Under the Drug Supply Chain Security Act (DSCSA), the T3 data for most medicines must be exchanged at change of ownership. The T3 data requirements includes the sending the Transaction history (TH), the Transaction information (TI), and the Transaction statement (TS).
Transaction History is a statement that details all information on all transactions for a product starting with the manufacturer. It is required until the final November 27, 2023, deadline.
Transaction Information includes the established name or names of the product, the strength and dosage form of the product, the national drug codes, the container, the number of containers, the lot number of the product, the date of the transaction, the date of the shipment. If more than 24 hours after the date of the transaction, the business names and address of the person from whom ownership is being transferred, and the business name and address of the person to whom ownership is being transferred.
Transaction Statement is a statement, in paper or electronic format, that states the partner is authorized to transfer ownership, received the product from an authorized entity, received the TI and TS from the prior owner of the product, did not knowingly ship a suspect or counterfeit product, had systems and processes in place to comply with verification requirements, did not knowingly provide false TI, and did not knowingly alter the TH.
What do the T3 data requirements mean for me?
Manufacturers need to start the T3 data requirements process by providing all necessary information to the new owner in a electronic format. Wholesale distributors, repackagers, and even dispensers selling products to other dispensers without the medication going to a distinct patient, must continue to produce and transfer this T3 information as they exchange ownership. At the same time, wholesale distributors, repackagers, and dispensers cannot accept ownership of a product unless they are provided with associated T3 data. The T3 data requirements mandate all parties who have ownership of a product need to keep that product’s T3 data for 6 years.
For any member of the supply chain, if a product is thought suspect, or is found to be counterfeit, the product needs to be quarantined and investigated. The product’s ownership cannot be exchanged during the time that it is quarantined or investigated. If an FDA official requests information in relation to any drug recall, the member of the supply chain needs to be able to produce the T3 data, and in most circumstances, give it to the official within 48 hours.
Dispensers have separate regulations. Dispensers are currently required to accept and maintain transactional data for 6 years. By 2020 the DSCSA will require dispensers to verify the product identifier printed on at least 3 units or 10% of all units (whichever one is bigger), and match them to the recorded T3 data – if there are less than 3 packages, then all must be checked. By November 27, 2023, all pharmacies must have an electronic, interoperable system in place trace products at the package level.
Dispensers may enter into agreements with 3rd parties, where the 3rd party would store all T3 data. However, the dispenser is still responsible for producing all T3 data if a regulatory body makes a request. Relying on another partner, whose system is out of the dispenser’s control, may not be ideal. Many of these agreements only cover the products that 3rd party interacts with, requiring the dispenser to still track all T3 data for items that it received directly from a manufacturer or secondary wholesaler. Also, in 2020 dispensers will be required to check lot numbers regardless.
How rfxcel can help
rfxcel has been a leading traceability provider since 2003. Our expertise helps hundreds of customers achieve full regulatory compliance with the DSCSA. Our traceability system allows seamless integration with partner systems and provides no delays to your day-to-day business operations.
With DSCSA looming around the corner it is important to find a solutions provider who focuses on data integrity and flexibility. rfxcel’s system provides over a hundred data checks to ensure that there is no garbage data going in or going out, and with thousands of T3 data reports being created every day, ensuring that data is correct is top priority.
To learn more about the DSCSA, and how rfxcel can help you achieve compliance, click here.