Sterile Compounding Adverse Event Reporting

October 2016

COMAR Updates

COMAR 10.34.19 revisions were effective February 1, 2016.  These changes govern Board inspections, new mandatory reporting requirements, and permitting requirements for sterile compounding facilities.

Adverse Event Reporting

The new reporting requirements include reporting of adverse patient events and environmental contamination events.  The following form must be used for reporting of an adverse patient event, environmental contamination, or both:

NOTE: Adverse event reporting is a requirement for sterile compounding establishments only.  Patients who experience an adverse event related to a compounded product should file a complaint with the Board.
Phone: (410) 764-4755
Sterile Compounding Monitoring Program
Maryland Board of Pharmacy
4201 Patterson Ave
Baltimore, MD 21215