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A guidance document published just before the Jan. 1, 2015 deadline adds a four-month grace period.
Indicating that the pharmaceutical-distribution supply chain is not ready to comply with product tracing provisions in the Food, Drug, and Cosmetic Act of 2013 (FD&C) scheduled to take effect on Jan. 1, 2015, FDA issued a new guidance document that delays enforcement of the regulations for trading partners.
In the guidance DSCSA (Drug Supply Chain Security Act) Implementation: Product Tracing Requirements Compliance Policy, FDA announced that the agency does not intend to take action against manufacturers, wholesale distributors, and repackagers who do not, prior to May 1, 2015, provide or capture the transaction information, history, and statement associated with finished prescription drugs, as required by FD&C.
According to the FDA guidance, “some trading partners have expressed concern that unforeseen complications with the exchange of the required information may result in disruptions in the supply chain, and ultimately could impact patients’ access to needed prescription drugs. FDA recognizes that some manufacturers, wholesale distributors, and repackagers may need additional time beyond January 1, 2015, to work with trading partners to ensure that all of the product tracing information required under section 582 of the FD&C Act is provided to and captured by the recipient trading partner. 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.”
The compliance policy is limited to the requirements that trading partners provide and capture product tracing information and not extend to other requirements in section 582 of the FD&C Act. FDA notes that guidances describe the agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
DSCSA outlines steps to build an electronic, interoperable system by Nov. 27, 2023, to identify and trace certain prescription drugs distributed within the United States. FDA published a draft guidance entitled DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information (November 2014), which established initial standards for the interoperable exchange of the product tracing information related to each transaction of certain human, finished, prescription drugs covered by the statute, in paper or electronic format, through the extension and/or use of current systems and processes.
Some have complained that FDA's DSCSA-related guidance documents so far have been 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."