ePedigree – Background, Overview of Regulations and Compliance

• By: Staff Editor
• Date: August 16, 2011

Background

A drug pedigree is defined by the FDA in its Compliance Policy Guide to the Prescription Drug Marketing Act as:

“…a statement of origin that identifies each prior sale, purchase, or trade of a drug, including the date of those transactions and the names and addresses of all parties to them.”

An ePedigree is an electronic version of such a document. The aim of an ePedigree is to protect consumers from counterfeit drugs and contaminated medicine. It should include the following data:

• Lot number
• Potency
• Expiration
• National Drug Code and Electronic Product Code
• Manufacturer’s name
• Name of distributor, wholesaler or pharmacy
• Unique identifier of the saleable unit

Overview of regulatory requirements

A number of states have already implemented or are in the process of implementing pedigree laws. The FDA has at present no specific regulations governing the use and implementation of electronic pedigree systems. Among the states, only California has formulated electronic pedigree specific regulations that will be implemented in a staggered manner from 2015-17.

Summary of California’s ePedigree Law

California’s ePedigree Law was added to the 2006 Pedigree Definition Legislation. It states that pedigree should be created and maintained in an interoperable electronic system, ensuring compatibility throughout all stages of distribution.

Definition of interoperable electronic system

According to the law, an interoperable electronic system is one that:

• Is an electronic track and trace system
• Is for prescription drugs
• Uses unique identification numbers
• Is established at point of manufacture
• Is contained within standardized non-proprietary data format and architecture
• Is uniformly used by manufacturers, wholesalers and pharmacies

Document requirements

An electronic pedigree should include the following documents:

• Prescription drug information
• Transaction and source information
• Ownership information
• Certification

Status of implementation

California’s electronic pedigree requirement to track prescription drugs from point of manufacture to the final destination (pharmacy or hospital) should have been implemented by January 2007. The technological and production line complexities this system would have entailed delayed the compliance date to 2009 and then 2011. In 2008 a bill was passed by the state legislature and signed into law by the governor replacing the 2011 implementation date with a series of staggered implementation dates requiring total compliance throughout the supply chain by July 1, 2017.

The dates for implementation of the ePedigree system in California are:

-    50 percent of a manufacturer’s products should comply with the law’s requirements by 2015
-    Remaining 50 percent to comply by 2016
-    Wholesalers and repackagers must accept and forward products with ePedigree by July 1, 2016
-    Pharmacy and pharmacy warehouses must accept ePedigrees by July 1, 2017

California’s ePedigree law includes a provision that states that in the case of

Additional Resources

-    Read the Prescription Drug Marketing Act (PDMA) in full
-    Read the FDA’s Compliance Policy Guide to the PDMA
-    Read California’s Pedigree Legislation in full