Posted 08 October 2014
By Alexander Gaffney, RAC
US regulators have released more information regarding an emerging system intended to prevent counterfeit medicines from reaching US consumers.
In 2013, Congress passed and President Barack Obama signed into law the Drug Quality and Security Act (DQSA). While the law is perhaps better known for its extensive pharmaceutical compounding reform provisions, it also contains another major component formally known as the Drug Supply Chain Security Act (DSCSA).
The core of the DSCSA is meant to establish a nationwide pharmaceutical track and trace system that deters drug counterfeiting. Drug packages would be required to carry a serial number as part of a lot-level tracking system within four years of the law's implementation, with a package-level tracing system coming six years after that.
One of the key components to the track and trace system is its traceability provisions. Each entity in the supply chain, from the original manufacturer to the end distributor, is supposed to keep track of the product coming into and out of its possession, allowing its path to be traced by federal regulators in the event of a problem. FDA could, for example, determine the point at which a counterfeit product entered into a legitimate supply chain, making it easier to bring a company into compliance or track down a counterfeiter.
To date, FDA has released only a handful of details about the emerging system. For example, in February 2014 the agency called for comments on which interoperable data standards companies should use to record transaction information. Then, in June 2014, the agency released a new draft guidance intended to explain how to identify and notify FDA of suspect products.
Now FDA is out with a second draft guidance on the DSCSA: The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements: Questions and Answers.
The guidance refers to Section 858 of the DQSA, "Uniform National Policy." The section calls for uniform enforcement of track and trace standards throughout the country—a major concern leading up to the passage of the legislation because some states, like California, had already passed into law their own standards for traceability. Legislators feared a patchwork of systems that would increase the costs of compliance for companies and make it difficult to track drugs across state lines.
The section also provides for the federal regulation of wholesale distributors, and prevents states from regulating third-party logistics providers as wholesale distributors as of 1 January 2015.
As FDA explains, together these requirements effectively preclude most state efforts to regulate or implement track and trace standards. Though they can continue to implement some protections until traceability requirements come into effect on 1 January 2015, they will be severely restricted thereafter.
"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," FDA explains in the guidance.
The same goes for wholesaler distributor regulators, FDA notes in the guidance. States can't establish regulations which "fall below the minimum standards established by Federal law," and any regulations must be "consistent" with the DQSA.
Overall, that's good news for the pharmaceutical industry, which will have to worry about adhering to just one standard—the federal government’s—and not 51 different standards when the DSCSA comes into effect.
Comments on the guidance are due to FDA by 8 December 2014.
DSCSA: The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements: Questions and Answers