The Drug Enforcement Administration (DEA) has approved iBeta’s Certification Process for a Biometrics Subsystem for the Electronic Prescriptions for Controlled Substances (EPCS) pursuant to 21 Code of Federal Regulations (C.F.R) § 1311.300. This announcement can be found on the federal Registry site.
iBeta is now authorized to review, verify and certify that particular electronic prescribers or electronic pharmacy applications meet the requirements of DEA’s regulations governing EPCS.
The DEA-EPCS program allows practitioners, hospitals and pharmacies the option to utilize electronic prescriptions for controlled substances.
The Department of Health of New York State has mandated electronic prescribing effective March 27, 2015.
How to get started:
- The applicable EPCS questionnaire will be filled out and submitted to iBeta: Click to download the EPCS Prescriber Questionnaire or the EPCS Pharmacy Questionnaire.
- The next step is to obtain a pre-certification:
The objective of iBeta’s EPCS Pre-Certification services is to review the Client’s system against the DEA EPCS regulations specifically the 21 CFR Part 1300, 1304, 1306 and 1311 requirements to assess readiness for a certification. iBeta will work with the client to review to verify that the certification candidate meets the DEA/EPCS requirements. This review consists of the following tasks:
- Provide client with a check-list of requirements (a list of the DEA regulations that apply to the prescribing and or pharmacy application)
- Walk-through and discussion of the regulations in a system demo (either the certification candidate or the current application with discussions on how and where the application will be modified to address the DEA EPCS regulations);
- Deliver an assessment matrix and discrepancy report to the client as the gap analysis.
- Discrepancy report is a numbered list of findings that were not found or were found to not satisfy the DEA requirement(s).
- Issue a pre-certification letter that includes the full list of DEA EPCS regulations that will be validated during the Certification and the test method for the verification/validation.
- Once the pre-certification has been successfully completed, the full certification process can begin:
Once the EPCS Pre-Certification is completed, iBeta will audit the Client’s application to validate that it meets DEA EPCS requirements. Once iBeta validates that the application meets DEA EPCS CFR requirements, iBeta will produce an EPCS Certification Report and issue to the Client.