[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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