STERILE COMPOUNDING ADVERSE EVENT REPORTING

October 2016

COMAR Updates
 
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:
 
Adverse Event Reporting Form Version 1.4 (Updated Oct 2016)
 
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
Address:
Sterile Compounding Monitoring Program
Maryland Board of Pharmacy
4201 Patterson Ave
Baltimore, MD 21215