# COMAR Title 10 — Maryland Department of Health

## Subtitle 34 — Board of Pharmacy

### Chapter 19 — Sterile Pharmaceutical Compounding

#### Regulation .18 Reporting Requirements Pharmacies.

*COMAR 10.34.19.18*

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.