Track and Trace – The Drug Supply Chain Security Act
What is the Drug Supply Chain Security Act?
On November 27, 2013 President Barak Obama signed The Drug Quality and Security Act (DQSA), which changed the regulations on tracking prescription medications under Title II – the Drug Supply Chain Security Act (DSCSA). The purpose of the DSCSA is to establish a nationwide drug track and trace system that would potentially eliminate counterfeit or illegitimate medications to enter the market.
According to the Regulator Affairs Professional Society, 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 route to be traced by federal regulators in the event of a problem. This includes manufacturers, repackagers, wholesale distributers, and dispensers. The FDA states that ten years after enactment, the system will facilitate the exchange of information at the individual package level about where a drug has been in the supply chain. The new system will enable verification of the legitimacy of the medication identifier down to the package level (lot number); enhance detection and notification of illegitimate products in the drug supply chain; and facilitate more efficient recalls of drug products.
As of January 1, 2015 all manufacturers, repackagers, and wholesale distributors are required to track drug products as they move through the supply chain and become authorized trading partners. This will apply to all pharmacies starting on July 1, 2015.
Dispenser Deadline – July 1, 2015
In order for pharmacies to comply with the new regulation they must capture what has come to be known as the 3T documentation; transaction information (TI), transaction history (TH), and a transaction statement (TS) then maintain these records for 6 years. The following should be included in the TI:
- The proprietary or established name or names of the product
- The strength and dosage of the product
- The National Drug Code (NDC) of the product
- The container size
- The lot number of the product
- The date of the transaction
- The date of shipment, if more than 24 hours after the date of the transaction
- The business name and address of the person from whom ownership is being transferred, and
- The business name and address of the person whom ownership is being transferred
TH refers to a statement in paper or electronic form, including the transaction information for each prior transaction going back to the manufacturer of the product. TS is a statement, in paper or electronic form, that the entity transferring ownership in a transaction:
- Is authorized as required under the DSCSA
- Received the product from a person that is authorized as required under the DSCSA
- Received transaction information and a transaction statement from the prior owner of the product
- Did not knowingly ship a suspect or illegitimate product
- Had systems and processes in place to comply with verification requirements
- Did not knowingly provide false transaction history, and
- Did not knowingly alter transaction history
Beginning on July 1, pharmacies will not be able to accept any product from any manufacturer or trading partner unless it is accompanied by these 3Ts. According to the document, trading partners can use current paper-based or electronic-based methods for the interoperable exchange of data. The following payer 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. Pharmacies can contract with their wholesalers to maintain these records electronically as long as they are able to access and retrieve the data at anytime, as well as other required entities. However, according to Cohen, in November 2017, manufacturers will be required to provide the 3Ts electronically and, at the end of the 10 year period, all trading partners must apply a uniform system of “serialized” drug product information that will allow for quick tracing of drug products in the supply chain.
If your pharmacy does not have systems in place to ensure compliance to the new regulation you should consider taking the steps to guarantee appropriate policies and procedures are implemented, as well as train your staff on the new system.
Pharm.D. Candidate 2016
UMKC – School of Pharmacy
- Cohen, Jordan and Hawana, J. “Is Your Pharmacy Ready for Drug Supply Chain Integrity? | Health Law & Policy Matters.” Health Law Policy Matters. Mintz Levin, 13 May 2015. Web. 11 June 2015.
- “FDA Issues Guidance for Track-and-Trace of Pharmaceuticals, Two Important Takeaways for 3PLs by Jan. 1.” Iwla1891. 03 Dec. 2014. Web. 10 June 2015.
- Gafney, Alexander, RAC. “With Weeks Until Drug Track and Trace System Launches, FDA Issues New Guidance.” Regulatory Affairs Professional Society. 9 Dec. 2014. Web. 10 June 2015.
- “U.S. Food and Drug Administration.” Drug Supply Chain Security Act (DSCSA). FDA, 1 Apr. 2015. Web. 10 June 2015.
- “U.S. Food and Drug Administration.” Title II of the Drug Quality and Security Act. FDA, 16 Dec. 2014. Web. 10 June 2015.