FDA to Exercise Enforcement Discretion for DSCSA
The FDA has published updated industry guidance for implementation of the Drug Supply Chain Security Act.
This guidance “DSCSA Implementation: Product Tracing Requirements – Compliance Policy Guidance for Industry”, describes the FDA’s intent for enforcement of the Product Tracing requirements of DSCSA
The FDA does not intend to take action against trading partners who do not, prior to May 1, 2015, provide or capture the TH, TI, TS as required by DSCSA. Thus the FDA is using its enforcement discretion in determining non-compliance with January 1, 2015, date for DSCSA. NOTE: This is not a change in the law or the dates of compliance.
DSCSA requires that manufacturers, wholesale distributors, and repackagers meet Product Tracing and Verification regulations starting on Jan. 1, 2015. The Product Tracing regulations mandate that companies performing these operations provide or receive a Transaction History, Transaction Information and Transaction Statement for each change of ownership of pharmaceutical drug products. The Verification regulations mandate that these companies investigate, quarantine and notify appropriate parties about the existence of suspect or illegitimate drug products in the supply chain.
The FDA has discretion on whether or not to enforce DSCSA regulations. In the last month, the FDA has received feedback from members of the pharmaceutical supply chain that although they have been working incredibly hard to meet the Jan. 2015 deadlines, not all drug products across all transactions will be in compliance. DSCSA has many complex requirements impacting business operations, supply chain transactions and IT systems.
Given this industry feedback, the FDA recognized that more time was needed to ensure 100% compliance with DSCSA requirements and minimize potential supply disruptions.
The FDA also commented that other provisions of the DSCSA regulations are still subject to enforcement such as the Verification and authorized trading partner requirements of the law.