DSCSA Compliance aka “Track and Trace”

 

The Drug Supply Chain Security Act (DSCSA), also referred to as Track and Trace, outlines requirements for manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers (trading partners). DSCSA is an FDA unfunded, multi-requirement Act that is being phased in over a 10-year period.  The FDA began providing guidelines in 2013 and have been implementing several key requirements at various stages since 2014. These requirements, development of standards, and the system for product tracing will continue to be phased in through the November 27, 2023.

 

As of today, there are 7 requirements that are currently enacted by the FDA and 3 additional requirements referred

to as Enhanced Drug Distribution Security (EDDS) that will be released over staggered timelines between early 2022 and November 27, 2022.

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  • Customized DSCSA Compliance Standard Operating Procedures (SOPs)

  • Ongoing Validation and Authentication of Your Suppliers

  • Automatic Suspicious Order and Fraud & Abuse Monitoring

  • Create customized modules for ASNs (Advanced Ship Notices)

  • Set Up ASN AS2 Connections and Maintaining Dynamic Supplier Database

  • Inspection and Routine Auditing of Supplier ASNs for Accuracy

  • Validating ASNs as 3rd Party for Inspectors

  • Aggregated and Facility Specific DSCSA Compliance Reports that are Standard and Customized

  • On-Line and On-Phone Support during and after an inspection