California Now Requires Medication Error Reporting

 Important Notice for Resident and Non-Resident Pharmacies

As of 2025, pharmacies licensed to dispense medications to California patients—including both resident and non-resident pharmacies—are now subject to mandatory medication error reporting requirements under Business and Professions Code (BPC) § 4113.1. 

Key Points: 

• Who is affected: All community pharmacies dispensing to outpatients in California, including non-resident pharmacies, must comply. The only exclusions are Department of Corrections facilities and outpatient hospital pharmacies already reporting adverse events to the California Department of Public Health under Health & Safety Code § 1279.1. 

• What is required: Pharmacies must report medication errors within 14 days of discovery to a Board-approved third-party. 

• Where to report: The California Board of Pharmacy has selected the Institute for Safe Medication Practices (ISMP) to collect and review reports. 

• Record retention: Pharmacies must maintain documentation of compliance for 3 years and provide it upon Board request. 

Important: Already Part of a PSO? Please Read 

If your pharmacy currently participates in a Patient Safety Organization (PSO), such as APMS, we recommend that you do not immediately register with ISMP. PSOs may be able to fulfill this reporting requirement on your behalf. 

APC is actively monitoring the implementation of this new mandate and working to clarify whether existing PSO reporting pathways will be accepted under BPC § 4113.1. We will update members as soon as we receive definitive guidance and will have more information to share at our next monthly PFM Public Policy Briefing on May 7.  

Registration Timeline (for those not in a PSO): 

• ISMP mailed registration instructions the week of April 21, 2025. 

• You may also register online at: https://mederrors.ismp.org/ 

• Deadline to register: May 24, 2025. 

• Reporting system launch: Early June 2025. ISMP will email registered users access credentials at that time. 

We know this new requirement adds complexity, particularly for non-resident pharmacies and those already committed to quality improvement through a PSO. APC will continue advocating for streamlined processes and providing timely updates as details emerge. 

California’s FAQ on the program can be found here.