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Achieving EPCS Certification With Ibeta
iBeta Quality Assurance provides Drug Enforcement Administration (DEA) approved Electronic Prescribing for Controlled Substances (EPCS) Certification for auditing Prescriber and Pharmacy applications for compliance to 21 CFR Part 1311 and related EPCS application requirements, and for validating Biometrics Subsystem for use in EPCS applications pursuant to 21 Code of Federal Regulations (C.F.R) § 1311.300.
iBeta is the only approved auditor approved by DEA to review, verify, and certify that transmission or receiving of electronic prescriptions with controlled substances by prescriber or pharmacy applications meet the requirements of DEA’s 21 CFR Part 1311 regulations as well as to validate Biometric Subsystems for use in two factor authentication to electronically sign prescriptions that include controlled substances for transmission to pharmacies.
What Is EPCS?
EPCS, or Electronic Prescriptions for Controlled Substances, is a secure method of transmitting prescriptions for controlled medications electronically. Electronic transmission, versus a manual paper-based approach, helps to reduce prescription fraud, improve patient safety, and streamline the prescribing process for healthcare providers and pharmacies.
EPCS allows healthcare providers to electronically send prescriptions directly to pharmacies, eliminating the need for paper prescriptions that can be lost or forged. It’s regulated by the DEA under 21 CFR Part 1311 to ensure strict compliance and security, including two-factor authentication and tamper-resistant systems. This technology not only enhances efficiency but also ensures controlled substances are prescribed responsibly and securely.
What States Require EPCS?
As of January 2025, there are 36 states that mandates the use of e-prescribing controlled substance prescriptions. The main reason for the mandates is to combat prescription fraud and opioid abuse. These mandates vary by state, but most include deadlines for compliance. Below are examples of states with EPCS requirements:
- New York: Mandated since 2016.
- California: Required since January 2022.
- Florida: Mandatory as of January 2021.
- Texas: Enforced as of January 2021.
- Arizona: Mandated for most prescribers as of 2020.
- Illinois: Required for controlled substances as of January 2023.
Always check your state’s specific requirements and deadlines for compliance.
What Are Some Of The
Prescriber Application EPCS Requirements?
To comply with EPCS state mandates, healthcare providers must utilize prescriber applications that meet specific DEA requirements. Below are the key components:
Compliant Software:
Use DEA-compliant prescribing software.
Prescriber Identity Proofing:
Verify prescriber identities through a third party.
Access Controls:
Limit system access to authorized users only.
Two-Factor Authentication:
Implement systems requiring two separate credentials, such as passwords and biometrics.
Audit Trails:
Maintain detailed records of all prescriptions and transactions.
Digitally Signed Archival:
Use digital certificates issued by DEA-approved organizations to sign and archive controlled-substance prescription scripts.
And more…
What Are Some Of Application Requirements For EHR Systems That Use Integrated EPCS Modules?
To comply with EPCS state mandates, prescriber applications that integrated 3rd Party EPCS modules, like DrFirst, NewCrop, and others, must also meet specific DEA requirements as prescriber applications. However, many of these requirements are satisfied by the 3rd Party EPCS Module vendor. Below are the key components:
- Compliant Software: Use DEA-compliant prescribing EHR with integrated 3rd Party Module.
- Prescriber Identity Proofing: Verify prescriber identities through a third party.
- Access Controls: Limit system access to authorized users only.
- Two-Factor Authentication: Implement systems requiring two separate credentials, such as passwords and biometrics.
- Audit Trails: Maintain detailed records of all prescriptions and transactions.
- Digitally Signed Archival: Use digital certificates issued by DEA-approved organizations to sign and archive controlled-substance prescription scripts.
- And more…
What Are Some Of The Pharmacy Application EPCS Requirements?
To comply with EPCS state mandates, pharmacies must utilize pharmacy applications that meet specific DEA requirements. Below are the key components:
- Compliant Software: Use DEA-compliant pharmacy software.
- Access Controls: Limit system access to authorized users only.
- Prescription Requirements: Verify that controlled substance prescriptions contain the necessary information required by 21 CFR Part 1311, prescription modification controls, satisfy refill requests, etc.
- Audit Trails: Maintain detailed records of all prescriptions and transactions.
- Digitally Signed Archival: Use digital certificates issued by DEA-approved organizations to sign and archive controlled-substance prescription scripts.
- And more…
Benefits Of EPCS Certification
Obtaining EPCS certification offers numerous advantages. Here are some key benefits explained in detail:
Regulatory Compliance:
Achieving certification ensures that your software complies with DEA regulations. This minimizes legal risks and positions your organization as a trustworthy, compliant provider in the healthcare ecosystem.
Enhanced Security:
EPCS certification helps protect against prescription fraud and unauthorized access. By implementing robust authentication and encryption, you safeguard sensitive patient and prescription data.
Operational Efficiency:
Streamlined workflows for prescribers and pharmacies reduce paperwork and processing delays. EPCS eliminates manual errors, making the prescribing process faster and more reliable.
Improved Patient Safety:
With real-time electronic prescriptions, pharmacies can accurately dispense medications, reducing the risk of errors and ensuring timely treatment for patients.
Streamline Prescription Processing:
Demonstrates your commitment to quality and streamlining prescription processing. It shows you are ahead of the curve in adopting advanced healthcare technology.
iBeta Process To Get EPCS Certified
The DEA-EPCS program allows practitioners, hospitals and pharmacies the option to utilize electronic prescriptions for controlled substances. The program consists of the following three steps:
Enrollment:
iBeta provides a cost-effective certification process with easy enrollment. Completing an EPCS certification agreement is the first step to getting started.
Pre-Certification:
We will work with your team to review all EPCS requirements that must be implemented and verify that the certification release candidate meets DEA EPCS requirements. This process consists of the following tasks:
- Provide Client with a thorough understanding of the EPCS requirements. Client then confirms their software meets the checklist of requirements with ongoing support by a team of expert iBeta EPCS auditors.
- Ongoing gap analysis, discussion and walk-through of any requirements that need clarity for the development team that is tasked to implement these requirements. This includes how and where the system must be modified to meet DEA EPCS regulations to achieve EPCS certification.
- Final pre-certification review of list of DEA EPCS regulations that had to be addressed and validated during the certification process.
Final Certification:
Once iBeta verifies that the application meets DEA EPCS 21 CFR Part 1311 application requirements, iBeta will issue an EPCS Certification Report to the company’s EPCS application for use in production.
Get Started Today With iBeta
Are you ready to ensure your application meets DEA EPCS requirements? Partner with iBeta for a seamless and staged certification process. Our experts will guide you through every step, from pre-certification to receiving your EPCS Certification Report. With our DEA-approved process, you can enhance security, streamline operations, and achieve compliance with confidence.
Contact us today to start your EPCS certification journey and ensure your application is compliant with the highest standards!
FAQs
Who is Required to Achieve EPCS Certification?
Healthcare providers, hospitals, pharmacies, and software vendors developing and selling electronic prescribing systems for controlled substances must obtain EPCS certification. It ensures compliance with DEA 21 CFR Part 1311 regulations and secures the prescription process.
What are the Costs of EPCS Certification?
The cost of EPCS certification varies depending on the complexity of the application and the scope of certification. Contact iBeta for a cost-effective and competitive customized quote based on your specific needs.
How Often is EPCS Recertification Needed?
EPCS recertification is mandated every 2-years from the date of issuance of your EPCS certification report. It is also required when significant updates or changes are made to the certified application. Regular audits may also be necessary to maintain compliance with DEA regulations. iBeta offers compliance review of these ongoing changes by providing DELTA EPCS audits thereby reducing your ongoing EPCS certification fees so you don’t have to constantly be paying for full certification auditing.
What Happens if an Application Does Not Meet EPCS Requirements?
If an application does not meet EPCS 21 CFR Part 1311 requirements during the pre-certification or certification process, iBeta provides detailed feedback and recommendations to address non-compliance issues. During the pre-certification stage the application is continuously reviewed after necessary compliance gap corrections are made. Ongoing pre-certification compliance gap reviews are included in the pricing.
What are the Consequences of not Using Certified EPCS Applications?
Failure to use certified EPCS applications where mandated can result in DEA legal penalties and fines. It can also lead to disruptions to your practice or pharmacy operations. It may also undermine patient safety and trust, as electronic systems reduce the risk of fraud and errors.
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