One goal of the Drug Quality and Security Act (DQSA) is to prevent counterfeit pharmaceuticals from getting in the hands of unsuspecting people because many of them don’t have the correct ingredients in them. In fact, some of the ineffective medicines contain unsafe ingredients.
In January 2014, two people were charged with shipping fake cancer drugs to the United States, some of which authorities say were only vials of water and mold.
In February 2013, the FDA found a product labeled as an injectable cancer medicine, but there were no active ingredients in it.
In 2012, the FDA warned consumers about a counterfeit drug to treat attention deficit hyperactivity disorders (ADHD) and narcolepsy. The FDA’s laboratory tests concluded the counterfeit version of the drug contained the wrong active ingredients. Instead, the pills contained ingredients to treat pain.
The World Health Organization estimates that up to 10% of the pharmaceutical market is fake, much of it can be found on illegal websites that hide their geographic location.
The DQSA was signed into law by President Obama on November 27, 2013, which means pharmaceutical companies will be required to adopt an electronic system to identify and trace their medicines as they make their way from the manufacturer to a pharmacy. Some of the requirements of the DQSA start on January 1, 2015. Read more about the implementation timeline here.
USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet these regulations. Our team of experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to foreign medical agency databases for pharmaceutical tracking. Also, USDM experts ensure that all changes and enhancements are implemented under the governing GMP regulations, under change control and validated prior to release for production.