This is Why Humans Don't Like Lawyers: In February 2014, the Food and Drug Administration (FDA) opened a docket entitled "FDA's Standards for the Interoperable Exchange of TI, TH and TS Information for Tracing of Human Finished, Prescription Drugs." Translation: "help the FDA come up with a system to trace all drug products and their component parts."
FDA's docket sought comments to further its efforts to implement the Drug Supply Chain Security Act (DSCSA), which was signed into law on November 27, 2013. The new law provides for building an electronic "interoperable" system to identify and trace certain prescription drugs as they are distributed in the United States. An "interoperable" system, is where all participants "in the drug supply chain will be able to communicate with each other and share information about the drug and its location." See FDA Blog.
The new law requires the creation and implementation of a drug tracking information system within 10 years. When fully implemented, the new system will allow for tracking specific packages of drugs in the supply chain. The FDA's goal with this new system is to improve its ability to detect and recall illegitimate products. Under the new law, manufacturers, wholesale distributors, repackagers, and pharmacies are required to maintain product tracing data, and to quarantine and investigate suspect or illegitimate drug products, including suspected counterfeits, unapproved drugs, or dangerous goods, such as a recalled drug products.
The interoperable system will require each participant in the drug supply and distribution system to exchange transaction information ("TI"), transaction history ("TH") and transaction statements ("TS").
The deadline for comments to the FDA was April 21, 2014, and a number of stakeholders responded providing a glimpse into what systems are in place today and the hurdles the DSCSA implementation faces. For example, according to the Pharmaceutical Distribution Security Alliance (PDSA):
No one in the supply chain currently exchanges transaction history or the transaction statement required by DSCSA. While manufacturers include much of what the Act requires there is work to be done to correlate the various fields of data and wholesalers rarely and dispensers rarely have lot numbers and are not equipped to include this information.
The comments further note that there is "variable 'interoperability'" in processes (i.e., not all participants in the supply chain are ready for the new law), including processes related to Advance Ship Notices, Database/Portal input, Drug Pedigree Messaging Standard, Electronic Invoices, Electronic Product Code Information Service, and Paper invoices and packing slips.
Pharmacies and wholesalers present a unique challenge, and will be required to make changes to modify systems and practices to support the exchange and maintenance of the transaction information, history and statements including lot level information. The National Association of Chain Drug Stores submitted comments on behalf of its members stating:
Chain pharmacies would like to move to an electronic format for conveying TI, TH, and TS by 2017-2018, or earlier if feasible. However, we recognize that not all pharmacies will be ready to do so in this time frame. In addition, pharmacies would need adequate time to adapt and to make needed changes to their internal computer systems and to work with their trading partners for testing and to assure workability between the systems.
While the DSCSA looks for implementation in January 2015, estimating the timeframe necessary to implement these system-wide changes is difficult to forecast, even for individual participants in the supply chain. Based on the following comments of the PDSA, in the near term, a uniform standard for exchanging information is not feasible:
No solution, even paper, is today capable of accommodating all of the information required as of Jan. 1, 2015. Many in the supply chain are estimating that it will take at least six months to implement the standards, and a majority has indicated that they are waiting on FDA guidance before finalizing their companies' proposed solutions. Given the importance of FDA guidance to stakeholders' ability to comply with the law, stakeholders respectfully ask FDA to release its final guidance in advance of the statutory deadline, understanding that building consensus across stakeholders to reach an interoperable solution that can be implemented in a reasonable timeframe is the foremost goal.
FDA's own timetable for implementation of the DSCSA, including issuance of a draft guidance by mid-2014, seems doubtful; but as new technologies and approaches develop and evolve, the goal of system wide transparency will eventually be achieved. For now, the timing set forth in DSCSA appears more aspirational than possible.
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