[Federal Register Volume 78, Number 58 (Tuesday, March 26, 2013)]
[Pages 18364-18365]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-06918]



Drug Enforcement Administration

[Docket No. DEA-364]

Electronic Prescriptions for Controlled Substances Notice of 
Approved Certification Process

AGENCY: Drug Enforcement Administration (DEA), Department of Justice.

ACTION: Notice.


SUMMARY: DEA is announcing two new DEA-approved certification processes 
for providers of Electronic Prescriptions for Controlled Substances 
(EPCS) applications. Certifying organizations with a certification 
process approved by DEA pursuant to 21 Code of Federal Regulations 
(CFR) 1311.300(e) are posted on DEA's Web site upon approval.

Assistant, Office of Diversion Control, Drug Enforcement 
Administration; Mailing Address: 8701 Morrissette Drive, Springfield, 
Virginia 22152; Telephone: (202) 307-7165.



    The Drug Enforcement Administration (DEA) implements and enforces 
Titles II and III of the Comprehensive Drug Abuse Prevention and 
Control Act of 1970 and the Controlled Substances Import and Export Act 
(21 U.S.C. 801-971), as amended, and referred to as the Controlled 
Substances Act (CSA).\1\ DEA publishes the implementing regulations for 
these statutes in Title 21 of the Code of Federal Regulations (CFR), 
Parts 1300 to 1321. The CSA and its implementing regulations are 
designed to prevent, detect, and eliminate the diversion of controlled 
substances and listed chemicals into the illicit market while ensuring 
a sufficient supply of controlled substances and listed chemicals for 
legitimate medical, scientific, research, and industrial purposes.

    \1\ The Attorney General's delegation of authority to DEA may be 
found at 28 CFR 0.100.

    The CSA and DEA's implementing regulations establish the legal 
requirements for possessing and dispensing controlled substances, 
including the issuance of a prescription for a legitimate medical 
purpose by a practitioner acting in the usual course of professional 
practice. ``The responsibility for the proper prescribing and 
dispensing of controlled substances is upon the prescribing 
practitioner, but

[[Page 18365]]

a corresponding responsibility rests with the pharmacist who fills the 
prescription.'' 21 CFR 1306.04(a). A prescription serves both as a 
record of the practitioner's determination of the legitimate medical 
need for the drug to be dispensed, and as a record of the dispensing. 
The prescription also provides a record of the actual dispensing of the 
controlled substance to the ultimate user (the patient) and, therefore, 
is critical to documenting that controlled substances held by a 
pharmacy have been properly dispensed. The maintenance of complete and 
accurate prescription records is an essential part of the overall CSA 
regulatory scheme established by Congress.

Electronic Prescriptions for Controlled Substances (EPCS)

    Historically, where federal law required that a prescription for a 
controlled substance be issued in writing, that requirement could only 
be satisfied through the issuance of a paper prescription. Given 
advancements in technology and security capabilities for electronic 
applications, DEA amended its regulations to provide practitioners with 
the option of issuing electronic prescriptions for controlled 
substances in lieu of paper prescriptions. Efforts to develop EPCS 
capabilities have been underway for a number of years. DEA's Interim 
Final Rule for Electronic Prescriptions for Controlled Substances was 
published on March 31, 2010, at 75 FR 16236-16319, and became effective 
on June 1, 2010.


Certifying Organizations With a Certification Process Approved by DEA 
Pursuant to 21 CFR 1311.300(e)

    As noted above, 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. Relevant information has been posted on DEA's 
Web site at http://www.DEAdiversion.usdoj.gov.

    Dated: March 20, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 2013-06918 Filed 3-25-13; 8:45 am]