The Risks of Distributing COVID-19 Therapies: What Wholesale Distributors Need to Know About Track and Trace

Wholesale drug distributors need to maintain adequate track and trace documents, especially when acquiring and distributing COVID-19 therapies. The COVID-19 epidemic has sparked a demand for various drug products including, hydroxychloroquine. To ensure adequate supply, some countries have gone so far as to institute full-scale lockdowns on the exportation of this and other drugs. With the ever-increasing demand for COVID-19 therapies, wholesale distributors may find themselves on the receiving end of a variety of COVID-19 related drug products, including hydroxychloroquine. Distributors should be aware that, despite this ongoing, unprecedented global crisis, the requirements set forth in the Drug Quality and Security Act (DQSA) are still applicable and violations of this Act could carry serious consequences for wholesale distributors. Specifically, Title II of DQSA, also known as the Drug Supply Chain Security Act (DSCSA), provides a series of requirements concerning drug product tracking and tracing. For example, wholesale distributors are prohibited from accepting “ownership of a product unless the previous owner prior to, or at the time of, the transaction provides the transaction history, transaction information, and a transaction statement for the product.” 21 U.S.C.A. § 360eee-1. Other stringent track and trace requirements make it all the more important to ensure that distributors are maintaining adequate records, especially during times like these, where scarce drug products are in high demand and post-crises scrutiny are likely to be heightened. Pharmacies have similar responsibilities regarding the maintenance of track and trace documents and PBMs have taken a hard stance on these requirements during audits.

How Frier Levitt Can Help

Frier Levitt is acutely familiar with the intricacies of the DQSA and DSCSA and has counseled numerous wholesalers, drug distributors and pharmacies on the importance of maintaining adequate track and trace documents. If you are distributing COVID-19 therapies and have questions concerning your responsibilities outlined in the DQSA or DSCSA, call Frier Levitt today and speak with one of our highly trained Life Sciences attorneys.  

 

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