Pharmaceutical Serialization And The USA Drug Supply Chain Security Act

In the past decade, governments around the world have begun to phase in specific regulations regarding heightened identification of pharmaceuticals. In an effort to reduce the cost to human life and economics by drug counterfeiting, countries around the globe are demanding drug producers, packaging firms and distributors implement measures to take control of the situation. They see pharmaceutical serialization as the best method to control drug safety.

Definition

Essentially, serialization is the establishment of a unique number or code for each carton or container. Specific data asked for include:

 * Batch
 * Expiry date
 * Global Trade Identification Number (GTIN)
 * Serial number

The information will identify each type of drug as a legitimate pharmaceutical product.

The Drug Supply Chain Security Act

In the United States, the Drug Supply Chain Security Act (DSCSA) is mandating that all drugs begin the process of pharmaceutical serialization in 2017. Eschewing an immediate implementation, the government agencies have opted for the process to occur in various phases. The rationale behind this plan has its basis in the cost to the involved parties for overhauling and/or adjusting their production to adhere to the new norm.

 * Step One: Numerical identification at the salable unit and case level (November 2017)
 * Step Two: Repackaging (2018)
 * Step Three: Complete traceability (Track and Trace) by all companies of individual packages through their serial number (2023)

The perception is this will provide sufficient time for companies of all sizes to “get with” the program.

Pharmaceutical Serialization

To meet the deadlines, pharmaceutical manufacturers, packaging firms, and distributors will have to alter their means of packaging. They will have to adapt new ways of labeling and marking the products to accommodate the new demands. This will mean redesigning some packaging to fit on the necessary barcodes, serial numbers, and any other requisite material. Furthermore, for pharmaceutical serialization to be truly successful, it will require communication among the various parties and even standardization across states and countries.

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