E-pedigree Federal and State Requirements Presented

April 24, 2007
Brianne Harrison
Pharmaceutical Technology

Interphex, New York, NY (Apr. 24)-Radio-frequency identification (RFID) technology is an increasingly important tool in the pharmaceutical supply chain. Paul Rudolph of Arent Fox PLLC gave the first of several talks on RFID and e-pedigree at Interphex today in his presentation, "Pedigrees: Update on Federal and State Regulation and Effect on RFID Tagging of Products."

Interphex2007, New York, NY (Apr. 24)-Radio-frequency identification (RFID) technology is an increasingly important tool in the pharmaceutical supply chain. Paul Rudolph of Arent Fox PLLC gave the first of several talks on RFID and e-pedigree at Interphex today in his presentation, “Pedigrees: Update on Federal and State Regulation and Effect on RFID Tagging of Products.”

RFID and e-pedigree are subjects of increasing interest in the pharmaceutical industry, as states begin enacting requirements for e-pedigree tracking of pharma ingredients and devices. 

According to Rudolph, the federal government has not yet been able to implement a requirement for pedigrees to go back to the manufacturer-the proposed requirement has been enjoined and US Food and Drug Administration (Rockville, MD) is appealing to the US Court of Appeals. FDA, however, has issued a guidance on several issues, including returns and requirements for third-party logistics providers. .

The bulk of e-pedigree activity has been at the state level. Nevada, Arizona, Colorado, Indiana, Oregon, and Florida had e-pedigree requirements as of 2006. In the first few months of 2007, Idaho, Wyoming, Maryland, and North and South Dakota enacted similar requirements. California, Iowa, Kansas, Mississippi, Nebraska, New Mexico, Texas, and Vermont have all proposed legislation or planned a timeline for enacting e-pedigree.

Most e-pedigree requirements apply to products that leave the normal distribution channel by passing from the manufacturer to two or more wholesalers.  This requirement is becoming more uniform from state to state. It does not, however, apply to manufacturers, and, as Rudolph pointed out, the definition of manufacturer varies from state to state, which can make matters complicated, as suppliers sending goods to other states will have to comply with different states’ different requirements.

Although some state laws have been drafted with the Prescription Drug Marketing Act and FDA’s regulatory guidance in mind, many state pedigree requirements are not consistent with federal pedigree requirements. For instance, current federal requirements state that nonauthorized distributors (nonADRs) must pass pedigree, and authorized distributors (ADRs) are encouraged to pass pedigree-related information on to nonADRs. The concept of ADRs is not common in state law, and it is not parallel to the “normal chain” concept used on the state level.

Looking to the future, Rudolph anticipates the lifting of the injunction on the federal requirement, more enforcement of the federal requirements, and further guidance on outstanding issues. Manufacturers probably will not be required to use RFID tags in the near future, at least until the benefits definitely outweigh the costs. More states will begin requiring e-pedigree, Rudolph predicts, and the state-by-state requirements will become more uniform over time, dispensing with varying definitions that add to confusion and lead to compliance problems.

Rudolph closed by exhorting companies to look to the future, when e-pedigree will be required in all states, and to establish internal teams to devise a strategy for adopting e-pedigree.