Multi-Dose Eye Drops Expiration Dates

Did you know that on June 3, 2022, the Centers for Medicare and Medicaid Services (CMS) updated the guidance for the use of multi-dose eye drop bottles? This updated guidance includes the following when certain criteria listed below are met: 

• Multi-dose eye drop bottles may be used on more than one patient.  
• Multi-dose eye drop bottles do not need an expiration date written on the bottle once opened; the manufacturer’s expiration date printed on the label should be followed unless the manufacturer specifies a different date for the opened bottle. 
• The 28-day discard date does not apply to multi-dose eye drop bottles. 
• Multi-dose eye drop bottles may be stored in the immediate patient care area including the operating room, anesthesia cart, etc., provided they are protected from possible contamination.

Facilities need to keep in mind that eye drop medications labeled as multi-dose may be used for more than one patient if, and only if, aseptic technique and standard precautions are followed. Additionally, if the eye drop medication is labeled as single-use, it must be discarded immediately after use on a single patient. 

The facility must monitor and perform surveillance activities to observe the administration of multi-dose eye drops as part of its infection control program and quality assessment and performance improvement plan.  This includes facility staff being trained initially and then having ongoing annual education and competencies documented specific to multi-dose eye drops. This will help reduce cross-contamination and mitigate infection risks from patient to patient.  

The facility must also have this process documented in its policies and procedures, including a clear distinction for the expiration dates of single-dose and multi-dose medications and single-dose and multi-dose eye drops. Upon survey, all facility staff must be able to demonstrate knowledge of the facility’s policy for the use of multi-dose eye drops. 

Additional information and policy templates can be found within these links: 

American Society of Ophthalmic Registered Nurses: Recommended Practice: Use of Multi-dose Medications 

CMS Center for Clinical Standards and Quality/Quality, Safety & Oversight Group:  QSO-22-16-ASC  

Since 1980, QUAD A (a non-profit, physician-founded and led global accreditation organization) has worked with thousands of healthcare facilities to standardize and improve the quality of healthcare they provide – believing that patient safety should always come first.