Reassessment/Revalidation/Re-evaluation Requirements for Sterile Compounding Staff Competencies – Title 16, California Code of Regulations, sections 1751.6(e)(2) and 1751.7(b) and (d)

This waiver extends the reassessment, revalidation, or re-evaluation requirements in Title 16 CCR sections 1751.6(e)(2) and 1751.7(b) and (d) for up to an additional 90 days with respect to semi-annual and annual reassessment, revalidation, or re-evaluation requirements for individuals involved in sterile compounding under the following conditions:

1. The pharmacist-in-charge makes a determination that such a suspension in the reassessment, revalidation, or re-evaluation frequency is necessary and appropriate, balancing site-specific limitations and current staff competencies.
2. The pharmacist-in-charge ensures only properly trained persons are allowed to perform compounding.
3. Documentation is maintained identifying when reassessments, revalidations, or re-evaluations pursuant to this waiver were extended for each staff member involved in sterile compounding. Such documentation must be maintained for three years from the date of making.

Effective: April 15, 2020
Expires: August 12, 2020