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Editorial: Implications of Serialization for the U.S. Pharma Industry

SerializationArticle_Cover.pngAs published in Pharma's Almanac Q2 2017.


New requirements under the U.S. Drug Supply Chain Security Act (DSCSA) have been set for pharmaceutical manufacturers, repackagers, wholesale distributors, dispensers and third-party logistics providers. Some of these requirements began in 2014; additional requirements will be phased in until 2023. The next deadline — November 2017 — applies to manufacturers. Compliance is challenging, but noncompliance carries the risk of significant consequences. In addition, challenges won’t end with implementation: there will be vast quantities of data to manage to support serialized production moving forward.

WHY WAS THE DSCSA NEEDED?

One in ten medicines worldwide are counterfeit, according to the Pharmaceutical Research and Manufacturer’s Association.¹  Routine testing of drugs purchased online by the U.S. FDA has revealed that more than 50% are fake.²  In 2015 alone, FDA and Interpol seized illegal medicines and medical devices from more than 1,050 websites.¹ Meanwhile, the World Health Organization estimates that 10% of drugs in the global marketplace are counterfeit, with much higher levels (30%-40%) in developing countries and approximately 1% in developed nations.²  Counterfeiting of medicines is clearly big business — $200 billion annually, according to the World Customs Organization.²

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Topics: Regulatory Compliance Serialization Supply Chain Editorials