[Federal Register Volume 79, Number 239 (Friday, December 12, 2014)]
[Notices]
[Page 73907]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-29118]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-405]


Electronic Prescriptions for Controlled Substances: Notice of 
Approved Certification Process

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice of approved certification process.

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SUMMARY: The Drug Enforcement Administration is announcing one new DEA-
approved certification process for providers of Electronic 
Prescriptions for Controlled Substances applications. Certifying 
organizations with an approved certification process are posted on the 
Drug Enforcement Administration's Web site upon approval.

FOR FURTHER INFORMATION CONTACT: Imelda L. Paredes, Office of Diversion 
Control, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, Virginia 22152, Telephone: (202) 598-
6812.

SUPPLEMENTARY INFORMATION:

Legal Authority

    The Drug Enforcement Administration (DEA) implements and enforces 
titles II and III of the Comprehensive Drug Abuse Prevention and 
Control Act of 1970, as amended. Titles II and III are referred to as 
the ``Controlled Substances Act'' and the ``Controlled Substances 
Import and Export Act,'' respectively, and are collectively referred to 
as the ``Controlled Substances Act'' or the ``CSA'' for the purpose of 
this notice. 21 U.S.C. 801-971. The DEA publishes the implementing 
regulations for these statutes in title 21 of the Code of Federal 
Regulations (CFR), chapter II. 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 providing for the legitimate medical, scientific, research, and 
industrial needs of the United States. Controlled substances have the 
potential for abuse and dependence and are controlled to protect the 
public health and safety.
    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 a 
corresponding responsibility rests with the pharmacist who fills the 
prescription. 21 CFR 1306.04(a). The prescription 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 dispensed. The 
maintenance of complete and accurate records is an essential part of 
the closed system of distribution established by Congress.

Electronic Prescriptions for Controlled Substances

    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, the DEA amended its regulations to provide practitioners 
with the option of issuing electronic prescriptions for controlled 
substances in lieu of paper prescriptions. The 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.

Update

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

    The interim final rule and the DEA's Electronic Prescriptions for 
Controlled Substances Clarification (76 FR 64813) provide that, as an 
alternative to the third-party 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 the DEA. The preamble to the interim final rule further 
indicated that, once a certifying organization's certification process 
has been approved by the DEA in accordance with 21 CFR 1311.300(e), 
such information will be posted on the DEA's Web site. 75 FR 16243 
(March 31, 2010). On December 3, 2014, the DEA approved the 
certification process developed by Electronic Healthcare Network 
Accreditation Commission. Relevant information has been posted on the 
DEA's Web site at: http://www.DEAdiversion.usdoj.gov.

    Dated: December 3, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2014-29118 Filed 12-11-14; 8:45 am]
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