With Weeks Until Drug Track and Trace System Launches, FDA Issues New Guidance

Posted 09 December 2014 By Alexander Gaffney, RAC


With just weeks left until new tracking standards come into effect, the US Food and Drug Administration (FDA) is releasing new recommendations it hopes will better secure the pharmaceutical supply chain from accidents and counterfeiters alike.


In 2013, Congress passed and President Barack Obama signed into law the Drug Quality and Security Act (DQSA). While the law is perhaps better known for its extensive pharmaceutical compounding reform provisions, it also contains another major component formally known as the Drug Supply Chain Security Act (DSCSA).

The core of the DSCSA is meant to establish a nationwide pharmaceutical track and trace system that deters drug counterfeiting. Drug packages would be required to carry a serial number as part of a lot-level tracking system within four years of the law's implementation, with a package-level tracing system coming six years after that.

One of the key components to the track and trace system is its traceability provisions. Each entity in the supply chain, from the original manufacturer to the end distributor, is supposed to keep track of the product coming into and out of its possession, allowing its path to be traced by federal regulators in the event of a problem. FDA could, for example, determine the point at which a counterfeit product entered into a legitimate supply chain, making it easier to bring a company into compliance or track down a counterfeiter.

With just weeks to go before its 1 January 2015 launch date, the system has been seen by some as lacking key details. To date, FDA has released a handful of guidance documents on how the system will work in practice. In February 2014 the agency called for comments on which interoperable  data standards companies should use to record transaction information. In June 2014, the agency released a  new draft guidance intended to explain how to identify and notify FDA of suspect products. In October 2014, FDA released a draft guidance on the "Uniform National Policy" confirming that FDA's track and trace efforts will preclude other state-led efforts.

New GuidanceDocuments

This month, however, FDA has unveiled two new draft guidance documents intended to clarify much more substantial aspects of the track and trace system established by the DSCSA.

DSCSA Standards for the InteroperableExchange of Information for Tracing of Certain Human, Finished, PrescriptionDrugs: How to Exchange Product Tracing Information, released by FDA on 28 November 2014, is meant to address what is in some ways the core of the DSCSA: How information is exchanged between entities within the pharmaceutical supply chain.

Starting 1 January 2015, trading partners--manufacturers, wholesale distributors, dispensers, and repackagers –must provide "the subsequent purchaser with product tracing information for certain prescription drugs," FDA explains in its guidance. That information must then be captured and maintained for at least 6 years.

Products included under the guidance are finished prescription drugs intended for human consumption—not veterinary products, unfinished human pharmaceuticals, blood or blood components intended for transfusion, radioactive drugs, imaging drugs, intravenous products, medical gases, homeopathic drugs, compounded pharmaceuticals or over-the-counter (OTC) drugs.

When it comes to the exchange of information, FDA says the most important concept to remember is "interoperability."

"In order for any system, process, or practice to be interoperable, the subsequent purchaser must be able to successfully capture and maintain the product tracing information, regardless of whether the information is provided in a paper or electronic format," FDA explained.

Currently, trading partners can use either paper- or electronic-based product tracing systems. Acceptable information might include invoices, packing slips, shipping notices or information about the movement of products throughout the supply chain. Information can also be transmitted over email and the web "as long as the information is captured, maintained and provided in compliance with Section 582" of the Federal Food, Drug and Cosmetic Act, FDA said.

Second Guidance:Reporting

FDA's second guidance document, DSCSA Implementation: Annual Reporting byPrescription Drug Wholesale Distributors and Third-Party Logistics Providers, was released on 8 December 2014 and explains how wholesalers and third-party logistics providers (3PLs) should report DSCSAinformation to FDA on an annual basis.

The DSCSA requires wholesalers and 3PLs to report state licensure information, the name and address of each facility, contact information for each facility, and whether the company is subject to state or federal disciplinary actions. The exact information that must be transmitted to FDA is explained in detail within the guidance document.

FDA said it also wants to be provided with a "unique facility identifier" (DUNS) for each facility, as well as the date each facility's state license expires.

Reports are due by 31 March of each year, and should be submitted using the Structured Product Labeling (SPL) format at http://www.fda.gov/wdd3plreporting.


DSCSA Implementation: Annual Reporting byPrescription Drug Wholesale Distributors and Third-Party Logistics Providers (FR)

DSCSA Standards for the InteroperableExchange of Information for Tracing of Certain Human, Finished, PrescriptionDrugs: How to Exchange Product Tracing Information (FR)

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Categories: Biologics and biotechnology, Prescription drugs, Generic drugs, Compliance, Distribution, News, US, CDER

Tags: DSCSA, Drug Quality and Security Act, Drug Supply Chain Security Act, Guidance, Draft Guidance, Supply Chain

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