On July 20, 2017, the Food and Drug Administration (FDA) published a notice announcing three public meetings entitled “Enhanced Drug Distribution Security Under the Drug Supply Chain Security Act” (DSCSA), and a notice announcing a pilot program project under the DSCSA. The FDA requests comments on the meeting topics and the pilot program.
The DSCSA, enacted on November 27, 2013, established a new track-and-trace system for prescription drugs distributed in the United States, and sets forth a series of requirements that will culminate in the establishment of a fully electronic, interoperable system to identify and trace certain prescription drugs by 2023. This system is intended to enhance the FDA’s ability to protect U.S. consumers from exposure to drugs that may be counterfeit, diverted, stolen, intentionally adulterated or otherwise harmful by improving the detection and removal of potentially dangerous drugs from the drug supply chain.
Sidley Austin LLP provides this information as a service to clients and other friends for educational purposes only. It should not be construed or relied on as legal advice or to create a lawyer-client relationship. Readers should not act upon this information without seeking advice from professional advisers.
Attorney Advertising—Sidley Austin LLP, One South Dearborn, Chicago, IL 60603. +1 312 853 7000. Sidley and Sidley Austin refer to Sidley Austin LLP and affiliated partnerships, as explained at www.sidley.com/disclaimer.
© Sidley Austin LLP