FDA announces compliance policy guidance for drug distribution security

[Blog] DSCSA Postponement for 2024


Discover what stands behind the DSCSA postponement for 2024 – Key track and trace requirements ahead






In 2023, the FDA announced that the deadline for DSCSA`s enforcement will be extended to November 2024. In the published Compliance Policy Guidance, it is stated that the extension of the compliance period “will help supply chain stakeholders, particularly trading partners*, by accommodating the additional time that may be needed to continue to develop and refine appropriate systems and processes to conduct interoperable, electronic tracing at the package level, to achieve robust supply chain security under the DSCSA while helping ensure continued patient access to prescription drugs.”


*Trading partners – manufacturers, wholesale distributors, dispensers, and repackagers

Requirements in front of trading partners


1. Use secure, interoperable, electronic approaches to exchange transaction information, which must include package-level product identifiers for each package included in the transaction, and to exchange transaction statements;


2. Implement systems and processes in place to verify products at the package level;


3. Implement systems and processes in place 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 investigations of suspect or illegitimate product;
4. Implement systems and processes in place to facilitate the gathering of information needed to produce the transaction information for a product going back to the manufacturer, as applicable, in the event of a request by the Secretary, or other appropriate Federal or State official, on account of a recall or for suspect or illegitimate product investigations, or in the event of a request by an authorized trading partner;


5. Implement systems and processes in place to accept saleable returns under appropriate conditions.




Transaction Information Requirements


The transaction information required to be exchanged includes the product identifier (i.e., the standardized numerical identifier consisting of the NDC and serial number, lot number, and expiration date) at the package level for each package included in the transaction.


In light of readiness considerations, the FDA announced the one-year extension period will be of great use for the trading partners and other stakeholders to stabilize the systems and be fully interoperable for accurate, secure, and timely electronic data exchange.
The FDA stated that the agency will continue to monitor trading partner readiness to meet the requirements during and after the period of the compliance policy and is committed to supporting the efforts of trading partners to achieve enhanced drug distribution security.



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