The Fight Against Counterfeit Medicines – U.S. Edition

Legislation

The United States (US) Federal Drug Supply Chain Security Act (DSCSA) is a federal law enacted in 2013 by the Food and Drug Administration (FDA) with the aim of improving the safety and traceability of medicines in the U.S. supply chain. This enables the U.S. government to protect its citizens from counterfeit drugs, stolen drugs, and other potentially dangerous drugs that may be circulating in the supply chain.

The FDA gave pharmaceutical manufacturers, distributors, repackagers, and dispensers (pharmacies and hospitals) a 10-year period to comply with the DSCSA requirements through a progressive, phased approach, with a deadline of November 27, 2023. However, in August of last year, a one-year extension was granted to the pharmaceutical industry, pushing the final implementation deadline to November 27, 2024. This one-year stabilization period is intended to accommodate the additional time all parties need to refine and stabilize their processes and systems.

Requirements

The DSCSA requirements for the pharmaceutical industry can be divided into four pillars:

1. Product Identification

This pillar encompasses the principles of serialization and aggregation.

Serialization:

= The unique identification of individual units (medication packages) using assigned serial numbers. These serial numbers are printed on the package along with the product code, lot number, and expiration date, as well as the 2D matrix containing this information.

Aggregation

= Using serial numbers to link an individual unit (medication package) to higher-level packaging units further down the supply chain (cases and pallets). This establishes hierarchical relationships and ensures the exact contents of a case or pallet are known.

To comply with DSCSA requirements, at least “unit-to-case” aggregation is required. However, most pharmaceutical manufacturers choose to also implement “case-to-pallet” aggregation so that processes further down the supply chain can run more efficiently. This way, when a pallet is received, the pallet label can be scanned, and the pallet does not need to be opened to scan the labels on the individual units or cases.

2. Product Verification

Product verification is based on the principle of vertical reporting. The DSCSA stipulates that a returned, intact medication package may only be resold if its authenticity has been verified in advance. The method by which this must be done is not specified. The pharmaceutical industry has decided that each pharmaceutical manufacturer must upload the product-specific data (serial number, GTIN, lot number, expiration date) for each medication package to its “Verification Router Service” (VRS). Distributors and dispensers further down the supply chain can, if they are subscribed to the VRS, use this service to verify whether the data on the medication package matches the data uploaded to the VRS. If a distributor or dispenser is not subscribed to the VRS, they can contact the manufacturer directly to verify the data on the package.

3. Tracing

Tracing is based on the principle of “transfer of ownership” and horizontal reporting. The specific data for each individual medication package is transferred from one step in the supply chain to the next, from the manufacturer all the way to the dispenser. Shipping and transport information is also shared in this process. This allows for a complete picture of the path the medication package has taken through the supply chain. If a medication package is suspected of being counterfeit, this information can be used to investigate where the suspicious package entered the supply chain. It is important to note that this complete set of information must only be made available if an investigation into a suspicious medication package is necessary following a complaint from one of the “authorized trade partners,” the FDA, or the “State Board of Pharmacy,” or during process audits by the authorities.

4. Authorized Trade Partner

A manufacturer may only sell drugs to distributors and dispensers with a valid license. In turn, distributors and dispensers may only purchase drugs from manufacturers and distributors, respectively, with a valid license. It is up to the manufacturers, distributors, and dispensers themselves to verify that their partners hold such a license.

Conclusion

Just as with the implementation of the European serialization requirements, the implementation of the DSCSA entailed a great deal of work for pharmaceutical companies. The primary goal of both pieces of legislation is the same: to ensure the integrity of the pharmaceutical supply chain, prevent the circulation of counterfeit medicines, and improve patient health and safety. The way in which the European Medicines Agency and the FDA intend to implement these requirements has similarities but also many differences, making this yet another significant challenge even for pharmaceutical companies that are already manufacturing in compliance with the European serialization guidelines.

Sources:

https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa

Fig. 1: https://www.fagg.be/nl/news/nieuw_verificatiesysteem_tegen_vervalste_geneesmiddelen_in_elke_schakel_van_de_distributieketen

Fig. 2: https://www.researchgate.net/figure/Serialization-and-packaging-hierarchy-unit-box-case-box-and-pallet_fig2_340456649