Pharmaceutical Product Serialization Regulations and Strategies for Compliance
The Drug Supply Chain Security Act – DSCSA (Title II, Drug Quality and Security Act, 2013) has been signed into law, with full implementation phased in over the next 10 years. The next milestone for manufacturers, November 27, 2017, is the date by which pharmaceutical manufacturers are required to print a unique product identification code on all Rx units of sale and homogenous cases distributed domestically.
Serialization: Delay No Longer an Option
Starting November 27, 2017, prescription drug products can no longer be shipped without a DSCSA-required unique serial identification code. Although manufacturers already print lot and date codes on each unit of sale, either by a static or variable barcode, the reality of these new regulations goes far beyond printing a few more attributes and modification of the template on the manufacturers’ vision system. The core concept behind DSCSA is to develop and maintain a tracking system from the manufacturing floor through point-of-sale capable of 100% accuracy.
Drug manufacturers are first in line to comply with the following by the November 2017 deadline:
Serialize units of sale and sealed homogeneous cases with a unique product identifier.
Provide transaction data to trading partners in electronic format only. The Transaction Data (TD) set includes Transaction Information (TI), Transaction History (TH) and Transaction Statement (TS).
Respond to verification requests from trading partners within 24 hours.
Verify the unique product identifier of suspect products at the unit of sale level.
Verify the unique product identifier of returned products intended for resale.
Quarantine product determined suspect until it is cleared or dispositioned.
Will Your Manufacturing Operations Be Ready?
Each of the components required by the milestone is highly complex, technical, and must provide accurate interoperability among key stakeholders (manufacturers, wholesale distributors, repackagers, and dispensers). As with any major change, there are myriad risks, decisions, and planning steps that must be undertaken prior to implementation. Questions manufacturers must answer include, but are not limited to:
What will your standard information system architecture look like for hardware and software? Have you accounted for backup and recovery capability? Are you engaged with cloud capability or local servers?
How have you interpreted the standards for interoperable data exchange, and the legislative and regulatory requirements, and are they consistent with everyone in your supply chain?
Have you coordinated with all of your trading partners and your CMOs?
What are your budgetary and schedule constraints? Do you have the resources available to implement your enterprise-wide program?
How will serialization impact your line efficiency, operations, and distribution?
Does your current label or carton artwork accommodate the area required for printing of serialized information?
What is your interpretation for an aggregation strategy – DSCSA does not require it for 2017, but will downstream trading partners interpret it differently and/or require it to manage their business processes and/or be in compliance?
How do you plan on handling rework/returns and exceptions? The answers to any or all of these questions could impact drug manufacturers’ ability to comply with the requirements and inhibit the shipping of products.
Aseptic Enclosures has the Expertise to Help
We can leverage our pharmaceutical system project management and integration experience along with our serialization experience to not only guide you through a successful implementation, but also to help drive down your overall implementation costs. We’ll handle your serialization implementation for your bottles, cartons, labeling, tracking codes, aggregation strategy and case packing applications. We provide complete turnkey integration services including:
Serialization Strategies and Master Implementation Plans
Vendor Analysis and Equipment Procurement
Installation and Contractor Management
Start-up, Checkout, and Validation