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.


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