FDA Letters and Warnings? Are you audit ready for DSCSA?
We felt it was important to highlight the increase in DSCSA activities in 2022 by the FDA.
Don't forget the last critical step in your journey to DSCSA compliance of ensuring that your organizations policies, procedures and training are updated appropriately to clearly document your compliance. The FDA increased mentions of DSCSA in warning letters and other activities in 2022 and we expect this to continue to increase as the important DSCSA requirement of November 27th, 2023 approach. State Boards of Pharmacies are now becoming more aware of the law and are expected to incorporate more aspects in their inspections and activities as well.
Several related discussions by trading partners at the recent 2022 FDA DSCSA Public Meeting highlight why some should be concerned:
- Serial Level TI Data- A significant portion of manufacters have not yet started providing serialized saleable unit level transactional data to trading partners. This is concerning because the manufactures have now had over 9 years to implement systems and begin sending serialized data that is exponentially more complicated that lot level data such as a single EDI 856- ASN (Advance Ship Notice) file. It is unlikely that their customers will have sufficient time to onboard, perform cascading onboarding and work through stabilization issues which have been common in the related EPCIS file transmissions implemented to date. Trading partners will ultimately need to then incorporate these new systems and related processes into their procedures and training.
- Barcode Quality- A distributor highlighted examples of recent barcode issues with photo examples, which can be found in the oral remarks slides, that highlight lack of readiness and conformance testing at manufacturers and repackagers. All manufacturers and repackagers should ensure that their processes include barcode readability and conformance checks to avoid non-compliance. Many distributors are also offering to test barcodes and provide feedback which is a offer that all should be taking.
- 3911 Reporting- A manufacturer highlighted that some trading partners appear to not be following requirements related to submitting 3911 suspect/illegitimate notification forms to the FDA or notify trading partners in the event of confirmed illegitimate cases such as stolen product. All trading partners should already have procedures that outline how to look for, quarantine, investigate and notify FDA/trading partners in the event of suspect/illegitimate product.
- 2023 Requirements Planning- Trading partners should be allowing time for implementation, adoption, stabalization, procedure updates and training prior to the November 27th due date, which means you should already be well on your way to compliance. These requirements have significant cross organizational communication needs and should be coupled with change management plans to ensure alignment.
The following are some examples of increases in activity from the FDA in 2022:
- The FDA highlighted aspects of DSCSA that were not being followed by previous activities at ValisureRx. Valisure noted the related services are no longer active but it highlights aspects that FDA is looking for in inspections around investigating suspect product as well as notifying trading partners.
- The FDA highlighted that DSCSA labeling should be followed in several warning letters to facilities that did not follow or fit into 503b compounding requirements.
In addition to these more formal methods of showing DSCSA activity, TCC has seen a clear pattern in NDA/BLA submissions where the FDA is ensuring that DSCSA labeling requirements including human and barcode scanner readable sections are well understood and followed. Don't wait for the FDA to point out your organization does not understand the requirements in the review process.
At the state level, more clients are highlighting increasing awareness and activity by the boards of pharmacies to raise awareness and check for compliance with the already existing lot level requirements of DSCSA. We expect this activity to pick up significantly as the year progresses and groups like NABP (National Association of Boards of Pharmacy) have been leading efforts to help inform and prepare regulators and the pharmacies they regulate.
We are proud to offer clients a comprehensive DSCSA Readiness Assessment that includes a complete review of all aspects of DSCSA.
We will highlight any found areas where your organization needs to improve documentation, systems or processes to be able to show full compliance.
Please reach out to us at firstname.lastname@example.org for more information.