[Federal Register Volume 77, Number 148 (Wednesday, August 1, 2012)]
[Notices]
[Pages 45688-45689]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-18748]


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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.

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SUMMARY: DEA is announcing a new DEA-approved certification process for 
Electronic Prescriptions for Controlled

[[Page 45689]]

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.

SUPPLEMENTARY INFORMATION:

Background

    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.
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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 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.

Update

    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 
approved.
    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]
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