Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy.
The Drug Supply Chain Security Act (DSCSA) was signed into law on November 27, 2013. Section 202 of the DSCSA added section 582 to the FD&C Act, which established product tracing, product identifier, and verification requirements for manufacturers, repackagers, wholesale distributors, and dispensers to facilitate the tracing of a product through the pharmaceutical distribution supply chain; requires that each package and homogenous case of product in the pharmaceutical distribution supply chain bear a product identifier in both a human-readable form and on a machine-readable data carrier; and requires that the product identifier include the product’s standardized numerical identifier, lot number, and expiration date. The requirements set forth in the applicable section of the FD&C Act are in effect as of November 27, 2017. However, the FDA recognizes that some manufacturers may need additional time beyond November 27, 2017, to ensure that products are properly labeled with a product identifier. To minimize possible disruptions in the distribution of prescription drugs in the United States, FDA has adopted the compliance policy set forth in this draft guidance.Download Summary