The first two parts talked about DSCSA authorized trading partners β manufacturers, wholesale distributors, repackagers, third-party logistics providers, and dispensers. So, in a little more than 2 years and 8 months from now, the U. For its part, the pharma industry has tended to see the DSCSA as having four pillars, as illustrated below.
To date, the DSCSA has focused on lot-level traceability, or exchanging information about every package of medication so supply chain stakeholders can see exactly where each has been. DSCSA is all about complete unit-level serialization through the use of product identifiers, meaning stakeholders will have to electronically track products at the individual package level.
TI includes the product name; its strength and dosage form; its National Drug Code; container size and number of containers; lot number; transaction date; shipment date; and the name and address of the businesses from which and to which ownership is being transferred. The upshot of this requirement is unit-level traceability i. PIs must be human- and machine-readable. Suspect and illegitimate products include drugs that may be counterfeit, diverted, stolen, intentionally adulterated, or unfit for distribution.
This requirement is similar to No. The law says these systems and processes. Here a few of our resources to answer any questions you may have:. From our rfxcel Serialization Processing and Compliance Management solutions to the full-scale power of our rfxcel Traceability System , we ensure compliance no matter your role in the supply chain. DSCSA six key requirements To date, the DSCSA has focused on lot-level traceability, or exchanging information about every package of medication so supply chain stakeholders can see exactly where each has been.
Here are the six requirements for DSCSA laid out in Section g 1 : Authorized trading partners must exchange transaction information TI and a transaction statement TS in a secure, interoperable, electronic manner. Trading partners must maintain all transaction data for 6 years. TI must include the product identifier PI at the package level for each package included in the transaction. Authorized trading partners must have systems and processes to verify products at the package level, including the SNI.
