[Federal Register Volume 79, Number 161 (Wednesday, August 20, 2014)]
[Notices]
[Pages 49340-49341]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-19783]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-396]
Electronic Prescriptions for Controlled Substances Notice of
Approved Certification Process
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Notice.
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SUMMARY: The Drug Enforcement Administration (DEA) is announcing one
new DEA-approved certification process for providers of Electronic
Prescriptions for Controlled Substances (EPCS) applications. Certifying
organizations with a certification process approved pursuant to 21 CFR
1311.300(e) are posted on DEA'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 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), 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 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
[[Page 49341]]
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). A
prescription serves as a record of the practitioner's determination of
the legitimate medical need for the drug to be dispensed. 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 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, DEA amended its regulations to provide practitioners with
the option of issuing electronic prescriptions for controlled
substances in lieu of paper prescriptions. 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 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) provides 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 DEA. The preamble to the Interim Final Rule further
indicated that, once a 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 July 25, 2014, DEA approved the certification process
developed by ComplySmart, LLC. Relevant information has been posted on
DEA's Web site at http://www.DEAdiversion.usdoj.gov.
Dated: August 11, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2014-19783 Filed 8-19-14; 8:45 am]
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