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FDA Announces Enforcement Discretion in Implementing the DSCSA’s Product Tracing Requirements, Delaying Enforcement until May 1, 2015

Michael N. Druckman

Michael N. Druckman,

Washington, D.C.

29 December 2014
FDA recently issued a Guidance document announcing that it will exercise its discretion not to enforce the product tracing requirements of the Drug Supply Chain Security Act (DSCSA) until May 1, 2015.  The Guidance, entitled DSCSA Implementation:  Product Tracing Requirements — Compliance Policy, is being implemented immediately.  Under the DSCSA, the product tracing requirements for manufacturers, wholesale distributors, and repackagers take effect on January 1, 2015.  FDA made the decision to exercise enforcement discretion until May 1 in response to concerns expressed by some trading partners that unforeseen complications with the exchange of the required information could result in disruptions in the supply chain, and ultimately could impact patients’ access to needed prescription drugs.

FDA made clear, however, that it will not exercise enforcement discretion regarding the other requirements in the DSCSA that are scheduled to take effect on January 1, 2015, or regarding those that have already gone into effect.  Among the provisions that FDA expects to be implemented by January 1, 2015 are the requirements that trading partners have systems in place to verify whether suspect products are illegitimate and that trading partners engage in transactions only with authorized trading partners. 

The Compliance Policy Guidance does not address how trading partners should handle potential conflicts in obligations that might arise under this policy.  For example, under the DSCSA’s verification provisions, wholesale distributors must validate any applicable transaction history and transaction information in their possession while investigating suspect products, in coordination with trading partners.  Under FDA’s announced enforcement discretion, however, wholesale distributors’ trading partners are not required to start retaining transaction information and history until May 1.  The Guidance does not address how a wholesale distributor should validate any transaction information or history in its possession if the trading partners from whom it received that tracing information have not retained that information.

Consequently, all parties subject to the DSCSA’s requirements would be wise to communicate with their trading partners regarding DSCSA implementation.  At a minimum, they should determine by when their trading partners will comply fully with the DSCSA’s product tracing requirements and they should coordinate on applicable aspects of DSCSA’s compliance. 

If you have questions about FDA compliance policy or about the DSCSA, please contact the author or the Hogan Lovells attorney with whom you work.

Michael N. Druckman

Michael N. Druckman,

Washington, D.C.

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