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US: FDA publishes additional guidances on delay of enforcing DSCSA electronic tracking requirements

2023/09/06  RAPS

The US Food and Drug Administration (FDA) published two additional guidances with immediate effect that provide more details for trading partners on the one-year extension from enforcement of requirements for tracking products electronically under the Drug Supply Chain Security Act (DSCSA).

A final guidance concerning the agency’s compliance policies of enhanced drug distribution security requirements was also recently published and intended for trading partners such as manufacturers, wholesale distributors, dispensers, repackagers and other stakeholders who are subject to DSCSA.

Together, the guidances comprise FDA’s plan so far for extending the deadline established by DSCSA, which requires trading partners to “achieve interoperable, electronic tracing of products to identify and trace certain prescription drugs as they are distributed throughout the U.S.” DSCSA’s requirements were set to go into effect by 27 November 2023, with the guidances extending that period by another year “to allow trading partners to implement, troubleshoot and mature their electronic interoperable systems,” FDA said in an statement announcing the guidances.

“FDA expects trading partners to use this stabilization period to build and validate interoperable systems and processes, manage products and data, and ensure continuity of the supply chain and product availability to patients. This period is not intended to provide, and should not be viewed as providing, a justification for delaying efforts to comply with the DSCSA,” they explained.

The two additional guidances include a guidance with immediate effect describing enhanced drug distribution security requirements for DSCSA at the package level, and a revised final guidance outlining compliance policies for wholesale distributors and dispensers on how to verify product identifiers in products subject to DSCSA.

Wholesale distributor verification requirement
The guidance outlining the wholesale distributor verification requirement for saleable returned drug product was developed to replace a 2020 compliance policy with the same name and is a one-year extension of that policy. FDA said it decided to publish the new guidance after receiving feedback from stakeholders such as wholesale distributors and other trading partners “expressing additional concern with industry-wide readiness for implementation of the verification of saleable returned product requirement for wholesale distributors.” Stakeholders told the agency that some of the factors that led to the initial delay in enforcing DSCSA requirements still exist, such as the need to verify a large volume of saleable returned product, real-time testing and refining of verification systems, and other complexities of creating an electronic system to facilitate the “large volume of saleable returned products amid immature technologies.”

FDA said it does not intend to take action against wholesale distributors who do not adhere to DSCSA requirements regarding verifying a product identifier before resale, or providing a transaction statement to a subsequent product purchaser if the distributor does not have systems already in place for compliance.

Enhanced drug distribution security at package level
In its final guidance on enhanced drug distribution security at the package level under DSCSA, FDA clarifies terms and enhanced drug distribution security requirements described in a June 2021 guidance with the same name as well as provides recommendations on attributes a system that securely traces products at a package level should contain, as well as enhanced security processes such as verification, inference and aggregation components.

“FDA considers these recommendations to be important to assist in implementing the robust supply chain security envisioned under the DSCSA,” they wrote in the guidance.

These system attributes include the secure exchange of transaction information that contains a product identifier at the package level, verification systems and processes for verification and prompt responses for recall and investigation, and the ability to “associate a saleable return product with its applicable transaction information and transaction statement to allow a trading partner to accept the returned product.”

A trading partner’s system structure that meets these requirements should be individual to the trading partner and “should permit secure, appropriate, and efficient sharing of electronic information (i.e., data) between trading partners.” The system should also allow the exchange of data between other trading partners “in an accurate, interoperable manner that also protects confidential commercial information and trade secrets,” while also being easily retrievable by the trading partner for FDA requests for information.

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