FDA’s Remote Regulatory Assessments Enhance DSCSA Compliance With Technology-Driven Oversight

Read the final guidance here.

Takeaways

• The guidance underscores the FDA’s commitment to leveraging remote oversight to protect public health and ensure compliance.
• The Drug Supply Chain Security Act (DSCSA) has extensive electronic documentation requirements for pharmaceutical supply chain trading partners that become fully effective at various times in the coming months. Manufacturers subject to the law should already be complying unless they are specifically exempted.
• Given the DSCSA’s considerable electronic documentation requirements, Remote Regulatory Assessments (RRAs) may prove to be a go-to tool for the FDA to evaluate DSCSA compliance at both domestic and foreign establishments.

Background and Purpose

RRAs are a mechanism for the FDA to conduct oversight of regulated entities without the need for on-site visits. RRAs were initially adopted during the COVID-19 pandemic to overcome travel restrictions and have since become a valuable method for maintaining regulatory oversight.

The FDA’s guidance on RRAs clarifies how these assessments are conducted, what is expected from companies, and aims to provide transparency and consistency in the process. RRAs can be initiated when in-person inspections are impractical or when the FDA wants to focus on specific risks. During an RRA, the FDA may request records, hold virtual meetings, or use video technology to review facilities. RRAs differ from traditional inspections but can inform the FDA’s decisions about whether further regulatory action or follow-up inspections are necessary.

The DSCSA imposes significant prescription drug traceability documentation, record-keeping, and investigation procedure requirements on trading partners to better secure the US pharmaceutical supply chain. The final DSCSA traceability requirements are being phased in with key deadlines for electronic documentation already in effect for manufacturers and additional deadlines extending later into the year for most other trading partners.                                                                             

Conclusion

The FDA’s guidance on RRAs, combined with the electronic documentation requirements of the DSCSA, signal a potential shift toward more technology-driven oversight of the pharmaceutical supply chain. Being prepared for RRAs and maintaining DSCSA requirements will help ensure smooth interactions with the FDA and ongoing compliance with federal law.