Notices - 2013
[Federal Register Volume 78, Number 58 (Tuesday, March 26, 2013)]
[Notices]
[Pages 18364-18365]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06918]
DEPARTMENT OF JUSTICE
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.
FOR FURTHER INFORMATION CONTACT: John W. Partridge, Executive
Assistant, Office of Diversion Control, Drug Enforcement
Administration; Mailing Address: 8701 Morrissette Drive, Springfield,
Virginia 22152; Telephone: (202) 307-7165.
SUPPLEMENTARY INFORMATION:
Background
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.
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\1\ The Attorney General's delegation of authority to DEA may be
found at 28 CFR 0.100.
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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.
Update
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]
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