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New DSCSA Guidance Details Layers Of Verification System Requirements

New DSCSA Guidance Details Layers Of Verification System Requirements
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FDA Gives More Time To Comply With Certain DSCSA Requirements

FDA Gives More Time To Comply With Certain DSCSA Requirements
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ICYMI: FDA issues three pieces of guidance on DSCSA that affect pharmacies

Last week, the FDA issued three pieces of guidance for pharmacies. The first, entitled Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act, updated and finalized a June 2021 draft guidance. In this guidance, FDA emphasized that pharmacies (known as “dispensers” in the DSCSA) and other trading partners’ product tracing information should be true, accurate, and complete.

Standards for the interoperable exchange of informationCardinal healthEnhanced drug distribution securityPackage level underDrug supply chain security actWholesale distributor verification requirementSaleable returned drug productIllegitimate productInteroperable exchangeCertain humanPrescription drugs guidanceSmith drug

FDA issues guidance on DSCSA that affect pharmacies

Last week, the FDA issued three pieces of guidance for pharmacies. The first, entitled Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act, updated and finalized a June 2021 draft guidance. In this guidance, FDA emphasized that pharmacies (known as “dispensers” in the DSCSA) and other trading partners’ product tracing information should be true, accurate, and complete.

Standards for the interoperable exchange of informationCardinal healthEnhanced drug distribution securityPackage level underDrug supply chain security actWholesale distributor verification requirementSaleable returned drug productIllegitimate productInteroperable exchangeCertain humanPrescription drugs guidanceSmith drug

Drug Supply Chain Security Act Requires Electronic Tracking

Drug Supply Chain Security Act Requires Electronic Tracking
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