Sec. 10.34.19.18. Reporting Requirements Pharmacies

A pharmacy shall:

A. Document and perform routine testing as required by USP 797 Standards for the appropriate risk levels of sterile compounded preparations; and

B. Report to the Board within 5 calendar days:

(1) Adverse events that have been discovered including corrective actions taken or proposed;

(2) Deficiencies related to the sterile compounding process;

(3) Disciplinary actions in other states or by other state agencies;

(4) Changes in accreditation status;

(5) Disciplinary actions taken against a pharmacist who is an owner, operator, or employee of the pharmacy; and

(6) Disciplinary actions taken against any other known permit, or any other authorization, held by the pharmacy permit holder.