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US: FDA gives firms one-year reprieve from DSCSA track and trace requirements

2023/08/29  RAPS

The US Food and Drug Administration (FDA) on Friday announced it is granting manufacturers and their trading partners a temporary reprieve from requirements for system-wide electronic interoperable systems for tracking products through the supply chain under the Drug Supply Chain Security Act (DSCSA). This enforcement discretion also applies to processing saleable returns.

These systems were supposed to be in place by 27 November 2023; this means that FDA will not take enforcement action until the following year, until 27 November 2024. The announcement was made in an immediately effective guidance issued on Friday.

FDA said that “additional time beyond November 27, 2023, may be needed for systems to stabilize and be fully interoperable for accurate, secure, and timely electronic data exchange.”

The agency stressed this action “is 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 under section 582(g)(1) of the FD&C Act. FDA strongly urges trading partners to continue their efforts to implement necessary measures to satisfy these enhanced drug distribution security requirements.”

FDA also will not enforce the DSCSA requirement that each person accepting a saleable return “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 for the product.”

FDA said this action responds to stakeholders’ concerns on the readiness among trading partners in implementing these systems. At a virtual public meeting last December, stakeholders indicated that trading partners “are at different stages of readiness, with some trading partners being further behind not only in terms of understanding their obligations under section 582(g)(1) of the FD&C Act, but also being aware of the time and resources necessary to meet those obligations.”

Stakeholders also requested more clarity with respect to dealing with non-serialized products that are already in the supply chain. Another challenge cited by stakeholders is difficulties in predicting the volume of requests for product tracing information from federal and state authorities as well as the resources needed to respond to such requests.

“We’re grateful to the FDA for listening to NCPA’s concerns and from others in the pharmacy space who are working to comply while also minimizing any delays of patient care that may result from new requirements. There are many complexities associated with implementing DSCSA. This additional time will be beneficial to ensuring that all sectors of the pharmaceutical supply chain are sufficiently prepared and helping prevent any unintended consequences impacting patient care,” said National Community Pharmacists Association (NCPA) CEO B. Douglas Hoey in response to the announcement.

At a recent Healthcare Distribution Alliance (HDA) webinar, a pharmaceutical distributor noted that only 35% of manufacturers are sending serialized data to distributors, prompting “significant concern” that most products will not be serialized in time to meet the 27 November deadline; the group requested a two -year enforcement delay requested and a phased approach to implementation.

Members of Congress also warned FDA of potential drug shortages if enforcement took effect this November considering these readiness problems.

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