Controlled Substance Utilization Review and Evaluation System
New Proposed CURES Regulations
Proposed regulations pertaining to the Controlled Substance Utilization Review and Evaluation System (CURES) have been posted. The proposed regulations revise and add to the CURES access and use regulations that took effect on July 1, 2020. Relevant information concerning these regulations, including the Initial Statement of Reasons and related documents, may be found on the following webpage of the Office of Attorney General’s website: https://oag.ca.gov/jdis/regs#cures
AB 149 – New Requirements for Rx Forms
Beginning January 1, 2021, the only California controlled substances prescription forms that will remain valid and acceptable by pharmacies will be those possessing a 12 character serial number and corresponding barcode compliant with the requirements introduced in Assembly Bill 149. For more information about these requirements, please review the following bulletin, which has been jointly released by the California Department of Justice and the California Department of Consumer Affairs: AB 149 – New Requirements for Rx Forms. If you need to acquire new forms, please consult the Approved List of Security Prescription Printers.
To hear the CA Department of Consumer Affairs’ guidance to consumers for identifying AB 149-compliant controlled substance prescription forms, please go to the Public Service Announcement.
AB 528 – Updates
Beginning on January 1, 2021, dispensing pharmacies, clinics, or other dispensers are required to report dispensation data for Schedule V controlled substance prescriptions to the Department of Justice. Additionally, dispensation reporting for Schedules II-V controlled substance prescriptions are required to be reported not more than one working day after the date a controlled substance is released to a patient or a patient’s representative. The CURES database will reflect updated dispensation information within 24 - 72 hours from the time a dispenser reports the information.
Additionally, implementation of new system features that support certain requirements concerning expanded access to CURES is expected by April 2022. For more information on the delayed implementation of system functionality, please review the joint bulletin, released by the California Department of Justice and the California Department of Consumer Affairs: AB 528 – Update on Implementation of System Enhancements.
For more information on the dispensation of controlled substances, please review the following bulletin, which has been jointly released by the California Department of Justice and the California Department of Consumer Affairs: AB 528 – New Requirements for Reporting to CURES.
Controlled Substance Utilization Review and Evaluation System
California’s Prescription Drug Monitoring Program
CURES (Controlled Substance Utilization Review and Evaluation System) is a database of Schedule II, Schedule III, Schedule IV and Schedule V controlled substance prescriptions dispensed in California serving the public health, regulatory oversight agencies, and law enforcement. CURES is committed to the reduction of prescription drug abuse and diversion without affecting legitimate medical practice or patient care.
The operation of CURES complies with all applicable federal and state privacy and security laws and regulations. The controlled substances dispensation history of an individual that is received by a practitioner or pharmacist from CURES is subject to the Confidentiality of Medical Information Act and the Health Insurance Portability and Accountability Act of 1996 (HIPAA), including the HIPAA regulations in 45 Code of Federal Regulations parts 160 and 164.
Access to CURES is strictly limited. Licensed health care practitioners and licensed pharmacists may access information in CURES only for patients under their care. Regulatory agency officials and law enforcement officials may access information in CURES only to assist the efforts of their agencies to control the diversion and resultant abuse of controlled substances.
CURES Registration Requirements
California law (Health and Safety Code Section 11165.1) requires all California licensed health care practitioners authorized to prescribe Schedule II, Schedule III, Schedule IV and Schedule V controlled substances to register for access to CURES upon issuance of a Drug Enforcement Administration Controlled Substance Registration Certificate. California licensed pharmacists must register for access to CURES upon issuance of a Board of Pharmacy Pharmacist License.
Prescriber and Pharmacist registration to access CURES is simple and fully automated. Prescribers and Pharmacists can register by accessing the CURES User Registration.
CURES Mandatory Consultation
Section 11165.4 of the Health and Safety Code, sets forth the requirements for mandatory consultation of CURES. Please refer to your respective state licensing board for additional information regarding the CURES consultation requirement.
Submission of Controlled Substance Data
California Health & Safety Code Section 11165(d) requires dispensing pharmacies, clinics, or other dispensers of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances to provide specified dispensing information to the Department of Justice as soon as reasonably possible, but not more than one working day after the date a controlled substance is released to the patient or patient’s representative, in a format approved and accepted by the DOJ. Currently, the ASAP 2009 Version 4.1 format is accepted.
Veterinarians shall report the dispensation information required by California Health & Safety Code Section 11165(d) to the department as soon as reasonably possible, but not more than seven days after the date a controlled substance is dispensed.
Direct Dispense Reporting Application
The California Department of Justice (CA DOJ), in coordination with Atlantic Associates, Inc. (AAI), allows direct dispense prescribers and entities, including pharmacies filling less than 25 prescriptions per month, to electronically report dispensing data to the CA DOJ. The direct dispense application can be accessed on the Direct Dispense website. Also available at this website are instructions on how to apply for an account and submit dispense data. Please note that the CA DOJ no longer accepts paper direct dispense reports.
To access the secured direct dispense site, dispensers must first complete the application at http://aaicures.com/register.for.access.php. Once an application has been submitted, an email confirmation from AAI will provide approved users with a username and temporary password. If an email confirmation is not received within 48 hours of submitting the application, please contact AAI at CACures@aainh.com or (800) 539-3370.
For additional information concerning controlled substance prescription data reporting, please contact AAI at CACures@aainh.com or (800) 539-3370.
In accordance with California Health & Safety Code section 11165(c)(2)(A) the California Department of Justice (CA DOJ) may provide CURES data to public or private entities, as approved by the CA DOJ, for educational, peer review, statistical, or research purposes, provided that the patient information, including any information that may identify the patient, is not compromised.
To request CURES data for any of the above listed purposes, or for additional information about the data request process, you can go to the Research Center “Data Request Process” website at https://oag.ca.gov/research-center/request-process.
PRESCRIPTION FORMS (FOR PRESCRIBERS)
Obtain Security Prescription Forms
California law requires prescribers of any Schedule II, Schedule III, Schedule IV, and Schedule V controlled substance to obtain and use tamper-resistant prescription forms ordered only from state-approved security printers. To order tamper-resistant prescription forms, please refer to the Approved List of Security Prescription Printers for vendors authorized by the California Department of Justice and the vendor’s contact information.
Report Lost or Stolen Prescription Forms
Reports of lost or stolen prescription forms or pads must be reported to local law enforcement and CURES. Users registered with CURES can electronically report their lost or stolen prescription forms or pads online when logged into their CURES account. A law enforcement agency report number is required when submitting a report of lost or stolen prescription forms to CURES.
For questions concerning how to report lost or stolen prescription pads or forms, please contact the Security Prescription Printer Program at SecurityPrinter@doj.ca.gov.