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Certifying organizations with a certification process approved by DEA

from AzPA

In the March 26 Federal Register, the DEA published the attached notice regarding qualified certifying organizations’ certification processes for electronic prescription or pharmacy applications to be verified and certified as meeting the requirements of 21 CFR Part 1311. The notice indicates the following:

    Certifying organizations with a certification process approved by DEA pursuant to 21 CFR 1311.300(e)
    “… the Interim Final Rule provides that, as an alternative to the audit requirements of 21 CFR 1311.300(a) through (d), an electronic prescription or pharmacy application may be verified and certified as meeting the requirements of 21 CFR Part 1311 by a certifying organization whose certification process has been approved by DEA. The preamble to the Interim Final Rule further indicated that, once a qualified certifying organization’s certification process has been approved by DEA in accordance with 21 CFR 1311.300(e), such information will be posted on DEA’s Web site. 75 FR 16243 (March 31, 2010). On January 18, 2013, DEA approved the certification processes developed by Global Sage Group, LLC, and by iBeta, LLC. iBeta’s certification process was previously approved by DEA but only with regard to the certification of the application’s biometrics subsystem, including its interfaces. 77 FR 45688 (August 1, 2012). This approval for iBeta’s certification process is expanded to include the entire certification process.”


A list of qualified certifying organizations with a certification process that has been approved by DEA is posted on the DEA Office of Diversion Control website.

Please refer to the Federal Register notice for further details. more


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