On August 25, 2023, the U.S. Food and Drug Administration (FDA) announced compliance policies for Drug Supply Chain Security Act (DSCSA) enhanced drug distribution security requirements that were scheduled to go into effect November 27, 2023. The compliance policies state that FDA will not take action until November 27, 2024, to enforce requirements in Section 582(g)(1) of the Federal Food, Drug and Cosmetic Act (FDCA), including the requirements to include product identifiers in the transaction information for each transaction and to exchange transaction information and the transaction statement in a secure, interoperable, electronic manner in accordance with FDA guidance. Further, FDA stated it would not enforce the requirement that the product identifier be included in the transaction information for any product introduced in a transaction into commerce by the product’s manufacturer or repackager before November 27, 2024.
FDA cautioned industry that the compliance policies are “not intended to provide, and should not be viewed as providing, a justification for delaying efforts by trading partners to implement the enhanced drug distribution security requirements.” And FDA “strongly urges” continued efforts to implement requirements in Section 582(g)(1) of the FDCA.
Trading partners should review these clarified expectations from FDA regarding enhanced drug distribution security requirements and incorporate into existing project workstreams to implement secure, interoperable, electronic exchange of transaction information, including product identifiers at the package level. Sidley can help analyze the impact of this guidance on current and future operations.
FDA continues to enforce other product tracing and verification requirements in Section 582 not within the scope of this or other compliance policies as evidenced by the warning letter issued to Safe Chain Solutions, LLC, in June 2023 and an untitled letter issued to Valisure, LLC, in December 2022. Sidley’s experienced enforcement attorneys are available to assess your DSCSA program and work with your team to ensure sustainable DSCSA compliance.
Summary of August 2023 Enhanced Drug Distribution Security Compliance Policies
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FDCA §582(g)(1) Requirement |
FDA Compliance Policy |
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(A) The transaction information and the transaction statements as required under this section shall be exchanged in a secure, interoperable, electronic manner in accordance with the standards established under the guidance issued pursuant to paragraphs (3) and (4) of subsection (h), including any revision of such guidance issued in accordance with paragraph (5) of such subsection. |
FDA does not intend to take action to enforce this requirement until November 27, 2024. |
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(B) The transaction information required under this section shall include the product identifier at the package level for each package included in the transaction. |
FDA does not intend to take action to enforce this requirement until November 27, 2024. FDA does not intend to take action to enforce this requirement with respect to product that is introduced in a transaction into commerce by the product’s manufacturer or repackager before November 27, 2024, and for subsequent transactions of such product through the product’s expiry. |
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(C) Systems and processes for verification of product at the package level, including the standardized numerical identifier, shall be required in accordance with the standards established under the guidance issued pursuant to subsection (a)(2) and the guidances issued pursuant toparagraphs (2), (3), and (4) of subsection (h), including any revision of such guidances issued in accordance with paragraph (5) of such subsection, which may include the use of aggregation and inference as necessary. |
FDA does not intend to take action to enforce this requirement until November 27, 2024. |
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(D) The systems and processes necessary to promptly respond with the transaction information and transaction statement for a product 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 product or an illegitimate product shall be required. |
FDA does not intend to take action to enforce this requirement until November 27, 2024. |
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(E) The systems and processes necessary to promptly facilitate gathering the information necessary to produce the transaction information for each transaction going back to the manufacturer, as applicable, shall be required— (i) in the event of a request by the Secretary (or other appropriate federal or state official), on account of a recall or for the purposes of investigating a suspect product or an illegitimate product, or (ii) in the event of a request by an authorized trading partner, in a secure manner that ensures the protection of confidential commercial information and trade secrets, for purposes of investigating a suspect product or assisting the Secretary (or other appropriate federal or state official) with a request described in clause (i). |
FDA does not intend to take action to enforce this requirement until November 27, 2024. |
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(F) Each person accepting a saleable return shall have systems and processes in place to allow acceptance of such product and may accept saleable returns only if such person can associate the saleable return product with the transaction information and transaction statement associated with that product. |
FDA does not intend to take action to enforce this requirement until November 27, 2024. |
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