12 Common DSCSA Questions Answered
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DSCSA compliance continues to pose challenges and raises questions for many in the industry. Whether your pharmacy was ahead of the DSCSA curve or you're still in the starting blocks, questions and concerns about requirements, impact, and scope likely linger. These questions are made more daunting in light of last year’s last-second enforcement delay and recent news of federal pharmacy exemption criteria. Read below for answers to 12 common customer questions regarding DSCSA to see what other LTC pharmacies are asking.
Will DSCSA requirements be postponed again, similar to last November's delay?
The FDA recently issued a letter providing certain Drug Supply Chain Security Act exemptions for small pharmacies regarding interoperability. However, this was not a blanket DSCSA pharmacy exemption, and all other aspects of the law must be fully compliant. The FDA has confirmed that the stabilization period will end on November 27, 2024, with no further DSCSA delay expected. All stakeholders should work toward 100% compliance with the Drug Supply Chain Security Act (DSCSA) on the enforcement date. Unlike last year, members across the drug distribution supply chain have implemented DSCSA-compliant workflows, establishing the infrastructure needed to meet the federal mandates that caused the 2023 enforcement delays.
Does the DSCSA apply to drug tracing only, or does it include testing supplies, wound care, and other medical supplies dispensed by the pharmacy?
The DSCSA only regulates the distribution and dispensing of drugs. Currently, over-the-counter products, medical supplies, and testing supplies are not regulated under the scope of the Drug Supply Chain Security Act, and tracking these items is not required.
What should we be doing if we sell stock medications to physician's offices?
If your pharmacy sells stock medication (non-patient-specific drugs) to medical offices, you must produce transaction documentation and keep the data for six years. While the pharmacy does not need to send data to the doctor’s office automatically, you must be able to provide it if requested within three years.
What is the turnaround to receive corrected data? does it depend on the vendor?
The typical turnaround time for vendor replacement data should be within 24-48 hours. Currently, many vendors are likely unable to reliably meet this 48-hour timeline. If you receive missing or incorrect data, quarantine the product until the data is corrected. If you are using a third-party vendor to assist with DSCSA tracing and tracking, they should be able to help you retrieve replacement data. It's advisable to produce an exception report and issue it to the vendor, requesting the correct data be documented appropriately. PTMR
On-Demand Webinar On LTC Pharmacy DSCSA Compliance
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