Drug counterfeiting is big business worldwide. The World Health Organization estimates that 1 in 10 medical products in low and middle-income countries either do not meet quality standards or are flat out fake. While the problem is seen with less frequency in the United States, Congress passed the Drug Supply Chain Security Act (DSCSA) to provide FDA the tools needed to protect patients from sub-standard or counterfeit drugs. DSCSA directed FDA to create standards making it possible to build an electronic, inter-operable system to identify and trace certain prescription drugs as they are distributed in the United States. The two draft guidances recently issued by FDA in March 2018 are part of this effort.
The guidances are titled, Standardization of Data and Documentation Practices for Product Tracing, and Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act, respectively.
Product tracing information
A legitimate drug passes through a number of hands on the way to the consumer. For example, the original manufacturer may sell the drug to a wholesaler, who then provides it to a national pharmacy chain, who then sends it to individual pharmacies, where the consumer who has a prescription for that drug receives it. And remember, between each step, the drug must be transported in some manner. DSCSA requires that manufacturers, repackagers, wholesale distributors, and dispensers of drugs be able “to exchange transaction information, transaction history, and transaction statements,” which the guidance calls product tracing information.
The idea here is that at every transaction in the supply chain, there is a buyer and a seller who must exchange transaction information such as:
- Proprietary or Established Name of Product
- Strength and Dosage Form of the Product
- National Drug Code Number of the Product
- Container Size
- Number of Containers
- Lot Number of the Product
- Date of the Transaction
- Date of the Shipment, If More Than 24 Hours After the Date of the Transaction
- Business Name and Address of the Person From Whom Ownership Is Being Transferred
- Business Name and Address of the Person to Whom Ownership Is Being Transferred
With the data above, the series of transactions from the original manufacturer up to the eventual consumer can be traced.
Grandfathered products
One of the biopharmaceutical industry’s biggest concerns with DSCSA is how to handle so-called grandfathered products (products that entered the supply chain before January 1, 2015). These products were exempt from the law since they were already in commerce when the law took effect. By acting with deliberate speed on these guidances, the FDA has gone a long way to solving the problem: most drugs manufactured prior to January 1, 2015 will have expired by now. For those that have not, FDA provides guidance on how to handle these products, that is, by informing trading partners that the product is pre-2015 and sharing the information that is available.
The second guidance provides definitions of the following terms:
- Counterfeit
- Diverted
- Fraudulent Transaction
- Unit of Distribution
It is essential to have effective working definitions so that everyone within the supply chain can understand their responsibilities in protecting consumers and when to notify FDA.
What does this mean for you? To begin with, the key date is 2023, when this system is planned to be fully implemented to permit the exchange of the data described in electronic format. Currently there is a mix of paper and electronic forms out there; by 2023 it is supposed to be electronic only. Pearl Pathways is ready to help you navigate the challenging world of supply chain security. Contact us today for a free 30-minute consultation.