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:

The following are some examples of increases in activity from the FDA in 2022:

FDA Letter to Valisure

- 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 Valisure noted the related services are no longer active but it highlights aspects that FDA is looking for in inspections around investigating suspect product as well as notifying trading partners.

Sagent Pharmaceuticals, Inc Warning Letter

Nephron Pharmaceuticals Corporation Warning Letter

Hybrid Pharma, LLC Warning Letter

Apothecary Health Solutions-Right Value Drug Stores, LLC Warning Letter

- 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 info@tencountconsulting.com for more information.

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