DSCSA Compiance as a Serivce 2017-12-01T23:35:48+00:00

Facilitate
Compliance

DSCSA
Compliance as a Service
(CaaS)

DSCSA Compliance as a Service (CaaS) removes the burden of track and trace compliance from the dispenser community with comprehensive data collection and product traceability services. With DSCSA Compliance as a Service, you can be confident you’re compliant …from Pedigree to Patient®.

  • Assures compliance by enabling you to conveniently capture, validate, and maintain T3 documents for 6 years, including T3 documentation for borrowing, selling, and distributing to other health systems.
  • Minimizes time required to implement Suspect and Illegitimate Product Management.
  • Quickly & efficiently collects data, including data from EDI feeds as well as paper documents – and offers easy access to data required for audits within the 48-hour requirement.

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Simplifying Compliance
Facilitating Loan/Borrow Mgt.

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DSCSA COMPLIANCE AS A SERVICE

Drug Supply Chain Security Act

The Drug Quality and Security Act (DQSA), was enacted by Congress on November 27, 2013. Title II of the DQSA the Drug Supply Chain Security Act (DSCSA), outlines steps to build an electronic, interoperable system to identify and trace prescription drugs throughout the drug supply chain. The goal of the DSCSA is to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful while identifying and removing potentially dangerous drugs from the U.S. drug supply chain.

The DSCSA outlines requirements for manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers (trading partners). Requirements of the DSCSA are being implemented in a phased approach over a 10-year period, which started in 2013 and ends in 2023 with the fully operational electronic interoperable track and trace system.

Since March 1, 2016, the DSCSA requires hospital pharmacies or dispensers to capture, maintain, and store drug transactional records known in the pharmacy industry as T3s (transaction history, transaction information, transaction statement), for six years.

Future DSCSA implementation requirements include…

  • Product serialization by manufacturers affixing human and bar code readable unique identifiers including lot number and expiration date to products at the package and case level
  • Pharmacy lot-level traceability
  • Pharmacy unit level traceability

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