RxScan's DSCSA Solution
RxscanPI is an all in one DSCSA solution that simplifies complying with the DSCSA Title II regulations and at the same time increases your operational efficiency.
Why use a DSCSA solution?
- Decreases labor hours devoted to DSCSA by automating the storing of your serialized drug information.
- Simplifies your access to the DSCSA information by keeping all the data from your various suppliers in one centralized database, securely stored and easily accessible from anywhere.
- RxScanPI.com enables adding new suppliers / wholesalers at any time. No fear of losing access to your drug’s serialized information from an old supplier. Eliminates being supplier locked because of DSCSA’s 6 year minimum saving of the serialized information.
Our DSCSA solution is web based and meets all of the Title II 2023 and future requirements for:
- Storing the Transaction Information (TI), and Transaction Statement (TS) information for 6 years (possibly up to 12 years for a 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 each drug’s serial number level information (NDC number, lot number, expiration date and serial number) as defined by Title II.[Title II Section 582 (d)(1)(A)(iii)].
- Enables validating a drug package’s serialized information against the data file of serialized information your supplier has to make available to you for each prescription drug that falls under DSCSA [Title II Section 582 (d)(1)].
See our flyer RxScanPI DSCSA Flyer for a full list of our solution’s features and examples of questions a regulator (e.g., BPM, Board of Pharmacy, FDA) may ask you. Depending on the question you only have 1 or 2 business days to respond.
Features
- Automatically and electronically receives and stores your DSCSA information
- Automatically identifies incorrect quantity and missing DSCSA information
- Enables reporting on your DSCSA information by location, NDC, Lot #, Expiration date, Serial # and GTIN14
- Provides for transferring DSCSA information when medications are loaned or sold between unrelated pharmacies
- Quarantine information is electronically documented and stored Enables scanning the DSCSA 2D barcode to document the NDC, lot #, expiration date, serial number and GTIN-14 of the medications as they are received
- Serialized information is stored along with the item's PO number and invoice information. This makes returning an item simpler. An item can only be returned to the supplier of a particular serial number.
- There is an expiring product report based on the items you have received. This gives you a short list of expiring items to look for. After an item is checked for and found not to be in stock it can be marked so it doesn't show the next time the report is run.
Resource Center
T3 Rx DSCSA Compliance Data Sheet
RxScanPI DSCSA Flyer
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 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. 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.
- January 1, 2015: Dispensers must only trade with authorized trading partners
- January 1, 2015: Dispensers must provide transaction information to trading partners and regulators upon request
- January 1, 2015: Dispensers are required to quarantine and investigate suspect products
- January 1, 2015: Dispensers must identify and remove illegitimate products, and notify FDA and trading partners
- November 27, 2017: Track & Trace T3 information (transaction data, transaction history and transaction statement) must be available electronically
- November 27, 2018 Manufacturers and repackagers must serialize each drug with unique product identifier
- November 27, 2020: Dispensers are required to accept only serialized products
- November 27, 2020: Dispensers must verify unique product identifier of suspect products at package level
- November 27, 2023: Dispensers are required to participate in electronic package-level traceability system
Contact a Representative at 800-572-2648 x 1 or sales@rxscan.com for more information.
