States, FDA Pressing Forward with Pedigree, Track and Trace Rules and Regulations

May 3, 2011 3:10 pm Topics: Pedigrees

Originally published in the May 2011 NABP Newsletter

One method of helping ensure the integrity of the US drug supply chain is through the use of drug pedigrees, verifiable written or electronic documents that track each move in a drug’s journey from manufacturer to patient. When enforcement of federal drug pedigree requirements, originally established by the Prescription Drug Marketing Act of 1987, was put on hold by a legal challenge, some states opted to move ahead with their own requirements. As of March 2011, according to the Healthcare Distribution Management Association, 18 states had adopted final rules regarding distributor licensing and pedigree requirements, three states had enacted legislation but rules were pending, eight states had enacted legislation, one state had proposed pedigree legislation, and 20 states had no legislation or regulations on the topic.

California’s pedigree law has arguably drawn the most attention nationwide; its comprehensive requirements include those for an electronic pedigree, product serialization, and track-and-trace capability from manufacturer to point of sale. Industry concerns that the legislation would require a supply chain infrastructure and standards not currently in place have led to a delayed implementation date. Currently, the requirements are scheduled to take effect on a staggered basis starting in 2015 through 2017.

In another example, Idaho enacted legislation requiring wholesale drug distributors of prescription drugs “that leaves, or has ever left, the normal distribution channel” to provide a pedigree to the person receiving the drug; the Idaho State Board of Pharmacy was tasked with determining an implementation date for electronic track and trace pedigree technology, and allowed to extend the date “in one . . . year increments if it appears the technology is not universally available across the entire prescription pharmaceutical supply chain.” The Board extended the implementation date once, to July 2011, when it is currently scheduled to go into effect.

In a report issued at the end of 2010, the National Council for Prescription Drug Programs predicted that “state level pressure for electronic pedigrees will intensify should pre-emptive federal legislation not materialize in a timely fashion.”

While such federal legislation is still pending, FDA did issue during 2010 the first of several intended guidances and regulations required by the Food and Drug Administration Amendments Act of 2007, which instructs the Health and Human Services Secretary “to develop standards and identify and validate effective technologies for the purpose of securing the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs.” The guidance addresses the standardized numerical identification (SNI) for prescription drugs at the “package” level – that is, the smallest unit placed into interstate commerce by the manufacturer or repackager intended for individual sale to a pharmacy (or other dispenser). FDA Commissioner Hamburg compared the SNI to a “‘license plate’ for individual packages of drug products as they travel through the supply chain.” She flagged the guidance as “an important first step in developing a track and trace authentication system in the US.”