A web based solution that meets the Title II requirements for:
- Storing the Transaction History (TH), Transaction Information (TI), and Transaction Statement (TS) information for 6 years (12 years for suspect product). [Title II Section 582 (d)(1)(A)
(iii) & (d)(1)(D)(4)(iv)].
- Replying to an FDA information request within 2 business days. [Title II Section 582 (d)(1)(D)].
- Storing lot level information (NDC number, lot number, expiration date and serial number) as defined by Tittle II.[Title II Section 582 (d)(1)(A)(iii)].
- Verifying the T3 information against what was received [Title II Section 582 (d)(1)].
- Item quarantine processing and documentation [Title II Section 582 (d)(1)(D)(4)(A)].
- Automatically and electronically receives and stores your T3 information.
- Automatically identifies incorrect quantity and missing T3 information.
- Enables reporting on your T3 information by location, NDC, Lot #, Expiration date and Serial #.
- Provides for transferring T3 information between unrelated pharmacies.
- Quarantine information is electronically documented.
- Enables scanning the DSCSA 2D barcode to document the lot #, expiration date, GTIN-14 and serial number of the medications received with your T3 information.
- Reports on the expiration dates of items you have received. This gives you a short list of expiring items to look for.
More about The Drug Supply Chain Security Act (DSCSA)
The Drug Supply Chain Security Act (DSCSA), outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. Its goal is to enable complete tracking of a product from the manufacturer to the dispenser. Information about each previous owner of a product must be forwarded to the new owner and this continues all the way to the dispenser.
It was signed into law on November 27, 2013. The official wording for DSCSA is at: http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/ucm376829.htm
It is Title II of the Drug Quality and Security Act (DQSA). The DQSA is a set of federal prescription medication safety regulations made to primarily address the issue of counterfeit and illegitimate medications. Also in response to compounded medications such as what caused the New England Compounding Center (NECC) meningitis tragedy.
Implementation of DSCSA is a 10 year process. As part of this manufactures are required to place a 2D barcoded product identifier on the product. The DSCSA regulations require that manufacturers place a serial number on each package by November 27, 2017.
By November 2017 all of the Track & Trace information (transaction data, transaction history and transaction statement) must be available electronically.
It will eventually lead to a better drug recall process because the location of each lot and serial number of a drug will be known. Who owned a product throughout its lifespan will be known.
New parts of the regulations roll out every year until 2023.