FDA recently released its first draft guidance document as part of the implementation of the Drug Supply Chain Security Act (DSCSA). Signed into law in November 2013 as Title II of the Drug Quality and Security Act, the DSCSA outlines a 10-year plan to establish a standard electronic, interoperable track and trace system for prescription drugs. The law is significant in that it creates a national, uniform system for tracking prescription drugs, as opposed to the varying requirements that have been implemented over the years by some states. Companies can expect greater regulatory oversight and additional documentation requirements as FDA issues implementing regulations and guidance.
Key provisions to be implemented include requirements for product identification, tracing and verification; suspect drug detection and response; notification of illegitimate drugs; wholesaler licensing, and third-party logistics provider licensing. In addition to other requirements, the statute requires the Food and Drug Administration (FDA) to develop standards, issue guidance documents, implement pilot programs, and conduct public meetings as part of implementation efforts. FDA’s website provides a detailed implementation plan, including estimated target dates for each deliverable.
The draft guidance aims to assist trading partners (defined, for purposes of the guidance, as manufacturers, repackagers, wholesale distributors, or dispensers) in identifying a “suspect product” and outlines the process for terminating notifications to the agency regarding “illegitimate product.” Each topic is discussed in further detail below.
To review the entire document and formatting for this alert (e.g., footnotes), please access the original below: