The DSCSA immediately preempts all state laws, regulations, and requirements for tracing products through the supply chain, including any recordkeeping and pedigree requirements. All such laws are preempted, regardless of whether they are more burdensome, less burdensome, or inconsistent with the federal traceability requirements. The preemption provision applies to state requirements for tracing “products.” Therefore, the preemption provision does not extend to items that are not products under the DSCSA, such as animal drugs, medical devices, over-the-counter drugs, active pharmaceutical ingredients, and clinical trial drugs, and states retain the authority to impose tracing or pedigree requirements on such items.
The DSCSA also preempts state laws, regulations, and requirements regarding wholesale distributor and third-party logistics provider licensure that are inconsistent with, less stringent than, directly related to, or covered by the standards established by the DSCSA. In other words, states cannot alter the standards established by the DSCSA, but they may continue to regulate wholesale distributors and third-party logistics providers in areas that are not covered by and not directly related to the licensing standards in the DSCSA.
In February 2022, the FDA released final guidance for industry on Drug Product Tracing: The Effect of Section 585 of the Federal Food, Drug, and Cosmetic Act-Questions and Answers.
For more information, see PDSA’s FAQs on the preemptive effect of the DSCSA.