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.

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Are pharmacies required to track serialized data while dispensing products to patients under DSCSA?

Serialized data tracking does not extend to dispensing under DSCSA today. The pharmacy's duty to track the serialized drug transaction and distribution history stops once the pharmacy assumes ownership of the drug.

Will FrameworkLTC handle serialized product tracing, or will it require a third-party tool to be compliant with DSCSA?

Serialized product tracking and verification are currently not supported natively in FrameworkLTC. Future integrations with our DSCSA compliance partners will provide the opportunity to help these functions within FrameworkLTC. If you would like to see this in our application, please submit or vote on this idea in FrameworkSpark.

Is there a requirement for having a written DSCSA-specific Standard Operating Procedure (SOP)?

The Pharmacies DSCSA SOP must cover how the pharmacy stays compliant with the entire law. Some third-party DSCSA services provide SOP templates with pre-configured formatting and guidelines as an additional consultative service to pharmacies. When creating SOPs, the most important thing to remember is to be well organized, clearly lay out all information in an easy-to-understand way, and over-communicate by providing as many guidelines and as much information as possible. This DSCSA SOP Checklist created by the National Community Pharmacists Association (NCPA) in 2023 offers helpful considerations and a framework for developing a comprehensive and audit-friendly SOP.

What impact does DSCSA have on the pharmacy-to-patient relationship for patient-specific dispensing?

If a pharmacy owns the dispensing machine, the transaction is exempt, as the machine is considered part of a commonly held network. In this instance, the transaction is deemed as ‘patient-specific.’ Suppose another entity owns the machine (i.e., another pharmacy entity, pharmacy satellite branch, patient facility, care community, etc.). In that case, the pharmacy should produce transaction data and track it to the licensed pharmacy entity that owns the machine.

How should accidental receipt of medication not listed on a manifest/invoice be reported?

If the pharmacy keeps the medication, the drug should be quarantined until the T3 (Transaction Information, Transaction History, and Transaction Statement) data is received. If the pharmacy returns the product to the distributor, no compliance responsibilities exist for the pharmacy related to that null order.

Will FrameworkLTC include new receiving information for the serialized product, or will it be able to verify the accuracy of the received product?

Verification Router Service (VRS) is a system that helps assist with data transfer provided by third-party wholesale or DSCSA compliance vendors. Explore SoftWriters' DSCSA Partner Integrations for solutions, functionality, and supplementary services leveraging methods like VRS to streamline DSCSA data collection and reporting accuracy and reliability.

What happens if you donate or resell unused or expired medications?

If the pharmacy is selling any unused medications, they must be tracked as outgoing transactions, and the pharmacy needs the ability to produce the T3 data to track the medication. Many third-party DSCSA software solutions are equipped with functionality to easily perform this function. If the medication is expired and/or destroyed, there are no tracking compliance requirements since it is not re-entering the supply chain.

Browse FrameworkLTC DSCSA Partner Integrations

Don’t want to take on DSCSA compliance by yourself? Explore third-party DSCSA partners integrated with FrameworkLTC to ensure a seamless and reliable DSCSA-friendly workflow. In addition to providing software solutions that enable you to track, trace, and report on medication history, our partners offer supplementary consulting, lending their DSCSA expertise to ensure that you maximize their solutions' use and configure audit-friendly processes and procedures.

Explore Additional DSCSA Resources From SoftWriters

Browse On-Demand DSCSA Webinars from SoftWriters