In November 2013 the President of the United States signed a bill called H.R. 3204 into law. This was the culmination of a decade of state and regulatory agency negotiations to tackle the disparity in interstate drug traceability. Going forward, the responsibility falls under the purview of the federal government. At the base, this guidance represents a major step forward for the U.S. drug industry to thwart counterfeiting and drug diversion activity, and to promote safety in a modern way.
H.R. 3204 modifies the Federal Food, Drug, and Cosmetic Act (FFDCA) and consists of two parts:
Title I gives the power back to the FDA to inspect sterile compounders; Title II is known as Drug Supply Chain Security and sets out the requirements, more commonly known as the Drug Quality Security Act (DQSA). As such, the DQSA addresses many of the problems inherent in managing the chain of custody, and lays out a plan for implementing track and trace solutions across multiple states. The DQSA is a phased implementation for manufacturers, wholesalers, dispensers, and re-packagers, and it involves a high degree of accountability. Beginning January 1, 2015, all drug manufacturers will be required to capture and provide transaction history, a transaction statement, and transaction information, including the lot number, for all products. Not only will the downstream processors—as cited above—be required to embargo products that do not comply with the DQSA requirements, they will have to create systems to capture this information for every shipment. In fact, they will be required to pass certain information and representations about pharmaceutical transactions whenever there is a change of ownership, all along the supply chain. Once products are serialized, manufacturers, re-packagers, and wholesale distributors must be able to respond to requests for verification at the unit level in circumstances pertaining to suspect and illegitimate product, and for saleable returns.
Because HR3204 was signed into law and is not FDA guidance, industry does not have the luxury of slowly implementing it. Things must happen quickly. For example, the big three wholesalers – Cardinal, McKesson, and AmerisourceBergen – issued their “Dear Valued Manufacturer/Supplier” letter mandating compliance with the guidelines in November 2014, and have threatened to embargo any customers that either do not comply or who do so inconsistently.
Serialization as a foundation for drug security is not new or unique to the U.S. More than 70 countries around the world have active or planned legislation to incorporate it as part of a track and trace strategy. Major markets such as China already require serialization of the drugs on their 2009/2012 Essential Drugs List. By 2015, all drugs in the Chinese markets will have to be serialized.
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One thing is for sure – it is reasonable to expect more disruption to the drug supply chain as the industry moves to standardize and implement these new requirements. While the DQSA defines a plan for implementing a national, unified track and trace system, the ultimate goal is to create a fully interoperable system that covers every step in the physical supply chain. While these objectives seem intuitive, the devil is once again in the details.
DQSA implementation: Strategy and challenges
Creating a compliance strategy capable of evolving with the escalating requirements of the DQSA means establishing a clear plan for both the organizational and information management elements of the supply chain.
- Define a global network strategy: Building an interoperable database means integration of potentially hundreds of different supply chain partners into a cohesive enterprise solution accessible by all participants. Identifying all the pieces of information required as inputs and outputs that must be reported to government agencies is the first step.
- Big data: The challenge with a fully executed DQSA network is the management of large amounts of data, in specific information architectures. Classifying data according to analysis type (real time or batch), processing methodology, data frequency, data type, content format, data source, data consumers, and hardware will help. Many of these factors can be captured in a master data plan as part of an overall data strategy.
- Regulations and standards: A lack of unity across potential commercial markets is a very real challenge. The ability to adapt and address evolving country-specific serialization standards and reporting requirements is an essential element of a viable DQSA strategy.
- Business value: In reality, no architecture is perfect and there are bound to be compromises based upon evolving market requirements and integration capability across suppliers. Utilizing risk assessment tools to understand where the maximum value can be derived will be important in prioritizing activities within the implementation plan.
The advent of the DQSA heralds a dramatic escalation in IT infrastructure and data integration over the next five to seven years. Compliance will require a focused effort and significant investment in identifying the data generation, capture, transmission, and reporting elements across all marketplaces. It is not a side project.
• H.R. 3204. http://www.gpo.gov/fdsys/pkg/BILLS-113hr3204enr/pdf/BILLS-113hr3204enr.pdf
• FDA Guidance for Industry: Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages
Bikash Chatterjee, President and CTO, Pharmatech Associates, has been involved in the biopharmaceutical, pharmaceutical, medical device, and diagnostics industry for over 30 years. His expertise includes site selection, project management, design, and validation of facilities for U.S. and European regulatory requirements.
This article appeared in the January/February 2015 issue of Controlled Environments.