Upon making a determination that a product is suspect or upon receiving a request for information, promptly conduct an investigation to determine whether the product is an illegitimate product by verifying the standardized product identifier on the package.The product identifier information must be maintained by the manufacturers for not less than six years after the date of the transaction. SCORPION BARCODE SERIAL SERIALHaving a system in place to affix or imprint a product identifier [including the National Drug Code (NDC number), serial number, lot number and expiration date printed in aĢ-D barcode and human readable form to each package and homogenous case of a product intended to be introduced in a transaction into commerce.The provision of transaction information, transaction history and transaction statements in electronic format.There are several requirements that manufacturers must meet, including: The next deadline of November 27, 2017, applies to manufacturers, which are defined as application holders. It is essential that all participants in the pharmaceutical drug supply chain become familiar with the law and its implementation over the next six years, and work with partners that understand and comply with the regulation. Following these dates, products can only be transferred between authorized trade partners. Verification requirements start in 2017 for manufacturers, 2018 for repackagers, 2019 for wholesale distributors and 2020 for dispensers. The objectives of the DSCSA are to enable tracking of drug product down to the individual unit of sale, improve detection and removal of counterfeit products in the drug supply chain, and facilitate more efficient drug recalls. 2 Counterfeiting of medicines is clearly big business - $200 billion annually, according to the World Customs Organization. 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 In 2015 alone, FDA and Interpol seized illegal medicines and medical devices from more than 1,050 websites. FDA has revealed that more than 50% are fake. 1 Routine testing of drugs purchased online by the U.S. One in ten medicines worldwide are counterfeit, according to the Pharmaceutical Research and Manufacturer’s Association. In addition, challenges won’t end with implementation: there will be vast quantities of data to manage to support serialized production moving forward. Compliance is challenging, but noncompliance carries the risk of significant consequences. The next deadline - November 2017 - applies to manufacturers. Some of these requirements began in 2014 additional requirements will be phased in until 2023. Drug Supply Chain Security Act (DSCSA) have been set for pharmaceutical manufacturers, repackagers, wholesale distributors, dispensers and third-party logistics providers.
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