Cost Options for DSCSA Compliance
Randy Hoggle, Managing Director, Advasur, LLC In previous articles, I explained what the Drug Supply Chain Security Act (DSCSA) is and what pharmacy teams must do today to meet the current five requirements listed below (of 10 requirements) as I categorize them in the absence of FDA CDER (Food and Drug Administration Center for Drug Evaluation and Research) requirement categorization.
Current Five DSCSA Compliance Requirements
Requirement #1: Authenticate and validate authorized trading partners (ATPs).
Requirement #2: Receive and validate Rx product electronic advance shipment notifications.
Requirement #3: Quarantine suspected illegitimate drugs.
Requirement #4: Notify the FDA and trading partners of suspect illegitimate drugs.
Requirement #5: Provide a timely response to government authorities and trading partners.
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