Regulation .18 Reporting Requirements Pharmacies.

A pharmacy shall:

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

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.