There are many myths in the world of DSCSA Compliance.
Knowing what is required - and what is not - can protect dispensers from making unnecessary investments.
Common DSCSA Compliance Myths
Myth: “I must scan everything that arrives.”
Reality: Barcode scanning is not mandated by DSCSA.
Barcode scanning at receiving can streamline purchasing and inventory management and help simplify recall management.[3]
Myth: “I must check every serial number that arrives at my pharmacy.”
Reality: Checking serial numbers is not required for Dispensers under DSCSA.[4]
DSCSA tracking requirements only apply to product ownership.[1]
Myth: “I must use Verification Routing Services (VRS) to verify every package or serial number with the Manufacturer.”
Reality: There is no DSCSA requirement for Dispensers to verify every item.
VRS are designed for distributors to authenticate returned items prior to accepting these as Saleable Returns. Many distributors have created their own solutions and have no plans to use VRS.[2]
Current Verification Routing Services (VRS) are not designed or required to be used by Dispensers to comply with DSCSA.
Myth: “I must track every item from receiving to patient administration.”
Reality: Not required. DSCSA specifically exempts the pharmacy dispensing and patient administrations processes from any tracking requirements.
Myth: “I should make plans today to meet clear technology requirements for DSCSA in 2023.”
Reality: The FDA has issued no guidance on technology to meet 2023 requirements. Until the Agency issues clear Guidance, DSCSA compliance investment decisions should focus on today’s clear requirements.
Understanding Compliance and Serialization
Manufacturers must meet specific serialization requirements today. These requirements have no impact on dispenser compliance.
As highlighted above:
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- Dispensers DO NOT need to scan every item that arrives.
- Dispensers DO NOT need to track or capture individual serial numbers.
- Dispensers DO NOT need to confirm serial numbers they receive with suppliers.
How to be Compliant, Today
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- Dispensers should only accept products with FDA-specified 2D Data Matrix barcodes.
- T3 data for all Human Prescription Drugs must be stored in an easily accessible database for six years, and able to be produced within 48-hours
*T3 data can be sent via physical document, or electronically via EDI
Our Solution
ConsortiEX offers DSCSA Compliance as a Service, a SaaS model designed to meet current and future DSCSA requirements. Our team takes on the manual work that competing solutions place on you.
If you have any concerns about your compliance, or general questions about what it means to be compliant, contact us today.
1 - https://oig.hhs.gov/oei/reports/oei-05-17-00460.asp
2 - https://www.fda.gov/media/131005/download
3 - https://www.fda.gov/media/116304/download
4 - https://www.fda.gov/media/93779/download