

There are both state and federal as well as local governing bodies that will ensure compliance.

(1), a State—‘‘(A) may take administrative action, including fines, to enforce a requirement promulgated by the State in accordance with section 503(e) (as amended by the Drug Supply Chain Security Act) or this subchapter;
‘‘(B) may provide for the suspension or revocation of licenses issued by the State for violations of the laws of such State;
‘‘(C) upon conviction of violations of Federal, State, or local drug laws or regulations, may provide for fines, imprisonment, or civil penalties; and
‘‘(D) may regulate activities of licensed entities in a manner that is consistent with product tracing requirements under section 582.”

In addition the state no longer controls what consequences you face under DSCSA this is now controlled at a federal level.

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