FDA Track and Trace Law - Pharmaceutical Supply Chain

FDA Track and Trace Law - Pharmaceutical Supply Chain

Aug 28, 2015

The FDA signed the Drug Supply Chain Security Act (DSCSA) into law on November 27, 2013.The purpose of this law is to establish a “track and trace” system to protect the U.S. drug supply against counterfeiting and other practices that would pose a threat to the safety of patients. Critical steps are outlined in the DSCSA to build an electronic, “interoperable” system by November 27, 2023 and improve detection and removal of potentially harmful products from the pharmaceutical distribution supply chain.


Under the DSCSA, every drug coming in and out of any entity in the supply chain (from the original manufacturer to the end distributor), will need to be tracked, so that in the event of a problem, it’s path can be traced.

The law had two immediate deadlines. As of January 1, 2015, dispensers, or pharmacies, are required to establish a system for verification and handling of suspect or illegitimate product. Part of this verification requirement includes quarantine and investigation of the suspect product and notification to the FDA and any trading partners, if the product was found to be illegitimate. Another requirement is that the pharmacies are required to develop their own standard operating procedures, outlining what steps pharmacy employees should take when receiving drug orders. The dispensers are also required to to confirm that the manufacturers, repackagers, wholesale distributors, and other dispensers (known as trading partners), are authorized, as defined by the Food, Drug & Cosmetic Act.

According to the law, as of July 1, 2015, dispensers were required to comply with the new regulations. Compliance with the regulations means maintaining what is known as the 3Ts. The 3T documentation is comprised of Transaction Information (TI), Transaction History (TH), and Transaction Statement (TS).These records must be maintained for 6 years.

TI should include the name of the product, strength and dose of the product, National Drug Code, container size, and the name and address of seller and purchaser.

TH is a paper or electronic statement that includes the transaction information for each prior transaction going back to the manufacturer of the product.

TS is a paper or electronic statement by the entity transferring ownership of the product stating that it is authorized by the DSCSA, that the product was received from an authorized party, and other information specified by the DSCSA.


As of the July 1, 2015 date, pharmacies must maintain the entire chain of custody information, both incoming in and outgoing, to enable tracing of all products.They will not be able to accept products from any manufacturer, or trading partner, without the 3Ts.

This is a big undertaking for pharmacies, and as a result of a group letter asking the FDA to extend the deadline for the DSCSA compliance to “forestall potential disruptions in the pharmaceutical supply chain”, the FDA is now giving suppliers a little leeway in complying with the requirements. While the statutory date is still July 1, 2015, the FDA is giving drug dispensers until November 1, 2015, to comply with the requirements.

One of the known issues is that the new “track-and-trace” law will generate a tremendous amount of data. To help with this issue, The FDA will allow paper transactions at the beginning, but eventually the paper trail will be phased out and digital storage of the data will be required. This will cause a huge increase in network/IT resources for hospitals/pharmacies. An alternative will be to look towards secure cloud-based storage.

E-Control Systems can help in automating these new requirements. We have complete hosted solutions in the cloud for health care facilities, labs, and pharmacies. Our cloud-based storage helps you store your critical data securely. Data is stored in our secure private cloud with server redundancy and automated system backups, making sure that your valuable data is never lost. Besides not ever having to worry about losing data due to a system failure, with our secure cloud, your IT resources are not impacted.

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