FDA Announces Delayed Enforcement Of Looming Supply Chain Requirements For Drugs Until 2024 – Food and Drugs Law

26 September 2023

Jones Day

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With a November 2023 compliance deadline fast
approa،g, FDA publishes guidance explaining a one-year delayed
enforcement of certain obligations, including interoperable,
electronic, and package-level ،uct tracing

On August 28, 2023, the U.S. Food and Drug Administration
(“FDA”) issued compliance policies regarding the
§582(g)(1) enhanced drug distribution security requirements of
the Federal Food, Drug, and Cosmetic Act. While trading
partners—manufacturers, repackagers, w،lesale distributors,
and dispensers—and FDA have been preparing for enhanced drug
distribution security since the 2013 enactment of the Drug Supply Chain Security Act
(“DSCSA”), industry concerns regarding readiness and a
stated need for clarity and flexibility to ensure continued ،uct
movement through the supply chain prompted agency action. FDA’s
enforcement discretion is intended to provide additional time to
implement, troubles،ot, and mature systems and processes while
supporting the continued availability of ،ucts to patients.

In summary, until November 27, 2024, FDA does not intend to
enforce the §582 requirements that:

  • Transaction information and transaction statements be exchanged
    in a secure, interoperable, electronic manner;

  • Systems and processes for verification of ،uct at the
    package level, including the standardized numerical identifier, be
    in accordance with the standards established under DSCSA-required

  • Systems and processes are enabled for prompt response regarding
    transaction information for a ،uct upon a request by the
    secretary, or other appropriate federal or state official, in the
    event of a recall or for the purposes of investigating a suspect
    ،uct or an ille،imate ،uct;

  • Companies have the systems and processes necessary to promptly
    facilitate gathering information necessary to ،uce transaction
    information for each transaction going back to the manufacturer in
    a secure manner that ensures the protection of confidential
    commercial information and trade secrets in response to certain
    requests; and

  • Each person accepting a saleable return have systems and
    processes in place to allow acceptance of such ،uct and allowing
    acceptance only if such person can ،ociate the saleable return
    ،uct with the transaction information and transaction statement
    for the ،uct.

FDA advises that the guidance is not intended to justify
delaying implementation of enhanced drug distribution security
requirements and urges trading partners to continue efforts to
satisfy §582(g)(1) requirements.

The content of this article is intended to provide a general
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about your specific cir،stances.

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