The Drug Supply Chain Security Act – Are Your Operations Ready for Final Implementation?

As the Food and Drug Administration (FDA) enters the final year of its 10-year implementation period for the Drug Supply Chain Security Act (DSCSA), the time is ripe to check corporate compliance, operating procedures, and recent experience with the detailed requirements of this wide-reaching act. 

This month’s roundtable will address requirements currently in place and those to be implemented by November 2023.  It also will consider ways in which DSCSA requirements and its new collections of information might be used in activities including recalls, corporate transactions and product risk management.

Topics for discussion include:

 – The scope of requirements and implementation dates—past, present and upcoming—for product serialization, transaction information delivery, verification, investigation of “suspect” or “illegitimate” products, and facility licensure;

 – How DSCSA impacts actors at multiple levels in the healthcare system, including manufacturers, repackagers, distributors, pharmacies and healthcare providers;

 – Newly-published FDA guidance to establish the standard for “interoperable” electronic data exchange among trading partners;

 – The current opportunity to comment on FDA’s proposed regulations establishing facility licensing standards and expectations for national uniformity; and

 – How compliance with DSCSA might be considered in other areas of law, such as corporate due diligence, False Claims Act compliance and product liability defense

For questions, contact Chayako Williams at cbwilliams@kslaw.com.

CLE

King & Spalding is an accredited provider of CLE credit in California, Georgia, Illinois, New York and Texas. We can issue reciprocal credit for attorneys licensed in Connecticut, Florida and New Jersey. We will apply for credit in Colorado, North Carolina and Virginia (subject to MCLE Board approval). For jurisdictions not listed, attendees are provided with a Universal Certificate of Attendance. New York licensed attorneys: Transitional/Appropriate for newly admitted and experienced attorneys. Financial aid is available for qualifying lawyers. For CLE-related questions, please contact Gisel Arias at garias@kslaw.com. King & Spalding, 1180 Peachtree Street NE, Atlanta, GA 30309. CA Provider #10947.