Pharmacy Technology & Management Review

Pharmacy Technology & Management Review

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Pharmacy Technology & Management Review
Cost Options for DSCSA Compliance
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Cost Options for DSCSA Compliance

Jan 05, 2023
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Pharmacy Technology & Management Review
Pharmacy Technology & Management Review
Cost Options for DSCSA Compliance
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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.

Randy Hoggle Advasur DSCSA Track and Trace Compliance Costs
Randy Hoggle

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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