• Regulatory NewsRegulatory News

    Companies Collaborate on DSCSA Guideline as Deadlines Approach

    Beginning next November, pharmaceutical companies will be required to mark their products with a National Drug Code (NDC), serial number, lot number and expiration date in both machine-readable and human-readable format thanks to the Drug Supply Chain Security Act (DSCSA) of 2013. In preparation for that deadline and others over the next seven years, a diverse group of 44 companies – from manufacturers to wholesalers to solution providers – came together to develo...
  • Feature ArticlesFeature Articles

    Global Tracking Regulations Present Challenges and Benefits

    • 16 July 2013
    Drug makers are facing an ever-increasing challenge as more countries implement serialization and tracking regulations and set compliance deadlines in an effort to ensure the safety and quality of prescription drugs being sold within their borders. Complying with regulations coming into effect will be a demanding task due to a lack of global harmonization. The foundation of any tracking system is serialization, which entails affixing to finished drugs a unique serial num...
  • Senate Releases Draft Proposal of National Track and Trace System

    • 25 October 2012
    The Senate has released a draft proposal to develop a so-called "track and trace" provision legislators say will increase the security of the US' pharmaceutical supply chain. The system, so named because it would allow regulators to track the movement of a product throughout the supply chain and trace the path of any product found later, is intended to reduce the supply chain's susceptibility to the introduction of counterfeit products without detection. The provision...
  • Report: Track and Trace Negotiations Resume in Congress

    • 10 August 2012
    Track-and-trace is dead; long live track-and-trace. Politico reports staff members associated with the House Energy and Commerce (E&C) Subcommittee on Health and the Senate Health, Education, Labor and Pensions (HELP) Committee are meeting over the August congressional recess to restart stalled negotiations over pharmaceutical track-and-trace provisions. Track-and-trace refers to a system by which regulators and pharmaceutical companies can track the movement of...
  • Report: Track and Trace Provisions Removed from User Fee Bill

    • 18 June 2012
    Provisions aimed at establishing a system in which drug products would be given unique identifying numbers-a so-called ' track and trace ' system-has been removed from a draft user fee bill intended to fund the US Food and Drug Administration, reports Politico . Negotiators, currently attempting to resolve differences between the House and Senate versions of the user fee bill, have reportedly reached an impasse in their attempt to get track and trace provisions into the...
  • Legislators: To Help Alleviate Drug Shortages, Establish Track and Trace Provisions

    • 13 June 2012
    Two Democratic legislators this week sent a letter to members of the Senate's and House of Representatives' healthcare oversight committees detailing the findings of the legislators' investigation into the effects of the so-called "gray market" on prescription drug shortages. In their 11 June letter, Senator Jay Rockefeller (D-WV) and Representative Elijah Cummings (D-MD) said their investigation had "identified significant risks in the US pharmaceutical distribution cha...
  • With EDQM Absent, EFPIA Launching Own Anti-Counterfeit Strategy

    • 03 May 2012
    The European Federation of Pharmaceutical Industries and Associations (EFPIA) announced it has signed on to a Memorandum of Understanding (MoU) that it says will help to set up a harmonized system of international standards to prevent counterfeit products from entering or proliferating within the pharmaceutical supply chain. EFPIA said the MoU, reportedly developed jointly between groups representing pharmacists, wholesalers and distributors, adopts what is known at the ...
  • EDQM Continuing Development of New, Comprehensive Anti-Counterfeiting Strategy

    • 18 April 2012
    The European Directorate for Quality in Medicines and Healthcare ( EDQM ), the Council of Europe's (EC) pharmaceutical standards body, announced it is continuing to develop and expand a new anti-counterfeiting strategy it says will reduce pharmaceutical-related crime. In its 18 April announcement, EDQM said the multi-layer legislative strategy aims to increase, among other things, training for inspection officials from EC member states, increased inspection and testing a...