Pharmacies now have until November 1 to comply with certain parts of the Drug Supply Chain Security Act (DSCSA) that were previously scheduled to go into effect on July 1.
The FDA recognizes that some pharmacies require more time to implement the electronic systems designed to capture and maintain product tracking information. The agency has no intention of taking action against pharmacies whose electronic systems are not ready to process the federally required tracking data. The FDA will also not take action against pharmacies that are accepting ownership of prescription drugs that do not have the required tracking information.
The FDA does, however, require pharmacies to adhere to the July 1 deadline to provide tracking information, down to the lot level, on prescription drugs and biologics being sent to other supply chain partners.
According to corporate director of pharmacy operations for Columbia, Maryland-headquartered MedStar Health, Raymond Lake, the reprieve will help the regional health system because it has spent a lot of time since late 2014 crafting the necessary policies and procedures for compliance with DSCSA requirements.
Lake says they were missing an important piece of the tracking system – a vendor. The contract for the vendor has yet to be finalized, but once everything has been finalized, it’s going to be another one to two months before the system could go live.
McKesson, MedStar’s primary wholesaler, already maintains the electronic portal for product tracing information required under the DSCSA. But MedSTAR also purchases medications from 100 other vendors, not all of which are using electronic documentation. There is no standardization of the tracing documents, so there is variety in what is being provided. Lake says the July deadline had him worried about needing to store paper tracking documents from the direct vendors.
The electronic system that will be implemented soon will organize all of the tracking information in one place.
Under the DSCSA, dispensers must collect product transaction data and store it for six years. Any data requested about product recalls or FDA investigations of illegitimate drugs must be able to be retrieved within two business days.
The FDA made adjustments to the deadline because they do not want to cause interruptions within the supply chain and if interruptions or cause, they want to minimize them. Starting in November, the failure to obtain the necessary tracking and tracing documentation may lead to the inability to get a certain product. This could affect patient care.
The FDA guidance document provided a great deal of information about the delay in compliance deadline, but it did not address issues about exemptions to documentation requirements for the transfer of medication between hospitals, ambulance services, rural clinics, and first responders. Clarity from the FDA on these situations will help pharmacists and pharmacies tremendously.