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    September 29, 2016

    What is Track & Trace?

    Written by SmartSense

    Pharmaceutical track and trace legislation has arrived. Signed in 2013, Title II of the Drug Quality and Security Act outlines specific steps to build an electronic system to track and trace prescription drugs in the U.S.This legislation takes the long view toward drug safety. According to the FDA DSCSA Overview, the new system will:

    • Enable verification of the legitimacy of a drug at the package-level
    • Enhance detection and notification of illegitimate products in the drug supply chain
    • Facilitate more efficient recalls

    This legislation is a critical step to ensuring the safety and efficacy of prescription drugs in the U.S. The law was supposed to go into force on July 1, 2015 but this was extended to March 1, 2016. The law requires the following key provisions be implemented over the next 10 years:
     
    • Product Identification: A unique product identifier will be required on certain prescription drug packages. For example, a barcode that can be easily read electronically.
    • Product Tracing: Individual players in the supply chain will need to provide information about who handled the drug every time it is sold in the U.S.
    • Product Verification: Systems and processes will need to be put in place to verify the product identifier on prescription drug packages.
    • Detection & Response: Drugs identified as suspect will need to quarantined and investigated to determine whether they are counterfeit, unapproved, or potentially dangerous.
    • Notification: Systems and processes will need to be put in place to notify the FDA and other stakeholders if an illegitimate drug is found.
    • Wholesaler Licensing: Wholesale distributors must report their licensing status and contact information to the FDA. This information will be made available in a public database.
    • Third-party Logistics Provider Licensing: Third-party logistic providers, those who provide storage and logistical operations related to drug distribution, will need to obtain a state or federal license.
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