The U.S. Food and Drug Administration (FDA) says the goal of the DSCSA is “to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.”
The DSCSA “will enhance FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful” and “improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.”
Who has to comply?
Manufacturers, wholesalers, dispensers, repackagers, and third-party logistics providers (3PLs) must comply with DSCSA if they want to do business in the United States.
Key requirements
The FDA puts DSCSA requirements into four categories.
- Product identification (serialization). A unique product identifier (PI), such as a bar code, must be placed on certain prescription drug packages.
- Product tracing. Stakeholders must provide information about a drug and who handled it each time it is sold. This includes the following:
- Transaction information (TI) includes the product’s name; strength and dosage form; National Drug Code (NDC); container size and the 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 transaction statement (TS) is a paper or electronic attestation by the business transferring ownership of the product that it has complied with the DSCSA.
- Transaction history (TH) is an electronic statement with the TI for every transaction going back to the manufacturer. Note: TH will not be required after November 27th, 2023.
- Verification (VRS). Stakeholders must establish systems and processes to verify PIs for certain prescription drugs packages. The Verification Router Service (VRS) enables rapid, secure exchange of data to do this.
- Authorized trading partners (ATPs). If you’re not an ATP, your access to the U.S. pharma supply chain will be severely restricted or denied altogether. All manufacturers, wholesale distributors, repackagers, 3PLs, and dispensers, and their trading partners must be ATPs.
And those are the basics of the DSCSA. It’s one of the most important, comprehensive pieces of pharma legislation in the world.
