Simplify Compliance 2017-11-28T04:46:01+00:00

Simplify DSCSA Compliance

The Assure-Trak® DSCSA Compliance as a Service exceeds current Drug Supply Chain Security Act (DSCSA) requirements. As part of the breakthrough Assure-Trak® System, DSCSA Compliance as a Service offers healthcare providers a versatile platform specifically designed to meet current and approaching DSCSA requirements and set new standards for quality assurance and product traceability.

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Drug Supply Chain Security Act

Effective March 1, 2016, the U.S. Food and Drug Administration (FDA) began enforcing Title II of the Drug Quality Security Act (DQSA) the Drug Supply Chain Security Act (DSCSA). DSCSA requires organizations that dispense prescription medicines to maintain storage of the transactional record of those medicines, known in the pharmacy industry as T3s, for six years.

Future DSCSA implementation includes…

  • November 27, 2017 – Manufacturers must affix human and bar code readable unique identifiers including lot number and expiration date (serialization) to package and case
  • November 27, 2020 – Pharmacy must have lot-level traceability

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