Uniform National Serialization Strategy To Negate State Strategies

The U.S. Food and Drug Administration (FDA) has divulged new information about a planned nation-wide serialization system aimed at preventing counterfeit drugs from reaching U.S. customers, Regulatory Affairs Professionals Society (RAPS) reports. The regulation will eliminate the “patchwork” of unique state systems in order to lower the cost of compliance and make it relatively easier to track drugs across state lines.

This second draft guidance stems from the Drug Quality and Security Act (DQSA) that Congress passed and President Barack Obama signed into law in 2013. The legislation primarily offers provisions for pharmaceutical compounding reform, but also highlights the Drug Supply Chain Security Act (DSCSA). In particular, this second guidance clarifies Section 858 of the DSCSA, entitled "Uniform National Policy,” which outlines a consistent strategy to label all drug packages with serial numbers within four years of the law coming into effect, RAPS reported.

Although this new provision could make things a little simpler for drug makers due to the fact they would only need to adhere to one national standard, rather than 51 different state standards, some states, like California, do have cause for concern, considering they have already passed their own track and trace legislation. The FDA has admitted that the new national requirements will negate most state efforts to implement their own track and trace systems. The agency says each state can continue serialization plans to a point, in the name of product protection. However, once the U.S. traceability requirements hit on January 1, 2015, they will be “severely restricted.”

Section 858 also allows for the federal regulation of wholesale distributors, preventing state government oversight of third-party logistics providers as wholesale distributors as of January 1, 2015. States can't establish regulations which "fall below the minimum standards established by Federal law," and regulations must be "consistent" with the DQSA.

"Any requirements for tracing drugs through the pharmaceutical distribution supply chain that are inconsistent with, more stringent than, or in addition to any requirements applicable under section 503(e) of the FD&C Act, as amended by the DSCSA, or under subchapter H (or regulations issued thereunder) are preempted," the FDA explained in the guidance.

Up until this point, the FDA has not given many hints about what the emerging track and trace system will look like. In February 2014, the agency asked for comments regarding the preferred interoperable data standards that companies should use to record transaction information. This was followed by a draft guidance explaining how to identity suspicious products and notify the FDA of the matter in June 2014.