FDA Asks for Input on Development of Electronic Drug Track and Trace System
The Food and Drug Administration is asking for input by April 21 on the standards it should use to develop the electronic track and trace system for drug products required by the Drug Supply Chain Security Act. The November 2013 law requires an electronic interface track and trace interface between FDA and drug manufacturers, wholesalers, repackagers, and dispensers (including pharmacies) that would allow for the electronic exchange of product and transaction information to enable verification of the legitimacy of drug products and improved efficiency of recalls (see 13121725).
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According to FDA, the Drug Supply Chain Security Act requires the electronic track and trade interface include the exchange of transaction information, transaction history, and a transaction statement. “Transaction information” means (1) the name of the product; (2) the strength and dosage form of the product; (3) the National Drug Code number of the product; (4) the container size; (5) the number of containers; (6) the lot number of the product; (7) the date of the transaction; (8) the date of shipment, if more than 24 hours after the date of transaction; (9) the business name and address of the person from whom ownership in being transferred; and (10) the business name and address of the person to whom ownership is being transferred. “Transaction history” means a statement in paper or electronic form, including the transaction information for each prior transaction going back to the manufacturer of the product. The “transaction statement” is a statement, in paper or electronic form, that the entity transferring ownership in a transaction meets certain requirements under the new law.
FDA is seeking comments by April 21 from drug supply chain stakeholders on current data exchange practices and ideas for transferring this transaction data between drug supply chain members and the FDA. It is also asking for input on the feasibility of establishing standardized documentation to be used by members of the drug supply chain to convey the transaction information, history, and statement to the subsequent purchaser of a product and to facilitate the exchange of lot level data.
(Federal Register 02/20/14)