Manufacturers must begin to comply with the Drug Supply Chain Security Act (DSCSA) serialization and verification requirements on November 27, 2017 (Compliance Date). Serialization and verification are intended to enable entities in the drug supply chain to exchange information about products at the package level. Product identifiers, including Standardized Numerical Identifiers (SNI), will enable repackagers, wholesale distributors, and dispensers to communicate with a manufacturer about a particular unit of product to ensure its authenticity.
The DSCSA and related guidance provide that SNI, including a National Drug Code (NDC) and serial number, lot number and expiration date must be affixed or imprinted on “each package and homogenous case of product intended to be introduced in a transaction into commerce.” The FDA previously released guidance on SNI in March 2010. Under the DSCSA, changes to product labeling to comply with serialization are “minor changes” that can be described in an annual report to the U.S. Food and Drug Administration as required under 21 C.F.R. 314.70(d).
Beginning on the Compliance Date, manufacturers must have systems in place to verify a product at the package level using the product identifiers required by the DSCSA. Manufacturers will be required to respond to requests for verification by authorized repackagers, wholesale distributors, or dispensers that are in possession or control of a product they believe to be manufactured by the manufacturer. In its response to a request for verification, a manufacturer must notify the requestor whether the product identifier “corresponds to the product identifier affixed or imprinted by the manufacturer.”
The DSCSA provides that a manufacturer may implement its verification process through a secure electronic database developed by the manufacturer or developed or operated by a third party. Manufacturers who utilize a such a database must still respond to requests for verification submitted through a means other than the database.
Non-compliance with the DSCSA serialization and verification requirements could result in a drug being considered misbranded, as well as individual imprisonment and fines. Further, the DSCSA specifically prohibits repackagers (beginning 11/27/2018), wholesalers (beginning 11/27/2019), and dispensers (beginning 11/27/2020) from purchasing drugs lacking a product identifier.
Manufacturers who are not already preparing for the Compliance Date should begin to revise their labeling and develop and implement a policy and process for responding to verification requests. The Compliance Date is the next of many for the DSCSA, which will not be fully implemented until 2024.