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A guidance document published just before the Jan. 1, 2015 deadline adds a four-month grace period.
FDA published a guidance for industry, DSCSA Implementation: Product Tracing Requirements-Compliance Policy, the agency announced just days before it was to begin enforcing compliance with Drug Supply Chain Security Act (DSCSA) on Jan. 1, 2015. The latest guidance says that FDA does not intend to enforce the requirements for providing or capturing transaction information, transaction history, and transaction statements each time a product changes hands until May 1, 2015.
FDA stated in the notification, "Some trading partners have expressed concern that unforeseen complications with the exchange of the required information may result in disruptions in the pharmaceutical supply chain, and ultimately could impact patients' access to needed prescription drugs. FDA recognizes that some manufacturers, wholesale distributors, and repackagers may need time beyond January 1, 2015, to work with trading partners to ensure that all the proper product tracing information is provided and captured. To minimize possible disruptions in the distribution of prescription drugs in the United States, FDA does not intend to take action against trading partners who do not, prior to May 1, 2015, provide or capture the product tracing information required by section 582(b)(1), (c)(1), and (e)(1) of the FD&C Act. This compliance policy is limited to the requirements that trading partners provide and capture product tracing information; it does not extend to other requirements in section 582 of the FD&C Act, such as verification of suspect and illegitimate products (including quarantine, investigation, notification, and recordkeeping) or the requirement to engage only in transactions with authorized trading partners."
The delay comes after FDA released DSCSA-related guidance documents in 2014 in anticipation of implementation, such as a Q&A published in October 2014. Some have complained that the documents were limited and failed to answer the questions presented by industry. Companies have been moving forward with implementation, however.
"In 2014, we helped 25 separate life-sciences manufacturers, seven large distributors, and one of the largest third-party logistics (3PL) companies to comply with the DSCSA requirements for 2015," says Bill Fletcher, managing partner at Pharma Logic Solutions. "All are in full compliance and most completed their updates for compliance before Nov. 1, 2014."
"The legal and regulatory groups at several of my separate clients have instructed staff that the failure to enforce does not change the legal requirement to comply with the law," adds Fletcher. "Several have stated the same will apply for the Nov. 27, 2017 requirements for serialization, even if FDA bypasses congressional oversight and does not enforce the law in 2017."