FDA Releases DSCSA Draft Guidances on Standardization of Data and Documentation Practices for Product Tracing and Definitions of Suspect and Illegitimate Products; FDA Hints at a New Proposed DSCSA Preemption Regulation

March 7, 2018By Karla L. Palmer

On February 28, 2018, Commissioner Gottlieb announced FDA’s release of two draft guidance documents addressing certain requirements under the 2013 Drug Supply Chain Security Act (DSCSA), concerning standardization of data and documentation practices for product tracing (here), and definitions of suspect and illegitimate products (here).  In announcing the release of the two draft documents, however, Commissioner Gottlieb also stated that FDA intends to release later this year regulations revisiting FDA’s interpretation of the express preemption provisions in the DSCSA for state licensure and product tracing.  The Commissioner noted that, in 2014, FDA interpreted DSCSA’s preemption provision to mean that “states are not preempted from doing their own licensing of wholesale distributors and third party logistic providers so long as the state regulations did not contradict or fall below the minimum standards established by federal law.”  Thus, states could still impose requirements more restrictive than the “federal scheme.”  Based on comments received concerning the scope of federal preemption, the continued patchwork of state laws that would ensue, and the fact that “Congress wanted the federal system to provide both a floor and a ceiling when it came to the issue of preemption,” FDA is taking another (welcomed) look at its earlier guidance.  In what is surely a positive change for industry and one that will lead to more consistency and less confusion, FDA plans to release later this year new regulations that will apply to “all state and federal licenses issued to wholesale distributors and 3PLs.”

Concerning the new draft guidance documents, FDA’s definitional guidance on suspect and illegitimate products intends to clarify what “suspect” and “illegitimate” products are in order to help the industry meet notification requirements if they identify such products in their possession. (FDA released draft guidance on such notification requirements back in December 2016.)  FDA also clarifies interpretations of the terms “counterfeit,” “diverted,” “fraudulent transaction,” and “unfit for distribution” to aid trading partners in determining whether a product is suspect and/or counterfeit. Note that “unfit for distribution” would include drugs that are considered adulterated under FDCA Section 501 or conditions rendered nonsalable because certain conditions (including return, recall, damage or expiry) “cast doubt on the drug’s safety, identity, strength, quality, or purity.”

The second recently released draft guidance document addresses standardization of data and documentation practice for product tracing. The guidance document intends to help trading partners understand data elements that should be included in product tracing information, and details when partners are permitted to omit certain data that otherwise would be required.  Because that lengthy guidance document deserves its own blog post, stay tuned, one will be forthcoming in later this week.