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Achieving & Maintaining DSCSA Compliance

At the heart of DSCSA, precision is of utmost importance, transitioning from a mere identification of drugs and strengths to encompassing specific bottles with unique serial numbers.

DSCSA Then to Now

The FDA’s focal point for audit and compliance is the T3 concept–comprising Transaction Information (TI), Transaction History (TH) and Transaction Statement (TS). TI embodies purchase specifics, acting like an invoice detailing origin, destination, and product identifiers. TH extends further upstream in the supply chain. As a pharmacy, your pertinent transaction information stems from distributors or direct manufacturers, while history may encompass multiple steps prior. The TS serves as a compliance declaration across all communications. This pertains to lot-level data, which must be upheld for six years regardless of the data’s origin. Pharmacies are mandated to promptly isolate and report suspected products, responding to audit requests within specific timeframes–24 hours for technical literature and 48 hours for state or federal authorities.

So What’s Changing in November 2024?

A notable shift is anticipated with the introduction of T2. This transition entails a departure from transaction history, prompted by the shift towards electronic data maintenance. While paper invoices were permissible previously, the new regulations mandate an electronic and interoperable format, primarily pointing to EPCIS as the standard meeting these criteria. Notably, the inherent historical structure of EPCIS aligns with these requirements, rendering the concept of transaction history redundant within the comprehensive historical system. With T3 evolving into T2 by November, the electronic storage of data at the package level, as opposed to the lot level, becomes essential, demanding the implementation of well-defined protocols to uphold these standards. A pertinent inquiry emerges concerning the identification of items subject to robust traceability, including a deeper exploration of traceable and non-traceable distinctions within prescription items, underscoring the need to clarify what precisely qualifies as a direct pathway and what falls outside this categorization. Read more >

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