Enforcement Discretion on Rx Drug Packaging Until 11/2018

FDA has issued a draft guidance on Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy. The document tells manufacturers and other supply chain stakeholders that although manufacturers are to begin including a product identifier on prescription drug packages and cases 11/27, the agency is delaying enforcement until 11/26/2018 to provide additional time and avoid supply disruptions. Product identifiers allow trading partners to trace drug packages as they move through the supply chain. They include the product’s lot number, expiration date, national drug code, and a serial number. The serial number is different for each package or case. This creates a unique identifier – human and machine readable – to enable product tracing throughout the supply chain and enable all trading partners to better detect illegitimate products within the supply chain. While manufacturers work to meet product identifier requirements, they must comply with other Drug Supply Chain Security Act requirements.