On November 27, 2013, the Drug Supply Chain Security Act (DSCSA) was enacted "to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed within the United States." To accomplish this, the U.S. Food and Drug Administration (FDA) is required "to establish standards for the interoperable exchange of transaction information, transaction history, and transaction statements, in paper or electronic format," definitions of which are provided at 79 Fed. Reg. 9745 (Feb. 20, 2014), [enhanced version available to lexis.com subscribers]. The FDA believes that the "ability to track and trace finished prescription drugs plays a significant role in providing transparency and accountability in the drug supply chain" and "will enhance FDA's ability to protect U.S. consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful." FDA has, therefore, generated an implementation plan for the next 10-year period.
As part of this plan, the FDA established a public docket where interested parties can share information relevant to the implementation of the DSCSA. More specifically, the FDA, through a series of questions, has requested comments and supporting information regarding the following:
1. Current practices and ideas that may be used for the interoperable exchange of transaction information, transaction history and transaction statements, in paper or electronic format, for each transfer of a product in which a change of ownership occurs (i.e., transaction);
2. the feasibility of establishing standardized documentation to be used by members of the pharmaceutical distribution supply chain to convey the transaction information, transaction history and transaction statement to the subsequent purchaser of a product and to facilitate the exchange of lot level data; and
3. current practices and ideas that may be used for the exchange of information between members of the pharmaceutical distribution supply chain and FDA to provide, receive and terminate notifications; respond to requests for verification of a product; and respond to requests for information from FDA or other appropriate federal or state officials in the event of a recall or for the purpose of investigating a suspect or illegitimate product.
To further facilitate discussions, by way of 79 Fed. Reg. 18562 (April 2, 2014), [enhanced version available to lexis.com subscribers], the FDA has announced a public workshop to be held on May 8–9, 2014. In addition to the information requested above, the FDA is interested in learning about current practices used by supply chain stakeholders "to exchange information, such as product information, information related to the sale or change of ownership of prescription drugs, or communications about drugs in distribution … [and] to provide, receive, and terminate notifications." Participants in this workshop may also discuss "how trading partners should respond to requests for verification of suspect drug product." The purpose of the workshop is not to provide a "consensus," but instead, to present "individual perspectives."
If you have any questions about this Alert, please contact Frederick (Rick) R. Ball, Carolyn A. Alenci, any member of the Pharmaceutical, Medical Device, Pharmacy & Food industry group or the attorney in the firm with whom you are regularly in contact.
Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.
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