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Ensuring Compliance With Pharmaceutical Serialization Requirements

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Ensuring Compliance With Pharmaceutical Serialization Requirements

The reputable pharmaceutical companies have long been faced with very severe issues with counterfeit drugs and modified or adulterated drugs on the market. These counterfeit drugs are expertly designed to be identical to the original product, and even experienced doctors and pharmacists may have difficulties in spotting the phony medications.

To end this issue, and to create a higher standard and quality for all drugs sold in the United States, pharmaceutical serialization for packaging was brought into place through the Drug Quality and Security Act (DQSA), which was signed into law in November of 2013. This law was developed in consultation with the many large pharmaceutical companies, as well as with various other stakeholder groups.

A Uniform Approach
Many other areas of the world, including throughout the European Union, Brazil and China are also on track to having laws in place with regards to packaging and serialization. Different countries have different deadlines, with some components of these laws already in place, and others set to be implemented between 2015 and 2018.

In the past in the United States, different states already had some level of pharmaceutical serialization, although it varied greatly between states. The signing of the DQSA created a uniform and consistent approach to allow all pharmaceutical companies to come into regulation and to follow on national guideline regardless of where the products were distributed and sold.

Essential Considerations
It is important to realize that the pharmaceutical serialization process is not just in place for the pharmaceutical companies. The movement of the medications will be tracked throughout the supply chain, meaning that any change in the ownership or transactions of the drugs will be tracked through the system.

This will include wholesalers, repackagers and dispenses in addition to the pharmaceutical manufacturing companies. The information that will need to be captured as the medications go through each transaction, or change in ownership, include:

  • The information for the transaction including the name, dose, strength, container size, the number of containers, lot number, date, shipment and the past owner information.
  • Each transaction will also be accompanied by a complete transaction history either as an electronic copy or as a hard copy.
  • Information on the transaction history that verifies all transactions are authorized under the DSQA and meet all other legal requirements.

While the DSQA and pharmaceutical serialization will be an adjustment for many involved in the pharmaceutical supply chain, it will be an essential step in preventing counterfeit medications from entering into the American and international medicine markets.

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