Notices - 2012
[Federal Register Volume 77, Number 148 (Wednesday, August 1, 2012)]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18748]
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.
SUMMARY: DEA is announcing a new DEA-approved certification process for
Electronic Prescriptions for Controlled
Substances (EPCS). 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 once approved.
FOR FURTHER INFORMATION CONTACT: Alan G. Santos, Associate Deputy
Assistant Administrator, Office of Diversion Control, Drug Enforcement
Administration; Mailing Address: 8701 Morrissette Drive, Springfield,
Virginia 22152; Telephone: (202) 307-7165.
The Drug Enforcement Administration (DEA) is a component of the
Department of Justice and is the primary agency responsible for
coordinating the drug law enforcement activities of the United States.
DEA also assists in the implementation of the President's National Drug
Control Strategy. The Diversion Control Program (DCP) is a strategic
component of the DEA's law enforcement mission. It is primarily the DCP
within DEA that implements and enforces Titles II and III of the
Comprehensive Drug Abuse Prevention and Control Act of 1970, often
referred to as the Controlled Substances Act (CSA) and the Controlled
Substances Import and Export Act (CSIEA) (21 U.S.C. 801-971), as
amended (hereinafter, "CSA").\1\ DEA drafts and publishes the
implementing regulations for these statutes in Title 21 of the Code of
Federal Regulations (CFR), Parts 1300 to 1321. The CSA together with
these regulations are designed to establish a closed system for
controlled substances and 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 possession and dispensing of controlled substances,
most notably pursuant to a prescription issued 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 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, providing the pharmacy
with the legal justification and authority to dispense the medication
prescribed by the practitioner. 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 legally.
The maintenance by pharmacies 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 recently amended its regulations to provide
practitioners with the option of issuing electronic prescriptions for
controlled substances (EPCS) in lieu of paper prescriptions. Efforts to
develop EPCS 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. While these regulations have paved the way for
controlled substance prescriptions to be issued electronically, not all
states have authorized electronic prescriptions for controlled
substances, particularly Schedule II controlled substances, which have
a significant potential for abuse.
All certifying organizations with a certification process approved
by DEA pursuant to 21 CFR 1311.300(e) are posted on DEA's Web site once
As noted above, the Interim Final Rule provides that, as an
alternative to the audit requirements of 21 CFR 1311(b) 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 May 22, 2012, DEA approved the certification processes
developed by Drummond Group and by iBeta LLC. iBeta's approved
certification process is limited to the certification of the biometrics
subsystem, including its interfaces, to the requirements of the overall
regulations and specifically to those in 1311.116. Relevant information
has been posted on DEA's Web site at http://www.DEAdiversion.usdoj.gov.
Dated: July 25, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 2012-18748 Filed 7-31-12; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).