In this session of the American Society for Automation in Pharmacy (ASAP) Insights webcast, host Will Lockwood sits down with Mark Tate, co-founder, president, and CCO of InfiniTrak, to discuss the final stages of the Drug Supply Chain Security Act (DSCSA).
As the small business exemption deadline approaches on November 27th, pharmacies must fully transition to receiving, verifying, and storing serialized data for six years. Tate breaks down the realities of current enforcement actions — noting that Pharmacy Benefit Managers (PBMs) are currently auditing compliance data more frequently than regulatory bodies. He also provides crucial best practices for managing supply chain “exceptions” (missing or inaccurate delivery data), the legality of dispensing critical medications during a clerical data delay, and how to properly structure your Standard Operating Procedures (SOPs) for audits.
Highlights from the Update:
The Small Business Exemption: Applies to pharmacies with fewer than 25 full-time pharmacists and pharmacy technicians (not total employees). The exemption expires on November 27th.
PBMs Lead Enforcement: While the FDA and state boards inspect for compliance, PBMs are leading data verification requests, especially within specialty pharmacies.
Handling Exceptions: If you receive a product tote without matching transaction data, it must be quarantined immediately while you contact the trading partner to resolve the clerical error.
Patient-First Dispensing: Under specific scenarios, if a patient urgently needs a quarantined medication due to a data error, the pharmacist may dispense it provided they trust the trading partner and see no physical signs of a suspect product.
Data Retention: While data must be stored for six years—and can legally be done via wholesaler portals—pharmacies must explicitly document this manual audit process in their SOPs.
Watch to the full webcast to learn how automating your compliance workflows can save your pharmacy team hours of manual tracking and protect your bottom line from costly product quarantines.
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