Bridge the Gap: Conduct a <797> Gap Analysis to Extend BUDs

While the revised USP <797> allows compounders to achieve longer beyond-use dates (BUDs) via Category 3 compounded sterile preparations (CSPs), these “extended” BUD CSPs require enhanced quality assurance to ensure safety and stability.

Through various measures including quality assurance elements, pertinent stability-indicating studies, and quality control testing for each CSP formulation, BUDs may be extended up to 180 days when all conditions are met. Implementing these requirements to meet Category 3 CSPs necessitates careful planning and a firm understanding of the current state of compounding, the desired state, and any gaps between the two.

To facilitate USP <797> Category 3 compounding compliance, Cone Health has created a gap analysis and tracker to ensure all requirements for this process are met.

Successful implementation of a Category 3 compounding operation can help the organization maintain a stable supply of ready-to-administer sterile injectable medications.

In addition, this approach can provide a bridge during shortages or disruptions of conventionally manufactured preparations when 503B outsourcing facilities are unable to meet the increased need.

Despite these benefits, ensuring that a facility can comply with the rigorous standards requires careful planning. Conducting a gap analysis and creating a compliance plan can help ensure all conditions are met so that facilities are able to benefit from the enhanced stability Category 3 compounding provides.

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