Md. Code Regs. 10.34.19.18

Current through Register Vol. 51, No. 22, November 1, 2024

Section 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.

Md. Code Regs. 10.34.19.18

Regulation .18 amended effective 41:13 Md. R. 752, eff.1/1/2015; amended effective 43:2 Md. R. 127, eff.2/1/2016