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.
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