[Federal Register Volume 75, Number 61 (Wednesday, March 31, 2010)]
[Rules and Regulations]
[Pages 16235-16319]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-6687]



[[Page 16235]]

-----------------------------------------------------------------------

Part II





Department of Justice





-----------------------------------------------------------------------



Drug Enforcement Administration



-----------------------------------------------------------------------



21 CFR Parts 1300, 1304, 1306, and 1311



Electronic Prescriptions for Controlled Substances; Final Rule

Federal Register / Vol. 75 , No. 61 / Wednesday, March 31, 2010 / 
Rules and Regulations

[[Page 16236]]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1300, 1304, 1306, and 1311

[Docket No. DEA-218I]
RIN 1117-AA61


Electronic Prescriptions for Controlled Substances

AGENCY: Drug Enforcement Administration (DEA), Department of Justice.

ACTION: Interim Final Rule with Request for Comment.

-----------------------------------------------------------------------

SUMMARY: The Drug Enforcement Administration (DEA) is revising its 
regulations to provide practitioners with the option of writing 
prescriptions for controlled substances electronically. The regulations 
will also permit pharmacies to receive, dispense, and archive these 
electronic prescriptions. These regulations are in addition to, not a 
replacement of, the existing rules. The regulations provide pharmacies, 
hospitals, and practitioners with the ability to use modern technology 
for controlled substance prescriptions while maintaining the closed 
system of controls on controlled substances dispensing; additionally, 
the regulations will reduce paperwork for DEA registrants who dispense 
controlled substances and have the potential to reduce prescription 
forgery. The regulations will also have the potential to reduce the 
number of prescription errors caused by illegible handwriting and 
misunderstood oral prescriptions. Moreover, they will help both 
pharmacies and hospitals to integrate prescription records into other 
medical records more directly, which may increase efficiency, and 
potentially reduce the amount of time patients spend waiting to have 
their prescriptions filled.

DATES: This rule has been classified as a major rule subject to 
Congressional review. The effective date is June 1, 2010. However, at 
the conclusion of the Congressional review, if the effective date has 
been changed, the Drug Enforcement Administration will publish a 
document in the Federal Register to establish the actual effective date 
or to terminate the rule.
    The incorporation by reference of certain publications listed in 
the rule is approved by the Director of the Federal Register as of June 
1, 2010.
    Written comments must be postmarked and electronic comments must be 
submitted on or before June 1, 2010. Commenters should be aware that 
the electronic Federal Docket Management System will not accept 
comments after Midnight Eastern Time on the last day of the comment 
period.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-218'' on all written and electronic correspondence. 
Written comments sent via regular or express mail should be sent to the 
Drug Enforcement Administration, Attention: DEA Federal Register 
Representative/ODL, 8701 Morrissette Drive, Springfield, VA 22152. 
Comments may be sent to DEA by sending an electronic message to 
[email protected]. Comments may also be sent 
electronically through http://www.regulations.gov using the electronic 
comment form provided on that site. An electronic copy of this document 
is also available at the http://www.regulations.gov Web site. DEA will 
accept attachments to electronic comments in Microsoft Word, 
WordPerfect, Adobe PDF, or Excel file formats only. DEA will not accept 
any file formats other than those specifically listed here.
    Please note that DEA is requesting that electronic comments be 
submitted before midnight Eastern Time on the day the comment period 
closes because http://www.regulations.gov terminates the public's 
ability to submit comments at midnight Eastern Time on the day the 
comment period closes. Commenters in time zones other than Eastern Time 
may want to consider this so that their electronic comments are 
received. All comments sent via regular or express mail will be 
considered timely if postmarked on the day the comment period closes.

FOR FURTHER INFORMATION CONTACT: Mark W. Caverly, Chief, Liaison and 
Policy Section, Office of Diversion Control, Drug Enforcement 
Administration, 8701 Morrissette Drive, Springfield, VA 22152, 
Telephone (202) 307-7297.

SUPPLEMENTARY INFORMATION: 
    Comments: DEA is seeking additional comments on the following 
issues: Identity proofing, access control, authentication, biometric 
subsystems and testing of those subsystems, internal audit trails for 
electronic prescription applications, and third-party auditors and 
certification organizations.
    Posting of Public Comments: Please note that all comments received 
are considered part of the public record and made available for public 
inspection online at http://www.regulations.gov and in the Drug 
Enforcement Administration's public docket. Such information includes 
personal identifying information (such as your name, address, etc.) 
voluntarily submitted by the commenter.
    If you want to submit personal identifying information (such as 
your name, address, etc.) as part of your comment, but do not want it 
to be posted online or made available in the public docket, you must 
include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first 
paragraph of your comment. You must also place all the personal 
identifying information you do not want posted online or made available 
in the public docket in the first paragraph of your comment and 
identify what information you want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be posted online or made available 
in the public docket, you must include the phrase ``CONFIDENTIAL 
BUSINESS INFORMATION'' in the first paragraph of your comment. You must 
also prominently identify confidential business information to be 
redacted within the comment. If a comment has so much confidential 
business information that it cannot be effectively redacted, all or 
part of that comment may not be posted online or made available in the 
public docket.
    Personal identifying information and confidential business 
information identified and located as set forth above will be redacted 
and the comment, in redacted form, will be posted online and placed in 
the Drug Enforcement Administration's public docket file. Please note 
that the Freedom of Information Act applies to all comments received. 
If you wish to inspect the agency's public docket file in person by 
appointment, please see the FOR FURTHER INFORMATION paragraph.

I. Legal Authority
II. Regulatory History
III. Discussion of the Interim Final Rule
IV. Discussion of Comments
    A. Introduction
    B. Identity Proofing and Logical Access Control
    1. Identity Proofing
    2. Access Control
    C. Authentication Protocols
    D. Creating and Signing Electronic Controlled Substance 
Prescriptions
    1. Reviewing Prescriptions
    2. Timing of Authentication, Lockout, and Attestation
    3. Indication That the Prescription Was Signed
    4. Other Prescription Content Issues
    5. Transmission on Signing/Digitally Signing the Record
    6. PKI and Digital Signatures
    E. Internal Audit Trails

[[Page 16237]]

    F. Recordkeeping, Monthly Logs
    1. Recordkeeping
    2. Monthly Logs
    G. Transmission Issues
    1. Alteration During Transmission
    2. Printing After Transmission and Transmitting After Printing
    3. Facsimile Transmission of Prescriptions by Intermediaries
    4. Other Issues
    H. Pharmacy Issues
    1. Digital Signature
    2. Checking the CSA Database
    3. Audit Trails
    4. Offsite Storage
    5. Transfers
    6. Other Pharmacy Issues
    I. Third Party Audits
    J. Risk Assessment
    K. Other Issues
    1. Definitions
    2. Other Issues
    3. Beyond the Scope
    L. Summary of Changes From the Proposed Rule
V. Section-by-Section Discussion of the Interim Final Rule
VI. Incorporation by Reference
VII. Required Analyses
    A. Risk Assessment for Electronic Prescriptions for Controlled 
Substances
    B. Executive Order 12866
    C. Regulatory Flexibility Act
    D. Congressional Review Act
    E. Paperwork Reduction Act
    F. Executive Order 12988
    G. Executive Order 13132
    H. Unfunded Mandates Reform Act of 1995

I. Legal Authority

    DEA implements 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 (21 U.S.C. 801-
971), as amended. DEA publishes the implementing regulations for these 
statutes in Title 21 of the Code of Federal Regulations (CFR), Parts 
1300 to 1399. These regulations are designed to ensure an adequate 
supply of controlled substances for legitimate medical, scientific, 
research, and industrial purposes, and to deter the diversion of 
controlled substances to illegal purposes. The CSA mandates that DEA 
establish a closed system of control for manufacturing, distributing, 
and dispensing controlled substances. Any person who manufactures, 
distributes, dispenses, imports, exports, or conducts research or 
chemical analysis with controlled substances must register with DEA 
(unless exempt) and comply with the applicable requirements for the 
activity.

Controlled Substances

    Controlled substances are drugs and other substances that have a 
potential for abuse and psychological and physical dependence; these 
include opioids, stimulants, depressants, hallucinogens, anabolic 
steroids, and drugs that are immediate precursors of these classes of 
substances. DEA lists controlled substances in 21 CFR part 1308. The 
substances are divided into five schedules: Schedule I substances have 
a high potential for abuse and have no currently accepted medical use 
in treatment in the United States. These substances may only be used 
for research, chemical analysis, or manufacture of other drugs. 
Schedule II-V substances have currently accepted medical uses in the 
United States, but also have potential for abuse and psychological and 
physical dependence that necessitate control of the substances under 
the CSA. The vast majority of Schedule II, III, IV, and V controlled 
substances are available only pursuant to a prescription issued by a 
practitioner licensed by the State and registered with DEA to dispense 
the substances. Overall, controlled substances constitute between 10 
percent and 11 percent of all prescriptions written in the United 
States.

II. Regulatory History

    The Controlled Substances Act and Current Regulations. The CSA and 
DEA's regulations were originally adopted at a time when most 
transactions and particularly prescriptions were done on paper.
    The CSA provides that a controlled substance in Schedule II may 
only be dispensed by a pharmacy pursuant to a ``written prescription,'' 
except in emergency situations (21 U.S.C. 829(a)). In contrast, for 
controlled substances in Schedules III and IV, the CSA provides that a 
pharmacy may dispense pursuant to a ``written or oral prescription.'' 
(21 U.S.C. 829(b)). Where an oral prescription is permitted by the CSA, 
the DEA regulations further provide that a practitioner may transmit to 
the pharmacy a facsimile of a written, manually signed prescription in 
lieu of an oral prescription (21 CFR 1306.21(a)).
    Under longstanding Federal law, for a prescription for a controlled 
substance to be valid, it must be issued for a legitimate medical 
purpose by a practitioner acting in the usual course of professional 
practice (United States v. Moore, 423 U.S. 122 (1975); 21 CFR 
1306.04(a)). As the DEA regulations state: ``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 Controlled Substances Act is unique among criminal laws in that 
it stipulates acts pertaining to controlled substances that are 
permissible. That is, if the CSA does not explicitly permit an action 
pertaining to a controlled substance, then by its lack of explicit 
permissibility the act is prohibited. Violations of the Act can be 
civil or criminal in nature, which may result in administrative, civil, 
or criminal proceedings. Remedies under the Act can range from 
modification or revocation of DEA registration, to civil monetary 
penalties or imprisonment, depending on the nature, scope, and extent 
of the violation.
    Specifically, it is unlawful for any person knowingly or 
intentionally to manufacture, distribute, or dispense, a controlled 
substance or to possess a controlled substance with the intent of 
manufacturing, distributing, or dispensing that controlled substance, 
except as authorized by the Controlled Substances Act (21 U.S.C. 
841(a)(1)).
    Further, it is unlawful for any person knowingly or intentionally 
to possess a controlled substance unless such substance was obtained 
directly, or pursuant to a valid prescription or order, issued for a 
legitimate medical purpose, from a practitioner, while acting in the 
course of the practitioner's professional practice, or except as 
otherwise authorized by the CSA (21 U.S.C. 844(a)). It is unlawful for 
any person to knowingly or intentionally acquire or obtain possession 
of a controlled substance by misrepresentation, fraud, forgery, 
deception, or subterfuge (21 U.S.C. 843(a)(3)).
    It is unlawful for any person knowingly or intentionally to use a 
DEA registration number that is fictitious, revoked, suspended, 
expired, or issued to another person in the course of dispensing a 
controlled substance, or for the purpose of acquiring or obtaining a 
controlled substance (21 U.S.C. 843(a)(2)).
    Beyond these possession and dispensing requirements, it is unlawful 
for any person to refuse or negligently fail to make, keep, or furnish 
any record (including any record of dispensing) that is required by the 
CSA (21 U.S.C. 842(a)(5)). It is also unlawful to furnish any false or 
fraudulent material information in, or omit any information from, any 
record required to be made or kept (21 U.S.C. 843(a)(4)(A)).
    Within the CSA's system of controls, it is the individual 
practitioner (e.g., physician, dentist, veterinarian, nurse 
practitioner) who issues the prescription authorizing the dispensing of 
the controlled substance. This prescription

[[Page 16238]]

must be issued for a legitimate medical purpose and must be issued in 
the usual course of professional practice. The individual practitioner 
is responsible for ensuring that the prescription conforms to all legal 
requirements. The pharmacist, acting under the authority of the DEA-
registered pharmacy, has a corresponding responsibility to ensure that 
the prescription is valid and meets all legal requirements. The DEA-
registered pharmacy does not order the dispensing. Rather, the 
pharmacy, and the dispensing pharmacist merely rely on the prescription 
as written by the DEA-registered individual practitioner to conduct the 
dispensing.
    Thus, a prescription is much more than the mere method of 
transmitting dispensing information from a practitioner to a pharmacy. 
The 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.
    American Recovery and Reinvestment Act. On February 17, 2009, the 
President signed the American Recovery and Reinvestment Act of 2009 
(Recovery Act) (Pub. L. 111-5, 123 STAT. 115). Among its many 
provisions, the Recovery Act promotes the ``meaningful use'' of 
electronic health records (EHRs) via incentives. The health information 
technology provisions of the Recovery Act are primarily found in Title 
XIII, Division A, Health Information Technology, and in Title IV of 
Division B, Medicare and Medicaid Health Information Technology. These 
titles together are cited as the Health Information Technology for 
Economic and Clinical Health Act or the HITECH Act. Under Title IV, the 
Medicare and Medicaid health information technology provisions in the 
Recovery Act provide incentives and support for the adoption of 
certified electronic health record technology. The Recovery Act 
authorizes incentive payments for eligible professionals and eligible 
hospitals participating in Medicare or Medicaid if they can demonstrate 
to the Secretary of HHS that they are ``meaningful EHR users'' as 
defined by the Act and its implementing regulations. Such incentive 
payments to encourage electronic prescribing are allowed, but penalties 
in any form, by third party payers are prohibited. These incentive 
payments will begin in 2011.
    On January 13, 2010, HHS published two rules to implement the 
provisions of the HITECH ACT. The Centers for Medicare and Medicaid 
Services published a notice of proposed rulemaking entitled ``Medicare 
and Medicaid Programs; Electronic Health Record Incentive Program'' (75 
FR 1844) [CMS-0033-P, RIN 0938-AP78]. The proposed rule would specify 
the initial criteria an eligible professional and eligible hospital 
must meet to qualify for the incentive payment; calculation of the 
incentive payment amounts; and other payment and program participation 
issues.
    The Office of the National Coordinator for Health Information 
Technology published an interim final rule entitled ``Health 
Information Technology; Initial Set of Standards, Implementation 
Specifications, and Certification Criteria for Electronic Health Record 
Technology'' (75 FR 2014) [RIN 0991-AB58]. The interim final rule 
became effective February 12, 2010. The certification criteria adopted 
in the interim final rule establish the capabilities and related 
standards that certified electronic health record technology will need 
to include in order to, at a minimum, support the achievement of the 
proposed meaningful use Stage 1 (beginning in 2011) by eligible 
professionals and eligible hospitals under the Medicare and Medicaid 
EHR incentive programs. The comment period for both rules ended March 
15, 2010.
    The Office of the National Coordinator for Health Information 
Technology also published a notice of proposed rulemaking entitled 
``Proposed Establishment of Certification Programs for Health 
Information Technology'' (75 FR 11328, March 10, 2010) (RIN 0991-AB59) 
which proposes the establishment of certification programs for purposes 
of testing and certifying health information technology. The proposed 
rule specifies the processes the National Coordinator for Health 
Information Technology would follow to authorize organizations to 
perform the certification of health information technology.
    Electronic Prescription Applications. Electronic prescription 
applications \1\ and electronic health record (EHR) applications have 
been available for a number of years and are anticipated by many to 
improve healthcare and possibly reduce costs by increasing compliance 
with formularies and the use of generic medications. Electronic 
prescriptions may reduce medical errors caused by illegible 
handwriting. Adoption of these applications has been relatively slow, 
primarily because of their cost, the disruption caused during 
implementation, and lack of mature standards that allow for 
interoperability among applications.\2\ Some have also expressed a 
concern about the inability to use electronic prescription applications 
for all prescriptions.
---------------------------------------------------------------------------

    \1\ ``Application'' means a software program used to perform a 
set of functions.
    \2\ California Healthcare Foundation. ``Gauging the Progress of 
the National Health IT Technology Initiative'', January 2008; 
Congressional Budget Office, Evidence on the Costs and Benefits of 
Health IT, May 2008.
---------------------------------------------------------------------------

    Electronic prescription applications may be stand-alone 
applications (i.e., applications that only create prescriptions) or 
they may be integrated into EHR applications that create and link all 
medical records and associated information.\3\ Either type of 
application may be installed on a practitioner's computers (installed 
applications) or may be an Internet-based application, where the 
practitioner accesses the application through the Internet; for these 
latter applications, the application service provider (ASP) retains the 
records on its servers. For most practitioners and pharmacies, the 
applications are purchased from application providers. Some large 
healthcare systems and chain pharmacies, however, may develop and 
maintain the applications themselves, serving as both the practitioner 
or pharmacy and the application provider.
---------------------------------------------------------------------------

    \3\ The National Alliance for Health Information Technology has 
defined the terms ``electronic Medical record (EMR),'' ``electronic 
health record (EHR),'' and ``personal health record (PHR.'' Both 
EMRs and EHRs are defined to be maintained by practitioners, whereas 
a PHR is defined to be maintained by the individual patient. The 
main distinction between an EMR and an EHR is the EHR's ability to 
exchange information interoperably. DEA's use of the term EHR in 
this rule relates to those records maintained by practitioners, as 
opposed to a PHR maintained by an individual patient, regardless of 
how those records are maintained.
---------------------------------------------------------------------------

    The existing electronic prescription applications allow 
practitioners to create a prescription electronically, but accommodate 
different means of transmitting the prescription to the pharmacy. 
Practitioners may print the prescription for manual signature; the 
prescription may then be given to the patient or the practitioner's 
office may fax it to a pharmacy. Some applications will automatically 
transmit an image of the prescription as a facsimile. True

[[Page 16239]]

electronic prescriptions, however, are transmitted as electronic data 
files to the pharmacy, whose applications import the data file into its 
database. Virtually all pharmacies maintain prescription records 
electronically; prescriptions that are not received as electronic data 
files are manually entered into the pharmacy application.
    Because of the large number of electronic prescription and pharmacy 
applications and the current lack of a mature standard for the 
formatting of prescription data, most electronic prescriptions are 
routed from the electronic prescription or EHR application through 
intermediaries, at least one of which determines whether the 
prescription file needs to be converted from one software version to 
another so that the receiving pharmacy application can correctly import 
the data. There are generally three to five intermediaries that route 
prescriptions between practitioners and pharmacies. For example, a 
prescription may be routed to the application provider, then to a hub 
that converts the prescription from one software version to another to 
meet the requirements of the receiving pharmacy, then to the pharmacy 
application provider or chain pharmacy server before reaching the 
dispensing pharmacy. Some application providers further route 
prescriptions through aggregators who direct the prescription to a hub 
or to a pharmacy. For closed healthcare systems, where the 
practitioners and pharmacies are part of the same system, 
intermediaries are not needed.
    Standards. Any electronic data transfer depends on the ability of 
the receiving application to open and read the information accurately. 
To be able to do this, the fields and transactions need to be defined 
and tagged so that the receiving application knows, for example, that a 
particular set of characters is a date and that other sets are names, 
etc. The National Council for Prescription Drug Programs (NCPDP) has 
developed a standard for prescriptions, called SCRIPT, which is 
generally used by application providers; hospital-based applications 
may also use Health Level 7 (HL7) standards. SCRIPT is a data 
transmission standard ``intended to facilitate the communication of 
prescription information between prescribers, pharmacies, and payers.'' 
\4\ It defines transactions (e.g., new prescription, refill request, 
prescription change, cancellation,), segments (e.g., provider, 
patient), and data fields within segments (e.g., name, date, quantity). 
Each data field has a number and a defined format (e.g., DEA number is 
nine characters). The standardization allows the receiving pharmacy to 
identify and separate the data it receives and import the information 
into the correct fields in the pharmacy database. SCRIPT does not 
address other aspects of prescription or pharmacy applications (e.g., 
what information is displayed and stored at a practice or pharmacy, 
logical access controls, audit trails). SCRIPT provides for, but does 
not mandate the use of, some fields (e.g., practitioner first name and 
patient address) that DEA requires. In addition, although the standard 
mandates that applications include certain fields, it does not require 
that those fields be completed before transmission is allowed. The 
SCRIPT standard is still evolving; the most recent is Version 10 
Release 6. The interoperability issues that require intermediaries 
generally relate to pharmacy and practitioner applications using 
different versions of the standard as well as varying approaches to 
providing opening and reading instructions.
---------------------------------------------------------------------------

    \4\ National Council for Prescription Drug Programs, Prescriber/
Pharmacist Interface SCRIPT Standard Implementation Guide Version 
10.0, October 2006.
---------------------------------------------------------------------------

    One intermediary, SureScripts/RxHub, certifies electronic 
prescription and pharmacy applications for compliance with the SCRIPT 
standard; SureScripts/RxHub determines whether the electronic 
prescription application creates a prescription that conforms to the 
SCRIPT standard and whether the pharmacy application is able to open 
and read a SCRIPT prescription correctly.\5\ SureScripts/RxHub 
certification does not address aspects of applications unrelated to 
their ability to produce or read a prescription in appropriate SCRIPT 
format.
---------------------------------------------------------------------------

    \5\ http://www.surescripts.com/certification.html, accessed 
April 29, 2009.
---------------------------------------------------------------------------

    The Certification Commission for Healthcare Information Technology 
(CCHIT) is a private, nonprofit organization recognized by the 
Secretary of HHS as a certification body for EHRs under the exception 
to the physician self-referral prohibition and safe harbor under the 
anti-kickback statute, respectively, for certain arrangements involving 
the donation of interoperable EHR software to physicians and other 
health care practitioners or entities (71 FR 45140 and 71 FR 45110, 
respectively, August 8, 2006). CCHIT develops criteria for electronic 
medical records (EMRs or EHRs) and certifies applications against these 
criteria. Although electronic prescribing is addressed in the CCHIT 
ambulatory certification criteria, these criteria do not address all 
elements with which DEA has concern, such as the particular information 
required in a prescription. The CCHIT criteria do address security 
issues, such as access control and audit logs. CCHIT is developing 
standards for stand-alone electronic prescription applications. DEA has 
not been able to identify any organization that sets standards for or 
certifies pharmacy applications for security issues or even for the 
ability to record and retain information such as dispensing data.
    Proposed Rule. On June 27, 2008, DEA published a Notice of Proposed 
Rulemaking (NPRM) to revise its regulations to allow the creation, 
signature, transmission, and processing of controlled substance 
prescriptions electronically (73 FR 36722). The proposed rule followed 
consultations with the industry and the Department of Health and Human 
Services, which is responsible for establishing transmission standards 
for electronic prescriptions and security standards for health 
information. The proposed rule provided two approaches, one for the 
private sector and one for Federal healthcare providers. The private 
sector approach included identity proofing of individual practitioners 
authorized to sign controlled substances prescriptions prior to 
granting access to sign such prescriptions, two-factor authentication 
including a hard token separate from the computer for accessing the 
signing functions, requirements for the content and review of 
prescriptions, limited transmission provisions, requirements of 
pharmacy applications processing controlled substances prescriptions 
for dispensing, third party audits of the application providers, and 
internal audit functions for electronic prescription application 
providers and pharmacy applications. The Federal healthcare providers 
told DEA that the approach proposed for the private sector was 
inconsistent with their existing practices and did not meet the 
security requirements imposed on all Federal systems. The approach 
proposed for Federal healthcare systems was based, therefore, on the 
existing Federal systems, which rely on public key infrastructure (PKI) 
and digital certificates to address basic security issues related to 
non-repudiation, authentication, and record integrity.
    DEA's Concerns. DEA's proposed rule was a response to existing and 
potential problems that exist when prescriptions are created 
electronically. It is essential that the rules governing the electronic 
prescribing of controlled substances do not inadvertently facilitate 
diversion and abuse and undermine the ability of

[[Page 16240]]

DEA, State, and local law enforcement to identify and prosecute those 
who engage in diversion. In this vein, DEA's primary goals were to 
ensure that nonregistrants did not gain access to electronic 
prescription applications and generate or alter prescriptions for 
controlled substances and to ensure that a prescription record, once 
created, could not be repudiated. In the case of at least some existing 
electronic prescription application service providers, individuals are 
allowed to enroll online. ASPs may ask for DEA registration and State 
authorization numbers, although they are not required to do so; the 
degree to which these are verified is at the discretion of the 
application provider. Similarly, application providers that sell 
installed applications may or may not determine whether the 
practitioners have valid State and DEA authorizations. Where a medical 
practice purchases an application or service, providers may or may not 
obtain this information for all practitioners in the practice.
    Most of the applications appear to rely on passwords to identify a 
user of the application. Passwords are often described as the weakest 
link in security because they are easily guessed or, in healthcare 
settings, where multiple people use the same computers, easily 
observed. Where longer, more complex passwords are required by 
applications as a means to increase their effectiveness, this can 
actually be counterproductive, as it often causes users to write down 
their passwords, which weakens overall security.\6\ There are, in 
general, very limited standards for security of electronic prescription 
applications and no assurance that even where security capabilities 
exist, that they are used. For example, applications may be able to set 
access controls to limit who may sign a prescription, but unless those 
controls are set properly, anyone in a practice might be able to sign a 
prescription in a practitioner's name. The Certification Commission for 
Healthcare Information Technology (CCHIT) requires that an application 
have logical access controls and audit trails to gain certification, 
but there is no requirement that these functions be used. More than 
half the electronic prescription application providers certified with 
SureScripts/RxHub (for transmission) are not certified with CCHIT.
---------------------------------------------------------------------------

    \6\ National Institute of Standards and Technology. Special 
Publication 800-63-1, Draft Electronic Authentication Guideline, 
December 8, 2008. Appendix A.
---------------------------------------------------------------------------

    Even if there are logical access controls, they may not limit who 
can perform functions such as approving a prescription or signing it. 
At medical practices and even more so at hospitals and clinics, many 
staff members may use the same computers. The person who logged onto 
the application may not be the person entering prescription information 
later or the person who transmits the prescription. Some applications 
have internal audit trail functions, but whether these are active and 
reviewed is at the practitioner's discretion. In addition, with 
multiple people using computers, it is unclear that the audit trail can 
accurately identify who is performing actions. Except for those Federal 
electronic prescription applications that require practitioners to 
digitally sign prescriptions, none of the applications transmit any 
indication that a prescription was actually signed.
    With multiple intermediaries moving prescriptions between 
practitioners and pharmacies, there is no assurance that a prescription 
may not be altered or added during transmission. Some intermediaries 
have good security, but there is no requirement for them to do so and 
practitioners and pharmacies have no control over which intermediaries 
are used. The pharmacy has no way to verify that the prescription was 
sent by the practitioner whose name is on the prescription or that if 
it was, that it was not altered after the practitioner issued it. The 
evidence of forgery and alteration that pharmacies use to identify 
illegitimate paper prescriptions do not exist in an electronic record--
not only because electronic prescriptions contain no handwritten 
signatures, but also because electronic prescriptions are typically 
created from drop-down menus, which prevent or reduce the likelihood of 
misspelled drug names, inappropriate dosage forms and units, and other 
indicators of possible forgery.
    The existing processes used for electronic prescriptions for 
noncontrolled substances, therefore, make it easy for every party to 
repudiate the prescription. A practitioner can claim that someone 
outside the practice issued a prescription in his name, that someone 
else in the practice used his password to issue a prescription, or that 
it was altered after he issued it either in transmission or at the 
pharmacy. Proving or disproving any of these claims would be very 
difficult with the existing processes. DEA and other law enforcement 
agencies might not be able to prove a case against someone issuing 
illegitimate prescriptions; equally important, practitioners might have 
trouble proving that they were not responsible for illegitimate 
prescriptions issued in their name.
    Because regulations do not currently exist permitting the use of 
electronic prescriptions for controlled substances, there is naturally 
no evidence of diversion related to electronic prescriptions of these 
substances. That there is no evidence that other noncontrolled 
prescription drugs have been diverted through electronic prescriptions 
is not relevant for several reasons. First, there is a very limited, if 
any, black market for other prescription medications. Second, there is 
no reason for law enforcement to investigate diversion of these 
medications, if it occurs, because such diversion may not be illegal 
(this would depend on State law). Finally, the number of electronic 
prescriptions, including refill requests, has not been great (4 percent 
in 2008, according to SureScripts/RxHub).
    In contrast, prescription controlled substances have always carried 
a significant inherent risk of diversion, both because they are 
addictive and because they can be sold for significantly higher prices 
than their retail price. The recent studies showing increasing levels 
of abuse of these drugs throughout the United States heightens the 
cause for concern. Accordingly, with controlled substances there is a 
considerable incentive for individuals and criminal organizations to 
exploit any vulnerabilities that exist to obtain these substances 
illegally.
    The National Survey on Drug Use and Health (NSDUH) (formerly the 
National Household Survey on Drug Abuse) is an annual survey of the 
civilian, non-institutionalized, population of the United States aged 
12 or older. The survey is conducted by the Office of Applied Studies, 
Substance Abuse and Mental Health Services Administration, of the 
Department of Health and Human Services. Findings from the 2008 NSDUH 
are the latest year for which information is currently available. The 
2008 NSDUH \7\ estimated that 6.2 million persons were current users, 
i.e., past 30 days, of psychotherapeutic drugs--pain relievers, anti-
anxiety medications, stimulants, and sedatives--taken nonmedically. 
This represents 2.5 percent of the population aged 12 or older. From 
2002 to 2008, there was an increase among young adults aged 18 to 25 in 
the rate of current use of prescription pain

[[Page 16241]]

relievers, from 4.1 percent to 4.6 percent. The survey found that about 
52 million people 12 and older had used prescription drugs for non-
medical reasons in their lifetime; about 35 million of these had used 
prescription painkillers nonmedically in their lifetime.
---------------------------------------------------------------------------

    \7\ Substance Abuse and Mental Health Services Administration. 
(2009). Results from the 2008 National Survey on Drug Use and 
Health: National Findings (Office of Applied Studies, NSDUH Series 
H-36, DHHS Publication No. SMA 09-4434). Rockville, MD. http://www.oas.samhsa.gov/nsduh/2k8nsduh/2k8Results.pdf.
---------------------------------------------------------------------------

    The consequences of prescription drug abuse are seen in the data 
collected by the Substance Abuse and Mental Health Services 
Administration on emergency room visits. In the latest data, Drug Abuse 
Warning Network (DAWN), 2006: National Estimates of Drug-Related 
Emergency Department Visits,\8\ SAMHSA estimates that, during that one 
year, approximately 741,000 emergency department visits involved 
nonmedical use of prescription or over-the-counter drugs or dietary 
supplements, a 38 percent increase over 2004. Of the 741,000 visits, 
195,000 involved benzodiazepines (Schedule IV) and 248,000 involved 
opioids (Schedule II and III). Overall, controlled substances 
represented 65 percent of the estimated emergency department visits 
involving prescription drugs or over-the-counter drugs or dietary 
supplements. Between 2004 and 2006, the number of visits involving 
opioids increased 43 percent and the number involving benzodiazepines 
increased 36 percent. Of all visits involving nonmedical use of 
pharmaceuticals, about 224,000 resulted in admission to the hospital; 
about 65,000 of those individuals were admitted to critical care units; 
1,574 of the visits ended with the death of the patient. More than half 
of the visits involved patients 35 and older.
---------------------------------------------------------------------------

    \8\ Substance Abuse and Mental Health Services Administration, 
Office of Applied Studies. Drug Abuse Warning Network, 2006: 
National Estimates of Drug-Related Emergency Department Visits. DAWN 
Series D-30, DHHS Publication No. (SMA) 08-4339, Rockville, MD, 
2007. http://dawninfo.samhsa.gov/.
---------------------------------------------------------------------------

    People dependent on the drugs are willing to pay a high premium to 
obtain them, creating a black market for these drugs. The problem of 
illegitimate prescriptions, which exists with paper prescriptions, is 
exacerbated by the speed of electronic transmissions and the difficulty 
of identifying an electronic prescription as invalid. A single 
prescription can be sent to multiple pharmacies; multiple 
practitioners' identities can be stolen and each identity used to issue 
a limited number of prescriptions to prevent a pharmacy or a State 
prescription monitoring program from noticing an unusual pattern. DEA's 
goal in the proposed rule was to address these vulnerabilities and 
ensure that before controlled substance prescriptions are issued 
electronically, the process is adequately secure to protect both DEA 
registrants and society.
    Based on DEA's concerns, certain requirements must exist for any 
system to be used for the electronic prescribing of controlled 
substances:
     Only DEA registrants may be granted the authority to sign 
controlled substance electronic prescriptions. The approach must, to 
the greatest extent possible, protect against the theft of registrants' 
identities.
     The method used to authenticate a practitioner to the 
electronic prescribing system must ensure to the greatest extent 
possible that the practitioner cannot repudiate the prescription. 
Authentication methods that can be compromised without the practitioner 
being aware of the compromise are not acceptable.
     The prescription records must be reliable enough to be 
used in legal actions (enforcing laws relating to controlled 
substances) without diminishing the ability to establish the relevant 
facts and without requiring the calling of excessive numbers of 
witnesses to verify records.
     The security systems used by any electronic prescription 
application must, to the greatest extent possible, prevent the 
possibility of insider creation or alteration of controlled substance 
prescriptions.
    Comments. DEA received 229 comments, 35 of which were copies. 
Twenty-one practitioner organizations, 24 pharmacy organizations, 18 
States (State licensing boards of medicine and pharmacy, and three 
State health departments), and 19 application providers were among the 
commenters. Several States supported the rule as proposed, expressing 
concern about the security of electronic prescriptions and stating that 
the rule should prevent insider tampering or creation of controlled 
substance prescriptions. Advocacy groups concerned with drug use 
similarly supported the proposed rule as did a few other commenters. A 
number of commenters generally supported electronic prescriptions 
without addressing the proposed rule.
    Most commenters, however, raised a substantial number of issues 
about various provisions of the proposed rule; their comments are 
addressed in detail in section IV of this preamble. On a general level, 
they expressed concern that the proposed requirements would prove too 
burdensome and would create a barrier to the adoption of electronic 
prescribing. They also raised two overarching issues that have affected 
the approach that DEA has adopted in this interim final rule.
    First, the commenters noted that DEA's proposed approach addressed 
primarily one model for electronic prescription applications, 
application service providers (ASPs). In this model, the practitioner 
subscribes to a service and accesses, usually over the Internet, an 
electronic prescription application that is maintained on the ASP's 
servers. The ASP controls access to the application, has access to all 
of the records, and maintains security. The practitioner does not need 
to install the application or maintain servers that archive the 
records. Many electronic prescription application providers, 
particularly those that develop EHRs and hospital applications, install 
their software on the practitioner's computers. Once the application is 
installed, the electronic prescription application provider's role is 
limited to providing technical assistance when needed. Access control, 
records, and security are handled by the practitioners or their staff. 
Some of the proposed provisions did not work when the electronic 
prescription application provider is not involved in logical access 
control.
    Second, many commenters pointed out that the technology continues 
to evolve, the EHR applications are still changing, and that the 
standards for electronic prescriptions are not mature. A number of 
commenters indicated that the current transmission system, which relies 
on a series of intermediaries to provide interoperability, may not be 
needed when both technology and the standards evolve. These commenters 
wanted DEA to provide more flexibility to be able to adjust to 
advancements as they occur.

III. Discussion of the Interim Final Rule

    This section provides an overview of the interim final rule. As 
noted above, commenters raised a number of issues related to specific 
proposed provisions. DEA has revised the rule to address commenters' 
concerns and to recognize the variations in how electronic prescription 
applications are implemented. In arriving at an interim final rule, DEA 
has balanced a number of considerations. Chief among these is DEA's 
obligation to ensure that the regulations minimize, to the greatest 
extent possible, the potential for diversion of controlled substances 
resulting from nonregistrants gaining access to electronic prescription 
applications and electronic prescriptions. At the same time, DEA has 
sought to streamline the rules to reduce the burden on registrants.

[[Page 16242]]

Another of DEA's goals has been to provide flexibility in the rule so 
that as technologies and standards mature, registrants and application 
providers will be able to take advantage of advances without having to 
wait for a revision to the regulations. Finally, DEA has revised the 
rules to place requirements on either the application or on registrants 
so that neither DEA nor registrants are dependent on intermediaries for 
maintenance of information.
    In response to commenters' concerns, DEA is adopting an approach to 
identity proofing (verifying that the user is who he claims to be) and 
logical access control (verifying that the authenticated user has the 
authority to perform the requested operation) that is different from 
the approach that it proposed. The interim final rule provisions 
related to these two steps are based on the concept of separation of 
duties: No single individual will have the ability to grant access to 
an electronic prescription application or pharmacy application. For 
individual practitioners in private practice (as opposed to 
practitioners associated with an institutional practitioner 
registrant), identity proofing will be done by an authorized third 
party that will, after verifying the identity, issue the authentication 
credential to a registrant. As some commenters suggested, DEA is 
requiring registrants to apply to certain Federally approved credential 
service providers (CSPs) or certification authorities (CAs) to obtain 
their authentication credentials or digital certificates. These CSPs or 
CAs will be required to conduct identity proofing at National Institute 
of Standards and Technology (NIST) SP 800-63-1 Assurance Level 3, which 
allows either in-person or remote identity proofing. Once a Federally 
approved CSP or CA has verified the identity of the practitioner, it 
will issue the necessary authentication credential.
    The successful issuance of the authentication credentials will be 
necessary to sign electronic controlled substance prescriptions, but 
possession of the credential will not be sufficient to gain access to 
the signing function. The electronic prescription application must 
allow the setting of logical access controls to ensure that only DEA 
registrants or persons exempted from the requirement of registration 
are allowed to indicate that prescriptions are ready to be signed and 
sign controlled substance prescriptions. Logical access controls may be 
by user or role-based; that is, the application may allow permissions 
to be assigned to individual users or it may associate permissions with 
particular roles (e.g., physician, nurse), then assign each individual 
to the appropriate role. Access control will be handled by at least two 
people within a practice, one of whom must be a registrant. Once the 
registrant has been issued the authentication credential, the 
individuals who set the logical access controls will verify that the 
practitioner's DEA registration is valid and set the application's 
logical access controls to grant the registrant access to functions 
that indicate a prescription is ready to be signed and sign controlled 
substance prescriptions. One person will enter the data; a registrant 
must approve the entry, using the two-factor authentication protocol, 
before access becomes operational.
    DEA is allowing, but not requiring, institutional practitioners to 
conduct identity proofing in-house as part of their credentialing 
process. At least two people within the credentialing office must sign 
any list of individuals to be granted access control. That list must be 
sent to a separate department (probably the information technology 
department), which will use it to issue authentication credentials and 
enter the logical access control data. As with private practices, two 
individuals will be required to enter and approve the logical access 
control information. Institutional practitioners may require 
registrants and those exempted from registration under Sec.  1301.22 to 
obtain identity proofing and authentication credentials from the same 
CSPs or CAs that individual practitioners use. The institutional 
practitioner may also conduct the identity proofing in-house, then 
provide the information to these CSPs or CAs to obtain the 
authentication credentials. In this last case, the institutional 
practitioners would be acting as trusted agents for the CSPs or CAs, 
under rules that those organizations set. Because DEA has made 
extensive changes to the requirements related to identity proofing and 
logical access control, DEA is seeking further comments on these 
issues.
    As proposed, DEA is requiring in this interim final rule that the 
authentication credential be two-factor. Two-factor authentication (two 
of the following--something you know, something you have, something you 
are) protects the practitioner from misuse of his credential by 
insiders as well as protecting him from external threats because the 
practitioner can retain control of a biometric or hard token. 
Authentication based only on knowledge factors is easily subverted 
because they can be observed, guessed, or hacked and used without the 
practitioner's knowledge. In the interim final rule DEA is allowing the 
use of a biometric as a substitute for a hard token or a password. If a 
hard token is used, it must meet FIPS 140-2 Security Level 1 for 
cryptographic devices or one-time-password devices and must be stored 
on a device that is separate from the computer being used to access the 
application. The CSPs and CAs may issue a new hard token or register 
and provide credentials for an existing token. Regardless of whether a 
new token is provided and activated or an existing token is registered 
for the signing of controlled substances prescriptions, communications 
between the CSP or CA and practitioner applicant must occur through two 
channels (e.g., mail, telephone, e-mail).
    However, while DEA is requiring in this interim final rule that the 
authentication credential be two-factor, DEA is seeking further 
comments on this issue. Specifically, DEA seeks comments in response to 
the following question:
     Is there an alternative to two-factor authentication that 
would provide an equally safe, secure, and closed system for electronic 
prescribing of controlled substances while better encouraging adoption 
of electronic prescriptions for controlled substances? If so, please 
describe the alternative(s) and indicate how, specifically, it would 
better encourage adoption of electronic prescriptions for controlled 
substances without diminishing the safety and security of the system.
    DEA is establishing standards with which any biometric being used 
as one factor to sign controlled substance prescriptions must comply; 
however, DEA is not specifying the types of biometrics that may be used 
to allow for the greatest flexibility and adaptation to new 
technologies in the future. DEA consulted extensively with NIST in the 
development of these standards and has relied on their recommendations 
for this aspect of the rule. If a biometric is used, it may be stored 
on a computer, a hard token, or the biometric reader. Storage of 
biometric data, whether in raw or template format, has implications for 
data protection and maintenance. These are considerations that should 
be weighed by application providers and implementers when choosing 
where and how biometric data may be stored. Additionally, application 
providers and implementers may wish to consider using open standard 
biometric data formats when available, to provide interoperability 
where more than one application provider may be providing biometric 
capabilities (e.g., a network that spans multiple entities) and to 
protect their interests. Because the use

[[Page 16243]]

of biometrics and the standards related to their use were not discussed 
in the notice of proposed rulemaking, DEA is seeking further comments 
on these issues.
    DEA is requiring that the application display a list of controlled 
substance prescriptions for the practitioner's review before the 
practitioner may authorize the prescriptions. A separate list must be 
displayed for each patient. All information that the DEA regulations 
require to be included in a prescription for a controlled substance, 
except the patient's address, must appear on the review screen along 
with a notice that completing the two-factor authentication protocol is 
legally signing the prescription. A separate key stroke will not be 
required for this statement. Registrants must indicate that each 
controlled substance prescription shown is ready to be signed. When the 
registrant indicates that one or more prescriptions are to be signed, 
the application must prompt him to begin the two-factor authentication 
protocol. Completion of the two-factor authentication protocol legally 
signs the prescriptions. When the two-factor authentication protocol is 
successfully completed, the application must digitally sign and archive 
at least the DEA-required information. If the practitioner is digitally 
signing the prescription with his own private key,\9\ the application 
need not digitally sign the record separately, but must archive the 
digitally signed record. DEA is allowing any practitioner to use the 
digital signature option proposed for Federal healthcare systems. 
Unless a practitioner has digitally signed a prescription and is 
transmitting the prescription with the digital signature, the 
electronic prescription must include an indication that the 
prescription was signed.
---------------------------------------------------------------------------

    \9\ For technical accuracy, DEA is describing the method of 
digitally signing as ``applying the private key.'' The private key 
is a secret quantity stored on the user's token that is used in the 
computation of digital signatures. Digital certificates contain a 
related quantity called the public key, which is used to verify 
signatures generated by the corresponding private key. The user is 
not required to know, and does not enter either key. A message 
digest is computed by the signing software on the user's computer, 
and the portion of the signing function that involves the private 
key is automatically performed by the user's token, once the user 
has provided the token and a second authentication factor such as a 
password or PIN. From the user's perspective, the experience is 
similar to using an ATM card.
---------------------------------------------------------------------------

    The electronic prescription application must generate a monthly log 
of controlled substance prescriptions issued by a registrant, archive a 
record of those logs, and provide the logs to the practitioner. The 
practitioner is not required to review the monthly log.
    Because the prescription information will be digitally signed when 
the practitioner completes the two-factor authentication protocol, the 
prescription need not be transmitted immediately. Information other 
than the information that must be digitally signed may be added to the 
file (e.g., pharmacy URLs) or the prescription may be reviewed (e.g., 
at a long-term care facility) after it is signed and before it is 
transmitted to the pharmacy. After the practitioner completes the 
authentication protocol, the information that the DEA regulations 
require to be included in a prescription for a controlled substance may 
not be modified before or during transmission.
    DEA has clarified that the application may print copies of an 
electronically transmitted prescription if they are clearly labeled as 
copies, not valid for dispensing. If a practitioner is notified by an 
intermediary or pharmacy that a transmission failed, he may print a 
copy of the transmitted prescription and manually sign it. The 
prescription must indicate that it was originally transmitted to a 
specific pharmacy and that the transmission failed. The pharmacy is 
responsible for checking to ensure that the prescription was not 
received electronically and no controlled substances were dispensed 
pursuant to the electronic prescription prior to filling the paper 
prescription.
    DEA has also clarified that the requirement that the DEA-required 
contents of the prescription not be altered during transmission applies 
only to changes to the content (not format) by intermediaries, not to 
changes that may lawfully be made at a pharmacy after receipt. Pharmacy 
changes to electronic prescriptions for controlled substances are 
governed by the same statutory and regulatory limitations that apply to 
paper prescriptions. Intermediaries may not convert an electronic 
controlled substance prescription into a fax. Once a prescription is 
created electronically, all records of the prescription must be 
retained electronically.
    Unless the prescription is being transmitted with a digital 
signature, either the last intermediary or the pharmacy must digitally 
sign the prescription; the pharmacy must archive the digitally signed 
prescription. Both the electronic prescription application and the 
pharmacy application must maintain an internal audit trail that records 
any modifications, annotations, or deletions of an electronic 
controlled substance prescription or when a functionality required by 
the rule is interfered with; the time and date of the action; and the 
person taking the action. The application provider and the registrants 
must develop a list of auditable events; auditable events should be 
occurrences that indicate a potential security problem. For example, an 
unauthorized person attempting to sign or alter a prescription would be 
an auditable event; a pharmacist annotating a record to indicate a 
change to a generic version of a drug would not be. The applications 
must run the internal audit function daily to identify any auditable 
events. When one occurs, the application must generate a readable 
report for the practitioner or pharmacist. If a practitioner or 
pharmacy determines that there is a potential security problem, they 
must report it to DEA within one business day.
    Application providers must obtain a third-party audit before the 
application may be used to create, sign, transmit, or process 
controlled substance prescriptions and whenever a functionality related 
to controlled substance prescription requirements is altered, or every 
two years after the initial audit, whichever occurs first. If one or 
more certification organizations establish procedures to review 
applications and determine whether they meet the requirements set forth 
in the DEA regulations, DEA may allow this certification to replace the 
third-party audit. DEA will notify registrants of any such approvals of 
organizations to conduct these third-party certifications through its 
Web site. At this time, no such certification exists for either 
electronic prescription or pharmacy applications, but the Certification 
Commission for Healthcare Information Technology (CCHIT) has developed 
a program for electronic prescription applications.
    All records must be maintained for two years from the date on which 
they were created or received. Pharmacy records must be backed up 
daily; DEA is not specifying where back-up files must be stored.
    Because DEA is allowing any registrant to use the public key 
infrastructure (PKI) option proposed for Federal healthcare systems, 
the interim final rule does not include separate requirements for these 
systems.
    When a prescription is transmitted (outside of a closed system), it 
moves through three to five intermediaries between practitioners and 
pharmacies. Although prescriptions could be altered, added, or deleted 
during transmission, DEA is not regulating transmission. Registrants 
have no control over the string of intermediaries. A practitioner might 
be able to determine from his

[[Page 16244]]

application provider which intermediaries it uses to move the 
prescription from the practitioner to SureScripts/RxHub or a similar 
service, but neither the practitioner nor the application provider 
would find it easy to determine which intermediaries serve each of the 
pharmacies a practitioner's patients may choose. Pharmacies have the 
problem in reverse; they may know which intermediaries send them 
prescriptions, but have no way to determine the intermediaries used to 
route prescriptions from perhaps hundreds of practitioners using 
different applications to SureScripts/RxHub or a similar service. DEA 
believes the involvement of intermediaries will not compromise the 
integrity of electronic prescribing of controlled substances, provided 
the requirements of the interim final rule are satisfied. Among these 
requirements is that the prescription record be digitally signed before 
and after transmission to avoid the need to address the security of 
intermediaries. DEA realizes that this approach will not prevent 
problems during the transmission, but it will at least identify that 
the problem occurred during transmission and protect practitioners and 
pharmacies from being held responsible for problems that may arise 
during transmission that are not attributable to them.
    Some commenters on the NPRM claimed that the security practices of 
intermediaries were sufficient to protect electronic prescriptions. 
These practices, which are voluntary, do not address the principal 
threats of diversion, which occur before and after transmission. 
Maintaining the integrity of the record during transmission is of 
little value if there is no assurance that a registrant created and 
transmitted the prescription or that pharmacy staff did not alter it 
after receipt.
    DEA wishes to emphasize that the electronic prescribing of 
controlled substances is in addition to, not a replacement of, existing 
requirements for written and oral prescriptions for controlled 
substances. This rule provides a new option to prescribing 
practitioners and pharmacies. It does not change existing regulatory 
requirements for written and oral prescriptions for controlled 
substances. Prescribing practitioners will still be able to write, and 
manually sign, prescriptions for Schedule II, III, IV, and V controlled 
substances, and pharmacies will still be able to dispense controlled 
substances based on those written prescriptions and archive those 
records of dispensing. Further, nothing in this rule prevents a 
practitioner or a practitioner's agent from using an existing 
electronic prescription application that does not comply with the 
interim final rule to prepare a controlled substance prescription, so 
that EHR and other electronic prescribing functionality may be used, 
and print the prescription for manual signature by the practitioner. 
Such prescriptions are paper prescriptions and subject to the existing 
requirements for paper prescriptions.

IV. Discussion of Comments

A. Introduction

    This section summarizes the 194 comments received to the NPRM by 
issue and provides DEA's responses. For each issue, DEA first 
summarizes the proposed rule, then presents the comments and DEA's 
responses. The subjects are presented in an order that tracks the 
process of issuing and dispensing a prescription from practitioner to 
pharmacy. Issues that apply to both types of applications (e.g., third-
party audits, recordkeeping) are presented once. General comments and 
ancillary issues are discussed at the end of this section.

B. Identity Proofing and Logical Access Control

    DEA proposed that practitioners would be required to undergo in-
person identity proofing, with DEA-registered hospitals, State 
licensing boards, or law enforcement agencies checking the 
identification documents. The record of the identity proofing would 
then have been sent to the electronic prescription application 
provider, which would use the information to set access controls to 
ensure that only practitioners eligible to issue controlled substance 
prescriptions were allowed to sign these prescriptions.
1. Identity Proofing
    Comments. Some commenters, including electronic prescription 
application providers and practitioner organizations, supported 
identity proofing, but recommended changes to the proposed rule. One 
physician noted that identity proofing was particularly important to 
prevent online enrollment without any checks on the veracity of the 
information submitted. Other commenters, including insurance 
organizations, some practitioner organizations, and some pharmacy 
organizations, opposed the requirement for identity proofing, stating 
that it would be burdensome to practitioners and a barrier to adoption 
of electronic prescribing. One electronic prescription application 
provider noted that DEA does not conduct identity proofing for issuing 
paper prescriptions. Several practitioner organizations and a State 
Board of Pharmacy stated that there was no assurance that identity 
proofing would reduce diversion, citing the vulnerabilities of paper 
prescriptions. One pharmacy chain stated that DEA should restrict 
access to the database of DEA registration numbers.
    DEA Response. DEA continues to believe that it is critical to the 
security of electronic prescribing of controlled substances that 
authentication credentials used to sign controlled substance 
prescriptions be issued only to individuals whose identities have been 
confirmed based on information presented in, and consistent with, the 
application (except for institutional practitioners; see discussion 
below). Without this step, nonregistrants--at a practitioner's office, 
at an application provider, or elsewhere--could obtain an 
authentication credential in a registrant's name and use it to issue 
illegal prescriptions. As DEA discussed in the NPRM, some existing 
electronic prescription application providers allow people to enroll 
online, with no checks on whether the person is who he claims to be. 
Although it is true that DEA does not require in-person identity 
proofing for registration and allows applications to be filed online, 
DEA conducts a number of checks on registration applications before 
issuing a registration. In addition, filing a false registration 
application is a Federal crime punishable by up to four years in prison 
under 21 U.S.C. 843. Moreover, electronic prescriptions, unlike written 
or oral prescriptions, lack the human elements of handwriting or the 
spoken voice, which a pharmacist can take into account in ascertaining 
whether the prescription was issued by the actual practitioner or an 
impostor; identity proofing serves to some degree to fill this void.
    In response to comments on whether this requirement will reduce 
diversion, DEA is well aware of the vulnerabilities of the paper-based 
prescription system, but that such vulnerabilities exist does not mean 
that DEA should allow similar or greater vulnerabilities with 
electronic prescriptions for controlled substances. A forged paper 
prescription provides forensic evidence of who committed the forgery 
and can exonerate a practitioner based on that evidence; an electronic 
prescription issued in a practitioner's name provides no such evidence, 
making it difficult for law enforcement to identify the person who 
issued it and difficult for the practitioner to prove that he did not. 
Restricting access to the CSA database would not solve the problem of 
patients, medical office staff,

[[Page 16245]]

and pharmacy staff, all of whom have routine access to DEA numbers, 
issuing fraudulent prescriptions.
    DEA recognizes that identity proofing and logical access controls 
(discussed below) will not stop all misuse of electronic prescription 
applications. Identity proofing will not prevent a registrant from 
issuing invalid prescriptions or allowing a staff member to issue 
prescriptions in his name, and it is not intended to prevent such 
activity. The purpose of identity proofing is to limit to as great an 
extent as possible the ability of nonregistrants to obtain an 
authentication credential and issue electronic controlled substance 
prescriptions under a practitioner's name.
    Comments. A substantial number of commenters raised issues related 
to who would conduct the identity proofing. The State Boards generally 
objected to being asked to conduct identity proofing, asserting that 
they did not have the staff or resources to do so. They noted that they 
would need to train staff and perhaps seek legislative authority and 
funding to carry out this function. Other commenters doubted that 
hospitals or law enforcement agencies would be willing to conduct the 
checks or thought that DEA intended to charge for the process. Some 
practitioners objected to the idea of having law enforcement agencies 
involved. Many commenters objected to the cost of trips to a third 
party and stated that it would be a barrier to adoption, particularly 
for practitioners who are not affiliated with a hospital, such as mid-
level practitioners and dentists. Some commenters, including electronic 
prescription application providers, asked that other entities be 
allowed to conduct identity proofing (e.g., notaries, application 
providers, passport processing agencies, the American Association of 
Medical Colleges).
    A long-term care facility (LTCF) organization, several information 
technology organizations, and an application provider suggested that 
DEA use existing certification authorities (CAs) that issue digital 
certificates and routinely conduct identity proofing as part of the 
enrollment process. An information technology firm suggested that DEA 
establish a set of common criteria under which credential issuers can 
become accredited, citing the Department of Defense External 
Certification Authority program as an example. The commenter also 
suggested that DEA specify that firms qualified as shared service 
providers by the Federal Bridge Certification Authority (FBCA) could 
serve as CSPs. A few commenters associated with application providers 
or information technology organizations asked DEA to consider remote 
identity proofing systems.
    DEA Response. In view of the comments, DEA has revised the 
requirements for identity proofing to adopt an approach that does not 
involve parties discussed in the proposed rule. As suggested by some 
commenters, for individual practitioners in private practice (i.e., 
those practitioners not seeking access to an institutional 
practitioner's applications), DEA will use existing certification 
authorities (CAs) and similar credential service providers (CSPs) that 
have been approved by a Federal authority. These organizations conduct 
identity proofing and issue digital certificates and other identity 
credentials as part of their existing businesses. The standards they 
use to conduct identity proofing and issue credentials are established 
in documents (e.g., Certificate Policies, Certificate Practice 
Statements, and Assurance Frameworks) that are reviewed and approved by 
Federal authorities and subject to third-party audits for their 
implementation. DEA is specifying that the identity proofing must meet 
NIST SP 800-63-1 Assurance Level 3 although a CA or CSP may impose 
higher standards.
    DEA's objective is to ensure that identity proofing and the 
provision of two-factor authentication credentials will be done by a 
third party that is not involved in any other part of the electronic 
prescribing process. This approach is based on the concept of 
separation of duties, to ensure that the ability to sign controlled 
substance prescriptions will not depend on the action of a single 
entity or person. A registrant will need the two-factor authentication 
credential before he will be able to sign electronic prescriptions for 
controlled substances, but the possession of the token or tokens 
associated with the credential will not, itself, authorize a registrant 
to access the application to sign controlled substances prescriptions. 
Logical access control will be granted separately. Without the two-
factor authentication credential, a practitioner will not be able to 
sign controlled substance prescriptions even if granted access.
    For practitioners who are obtaining a two-factor authentication 
credential that does not include a digital certificate, DEA is 
requiring that they obtain their authentication credential from a 
credential service provider (CSP) that has been approved by the General 
Services Administration Office of Technology Strategy/Division of 
Identity Management to conduct identity proofing that meets NIST Sp 
800-63-1 Assurance Level 3 or above. For practitioners obtaining a 
digital certificate, DEA is requiring that they obtain the digital 
certificate from a certification authority that is cross-certified with 
the Federal Bridge Certification Authority (FBCA) at a basic assurance 
level or higher and that conducts identity proofing at NIST SP 800-63-1 
Assurance Level 3 or above. DEA believes that shared service providers 
would be too restrictive and believes that the approach it is 
implementing provides greater flexibility for the regulated industry.
    DEA is not dictating how a CSP or CA conducts identity proofing. 
The standards for identity proofing are set by the Federal Bridge 
Certification Authority (FBCA) or the General Services Administration 
in their certificate policies and frameworks and in NIST SP 800-63-1. 
Level 3 requires either in-person identity proofing based on checking 
government-issued photographic identification or remote identity 
proofing. For in-person identity proofing, Level 3 requires the 
examination of a government-issued photographic identification, which 
must be verified with either the issuing agency, credit bureaus, or 
other similar databases. The verification must confirm that the name, 
date of birth, and address listed in the application for the credential 
are consistent with the information in other records checked. The 
person checking the identification must compare the person with the 
photograph, record the identification number, address (if listed), and 
date of birth. If the identification is valid, the issuing organization 
may authorize or issue the credential and send notice to the address of 
record; if the identification or other records checked do not confirm 
the address listed in the application (as may happen if the person has 
recently moved), the organization must issue credentials in a manner 
that confirms the address of record (the address of record is the 
address listed in the application).
    For remote identity proofing, Level 3 requires a valid government-
issued identification number and a financial account number. These 
numbers must be confirmed via record checks with either the issuing 
agency or institution or through credit bureaus or similar databases. 
The check must confirm that the name, address, date of birth, and other 
personal information in the records are consistent with the application 
and sufficient to identify a unique individual. The address or 
telephone number must be confirmed by issuing the credential in a 
manner that

[[Page 16246]]

confirms the ability of the applicant to receive communications at the 
listed address or number. DEA notes that CAs and CSPs may conduct more 
extensive remote identity proofing and may require additional 
information from applicants. DEA believes that the ability to conduct 
remote identity proofing allowed for in Level 3 will ensure that 
practitioners in rural areas will be able to obtain an authentication 
credential without the need for travel. DEA expects that application 
providers will work with CSPs or CAs to direct practitioners to one or 
more sources of two-factor authentication credentials that will be 
interoperable with their applications. DEA is seeking comment on this 
approach to identity proofing.
    DEA is not requiring the CSP or CA to check DEA registrations or 
State authorizations to practice or dispense controlled substances as 
part of the identity-proofing process; these will be checked as part of 
logical access control, as discussed in the next section. DEA decided 
to have checks for the DEA registration, authorization to practice, and 
authorization to dispense controlled substances for individual 
practitioners handled separately from identity proofing for three 
reasons. First, the information that is used to verify identity may not 
be the information associated with a DEA registration. Government-
issued photographic identifications and credit cards usually are 
associated with home addresses and, perhaps, Social Security numbers; 
DEA registrations are usually associated with business locations and, 
in some cases, taxpayer identification numbers. In addition, the 
registration database that DEA makes available through the National 
Technical Information Service does not include this personal 
information, so that a CA or CSP would have to contact DEA for each 
applicant. Second, some practices or application providers may want 
some or all of the nonregistrants on the staff to obtain authentication 
credentials so that there will be only one method of authenticating to 
the application. The possession of a two-factor authentication 
credential would not, in these cases, distinguish between those who can 
sign controlled substance prescriptions and those who cannot. Third, 
the decision to grant access to the functions that allow a practitioner 
to indicate that a prescription is ready for signing and to sign 
controlled substance prescriptions is based on whether the person is a 
DEA registrant, not on the possession of a two-factor authentication 
credential. The two-factor authentication credential is a necessary, 
but not a sufficient, condition for signing a controlled substance 
prescription. It is logical, therefore, to require the people who set 
logical access controls, rather than those who conduct identity 
proofing, to check the DEA and State authorizations to practice and, 
where applicable, authorizations to dispense controlled substances of 
prescribing practitioners.
    Comments. One medical group association and a healthcare system 
recommended that the larger practices be allowed to conduct the 
identity proofing themselves as they already conduct Level 4 identity 
proofing when they issue credentials.
    DEA Response. In view of the comments, DEA has expanded upon the 
proposed rule to allow institutional practitioners, which are 
themselves DEA registrants, to conduct the identity proofing for any 
individual practitioner whom the institutional practitioner is granting 
access to issue prescriptions using the institution's electronic 
prescribing application. Because institutional practitioners have 
credentialing offices, the interim final rule allows those offices to 
conduct in-person identity proofing, which they can do as part of their 
credentialing process. DEA is not requiring institutional practitioners 
to meet the requirements of NIST SP 800-63-1 for identity proofing. As 
some commenters stated, these institutions already conduct extensive 
checks before they credential a practitioner. The interim final rule 
simply requires that before they issue the authentication credential 
they check the person's government-issued photographic identification 
against the person presenting it. They must also check State licensure 
and DEA registrations, where applicable, but they do this as part of 
credentialing and do not need to repeat the checks for practitioners 
whom they have already credentialed.
    The rule only allows institutional practitioners to conduct in-
person identity proofing, not remote identity proofing. There are two 
reasons for this limitation. First, the practitioners will be visiting 
the institution on a regular basis so the burden should be relatively 
low. Second, most institutional practitioners may not have the ability 
or desire to conduct the credit and other background checks that are 
part of remote identity proofing at NIST Levels 2 and 3. DEA recognizes 
that in some large systems, the credentialing office may be at a 
central location and many staff may work at other locations. In those 
cases, the institutional practitioner can decide whether to have the 
staff visit the central location or send someone from the credentialing 
office to the other locations to conduct the identity proofing. DEA 
notes that this issue will arise only during the initial enrollment of 
previously credentialed practitioners. After that, practitioners being 
newly credentialed by an institution can undergo identity proofing when 
and where they are credentialed. The rule also requires that the 
credentialing office check the DEA and State authorizations to practice 
and, where applicable, authorizations to dispense controlled substances 
because this check should be part of their standard credentialing 
process.
    Under the rule, the institutional practitioner may issue the two-
factor authentication credentials itself or obtain them from a third 
party, which will have to be a CSP or CA that meets the criteria 
specified above. In the latter case, the institutional practitioner 
could have each practitioner apply for the two-factor credential 
himself, which would entail undergoing identity proofing by the CSP or 
CA. Alternatively, the institutional practitioner can serve as a 
trusted agent for the third party. Trusted agents conduct part of the 
identity proofing on behalf of the CSP or CA and submit the information 
for each person along with a signed agreement that specifies the 
trusted agent's responsibilities. DEA emphasizes that institutional 
practitioners are allowed, but not required, to conduct identity 
proofing. If an institutional practitioner (e.g., a small hospital or 
clinic) decides to have each practitioner obtain identity proofing and 
the two-factor authentication credential on his own, as other 
individual practitioners do, that is permissible under the rule. DEA is 
seeking comment on this approach to identity proofing by institutional 
practitioners.
    Comments. An intermediary, a pharmacist organization, and a State 
asked whether practitioners would need to undergo identity proofing 
more than once if they used multiple electronic prescription 
applications. An application provider and a practitioner organization 
asked if the identity proofing needed to be revalidated every year. 
Several commenters asked about the need to obtain separate 
authentication credentials if the practitioner holds multiple DEA 
numbers.
    DEA Response. Identity proofing is required to obtain a two-factor 
authentication credential. If a practitioner uses multiple applications 
(e.g., at his practice and at a hospital), he may need to obtain 
separate authentication credentials, based on the

[[Page 16247]]

following considerations. A practitioner will need to undergo identity 
proofing for each such credential that he needs unless the applications 
he wishes to use require authentication credentials from the same CSP 
or CA; in that case, the CSP or CA will determine whether a single 
application for identity proofing and issuance of the authentication 
credential can serve as a basis for issuing multiple credentials. It 
may also be possible that multiple applications will accept the same 
two-factor authentication credential. For example, if a practitioner 
obtains a digital certificate from an approved CA, he may be able to 
use it to digitally sign prescriptions on multiple applications, if 
they accept digital signatures. For those practitioners who use more 
than one DEA registration to issue controlled substance prescriptions, 
DEA is not requiring a practitioner to have a separate authentication 
credential based solely on the fact that he uses more than one DEA 
registration. As for the need for revalidation of identity proofing, 
those periods will be set by the CSP or CA.
    Comments. Practitioner organizations asked if practitioners will be 
charged for the identity proofing.
    DEA Response. DEA expects that the CSP or CA will charge for the 
issuance of a two-factor authentication credential, which will 
generally include the cost of identity proofing. Whether practitioners 
will pay directly or through the application provider will be a 
business decision on the part of application providers.
    Comments. A practitioner organization expressed concern with the 
proposed rule language that referenced ``State licenses'' because some 
States do not issue licenses to mid-level practitioners.
    DEA Response. DEA agrees with this commenter and has revised the 
language in the interim final rule to refer to State authorization to 
practice and State authorization to dispense controlled substances.\10\
---------------------------------------------------------------------------

    \10\ Under the CSA, every person who dispenses a controlled 
substance must have a DEA registration, and may only dispense 
controlled substances to the extent authorized by his registration, 
unless DEA has by regulation, waived the requirement of registration 
as to such person. 21 U.S.C. 822(a)(2), 822(b), 822(d). To be 
eligible to obtain a DEA registration, a practitioner must be 
licensed or otherwise authorized by the State or jurisdiction in 
which he practices to dispense controlled substances. 21 U.S.C. 
802(21), 823(f), 824(a)(3).
---------------------------------------------------------------------------

2. Access Control
    In the NPRM, DEA proposed that the identity proofing document had 
to be submitted to the application provider, which would then check the 
DEA registration and State authorizations to practice, and set access 
controls. DEA also proposed that the application providers check DEA 
registration status weekly and revoke authentication credentials if 
practitioners' registrations had been terminated, revoked, or 
suspended.
    Comments. A LTCF organization stated that any electronic 
prescribing application must have, at its core, control over access 
rights. A practitioner organization also emphasized the need to limit 
access to signing authority within an application. An electronic 
prescription application provider stated that it did not set access 
controls for the applications it sells and installs at medical 
practices. Although its applications have logical access controls, the 
practice administrator is responsible for setting the controls. The 
application provider is not involved in the process.
    DEA Response. In its proposed rule, DEA did not adequately 
differentiate between authentication, authorization, and access. NIST, 
in its special publication SP 800-12, provides the following 
description of these three steps:

    Access is the ability to do something with a computer resource. 
This usually refers to a technical ability (e.g., read, create, 
modify, or delete a file, execute a program, or use an external 
connection). Authorization is the permission to use a computer 
resource. Permission is granted, directly or indirectly, by the 
application or system owner. Authentication is proving (to some 
reasonable degree) that users are who they claim to be.

    NIST SP 800-12 further states:

    Access control is the means by which the ability is explicitly 
enabled or restricted in some way (usually through physical and 
system-based controls). Computer-based access controls are called 
logical access controls. Logical access controls can prescribe not 
only who or what (e.g., in the case of a process) is to have access 
to a specific system resource but also the type of access that is 
permitted. These controls may be built into the operating system, 
may be incorporated into applications programs or major utilities 
(e.g., database management systems or communications systems), or 
may be implemented through add-on security packages.\11\
---------------------------------------------------------------------------

    \11\ National Institute of Standards and Technology. Special 
Publication 800-12 An Introduction to Computer Security--The NIST 
Handbook, Chapter 17; October, 1995. http://csrc.nist.gov/publications/nistpubs/800-12/800-12-html/chapter17-printable.html.

    DEA has revised its approach to access control to remove the 
application provider and its staff from direct involvement in the 
process. Instead, the interim final rule will require that the 
application must have the capability to set logical access controls 
that limit access to the functions for indicating a prescription is 
ready for signing and for signing the prescription to DEA registrants. 
The interim final rule will also limit access to setting these logical 
access controls. The application may set logical access controls on an 
individual basis or on roles. If the logical access controls are role-
based, one or more roles will have to be limited to individuals 
authorized to prescribe controlled substances. This role may be labeled 
``DEA registrant'' or physician, dentist, nurse practitioner, etc., 
provided the role is limited to those authorized to issue controlled 
substance prescriptions. For an individual practitioner who is an agent 
or employee of an institutional practitioner, and who has been 
authorized to prescribe controlled substances under the registration of 
the institutional practitioner pursuant to 21 CFR 1301.22(c), if 
logical access controls are role-based, one role will have to be 
``authorized to sign controlled substance prescriptions.'' (Other 
methods of setting logical access controls that NIST cites--location or 
time--do not appear to be relevant, although applications or users may 
add such limits based on their own concerns.)
    The application logical access control capability must require that 
data entry of authorizations for setting logical access controls and 
the functions limited to registrants (indicating that a controlled 
substance prescription is ready for signing and signing a controlled 
substance prescription) involve two people. The requirement for two 
people to be involved in such data entry is frequently used to protect 
applications from internal security threats. If a person is able, 
through the use of false identity documents, to obtain a two-factor 
authentication credential in a registrant's name, he will still not be 
able to sign controlled substance prescriptions unless he is granted 
access, by two people (one of whom is a registrant). The interim final 
rule does not specify in detail how the application must be structured 
to ensure that two people concur with the data entry; rather, the rule 
simply requires that the application must not accept these logical 
access controls without the action of two parties. For example, a small 
practice with two registrants neither of whom is expecting to leave may 
decide that only the registrants will perform this function, which may 
occur only at the initial installation or upgrade of an electronic 
prescription application to comply with controlled substance

[[Page 16248]]

prescription requirements. In large practices, the registrants might 
find it beneficial to allow nonregistrants, such as a practice 
information technology administrator, to administer logical access 
controls in conjunction with a registrant.
    The interim final rule requires that at least one of the people 
assigned the role of administering logical access control must verify 
that any registrant granted authorization to indicate that a 
prescription is ready for signing and to sign controlled substance 
prescriptions has a valid DEA registration, a State authorization to 
practice and, where applicable, a State controlled substance 
authorization. In small practices, this verification may require 
nothing more than checking expiration dates on the practitioners' DEA 
Certificate of Registration and State authorization(s), unless there is 
reason to question the current validity. In larger practices, 
verification may take more time. Individual registrations can be 
checked online at DEA's Web site at http://www.deadiversion.usdoj.gov/ 
by clicking on the Registration Validation button on the left side of 
the Web page.
    Once DEA registration and State authorization to practice and State 
authorization to dispense controlled substances have been verified, two 
people must be involved in entering the data to the application to 
identify those people authorized to indicate that a prescription is 
ready for signing and to sign controlled substance prescriptions; those 
two people are also involved in entering data to the application to 
identify people whose authorization has been revoked. The first person 
must enter the data. A registrant must then use his two-factor 
authentication credential to provide the second approval. The 
application must ensure that until the second approval occurs, logical 
access controls for controlled substance prescription functions cannot 
be activated or altered. DEA recognizes that some solo practitioners 
may not have other employees although it seems unlikely that they do 
not have at least part-time help for office management and back office 
functions. DEA is not requiring that the second person be an employee, 
simply that there be two people involved and that the persons involved 
be specifically designated by the practitioner(s). For such solo 
practitioners and for many small practices, logical access controls may 
need to be set only once because they will usually be set or changed 
only with staff turnover.
    All entries and changes to the logical access controls for setting 
the controls and for the controlled substance prescription functions 
must be defined as auditable events and a record of the changes 
retained as part of the internal audit trail. DEA is seeking comment on 
this approach to logical access control for individual practitioners.
    Logical access must be revoked whenever any of the following 
occurs: A DEA registration expires without renewal, or is terminated, 
revoked, or suspended; the registrant reports that a token associated 
with the two-factor authentication credential has been lost or 
compromised; or the registrant is no longer authorized to use the 
practice's application. DEA anticipates that for most practices, 
logical access controls will be set and changed infrequently, usually 
when a new registrant joins the practice or a registrant leaves. Even 
in larger practices, changes to authorizations are likely to occur 
relatively infrequently.
    DEA recognizes that application service providers (ASPs) may 
currently set access controls, to the extent that they do, at the ASP 
level and that the interim final rule may require them to reprogram 
some of their security controls. DEA believes these steps are necessary 
to ensure that a registrant is involved in the process of setting 
logical access controls and that these cannot be set or changed without 
the concurrence of a registrant. If registrants submitted a list of 
people to be authorized to perform the controlled substance 
prescription functions to an ASP, there would need to be a process to 
ensure that the list was from a legitimate source (e.g., notarization), 
which could be cumbersome, particularly for larger practices where the 
list may change more frequently than is the case for small practices. 
In addition, the responsibility for data entry would then rest with ASP 
staff, who will not have the same degree of interest in protecting 
registrants from the misuse of the applications as the registrants 
themselves have.
    For institutional practitioners, the setting of logical access 
controls will necessarily be somewhat different because the registrant 
is not an individual. The principle, however, is the same. Identity 
proofing must be separate from setting logical access controls; two 
individuals must be involved in each step. The interim final rule 
therefore requires that two individuals from the credentialing office 
provide the part of the institution that controls the computer 
applications with the names of practitioners authorized to issue 
controlled substance prescriptions. The entry of the data will also 
require the involvement of two individuals. The institutional 
registrant is responsible for designating and documenting individuals 
or roles that can perform these functions. Logical access must be 
revoked whenever any of the following occurs: The institutional 
practitioner's or, where applicable, individual practitioner's DEA 
registration expires without renewal, or is terminated, revoked, or 
suspended; the practitioner reports that a token associated with the 
two-factor authentication credential has been lost or compromised; or 
the individual practitioner is no longer authorized to use the 
institutional practitioner's application. DEA is seeking comment on 
this approach to logical access control for institutional 
practitioners.
    Comments. An application provider to a major healthcare system 
agreed that access controls were needed, but noted that in a large 
healthcare system this is complex because of the variety of 
practitioners involved and will take time to implement.
    DEA Response. The interim final rule does not require applications 
to distinguish which schedules of controlled substances a registrant is 
authorized to prescribe. Practitioners are responsible for knowing 
which schedules they may prescribe; if a practitioner prescribes beyond 
the extent authorized by his registration, he is dispensing in 
violation of the CSA.\12\ In addition, asking applications to 
distinguish among all the variations of prescribing authority may add 
unnecessary complication to applications that will mostly be used by 
practitioners who are authorized to prescribe all Schedule II, III, IV, 
and V substances. This approach should reduce some of the complexity in 
programming logical access controls because the application providers 
will not need to distinguish among DEA registrants. DEA also notes that 
the 2009 security survey of the Health Information and Management 
Systems Society (HIMSS) indicated that all of the 196 healthcare 
systems surveyed have established user access controls.\13\
---------------------------------------------------------------------------

    \12\ 21 U.S.C. 822(b), 841(a)(1).
    \13\ Healthcare Information and Management Systems Society. 2009 
HIMSS Security Survey, November 3, 2009. http://www.himss.org/content/files/HIMSS2009SecuritySurveyReport.pdf.
---------------------------------------------------------------------------

    Comments. Several application providers objected to the proposed 
requirement that they check DEA registration status weekly.
    DEA Response. Because application providers are no longer 
responsible for controlling access, DEA has removed this requirement in 
the interim final rule. People within a practitioner's office or an 
institutional practitioner

[[Page 16249]]

will be familiar with any issues related to the status of a DEA 
registration. They will have access to the expiration date of the DEA 
registration and State authorization(s) to practice and, where 
applicable, to dispense controlled substances and be able to check with 
the practitioner to ensure that the registration has been renewed. If a 
practitioner is subject to suspension or revocation, other registrants 
in the practice or the institutional practitioner are likely to be 
aware of the legal problems and can revoke access control.
    DEA recognizes that this approach will not prevent a registrant in 
solo practice from continuing to issue controlled substances 
prescriptions under an expired, terminated, suspended, or revoked 
registration. However, it is already clear under existing law and 
regulations that a practitioner who prescribes or otherwise dispenses 
controlled substances beyond the scope of his registration is 
committing a violation of the CSA and subject to potential criminal 
prosecution, civil fine, and loss of registration. Any practitioner who 
would use his two-factor authentication credential to issue 
prescriptions after he is legally barred from doing so would be 
creating evidence of such criminal activity. As discussed above, the 
purpose of identity proofing and access control is to prevent 
nonregistrants from gaining the ability to issue controlled substance 
prescriptions.

C. Authentication Protocols

    Authentication protocols are classified by the number of factors 
they require. NIST and others recognize three factors: something you 
know, something you have, and something you are. Combinations of user 
IDs and passwords are one-factor because they require only information 
that you know. A standard ATM uses two-factor--something you know (a 
personal identification number (PIN)) and something you have (bank 
card). DEA proposed that practitioners be required to use a two-factor 
authentication protocol to access the electronic prescription 
application to sign controlled substance prescriptions. DEA proposed 
that one factor would have to be a hard token that met NIST SP 800-63 
Level 4 and that the cryptographic module would have to be validated at 
Federal Information Processing Standard (FIPS) 140-2 Security Level 2 
overall and Level 3 security.
    Comments. Three information technology firms asserted that two-
factor authentication is not common. They suggested that a clear `audit 
log' be generated upon the provider authentication, prescription 
approval, transmission of prescription, and successful prescription 
transmittal. They suggested that this audit log should be in the form 
defined by Healthcare Information Technology Standards Panel (HITSP) 
T15 ``Collect and Communicate Security Audit Trail Transaction.'' Other 
commenters noted that the Certification Commission for Healthcare 
Information Technology (CCHIT) does not require two-factor 
authentication and has only listed it as a possibility for its 2010 
standard. A State Board of Pharmacy supported two-factor 
authentication, stating that concerns expressed by some members of 
industry about the added time to complete two-factor authentication are 
misplaced. It said that the two-factor authentication will take a 
minimal amount of time compared to the time it takes to move through 
the multiple screens used to create a prescription in most 
applications.
    DEA Response. DEA agrees that CCHIT does not yet require two-factor 
authentication. Two-factor authentication is roadmapped by CCHIT in 
2010 and beyond. DEA emphasizes, however, that an audit log will not 
provide any assurance of who issued a prescription. The commenters 
appear to have confused logical access control with authentication. The 
problem DEA is addressing with the requirement for two-factor 
authentication credentials is not that someone may use their own 
authentication credential to alter or create a prescription, but that a 
nonregistrant will use a registrant's authentication credential to 
create and sign a prescription. If a nonregistrant has been able to use 
a registrant's authentication credential, the audit trail will 
incorrectly indicate that the registrant was responsible for the 
prescription. DEA believes that use of two-factor authentication limits 
this possibility.
    As commenters indicated, single-factor authentication usually means 
passwords alone or in combination with user IDs. NIST states in its 
special publication SP 800-63-1: ``* * * the ability of humans to 
remember long, arbitrary passwords is limited, so passwords are often 
vulnerable to a variety of attacks including guessing, use of 
dictionaries of common passwords, and brute force attacks of all 
possible password combinations. * * * all password authentication 
mechanisms are vulnerable to keyboard loggers and observation of the 
password when it is entered.'' NIST also states that ``* * * many 
users, left to choose their own passwords will choose passwords that 
are easily guessed and even fairly short[.]'' \14\ This problem is 
exacerbated in healthcare settings where multiple people may use the 
same computers and work in close proximity to each other. Even if other 
staff cannot guess the password, they may have many opportunities to 
observe a practitioner entering the password. Strong passwords 
(combinations of 8 or more letters, numbers, and special characters) 
are hard to remember and are often written down. None of these 
strategies alters the ability of others in a healthcare setting to 
observe the password. NIST, in its draft guidance on enterprise 
password management (SP 800-118) states the following:
---------------------------------------------------------------------------

    \14\ National Institute of Standards and Technology. Special 
Publication 800-63-1, Draft Electronic Authentication Guideline, 
December 8, 2008, Appendix A. http://csrc.nist.gov/Publications/PubsSPs.html.

    Organizations should be aware of the drawbacks of using 
password-based authentication. There are many types of threats 
against passwords, and most of these threats can only be partially 
mitigated. Also, users are burdened with memorizing and managing an 
ever-increasing number of passwords. However, although the existing 
mechanisms for enterprise password management can somewhat alleviate 
this burden, they each have significant usability disadvantages and 
can also cause more serious security incidents because they permit 
access to many systems through a single authenticator. Therefore, 
organizations should make long-term plans for replacing or 
supplementing password-based authentication with stronger forms of 
authentication for resources with higher security needs.\15\
---------------------------------------------------------------------------

    \15\ National Institute of Standards and Technology. Special 
Publication 800-118, Guide to Enterprise Password Management 
(draft), April 2009; http://csrc.nist.gov/publications/drafts/800-118/draft-sp800-118.pdf.

    DEA remains convinced that single-factor authentication is 
insufficient to ensure that a practitioner will not be able to 
repudiate a prescription he signed.
    Comments. Although only a few commenters opposed two-factor 
authentication, believing that passwords were sufficient, most comments 
DEA received on the issue raised substantial concerns about the details 
of the proposed rule on this subject. These concerns focused on the 
requirement for a hard token and the security levels proposed.
    A practitioner organization, a hospital organization, a pharmacy 
association, a health information technology organization, a healthcare 
system, other medical associations, and a number of application 
providers asked DEA to allow the use of biometrics as an alternative to 
a hard token. The practitioner organization stated that a

[[Page 16250]]

second authentication at the time of transmission is reasonable given 
the potential for unintentional or intentional failure to have only 
authorized prescribers actually transmit the prescription. That 
commenter asserted that the key is to view authentication as having 
many highly acceptable approaches and requiring that a certain strength 
of authentication be the outcome, but not prescribe the exact method by 
which that authentication is generated. A health information technology 
organization asserted that the Association of American Medical Colleges 
uses a fingerprint biometric strategy to permanently identity proof all 
future physicians at the time they take their Medical College Admission 
Test (MCAT). An application provider noted that biometric identifiers 
will limit unauthorized access to electronic prescription applications 
and ensure non-repudiation with absolute certainty; the commenter 
asserted that these applications cannot be compromised without the 
practitioner's knowledge. The commenter noted that biometric 
identifiers cannot be misplaced, loaned to others or stored in a 
central location for use by other persons. The commenter noted, 
however, that the technology may not be ready to deploy in a scalable, 
cost-effective way at this time.
    DEA Response. DEA agrees with these commenters and has revised the 
interim final rule to allow the use of a biometric as a second factor; 
thus, two of the three factors must be used: a biometric, a knowledge 
factor (e.g., password), or a hard token. While DEA is uncertain about 
the extent to which existing biometric readers will be used in 
healthcare settings, DEA believes it is reasonable to allow for such 
technology because the technology is likely to improve. The HIMSS 2009 
security survey indicated that 19 percent of the 196 healthcare systems 
surveyed use biometric technologies as a tool to provide security for 
electronic patient data; the HIMSS 2009 leadership survey of larger 
healthcare systems found that 18 percent used biometrics as a tool to 
provide security for electronic patient data, but 36 percent indicated 
that they intended to do so.\16\ The 2009 security survey also found 
that 33 percent of the systems already use two-factor authentication 
for security.
---------------------------------------------------------------------------

    \16\ Healthcare Information and Management Systems Society. 2008 
HIMSS Security Survey, October 28, 2008. HIMSS, 20th Annual 2009 
HIMSS Leadership Survey, April 6, 2009. http://www.himss.org.
---------------------------------------------------------------------------

    DEA is establishing several requirements for the use of biometrics, 
and for the testing of the software used to read the biometrics. DEA is 
establishing these standards after extensive consultation with NIST, 
and based on NIST recommendations. A discussion of these requirements 
follows.
     The biometric subsystem must operate at a false match rate 
of 0.001 or lower.
    The term ``false match rate'' is similar to the term ``false accept 
rate''--it is the rate at which an impostor's biometric is falsely 
accepted as being that of an authorized user. DEA is not establishing a 
false non-match (rejection) rate; while users may be interested in this 
criterion, DEA does not have an interest in setting a requirement for a 
tolerance level for false rejections for electronic prescription 
applications.
     The biometric subsystem must use matching software that 
has demonstrated performance at the operating point corresponding with 
the required false match rate specified (0.001) or a lower false match 
rate. This testing must be performed by the National Institute of 
Standards and Technology (NIST) or another DEA-approved (government or 
non-government) laboratory.
    This criterion is designed to ensure that an independent third-
party has tested the software and has determined its effectiveness on a 
sequestered data set that is large enough for high confidence in the 
results, which will be made publicly available for consumers. DEA 
believes that the requirement to have the biometric software tested by 
an independent third party, as discussed further below, will provide 
greater assurance to electronic prescription application providers and 
practitioners that the biometric subsystem being used, in fact, meets 
DEA's requirements. NIST currently lists technologies which it has 
tested and their rates of performance at the following URLs: http://fingerprint.nist.gov for fingerprint testing, http://face.nist.gov for 
facial testing, and http://iris.nist.gov for iris testing.
     The biometric subsystem must conform to Personal Identity 
Verification authentication biometric acquisition specifications, 
pursuant to NIST Special Publication 800-76-1, if they exist for the 
biometric modality of choice.
    This requirement specifies minimum requirements for the performance 
of the device that is used to acquire biometric data (usually an 
image), whereas the prior requirements relate to the software used to 
compare biometric samples to determine if a user is who he claims to 
be. NIST Special Publication 800-76-1 \17\ describes technical 
acquisition and formatting specifications for the biometric credentials 
of the PIV system. Section 4.2 covers sensor specifications for 
fingerprint acquisition for the purpose of authentication; Section 8.6 
covers conformance to this specification. Section 5.2 covers both 
format and acquisition specifications for facial images. While the 
format requirements for PIV will not be required by DEA here, the 
normative requirements for facial image acquisition establish minimum 
criteria for automated face recognition, specifically the ``Normative 
Notes,'' numbers 4 through 8 under Table 6. DEA also recommends using 
the normative values for PIV conformance in Table 6 rows 36 through 58 
for frontal facial image acquisition. Currently, specifications exist 
only for fingerprint and face acquisitions.
---------------------------------------------------------------------------

    \17\ National Institute of Standards and Technology. Special 
publication 800-76-1, Biometric Data Specification for Personal 
Identity Verification, January 2007. http://csrc.nist.gov/
publications/PubsSPs.html.
---------------------------------------------------------------------------

    DEA wishes to emphasize that the use of SP 800-76-1 does not imply 
that all requirements related to Federally mandated Personal Identity 
Verification cards apply in this context, only those specified for 
biometric acquisition for the purposes of authentication. PIV goes 
beyond this application, in that it has additional requirements for 
fingerprint registration (or enrollment) suitable for a Federal Bureau 
of Investigation background check, and the PIV credential has 
interoperability requirements that will not necessarily apply to users 
of controlled substance electronic prescription applications.
     The biometric subsystem must either be co-located with a 
computer or PDA that the practitioner uses to issue electronic 
prescriptions for controlled substances, where the computer or PDA is 
located in a known, controlled location, or be built directly into the 
practitioner's computer or PDA that he uses to issue electronic 
prescriptions for controlled substances.
    This criterion is intended to add to the security of the biometric 
factor by physically controlling access to the biometric device to 
reduce the potential for spoofing.
     The biometric subsystem must store device ID data at 
enrollment (i.e., biometric registration) with the biometric data and 
verify the device ID at the time of authentication.
    Within this context, enrollment is the process of collecting a 
biometric sample from a new user and storing it (in some format) 
locally, on a network, and/or on a token. These enrolled data are 
stored

[[Page 16251]]

for the purpose of future comparisons when someone (whether the genuine 
user or an impostor) attempts to log in. To help ensure that log-in 
attempts are being initiated by the genuine user (as opposed to a 
spoofed biometric), this requirement in combination with the above 
requirement increase the difficulty for an impostor to spoof a 
biometric and remotely issue an unlawful prescription.
     The biometric subsystem must protect the biometric data 
(raw data or templates), match results, and/or non-match results when 
authentication is not local.
     If sent over an open network, biometric data (raw data or 
templates), match results, and/or non-match results must be:
    [cir] Cryptographically source authenticated;
    [cir] Combined with a random challenge, a nonce, or a timestamp to 
prevent replay;
    [cir] Cryptographically protected for integrity and 
confidentiality;
    [cir] Sent only to authorized systems.
    The above requirements are to ensure the security and integrity for 
this authentication factor (a biometric), ensuring any data related to 
the biometric subsystem (biometric patterns and results of comparisons) 
are sent from an authorized source to an authorized destination and 
that the message was not tampered with in transit. Additionally, 
cryptographic protection of the biometric data addresses an aspect of 
the user's interests in confidentiality of personal data.
    The easiest way to meet the above requirements when authentication 
is not local is to run a client authenticated TLS connection or a 
similar protocol between the endpoints of any remote communication 
carrying data subject to the above requirements. Another possible 
solution that may be used is server authenticated TLS in combination 
with a secure HTTP cookie at the client that contains at least 64 bits 
of entropy.
    DEA also recognizes that biometrics application providers have a 
vested interest in either selling their applications directly to 
practitioners or electronic prescription application providers, or 
partnering with those electronic prescription application providers to 
market their applications. Therefore, as discussed above, to provide 
practitioners and electronic prescription application providers with an 
objective appraisal of the biometrics applications they may purchase 
and use, DEA is requiring independent testing of those applications. 
This testing is similar to the third-party audits or certifications of 
the electronic prescription and pharmacy applications DEA is also 
requiring. Testing of the biometric subsystem must have the following 
characteristics:
     The test is conducted by a laboratory that does not have 
an interest in the outcome (positive or negative) of performance of a 
submission or biometric.
    DEA wishes to ensure that the testing body is independent and 
neutral. As noted previously, tests may be conducted by NIST, or DEA 
may approve other government or nongovernment laboratories to conduct 
these tests.
     Test data are sequestered.
     Algorithms are provided to the testing laboratory (as 
opposed to scores).
    To the extent possible, independent testing should provide an 
unbiased evaluation of its object of study, which should yield 
repeatable, generalizable results. The above two requirements reflect 
the principle behind independent testing. If test participants had 
access to the test data used in an evaluation, they would have the 
opportunity to tune or augment their algorithms to maximize accuracy on 
that data set, but would likely fail to give a fair assessment of the 
algorithm's performance. Therefore, test data should not be made public 
before the testing period closes, and if test data are sequestered, 
algorithms must be provided to the independent testing laboratory for 
the experiment(s) to be conducted. Additionally, the latter requirement 
permits the independent testing laboratory to produce the results 
itself that are ultimately used to characterize performance.
     The operating point(s) corresponding with the false match 
rate specified (0.001), or a lower false match rate, is tested so that 
there is at least 95% confidence that the false match and non-match 
rates are equal to or less than the observed value.
    As discussed above, testing should yield results that are 
repeatable. The resulting measurements of an evaluation should have a 
reasonably high degree of reliability. A confidence level of 95% or 
greater will characterize the values from an evaluation as reliable for 
this context.
     Results are made publicly available.
    The provision of testing results to the public, either through a 
Web site or other means, will help to ensure transparency of the 
testing process and of the results. Such transparency will provide 
greater opportunity for interested electronic prescription application 
providers and others to compare results between biometrics application 
providers to find the biometric application that best meets their 
needs.
    DEA recognizes the need for assurance that a captured biometric 
sample is obtained from a genuine user--and not a spoofed copy, 
particularly in unattended applications such as electronic 
prescriptions for controlled substances, where many users may have 
access to computers that contain electronic prescription applications. 
Liveness detection is a tool that some biometric vendors have developed 
to address this issue. However, since this is an active area of 
research that has not been standardized, DEA is not setting a specific 
requirement for liveness detection at this time, but will reconsider 
this tool in the future as industry standards and specifications are 
developed.
    DEA emphasizes that the use of biometrics as one factor in the two-
factor authentication protocol is strictly voluntary, as is all 
electronic prescribing of controlled substances. As noted previously, 
DEA wishes to emphasize that these standards do not specify the types 
of biometrics that may be acceptable. Any biometric that meets the 
criteria specified above may be used as the biometric factor in a two-
factor authentication credential used to indicate that prescriptions 
are ready to be signed and sign controlled substance prescriptions. 
DEA, after extensive consultation with NIST, has written these criteria 
to be as flexible as possible to emerging technologies, allowing new 
biometrics systems to develop in the future that meet these criteria.
    Because the use of biometrics and the standards related to their 
use were not discussed in the notice of proposed rulemaking, DEA is 
seeking further comment on these issues. Specifically, DEA is seeking 
comments in response to the following questions:
     What effect will the inclusion of biometrics as an option 
for meeting the two-factor authentication requirement have on the 
adoption rate of electronic prescriptions for controlled substances, 
using the proposed requirements of a password and hard token as a 
baseline? Do you expect the adoption rate to significantly increase, 
slightly increase, or be about the same? Please also indicate why.
     Is there an alternative to the option of biometrics which 
could result in greater adoption by medical practitioners of electronic 
prescriptions for controlled substances while also providing a safe, 
secure, and closed system for prescribing controlled substances 
electronically? If so, please describe the alternative(s) and indicate

[[Page 16252]]

how, specifically, it would be an improvement on the authentication 
requirements in this interim rule.
    Also, based on the comments received, it appears that a number of 
commenters may have already implemented biometrics as an authentication 
credential to electronic applications. DEA is seeking information from 
commenters on their experiences implementing biometric authentication. 
DEA seeks the following information:
     Why was the decision made to adopt biometrics as an 
authentication credential? Why was the decision made to adopt 
biometrics as opposed to another option? What other options were 
considered?
     What are biometrics as an authentication credential used 
for (e.g., access to a computer, access to particular records, such as 
patient records, or applications)?
     How many people in the practice/institution use biometric 
authentication (number and percentage, type of employee--practitioners, 
nurses, office staff, etc.)?
     What types of biometric authentication credentials are 
used (e.g., fingerprint, iris scan, hand print)?
     How are the biometrics read, and what hardware is 
necessary (e.g., fingerprint readers built into keyboards or mouses, 
on-screen biometric readers, external readers attached to computers)?
     Is biometric authentication used by itself or in 
combination with a user ID or password?
     How are biometric readers distributed (e.g., at every 
computer workstation, at certain workstations based on location, 
allocated based on number of staff)?
     Was the adoption of biometrics part of installation of a 
new system or an addition to existing applications?
     How long did the implementation process take? Was the time 
related to implementing biometrics or other application installation 
issues?
     Which parts of the biometric implementation were completed 
without difficulty?
     What challenges were encountered and how were they 
overcome?
     Were workflows affected during or after implementation 
and, if so, how were they affected and for how long?
     How do the users feel about the use of biometrics as an 
authentication credential?
     Has the use of biometric authentication improved or slowed 
workflows? If so, how?
     Has the use of biometric authentication improved data and/
or network security?
     What other benefits have been realized?
    Comments. A practitioner organization recommended that the second 
factor be eliminated when a biometric authentication device is used.
    DEA Response. DEA believes that any authentication protocol that 
uses only one factor entails greater risk than a two-factor 
authentication protocol. While DEA recognizes the strength that 
biometrics provide, biometric readers themselves are not infallible. 
They can falsely accept a biometric, or purported biometric, that does 
not correspond to the biometric associated with a particular user. 
Requiring two-factor authentication, regardless of the factors used 
(Something you know, something you have, and something you are), 
ensures a strong authentication method, which DEA believes is necessary 
to sign electronic prescriptions for controlled substances.
    Comments. Some physician and pharmacy organizations objected to 
hard tokens, asserting that they are inconvenient, impractical, easily 
lost or shared, and generally not secure enough. They suggested tap-
and-go proximity cards because, they asserted, such cards would be more 
cost effective. These physician organizations further noted that 
hospital security systems may bar the use of certain hard tokens. One 
application provider indicated that it had tried one-time-password 
devices in an application used for electronically prescribing 
noncontrolled substances and found they discouraged use of the 
application. Two large healthcare systems suggested alternative 
challenge-response methods as well as biometrics as another approach 
for closed systems.
    Other commenters objected to the requirement for Level 4 security 
for the hard token. They noted that relatively few devices that are 
validated by Federal Information Processing Standards (FIPS) meet Level 
4. One application provider stated that DEA's description in the 
proposed rule is more like Level 3 with a hard token. It asserted that 
Level 4 would mean that any user of the application, not just 
practitioners signing controlled substance prescriptions, would need 
Level 4 tokens. Some commenters further asserted that few devices meet 
FIPS 140-2 Security Level 3 for physical security. An intermediary 
stated the current NIST SP 800-63-1 draft definition is different from 
the original SP 800-63 definition; the commenter indicated that SP 800-
63-1 does not require that approved cryptographic algorithms must be 
implemented in a cryptographic module validated under FIPS 140-2. Thus, 
the commenter believed, the requirements according to this new draft SP 
800-63-1 could be implemented more easily.
    DEA Response. DEA has revised this rule to allow the use of a hard 
token that is separate from the computer being accessed and that meets 
FIPS 140-2 Security Level 1 security or higher. Proximity cards that 
are smart cards with cryptographic modules could serve as hard tokens. 
The FIPS 140-2 requirements for higher security levels generally relate 
to the packaging of the token (tamper-evident coatings and seals, 
tamper-resistant circuitry). DEA does not consider this level of 
physical security necessary for a hard token.
    Contrary to the intermediary's statement, NIST SP 800-63-1 does 
require that cryptographic modules be FIPS 140-2 validated. NIST SP 
800-63-1 requires the following for one-time-password devices: ``Must 
use approved block cipher or hash function to combine a symmetric key 
stored on device with a nonce to generate a one-time password. The 
cryptographic module performing this operation shall be validated at 
FIPS 140-2 Level 1 or higher.'' For single-factor and multi-factor 
cryptographic tokens at Assurance Level 2 or 3, NIST SP 800-63-1 
requires: ``The cryptographic module shall be validated at FIPS 140-2 
Level 1 or higher.''
    DEA believes that NIST 800-63-1 Assurance Level 3 as described will 
meet its security concerns. As discussed above, DEA continues to 
believe that reliance on passwords alone, as a few commenters 
suggested, would not provide sufficient security in healthcare settings 
where computers are accessed and shared by staff. Many staff may be 
able to watch passwords being entered, and computers may be accessible 
to patients or other outsiders. In addition, DEA notes that 
practitioners might find strong passwords more burdensome than a 
biometric or token over the long run. Strong passwords generally need 
to be long (e.g., 8-12 characters) with a mix of characters, to 
maintain security. They also need to be changed frequently (e.g., every 
60 to 90 days). However, imposing these password requirements would 
make it more likely that practitioners would simply write down 
passwords, thereby rendering them useless for purposes of security. In 
contrast to the time limits typically required for strong passwords, a 
token and biometrics can last for years. Although initially simpler to 
implement, passwords impose a burden on the user, who has to remember 
and key in the password, and on the application, which has to reset 
passwords when the user forgets them.

[[Page 16253]]

DEA is not allowing the use of some two-factor combinations. For 
example, look-up secret tokens or out-of-band tokens are not 
acceptable. Look-up secret tokens, which are something you have, are 
often printed on paper or plastic; the user is asked to provide a 
subset of characters printed on the card. Unlike a hard token, these 
tokens can be copied and used without the practitioner's knowledge, 
undermining non-repudiation. Out-of-band tokens send the user a message 
over a separate channel (e.g., to a cell phone); the message is then 
entered with the password. Although DEA recognizes that these tokens 
might work, DEA doubts if they are practical because they require more 
time for each authentication than the other options.
    Based on the comments received, it appears that a number of 
commenters have already implemented a variety of hard tokens (e.g., 
proximity cards, USB devices) as an authentication credential to 
electronic applications. DEA is seeking information from commenters on 
their experiences implementing hard tokens as authentication 
credentials. DEA seeks the following information:
     Why was the decision made to adopt hard token(s) as an 
authentication credential? Why was the decision made to adopt hard 
tokens as opposed to another option? What other options were 
considered?
     What are hard token(s) as an authentication credential 
used for (e.g., access to a computer, access to particular records, 
such as patient records, or applications)?
     How many people in the practice/institution use hard 
tokens for authentication (number and percentage, type of employee--
practitioners, nurses, office staff, etc.)?
     What types of hard tokens are used (e.g., proximity cards, 
USB drives, OTP devices, smart cards)?
     Are the hard tokens used by themselves or in combination 
with user IDs or passwords?
     How are the hard tokens read (where applicable), and what 
hardware is necessary (e.g., card readers built into keyboards, 
external readers attached to computers)?
     How are hard token readers distributed (e.g., at every 
computer workstation, at certain workstations based on location, 
allocated based on number of staff)?
     Was the adoption of hard tokens part of installation of a 
new system or an addition to existing applications?
     How long did the implementation process take? Was the time 
related to implementing hard tokens or other application installation 
issues?
     Which parts of the implementation were completed without 
difficulty?
     What challenges were encountered and how were they 
overcome?
     Were workflows affected during or after implementation 
and, if so, how were they affected and for how long?
     How do the users feel about the use of hard tokens as an 
authentication credential?
     Has the use of hard tokens as an authentication credential 
improved or slowed workflows? If so, how?
     Has the use of hard tokens as an authentication credential 
improved data and/or network security?
     What other benefits have been realized?
    Comments. Practitioner organizations asked who will create and 
distribute hard tokens, and how losses, malfunctions, and application 
downtime will be handled. A physician stated that tokens should be able 
to create keys on the token immediately under user control to speed 
distribution and replacement that has been such a barrier in pilot 
work.
    DEA Response. Who distributes the hard tokens will depend on the 
application being used. In some cases, the credential service provider, 
working in conjunction with the electronic prescription application 
provider, may distribute the hard tokens; in other cases, the 
credential service provider, working in conjunction with the electronic 
prescription application provider, may tell the practitioners what type 
of token is required (e.g., a smart card, thumb drive, PDA), then 
securely register or activate the token. DEA agrees with the commenter 
that the latter scenario would make replacement easier because the 
practitioner could purchase a new token locally and obtain a new 
credential without having to wait for the application provider to send 
a new token. DEA, however, believes it is better to provide flexibility 
and allow credential service providers, electronic prescription 
application providers, and practitioners to determine how to provide 
and replace tokens when they are lost or malfunction.
    Electronic prescription application downtime is not specific to 
tokens; any electronic prescription application may experience downtime 
regardless of the authentication method used. Practitioners will always 
have the option of writing controlled substance prescriptions manually.
    Comments. A physician stated that there are special problems for 
physicians in small practices who do not normally wear institutional 
identification badges and have tighter time and budget constraints than 
large organizations. He stated that consideration should be given to 
allowing some exemptions for small practices or physicians who are 
willing to accept some risk from less than ideal authentication such as 
the use of biometrics as a substitute for cryptographic two-factor 
authentication or use of private keys or other cryptographic secrets 
protected by software installed on computers in a limited controlled 
office environment that would allow operation with only the PIN from a 
defined set of computers that were shared in a small practice. The 
commenter asserted that the cost of cryptographic tokens is not large, 
but a potential barrier nonetheless.
    DEA Response. As discussed above, DEA is allowing the use of 
biometrics as an alternative to hard tokens, as one factor in the two-
factor authentication protocol. DEA disagrees, however, with allowing 
an exception from two-factor authentication for small practices. DEA 
recognizes the constraints on small practices, but believes that the 
interim final rule, which allows Level 3 tokens and biometrics, will 
make it easier for small practices. One-factor authentication, such as 
a PIN, will not provide adequate security, particularly in a small 
practice where passwords may be more easily guessed than in a large 
practice because the office staff will be familiar with the words a 
practitioner is most likely to use (e.g., nickname, favorite team, 
child's or pet's name).
    Comments. A State agency reported on a vendor that uses a security 
matrix card; prescribers log on using a password and user ID and then 
have to respond to a challenge that corresponds to three interstices on 
the card. The commenter asserted that the challenge is unique to the 
provider, different every time, and only the card will provide the 
correct response. The commenter asserted that although there are some 
vulnerabilities, it is simple and inexpensive.
    DEA Response. DEA believes that such devices can be vulnerable as 
they may be physically reproduced and provided to others, or reproduced 
and used by others without the practitioner's knowledge. For that 
reason, DEA does not believe that these types of authentication tokens 
address DEA's concerns. Hard tokens are tangible, physical, objects, 
possessed by a practitioner. Giving this tangible, physical object to 
another person takes a specific physical act on the part of the 
practitioner. That act is difficult for the practitioner to deny, and 
thus strengthens the value of hard tokens as a method of security.

[[Page 16254]]

    Comments. A pharmacy association and an application provider asked 
whether practitioners would need multiple tokens if they used multiple 
applications.
    DEA Response. The number of tokens that a practitioner will need 
will depend on the applications and their requirements. It is possible 
that multiple authentication credentials could be stored on a single 
token (e.g., on a smart card or thumb drive). If a practitioner 
accesses two applications that require him to have a digital 
certificate, it is possible that a single digital certificate could be 
used for both.

D. Creating and Signing Electronic Controlled Substance Prescriptions

    DEA proposed that controlled substance prescriptions must contain 
the same data elements required for paper prescriptions. DEA proposed 
that, as with paper prescriptions, practitioners or their agents would 
be able to create a prescription. When the prescription was complete, 
DEA proposed that the application require the practitioner to complete 
the two-factor authentication protocol. The application would then 
present at least the DEA-required elements for review for each 
controlled substance prescription and the practitioner would have to 
positively indicate his approval of each prescription. Prior to 
signing, the proposed rule would have required the practitioner to 
indicate, with another keystroke, agreement with an attestation that he 
had reviewed the prescription information and understood that he was 
signing the prescription. The practitioner would then have signed the 
prescription for immediate transmission. If there was no activity for 
more than two minutes after two-factor authentication, the application 
would have been required to lock out the practitioner and require 
reauthentication to the signing function. The first intermediary that 
received the prescription would have been required to digitally sign 
and archive the prescription.
1. Reviewing Prescriptions
    DEA proposed that the application present to the practitioner 
certain prescription information including the patient's name and 
address, the drug name, strength, dosage form, quantity prescribed, 
directions for use, and the DEA registration number under which the 
prescription would be authorized. DEA further proposed to require the 
practitioner to indicate those prescriptions that were ready to be 
signed.
    DEA proposed allowing practitioners to indicate that prescriptions 
for multiple patients were ready for signing and allow a single signing 
to cover all approved prescriptions.
    Comments. A number of commenters were concerned about the data 
elements that must be presented to practitioners for review. Two 
application providers stated that the data elements should be limited 
because too much data will be confusing. They asserted that the 
patient's address is unlikely to be useful to practitioners as patients 
are usually identified by name and date of birth; it is unlikely that 
most practitioners would recognize an address as incorrect. They also 
expressed their view that the practitioner did not need to see the DEA 
registration number associated with the prescription.
    A practitioner organization expressed agreement with the 
requirement in the proposed rule that prior to the transmission of the 
electronic prescription, the application should show a summary of the 
prescription. It noted that while National Council for Prescription 
Drug Programs (NCPDP) SCRIPT provides fields and codes for all required 
data, not all are mandatory. In addition, this commenter indicated some 
applications do not show all of the DEA-required prescription 
information. The commenter asked how applications will be updated and/
or modified to meet the specifications required in the proposed rule. 
Another commenter, an application provider, stated that developers will 
have to redesign the applications at the screen level and at the user 
permission level, which will add costs. An insurance organization 
stated that the current NCPDP standards do not accommodate the 
described process and will have to be revised to conform next 
generation electronic prescribing software to the DEA requirements. The 
commenter believed that this would create another delay in the eventual 
use of electronic prescribing for controlled substances.
    DEA Response. DEA has revised the rule to limit the required data 
displayed for the practitioner on the screen where the practitioner 
signs the controlled substance prescription to the patient's name, drug 
information, refill/fill information, and the practitioner information. 
If there are multiple prescriptions for a particular patient, the 
practitioner information and the patient name could appear only once on 
the screen. The refill information, if applicable, will be a single 
number. For Schedule II substances, if a practitioner is writing 
prescriptions indicating the earliest date on which a pharmacy may fill 
each prescription under Sec.  1306.12(b), these dates will also have to 
appear, consistent with the current requirement for paper 
prescriptions. DEA emphasizes that although this rule allows for one 
element of the required controlled substance prescription information 
(the patient's address) not to appear on the review screen, the 
controlled substance prescription that is digitally signed by either 
the application or the practitioner and that is transmitted must 
include all of the information that has always been required under 21 
CFR part 1306.
    DEA realizes that many application providers will have to update 
their applications, but it notes that most perform regular updates and 
upgrades. They may choose to incorporate the changes required by these 
regulations as part of a regular revision cycle.
    Comments. A few application providers objected to requiring a 
review of the prescription information by the practitioner prior to 
signing, stating that this is not required for paper prescriptions.
    DEA Response. DEA recognizes that it is possible that some 
applications currently in use for the prescribing of noncontrolled 
substances might not require the practitioner to review prescription 
data prior to signing. Nonetheless, with respect to the prescribing of 
controlled substances, a practitioner has the same responsibility when 
issuing an electronic prescription as when issuing a paper prescription 
to ensure that the prescription conforms in all respects with the 
requirements of the CSA and DEA regulations. This responsibility 
applies with equal force regardless of whether the prescription 
information is entered by the practitioner himself or a member of his 
staff. Whether the prescription for a controlled substance is on paper 
or in electronic format, it would be irresponsible for a practitioner 
to sign the prescription without carefully reviewing it, particularly 
where the prescription information has been entered by someone other 
than the practitioner. Careful review by the practitioner of the 
prescription information ensures that staff or the practitioner himself 
has entered the data correctly. Doing so is therefore in the interest 
of both the practitioner and patient. Electronic prescriptions are 
expected to reduce prescription errors that result from poor 
handwriting, but as reports by Rand Health have stated, the 
applications create the potential for new errors that result from 
keystroke

[[Page 16255]]

mistakes.\18\ Rand Health reported many electronic prescribing 
applications are designed to create a prescription using a series of 
drop down menus; some of the applications do not display the 
information after it is selected so that keystroke errors (e.g., 
selecting the wrong patient or drug) may be difficult to catch. 
Comments on the proposed rule from a State Pharmacy Board indicate that 
such keystroke errors do occur in electronic prescriptions. Recent 
research on electronic prescribing in the United States and Sweden also 
found that electronic prescriptions have problems with missing and 
incorrect information, which indicates that the applications allow 
prescriptions to be transmitted without information in the standard 
prescription fields.\19\ A review screen should alert practitioners to 
these problems. DEA notes that a number of electronic prescription 
application providers indicated that their applications already meet 
this practitioner review requirement.
---------------------------------------------------------------------------

    \18\ Bell, D.S., et al., ``A Conceptual Framework for Electronic 
Prescribing,'' J Am Med Inform Assoc. 2004; 11:60-70.
    \19\ Warholak, T.L. and M.T. Mudd. ``Analysis of community chain 
pharmacists' interventions on electronic prescriptions.'' J. Am. 
Pharm. Assoc. 2009 Jan-Feb; 49(1): 59-64.
    Astrand, B. et al. ``Assessment of ePrescription Quality: an 
observational study at three mail-order pharmacies.'' BMC Med Inform 
Decis Mak. 2009 Jan 26; 9:8.
---------------------------------------------------------------------------

    Comments. Practitioner organizations expressed the view that 
checking an ``all'' box should be sufficient if a practitioner approves 
all of the prescriptions displayed, as opposed to indicating each 
prescription approved individually. Two State agencies, an information 
technology organization, and application providers objected to DEA's 
proposal to allow signing of prescriptions for multiple patients at one 
time. Some commenters believed that allowing practitioners to sign 
prescriptions for multiple patients at one time posed health and safety 
risks for the patients. Others stated that the prescriber might not 
notice fraudulent prescriptions in a long list.
    DEA Response. DEA agrees that allowing practitioners to 
simultaneously issue multiple prescriptions for multiple patients with 
a single signature increases the likelihood of the potential 
detrimental consequences listed by the commenters. Accordingly, DEA has 
revised the rule to allow signing of multiple prescriptions for only a 
single patient at one time. Each controlled substance prescription will 
have to be indicated as ready for signing, but a single two-factor 
authentication can then sign all prescriptions for a given patient that 
the practitioner has indicated as being ready to be signed. DEA notes 
that many patients who are prescribed controlled substances receive 
only one controlled substance prescription at a time.
2. Timing of Authentication, Lockout, and Attestation
    DEA proposed that the practitioner would use his two-factor 
authentication credential to access the review screen. The practitioner 
would indicate those prescriptions ready to be signed. Prior to 
signing, DEA proposed that the practitioner indicate agreement with the 
following statement: ``I, the prescribing practitioner whose name and 
DEA registration number appear on the controlled substance 
prescription(s) being transmitted, have reviewed all of the 
prescription information listed above and have confirmed that the 
information for each prescription is accurate. I further declare that 
by transmitting the prescription(s) information, I am indicating my 
intent to sign and legally authorize the prescription(s).'' If there 
was no activity for two or more minutes, the application would have to 
lock him out; he would have to reauthenticate to the application before 
being able to continue reviewing or signing prescriptions.
    Comments. DEA received a substantial number of comments on the 
timing of authentication and signing, lockout, and attestation. An 
application provider organization stated that delegating prescription-
related tasks (e.g., adding pharmacy information) to practitioner staff 
is a vital step in the prescribing process. The commenter believed that 
requiring all such tasks to occur before the practitioner approves and 
signs the prescription would change the workflow in practitioners' 
offices. The application provider recommended that DEA allow for 
variable workflows in which ancillary information regarding the 
prescription, such as which destination pharmacy to send to, may be 
completed by the nurse after signing, but all other data specific to 
the medication dispensed be locked down and only editable by the 
prescribing practitioner. Another application provider suggested 
revising the requirement for reviewing and indicating that a 
prescription is ready to sign to read: ``* * * where more than one 
prescription has been prepared at any one time[,] * * * prior to the 
time the practitioner authenticates to the application, the application 
must make it clear which prescriptions are to be signed and 
transmitted.'' This commenter expressed the view that although this may 
seem like a subtle distinction, the user interface design of electronic 
prescribing applications is variable, and many applications already 
clearly show the user which prescriptions are awaiting signature and 
transmittal (for instance, by displaying them in a different frame on 
the screen or in a different color). The commenter asserted that a 
requirement that the user take further action to specify the 
prescriptions he/she will sign would be superfluous.
    Commenters generally expressed concern about the additional 
keystrokes required to take these steps, stating that each new 
keystroke adds to the burden of creating an electronic prescription and 
discourages use of electronic prescriptions. An insurance organization 
stated that the process DEA proposed would require at least three 
practitioner confirmations of the electronic prescription. The 
commenter asserted that the more steps in the process, the less the 
workflow integration with current electronic prescribing workflow, and 
the increased potential for the reversion to written prescriptions. 
Another insurance organization stated the process of reviewing and 
signing should be streamlined. The commenter believed the process 
proposed by DEA seemed to have five steps with three confirmations.
    Commenters were particularly concerned about the 2-minute lockout 
period. They were unsure whether it applied to the initial access to 
the application or to access to the signing function. A number of 
application providers stated that requiring two-factor authentication 
to sign the prescription would be more effective and eliminate the need 
for a lockout; that is, they advocated making the use of the two-factor 
authentication synonymous with signing a controlled substance 
prescription. One practitioner organization stated that the 
authentication and lockout could interrupt work flows; access to other 
functions of the electronic medical record must be available with the 
authentication. The application providers also noted that lockouts are 
easy to implement.
    Those commenters who addressed the attestation statement expressed 
opposition to it. They emphasized that a practitioner must comply with 
the Controlled Substances Act and its implementing regulations in the 
prescribing of any controlled substance. Some were of the view that the 
statement did not serve any new purpose or address any new requirement. 
They emphasized that such a statement is not required for written 
prescriptions. Commenters

[[Page 16256]]

further stated that they believed it would be an annoyance, and that 
practitioners would not read it, but would simply click it and move on. 
They also asserted that each additional step DEA added to the creation 
of an electronic prescription made it more likely that practitioners 
would decide to revert to paper prescriptions. Many individual 
practitioners indicated they found the statement unnecessary and 
demeaning. A few commenters stated that if DEA believed this was 
essential, it should be a one-time notice, similar to licensing 
agreements that appear on first use of a new application.
    A number of organizations stated that they believed a better 
approach would be to present a simple dialog box with a clear and short 
warning that a prescription for a controlled substance is about to be 
signed. Some suggested this dialog could have three buttons: Agree, 
Cancel, and Check Record. Some commenters also noted that when 
prescribers get prescription renewal requests (for noncontrolled 
substances) in their electronic medical record applications now they 
have to minimize or temporarily ``cancel'' the request, check the chart 
for appropriateness, and then click yes or no. Commenters believed that 
the proposed rule does not seem to include this necessary capability.
    DEA Response. DEA has revised the rule to limit the number of steps 
necessary to sign an electronic controlled substance prescription to 
two. Practitioners will not have to use two-factor authentication to 
access the list of prescriptions prior to signing. When they review 
prescriptions, they will have to indicate that each controlled 
substance prescription is ready for signing, then, as some commenters 
recommended, use their two-factor authentication credential to sign the 
prescriptions. If the information required by part 1306 is altered 
after the practitioner indicated the prescription was ready for 
signing, a second indication of readiness for signing will be required 
before the prescription can be signed.
    As discussed previously, DEA has revised the rule to limit the 
required data displayed for the practitioner on the screen where the 
practitioner signs the controlled substance prescription to the 
patient's name, drug information, refill/fill information, and the 
practitioner information. The requirement in the proposed rule that the 
patient's address be displayed on the screen at this step of the 
process has been eliminated. (However, consistent with longstanding 
requirements for controlled substance prescriptions, the patient's 
address must be included in the prescription data transmitted to the 
pharmacy.) Because DEA is requiring that the application digitally sign 
the information required by the DEA regulations at the time the 
practitioner signs the prescription, additional non-DEA-required 
information (e.g., pharmacy URL) could also be added after signing. 
(See discussion below.) Using two-factor authentication as the signing 
function eliminates the need for the lockout requirement and, 
therefore, this rule contains no such requirement.
    DEA has revised the rule to eliminate a separate keystroke for an 
attestation statement and adopted the suggestion of some of the 
commenters that the statement be included on the screen with the 
prescription review list. Further, DEA has revised the statement 
displayed. The statement will read: ``By completing the two-factor 
authentication protocol at this time, you are legally signing the 
prescription(s) and authorizing the transmission of the above 
information to the pharmacy for dispensing. The two-factor 
authentication protocol may only be completed by the practitioner whose 
name and DEA registration number appear above.'' The practitioner will 
not be required to take any action with regard to the statement. 
Rather, the statement is meant to be informative and thereby eliminate 
the possibility of any uncertainty as to the significance of completing 
the two-factor authentication protocol at that time and the limitation 
on who may do so. The only keystrokes that the practitioner will have 
to take will be to indicate approval of the prescription and affix a 
legal signature to the prescription by execution of the two-factor 
authentication protocol. DEA notes that some applications already 
present practitioners with a list of prescriptions ready to be signed 
and require their approval. For these applications, only the two-factor 
authentication will be a new step.
3. Indication That the Prescription Was Signed
    Because the National Council for Prescription Drug Programs SCRIPT 
standard does not currently contain a field for the signature of a 
prescription, DEA proposed that the prescription record transmitted to 
the pharmacy must include an indication that the practitioner signed 
the prescription. This indication could be a single character.
    Comments. An application provider organization stated that existing 
logic in audit trails should cover the requirement for an indication 
that the prescription was signed. When a practitioner sends the 
prescription, the prescription is associated with the practitioner. One 
electronic prescription application provider objected to the addition 
of a field indicating that the prescription has been signed and asked 
whether the pharmacy could fill the prescription if the field was not 
completed. A standards development organization stated that DEA would 
have to request the addition of the field to NCPDP SCRIPT. Two 
application providers stated that without a prescription and signature 
format, there is no way to verify the signature.
    DEA Response. DEA is not specifying by regulation how the field 
indicating that a prescription has been signed could be formatted, only 
that such a field must exist and that electronic prescription 
applications must indicate that the prescription has been signed using 
that particular field. As DEA noted in the NPRM, the field indicating 
that the prescription was signed could be a single character field that 
populates automatically when the practitioner ``signs'' the 
prescription. DEA is not requiring that a signature be transmitted. The 
field is needed to provide the pharmacy assurance that the practitioner 
in fact authorized the prescription. Although most existing 
applications may not transmit the prescription unless the prescription 
is approved or signed, and DEA is making that an application 
requirement, the pharmacy has no way to determine whether the 
electronic prescription application the practitioner used to write the 
prescription meets the requirement absent an indication that the 
prescription was signed. The prescription application's internal audit 
trail is not available to the pharmacist who has to determine whether 
he can legally dispense the medication. If a pharmacy receives an 
electronic prescription for a controlled substance in which the field 
indicates that the prescription has not been signed, the pharmacy must 
treat this as it would any written prescription that does not contain a 
manual signature as required by DEA regulations.
    The required contents for an electronic prescription for a 
controlled substance set forth in the interim final rule are the same 
contents that have long been required under the DEA regulations for all 
paper and oral prescriptions for controlled substances. As with all 
regulations issued by any agency, the DEA regulations are publicly 
available, every standards organization and application provider has 
access to them, and all persons subject to the regulations are legally

[[Page 16257]]

obligated to abide by them. If any organization or application provider 
wants its standard or application to be compliant with the regulations 
and, therefore, usable for controlled substance prescriptions, they 
need only read the regulations and make any necessary changes.
    Comments. A standards organization asked how the signature field 
affected nurses that act as agents for practitioners and nurses at 
LTCFs who are given oral prescription orders.
    DEA Response. Longstanding DEA regulations allow agents of a 
practitioner to enter information on a prescription for a 
practitioner's manual signature and also permit practitioners to 
provide oral prescriptions to pharmacies for Schedule III, IV, and V 
controlled substances. Nurses, who are not DEA registrants, are not 
allowed to sign controlled substances prescriptions on behalf of 
practitioners regardless of whether the prescription is on paper or 
electronic. Accordingly, whether in the LTCF setting or otherwise, 
nurses may not be given access to, or use, the practitioner's two-
factor authentication credential to sign electronic prescriptions for 
controlled substances.
4. Other Prescription Content Issues
    DEA proposed that only one DEA number should be associated with a 
controlled substance prescription.
    Comments. A number of commenters associated with mid-level 
practitioners stated that some State laws require that a controlled 
substance prescription from a mid-level practitioner must contain the 
practitioner's supervisor's DEA registration number as well as the mid-
level practitioner's DEA registration number. Other commenters noted 
that under Sec.  1301.28 a DEA identification number is required in 
addition to the DEA registration number on prescriptions written by 
practitioners prescribing approved narcotic controlled substances in 
Schedules III, IV, or V for maintenance or detoxification treatment. 
Other commenters stated that the DEA requirements for paper 
prescriptions include, for practitioners prescribing under an 
institutional practitioner's registration, the special internal code 
assigned by the institutional practitioner under Sec. Sec.  1301.22 and 
1306.05. These commenters stated that NCPDP SCRIPT does not accommodate 
the special internal codes, which do not have a standard format, nor do 
most pharmacy computer applications. They also noted that a pharmacy 
has no way to validate the special internal codes.
    DEA Response. DEA's concern with multiple DEA numbers on a single 
prescription is based on a need to be able to identify the prescribing 
practitioner. The interim final rule allows multiple DEA numbers to 
appear on a single prescription, if required by State law or 
regulations, provided that the electronic prescription application 
clearly identifies which practitioner is the prescriber and which is 
the supervisor. NCPDP SCRIPT already provides such differentiation.
    DEA is aware of the issue of internal code numbers held by 
individual practitioners prescribing controlled substances as agents or 
employees of hospitals or other institutions under those institutions' 
registrations pursuant to Sec.  1301.22(c). DEA published an Advance 
Notice of Proposed Rulemaking (74 FR 46396, September 9, 2009) to seek 
information that can be used to standardize these data and to require 
institutions to provide their lists of practitioners eligible to 
prescribe controlled substances under the registration of the hospital 
or other institution to pharmacies on request.
    The problem with special codes for individual practitioners 
prescribing controlled substances using the institutional 
practitioner's registration and the DEA-issued identification number 
for certain substances used for detoxification and maintenance 
treatment is that SCRIPT does not currently have a code to identify 
them. Codes exist that identify DEA numbers and State authorization 
numbers; the fields are then defined to limit them to the acceptable 
number of characters. The general standard for the identification 
number field, however, is 35 characters. It should, therefore, be 
possible for NCPDP to add a code for an institution-based DEA number 
that allows up to 35 characters, with the first nine characters in the 
standard DEA format; the remaining characters should be sufficient to 
accommodate most institutional coding systems until DEA and the 
industry can standardize the format. Similarly, NCPDP should be able to 
add a code for the identification number for maintenance of 
detoxification treatment. Free text fields may also need to be used to 
incorporate other information required on certain prescriptions; for 
example, part 1306 requires that prescriptions for gamma hydroxybutyric 
acid the practitioner must indicate the medical need for the 
prescription; for certain medications being used for maintenance or 
detoxification treatment, the practitioner must include an 
identification number in addition to his DEA number.
    On the issue of the inability of pharmacies to validate the special 
code assigned by an institutional practitioner to individual 
practitioners permitted to prescribe controlled substances using the 
institution's DEA registration, DEA notes that the ``validation'' that 
some pharmacy applications conduct simply confirms that the DEA number 
is in the standard format and conforms to the formula used to generate 
the DEA registration numbers. The validation does not confirm that the 
number is associated with the prescriber listed on the prescription or 
that the registration is current and in good standing. To confirm the 
actual validity of the DEA number, the pharmacy would have to check the 
DEA registration database using the Registration Validation tool 
available at the Office of Diversion Control Web site (http://www.DEAdiversion.usdoj.gov). If a pharmacy has reason to question any 
prescription containing special identification codes for individual 
practitioners, it must contact the institutional practitioner.
    DEA recognizes that revisions to the SCRIPT standard to accommodate 
identification codes for individual practitioners prescribing 
controlled substances using the institutional practitioner's 
registration, identification numbers for maintenance or detoxification 
treatment, and dates before which a Schedule II prescription may not be 
filled may not occur immediately as they have to be incorporated into a 
revision to the standard that is subject to the standards development 
process. Application providers will then have to incorporate the new 
codes into their applications.
    Because DEA does not want to delay implementation of electronic 
prescribing of controlled substances for any longer than is necessary 
to accommodate the main provisions of the rule, DEA has added 
provisions to Sec. Sec.  1311.102 (``Practitioner responsibilities.''), 
1311.200 (``Pharmacy responsibilities.''), and 1311.300 (``Third-party 
audits.'') to address the short-term inability of applications to 
handle information such as this accurately and consistently. DEA is 
requiring that third-party auditors or certification organizations 
determine whether the application being tested can record, store, and 
transmit (for an electronic prescription application) or import, store, 
and display (for a pharmacy application) the basic information required 
under Sec.  1306.05(a) for every controlled substance prescription, the 
indication that the prescription was signed, and the number of refills. 
Any application that cannot perform these functions must not be 
approved, certified, or used for

[[Page 16258]]

controlled substance prescriptions. The third-party auditors or 
certification organizations must also determine whether the 
applications can perform these functions for the additional information 
required for a subset of prescriptions; currently this information 
includes the extension data, the special DEA identification number, the 
dates before which a prescription may not be filled, and notes required 
for certain prescriptions. If a third-party auditor or certification 
organization reports that an application cannot record, store, and 
transmit, or import, store, and display one or more of these data 
fields, the practitioner or pharmacy must not use the application to 
create, sign and transmit or accept and process electronic 
prescriptions for controlled substances that require this information.
    Comments. Some commenters stated that the requirement that the 
prescription be dated would remove the ability to create several 
Schedule II prescriptions for future filling.
    DEA Response. DEA does not allow practitioners to post-date paper 
prescriptions as some commenters seemed to think. Under Sec.  
1306.05(a), all prescriptions for controlled substances must be dated 
as of, and signed on, the day when issued. Under Sec.  1306.12(b), 
practitioners are allowed to issue multiple prescriptions authorizing 
the patient to receive up to a 90-day supply of a Schedule II 
controlled substance provided, among other things, the practitioner 
indicates the earliest date on which a pharmacy may fill each 
prescription. These prescriptions must be dated on the day they are 
signed and marked to indicate the earliest date on which they may be 
filled. All of these requirements can (and must) be satisfied when a 
practitioner elects to issue multiple prescriptions for Schedule II 
controlled substances by means of electronic prescriptions. At present, 
it is not clear that the SCRIPT standard accommodates the inclusion of 
these dates or that pharmacy applications can accurately import the 
data. As noted in the previous response, until applications accurately 
and consistently record and import these data, applications must not be 
used to handle these prescriptions.
    Comments. One application provider stated that DEA should not 
include the practitioner's name, address, and DEA number on the review 
screen because, in some cases, prescriptions are written for one of 
several practitioners in a practice to sign. This commenter stated that 
with paper prescriptions, there is no indication other than the 
signature as to which practitioner signed the prescription. A State 
pharmacist association asked DEA to require that the prescription 
include the practitioner's phone number and authorized schedules.
    DEA Response. Only a practitioner who has issued the prescription 
to the patient for a legitimate medical purpose in the usual course of 
professional practice may sign a prescription. As stated above, the 
requirements for the information on an electronic prescription are the 
same as those for a paper prescription. DEA notes that the NCPDP SCRIPT 
standard includes a field for telephone number, but DEA is not 
requiring its use. If a pharmacist has questions about a practitioner's 
registration and schedules, the pharmacist can check the registration 
through DEA's Web site.
    Comments. One company recommended registering actual written 
signatures and associating them with electronic prescriptions. A State 
asked that digital ink signatures be recognized and be allowed on 
faxes; this would allow people to avoid using SureScripts/RxHub, which 
the commenter indicated is expensive.
    DEA Response. DEA does not believe there is any way to allow the 
foregoing signature methods while providing an adequate level of 
assurance of non-repudiation. Verification of a manually written 
signature depends on more than the image of the signature.
5. Transmission on Signing/Digitally Signing the Record
    DEA proposed that the electronic prescription would have to be 
transmitted immediately upon signing. DEA proposed that the first 
recipient of the electronic prescription would have to digitally sign 
the record as received and archive the digitally signed copy. The 
digital signature would not be transmitted to the other intermediaries 
or the pharmacy.
    Comments. Some commenters disagreed with the requirement that 
prescriptions be transmitted on signing. A practitioner organization 
and a health information technology group supported the requirement, 
but stated that DEA should word this so the intent is clear that the 
electronic prescription application is to be configured to 
electronically transmit the prescription as soon as it has been signed 
by the prescriber. They stated that DEA must make it clear that an 
electronic prescription is not considered to be ``transmitted'' unless 
it has been successfully received by the pharmacist who will fill the 
prescription, and an acknowledgment has been returned to the 
prescriber's application. An application provider stated that DEA 
should remove the requirement for instant transmission of prescription 
data: Many electronic prescribing applications use processes where 
pending messages are stored and, with a fixed periodicity of 10 
seconds, transmitted to electronic prescribing networks. The commenter 
believed that this requirement might require complete re-architecting 
of these processes, which would create a substantial burden on 
electronic prescribing application developers. A chain pharmacy stated 
that DEA should allow the prescriber the option to put the prescription 
in a queue or to immediately transmit. The commenter suggested that if 
opting to hold in a queue, the prescriber would have to approve prior 
to sending. If, however, the prescription is automatically held in a 
queue due to connectivity problems, the prescriber should not be 
required to re-approve the prescription.
    A standards organization recommended extending to long-term care 
facilities (LTCFs) the option allowed to Federal health care agencies 
where the prescription may be digitally signed and ``locked'' after 
being signed by the practitioner, while allowing other facility-
determined information, such as resident unit/room/bed, times of 
administration, and pharmacy routing information to be added prior to 
transmission. The commenter noted that these additional data elements 
are distinct from the prescription data required by Sec.  1306.05(a). 
The commenter explained that this digitally signed version would be 
archived and available for audit. The organization stated that its 
recommended process matches a key aspect of the accepted LTCF order 
workflow, where the nursing facility reviews each physician order in 
the context of the resident's full treatment regimen and adds related 
nursing and administration notes. The commenter explained that after 
review and nursing annotation, the prescription is forwarded to the 
appropriate LTC pharmacy. By requiring that the prescription be 
digitally signed immediately after the physician's signature (or upon 
receipt if the facility system is the first recipient of the electronic 
prescription), this rule could appropriately be extended to non-Federal 
nursing facilities, enabling them to meet existing regulations 
requiring review of resident medication orders by facility nursing 
staff prior to transmission to the pharmacy. A pharmacist organization, 
whose members work in LTCFs and similar facilities, stated that the 
rule may be impossible to put into operation without

[[Page 16259]]

fundamental changes to pharmacy practice and workflow. Other commenters 
also stated that the workflow at LTCFs mean that nurses generally enter 
information about prescriptions into records and transmit them to 
pharmacies. The standards organization recommended a modification to 
allow nursing staff at LTCFs to review, but not change, the 
prescription before transmission. The commenter asserted that this 
modification would enable consultation with the prescriber regarding 
potential conflicts in the care of the resident, and could prevent 
dispensing of duplicate or unnecessary controlled medications. Further, 
the commenter asserted that this change would resolve a conflict 
between the proposed rule and existing nursing home regulations, which 
call for review of resident medication orders by facility nursing staff 
prior to their transmission to the pharmacy.
    On the issue of having the first recipient digitally sign the DEA-
required information, some commenters asked about the identity of the 
first recipient. One application provider expressed the view that 
unless the application provider is the first recipient, it cannot be 
held responsible for the digital signing and archiving. Where the first 
processor is a third-party aggregator, this commenter asserted, it 
should be responsible for complying. An application provider 
organization stated that adding a digital signature will greatly 
increase the storage cost of transaction data.
    One application provider stated that if the prescription is created 
on an Internet-based application, such as one on which the prescriber 
uses an Internet browser to access the application, the prescription 
would actually be digitally signed on the Internet-based application 
provider's servers by the prescriber. Therefore, the initial digital 
signature archived on the Internet-based prescribing application would 
be that of the prescriber, created using the hardware cryptographic 
key, rather than that of the application provider. The commenter 
indicated that in this case, the application network provider, rather 
than the electronic prescription application provider, should digitally 
sign the prescription with its own digital signature and archive the 
digitally signed version of the prescription as received. The commenter 
asserted that for true ASP applications (Web-based applications), the 
prescriber is actually digitally signing the prescription at the 
server. It is not necessary, this commenter indicated, for the Web-
based electronic prescription application provider to sign also. Some 
commenters thought that every intermediary would be required to 
digitally sign and archive a copy. A State board of pharmacy said the 
first recipient should not have to digitally sign the prescription 
unless the first recipient is the pharmacy. The responsible pharmacist 
should have to digitally sign the prescription.
    An application provider stated that the combination of 
authentication mechanisms, combined with reasonable security measures 
by the practice (e.g., at a minimum, not sharing or writing down 
passwords), is sufficient to prevent abuse. Additionally, this 
commenter indicated, the audit logs should be sufficient to recognize 
and document fraud or forgery. The commenter stated that the 
requirement for digitally signing the record should be dropped.
    DEA Response. DEA has revised the rule to eliminate the need for 
signing and transmission to occur at the same time. Under the proposed 
rule, the application of the digital signature to the information 
required under part 1306 would have occurred after transmission. Hence, 
under the proposed rule, it was critical that the information be 
transmitted immediately so that the DEA-required information could not 
be altered after signature but before transmission. Under the interim 
final rule, however, the application will apply a digital signature to 
and archive the controlled substance prescription information required 
under part 1306 when the practitioner completes the two-factor 
authentication protocol. Alternatively, the practitioner may sign the 
controlled substance prescription with his own private key. Because of 
the digital signature at the time of signing, the timing of 
transmission is less critical. DEA expects that most prescriptions will 
be transmitted as soon as possible after signing, but recognizes that 
practitioners may prefer to sign prescriptions before office staff add 
pharmacy or insurance information. In long-term care facilities, nurses 
may need to transfer information to their records before transmitting. 
By having the application digitally sign and archive at the point of 
two-factor authentication, practitioners and applications will have 
more flexibility in issuing and transmitting electronic prescriptions.
    DEA does not believe that the security mechanisms that the 
application provider cited at a practitioner's office would 
sufficiently provide for non-repudiation. DEA disagrees with the State 
Board of Pharmacy that the first recipient or the electronic 
prescription application need not digitally sign the record. Unless the 
record is digitally signed before it moves through the transmission 
system, practitioners would be able to repudiate prescriptions by 
claiming that they had been altered during transmission (inadvertently 
or purposefully). The only way to prove otherwise would be to obtain 
(by subpoena or otherwise) all of the audit log trails from the 
intermediaries, assuming that they retained them. As DEA is not 
requiring the intermediaries to retain records or audit trails, it 
might not be possible to obtain them. In addition, unless a 
practitioner was transmitting prescriptions to a single pharmacy, the 
number of intermediaries involved could be substantial; although the 
practitioner's application might use the same routers to reach 
SureScripts/RxHub or its equivalent, each of the recipient pharmacies 
may rely on different intermediaries.
6. PKI and Digital Signatures
    DEA proposed an alternative approach, limited to Federal healthcare 
facilities, that would be based on public key infrastructure (PKI) and 
digital signature technology. Under this approach, practitioners would 
obtain a digital certificate from a certification authority (CA) cross-
certified with the Federal Bridge CA (FBCA) and use the associated 
private key to digitally sign prescriptions for controlled substances. 
DEA proposed this approach based on requests from Federal health care 
agencies that have implemented PKI systems. Those agencies noted that 
the option DEA proposed for all health care practitioners did not meet 
the security needs of Federal health care agencies.
    Comments. A number of commenters, including practitioner 
associations, one large chain drug store, several electronic 
prescription application providers, and organizations representing 
computer security interests asked DEA to allow any practitioner or 
provider to use the digital signature approach, as an option. A 
pharmacist organization and a standards development organization stated 
that long-term care facilities should be able to use this approach. A 
practitioner organization and a healthcare management organization 
stated that the system would be more secure, and prescribers' liability 
would be reduced, if prescribers could digitally sign prescriptions. 
Three application providers preferred applying a practitioner's digital 
signature rather than a provider's. They stated that the added burden 
to the electronic health record is authentication using smart-cards (of 
a well known format), and that it can wrap the NCPDP SCRIPT 
prescription in XML-Digital signature

[[Page 16260]]

envelop with a signature using the identity of the authenticated user. 
The commenters stated that the added burden to the healthcare provider 
is the issuance of a digital certificate that chains to the Federal 
PKI, possibly SAFE Biopharma or possibly extending the Federal PIV 
card. A State pharmacist organization asked why DEA is in favor of a 
system that is less secure than the one Federal health agencies use.
    Some commenters noted that although the current system, based on 
intermediaries, makes use of digital signatures difficult, changes in 
technology may make it feasible in the future. In addition, for 
healthcare systems with their own pharmacies, a PKI-based approach 
would be feasible now. An intermediary stated that NCPDP SCRIPT could 
not accommodate a digital signature, but other IT organizations argued 
that this is not necessarily true. One information technology security 
firm stated that companion standards to NCPDP SCRIPT standard in XML 
and HL7, which ought to be considered, include the W3C's XML digital 
signature standard (XML-DSig) and the Document Digital Signature (DSG) 
Profile. Several application providers stated:

    The prescription should be digitally signed using encapsulated 
XML Digital Signature with XADES profile. The specific profile is 
recognized for optional use by CCHIT [the Certification Commission 
for Healthcare Information Technology] in S28. This is fully 
specified in HITSP C26 for documents, which points at the IHE DSG 
profile. HITSP C26 and IHE DSG profile uses detached signatures on 
managed documents. This might be preferred as it would have the 
least impact on the existing data flow, or further profiling could 
support encapsulation if necessary. CCHIT S28 is not fully clear and 
has not yet been tested.

    An information technology organization stated that DEA should 
require PKI. The government has a highly secure, interoperable digital 
identity system for Federal agencies and cross-certified entities 
through FBCA. The commenter asserted that this system should provide 
the framework for DEA's rule for electronic prescribing of controlled 
substances. The commenter believed that it is a widely available and 
supported system that provides the level of security, non-
repudiability, interoperability, and auditability required by 
legislation covering the prescribing of controlled substances. The 
commenter stated that such a system would provide strong evidence that 
the original prescription was signed by a DEA-registered practitioner, 
that it was not altered after it was signed and transmitted, and that 
it was not altered after receipt by the pharmacist.
    An information technology provider suggested the application allow 
the end users to choose credential types, including PKI and/or One Time 
Password (OTP) credentials, and recommended end users be permitted to 
use their existing PKI credentials if their digital certificates met 
Federal Medium Assurance requirements and are issued from a CA that is 
cross-certified with the Federal Bridge. The commenter asserted that it 
is expected that there will be a number of service providers who will 
offer a turnkey PKI service to issue digital certificates for non-
Federal entities that meet these requirements. This would lower costs 
for the overall system and would foster a stronger adoption curve for 
end users because they may be able to use a device they already possess 
to secure online accounts.
    A PKI system designer noted that digital signatures can be used for 
any data. Once prescription and pharmacy applications are using the 
same version of SCRIPT the commenter believed there will be no need for 
conversion of prescriptions from one software version to another. The 
commenter further asserted that:

* * * prescriptions need not be sent in a format that can be 
immediately interpreted by a pharmacy computer. It would be 
efficient, but it is not necessary. Free text messages can be 
digitally signed, too. * * * Free text messages may not be as 
efficient as NCPDP SCRIPT messages, but they do the job, just as the 
scores of faxes or paper-based prescriptions do, only better and 
faster.

Another information technology firm noted that digital signatures work 
for systems as simple as email and PDF. The commenter stated that Adobe 
Acrobat is capable of performing signature validation and checking for 
certificate revocation using either a Certificate Revocation List (CRL) 
or an Online Certificate Status Protocol (OCSP) request.
    An intermediary further stated that the FIPS 186-2 Digital 
Signature Standard published in January 2000 has some shortcomings that 
are addressed in the current draft version FIPS 186-3 of the standard. 
The commenter believed these shortcomings relate to the signature 
schemas. The commenter asserted that FIPS 186-2 does not support RSA 
signature schemes according to Public Key Cryptography Standard (PKCS) 
1 version 2.1, which is a widely used industry standard. The 
commenter indicated that PKCS1 is added to the FIPS 186-3 
draft for the Digital Signature Standard. Therefore, the commenter 
asserted, signatures according to PKCS1 version 2.1 (RSASSA-
PKCS1-v1--5 and RSASSA-PSS) should also be considered as appropriate 
for electronic prescriptions for controlled substances. This same 
commenter asserted that the minimum key sizes for digital signatures 
should meet the requirements specified in NIST SP 800-57 Part 1.
    DEA Response. DEA agrees with the practitioner organizations and 
other commenters that the digital signature option should be available 
to any practitioner or group that wants to adopt it and has revised the 
interim final rule to provide this option to any group. DEA believes it 
is important to provide as much flexibility as possible in the 
regulation and accommodate alternative approaches even if they are 
unlikely to be widely used in the short-term. DEA notes that a number 
of commenters, including a major pharmacy chain, anticipate that once 
the SCRIPT standard is mature, the intermediaries will no longer be 
needed and prescriptions will then move directly from practitioner to 
pharmacy as they do in closed systems. At that point, the PKI/digital 
signature approach may be more efficient and provide security benefits. 
In the short-term, some closed systems may find this approach 
advantageous. DEA emphasizes that the use of a practitioner digital 
signature is optional. DEA is including the option to accommodate the 
requirements of existing Federal systems and to provide flexibility for 
other systems to adopt the approach in the future if they decide that 
it would provide benefits for them.
    Under the interim final rule, using a private key to sign 
controlled substance prescriptions will be an option provided that the 
associated digital certificate is obtained from a certification 
authority that is cross-certified with the Federal PKI Policy Authority 
at a basic assurance level or above. The electronic prescription 
application will have to support the use of digital signatures, 
applying the same criteria as proposed for Federal systems. The private 
key associated with the digital certificate will have to be stored on a 
hard token (separate from the computer being accessed) that meets the 
requirements for FIPS 140-2 Security Level 1 or higher. If a 
practitioner digitally signs a prescription with his own private key 
and transmits the prescription with the digital signature attached, the 
pharmacy will have to validate the prescription, but no other digital 
signatures will need to be applied. (If the practitioner uses his own 
private key to sign a prescription, the electronic prescribing 
application will not have to apply an application digital signature.) 
If the

[[Page 16261]]

digital signature is not transmitted, the pharmacy or last intermediary 
will have to digitally sign the prescription. DEA emphasizes that 
Federal systems will be free to impose more stringent requirements on 
their users, as they have indicated that they do.
    As noted in other parts of this rulemaking, DEA has updated the 
incorporation by reference to FIPS 186-3, June 2009.

E. Internal Audit Trails

    DEA proposed that an application provider must audit its records 
and applications daily to identify if any security incidents had 
occurred and report such incidents to DEA.
    Comments. One application provider stated that daily audit log 
checks would not be feasible and objected to reporting incidents as no 
parallel requirement exists for paper prescriptions. The application 
provider stated that SureScripts/RxHub transmission standards should 
address all security concerns.
    DEA Response. DEA disagrees with this commenter. At the July 2006 
public hearing,\20\ application providers stated that their 
applications had internal audit trails and they suggested that the 
audit function provided security and documentation. In the HIMSS 2009 
Security Survey 83 percent of respondents reported having audit logs 
for access to patient records. The requirement for an internal audit 
trail should, therefore, not impose any additional burden on most 
application providers. DEA is requiring the application provider to 
define auditable events and run a daily check for such events. DEA does 
not expect that many such auditable events should occur. When they do 
occur, the application must generate a report for the practitioner, who 
must determine whether the event represented a security problem. DEA 
notes that only one application provider who commented on the NPRM had 
concerns regarding this requirement. The SureScripts/RxHub transmission 
standards provide no protection for attempts to access a practitioner's 
application.
---------------------------------------------------------------------------

    \20\ Transcripts, written comments, and other information 
regarding DEA's public meeting to discuss electronic prescriptions 
for controlled substances, held in conjunction with the Department 
of Health and Human Services, may be found at http://www.DEAdiversion.usdoj.gov/ecomm/e_rx/mtgs/july2006/index.html.
---------------------------------------------------------------------------

    Although practitioners are not expressly required under the DEA 
regulations to report suspected diversion of controlled substances to 
DEA, all DEA registrants have a duty to provide effective controls and 
procedures to guard against theft and diversion of controlled 
substances.\21\ Accordingly, there is a certain level of responsibility 
that comes with holding a DEA registration. With that responsibility 
comes an expectation of due diligence on the part of the practitioner 
to ensure that information regarding potential diversion is provided to 
law enforcement authorities, where circumstances so warrant. This 
requirement is no less applicable in the electronic prescribing context 
than in the paper or oral prescribing context. In fact, this concern 
might be heightened in the electronic context, due to the potential for 
large-scale diversion of controlled substances that might occur when a 
practitioner's electronic prescribing authority has fallen into 
unauthorized hands or is otherwise being used inappropriately.
---------------------------------------------------------------------------

    \21\ 21 CFR 1301.71(a).
---------------------------------------------------------------------------

    Comments. An application provider organization and two application 
providers asked how security incidents should be reported. A healthcare 
system had concerns about reporting an incident before it could be 
investigated. Another healthcare system requested further clarification 
and detail surrounding the documentation requirements for findings and 
reporting of suspicious activity. A number of commenters recommended 
differing reporting periods from the end of the business day to 72 
hours.
    DEA Response. At this time, DEA is not specifying by rule how a 
security incident should be reported. Accordingly, practitioners have 
several options, including providing the information to DEA by 
telephone or email. If DEA finds over time that enough of these reports 
are being submitted to merit a standard format, DEA may develop a 
reporting form in the future. As DEA and registrants gain experience 
with these incidents, DEA will be able to provide guidance on the 
specific information that must be included in the reports. In general, 
the security incidents that should be reported are those that represent 
successful attacks on the application or other incidents in which 
someone gains unauthorized access. These should be reported to both DEA 
and the application provider because a successful attack may indicate a 
problem with the application.
    DEA recognizes the concern about reporting incidents before the 
practitioner or application provider has had a chance to investigate. 
DEA's experience with theft and loss reporting, however, indicates that 
waiting for investigation may delay reporting for long periods and make 
it difficult to collect evidence. DEA believes that one business day is 
sufficient. DEA notes that this is the same length of time required 
under the regulations for reporting of thefts or significant losses of 
controlled substances.\22\
---------------------------------------------------------------------------

    \22\ 21 CFR 1301.76(b).
---------------------------------------------------------------------------

F. Recordkeeping, Monthly Logs

1. Recordkeeping
    DEA proposed that all records related to controlled substance 
electronic prescriptions be maintained for five years. DEA also 
proposed that the electronic records must be easily readable or easily 
rendered into a format that a person can read.
    Comments. Pharmacy commenters generally objected to the five-year 
record retention requirement, noting that they are required to retain 
paper prescriptions for only two years. Commenters believed that the 
added retention time conflicted with many State pharmacy laws and 
regulations. They also believed there would be additional costs for 
purchase of added storage capacity. Some electronic prescription 
application providers expressed their view that 21 U.S.C. 827 limits 
the applicability of DEA recordkeeping requirements solely to 
registrants. Accordingly, they believed that DEA has no statutory 
authority to impose recordkeeping requirements on application providers 
or intermediaries. Some of the commenters also stated they believed 
that 21 U.S.C. 827(b) does not give DEA statutory authority to require 
registrants to maintain records for more than two years. Finally, with 
respect to the statutory recordkeeping requirements for practitioners, 
some commenters stated they believed that the recordkeeping provisions 
are limited to the two sets of circumstances set forth at 21 U.S.C. 
827(c)(1)(A) and (B). They stated that if they were required to 
electronically store other data, such as that relating to identity 
proofing and transmissions with the digital signature and the monthly 
reports, this would result in overhead costs that application providers 
might not find relevant to the delivery of patient care and thus 
spending time developing such databases would have no value to the 
delivery of patient care. Commenters noted that these requirements are 
not part of the paper process and questioned why DEA would introduce it 
here. Commenters indicated that if five years of transactional data 
must be stored electronically for immediate retrieval, the cost to the 
application provider will be prohibitive. If offline or slower

[[Page 16262]]

means of data storage retrieval are required, the cost to the 
application provider will be drastically reduced while still providing 
data to the Administration in a timely manner. Finally, a State health 
care agency asked that all records handled by intermediaries should be 
easily sorted, should provide a clear audit trail, and should be 
available to law enforcement.
    DEA Response. In response to the comments, DEA has in the interim 
final rule changed the record retention period from that set forth in 
the proposed rule to two years, which is parallel to the requirement 
for paper prescriptions. Although DEA has revised the requirement, it 
should be noted that if the State in which the activity occurs requires 
a longer retention period, the State law must be complied with in 
addition to, and not in lieu of, the requirements of the Controlled 
Substances Act.
    With respect to the issue of placing certain recordkeeping 
responsibilities on application providers, which are nonregistrants, 
the following considerations should be noted. While the express 
recordkeeping requirements of the CSA (set forth in 21 U.S.C. 827) 
apply only to registrants, DEA has authority under the Act to 
promulgate ``any rules, regulations, and procedures [that the agency] 
may deem necessary and appropriate for the efficient execution of [the 
Act].'' (21 U.S.C. 871(b)). DEA also has authority under the Act ``to 
promulgate rules and regulations * * * relating to the * * * control of 
the * * * dispensing of controlled substances.'' (21 U.S.C. 821). The 
requirements set forth in the interim final rule relating to 
recordkeeping by nonregistrant application providers are being issued 
pursuant to this statutory authority. As stated in the interim final 
rule, for the purpose of electronic prescribing of controlled 
substances, DEA registrants may only use those applications that comply 
fully with the requirements of the interim final rule.
    It should also be noted that DEA is not requiring practitioners to 
create a copy of a prescription or a new record; it is requiring the 
practitioner to use an application that stores a copy of the digitally 
signed record and retains the record for two years. These records will 
be stored on an application service provider's servers if the 
practitioner is using an application service provider to prescribe or 
on the practitioner's computers for installed applications. DEA further 
notes that the electronic prescribing of controlled substances is 
voluntary; no practitioner is required to issue controlled substance 
prescriptions electronically.
    Although DEA had proposed having the first intermediary store the 
record, after taking into consideration the comments received to the 
NPRM, DEA decided that this approach risked losing the records. The 
practitioner can determine, through audit or certification reports, 
whether an electronic prescribing application meets DEA's requirements, 
but it may be difficult for the prescribing practitioner to ensure that 
an intermediary meets DEA's requirements if the first intermediary is a 
different firm, as it often is. Intermediaries may change or go out of 
business, destroying any records stored; intermediaries may also 
subcontract out some of the functions, further attenuating controls.
2. Monthly Logs
    DEA proposed that the electronic prescription application would 
have to generate, on a monthly basis, a log of all controlled substance 
prescriptions issued by a practitioner and provide the log to the 
practitioner for his review. DEA further proposed that the practitioner 
would be required to review the log, but would not be expected to 
cross-check it with other records. As DEA explained in the NPRM, the 
purpose of the log review was to provide a chance for the practitioner 
to spot obvious anomalies, such as prescriptions for patients he did 
not see, for controlled substances he did not prescribe, unusual 
numbers of prescriptions, or high quantity of drugs. The practitioner 
would have to indicate that he had reviewed the log.
    Comments. Commenters were divided on the viability and necessity of 
the log provision. Several practitioner organizations and one 
application provider stated that logs should be available for review, 
but opposed the requirement that practitioners confirm the monthly 
logs. A long-term care facility organization stated the log would be 
useful for detecting increased prescribing patterns. It, however, said 
the brief review proposed was too short and that the review should be 
reimbursable under Medicare. Other commenters stated that without 
checking the patients' records, it is unclear how this would increase 
the likelihood of identifying diversion. The State agency said the rule 
did not definitively state the mechanism for the review. A healthcare 
system stated that it would be helpful if DEA would provide further 
clarification surrounding the type of information that would need to be 
maintained. This commenter further asserted that DEA should allow 
noncontrolled prescription drug activity to be reviewed and archived in 
the same manner so as not to duplicate work for the physician.
    Other practitioner groups and application providers opposed the 
requirement that the practitioner review the monthly log check because 
such review is not required for paper prescriptions and because, these 
commenters asserted, it would be difficult to do without cross-checking 
patient records. An application provider stated that DEA does not have 
the authority to require the monthly log as 21 U.S.C. 827(c)(1) exempts 
practitioners from keeping prescription records. Some commenters 
mistakenly assumed that pharmacies would be generating the logs and 
that practitioners would have to review multiple logs each month; they 
opposed the requirement on that basis. An application provider and a 
State agency expressed doubt about the benefits of the requirement 
given the number of prescriptions that might be in an individual 
practitioner's monthly log. A few commenters suggested that DEA should 
enhance the log requirement to require the electronic prescription 
application to generate the logs every week (rather than every month, 
as was proposed). One application provider said that any log 
requirement would discourage electronic prescribing. Several commenters 
stated that the check would not enhance non-repudiation. A practitioner 
organization and a practitioner said that many providers would be 
worried about their liability if they fail to detect fraud. These 
commenters suggested that the regulations should protect unintentional 
failure to detect fraud and the purpose of the logs should be 
exclusively to help physicians recognize fraud if they are able to do 
so, but without penalty for failures to catch errors if a good faith 
review and signature were performed. Another practitioner organization 
stated that DEA did not detail the practitioner's ultimate 
responsibility to review and approve the information in the logs, the 
manner and timeframe in which the review must be completed, or the 
practitioner's liability for failing to review the log. The commenter 
asserted that this obligation, as well as the other requirements, seems 
to create a new practice standard that places more responsibility, and 
thus increased liability, for proper implementation of the law on 
practitioners. In addition, this commenter expressed the view that 
there is a need to specify the confidentiality of all such records,

[[Page 16263]]

including who has access and under what circumstances.
    A State board of pharmacy said that a review of prescription 
monitoring records should be accepted as a substitute. Several 
commenters asked that the review be done electronically. A State agency 
stated that DEA should prohibit the practitioner from delegating the 
review to members of his staff.
    DEA Response. DEA continues to believe that the monthly log 
requirement serves an important function in preventing diversion of 
controlled substances. In view of the comments, however, DEA has 
modified the requirement to lessen the burden on practitioners. 
Specifically, under the interim final rule, as in the proposed rule, 
the electronic prescription application will be required to generate, 
on a monthly basis, a log of all controlled substance prescriptions 
issued by a practitioner and automatically provide the log to the 
practitioner for his review. However, DEA has eliminated from the 
interim final rule the requirement that the practitioner mandatorily 
review each of the monthly logs. DEA believes this strikes a fair 
balance in the following respects. Maintaining in the rule the 
requirement that the application supply the practitioner with the 
monthly log will ensure that all practitioners receive the logs on a 
regular basis without requiring practitioners to expend extra time and 
effort to request the logs. As a practical matter, this will result in 
more practitioners actually receiving the logs and, in all likelihood, 
more practitioners actually reviewing logs than would be the case if 
practitioners had to affirmatively request each time that the 
application send the log. The more practitioners review the logs, the 
more likely it will be that they will detect, without excessive delay, 
any instances of fraud or misappropriation of their two-factor 
authentication credentials. Such early detection will allow for earlier 
reporting by the practitioner of these transgressions and thereby more 
quickly cut off the unauthorized user's access to electronic 
prescribing of controlled substances. Ultimately, this is likely to 
result in fewer instances of diversion of controlled substances and 
less resulting harm to the public health and safety.
    DEA is also maintaining in the interim final rule the requirement 
that the application be able to generate a log, upon request by the 
practitioner, of all electronic prescriptions for controlled substances 
the practitioner issued using the application over at least the 
preceding two years. As was proposed, the interim final rule requires 
that this log, as well as the monthly logs, be sortable at least by 
patient name, drug name, and date of issuance.
    With respect to 21 U.S.C. 827, it is true that this provision sets 
forth the statutorily mandated recordkeeping requirements for DEA 
registrants. However, this provision does not preclude DEA from 
requiring that practitioners who elect to prescribe controlled 
substances electronically use applications that meet certain standards 
designed to reduce the likelihood of diversion. In this same vein, 
nothing in 21 U.S.C. 827 precludes DEA from requiring that 
practitioners, when electronically prescribing controlled substances, 
use applications that, among other things, maintain records that the 
agency reasonably concludes are necessary to ensure proper 
accountability. As stated at the outset of this preamble, DEA has broad 
statutory authority to promulgate any rules and regulations that the 
agency deems necessary and appropriate to controlled against diversion 
of controlled substances or to otherwise efficiently execute the 
agency's functions under the CSA.\23\
---------------------------------------------------------------------------

    \23\ 21 U.S.C. 821, 871(b).
---------------------------------------------------------------------------

G. Transmission Issues

    DEA proposed that the information required under part 1306 
including the full name and address of the patient, drug name, 
strength, dosage form, quantity prescribed, directions for use, and the 
name, address, and registration number of the practitioner must not be 
altered during transmission; it could be reformatted.
1. Alteration During Transmission
    Comments. Many commenters misinterpreted this requirement to mean 
pharmacies would not be able to substitute generic versions for brand 
name versions as is allowed under many State laws. One application 
provider organization suggested that the rule state that no changes are 
allowed on the medication segment and an application provider could 
only augment the segments of the prescription pertaining to 
transaction, transaction source, patient, or physician. Further, this 
commenter suggested, the application provider would not be able to edit 
any existing data. A healthcare organization asked how alteration of 
content is identified (e.g., according to FIPS 180-2).
    DEA Response. DEA has revised the rule to clarify that the content 
of the required information must not be altered ``during transmission 
between the practitioner and pharmacy.'' The requirement not to alter 
prescription information during transmission applies to actions by 
intermediaries. It does not apply to changes that occur after receipt 
at the pharmacy. Changes made by the pharmacy are governed by the same 
laws and regulations that apply to paper prescriptions. Again, any 
applicable State laws must also be complied with. As for changes by 
intermediaries during transmission, DEA is limiting only changes to the 
DEA-required elements (those set forth in 21 CFR part 1306). An 
intermediary could add information about the practitioner other than 
his name, address, and DEA registration number or about the patient, 
other than name and address. Alteration during transmission would be 
identified by comparing the digitally signed prescription retained by 
the electronic prescription application and the digitally signed 
prescription retained by the pharmacy.
2. Printing After Transmission and Transmitting After Printing
    DEA proposed that if a prescription is transmitted electronically, 
it could not be printed. If it was printed, it could not be transmitted 
electronically.
    Comments. A number of commenters raised issues related to this 
requirement. A standards development organization noted that in some 
cases electronic prescriptions may be cancelled, for example when a 
transmission fails. In such cases, the commenter believed 
retransmission should be allowed. Pharmacies and pharmacy organizations 
stated that if transmission fails, the practitioner should be able to 
print the prescription. Practitioner organizations suggested the 
following language: ``If electronic transmission is prevented by 
weather, power loss, or equipment failure, or other similar system 
failure, prescriptions may be faxed to the pharmacy or printed.'' A 
healthcare organization stated that the rule does not define processes 
for transmission failures. The commenter asked if a second prescription 
is issued because the first was not received, how it would be clear 
that the first was cancelled. Many commenters, including pharmacy 
organizations, practitioner organizations, and electronic prescription 
application providers, stated that DEA should allow printing of a copy 
of the electronically transmitted prescription if it is clearly labeled 
as a copy. They noted that copies are often needed for insurance files 
and medical records; patients may be given a receipt listing all 
prescriptions written. Long-term care organizations also stated that 
these printed prescriptions were

[[Page 16264]]

necessary for medication administration records.
    DEA Response. DEA had noted in the preamble of the NPRM that 
transmitted prescriptions could be printed for medical records and 
other similar needs. DEA agrees with the commenters that such a 
statement should appear in the regulatory text and has revised the 
interim final rule to allow printing of a copy of a transmitted 
prescription, receipt, or other record, provided that the copy is 
clearly labeled as a copy that is not valid for dispensing. The copy 
should state, as recommended by commenters, that the original 
prescription was sent to [pharmacy name] on [date/time] and that the 
copy may not be used for dispensing. Printed copies of transmitted 
prescriptions may not be signed.
    DEA has also added a provision that the application may print a 
prescription for signing and dispensing if transmission fails. DEA will 
require that these original prescriptions include a note to the 
pharmacy that the prescription was originally transmitted to a specific 
pharmacy, but that the transmission failed. DEA considers this warning 
necessary because it is possible that the practitioner will be notified 
of a failure while the application is still attempting to transmit the 
prescription. The warning will alert the pharmacy to check its records 
to be certain a later transmission attempt had not succeeded. If the 
printed prescription is to be used for dispensing, it must be manually 
signed by the prescribing practitioner pursuant to Sec.  1306.05(a). As 
the printed prescription contains information regarding the prior 
transmission, this information will be retained by the pharmacy.
    Comments. A commenter recommended retaining the proposed language, 
but allowing the use of the SCRIPT CANCEL transaction. The commenter 
believed this would allow the application to either print the 
prescription or transmit it to another pharmacy. It noted that most 
vendors have not implemented support of this transaction. The commenter 
recommended that intermediaries that certify electronic prescription 
applications and pharmacy applications for interoperability should have 
to test and verify that vendors support the message before they are 
certified to accept controlled substances prescriptions.
    DEA Response. DEA agrees that if a transmission fails or is 
canceled, the practitioner will be able to print the prescription or 
transmit it to another pharmacy. DEA, however, does not believe it is 
appropriate to attempt through these regulations to dictate to 
intermediaries that certify electronic prescription applications and 
pharmacy applications for interoperability what to cover in their 
certification requirements. DEA does not consider it advisable to 
include, as part of its regulations, references to particular functions 
in the SCRIPT standard, or any other standard, as these standards are 
constantly evolving.
    Comments. A healthcare organization suggested a requirement for the 
receiving pharmacy to provide confirmation back to the prescriber's 
application. The commenter suggested that the confirmation may then be 
printed and given to the patient, thereby providing documentation to 
demonstrate that the patient's prescription has been successfully 
transmitted to the patient's pharmacy.
    DEA Response. Based on the comments, DEA does not believe that a 
requirement for a return receipt that would be provided to the patient 
would be reasonable because it would reduce the flexibility of the 
system. It would force the practitioner to write and transmit the 
prescription while the patient was still in the office. DEA does not 
have a similar requirement for oral or facsimile transmissions of paper 
Schedule III, IV, and V prescriptions and does not believe that this is 
warranted or necessary. In addition, as commenters made clear, it is 
not always possible to access a transmission system at a particular 
point in time.
3. Facsimile Transmission of Prescriptions by Intermediaries
    DEA proposed that intermediaries could not convert an electronic 
prescription into a fax if transmission failed. They would be required 
to notify the practitioner, who would then have to print and manually 
sign the prescription.
    Comments. A standards development organization, several electronic 
prescription application providers, and a pharmacy chain stated that 
intermediaries should be able to convert electronic prescriptions to 
faxes if the intermediaries cannot complete the transmission. One 
electronic prescription application provider stated that 20 percent of 
its transmissions need to be converted to facsimile because of pharmacy 
technology problems. An application provider organization stated that 
DEA is requiring that the prescription be digitally signed, so the 
prescription would have been signed. In the case of a temporary 
communication outage between physician and pharmacy, the commenter 
suggested that the pharmacy could receive a fax containing the ID tags 
of the script message. Those ID tags could then be later confirmed 
against the SCRIPT transaction when connectivity is resumed. The 
commenter believed that if DEA does not allow faxing by the 
intermediary, a unique workflow will be necessary for controlled 
substance transaction errors not required for legend drugs.
    One State Board of Pharmacy stated that it had found many problems 
with electronic prescriptions. Among the problems this State Board 
reported was that even when pharmacies are able to receive electronic 
prescriptions, their applications do not necessarily read electronic 
prescriptions accurately. Data entered by a practitioner may be 
truncated in the pharmacy application or moved to another field. These 
statements were echoed by a State pharmacist association.
    One application provider asked if faxed electronic prescriptions 
can continue to be treated as oral prescriptions.
    DEA Response. A faxed prescription is a paper prescription and, 
therefore, must be manually signed by the prescribing practitioner 
registered with DEA to prescribe controlled substances. If an 
intermediary cannot complete a transmission of a controlled substance 
prescription, it must notify the practitioner in the manner discussed 
above. Under such circumstances, if the prescription is for a Schedule 
III, IV, or V controlled substance, the practitioner can print the 
prescription, manually sign it, and fax the prescription directly to 
the pharmacy. DEA recognizes that not all pharmacies are currently 
capable of receiving fully electronic prescriptions and that there may 
be other transmission issues; however, it would be incompatible with 
effective controls against diversion to allow unsigned faxes of 
controlled substance prescriptions to be generated by intermediaries. 
As the commenters indicated, most of the reported transmission problems 
have to do with the lack of a mature standard for electronic 
prescriptions and the number of pharmacies that are not accepting 
electronic prescriptions. A number of commenters indicated that they 
anticipate that the need for intermediaries will disappear once the 
standard is mature. At that point, the issue of faxes will also be 
eliminated. As for the comment about treating faxed electronic 
prescriptions as oral prescriptions, this practice is not allowed under 
DEA's regulations as the commenter seemed to believe. To reiterate, the 
regulations have always required that a facsimile of a Schedule

[[Page 16265]]

III, IV, or V prescription be manually signed by the prescribing 
practitioner.
    Comments. A State Board of Pharmacy and a healthcare organization 
stated that under New Mexico and California law it was permissible to 
electronically generate a prescription and fax it. One commenter 
indicated that New Mexico allows electronic prescriptions to be sent 
``by electronic means including, but not limited to, telephone, fax 
machine, routers, computer, computer modem or any other electronic 
device or authorized means.'' A commenter noted that California, among 
others, allows for the faxing of controlled substances prescriptions 
with the text ``electronically signed by'' on the fax.
    DEA Response. As discussed above, under DEA's regulations, a faxed 
prescription is a paper prescription and must be manually signed. It is 
not permissible to electronically generate and fax a controlled 
substance prescription without the practitioner manually signing it.
4. Other Issues
    Comments. Several electronic prescription application providers 
stated that DEA had not specified the characteristics of the 
transmission system between the practitioner and the pharmacy, which 
could be insecure. They recommended that a clear ``secured'' 
communication be used between the electronic prescription application 
and the pharmacy. Commenters recommended that the communications should 
meet HITSP T17 ``Secured Communications Channel'' requirements. They 
stated that this is already required, though not tested, by the 
Certification Commission for Healthcare Information Technology today 
(S28, S29). One State agency recommended requiring end-to-end 
encryption. An electronic prescription and pharmacy application 
provider and an intermediary described their network security. A 
practitioner organization stated that DEA should not over-specify 
requirements because other specifications exist with which DEA's 
requirements must coexist.
    DEA Response. DEA has not addressed the security of the 
transmission systems used to transmit electronic prescriptions from 
practitioners to pharmacies, although some commenters asked DEA to do 
so and others claimed that the security of these systems provided 
sufficient protection against misuse of electronic prescriptions. As 
noted previously, the existing transmission system routes prescriptions 
through three to five intermediaries between a practitioner and the 
dispensing pharmacy. Practitioners and pharmacies have no way to 
determine which intermediaries will be used and, therefore, no way to 
avoid intermediaries that do not employ good security practices. As a 
practical matter, once a practitioner purchases an electronic 
prescription application, the practitioner must accept whatever 
transmission routing the application provider employs. Neither the 
practitioner nor electronic prescription application provider has any 
way of knowing which intermediaries are used by each of the pharmacies 
that patients' may designate.
    None of the security measures that are used for transmission 
address the threat of someone stealing a practitioner's identity to 
issue prescriptions or of office staff being able to issue 
prescriptions in a practitioner's name because of inadequate access 
controls or authentication protocols. None of the measures address the 
threat of pharmacy staff altering records to hide diversion. Some 
commenters indicated that they anticipate the elimination of 
intermediaries once the SCRIPT standard is mature and interoperability 
exists without the need for converting a data file from one software 
version to another so that it can be read correctly.
    Although DEA is concerned about the possibility that controlled 
substances prescriptions could be altered or created during 
transmission, it has chosen to address those issues by requiring that 
the controlled substance prescription is digitally signed when the 
practitioner executes the two-factor authentication protocol and when 
the pharmacy receives the prescription. The only transmission issues 
that DEA is addressing in the interim final rule concern one common 
practice--the conversion of prescriptions from one software version to 
another--and one possible practice--the facsimile transmission of 
prescriptions by intermediaries to pharmacies. As discussed above, DEA 
will permit intermediaries to convert controlled substances 
prescriptions from one software version to another; DEA will not allow 
intermediaries to transform an electronic prescription for a controlled 
substance into a facsimile as many of them do. DEA is also explicitly 
stating that any DEA-required information may not be altered during 
transmission.

H. Pharmacy Issues

1. Digital Signature
    DEA proposed that either the pharmacy or the last intermediary 
routing an electronic prescription should digitally sign the 
prescription and the pharmacy would archive the digitally signed record 
as proof of the prescription as received.
    Comments. State pharmacist associations and some pharmacy 
application providers asked DEA to analyze the cost of this 
requirement. One retail association stated that DEA had not considered 
that the software used to create the prescription might not be 
compatible with digital signatures. A number of pharmacy chains and 
pharmacy associations asked DEA to explain what regulatory requirements 
would apply to those electronic prescriptions that occur through direct 
exchanges between practitioners and pharmacies (i.e., transmission 
without intermediaries). A chain pharmacy noted that the intermediaries 
may be phased out, leaving pharmacies with no choice but to add digital 
signature functionality. A State Board of Pharmacy stated that the 
digital signature should be validated to ensure that the record had not 
been altered. An electronic prescription application provider stated 
that it will be very difficult for the pharmacies to digitally sign 
prescriptions in the short run and will require more time. It suggested 
that the rule include the following statement: ``Until 1/1/2011 
pharmacies can print out and wet sign controlled drug prescriptions as 
they arrive, and archive those paper records for an acceptable 
period.'' A standards organization stated that the requirement would 
require a major revision of its standard. A healthcare system 
recommended that DEA include reasonable alternatives to proposed 
requirements to address record integrity. This commenter asserted that 
DEA should allow flexibility regarding the use of digital signatures in 
systems with no intermediate processing.
    DEA Response. DEA did analyze the cost of this requirement in the 
Initial Economic Impact Analysis associated with the notice of proposed 
rulemaking \24\ and included estimates for the time and costs required 
to add digital signature functionality to existing applications. DEA 
disagrees with the commenters that asserted that electronic prescribing 
applications or the SCRIPT standard are incompatible with digital 
signatures. As a number of commenters noted, any data file can be 
digitally signed and can be digitally signed without affecting the 
formatting of the file.
---------------------------------------------------------------------------

    \24\ http://www.deadiversion.usdoj.gov/fed_regs/2008/index.gtml.
---------------------------------------------------------------------------

    The interim final rule requires the pharmacy or the last 
intermediary to digitally sign the prescription and the

[[Page 16266]]

pharmacy to archive the digitally signed record. These steps do not 
alter the data record that the pharmacy application will read. If the 
last intermediary digitally signs the record, the digital signature 
will be attached to the data record. Digital signatures, which under 
current NIST standards range from 160 to 512 bits (which generally 
equates to 20 to 64 bytes), would fit within the free-text fields that 
the SCRIPT standard provides (70 characters), or the digital signature 
could be linked to the prescription record rather than incorporated 
into the record. If the pharmacy digitally signs the prescription 
record, the issue of potential problems with the format will not apply. 
The digitally signed prescription-as-received record ensures that DEA 
can determine whether a prescription was altered during transmission or 
after receipt at the pharmacy. If the contents of the digitally signed 
record at the pharmacy do not match the contents of the digitally 
signed record held by the practitioner's electronic prescription 
application, the prescription was altered during transmission. If the 
record of the prescription in the pharmacy database does not match the 
digitally signed record of the prescription as received, the 
prescription was altered after receipt.
    About a third of registered pharmacies already have the ability to 
digitally sign electronic controlled substance orders through DEA's 
Controlled Substances Ordering System; the private key used for these 
electronic orders could be used to sign prescriptions upon receipt. 
Similarly, most applications that move files through virtual private 
networks or that conduct business over the Internet have digital 
signature capabilities. DEA has not imposed any requirements for the 
source of the digital signatures because pharmacies and intermediaries 
may already have signing modules that can be used. Pharmacies that have 
a Controlled Substance Ordering System digital certificate obtained it 
from DEA. In response to the comment on validating the digital 
signature, the pharmacy or intermediary will be signing the record; DEA 
sees no need to ask them to validate their own certificate. DEA does 
not believe that it is necessary to provide an alternative to the 
digital signature because it should be possible for either the 
intermediary or pharmacy to apply a digital signature within a 
reasonable time.
    On the issue of direct exchanges between a practitioner and a 
pharmacy, two digital signatures (the electronic prescription 
application's or practitioner's and the pharmacy's) would be required 
unless the practitioner's digital signature is transmitted to the 
pharmacy and validated. Even when intermediaries are not involved, 
there is the possibility that an electronic prescription could be 
intercepted and altered during transmission. When it becomes feasible 
for practitioners to transmit electronic prescriptions directly to 
pharmacies, without conversion from one software version to another, 
the PKI option that DEA is making available under the interim final 
rule may be an alternative that more applications and practitioners 
choose to use. The primary barrier to this option is the current need 
to convert prescription information from one software version to 
another during transmission because of interoperability issues; 
conversion of the prescription information from one software version to 
another makes it impossible to validate the digital signature on 
receipt. When interoperability issues have been resolved, transmitting 
a digital signature and validating the digital signature may be more 
cost-effective for some pharmacies. Because of the alternatives DEA is 
providing for practitioner issuance of electronic prescriptions for 
controlled substances, DEA does not believe it is necessary to develop 
alternative approaches that would apply only to those few truly closed 
systems. DEA notes that it has also made a number of changes to the 
proposed rule that are consistent with the practices described by the 
commenters from closed systems; for example, DEA is allowing 
institutional practitioners to conduct identity proofing in-house.
2. Checking the CSA Database
    DEA proposed that pharmacies would be required to check the CSA 
database to confirm that the DEA registration of the prescriber was 
valid at the time of signing.
    Comments. Several commenters objected to this requirement, stating 
that pharmacies are not required to check DEA registrations for paper 
prescriptions unless they suspect something is wrong with a 
prescription. They also stated that the requirement would be costly and 
probably not feasible because the CSA database must be purchased and is 
not up-to-date. Some commenters expressed the view that since DEA 
proposed to have electronic prescription application providers check 
the registration, requiring the pharmacy to do so would be redundant.
    DEA Response. DEA agrees with those commenters that expressed the 
view that, when filling a paper prescription, it is not necessary for a 
pharmacist who receives an electronic prescription for a controlled 
substance to check the CSA database in every instance to confirm that 
the prescribing practitioner is properly registered with DEA. 
Accordingly, DEA has removed this requirement from the interim final 
rule. It should be made clear that a pharmacist continues to have a 
corresponding responsibility to fill only those prescriptions that 
conform in all respects with the requirements of the Controlled 
Substances Act and DEA regulations, including the requirement that the 
prescribing practitioner be properly registered. Pharmacists also have 
an obligation to ensure that controlled substance prescriptions contain 
all requisite elements, including (but not limited to) the valid DEA 
registration of the prescribing practitioner. If a pharmacy has doubts 
about a particular DEA registration, it can now check the registration 
through DEA's Registration Validation Tool on its Web site rather than 
having to purchase the CSA database.\25\
---------------------------------------------------------------------------

    \25\ DEA provides a ``Registration Validation'' tool on its Web 
site, through which DEA registrants may query DEA's registration 
database regarding another DEA registrant to gather specific 
information about that registrant. Information available includes: 
The registrant's name, address, and DEA registration number; the 
date of expiration of the registration; business activity; and the 
schedules of controlled substances the registrant is authorized to 
handle.
---------------------------------------------------------------------------

3. Audit Trails
    DEA proposed that pharmacy applications have an internal electronic 
audit trail that recorded each time a controlled substance prescription 
was opened, annotated, altered, or deleted and the identity of the 
person taking the action. The pharmacy or the application provider 
would establish and implement a list of auditable events that, at a 
minimum, would include attempted or successful unauthorized access, 
use, disclosure, modification, or destruction of information or 
interference with application operations in the pharmacy application. 
The application would have to analyze the audit logs at least once 
every 24 hours and generate an incident report that identifies each 
auditable event. Security incidents would need to be reported within 
one business day.
    Comments. A substantial number of commenters representing 
pharmacies and pharmacy associations objected to the requirement that 
the audit trail document any time a prescription record was viewed, 
asserting that current applications do not have the capability to track 
this as opposed to tracking annotations, modifications, and deletions.

[[Page 16267]]

    DEA Response. In view of the comments, DEA agrees that the audit 
function does not need to document every instance in which a 
prescription record is opened or viewed and has revised the rule 
accordingly. The pharmacy application will only be required to document 
those instances in which a controlled substance prescription is 
received, annotated, modified, or deleted. In such circumstances, the 
application must record when the annotation, modification, or deletion 
occurred and who took the action.
    Comments. Several commenters stated that standards for the 
automation of capturing auditable events and interpretation of the 
resulting reports have not been published. Commenters asserted that 
many pharmacy applications have the ability to track auditable events, 
but not all have the ability to generate the reports desired by DEA. A 
number of commenters asked DEA to define auditable event and explain 
what level of security incident would need to be reported. A chain 
pharmacy asked DEA to define what constituted an alteration of the 
record and to clarify that a generic substitution is not an auditable 
event. An application provider asked if auditable events are limited to 
information changed at the order level (e.g., administration 
instructions) or at dispensing (e.g., NDC changed due to insufficient 
quantity). A number of commenters suggested that reporting of security 
incidents should be within 2 to 3 business days.
    DEA Response. The audit trail and the internal auditing of 
auditable events serve somewhat different purposes. The audit trail 
provides a record of all modifications to the prescription record. For 
example, the audit trail will note when the prescription was dispensed 
and by whom; it will indicate modifications (e.g., partial dispensing 
when the full amount is not available, changes to generic version). The 
auditable events, in contrast, are intended to identify potential 
security concerns, such as attempts to alter the record by someone not 
authorized to do so or significant increases in the dosage unit or 
quantity dispensed without an additional annotation (e.g., indicating 
practitioner authorization). DEA points out that during hearings on 
electronic prescriptions, representatives of the pharmacy and 
electronic prescription application industries uniformly stressed the 
audit trails as the basis for the security of their applications.
    DEA does not believe it is feasible to define or list every 
conceivable event that would constitute an auditable event for all 
pharmacies. The extent to which a particular event might raise concern 
at one pharmacy is not necessarily the same at other pharmacies. For 
example, a community pharmacy may want to set different triggers for 
changes to opioid prescriptions than a pharmacy that serves a large 
cancer center or a pharmacy that services LTCFs would. A community 
pharmacy that is closed overnight may want to identify any change that 
occurs during the hours when it is closed--an event that is not a 
consideration for a pharmacy that is open 24 hours a day. The auditable 
events must, at a minimum, include attempted or successful unauthorized 
access, modification, or destruction of information or interference 
with application operations in the pharmacy application. DEA has 
dropped the unauthorized ``use or disclosure'' from its list of 
auditable events. These events are included in the CCHIT standards for 
electronic health records and may be important to pharmacies, but are 
not directly relevant to DEA's concerns.
    DEA expects that application providers and developers will work 
with pharmacies to identify other auditable events. DEA emphasizes that 
application providers should define auditable events to capture 
potential security threats or diversion. Changes from brand name drug 
to a generic version of the same drug, for example, do not represent 
potential security issues.
    Comments. One State recommended that audit trails and event logs 
should be in a standard format.
    DEA Response. DEA understands the State's desire for a uniform 
format for audit trails and event logs, but in the absence of a single 
industry-wide standard being utilized by pharmacies, DEA does not 
believe it would be appropriate at this time to mandate one particular 
format over others.
    Comments. A pharmacy organization and pharmacist associations asked 
if audit trails and daily audits could be automated. One commenter 
asked DEA to clarify that the records could be kept on existing 
systems. Another asked if a pharmacy had to document that the record 
had been reviewed.
    DEA Response. Audit trails and daily audits are automated functions 
that occur on the pharmacy's computers and that should not require 
actions on the part of pharmacists or other pharmacy employees except 
when a security threat is identified, which DEA expects to occur 
relatively rarely. The internal audit trail records must be maintained 
for two years, but DEA is not requiring that the pharmacy retain a 
record of its review of reports of auditable events unless they result 
in a report to DEA of a potential security incident.
    Comments. A chain pharmacy asserted that as the record as received 
will be digitally signed, only a compromise of the encryption key 
should be an auditable event.
    DEA Response. The digital signature on a record as received does 
not address the concerns that the audit trail and review are intended 
to document. The digitally signed prescription as received documents 
the information content of the prescription on receipt. It does not 
help identify later alterations of the record; it can show that the 
record was altered later, but not who did it or when.
    Comments. A State asked if pharmacies should discontinue accepting 
electronic prescriptions if a security incident occurs.
    DEA Response. In general, it would be advisable to discontinue 
accepting electronic prescriptions for controlled substances until the 
security concerns were resolved. However, if, despite the security 
concerns associated with the application, the pharmacy is able to 
verify that a prescription has been issued lawfully, the pharmacy may 
fill the prescription.
4. Offsite Storage
    DEA proposed that back-up records be stored at a separate offsite 
location. DEA proposed that the electronic record be easily readable or 
easily rendered into a format that a person could read and must be 
readily retrievable.
    Comments. Most pharmacy commenters objected to offsite storage as 
costly and not required for paper prescriptions. A pharmacy 
organization stated that back-up copies should be transferred off-site 
weekly, not daily.
    DEA Response. DEA has removed the requirement for storage of back-
up records at another location. DEA, however, recommends as a best 
practice that pharmacies store their back-up copies at another location 
to prevent the loss of the records in the event of natural disasters, 
fires, or system failures.
    DEA believes that daily backup of prescription records is an 
acceptable length of time to ensure the integrity of pharmacy records.
    Comments. Several pharmacy chains asked that the functionality for 
retrieving records be at the headquarters rather than the pharmacy 
level; they supported the standard of ``readily retrievable,'' as DEA 
proposed, which is the same standard that applies to paper 
prescriptions. One State board of pharmacy stated that the provision 
for making the data available in a readable

[[Page 16268]]

format may require extensive reprogramming. A pharmacist association 
asked DEA to define readily retrievable. One commenter objected to 
storing information at pharmacies because it could be exposed.
    DEA Response. Under the interim final rule, it is permissible for a 
pharmacy to have records stored on headquarters' computers, but the 
dispensing pharmacy must be able to retrieve them if requested as they 
do for computerized refill records allowed under Sec.  1306.22. DEA 
does not believe that the requirement for readable records will impose 
significant burdens. Similar requirements exist for computerized refill 
records. In addition, it is unlikely that pharmacy applications would 
be useable by pharmacists unless the data can be provided in an easily 
readable form. ``Readily retrievable'' is already defined in Sec.  
1300.01. Finally, requirements currently exist for pharmacies to retain 
and store prescription records in compliance with HIPAA requirements to 
protect individuals' personal information.
5. Transfers
    In the NPRM, DEA confirmed existing regulations regarding the 
transfer of prescriptions for Schedule III, IV, and V controlled 
substances. Specifically, under Sec.  1306.25(a) a pharmacy is allowed 
to transfer an original unfilled electronic prescription to another 
pharmacy if the first pharmacy is unable to or chooses not to fill the 
prescription. Further, a pharmacy is also allowed to transfer an 
electronic prescription for a Schedule III, IV, or V controlled 
substance with remaining refills to another pharmacy for filling 
provided the transfer is communicated between two licensed pharmacists. 
The pharmacy transferring the prescription would have to void the 
remaining refills in its records and note in its records to which 
pharmacy the prescription was transferred. The notations may occur 
electronically. The pharmacy receiving the transferred prescription 
would have to note from whom the prescription was received and the 
number of remaining refills.
    Comments. Several commenters, including three pharmacy chains and 
an association representing chain drug stores, all indicated their 
belief that if a prescription transfer occurs within the same pharmacy 
chain, only one licensed pharmacist is necessary to complete the 
transfer if that pharmacy chain uses a common database among its 
pharmacies. One pharmacy chain noted that in many cases, pharmacists do 
not call each other to effectuate the transfer of the prescription from 
one pharmacy to another. Commenters requested that DEA revise the rule 
to address this industry practice.
    DEA Response. DEA has never permitted the transfer of a controlled 
substance prescription without the involvement of two licensed 
pharmacists, regardless of whether the two pharmacies share a common 
database. DEA emphasizes that this has been a longstanding requirement, 
one which was not proposed to be changed as part of this rulemaking. 
DEA believes that it is important that two licensed pharmacists be 
involved in the transfer of controlled substances prescriptions between 
pharmacies so that the pharmacists are aware that the prescription is 
actually being transferred. As the dispensing of the prescription is 
the responsibility of the pharmacist, DEA believes that it is critical 
that those pharmacists have knowledge of prescriptions entering their 
pharmacy for dispensing. Without this requirement, it would be quite 
feasible for other pharmacy employees to move prescriptions between 
pharmacies, thereby increasing the potential for diversion by pharmacy 
employees.
    Comments. One commenter, a large pharmacy, believed that while the 
NPRM addressed the transfer of prescription refill information for 
Schedule III, IV, and V controlled substance prescriptions, it did not 
address the transfer of original prescriptions that have not been 
filled.
    DEA Response. As DEA explained in the NPRM, the existing 
requirements for transfers of Schedule III, IV, and V controlled 
substances prescriptions remain unchanged. DEA currently permits the 
transfer of original prescription information for a prescription in 
Schedules III, IV, and V on a one-time basis. This allowance does not 
change. DEA wishes to emphasize that the only changes made to Sec.  
1306.25 as part of the NPRM were to revise the text to include separate 
requirements for transfers of electronic prescriptions. These revisions 
were needed because an electronic prescription could be transferred 
without a telephone call between pharmacists. Consequently, the 
transferring pharmacist must provide, with the electronic transfer, the 
information that the recipient transcribes when accepting an oral 
transfer.
6. Other Pharmacy Issues
    Comments. An advocacy group stated that although it expects the 
chain drug stores to be able to handle the administrative burden and 
expense of security measures demanded by DEA, it was concerned about 
the ability of independent pharmacies, especially those that rely 
almost exclusively on prescription revenues and not ``front-of-the-
store'' revenues, to cope with the proposed rule's added requirements.
    DEA Response. DEA has revised some of the requirements to reduce 
the burden imposed by this rulemaking, where DEA believes that doing so 
does not compromise effective controls against diversion. DEA has also 
clarified that the third-party audit applies to the application 
provider, not to the individual pharmacy unless the pharmacy has 
developed and implemented its own application, a circumstance which, at 
the present time, is likely limited to chain pharmacies. The audit 
trail is something that members of industry stated, prior to the 
proposed rule, was the basis for their security controls. The pharmacy 
applications should, therefore, have the capability to implement this 
requirement. DEA is simply requiring that the application identify 
security incidents, which should be infrequent, and that the pharmacy 
be notified and take action to determine if the application's security 
was compromised. This should not be an insurmountable burden for a 
small pharmacy. The other functions required are automated and do not 
require action on the part of the pharmacy staff. Most of the burden of 
the pharmacy requirements fall on the pharmacy application provider, 
not on the pharmacy.
    Comments. Some commenters stated that the requirements for paper 
prescriptions include, for practitioners prescribing under an 
institutional practitioner's registration, the specific internal code 
number assigned by the institutional practitioner under Sec.  1301.22. 
These commenters stated that NCPDP SCRIPT does not accommodate the 
extensions, which do not have a standard format, nor do most pharmacy 
computer applications. They also noted that a pharmacy has no way to 
validate the extension numbers.
    DEA Response. DEA is aware of the issue with extension data and 
published an Advance Notice of Proposed Rulemaking (74 FR 46396, 
September 9, 2009) to seek information that can be used to standardize 
these data and to require institutional practitioners to provide their 
lists to pharmacies on request. As discussed above, DEA believes that 
SCRIPT can be modified to accept extensions by adding a code that 
indicates that the DEA number is for an institutional practitioner and 
allowing the field to accept up to 35 characters.

[[Page 16269]]

Pharmacy applications will need to be revised to accept the longer 
numbers; without the extension data, there is no way to determine who 
issued the prescription if individual practitioners with the same name 
are associated with the institutional practitioner. DEA is not 
requiring pharmacies to validate the extension numbers unless the 
pharmacist has reason to suspect that the prescription or prescribing 
practitioner are not legitimate.
    Comments. A pharmacy organization asked if a pharmacy that services 
a Federal healthcare facility would need to operate separate systems, 
one for Federal facilities and one for other facilities it serves. It 
also asked what facilities were considered Federal healthcare 
facilities.
    DEA Response. As discussed above, DEA is allowing any application 
to use the digital certificate option proposed for Federal healthcare 
systems. DEA is not, therefore, imposing any different requirements on 
Federal facilities. Pharmacies may decide whether they will accept and 
verify digital signatures transmitted with a prescription, whether it 
was signed by a practitioner at a Federal facility or in private 
practice. If a pharmacy does not accept controlled substance 
prescriptions digitally signed with the individual practitioner's 
private key, it will have to ensure that it has a digitally signed 
record of the prescription as received. The rest of the requirements 
for annotating and dispensing a controlled substance prescription are 
the same for all electronic prescriptions for controlled substances. 
The determination of whether a particular facility is a Federal 
facility is not affected by this rulemaking.

I. Third Party Audits

    DEA proposed that both electronic prescription applications and the 
prescription processing module in pharmacy applications should be 
subject to a third-party audit that met the requirements of SysTrust or 
WebTrust audits (or for pharmacies, SAS 70). The standards for these 
audits are established and maintained by the American Institute of 
Certified Public Accountants.26 27 The audits are conducted 
by CPAs. DEA proposed that the application provider would have to have 
the third-party audit for processing integrity and physical security 
before the initial use of the application for electronic controlled 
substance prescriptions and annually thereafter to ensure that the 
application met the requirements of the rule. DEA sought comments on 
whether alternative audit types were available and appropriate.
---------------------------------------------------------------------------

    \26\ http://www.ffiec.gov/ffiecinfobase/booklets/audit/audit_06_3_party.html.
    \27\ http://www.ffiec.gov/ffiecinfobase/booklets/audit/audit_06_3_party.html.
---------------------------------------------------------------------------

    Comments. An application provider organization stated annual 
security audits are unrealistic and will not be performed or enforced. 
The commenter asserted that a better use of both DEA and application 
provider resources would be to write and enforce a set of standards 
around systems writing.
    DEA Response. Even if DEA had the technical expertise to develop 
standards, DEA does not believe that imposing an inflexible regulatory 
standard on applications is a reasonable approach. Security 
technologies are evolving. Locking applications into a specific format 
that would then have to be used until the regulation was revised, a 
time-consuming process, could delay implementation of more user-
friendly and efficient applications that may be developed. In addition, 
most pharmacy applications have been in use for years; forcing them to 
reprogram in a specified way could be more costly and disruptive than 
letting each application provider tailor a solution that works for a 
particular application. DEA is interested in the end result (a secure 
system that can reasonably be implemented and is consistent with 
maintenance of effective controls against diversion of controlled 
substances), not in the details of how they are achieved.
    DEA proposed third-party audits as a way to provide registrants 
with an objective appraisal of the applications they purchase and use. 
As a number of commenters stated, except for registrants associated 
with very large practices, large healthcare systems, or chain 
pharmacies, any of which may have their own information technology 
departments, the majority of registrants cannot be expected to 
determine, on their own, whether an application meets DEA's 
requirements. If they are to have assurance that the application they 
are using is in compliance with DEA regulatory requirements, that 
assurance must come from another source.
    As commenters noted, DEA essentially had to choose among four 
possibilities for determining whether an application meets the 
requirements of part 1311: The application provider could self-certify 
the application; DEA could review and certify applications; an 
independent certification organization could take on that role; or the 
application provider could obtain a third-party audit from a qualified 
independent auditor. DEA believes that self-certification would not 
provide any assurance to registrants as non-compliant application 
providers would have an incentive to misrepresent their compliance with 
DEA regulatory requirements, and registrants would have few ways to 
determine the truth. For example, an application provider could claim 
that its application required the setting of logical access controls 
when the application, in fact, allowed anyone access regardless of the 
logical access controls. Until a practitioner or pharmacy discovered 
that prescriptions were being written or altered by unauthorized 
persons there would be no reason to suspect a problem with the 
application.
    DEA does not have the expertise or the resources to conduct 
technical reviews of electronic prescription or pharmacy applications. 
Even if DEA elected to obtain such expertise, the time required for it 
to do so and then to review all of the existing applications would 
delay adoption.
    DEA believes that a third-party audit approach allows application 
providers to seek a review as soon as their applications are compliant, 
which should make applications available for electronic prescribing of 
controlled substances sooner than relying on DEA. Third-party audits, 
while perhaps new to some prescription and pharmacy application 
providers, are a common approach used by the private sector to ensure 
compliance with both government regulations and private sector 
standards. For example, the International Standards Organization (ISO) 
frequently requires companies to obtain a third-party audit to gain 
certification for compliance with its standards (e.g., ISO 9001, ISO 
14001).\28\
---------------------------------------------------------------------------

    \28\ http://www.iso.org/iso/iso_catalogue/management_standards/certification.htm.
---------------------------------------------------------------------------

    The fourth approach would be to rely on an independent 
certification organization, such as CCHIT, to test and certify 
electronic prescription and pharmacy applications. Under the interim 
final rule, DEA will allow the certifications of such independent 
organizations to substitute for a third-party audit if the 
certification process clearly determines that the application being 
tested is compliant with DEA regulatory requirements and clearly 
distinguishes between applications that are compliant with part 1311 
and those that are not. DEA notes, for example, that CCHIT currently 
tests and certifies EHRs against a set of published standards and plans 
to test and certify stand-alone electronic prescribing applications. 
However, at this time, CCHIT does not evaluate pharmacy applications. 
Once any certification

[[Page 16270]]

organization has incorporated tests for part 1311 compliance, DEA will 
work with the organization to determine whether the process and 
certification are sufficient so that a registrant purchasing an 
application can rely on the certification to ensure that the 
application is compliant. Because many application providers seek 
certification, this approach will reduce costs. DEA notes, however, 
that it has not been able to identify any independent organization that 
certifies pharmacy applications or any that certifies prescription 
modules at the level of detail DEA requires.
    Comments. Two commenters asserted that third-party audits are not a 
common practice and not required for paper prescriptions.
    DEA Response. Third-party audits, in this context, address the 
ability of the electronic prescription application or pharmacy 
application to handle controlled substance prescriptions securely. It 
is difficult to understand how that concept could be applied to paper 
prescriptions, where the only issues are whether they are written in 
compliance with the law and regulations, properly filed, and whether 
they have been altered. On a paper prescription, the alteration creates 
forensic evidence of the change, which is not necessarily the case with 
a prescription generated using an electronic application, where the 
lack of an audit trail or an audit function that has been disabled may 
eliminate any evidence of alterations.
    Comments. Many of the commenters on this issue focused on the costs 
associated with third-party audits. One electronic prescription 
application provider that currently obtains a SysTrust audit stated 
that the cost of the audit for the proposed requirements would be 
considerably less than DEA had estimated. This commenter estimated the 
cost to be ``in the lower tens of thousands of dollars range'' rather 
than the range of $100,000 to $125,000 that DEA mentioned in the NPRM. 
Another electronic prescription application provider asserted that the 
cost was underestimated and said the requirement would place a burden 
on application providers.
    A pharmacy organization stated application vulnerabilities should 
be addressed through technology and that they should not create extra 
paperwork. It also stated that DEA should ensure that the cost of these 
audits is reasonable for small practices and pharmacies. A pharmacy 
organization and an information technology organization stated that the 
audit requirement is a burden financially and logistically. These 
commenters noted that some clinics that serve as both practitioners and 
pharmacies will bear the costs of both sides of the transaction.
    DEA Response. DEA emphasizes that the requirement for a third-party 
audit applies to the application provider, not to the practitioner or 
pharmacy that uses the application. Unless a healthcare system or a 
pharmacy has developed its own application, it would not be subject to 
the requirement. Healthcare systems that serve as both practitioner and 
pharmacy may obtain a single third-party audit that addresses part 1311 
compliance of the integrated system.
    DEA has taken a number of steps to reduce the cost of the third-
party audit. First, recognizing that the electronic prescribing and 
prescription processing functions DEA is requiring may not change every 
year, DEA has revised the rule to require an audit whenever an 
application is altered in a way that could affect the functionalities 
within the electronic prescription or pharmacy application related to 
controlled substance prescription requirements or every two years, 
whichever occurs first. Second, DEA has clarified that the purpose of 
the third-party audit is to determine whether the application meets 
DEA's requirements, that is, that the application is capable of 
performing the functions DEA requires and does so consistently. Where 
the application is installed on practice or pharmacy computers, the 
audit will not need to address the application provider's physical 
security nor will it need to address physical security at the practice 
or pharmacy because that will vary with each installation and is beyond 
the control of the application provider. For application service 
providers, the physical security of the ASP will need to be audited.
    Third, as discussed above, if independent certification 
organizations develop programs that certify applications for part 1311 
compliance, DEA will review their processes to determine whether such 
certifications can substitute for a third-party audit.
    Finally, DEA has expanded the kinds of third-party auditors beyond 
those who perform SysTrust, WebTrust, or SAS 70 audits to include 
certified information system auditors (CISA) who perform compliance 
audits as a regular ongoing business activity. The CISA certification 
is sponsored by the Information Systems Audit and Control Association 
(ISACA) \29\ and is recognized by the American National Standards 
Institute under ISO/IEC 17024. The certification is required by the 
FBCA for third-party auditors and by the Federal Reserve Bank for its 
examiners and is approved by the Department of Defense. DEA believes 
that allowing other certified IT auditors will provide application 
providers with more options and potentially reduce the cost of the 
audit. DEA is seeking comments on the addition of CISA to the list of 
permissible auditors.
---------------------------------------------------------------------------

    \29\ http://www.isaca.org.
---------------------------------------------------------------------------

    Comments. A mail-order pharmacy said the rule should state that the 
annual SysTrust or SAS 70 audit meets DEA's regulatory requirements so 
that pharmacies passing their most recent audit can begin accepting 
electronic controlled substance prescriptions.
    DEA Response. The SysTrust or SAS 70 audit will be sufficient if 
the audit has determined that the application meets the applicable 
requirements of part 1311. Because the pharmacy requirements address 
internal audit trails, logical access controls, and the ability to 
annotate and retain prescription records, which may be standard 
functions in existing pharmacy applications, it is possible that the 
existing audit has covered these functions. The pharmacy and the 
auditor should review the requirements of part 1311 and determine 
whether compliance has been addressed by the existing audit.
    Comments. An intermediary suggested that certifying organizations 
such as itself and CCHIT could make the presentation of the audit a 
condition of certification. An information technology organization 
suggested that DEA might consider the North American Security Products 
Organization (NASPO) certification as a recognized standard for 
security products since, the commenter asserted, NASPO certification is 
sponsored by the FBI and Secret Service through the Document Security 
Alliance.
    DEA Response. DEA notes that the commenter's existing certification 
process does not address the functions that DEA is requiring, but 
rather focuses on compliance with the SCRIPT standard. The commenter, 
as it stated, would rely on third-party audits to determine whether the 
applications meet DEA's requirements. Although the commenter may choose 
to impose this requirement on entities it certifies, making the third-
party audit a condition of certification by this intermediary would not 
reduce the cost for the application providers because they would still 
need to obtain a third-party audit. Further, DEA cannot rely on one 
third party's certification of another third party's audit or 
certification of a particular application's compliance with DEA 
regulatory requirements. In

[[Page 16271]]

this regard, DEA must look to its own regulatory authority and 
regulatory requirements, not those of other entities. This is 
particularly true as DEA is not mandating the use of intermediaries.
    As discussed above, if a certification organization decides to 
incorporate, as part of its certification, a determination that the 
application meets the requirements of part 1311, DEA will review the 
process used to determine whether the certification can be used as a 
substitute for a third-party audit. Based on a review of the 
information available on its Web site,\30\ NASPO does not appear to 
address applications such as those used to create electronic 
prescriptions, but rather certifies organizations. Thus, DEA does not 
believe that NASPO is currently a suitable alternative to the third-
party audits or certifications DEA is requiring in this rule.
---------------------------------------------------------------------------

    \30\ http://www.naspo.info.
---------------------------------------------------------------------------

    Comments. Some commenters stated that there are multiple versions 
of applications in use and that third-party audits would not be 
feasible in these cases.
    DEA Response. The existing certification programs test and certify 
multiple versions of applications. The application providers should, 
therefore, be familiar with the process of gaining approval for new 
versions. DEA notes that it is requiring a new audit more frequently 
than once every two years only when one of the functions required by 
part 1311 is affected by an update or upgrade to the application. If an 
application provider has multiple versions of the application, all of 
which use the same code and controls for the functions that DEA is 
requiring, a single audit may be able to address multiple versions if 
other changes could not impact these functions.
    Comments. Some commenters thought that individual practitioners or 
pharmacies would have to obtain an audit of their applications.
    DEA Response. As discussed above, a practice or pharmacy will be 
required to obtain an audit only if it developed the application 
itself. Although there may be some pharmacy chains that developed their 
own applications, it appears that even large hospital systems usually 
obtain applications from application providers. If the application 
provider has tailored its application to meet the specific needs of a 
healthcare system or a pharmacy chain, the application provider will 
have to determine whether the changes it made for a particular client 
affect the capability of the application to meet DEA's requirements. If 
the healthcare system or pharmacy-specific changes do not affect the 
functions specified in part 1311, a single audit may be able to address 
the multiple tailored versions of its application. DEA expects that, 
except for very large healthcare systems or practices, applications 
will not be tailored in ways that will affect compliance with part 
1311.
    Comments. One application provider stated that some of the controls 
that DEA wants addressed in the audit are not under the application 
provider's control when the application has been installed on a 
practice or pharmacy computer.
    DEA Response. DEA recognizes that the proposed rule failed to 
address adequately the different roles played by application providers 
that install applications and those that serve as application service 
providers. To address the differences, DEA has revised the rule to 
clarify that a third-party audit does not need to address physical 
security of an application provider if its application is installed on 
practitioner office or pharmacy computers and servers. The audit for 
applications that will be installed on practice or pharmacy computers 
is limited to the application's ability to meet the part 1311 
application requirements. The application provider, in this case, has 
no control over physical security of the application installed at the 
practice or pharmacy location and the security of its own operations is 
not of concern to DEA because the prescription records are not created 
or stored on computers that the application provider controls. A third-
party audit for an application service provider, whose servers and Web 
sites host the files of practices or pharmacies, must, however, address 
physical security because the ability of the ASP to prevent insider and 
outsider attacks is critical to the security of prescription 
processing.
    Comments. Pharmacy commenters stated that SureScripts/RxHub 
certification and HIPAA compliance should be sufficient to meet DEA 
regulatory requirements. One pharmacy chain asserted that it should be 
allowed to self-certify that its pharmacy application was compliant 
with DEA requirements for electronic prescriptions. Two retail pharmacy 
associations stated that the rule was not needed for pharmacies because 
State pharmacy boards may inspect their computer applications. They 
stated that their applications must comply with HIPAA and the SCRIPT 
standard. A State agency stated that these audits for pharmacies may 
not be needed and would impose additional costs on pharmacies.
    DEA Response. SureScripts/RxHub certifies pharmacy and electronic 
prescription applications for interoperability and compliance with 
NCPDP SCRIPT, but not for their internal security or other 
functionalities; as commenters noted, SCRIPT supports, but does not 
mandate, the inclusion of all the DEA-required information. In 
addition, SureScripts/RxHub is not a neutral third party, but was 
established and is run by the pharmacy industry and may have a vested 
interest in promoting the existing model of transmission over others. 
Thus, DEA believes that SureScripts/RxHub certification, while 
beneficial from an industry perspective, is not suitable to address 
DEA's requirement for a neutral unbiased third-party audit of 
electronic prescription and pharmacy applications. DEA also notes that 
assertions (especially self-assertions, which are typically not 
verified by an outside party) of compliance with the HIPAA Security 
Rule provide limited assurance of security. The HIPAA Security Rule, 
which is focused on protecting personal health information from 
disclosure, is risk-based and designed to be flexible and scalable 
because the risks may vary with the number of patients. In contrast, 
DEA has based its requirements on its statutory obligations and must 
require all pharmacies to implement the defined security controls. As 
discussed above, application provider self-certification would not 
provide registrants with reasonable assurance of compliance.
    DEA would be willing to evaluate a request from a pharmacy board to 
carry out a third-party audit or review of an audit, but as no State 
Board offered to take on this role in its comments to the NPRM, DEA 
doubts that this approach is feasible.
    Comments. An application provider stated that the SysTrust and 
WebTrust audits are intended for e-commerce Web sites. The commenter 
asserted that a healthcare information application is considerably more 
complex than an e-commerce Web site, as an EMR may provide thousands of 
features/functions. The commenter asked what the auditor would examine 
and test during an audit of such a complex application. The commenter 
asked whether CPA firms are qualified to audit such complex 
applications in a consistent manner. With the overall complexity and 
the number of organizations that would be required to obtain the 
audits, it asked whether DEA had considered the impact of such a 
requirement if organizations are not able to get an audit performed due 
to overall demand.
    DEA Response. The WebTrust audit is intended for Web sites, but the 
SysTrust

[[Page 16272]]

audit and the SAS 70 audits are not. DEA stated in the NPRM that the 
only aspects of the applications that are subject to the audit are 
processing integrity and, for ASPs, physical security as they relate to 
the creation and processing of controlled substance prescriptions. DEA 
is not requiring an application provider to have all aspects and 
functions of their applications audited. Although a provider may want 
an auditor to determine whether its application accurately moves data 
from one part of an EHR to another (e.g., diagnosis codes from the 
patient record to an insurance form), DEA is not requiring that such 
functions be audited unless they directly affect the creation, signing, 
transmitting, or, for pharmacies, the processing of controlled 
substance prescriptions.
    As discussed above, if an organization develops a program to 
certify electronic prescription or pharmacy applications, DEA will 
review the processes for certification of applications proposed by that 
organization to determine if the certification standards adequately 
evaluate compliance with part 1311. DEA will provide a list of those 
organizations whose certification processes adequately address 
compliance with DEA's requirements and allow such certifications to 
take the place of third-party audits. This should reduce the cost to 
application providers. As for the concern about the availability of 
third-party auditors, DEA notes that there are a limited number of 
applications, which are unlikely all to be ready for audits at the same 
time. DEA, however, has expanded the range of potential auditors by 
including those who have CISA credentials.
    Comments. A number of commenters objected to the annual audit, 
stating that the applications do not change annually. They suggested a 
two- or three-year period would be more appropriate.
    DEA Response. DEA agrees with commenters on the issue of annual 
audits and has revised the rule to require an initial audit prior to 
use of the application for electronic prescriptions for controlled 
substances, and to require subsequent audits once every two years or 
whenever functions related to creating and signing or processing of 
controlled substance prescriptions are altered, whichever occurs first. 
Application providers will be required to keep their most recent audit 
report and any other reports obtained in the previous two years. DEA 
notes that CCHIT now requires recertification every two year.
    Comments. Practitioner organizations, healthcare organizations, and 
an intermediary stated that prescribers are not competent to review 
audits and that DEA should publish a list of qualifying applications. 
One association stated that the onus should be on the application 
provider to meet the requirements and fix any deficiencies so that 
practitioners do not need to stop using an application.
    DEA Response. SysTrust and WebTrust audit reports are intended for 
the public. It should not be difficult for an application provider to 
insist that the report include a summary that clearly states whether 
the application meets DEA requirements. If certification bodies take on 
the role of certifying applications for compliance with part 1311, the 
existence of the certification will be enough to meet the requirement 
to use a compliant application. DEA expects that application providers 
will have an incentive to address any shortcomings quickly to ensure 
customer satisfaction.
    Comments. Another commenter asked why the intermediaries are not 
required to be audited. A State agency asserted that intermediaries 
should be independently certified and audited annually. That commenter 
suggested that transmission should be limited to wired networks.
    DEA Response. DEA's rule does not address the use of intermediaries 
in the transmission of electronic prescriptions for controlled 
substances. Rather, it addresses requirements for applications used to 
write electronic prescriptions for controlled substances and process 
them at pharmacies, and requirements for the registrants who use those 
applications. DEA requires registrants to use only applications that 
meet certain requirements because the registrants choose the 
applications. Registrants have no control over the string of three to 
five intermediaries involved in some electronic prescription 
transmissions. A practitioner might be able to determine from his 
application provider which intermediaries it uses to move the 
prescription from the practitioner to SureScripts/RxHub or a similar 
conversion service, but neither the practitioner nor the application 
provider would find it easy to determine which intermediaries serve 
each of the pharmacies a practitioner's patients may choose. Pharmacies 
have the problem in reverse; they may know which intermediaries send 
them prescriptions, but have no way to determine the intermediaries 
used to route prescriptions from perhaps hundreds of practitioners 
using different applications to SureScripts/RxHub or a similar service. 
Despite these considerations, DEA believes the involvement of 
intermediaries will not compromise the integrity of electronic 
prescribing of controlled substances, provided the requirements of the 
interim final rule are satisfied. Among these requirements is that the 
prescription record be digitally signed before and after transmission 
to avoid the need to address the security of intermediaries. DEA 
realizes that this approach will not prevent problems during the 
transmission, but it will at least identify that the problem occurred 
during transmission and protect practitioners and pharmacies from being 
held responsible for problems that may arise during transmission that 
are not attributable to them.

J. Risk Assessment

    In the NPRM, DEA provided a detailed risk assessment, applying the 
criteria of OMB M-04-04, a guidance document for assessing risks for 
Federal agencies. (See 73 FR 36731-36739; June 27, 2008.) Under M-04-
04, risks are assessed for four assurance levels (1--little or no 
confidence in asserted identity--to 4--very high certainty in the 
asserted identity) across six potential impacts. M-04-04 classifies 
risks as low, medium, and high as described in Table 1 and associates 
risk levels with assurance levels as shown in Table 2.

[[Page 16273]]



                        Table 1--M-04-04 Potential Impacts of Authentication Errors \31\
----------------------------------------------------------------------------------------------------------------
                                           Low impact              Moderate impact             High impact
----------------------------------------------------------------------------------------------------------------
Potential Impact of                At worst, limited short-   At worst, serious short-  Severe or serious long-
 Inconvenience, Distress or         term inconvenience,        term or limited long-     term inconvenience,
 Damage to Standing or Reputation.  distress or                term inconvenience or     distress or damage to
                                    embarrassment to any       damage to the standing    the standing or
                                    party.                     or reputation of any      reputation to the party
                                                               party.                    (ordinarily reserved
                                                                                         for situations with
                                                                                         particularly severe
                                                                                         effects or which may
                                                                                         affect many
                                                                                         individuals).
Potential Impact of Financial      At worst, an               At worst, a serious       Severe or catastrophic
 Loss.                              insignificant or           unrecoverable financial   unrecoverable financial
                                    inconsequential            loss to any party, or a   loss to any party; or
                                    unrecoverable financial    serious agency            severe or catastrophic
                                    loss to any party, or at   liability.                agency liability.
                                    worst, an insignificant
                                    or inconsequential
                                    agency liability.
Potential impact of harm to        At worst, a limited        At worst, a serious       A severe or catastrophic
 agency programs or public          adverse effect on          adverse effect on         adverse effect on
 interests.                         organizational             organizational            organizational
                                    operations, assets, or     operations or assets,     operations or assets,
                                    public interests.          or public interests.      or public interests.
                                    Examples of limited        Examples of serious       Examples of severe or
                                    adverse effects are: (i)   adverse effects are:      catastrophic effects
                                    Mission capability         (i) Significant mission   are: (i) Severe mission
                                    degradation to the         capability degradation    capability degradation
                                    extent and duration that   to the extent and         or loss of [sic] to the
                                    the organization is able   duration that the         extent and duration
                                    to perform its primary     organization is able to   that the organization
                                    functions with             perform its primary       is unable to perform
                                    noticeably reduced         functions with            one or more of its
                                    effectiveness; or (ii)     significantly reduced     primary functions; or
                                    minor damage to            effectiveness; or (ii)    (ii) major damage to
                                    organizational assets or   significant damage to     organizational assets
                                    public interests.          organizational assets     or public interests.
                                                               or public interests.
Potential Impact of unauthorized   At worst, a limited        At worst, a release of    At worst, a release of
 release of sensitive information.  release of personal,       personal, U.S.            personal, U.S.
                                    U.S. government            government sensitive,     government sensitive,
                                    sensitive, or              or commercially           or commercially
                                    commercially sensitive     sensitive information     sensitive information
                                    information to             to unauthorized parties   to unauthorized parties
                                    unauthorized parties       resulting in a loss of    resulting in a loss of
                                    resulting in a loss of     confidentiality with a    confidentiality with a
                                    confidentiality with a     moderate impact, as       high impact, as defined
                                    low impact, as defined     defined in FIPS PUB 199.  in FIPS PUB 199.
                                    in FIPS PUB 199.
Potential Impact to Personal       At worst, minor injury     At worst, moderate risk   A risk of serious injury
 Safety.                            not requiring medical      of minor injury or        or death.
                                    treatment.                 limited risk of injury
                                                               requiring medical
                                                               treatment.
Potential impact of civil or       At worst, a risk of civil  At worst, a risk of       A risk of civil or
 criminal violations.               or criminal violations     civil or criminal         criminal violations
                                    of a nature that would     violations that may be    that are of special
                                    not ordinarily be          subject to enforcement    importance to
                                    subject to enforcement     efforts.                  enforcement programs.
                                    efforts.
----------------------------------------------------------------------------------------------------------------


                           Table 2--Maximum Potential Impacts for Each Assurance Level
----------------------------------------------------------------------------------------------------------------
                                       Level 1            Level 2            Level 3              Level 4
----------------------------------------------------------------------------------------------------------------
Potential Impact of               Low Impact.......  Moderate Impact..  Moderate Impact.  High Impact.
 Inconvenience, Distress, or
 Damage to Standing or
 Reputation.
Potential Impact of Financial     Low Impact.......  Moderate Impact..  Moderate Impact.  High Impact.
 Loss.
Potential impact of harm to       n/a..............  Low Impact.......  Moderate Impact.  High Impact.
 agency programs or public
 interests.
Potential Impact of unauthorized  n/a..............  Low Impact.......  Moderate Impact.  High Impact.
 release of sensitive
 information.
Potential Impact to Personal      n/a..............  n/a..............  Low Impact......  Moderate Impact.
 Safety.
Potential impact of civil or      n/a..............  Low Impact.......  Moderate Impact.  High Impact.
 criminal violations.
----------------------------------------------------------------------------------------------------------------

    In the risk assessment conducted as part of the NPRM, DEA 
determined that the potential impact of financial loss and the 
potential impact of unauthorized release of sensitive information were 
not applicable to the rule; the risk related to the potential impact of 
inconvenience, damage, or distress to standing or reputation was rated 
as moderate. DEA rated the other three factors as high risk, which is 
associated with Level 4. As DEA discussed in the NPRM, inadequate 
requirements for authentication protocols would make it difficult to 
detect diversion and to enforce the statutory mandates of the 
Controlled Substances Act; DEA's ability to carry out its statutory 
mandate would be seriously undermined. As DEA discussed extensively in 
the NPRM, the consequences of diversion and abuse of controlled 
substances are clearly severe to the users. The criminal penalties 
associated with diversion involve imprisonment and/or fines. (See 73 FR 
36733-36734, June 27, 2009, for a full description of the reasons for 
DEA's ratings.) Because the highest risk level rated for any element 
determines the overall assurance level, DEA proposed using Level 4 for 
the authentication protocols although it did not apply any assurance 
level to identity proofing.
---------------------------------------------------------------------------

    \31\ Office of Management and Budget. ``E-Authentication 
Guidance for Federal Agencies'' M-04-04.
---------------------------------------------------------------------------

    Comments. Only four commenters directly addressed the risk 
assessment. An application provider and an information technology firm 
addressed the requirements for a hard token and

[[Page 16274]]

asserted that Level 4 would be very hard to implement and that Level 3 
would be sufficient.
    The information technology firm stated that Level 4 token 
technology is significantly more costly to distribute, manage, and 
operate than multi-token Level 3 technologies. The commenter asserted 
that cell phone-based multi-factor one-time-password devices require 
the distribution of code that is unique to each cell phone platform. 
Consequently, the commenter asserted, the cost and complexity for the 
end-users is significant. The logistical management of the software and 
cryptographic solutions for multi-factor cryptographic hardware devices 
make their cost untenable in a large scale, heterogeneous deployment. 
The application provider asserted that Level 4 requires that every 
system user use a Level 4 token to access the system, not just 
practitioners accessing select functions in a single application. Both 
commenters suggested that DEA require Level 3 tokens that are stored on 
a device ``separate from the computer gaining access,'' citing OMB 
memorandum M-07-16 on safeguarding personal information.\32\ These 
commenters asserted that this approach would eliminate the risk that 
DEA cited with NIST Level 3, which allows storage on the computer 
gaining access. They stated that ``the use of such multi-token level 3 
two-factor authentication solutions has been proven successful in mass 
scale deployments with heterogeneous user populations since no hardware 
or software is required by the end-user specific to the authentication 
transaction. This has been done with no provisioning complexity and a 
variety of integrated identity proofing capabilities including face-to-
face and remote knowledge-based identity proofing.'' An intermediary 
stated that most PDAs or other handheld devices typically do not meet a 
FIPS 140-2 validation with physical security at Level 3 or higher. It 
also said that SP 800-63-1 does not require that approved cryptographic 
algorithms must be implemented in a cryptographic module validated 
under FIPS 140-2.
---------------------------------------------------------------------------

    \32\ http://www.whitehouse.gov/omb/assets/omb/memoranda/fy2007/m07-16.pdf.
---------------------------------------------------------------------------

    DEA Response. DEA agrees with some of the comments and has revised 
the interim final rule to allow authentication protocols that meet NIST 
Level 3; if the protocols involve a hard token, they must be either 
one-time-password devices or cryptographic modules that are not stored 
on the computer the practitioner is using to access the application. 
Contrary to the commenter's claim, NIST SP 800-63-1 requires both OTP 
devices and cryptographic tokens to be validated at FIPS 140-2 Security 
Level 1 or higher.\33\
---------------------------------------------------------------------------

    \33\ National Institute of Standards and Technology. Special 
Publication 800-63-1, Draft Electronic Authentication Guideline, 
December 8, 2008, pages 40-41.
---------------------------------------------------------------------------

    The primary purpose of the higher level of physical security for 
Level 4 is to prevent tampering with the device. Given the technical 
expertise needed to tamper with a device without making it 
nonfunctional, DEA does not consider that such tampering is enough of a 
risk in healthcare settings to justify imposing the higher costs 
associated with such devices. DEA believes that the other steps it is 
implementing regarding identity proofing and logical access control are 
sufficient to mitigate the risk to allow for Level 3 rather than Level 
4 tokens. By requiring that two factors are used to access the 
controlled substance functions in the application, DEA is limiting the 
threat from stolen or tampered-with tokens.
    Comments. Another application provider objected to DEA's assessment 
and argued that Level 2 protections (single-factor) were adequate. The 
application provider stated that Level 2, with the use of a strong 
password in addition to a known Internet Protocol address or out-of-
band token, would be sufficient. The application provider also 
suggested that DEA should adopt a tiered approach, with lesser 
requirements for Schedule III, IV, and V substances (just a strong 
password). For Schedule II, it suggested a combination of a strong 
password and other ``something you know'' (e.g., out-of-band message, 
challenge response questions) plus a printout of every prescription, 
with the printout manually signed to create an audit trail. As an 
alternative the application provider suggested that if DEA requires 
two-factor authentication, DEA should allow a variety of second factors 
including whitelisted IP address, biometrics, soft tokens, and hard 
tokens, such as proximity badges, barcode readers, thumb drives, etc.
    DEA Response. DEA disagrees with this commenter. DEA does not 
believe that one-factor authentication is adequate. As discussed at 
length above, passwords are not secure, particularly in healthcare 
settings where people work in close proximity to each other and many 
people may use the same computers. Even without the possibility of 
shoulder-surfing in such settings, strong passwords, because of their 
complexity and the need to change them frequently, are more likely to 
be written down. DEA also notes that maintenance of password systems 
imposes considerable costs.
    DEA also disagrees with the commenter's suggestion for different 
requirements for Schedule II prescriptions. As DEA has discussed, 
electronic prescriptions are written prescriptions. Requirements for 
written prescriptions are uniform, regardless of the schedule of the 
controlled substance. Further, to establish differing requirements for 
Schedule II controlled substance prescriptions as compared with 
Schedule III, IV, and V prescriptions would add unnecessary complexity 
to the electronic prescription application. The commenter's suggestion 
appears to be based on the assumption that Schedule II substances, and 
their related prescriptions, are more likely to be diverted; however, 
DEA notes that both Schedule III and Schedule IV substances, and their 
related prescriptions, are regularly diverted for nonlegitimate use. 
DEA believes that a single approach more accurately reflects the 
statutory and regulatory requirements for written prescriptions, is 
more appropriate, and will be easier for application providers and 
practitioners to implement.
    DEA has adopted some of the second factors that the commenter 
suggested, specifically the biometric and any hard token that meets 
NIST Level 3, which could include proximity cards and thumb drives that 
contain a cryptographic module. DEA does not believe that associating a 
prescription with a particular IP address will provide a pharmacy any 
assurance of the identity of the person who signed the prescription; 
any prescription generated on a practice's computers may have the same 
IP address. This suggestion also assumes that every pharmacy to which a 
practitioner may transmit would have the ability to determine whether 
the source IP address was whitelisted.
    Comments. An intermediary asserted that DEA should implement 
electronic prescriptions for controlled substances with Level 2 and 
increase the requirements only if needed. The commenter asserted that 
the existing system includes authentication of the clinician and the 
connections, access controls, audit trails, and pharmacist as a 
gatekeeper. It stated that electronic prescribing could not increase 
the speed of diversion because the pharmacist acts as a gatekeeper. The 
commenter claimed that electronic prescribing would have a low impact 
on harm to the agency and public interest. The commenter asserted that 
the ability to breach the electronic

[[Page 16275]]

prescribing infrastructure would take far greater expertise than 
today's paper system. The commenter further claimed that electronic 
prescribing would reduce the risk of injury and death by reducing 
undetectable diversion and abuse. The commenter asserted that personal 
safety should be considered low risk. Stronger authentication of the 
clinician minimally reduces the risk of alteration of the prescription; 
existing processes and controls audited by third parties reduce the 
overall risk more significantly. The commenter believed that existing 
electronic prescribing infrastructure and systems will dramatically 
reduce the chance of diversion and abuse seen in the existing paper 
process; thus, the commenter asserted, the risk of civil or criminal 
violations is actually reduced with electronic prescribing and should 
be considered low. The commenter stated that data mining would 
effectively address diversion concerns.
    DEA Response. DEA strongly disagrees with this commenter's claims. 
The existing system, where some applications allow individuals to 
enroll online with no identity proofing, provides no assurance that the 
person issuing a prescription is a practitioner. It takes no technical 
expertise to steal an identity, particularly for office staff who have 
access to DEA registration certificates and State authorizations. 
Applications that do not have logical access controls or do not 
implement them may allow any person with access to a practitioner's 
computers to write and issue prescriptions. Passwords, as discussed 
previously, are the most common form of authentication credential and 
provide no proof that the person entering the password is the person 
associated with the password. The security of the prescription as it 
moves through intermediaries is of limited value if there is no 
evidence of who issued the prescription. Strong authentication is 
needed, not simply to prevent alteration, but to prevent nonregistrants 
from issuing controlled substance prescriptions. The risk of diversion 
without strong authentication is high. The practitioners could be 
subject to civil and criminal prosecution if their applications are 
misused and prescriptions are written in their names, or if their 
identity is stolen.
    As to the claim that pharmacists will prevent wide-spread 
diversion, it is difficult to see how this could be the case. If 
someone issues multiple prescriptions to a patient and transmits them 
to multiple pharmacies, the pharmacists will have no ability to 
identify the problem, just as a single pharmacist will not be able to 
identify fraudulent prescriptions issued to multiple patients. Unlike 
paper prescriptions, electronic prescriptions lack many of the 
indications of a forged prescription that pharmacists use to identify a 
forged paper prescription. Electronic prescribing applications make it 
difficult for the person diverting to misspell a drug name or to select 
dosage forms that do not exist; they provide no indication of 
alterations.
    The commenter assumes that such problems will be discovered through 
data mining and that data mining will reduce diversion. DEA, however, 
has no authority to collect data on all prescriptions issued and, 
therefore, no ability to conduct data mining. Even if DEA had the 
authority to collect prescription data, data mining would only work if 
all prescription data were available (electronic prescriptions, paper, 
fax, and oral) and in a common electronic format. If the per-
prescription transaction fee charged by the commenter for transmission 
is any indication of the cost of that one step in data mining, the cost 
of data mining for controlled substance prescriptions to DEA could be 
high.
    Data mining, were it legally possible and economically feasible, is 
based on being able to identify patterns of unusual activities. Data 
mining might detect individuals diverting controlled substances for 
themselves or registrants issuing large numbers of prescriptions 
potentially other than for legitimate medical purposes. It would not 
identify the organized diverters who would easily determine what 
patterns would trigger investigation and avoid those patterns. One 
problem with poorly controlled or uncontrolled electronic prescription 
issuance is that it would be easy for criminals to steal practitioner 
identities, issue a limited number of prescriptions under each identity 
to a limited number of patients, and move on to the next set of stolen 
identities. Nothing in the pattern would trigger investigation, 
regardless of whether data mining was being conducted.
    Finally, data mining, even in real time if that were to be 
possible, would not prevent many of the injuries and deaths diversion 
causes because the drugs would have been obtained and used or sold 
before law enforcement could act. To claim that the risk to personal 
safety is low is to ignore the reality of the consequences of drug 
diversion. DEA considers it critical that electronic prescribing 
applications for controlled substance prescriptions be designed to 
limit the possibility of diversion to as great an extent as possible 
rather than assume that the problems will not occur. Fixing the problem 
after electronic prescribing applications are widely deployed, as the 
commenter suggested, could be done, would be far more difficult and 
more disruptive than implementing reasonable controls in the early 
stages of the applications' use.
    Because of DEA's statutory responsibilities and the magnitude of 
the harm to the public health and safety that would result if an 
insufficiently secure system were to cause an increase in diversion of 
controlled substances, any regulations authorizing the use of 
electronic prescriptions for controlled substances must contain 
adequate security measures from the outset. DEA cannot, consistent with 
its obligations, set the bar lower than it believes necessary with an 
eye toward increasing the security requirements at some later date 
should the vulnerabilities be exploited. Regulatory changes take 
significant time--time during which there could be continuing harm to 
the public health and safety.
    Comment. One application provider stated that the use of the 
government guidelines for risk assessment was inappropriate because 
those guidelines were developed to analyze people remotely accessing 
open networks.
    DEA Response. DEA recognizes that the guidelines were developed for 
government systems, but believes that the basic principles can be 
applied to the security of both Federal and private applications. 
Although practitioners may write most of their prescriptions while at 
their offices, they will probably want the ability to access their 
office applications when they are away from the office so they can 
issue prescriptions remotely when needed; such access will frequently 
be through the Internet and may use wireless connections. In addition, 
practitioners using application service providers access the electronic 
prescription application over the Internet, which they may do from any 
computer or location. Security concerns must address both of these 
situations.

K. Other Issues

1. Definitions
    In the NPRM, DEA proposed to move all of the existing definitions 
in part 1311 to a new section in part 1300 (Sec.  1300.03) and to add 
new definitions to that section. The proposed definitions included 
``audit,'' ``audit trail,'' ``authentication,'' ``authentication 
protocol,'' ``electronic prescription,'' ``hard token,'' ``identity 
proofing,'' ``intermediary,'' ``NIST SP 800-63,'' ``paper 
prescription,'' ``PDA,'' ``SAS 70 audit,'' ``service provider,'' 
``SysTrust,'' ``token,'' ``valid prescription,'' and ``WebTrust.''

[[Page 16276]]

    Definition of ``Service provider.'' In the NPRM, DEA proposed to 
define a service provider as follows:

    Service provider means a trusted entity that does one or more of 
the following:
    (1) Issues or registers practitioner tokens and issues 
electronic credentials to practitioners.
    (2) Provides the technology system (software or service) used to 
create and send electronic prescriptions.
    (3) Provides the technology system (software or service) used to 
receive and process electronic prescriptions at a pharmacy.

    Comments. Practitioner and pharmacy organizations requested that 
DEA define service providers and intermediaries. A practitioner 
organization stated that DEA had used ``service provider'' for any 
third party (vendor or intermediary). It believed that these should 
have separate names. A standards organization asked who the service 
provider is in the case where the software is loaded to the 
practitioners' computers. A pharmacy organization also asked for 
clarification of the term ``service provider'' and whether their 
functions can be delegated.
    An intermediary recommended modifying the definition of service 
provider to recognize that some prescribers and the entities for which 
they work have created their own electronic prescribing applications. 
The intermediary noted that some prescribers, as well as some 
pharmacies, have their own proprietary applications and do not connect 
to intermediaries through third-party service providers, but rather 
connect directly. Accordingly, some entities in fact act as both a 
prescriber or pharmacy, on the one hand, and an application provider, 
on the other hand. The intermediary also noted that the addition of the 
word ``trusted'' to the definition of service provider adds a 
subjective element that is not defined anywhere in the NPRM. While the 
word ``trusted'' is a term of art used in the industry, since it is not 
defined in the NPRM, the intermediary stated that DEA should delete the 
word ``trusted'' from the definition of service provider to avoid any 
ambiguity in the future. The intermediary argued that if an entity 
complies with the requirements as imposed by the rule, then that entity 
is and should be considered a trusted entity, and there is no need to 
introduce an undefined and subjective word such as ``trusted'' into the 
definition.
    DEA Response. DEA agrees that further delineation among the various 
entities involved in electronic prescribing of controlled substances is 
needed. In addition, DEA has changed the terms to use the more accurate 
word ``application,'' rather than service or system. In computer 
terminology, an application is software that performs specific tasks 
(e.g., word processing, EHRs); a system is the underlying operating 
program. DEA has, therefore, revised the rule to add the following 
definitions.
    Electronic prescription application provider means an entity that 
develops or markets electronic prescription software either as a stand-
alone application or as a module in an electronic health record 
application.
    Pharmacy application provider means an entity that develops or 
markets software that manages the receipt and processing of electronic 
prescriptions.
    Application service provider means an entity that sells electronic 
prescription or pharmacy applications as a hosted service, where the 
entity controls access to the application and maintains the software 
and records on its servers.
    Installed electronic prescription application means software that 
is used to create electronic prescriptions and that is installed on a 
practitioner's computers and servers, where access and records are 
controlled by the practitioner.
    Installed pharmacy application means software that is used to 
process prescription information and that is installed on the 
pharmacy's computers or servers and is controlled by the pharmacy.
    The definition of ``intermediary'' is unchanged from the NPRM: 
``Intermediary means any technology system that receives and transmits 
an electronic prescription between the practitioner and pharmacy.''
    DEA believes that these revisions will clarify the rule and allow 
DEA to make the distinction between application service providers, who 
host and manage the electronic prescription applications on an ongoing 
basis, and those providers that develop, market, or install software, 
but do not manage the application once it is installed. In the case of 
a closed system, a single entity may manage both the electronic 
prescription application and the pharmacy application and, therefore, 
would be considered to be the provider of both. Based on the inclusion 
of these new definitions, DEA has removed the term ``service provider'' 
from the interim final rule.
    Definition of ``electronic signature.'' In the NPRM, DEA proposed 
to define the term electronic signature as follows: ``Electronic 
signature means a method of signing an electronic message that 
identifies a particular person as the source of the message and 
indicates the person's approval of the information contained in the 
message.'' As DEA explained in the NPRM, this definition of electronic 
signature is taken directly from 21 CFR 1311.02, and was merely being 
merged into the definitions section for electronic ordering and 
prescribing activities.
    Comments. Several commenters stated that DEA should adopt the E-
Sign definition of electronic signature: ``Electronic Signature means 
an electronic sound, symbol, or process attached to or logically 
associated with a record and executed or adopted by a person with the 
intent to sign the record.''
    DEA Response. DEA disagrees. The definition of ``electronic 
signature'' in the proposed rule is the existing definition in Sec.  
1311.02 that was adopted in 2005 when DEA promulgated its ``Electronic 
Orders for Controlled Substances'' Final Rule (70 FR 16901, April 1, 
2005). DEA is simply moving the definitions codified in that final rule 
to a new section. DEA believes that the E-Sign definition is too 
general to provide the necessary clarity in the context of this interim 
final rule.
    Comments. A healthcare group asked DEA to further define ``manually 
signed.'' It asked whether the act of a practitioner signing with an 
electronic signature would suffice or is a handwritten signature on the 
computer-generated prescription that is printed or faxed required.
    DEA Response. DEA does not believe that ``manually signed'' 
requires further definition. The phrase ``manually signed'' has been a 
part of the DEA regulations since the inception of the CSA (and is 
currently found in Sec.  1306.05(a)) without the need for elaboration. 
It has a plain language meaning that is clear: The practitioner must 
use a pen, indelible pencil, or other writing instrument to sign by 
hand the paper prescription.
    Comments. An application provider organization stated that the word 
``signing'' is imprecise; instead it should say ``approve'' and/or 
``transmit.''
    DEA Response. DEA has revised the proposed rule, as discussed, to 
require that two-factor authentication act as signing and that the 
application must label the function as signing as well as presenting a 
statement on the screen that informs the practitioner that executing 
the two-factor authentication protocol is signing the prescription. 
Signing is the practitioner's final authorization for the transmission 
and dispensing of a controlled substance prescription, issued for a 
legitimate medical purpose in the usual course of

[[Page 16277]]

professional practice, and indicating the practitioner's intent to be 
legally responsible for such authorization.
    Comments. A State Board of Pharmacy provided definitions it uses 
for electronic prescriptions to define ``point of care vendors,'' 
``network vendors,'' ``prescribers,'' and ``contracted.''
    DEA Response. DEA considered these definitions in developing its 
definitions for the interim final rule. The definitions offered by the 
Board of Pharmacy commenter include requirements, which are not 
generally part of Federal definitions. The commenter's definitions 
appear to rely on contracts among the various vendors for security, but 
it is not clear how these contracts would be enforced or how a 
practitioner or pharmacy would be able to determine that they were in 
place. DEA also notes that the network vendor definition fails to 
consider that many intermediaries connect only to other intermediaries, 
not to practitioners and pharmacies. A definition of prescriber is not 
needed as DEA's rules limit who can prescribe controlled substances. 
Thus, while DEA appreciates the Board of Pharmacy's suggestions, it did 
not adopt any of the definitions specifically included in the comment.
    Definition of ``closed system.'' DEA did not propose to define the 
term ``closed system.'' This phrase would refer to situations in which 
both the electronic prescription application and the pharmacy 
application were controlled by the same entity and where practitioners 
and pharmacies outside of the closed system could not access or be 
accessed by users of the closed system.
    Comments. An insurance industry organization suggested that DEA add 
a definition of ``closed system'' to address healthcare systems that 
employ both the practitioner and pharmacists and handle the 
prescriptions within a single system.
    DEA Response. DEA does not believe that a definition of closed 
system is needed at this time because DEA is not imposing any 
additional or different requirements on closed systems. Closed systems 
are subject to the same rules as open systems. As discussed above, DEA 
is allowing non-Federal systems to use the rules proposed for Federal 
systems. Some closed systems may find it advantageous to adopt this 
approach, but they are not required to do so.
    Definition of ``hard token.'' In the NPRM, DEA proposed to define 
the term hard token as follows: ``Hard token means a cryptographic key 
stored on a special hardware device (e.g., a PDA, cell phone, smart 
card) rather than on a general purpose computer.''
    Comments. An information technology organization recommended that 
DEA add a USB fob to the list of hardware devices described in the 
definition of hard token. It also recommended the use of the term Key 
Storage Mechanism instead of hard token as this is the more standard 
industry term in current use.
    DEA Response. DEA has added USB fob to the list of devices 
described in the definition of ``hard token.'' DEA notes that this list 
merely provides examples and is not all-encompassing. If another 
hardware device meets DEA's requirements for security it can be used to 
meet the requirements of this interim final rule.
    Definitions related to digital signatures. DEA did not propose any 
definitions in the NPRM related to digital signatures other than those 
it was transferring from 21 CFR 1311.02.
    Comments. An information technology organization recommended adding 
definitions for registration agent and trusted agent. A security firm 
suggested the inclusion of several other definitions related to digital 
signatures.
    DEA Response. DEA does not believe that definitions of registration 
agent and other certification authority terms are needed. DEA has, 
however, added a definition of ``trusted agent,'' because institutional 
practitioners may fill this role if they elect to obtain authentication 
credentials from a certification authority or credential service 
provider for practitioners using their electronic prescription 
application to write controlled substances prescriptions. The 
definition is based on NIST's definition and describes the trusted 
agent as an entity authorized to act as a representative of a 
certification authority or credential Service provider in confirming 
practitioner identification as part of the identity proofing 
process.\34\
---------------------------------------------------------------------------

    \34\ National Institute of Standards and Technology. IR-7298 
Glossary of Key Information Security Terms, April 25, 2006.
---------------------------------------------------------------------------

    Definition of NIST SP 800-63. In the NPRM, DEA proposed to define 
the term NIST SP 800-63 as follows: ``NIST SP 800-63, as incorporated 
by reference in Sec.  1311.08 of this chapter, means a Federal standard 
for electronic authentication.'' While this term appeared in the 
definitions, DEA also notes that the Special Publication itself was 
also proposed to be incorporated by reference in proposed Sec.  
1311.08.
    Comments. A healthcare organization stated that the definition of 
NIST SP 800-63 should be modified to cover future revisions.
    DEA Response. DEA has revised the incorporation of NIST SP 800-63 
to cover the current version. Federal agencies are not permitted to 
incorporate by reference future versions of documents.
    Definitions of SysTrust and WebTrust. In the NPRM, DEA separately 
defined the terms SysTrust and WebTrust.
    Comments. A healthcare organization believed that SysTrust and 
WebTrust have converged under the reference of Trust Services for 
business to business commerce. The commenter believed that a new 
definition for Trust Services should be introduced and language within 
the rule modified accordingly for such references.
    DEA Response. Although SysTrust and WebTrust are considered part of 
Trust Services, they are still separate services and identified as such 
by the American Institute of Certified Public Accountants. Therefore, 
DEA has not revised these terms in this interim final rule.
    Other Definition Issues:
    Comment. One commenter stated that DEA should adopt the NIST SP 
800-63 definition of ``possession and control of a token'' and 
recommended that DEA define ``sole possession.''
    DEA Response. DEA does not believe that these definitions are 
necessary. Both phrases consist of plainly understood terms that have 
well-established legal meanings.
2. Other Issues
    Comments. A number of commenters asked DEA to provide a list of 
application providers that met DEA's requirements. A practitioner 
organization, a pharmacy organization, and a physician suggested that 
DEA make available to prescribers and application providers a database 
of pharmacies that accept electronic prescriptions. The physician 
suggested that DEA require all pharmacies to register their ability to 
accept electronic prescriptions for controlled substances with DEA and 
for DEA to provide an online automatic directory that enables all 
electronic health record application providers and electronic 
prescription application providers to query for all pharmacies and 
determine immediately if an electronic prescription for a controlled 
substance can be sent to a particular pharmacy. The commenter suggested 
that, if it was determined that a particular pharmacy did not accept 
electronic prescriptions, the electronic health record application or 
electronic prescription application could then automatically switch to 
print and notify the prescribing physician of the change and 
requirement for wet signature and

[[Page 16278]]

providing the prescription to the patient. This commenter asserted that 
physicians have had considerable difficulty with the current 
noncontrolled substance electronic prescribing systems because they 
could not rely on pharmacy participation or have a reliable means of 
locating pharmacies. A practitioner organization suggested that DEA 
could require pharmacies to indicate whether they accept electronic 
prescriptions as part of DEA's registration process.
    DEA Response. DEA does not believe that it is in a position to 
develop and maintain complete and accurate lists of either application 
providers that provide applications meeting DEA's requirements for 
electronic prescriptions for controlled substances, or of pharmacies 
that accept electronic prescriptions. Whether an application provider 
chooses to develop applications that comply with DEA's regulatory 
requirements and, thus, be in a position to supply applications that 
may lawfully be used by practitioners to create, sign, and transmit 
electronic prescriptions for controlled substances and by pharmacies to 
receive and process electronic prescriptions for controlled substances, 
is a business decision on the part of that provider. As all providers 
will be required to undergo third-party audits of their applications, 
DEA believes that these audit reports, which will be available to 
interested practitioners, will provide notice of application providers' 
compliance with DEA regulations. If certification organizations develop 
programs to certify compliance with DEA's requirements and DEA approves 
the programs, the certification will also provide practitioners with 
the information.
    Similarly, DEA does not believe it appropriate for DEA itself to 
maintain a list of pharmacies that accept electronic prescriptions for 
controlled substances. Again, whether a pharmacy chooses to accept such 
prescriptions is a business decision left to that pharmacy. DEA is not 
in a position to proactively and continually monitor pharmacies' 
involvement in this arena, nor is DEA in a position to continually 
receive updates from its approximately 65,000 pharmacy registrants 
regarding their involvement. The electronic prescribing of controlled 
substances by prescribing practitioners, and the dispensing of those 
electronic prescriptions by DEA-registered pharmacies, is strictly 
voluntary. DEA notes that electronic prescription application providers 
maintain databases of pharmacies that accept electronic prescriptions 
for routing or other purposes. DEA believes that application providers 
and/or intermediaries are better suited to the task of maintaining 
these listings. This is particularly necessary as, due to potential 
interoperability issues, a pharmacy that can process prescriptions from 
one application provider may not be able to process prescriptions from 
other application providers.
    Comments. A number of commenters urged DEA to adopt a particular 
version of the National Council for Prescription Drug Programs SCRIPT 
standard and cite particular SCRIPT functions. Several State pharmacist 
associations asserted that DEA should require the full support of all 
transaction types of the approved Centers for Medicare and Medicaid 
Services standards including fill status notification (RXFILL), cancel 
prescription notification (CANRX) transactions, and prescription change 
transactions (RXCHG), throughout the prescribing process for controlled 
substances. The commenters asserted that using these transactions 
supports medication adherence monitoring and decreases opportunities 
for diversion. These transactions are already present in the NCPDP 
SCRIPT standard. A pharmacy Application provider stated that DEA should 
clarify which SCRIPT transactions must be covered and recommended 
NEWRX, REFRES, and CHGRES. Pharmacy organizations noted that the SCRIPT 
standard does not provide explicit standards for some data elements in 
prescriptions (drug names, dosing, route, and frequency); without 
standards for these elements, interoperability between pharmacies and 
practitioners cannot be assured. A pharmacy organization urged DEA to 
encourage the development of discrete standards for these elements. 
Practitioner organizations also noted that the SCRIPT standard for sig 
(directions for use) has not been approved or accepted.
    A pharmacy organization stated that it is receiving many reports of 
errors occurring in electronic prescriptions. The commenter indicated 
that the prescriptions are quite legible, but, occasionally, quite 
wrong. Pharmacists are reporting that many prescriptions are being 
received by the pharmacy with the drug names and directions for use 
truncated. In other cases, the directions are incorrect in the space 
allocated for directions, while the intended instructions are placed in 
the ``comments'' section. In other situations, the wrong drug, wrong 
strength, or totally incorrect directions are transmitted. 
Occasionally, the quantity of drug is incorrect. There have been a few 
instances where a computer application, according to anecdotal reports, 
actually ``shuffled'' prescriptions in the application, such that the 
drug intended for one patient appeared on screen for another patient. 
The organization asserted that errors have been caused by practitioner 
software and pharmacy software, as well as practitioner keying errors.
    DEA Response. DEA shares the concern about prescription errors 
created by the SCRIPT standard, which is not yet fully functional. DEA, 
however, does not believe that mandating one version of the standard or 
particular functions would be useful. The standard continues to evolve; 
if DEA incorporated by reference one version, it would need to go 
through rulemaking to update the reference, which could delay 
implementation of improvements. DEA believes that the best approach is 
to set minimum requirements to ensure the integrity, authentication, 
and non-repudiation for controlled substance prescriptions (and in a 
manner consistent with maintaining effective controls against 
diversion) and leave the industry to develop all other aspects of 
electronic prescriptions. This will provide the maximum flexibility 
while ensuring that DEA's statutory obligations are addressed.
    Comments. A few commenters suggested that DEA apply different 
standards for Schedule II prescriptions. One application provider 
suggested that Schedule II prescriptions should remain permissible only 
as paper prescriptions and that a single-factor authentication protocol 
be allowed for Schedule III, IV and V prescriptions.
    DEA Response. It is true that prescriptions for Schedule II 
controlled substances are subject to greater statutory and regulatory 
controls than prescriptions for controlled substances in Schedules III, 
IV, and V. These differences in controls are commensurate with the 
differences among these drugs in relative potential for abuse and 
likelihood of causing dependence when abused. Along similar lines, it 
is accurate to state that, among the pharmaceutical controlled 
substances, drugs in Schedule II are subject to the most stringent 
controls because abuse of these drugs tends to be more harmful to the 
public health and welfare than abuse of pharmaceutical drugs in lower 
schedules. Nonetheless, DEA does not believe it is necessary or 
appropriate to disallow altogether the electronic prescribing of 
Schedule II controlled substances. Given the carefully crafted 
requirements contained in this interim final rule, DEA believes that 
electronic prescribing of all pharmaceutical controlled substances in

[[Page 16279]]

all schedules can take place without adversely affecting diversion 
control.
    It should also be noted that the required elements of a 
prescription for a controlled substance (those set forth in 21 CFR 
1306.05(a)) are the same for all prescriptions for controlled 
substances, and this same approach is followed in the interim final 
rule with respect to electronic prescriptions. Further, DEA believes 
that disallowing the electronic prescribing of Schedule II controlled 
substances could significantly hinder adoption of electronic 
prescribing of controlled substances in other schedules, as it would 
potentially create separate application requirements for separate 
schedules, causing confusion among practitioners, pharmacies, and 
application providers as to which requirements should be followed for 
which substances.
    Comments. An application provider believed that proposed Sec.  
1311.100 is redundant in view of current Sec.  1306.03 and should be 
deleted.
    DEA Response. Current Sec.  1306.03 (``Persons entitled to issue 
prescriptions.'') provides general requirements for the issuance of all 
prescriptions, written and oral. While the requirements of proposed 
Sec.  1311.100 (``Eligibility to issue electronic prescriptions.'') 
restated principles from Sec.  1306.03, DEA believes it appropriate to 
restate those important concepts specifically in regard to electronic 
prescriptions. Therefore, DEA is retaining the concepts proposed in 
Sec.  1311.100.
    Comments. A healthcare system asked DEA to clarify the specific 
consequences of non-compliance with each requirement.
    DEA Response. The potential consequences of failing to comply with 
the requirements in this interim final rule regarding the electronic 
prescribing of controlled substances are the same as the potential 
consequences of failing to comply with longstanding requirements 
regarding the general prescribing and dispensing of controlled 
substances. Just as one cannot list all the potential scenarios in 
which the existing prescription requirements might be violated, one 
cannot list all the possible ways in which the various requirements of 
this interim final rule might be violated. However, as a general 
matter, if a person fails to comply with the requirements of this 
interim final rule in a manner that constitutes a criminal or civil 
violation of the CSA, that person is subject to potential criminal 
prosecution or civil action as contemplated by the Act. In addition, a 
DEA registrant who fails to comply with the requirements of the 
regulations is subject to potential administrative action that may 
result in suspension or revocation of his DEA registration.
    Comments. A pharmacy organization and an intermediary stated that 
DEA should revise proposed Sec.  1306.11(a) (``Requirement of 
prescription [for controlled substances listed in Schedule II].'') to 
read ``pursuant to a written or electronic prescription.''
    DEA Response. DEA has defined paper prescription in Sec.  1300.03. 
A written prescription includes both paper and electronic prescriptions 
issued in conformity with the DEA regulations. Thus, the suggested 
revision is not necessary.
    Comments. A number of pharmacist organizations submitted the same 
comment, listing the following as objectives DEA should pursue in 
developing the final rule:
     Promoting scalability and nationwide adoption of 
electronic prescribing by enabling all prescribers, regardless of the 
volume of controlled substances prescribed, to create and transmit 
prescriptions for controlled substances via the same electronic media 
as prescriptions for noncontrolled substances;
     Reducing and eliminating additional costs and 
administrative burden on pharmacists and prescribers;
     Ensuring compliance and consistency with the uniform 
standards relating to the requirements for electronic prescription drug 
programs;
     Improving patient safety and quality of care; and
     Allowing for the expeditious adoption of technological 
advances and innovation.
    DEA Response. DEA has attempted to reduce the burden to 
practitioners, pharmacies, and others with changes in the interim final 
rule based on the comments received, providing flexibility to adopt 
other technologies as they become feasible, and facilitating adoption 
of electronic prescriptions for controlled substances. Although 
admirable goals, uniform standards and improved quality of care are not 
within DEA's statutory authority, other government agencies are 
responsible for these issues. DEA recognizes the benefits to pharmacies 
of uniform standards, but a variety of methods of signing and 
transmitting electronic prescriptions may satisfy the requirements of 
the interim final rule and should be allowed for those that wish to use 
them.
    Comments. A number of practitioner organizations urged DEA to 
ensure that the requirements for electronic prescriptions for 
controlled substances were cost-effective, particularly for small 
practices.
    DEA Response. DEA believes that the interim final rule will impose 
even lower costs on registrants than the proposed rule. DEA also notes 
that the incremental cost of its requirements is relatively small 
compared to the costs of adopting and installing new applications. A 
full discussion of the costs and benefits associated with this rule is 
provided in the required analyses section of this document.
    Comments. One advocacy organization asserted that DEA is placing 
much of the responsibility for application security on practitioners 
and pharmacies, and asked if DEA has sufficient statutory authority to 
do so. The commenter asked whether such authority to require this new 
responsibility lies within the Controlled Substances Act authority to 
register practitioners.
    DEA Response. As set forth at the outset of this preamble, DEA has 
broad statutory authority under the Controlled Substances Act to issue 
rules and regulations relating to, among other things, the control of 
the dispensing of controlled substances, and to issue and enforce rules 
and regulations that the agency deems necessary to effectuate the 
CSA.\35\ Also, the structure of the CSA is unlike most statutory 
schemes in that it prohibits all transactions involving controlled 
substances except those specifically allowed by the Act and its 
implementing regulations.\36\ The interim final rule is consistent with 
these aspects of the CSA. It is also worth reiterating here that DEA is 
not requiring any practitioner to issue electronic prescriptions for 
controlled substances or any pharmacy to accept them; it is simply 
setting the requirements that must be met before a practitioner may 
lawfully issue, and a pharmacy may lawfully process, electronic 
prescriptions for controlled substances.
---------------------------------------------------------------------------

    \35\ 21 U.S.C. 821 & 871(b).
    \36\ 21 U.S.C. 841(a)(1). See United States v. Moore, 423 U.S. 
122, 131 (1975) (``only the lawful acts of registrants are 
exempted'' from the prohibition on distribution and dispensing of 
controlled substances set forth in 21 U.S.C. 841(a)(1)).
---------------------------------------------------------------------------

    As has been discussed previously, nothing in this rule prevents a 
practitioner or a practitioner's agent from using an existing 
electronic prescription application that does not comply with the 
interim final rule to prepare a controlled substance prescription, so 
that EHR and other electronic prescribing functionality may be used, 
and print the prescription for manual signature by the practitioner. 
Such prescriptions are paper

[[Page 16280]]

prescriptions and subject to the existing requirements for paper 
prescriptions.
    Comments. Some commenters urged DEA to help tighten the security 
standards imposed under the Health Insurance Portability and 
Accountability Act. Others cited HIPAA as sufficient to protect the 
security of electronic prescriptions.
    DEA Response. The Department of Health and Human Services is 
responsible for the HIPAA standards; questions or comments about these 
standards should be addressed to HHS. The HIPAA security standards are 
general, leaving many details on implementation to individual 
healthcare providers; many of the specifications to implement the 
security standards are addressable and not mandatory. HIPAA generally 
focuses on protecting the privacy of the individual patient's 
information rather than on the possibility of alteration of records or 
the creation of fraudulent records. As HIPAA was not designed to 
prevent the diversion of controlled substances, compliance with HIPAA 
standards alone will not result in the implementation of the types of 
measures contained in this interim final rule that are specifically 
tailored to safeguard against diversion.
    Comments. A practitioner organization noted that the rule did not 
specify requirements for what the commenter termed ``pharmacy-generated 
electronic refill requests.'' The commenter stated that existing 
electronic prescription applications allow physicians to quickly review 
and approve electronic refill requests from pharmacies. The commenter 
asserted that the efficiency of electronic refills is one of the major 
incentives for physicians to electronically prescribe. The commenter 
suggested that the final rule should explicitly state whether 
electronic refill requests will require physicians to take additional 
steps when authorizing refills of controlled substance prescriptions.
    DEA Response. The interim final rule allows for a practitioner to 
authorize the refilling of an electronic prescription for a controlled 
substance in the same circumstances that the regulations currently 
allow a practitioner to authorize the refilling of a paper or oral 
prescription for a controlled substance. In this context, the following 
aspects of existing law and regulations should be noted. Part 1306 
allows practitioners to authorize refills for controlled substances in 
Schedules III, IV, and V when the original prescription is written. 
Schedule II prescriptions may not be refilled, as set forth in the CSA, 
and DEA has no authority to depart from that statutory prohibition in 
the context of paper or electronic prescriptions. If a patient is 
seeking additional medication not authorized by the original 
prescription, the practitioner must issue a new prescription regardless 
of the Schedule. If a pharmacy electronically requests that a 
practitioner authorize the dispensing of medication not originally 
authorized on a prescription, or authorize a new prescription based on 
a previously dispensed prescription, DEA would view any prescriptions 
issued pursuant to those requests as new prescriptions. If they are 
written, regardless of whether they are electronic or on paper, they 
must be signed by the practitioner. Thus, a manual signature would be 
required for a paper prescription pursuant to Sec.  1306.05, or a 
practitioner could follow the signature requirements for electronic 
prescriptions discussed in this rulemaking. Alternatively, for a 
Schedule III, IV, or V prescription, the pharmacy may receive an oral 
prescription for that controlled substance, but the pharmacy must 
immediately reduce that oral, unsigned, prescription to writing 
pursuant to current regulatory requirements.
    Comments. A number of commenters asked that DEA postpone the 
effective date of the final rule, i.e., grant what some commenters 
characterized as an ``extended compliance date.'' Among these 
commenters, the range of suggested effective dates was from 18 months 
to four years after issuance of the final rule.
    DEA Response. DEA believes it is unnecessary to postpone the 
effective date of the interim final rule because use of electronic 
prescriptions for controlled substances is voluntary. The interim final 
rule does not mandate that practitioners switch to electronic 
prescribing of controlled substances. As soon as electronic 
prescription applications can come into compliance with the 
requirements of these regulations they may be used for controlled 
substance prescriptions. Conversely, practitioners may not use existing 
electronic prescription applications to transmit electronic 
prescriptions for controlled substances until those applications are in 
compliance with the interim final rule. Pharmacy applications may also 
be used to process electronic prescriptions for controlled substances 
once they are in compliance with the interim final rule, but not 
before. DEA notes that existing electronic prescription applications 
may be used to create a prescription for controlled substances, but 
until the application is compliant with the rule, that prescription 
would have to be printed and signed manually, then given to the patient 
or, for Schedule III, IV, and V prescriptions, faxed to the pharmacy.
    Similarly, DEA does not believe it prudent to delay the effective 
date of this rule for any length of time. DEA wishes to encourage 
adoption of electronic prescriptions for controlled substances as 
rapidly as industry is willing and able to comply with the requirements 
of this rule. DEA recognizes that some health care entities, 
particularly Federal healthcare facilities, may be more prepared to 
begin electronically prescribing controlled substances in compliance 
with this rule than others. To delay the effective date of this rule 
may unnecessarily hinder those organizations from electronically 
prescribing controlled substances as quickly as they are able.
    Comments. A State pharmacy organization asserted that if it is 
required to use an intermediary in the transmission of a controlled 
substance prescription from a practitioner to a pharmacy, the only way 
to verify a prescription would be to call the practitioner.
    DEA Response. DEA does not require the use of any intermediaries in 
the transmission of electronic prescriptions between prescribing 
practitioners and pharmacies. There is nothing in the rule that bars 
the direct transmission of an electronic prescription from a 
practitioner to a pharmacy. Until the SCRIPT standard is mature, 
however, a practitioner whose patients use multiple pharmacies may have 
to use intermediaries to ensure that the pharmacy will read the data 
file correctly. DEA believes that the requirements of the interim final 
rule will provide adequate protections.
    Comments. A number of commenters believed that DEA would, could, or 
should conduct data mining of electronic controlled substance 
prescriptions. One commenter saw this as a potential threat to civil 
liberties. Others saw it as a benefit. A pharmacy organization and a 
chain pharmacy stated that adding requirements for electronic 
prescriptions will not improve DEA's ability to reduce abuse, but that 
data mining could. One commenter stated that the benefits to be gained 
from data mining would allow DEA to impose fewer requirements on 
electronic prescriptions.
    DEA Response. DEA does not conduct a prescription monitoring 
program (as some States do) or otherwise engage in the generalized 
collection or analysis of controlled substance prescription data;

[[Page 16281]]

nor is it the intent of this rule to provide a mechanism for such an 
activity. The real-time data mining that some commenters feared and 
others saw as an advantage of electronic prescribing is not 
contemplated as part of this rulemaking. This rule permits 
practitioners to write electronic prescriptions for controlled 
substances and pharmacies to process those electronically written 
prescriptions. Those applications work independently of DEA and do not 
directly report prescription information to DEA. This rule merely 
establishes requirements those applications must meet to be used for 
electronic prescriptions for controlled substances.
    DEA notes that 38 States have implemented prescription monitoring 
programs that are based on the submission of data from pharmacies after 
the prescriptions have been filled. These programs may be used to 
identify patients who are obtaining prescriptions from multiple 
practitioners at one time or practitioners who are issuing an unusual 
number of controlled substance prescriptions.
    Comments. A State Board of Pharmacy asserted that there should be a 
requirement for application integration with all electronic medical 
record applications and State prescription data banks so that 
controlled substance prescriptions are readily identifiable.
    DEA Response. DEA understands the Board's concern, but believes 
what the Board seeks is not feasible or appropriate as a DEA regulatory 
requirement at this time for two reasons. First, electronic 
prescription applications and electronic health record applications may 
be installed in many States. Unless all State data banks will be 
configured in exactly the same way, it would not be possible for an 
application provider to ensure its application would be integrated with 
any particular State system. DEA notes that the electronic prescription 
and electronic health record applications will have to be able to 
identify controlled substance prescriptions and generate logs of those 
prescriptions. Second, State systems have generally obtained data from 
pharmacies rather than practitioners. Pharmacy applications have to be 
able to identify controlled substance prescriptions.
    Comments. A number of commenters representing practitioner 
organizations and one application provider stated that DEA should not 
impose any requirements until those requirements have been tested and 
shown ready for use.
    DEA Response. DEA recognizes the value of pilot testing, but does 
not believe that waiting for pilot testing is necessary or appropriate. 
Many of the provisions DEA proposed in its NPRM have been revised based 
on comments received; DEA has provided options for some key items to 
give registrants and application providers alternatives. DEA also notes 
that with so many applications available, what may be feasible for one 
system may be burdensome for others, so that pilot testing would not 
necessarily prove whether a particular approach was feasible or 
difficult for any specific application provider. This is particularly 
true as electronic prescription applications can be either stand-alone 
applications or can be integrated into more robust applications, such 
as electronic health record applications.
    Comments. A pharmacy organization asked if the statement in 
proposed Sec.  1311.200(d) is imposing a strict liability standard.
    DEA Response. The statement the commenter references appeared in 
both proposed Sec.  1311.100(c) (``Eligibility to issue electronic 
prescriptions.'') and proposed Sec.  1311.200(d) (``Eligibility to 
digitally sign controlled substances prescriptions.'') It reads: ``The 
practitioner issuing an electronic controlled substance prescription is 
responsible if a prescription does not conform in all essential 
respects to the law and regulations.'' The statement in proposed Sec.  
1311.100(c) and Sec.  1311.200(d) is simply a repetition of the 
existing requirement in current Sec.  1306.05. This statement has been 
a part of the regulations implementing the CSA since the regulations 
were first issued in 1971 following the enactment of the CSA. In the 
ensuing 38 years, there has never been an occasion in which a court has 
declared the provision to be legally problematic or in need of 
elaboration. Accordingly, it is appropriate to retain the concept in 
the context of electronic prescriptions for controlled substances, 
which DEA is doing by incorporating the provision in Sec.  1311.100 and 
Sec.  1311.200.
    Comments. Several commenters questioned DEA's concern about 
diversion. A State Board of Pharmacy asserted that it had found less 
risk of fraud with electronic prescriptions. Another State Board of 
Pharmacy disagreed that record integrity was needed to prosecute 
individuals forging prescriptions, asserting that it did not need to 
prove when and where a prescription was forged or altered. One 
physician stated that the problem with diversion was with the patient, 
not the doctor.
    DEA Response. DEA notes that there is no substantial regulatory 
experience on which State Boards of Pharmacy or other regulating bodies 
may draw when it comes to electronic prescriptions for controlled 
substances as such method of prescribing has not, prior to the issuance 
of this interim final rule, been authorized by the DEA regulations. 
While there has been electronic prescribing of noncontrolled 
substances, it is not surprising that there may be little evidence of 
fraud with prescriptions for such drugs as they are far less likely to 
be abused and diverted than controlled substances. One State Board of 
Pharmacy seems to have misunderstood the purpose of the rule or the 
issues of establishing who altered a prescription when there is no 
forensic evidence. It is true that with a paper prescription, it may, 
depending on the circumstances, be unnecessary to establish when and 
where a prescription was altered because the alteration itself can 
provide evidence of who did it. With electronic prescriptions, however, 
there may be no effective means of proving who made the alteration 
absent evidence of when the change occurred. Likewise, without such 
evidence, it is difficult, if not impossible, to achieve non-
repudiation, and thus the persons actually responsible for the 
prescription may be able to disclaim responsibility. As for the 
practitioner commenter who attributed the problem to the patient, DEA 
agrees that patients can be sources of diversion of controlled 
substances, but a considerable amount of diversion also occurs from 
within practitioners' offices and pharmacies as well.
    Comments. One application provider stated that the evidence that 
DEA presented on insider threats in the NPRM would not have been 
available if these threats had not been identified. The commenter 
asserted that the ability of the Secret Service/Carnegie Mellon study 
\37\ to identify the character of the employees as well as their 
``technical'' status indicates that existing industry standards are 
sufficient to detect and investigate the nature of violations.
---------------------------------------------------------------------------

    \37\ Insider Threat Study: Illicit Cyber Activity in the Banking 
and Financial Sector, August 2004; Insider Threat Study: Computer 
System Sabotage in Critical Infrastructure Sectors, May 2005.
---------------------------------------------------------------------------

    DEA Response. That studies have been able to identify the kinds of 
people who commit insider crimes does not support an argument that 
insider crimes are, therefore, not a problem or are easily identified 
or prosecuted. Further, most of the insider attacks mentioned in the 
study to which this commenter

[[Page 16282]]

referred were identified because the insiders or former insiders 
intended the attack to be obvious and destructive; these were usually 
revenge attacks by disgruntled employees or former employees. With 
financial insider attacks, the victim has reason to identify the attack 
because the attack results in financial losses. If insider attacks 
occur with electronic prescription applications, the application 
providers will not be the target or suffer financial losses; their 
applications will simply be used to commit a crime. In any event, 
regardless of what studies might purport to show with respect to 
insider attacks of computer-based systems, DEA has an obligation in 
this rulemaking to establish requirements that are particularly crafted 
to maintain effective controls against diversion of controlled 
substances in the context of electronic prescribing. DEA is aware of no 
study that refutes DEA's determination about the need for the controls 
contained in this interim final rule.
    Comments. One commenter, a physician, suggested that DEA and the 
Centers for Medicare and Medicaid Services go back to the electronic 
prescribing and electronic health record industries and tell them to 
incorporate DEA's proposed system upgrades, that these be operational 
in any CCHIT-approved system before moving ahead with these standards, 
and that DEA tell Congress that no penalties should be applied to any 
non-adopting physician before the system has been upgraded to the 
satisfaction of DEA.
    DEA Response. Consistent with the Administrative Procedure Act, DEA 
will articulate through this interim final rule those regulatory 
requirements regarding electronic prescriptions for controlled 
substances. DEA does not believe it would be legally sound or 
consistent with the public health and safety to declare that physicians 
or any other persons may disregard, without legal consequence, the 
standards established by this interim final rule.
    Comment. A State said that checks for the validity and completeness 
of a prescription should occur at the prescriber's office. A pharmacy 
employee stated that prescribers should not be able to transmit 
prescriptions unless the prescription meets all regulations of the 
State where the prescription will be filled. This individual further 
believed that prescriptions should be allowed to be filled anywhere in 
the country. Finally, this individual recommended that there be 
provisions to permit the transfer of the prescription to another 
pharmacy even if it is out of State.
    DEA Response. Section 1306.05 states that the practitioner is 
responsible for ensuring that a prescription conforms in all essential 
respects with the law and regulation; it also places a corresponding 
liability on pharmacies to ensure that only prescriptions that conform 
with the regulations are dispensed. The interim final rule requires 
that the electronic prescription application be capable of capturing 
all of the information and that the practitioner review the 
prescription before signing it. This requirement, however, does not 
relieve a pharmacy of its responsibility to ensure that the 
prescription it receives conforms to the law and regulations.
    As this interim final rule is a DEA rule, it is, of course, focused 
on Federal, not State, requirements. In view of this comment, however, 
it should be noted that the CSA has long provided that a practitioner 
who fails to comply with applicable State laws relating to controlled 
substances is subject to loss of DEA registration.\38\ Similarly, it 
has always been the case that compliance with the CSA or DEA 
regulations does not relieve anyone of the additional obligation to 
comply with any State requirements that pertain to the same 
activity.\39\ Thus, it is both the practitioner's and the pharmacy's 
responsibility to ensure that the prescription complies with all 
applicable laws and regulations. DEA does not limit where a 
prescription may be filled, nor does it limit where a prescription may 
be transferred, provided such transfers take place in a manner 
authorized by the DEA regulations.
---------------------------------------------------------------------------

    \38\ 21 U.S.C. 823(f)(4).
    \39\ See 21 U.S.C. 903.
---------------------------------------------------------------------------

3. Beyond the Scope
    A number of commenters raised issues that are beyond the scope of 
this rulemaking (e.g., requirements on the number of registrations that 
a practitioner must hold, penalties and incentives for electronic 
prescribing, the inability to set an indefinite quantity in 
prescriptions for LTCF patients). Consistent with sound APA practice, 
and to avoid unnecessary discussion, DEA will not address in this 
interim final rule such comments that are not directly related to the 
electronic prescribing of controlled substances.

L. Summary of Changes From the Proposed Rule

    In view of the comments that DEA received, the interim final rule 
contains a number of changes to the proposed rule. For the most part, 
the changes are logical outgrowths of the proposed rule and comments. 
In some instances, however, DEA has determined that the changes from 
the proposed rule warrant additional public comment. To assist the 
reader in understanding the changes, this section summarizes the major 
revisions. Commenters made a variety of recommendations on each issue. 
Where DEA determined that it could accept recommendations without 
lessening the security and integrity of controlled substance 
prescriptions, it has done so to provide more flexibility and lessen 
the burden on practitioners and pharmacies.
    Identity proofing. DEA has adopted in the interim final rule an 
approach that is different from the approach it proposed. As some 
commenters recommended, the interim final rule requires individual 
practitioners to obtain NIST SP 800-63-1 Assurance Level 3 identity 
proofing from entities that are Federally approved to conduct such 
identity proofing; NIST SP 800-63-1 Assurance Level 3 allows either in-
person or remote identity proofing, subject to the NIST requirements. 
The federally approved entities will provide the two-factor 
authentication credentials for individual practitioners. As commenters 
suggested, institutional practitioners have the option to conduct 
identity proofing in-house through their credentialing offices and may 
issue the two-factor authentication credentials themselves.
    Access control. In contrast to the proposed rule, the interim final 
rule places the responsibility for checking the DEA and State 
authorities and setting logical access on the individual practice or 
institution rather than on the application provider. Commenters 
indicated that many application providers were not involved in these 
actions. Under the interim final rule, two individuals are required to 
enter or change logical access controls. The applications must limit 
access for indicating that a controlled substance prescription is ready 
for signing and signing to individuals authorized under DEA regulations 
to do so.
    Two-factor authentication. The interim final rule retains the 
proposed requirement of two-factor authentication, but as commenters 
requested, allows the option of using a biometric to replace the hard 
token or the knowledge factor. DEA has also revised the rule to allow 
the hard token, when used, to be compliant with FIPS 140-2 Security 
Level 1 or higher, provided that the token is separate from the 
computer being accessed. DEA has revised the rule to allow 
practitioners with multiple DEA numbers to use a

[[Page 16283]]

single two-factor authentication credential per practitioner; the 
application must require these practitioners to select the appropriate 
DEA number for the prescription being issued. As commenters requested, 
the interim final rule also includes an application requirement that 
will allow a supervisor's DEA number to appear on the prescription 
provided it is clear which DEA number is associated with the 
prescribing practitioner.
    Creating the prescription. As proposed, the interim final rule 
requires that practitioners indicate that each controlled substance 
prescription is ready to be signed. As commenters recommended, however, 
the patient's address need not appear on the review screen, but it must 
still be included on the transmitted prescription, consistent with 
longstanding regulations applicable to all prescriptions for controlled 
substances. The proposed attestation statement has been shortened and 
must appear on the screen at the time of the review, but, as some 
commenters recommended, does not require a separate keystroke. Also 
under the interim final rule, authentication to the application must 
occur at signing, eliminating the need for the proposed lock-out 
provision.
    Signing and transmitting the prescription. As some commenters 
recommended, the interim final rule requires two-factor authentication 
to be synonymous with signing. In fact, the interim final rule 
expressly states that the completion of the two-factor authentication 
protocol by the practitioner legally constitutes that practitioner's 
signature of the prescription. When the practitioner completes the two-
factor authentication protocol, the application must apply its (or the 
practitioner's) private key to digitally sign at least the information 
required under part 1306. That digitally signed record must be 
electronically archived. As commenters suggested, this revision allows 
other staff members to add information not required by DEA regulations 
after signature, such as pharmacy URLs, and at LTCFs, allows staff to 
review and annotate records before transmission, so that current 
workflows can be maintained. The interim final rule retains the 
proposed requirement that the electronic prescription application 
include an indication that the prescription was signed in the 
information transmitted to the pharmacy.
    PKI. At the suggestion of many commenters, the interim final rule 
allows any practitioner to use the digital signature option proposed 
for Federal healthcare systems.
    Transmission issues. The interim final rule adopts the suggestion 
of some commenters that printing of a transmitted electronic 
prescription be permissible provided the printed prescription is 
clearly marked as a copy not for dispensing. The interim final rule 
specifies the conditions for printing a prescription when transmission 
fails, as commenters asked. DEA has also clarified in the interim final 
rule that the prohibition on alteration of content during transmission 
applies to the actions of intermediaries; changes made by pharmacies 
are subject to the same rules that apply to all prescriptions for 
controlled substances. As proposed, intermediaries are not allowed 
under the interim final rule to transform an electronic prescription 
into a facsimile; facsimiles of prescriptions are paper prescriptions 
that must be manually signed.
    Monthly logs. As some commenters recommended, DEA has retained in 
the interim final rule the requirement that the application 
automatically provide the practitioner with a monthly log of the 
practitioner's electronic prescribing of controlled substances. 
However, the interim final rule eliminates the proposed requirement 
that the practitioner indicate his review of the log. DEA has also 
maintained in the interim final rule the proposed requirement that the 
application provide practitioners a log on request. The interim final 
rule goes somewhat further than the proposed rule in this respect by 
requiring that the application allow the practitioner to specify the 
time period for log review, and to allow the practitioner to request 
and obtain a display of up to a minimum of two years of prior 
electronic prescribing of controlled substances and to request a 
display for particular patients or drugs.
    Internal audit trails. DEA has provided in the interim final rule 
more detail on the requirements for the internal audit trails required 
for both prescription and pharmacy applications. The interim final rule 
does not provide a comprehensive list of auditable events as some 
commenters requested, but clarifies that auditable events should be 
limited to potential security problems. For pharmacy applications, the 
interim final rule eliminates the proposed requirement that the audit 
trail log each time a prescription is opened, as commenters suggested.
    Other pharmacy issues. DEA has retained in the interim final rule 
the proposed requirement that either the last intermediary or the 
pharmacy digitally sign the prescription as received unless a 
practitioner's digital signature is attached and can be verified by the 
pharmacy. However, as commenters suggested, the interim final rule 
revises the requirement for checking the DEA registration of the 
practitioner to make it consistent with other prescriptions: the 
pharmacy must check the DEA registration when it has reason to suspect 
the validity of the registration or the prescription. Although DEA 
recommends as a best practice offsite storage of backup copies, it is 
not requiring it in the interim final rule as was proposed.
    Third-party audits. As commenters recommended, the interim final 
rule allows certification of electronic prescription applications and 
pharmacy applications by a DEA-approved certification organization to 
replace a third-party audit. The interim final rule also expands beyond 
the proposed rule the list of potential auditors to include certified 
information system auditors. As commenters suggested, the interim final 
rule extends the time frame for periodic audits from one year to two 
years, or whenever a functionality related to controlled substance 
prescriptions is altered, whichever occurred first.
    Recordkeeping. Based on the comments received, the interim final 
rule reduces the recordkeeping period to two years from the proposed 
five years.
    DEA wishes to emphasize that the electronic prescribing of 
controlled substances is in addition to, not a replacement of, existing 
requirements for written and oral prescriptions for controlled 
substances. This rule provides a new option to prescribing 
practitioners and pharmacies. It does not change existing regulatory 
requirements for written and oral prescriptions for controlled 
substances. Prescribing practitioners will still be able to write, and 
manually sign, prescriptions for Schedule II, III, IV, and V controlled 
substances, and pharmacies will still be able to dispense controlled 
substances based on those written prescriptions and archive those 
records of dispensing. Further, nothing in this rule prevents a 
practitioner or a practitioner's agent from using an existing 
electronic prescription application that does not comply with the 
interim final rule to prepare a controlled substance prescription 
electronically, so that EHR and other electronic prescribing 
functionality may be used, and print the prescription for manual 
signature by the practitioner. Such prescriptions are paper 
prescriptions and subject to the existing requirements for paper 
prescriptions.

[[Page 16284]]

V. Section-by-Section Discussion of the Interim Final Rule

    In Part 1300, DEA is adding a new Sec.  1300.03 (``Definitions 
relating to electronic orders for controlled substances and electronic 
prescriptions for controlled substances.'') The definitions currently 
in Sec.  1311.02 are moved to Sec.  1300.03. Definitions of the 
following are established without revision from the NPRM: ``audit 
trail,'' ``authentication,'' ``electronic prescription,'' ``identity 
proofing,'' ``intermediary,'' ``paper prescription,'' ``PDA,'' ``SAS 
70,'' ``SysTrust,'' ``token,'' ``valid prescription,'' and 
``WebTrust.'' Based on comments received, DEA is establishing the 
definition of ``hard token,'' with changes as discussed above. Based on 
comments received, DEA is adding definitions of the terms ``application 
service provider,'' ``electronic prescription application provider,'' 
``installed electronic prescription application,'' ``installed pharmacy 
application,'' ``pharmacy application provider,'' and ``signing 
function.'' DEA is updating the proposed definition of ``NIST SP 800-
63'' to reflect the most current version of this document.
    Other changes to definitions. Beyond the revisions discussed above, 
DEA has made several changes to the definitions section established in 
this rulemaking. Although not specifically discussed by commenters, DEA 
has made other changes to certain definitions to provide greater 
clarity, specificity, or precision. Changes are discussed below.
    To address the use of a biometric as one possible factor in a two-
factor authentication credential, DEA is adding definitions specific to 
that subject. Specifically, DEA is adding definitions of ``biometric 
subsystem,'' ``false match rate,'' ``false non-match rate,'' ``NIST SP 
800-76-1,'' and ``operating point.'' While DEA is adding a definition 
of ``password'' to mean ``a secret, typically a character string 
(letters, numbers, and other symbols), that a person memorizes and uses 
to authenticate his identity,'' DEA is not establishing any regulations 
regarding password strength, length, format, or character usage.
    In the definition of authentication protocol, DEA revised the 
language slightly to read: ``Authentication protocol means a well 
specified message exchange process that verifies possession of a token 
to remotely authenticate a person to an application.'' The proposed 
language had read ``to remotely authenticate a prescriber.''
    As discussed elsewhere in this rule, DEA is revising certain 
recordkeeping requirements. To ensure that terms used regarding 
recordkeeping are understood, DEA has repeated the definition of 
``readily retrievable'' from 21 CFR 1300.01(b)(38). This definition is 
longstanding and is well understood by the regulated industry. DEA does 
not believe that this definition will cause the regulated industry any 
difficulty. Since the inception of the CSA, the DEA regulations have 
defined the term as follows: ``Readily retrievable means that certain 
records are kept by automatic data processing systems or other 
electronic or mechanized recordkeeping systems in such a manner that 
they can be separated out from all other records in a reasonable time 
and/or records are kept on which certain items are asterisked, 
redlined, or in some other manner visually identifiable apart from 
other items appearing on the records.''
    In its NPRM, DEA proposed to define the term ``audit'' as follows: 
``audit means an independent review and examination of records and 
activities to assess the adequacy of system controls, to ensure 
compliance with established policies and operational procedures, and to 
recommend necessary changes in controls, policies, or procedures.'' To 
provide greater specificity to this term, DEA has revised the term to 
be ``third-party audit'' rather than simply ``audit.'' The definition 
remains unchanged from the NPRM in all other respects.
    DEA has added definitions of credential and credential service 
provider based on the NIST definitions in NIST SP 800-63-1.
    DEA has added definitions for the updated NIST FIPS standards. 
Finally, DEA is defining the term ``trusted agent'' to provide greater 
specificity regarding identity proofing conducted by institutional 
practitioners.
    In Part 1304, Sec.  1304.04 is revised to limit records that cannot 
be maintained at a central location to paper order forms for Schedule I 
and II controlled substances and paper prescriptions. In paragraph 
(b)(1), DEA is removing the reference to prescriptions; all 
prescription requirements are moved to paragraph (h). Paragraph (h), 
which details pharmacy recordkeeping, is revised to limit the current 
requirements to paper prescriptions and to state that electronic 
prescriptions must be retrievable by prescriber's name, patient name, 
drug dispensed, and date filled. The electronic records must be in a 
format that will allow DEA or other law enforcement agencies to read 
the records and manipulate them; preferably the data should be 
downloadable to a spreadsheet or database format that allows DEA to 
sort the data. The data extracted should only include the items DEA 
requires on a prescription. Records are required to be capable of being 
printed upon request.
    DEA is adding a new Sec.  1304.06 (``Records and reports for 
electronic prescriptions.'') This section does not create new 
recordkeeping requirements, but rather simply consolidates and 
references in one section requirements that exist in other parts of the 
rule. This new section is intended to make it easier for registrants 
and application providers to understand the records and reports they 
are required to maintain. Practitioners who issue electronic 
prescriptions for controlled substances must use electronic 
prescription applications that retain the record of the digitally 
signed prescription information and the internal audit trail and any 
auditable event identified by the internal audit trail. Institutional 
practitioners must retain a record of identity proofing and issuance of 
the two-factor authentication credential, where applicable, as required 
by Sec.  1311.110. Pharmacies that process electronic prescriptions for 
controlled substances must use a pharmacy application that retains all 
prescription and dispensing information required by DEA regulations, 
the digitally signed record of the prescription as received by the 
pharmacy, and the internal audit trail and any auditable event 
identified by the internal audit trail. Registrants and application 
service providers must retain a copy of any security incident report 
filed with the Administration. Application providers must retain third-
party audit or certification reports and any adverse audit or 
certification reports filed with the Administration regarding problems 
identified by the third-party audit or certification. All records must 
be retained for two years unless otherwise specified. DEA is not 
establishing any recordkeeping requirements for credential service 
providers or certification authorities because they are already subject 
to such requirements under the terms of certificate policies or 
frameworks they must meet to gain Federal approval.
    In Part 1306 (``Prescriptions'') Sec.  1306.05 is amended to state 
that electronic prescriptions must be created and signed using an 
application that meets the requirements of part 1311 and to limit some 
requirements to paper prescriptions (e.g., the requirement that paper 
prescriptions have the practitioner's name stamped or hand-printed on 
the prescriptions). The section also adds ``computer printer'' to the 
list of methods for creating a paper prescription and clarifies that a 
computer-generated prescription that is printed out or faxed must be 
manually

[[Page 16285]]

signed. DEA is aware that in some cases, an intermediary transferring 
an electronic prescription to a pharmacy may convert a prescription to 
a facsimile if the intermediary cannot complete the transmission 
electronically. As discussed previously in this rule, for controlled 
substance prescriptions, transformation to facsimile by an intermediary 
is not an acceptable solution. The section, as proposed, is also 
revised to divide paragraph (a) into shorter units.
    Section 1306.08 is added to state that practitioners may sign and 
transmit controlled substance prescriptions electronically if the 
applications used are in compliance with part 1311 and all other 
requirements of part 1306 are met. Pharmacies are allowed to handle 
electronic prescriptions if the pharmacy application complies with part 
1311 and the pharmacy meets all other applicable requirements of parts 
1306 and 1311.
    As proposed, Sec. Sec.  1306.11, 1306.13, and 1306.15 are revised 
to clarify how the requirements for Schedule II prescriptions apply to 
electronic prescriptions.
    As proposed, Sec.  1306.21 is revised to clarify how the 
requirements for Schedule III, IV, and V prescriptions apply to 
electronic prescriptions.
    As proposed, Sec.  1306.22 is revised to clarify how the 
requirements for Schedule III and IV refills apply to electronic 
prescriptions and to clarify that requirements for electronic refill 
records for paper, fax, or oral prescriptions do not apply to 
electronic refill records for electronic prescriptions. Pharmacy 
applications used to process and retain electronic controlled substance 
prescriptions are required to comply with the requirements in part 
1311. In addition, DEA is breaking up the text of the existing section 
into shorter paragraphs to make it easier to read.
    As proposed, Sec.  1306.25 is revised to include separate 
requirements for transfers of electronic prescriptions. These revisions 
are needed because an electronic prescription could be transferred 
without a telephone call between pharmacists. Consequently, the 
transferring pharmacist must provide, with the electronic transfer, the 
information that the recipient transcribes when accepting an oral 
transfer. DEA notes that the NPRM contained language proposing to 
permit an electronic prescription to be transferred more than once, in 
conflict with the requirements for paper and oral prescriptions. DEA 
has removed this proposed requirement; all transfer requirements for 
electronic prescriptions are consistent with those for paper and oral 
prescriptions.
    Finally, DEA notes that it had proposed a new Sec.  1306.28 to 
state the basic recordkeeping requirements for pharmacies for all 
controlled substance prescriptions. Those requirements are present in 
Sec.  1304.22. Although DEA initially believed that including these 
requirements in part 1306 would be beneficial, after further 
consideration DEA believes that they would be redundant and could, in 
fact, create confusion. Therefore, DEA is not finalizing proposed 21 
CFR 1306.28.
    DEA is revising the title of part 1311 as proposed.
    Section 1311.08 is revised to include the incorporations by 
reference of FIPS 180-3, Secure Hash Standard; FIPS 186-3, Digital 
Signature Standard; and NIST SP 800-63-1 Draft Electronic 
Authentication Guideline.
    Subpart C is being added by this interim final rule. DEA has 
revised the content of proposed subpart C, as discussed above, and has 
reorganized the subpart. The following describes each of the sections 
in the interim final subpart C.
    Section 1311.100 provides the general requirements for issuing 
electronic controlled substance prescriptions. It clarifies that the 
rules apply to all controlled substance prescriptions; the same 
electronic prescription requirements apply to Schedule II prescriptions 
as apply to other controlled substance prescriptions. DEA notes that 
the statutory prohibition on refilling Schedule II prescriptions 
remains in effect regardless of whether the prescription is issued 
electronically or on paper (21 U.S.C. 829(a), 21 CFR 1306.12(a)). Only 
a practitioner registered or exempt from registration and authorized to 
issue the prescription may do so; the prescription must be created on 
an application that meets all of the requirements of part 1311 subpart 
C. A prescription is not valid if the application does not meet the 
requirements of the subpart or if any of the required application 
functions were disabled when it was created. A pharmacy may process 
electronic controlled substance prescriptions only if its application 
meets the requirements of the subpart.
    Section 1311.102 specifies the practitioner's responsibilities. A 
practitioner must retain sole control of the hard token, where 
applicable, and must not share the password or other knowledge factor 
or biometric information. The practitioner must notify the individuals 
designated to set logical access controls within one business day if 
the hard token has been lost, stolen, or compromised, or the 
authentication protocol has otherwise been compromised.
    If the practitioner is notified by an intermediary or pharmacy that 
an electronic prescription was not successfully delivered, he must 
ensure that any paper or oral prescription (where permitted) issued as 
a replacement of the original electronic prescription indicates that 
the prescription was originally transmitted electronically to a 
particular pharmacy and that the transmission failed.
    As discussed previously, if the third-party auditor or 
certification organization finds that an electronic prescription 
application does not accurately and consistently record, store, and 
transmit the information related to the name, address, and registration 
number of the practitioner, patient name and address, and prescription 
information (drug name, strength, quantity, directions for use), the 
indication of signing, and the number of refills, the practitioner must 
not use the application to sign and transmit electronic prescriptions 
for the controlled substances.
    Further, if the third-party auditor or certification organization 
finds that an electronic prescription application does not accurately 
and consistently record, store, and transmit other information required 
for prescriptions, the practitioner must not sign and transmit 
electronic prescriptions for controlled substances that are subject to 
the additional information requirements.
    In most cases, this will not be an issue as the SCRIPT standard 
supports the standard information required for a prescription. A 
limited number of prescriptions, however, require special information. 
Prescriptions for GHB require a note on medical need; prescriptions for 
drugs used for detoxification and maintenance treatment require an 
additional DEA identification number. Schedule II prescriptions may be 
issued with written instructions indicating the earliest date that the 
prescription may be filled. DEA is not certain that the existing SCRIPT 
standard accommodates the additional information or that existing 
pharmacy applications accurately and consistently capture and display 
such information. Because there are relatively few prescriptions with 
these requirements, DEA decided to place the onus on the third-party 
auditors or certification organizations to determine whether 
applications can create, transmit, import, display, and store all of 
the information needed for these prescriptions. If an electronic

[[Page 16286]]

prescription application does not allow the entry of this additional 
information, the practitioner must not issue the prescriptions 
electronically. DEA decided that this approach was preferable to making 
it an application requirement that all applications would have to meet 
before they could be used to issue or process any controlled substance 
prescriptions electronically. DEA believes that there may be a 
difference between adding a single-character field to the SCRIPT 
standard, indicating that the prescription was signed, which would be 
transmitted with almost all prescriptions, and adding a set of 
additional fields, some of which could be defined in multiple ways. For 
example, future fill dates could be placed in fields defined as future 
fill dates and presented as dates or they could be presented as text. 
NCPDP may need time to decide how to add fields to capture this 
information; application providers cannot begin to reprogram until 
decisions on the standard are reached. DEA does not believe it is 
necessary or appropriate to delay adoption of electronic controlled 
substance prescriptions until these issues are resolved.
    Section 1311.102 also states that a practitioner must not use the 
application for controlled substance prescriptions if any of the 
functions have been disabled or is not working properly. Finally, if 
the application provider notifies him that the third-party audit 
indicated that the application does not meet the requirements of part 
1311, or that the application provider has identified a problem that 
makes the application non-compliant, the practitioner must immediately 
cease to issue controlled substance prescriptions using the application 
and must ensure that access for signing controlled substance 
prescriptions is terminated. The practitioner must not use the 
application to issue controlled substance prescriptions until it is 
notified that the application is again compliant and all relevant 
updates to the application have been installed.
    Sections 1311.105 and 1311.110 specify the requirements for 
obtaining an authentication credential for individual practitioners and 
practitioners using an institutional practitioner's application, as 
discussed above.
    Section 1311.115 specifies the requirements for two-factor 
authentication. It allows the authentication protocol to use any two of 
the three authentication factors (something you know, something you 
are, and something you have) and sets the requirements that hard tokens 
must meet.
    Section 1311.116 specifies the requirements that biometric 
subsystems must meet.
    Section 1311.120 provides the electronic prescription application 
requirements.
    Section 1311.120(b)(1) requires an electronic prescription 
application to link each registrant, by name, with a DEA registration 
number. For practitioners exempt from the requirement of registration 
under Sec.  1301.22(c), the application must link each practitioner to 
the institutional practitioner's DEA registration number and the 
specific internal code number required under Sec.  1301.22(c)(5).
    Section 1311.120(b)(2) requires an electronic prescription 
application to allow setting of logical access controls for indicating 
that prescriptions are ready to be signed and signing controlled 
substance prescriptions. It also requires the application to allow the 
setting and changing of logical access controls.
    Section 1311.120(b)(3) states that logical access controls must be 
set by user name or role. If the application uses role-based access 
controls, it must not allow an individual to be assigned the role of 
registrant unless the individual is linked to a DEA registration 
number.
    Section 1311.120(b)(4) requires that setting and changing of 
logical access controls must take the actions of two individuals, as 
discussed above.
    Section 1311.120(b)(5) states that the application must accept two-
factor authentication credentials and require their use for approving 
logical access controls and signing prescriptions.
    Section 1311.120(b)(6) states that an electronic controlled 
substance prescription must contain all of the information required 
under part 1306. As commenters pointed out, although the SCRIPT 
standard has fields for most of this information, the use of these 
fields is not always mandated. Some of the required information may 
have to be put in free text fields (e.g., internal institutional code 
data or service identification numbers for practitioners exempt from 
registration, the medical need for GHB prescriptions, a separate 
identification number for certain prescriptions).
    Section 1311.120(b)(7) states that the application must require the 
practitioner or his agent to select the DEA number to be used for the 
prescription where the practitioner issues prescriptions under more 
than one DEA number. This provision is intended to prevent the 
application from automatically filling in the DEA number field when a 
practitioner uses more than one number.
    Section 1311.120(b)(8) states that the electronic prescription 
application must have a time application that is within five minutes of 
the official National Institute of Standards and Technology time 
source.
    Section 1311.120(b)(9) specifies the information that must appear 
on the review screen. As explained above, if a practitioner has written 
several prescriptions for a single patient, the practitioner's and 
patient's information may appear only once on the review screen.
    Section 1311.120(b)(10) states that the application must require 
the practitioner to indicate that each controlled substance 
prescription is ready for signing. If any of the information required 
under part 1306 is altered after the practitioner has indicated that it 
is ready for signing, the application must remove the indication that 
it is ready for signing and require another indication before allowing 
it to be signed. The application must not allow the signing or 
transmission of a prescription that was not indicated as ready to be 
signed.
    Section 1311.120(b)(11) provides the requirement that the 
practitioner use the two-factor authentication protocol to sign the 
prescription.
    Section 1311.120(b)(12) states that the application must not allow 
a practitioner to sign a prescription if his two-factor authentication 
credential is not associated with the prescribing practitioner's DEA 
number listed on the prescription (or an institutional practitioner's 
DEA number and the prescriber's extension data). The application will 
have to associate each two-factor authentication credential with the 
registrant's DEA number(s) (or institutional practitioner's DEA number 
plus the individual practitioner's extension data) and ensure that only 
the authentication credentials associated with the number on the 
prescription can indicate the prescription as ready for signing and 
sign it. This provision is needed to prevent one registrant in a 
practice from reviewing and signing prescriptions written by other 
registrants. DEA recognizes that with paper prescriptions, DEA numbers 
for every member of a practice may be printed on a prescription pad; 
only the signature indicates which practitioner issued the 
prescription. For electronic prescriptions, however, only one 
prescribing practitioner's name will appear and one DEA number. 
Although the authentication credential will be associated with only one 
practitioner, it

[[Page 16287]]

may be associated with more than one DEA number. If a practitioner 
needs to sign a prescription originally created and indicated as ready 
for signing by another practitioner in a practice, he must change the 
practitioner name and DEA number to his own, then indicate that the 
prescription is ready to sign and execute the two-factor authentication 
protocol to sign it.
    Section 1311.120(b)(13) states that where a practitioner seeks to 
prescribe more than one controlled substance at one time for a 
particular patient, the electronic prescription application may allow 
the practitioner to sign multiple prescriptions for a single patient at 
one time using a single invocation of the two-factor authentication 
protocol provided that the practitioner has individually indicated that 
each controlled substance prescription is ready to be signed while all 
the prescription information and the statement described in Sec.  
1311.140 are displayed.
    Section 1311.120(b)(14) states that the application must time and 
date stamp the prescription on signing.
    Section 1311.120(b)(15) states that when the practitioner executes 
the two-factor authentication protocol, the application must digitally 
sign and electronically archive at least the information required by 
DEA. If the practitioner is signing the prescription with his own 
private key, the application must electronically archive the digitally 
signed prescription, but need not digitally sign the prescription a 
second time.
    Section 1311.120(b)(16) specifies the requirements for a digital 
signature. The cryptographic module must be validated at FIPS 140-2 
Security Level 1. The digital signature application and hash function 
must comply with FIPS 186-3 and FIPS 180-3. The electronic prescription 
application's private key must be stored encrypted on a FIPS 140-2 
Security Level 1 validated cryptographic module using a FIPS-approved 
encryption algorithm. For software implementations, when the signing 
module is deactivated, the application must clear the plain text 
password from the application memory to prevent the unauthorized access 
to, or use of, the private key.
    Section 1311.120(b)(17) states that the prescription transmitted to 
the pharmacy must include an indication that the prescription was 
signed unless the prescription is being transmitted with the 
practitioner's digital signature.
    Section 1311.120(b)(18) states that a prescription must not be 
transmitted unless the signing function was used.
    Section 1311.120(b)(19) states that the information required under 
part 1306 must not be altered after the prescription is digitally 
signed. If any of the required information is altered, the prescription 
must be canceled.
    Section 1311.120(b)(20) through (22) specify the requirements for 
printing transmitted prescriptions.
    Section 1311.120(b)(23) states that the application must maintain 
an audit trail related to the following: The creation, alteration, 
indication of readiness for signing, signing, transmission, or deletion 
of a controlled substance prescription; the setting or changing of 
logical access controls related to controlled substance prescriptions; 
and any notification of failed transmission. Section 1311.120(b)(24) 
specifies the information that must be maintained in the audit trail: 
Date and time of the action, type of action, identity of the person 
taking the action, and outcome.
    Section 1311.120(b)(25) states that the application must be capable 
of conducting an internal audit and generating a report on auditable 
events.
    Section 1311.120(b)(26) states that the application must protect 
audit trail records from unauthorized deletion, and must prevent 
modifications to the records.
    Section 1311.120(b)(27) specifies the requirements for the monthly 
log.
    Section 1311.120(b)(28) specifies that all records that the 
application is required to generate and archive must be retained 
electronically for at least two years.
    Sections 1311.125 and 1311.130 specify the requirements for setting 
and changing logical access controls at an individual practitioner's 
practice and at an institutional practitioner, respectively.
    Section 1311.135 sets the basic application requirements for 
creating an electronic controlled substance prescription. It states 
that either a practitioner or his agent may enter prescription 
information. If a DEA registrant holds more than one registration that 
he uses to issue prescriptions, the application must require him to 
select the registration number for each prescription. The application 
cannot set a default or pre-fill the field if the practitioner has more 
than one registration. If a practitioner has only one registration, as 
most practitioners do, the application could automatically fill that 
field. If required by State law, a supervisor's name and DEA number may 
be listed on a prescription, provided the prescription clearly 
indicates who is the supervisor and who is the prescribing 
practitioner.
    Section 1311.140 provides the application requirements for signing 
an electronic prescription for a controlled substance. It requires that 
the screen displaying the prescription information for review include 
the statement that completing the two-factor authentication protocol 
signs the prescription and that only the practitioner whose name and 
DEA number are on the prescription may sign it. After the practitioner 
has indicated that one or more controlled substance prescriptions for a 
single patient are ready for signing, the application must prompt the 
practitioner to execute the two-factor authentication protocol. The 
completion of the two-factor authentication protocol must apply the 
application's (or practitioner's) digital signature to the DEA-required 
information and electronically archive the digitally signed record. The 
application must clearly label as the signing function the function 
that applies the digital signature. Any controlled substance 
prescription not signed in this manner must not be transmitted.
    Section 1311.145 specifies the requirements for the use of a 
practitioner's digital certificate and the associated private key. The 
digital certificate must have been obtained in accordance with the 
requirements of Sec.  1311.105. The digitally signed record must be 
electronically archived. The section specifies that if the prescription 
is transmitted without the digital signature attached, the application 
must check the Certificate Revocation List to ensure that the 
certificate is valid and must not transmit the prescription if the 
certificate has expired. The section also clarifies that if a 
practitioner uses his own private key, the application need not apply 
its private key to sign the record.
    Section 1311.150 specifies the requirements for auditable events 
for electronic prescription applications. Auditable events must include 
at least the following: attempted or successful unauthorized access to 
the application; attempted or successful unauthorized deletion or 
modification of any records required by part 1311; interference with 
application operations related to prescriptions; any setting of or 
changes to logical access controls related to controlled substance 
prescriptions; attempted or successful interference with audit trail 
functions; and, for application service providers, attempted or 
successful creation, modification, or destruction of controlled 
substance prescriptions or logical access controls related to 
controlled substance prescriptions by any agent or employee

[[Page 16288]]

of the application service provider. The application must run the 
internal audit once every calendar day and generate a report that 
identifies any auditable event. This report must be reviewed by an 
individual authorized to set access controls. If the auditable event 
compromised or could have compromised the integrity of the records, 
this must be reported to DEA and the application provider within one 
business day of discovery.
    Section 1311.170 requires that the application transmit the 
prescription as soon as possible after signature by the practitioner. 
The section requires that the electronic prescription application not 
allow the printing of an electronic prescription that has been 
transmitted unless the pharmacy or intermediary notifies the 
practitioner that the electronic prescription could not be delivered to 
the pharmacy designated as the recipient or was otherwise rejected. If 
a practitioner is notified that an electronic prescription was not 
successfully delivered to the designated pharmacy, the application may 
print the prescription for the practitioner's manual signature. The 
prescription must include information noting that the prescription was 
originally transmitted electronically to [name of specific pharmacy] on 
[date/time], and that transmission failed.
    The section indicates that the application may print copies of the 
transmitted prescription if they are clearly labeled as copies not 
valid for dispensing. Data on the prescription may be electronically 
transferred to medical records and a list of prescriptions written may 
be printed for patients if the list indicates that it is for 
informational purposes only. The section clarifies that the electronic 
prescription application must not allow the transmission of an 
electronic prescription if a prescription was printed for signature 
prior to attempted transmission.
    Finally, the section specifies that the contents of the 
prescription required under part 1306 must not be altered during 
transmission between the practitioner and pharmacy. Any change to this 
required content during transmission, including truncation or removal 
of data, will render the prescription invalid. The contents may be 
converted from one software version to another; conversion includes 
altering the structure of fields or machine language so that the 
receiving pharmacy application can read the prescription and import the 
data into its application. At no time may an intermediary convert an 
electronic controlled substance prescription data file to another form 
(e.g., facsimile) for transmission.
    Section 1311.200 specifies the pharmacy's responsibility to process 
controlled substance electronic prescriptions only if the application 
meets the requirements of part 1311. The section also requires the 
pharmacy to determine which employees may access functions for 
annotating, altering, and deleting prescription information (to the 
extent such alteration is permitted by the CSA and its implementing 
regulations) and for implementing those logical access controls. As 
discussed previously, if the third-party auditor or certification 
organization finds that a pharmacy application does not accurately and 
consistently import, store, and display the information related to the 
name, address, and registration number of the practitioner, patient 
name and address, and prescription information (drug name, strength, 
quantity, directions for use), the indication of signing, and the 
number of refills, the pharmacy must not accept electronic 
prescriptions for the controlled substance. If the third-party auditor 
or certification organization finds that a pharmacy application does 
not accurately and consistently import, store, and display other 
information required for prescriptions, the pharmacy must not accept 
electronic prescriptions for controlled substances that are subject to 
the additional information requirements.
    The section specifies that if a prescription is received 
electronically, all annotations and recordkeeping related to that 
prescription must be retained electronically. The section reiterates 
the responsibility of the pharmacy to dispense controlled substances 
only in response to legitimate prescriptions.
    Section 1311.205 provides the requirements for pharmacy 
applications.
    Section 1311.205(b)(1) states that the application must allow the 
pharmacy to set access controls to limit access to functions that 
annotate, alter, or delete prescription information, and to the setting 
or changing of logical access controls.
    Section 1311.205(b)(2) states that logical access controls must be 
set by name or role.
    Section 1311.205(b)(3) specifies that the application must 
digitally sign and archive an electronic prescription upon receipt or 
be capable of receiving and archiving a digitally signed record.
    Section 1311.205(b)(4) specifies the requirements for the digital 
signature functionality for pharmacy applications that digitally sign 
prescription records upon receipt.
    Section 1311.205(b)(5) states that the pharmacy application must 
validate a practitioner's digital signature if the pharmacy accepts 
prescriptions digitally signed by the practitioner and transmitted with 
the digital signature.
    Section 1311.205(b)(6) states that if a practitioner's digital 
signature is not sent with the prescription, either the application 
must check for the indication that the prescription was signed or the 
application must display the indication for the pharmacist to check.
    Section 1311.205(b)(7) states that the application must read and 
retain the entire DEA number including the specific internal code 
number assigned to an individual practitioner prescribing controlled 
substances using the registration of the institutional practitioner.
    Section 1311.205(b)(8) states that the application must read and 
store, and be capable of displaying, all of the prescription 
information required under part 1306.
    Section 1311.205(b)(9) states that the pharmacy application must 
read and store in full the information required under Sec.  1306.05(a). 
Either the pharmacist or the application must verify all the 
information is present.
    Section 1311.205(b)(10) states that the application must allow the 
pharmacy to add information on the number/volume of the drug dispensed, 
the date dispensed, and the name of the dispenser.
    Section 1311.205(b)(11) specifies that the application must be 
capable of retrieving prescription information by practitioner name, 
patient name, drug name, and date dispensed.
    Section 1311.205(b)(12) states that the application must allow 
downloading of prescription data into a form that is readable and 
sortable.
    Section 1311.205(b)(13) states that the application must maintain 
an audit trail related to the following: The receipt, annotation, 
alteration, or deletion of a controlled substance prescription; and the 
setting or changing of logical access controls related to controlled 
substance prescriptions.
    Section 1311.205(b)(14) specifies the information that must be 
maintained in the audit trail: Date and time of the action, type of 
action, identity of the person taking the action, and outcome.
    Section 1311.205(b)(15) states that the application must generate a 
daily report of auditable events (if they have occurred).
    Section 1311.205(b)(16) states that the application must protect 
the audit trail

[[Page 16289]]

from unauthorized deletion and shall prevent modification of the audit 
trail.
    Section 1311.205(b)(17) states that the application must back up 
files daily.
    Section 1311.205(b)(18) states that the application must retain 
records for two years from the date of their receipt or creation.
    Section 1311.210 sets the requirements for digitally signing the 
prescription as received and archiving the record. It also sets the 
requirements for validating a prescription that has the practitioner's 
digital signature attached.
    Section 1311.215 specifies the requirements for auditable events 
for pharmacy applications. Auditable events must include at least the 
following: Attempted or successful unauthorized access to the 
application; attempted or successful unauthorized deletion or 
modification of any records required by part 1311; interference with 
application operations related to prescriptions; any setting of or 
changes to logical access controls related to controlled substance 
prescriptions; attempted or successful interference with audit trail 
functions; and, for application service providers, attempted or 
successful annotation, alteration, or destruction of controlled 
substance prescriptions or logical access controls related to 
controlled substance prescriptions by any agent or employee of the 
application service provider. The application must run the internal 
audit once every calendar day and generate a report that identifies any 
auditable event. This report must be reviewed by the pharmacy. If the 
auditable event compromised or could have compromised the integrity of 
the records, this must be reported to DEA and the application service 
provider, if applicable, within one business day of discovery.
    Section 1311.300 specifies the requirements for third-party audits 
discussed above and includes the option of substituting a certification 
from an organization and certification program approved by DEA. Audits 
or certifications must occur before the application may be used to 
create, sign, transmit, or process electronic controlled substance 
prescriptions, and whenever a functionality related to controlled 
substance prescription requirements is altered or every two years, 
whichever occurs first. Audits must be conducted by a person qualified 
to conduct a SysTrust, WebTrust, or SAS 70 audit, or a Certified 
Information System Auditor who performs compliance audits as a regular 
ongoing business activity. DEA is seeking comment regarding the use of 
Certified Information System Auditors.
    Application providers must make audit reports available to any 
practitioner or pharmacy that uses or is considering using the 
application to handle controlled substance prescriptions. The rule also 
requires application providers to notify both their users and DEA of 
adverse audit reports or certification decisions. Users must be 
notified within five business days; DEA must be notified within one 
business day.
    Section 1311.302 requires application providers to notify 
practitioners or pharmacies, as applicable, of any problem that they 
identify that makes the application noncompliant with part 1311. When 
providing patches and updates to the application to address these 
problems, the application provider must inform the users that the 
application may not be used to issue or process electronic controlled 
substance prescriptions until the patches or updates have been 
installed. DEA is requiring that practitioners and pharmacies be 
notified as quickly as possible, but no later than five business days 
after the problem is identified.
    Section 1311.305 specifies recordkeeping requirements for records 
required by part 1311.

VI. Incorporation by Reference

    The following standards are incorporated by reference:
     FIPS Pub 180-3, Secure Hash Standard (SHS), October 2008.
     FIPS Pub 186-3, Digital Signature Standard (DSS), June 
2009.
     Draft NIST Special Publication 800-63-1, Electronic 
Authentication Guideline, December 8, 2008; Burr, W. et al.
     NIST Special Publication 800-76-1, Biometric Data 
Specification for Personal Identity Verification, January 2007.
    These standards are available from the National Institute of 
Standards and Technology, Computer Security Division, Information 
Technology Laboratory, National Institute of Standards and Technology, 
100 Bureau Drive, Gaithersburg, MD 20899-8930 and are available at 
http://csrc.nist.gov/.

VII. Required Analyses

A. Risk Assessment for Electronic Prescriptions for Controlled 
Substances

    The Office of Management and Budget's E-Authentication Guidance for 
Federal Agencies (M-04-04) requires agencies to ensure that 
authentication processes provide the appropriate level of 
assurance.\40\ The guidance describes four levels of identity assurance 
for electronic transactions and provides standards to be used to 
determine the level of risk associated with a transaction and, 
therefore, the level of assurance needed. Assurance is the degree of 
confidence in the vetting process used to establish the identity of an 
individual to whom a credential was issued, the degree of confidence 
that the individual who uses the credential is the individual to whom 
the credential was issued, and the degree of confidence that a message 
when sent is secure. OMB established four levels of assurance:
---------------------------------------------------------------------------

    \40\ Office of Management and Budget. ``E-Authentication 
Guidance for Federal Agencies'' M-04-04. December 16, 2003.
---------------------------------------------------------------------------

    Assurance Level 1: Little or no confidence in the asserted 
identity's validity.
    Assurance Level 2: Some confidence in the asserted identity's 
validity.
    Assurance Level 3: High confidence in the asserted identity's 
validity.
    Assurance Level 4: Very high confidence in the asserted identity's 
validity.
    M-04-04 states that to determine the appropriate level of assurance 
in the user's asserted identity, agencies must assess the potential 
risks and identify measures to minimize their impact. The document 
states that the risk from an authentication error is a function of two 
factors: (a) Potential harm or impact and (b) the likelihood of such 
harm or impact. NIST SP 800-63-1 supplements M-04-04 and defines the 
steps necessary to reach each assurance level for identity proofing 
that precedes the issuance of the credential; the use of credential 
once issued; and the transmission of any document ``signed'' with the 
credential. In plain language, an e-authentication risk assessment 
considers two issues:
     How important is it to know that the person who is issued 
a credential is, in fact, the person whose identity is associated with 
the credential.
     How important is it to be certain that the person who uses 
the credential, once it is issued, is the person to whom it was issued.
    This risk assessment addresses the level of assurance needed to 
allow the use of electronic prescriptions for controlled substances. 
This section summarizes the assessment that DEA conducted for the 
interim final rule. The full risk assessment is available in the 
docket.
    As discussed in Section IV J of this preamble, M-04-04 requires 
that an Agency assess risks as low, moderate, or

[[Page 16290]]

high for six factors (see Table 1), then determines the Assurance Level 
needed based on the ratings. Table 3 presents the ratings DEA developed 
in its risk assessment for the proposed rule and the rationale for each 
(for the full discussion, see 73 FR 36731-36739).

 Table 3--Initial Rating of Potential Impacts for Authentication Errors
         for Electronic Prescriptions for Controlled Substances
------------------------------------------------------------------------
      Potential impact           Initial rating           Rationale
------------------------------------------------------------------------
Inconvenience, Distress, or   Moderate--At worst,   Identity theft,
 Damage to Standing or         serious short-term    issuance of
 Reputation.                   or limited long-      illegitimate
                               term inconvenience,   prescriptions in a
                               distress, or damage   practitioner's
                               to the standing or    name, or alteration
                               reputation of any     of prescriptions
                               party.                could expose
                                                     practitioners to
                                                     legal difficulties
                                                     and force them to
                                                     prove that they had
                                                     not used an
                                                     electronic
                                                     prescription
                                                     application or
                                                     issued specific
                                                     prescriptions.
Financial Loss..............  N/A.                  ....................
Harm to Agency Programs or    High--A severe or     Were there identity
 Public Interests.             catastrophic          theft or the misuse
                               adverse effect on     of a credential
                               organizational        issued to a
                               operations or         registrant, the
                               assets, or public     potential exists
                               interests. Examples   for widespread and
                               of severe or          rapid diversion of
                               catastrophic          controlled
                               effects are: (i)      substances. Such
                               severe mission        diversion would
                               capability            undermine the
                               degradation or loss   effectiveness of
                               of (sic) to the       prescription laws
                               extent and duration   and regulations of
                               that the              the United States.
                               organization is       This diversion
                               unable to perform     would, by its very
                               one or more of its    nature, harm the
                               primary functions;    public health and
                               or (ii) major         safety, as any
                               damage to             illicit drug use
                               organizational        does. Such
                               assets or public      diversion would
                               interests.            undermine the
                                                     effectiveness of
                                                     the entire United
                                                     States closed
                                                     system of
                                                     distribution
                                                     created by the CSA
                                                     and would, for the
                                                     same reason, be
                                                     incompatible with
                                                     United States
                                                     obligations under
                                                     international drug
                                                     control treaties.
Unauthorized release of       N/A.                  ....................
 Sensitive Information.
Personal Safety.............  High--A risk of       Failure to limit the
                               serious injury or     potential for
                               death.                diversion could
                                                     result in an
                                                     increase in drug
                                                     abuse and in the
                                                     associated deaths
                                                     and illnesses as
                                                     well as other
                                                     social harms.
Civil or Criminal Violations  High--A risk of       A practitioner whose
                               civil or criminal     identity was stolen
                               violations that are   to gain a
                               of special            credential or whose
                               importance to         credential was used
                               enforcement           by someone else to
                               programs.             issue a
                                                     prescription for a
                                                     controlled
                                                     substance could be
                                                     subject to legal
                                                     action in which the
                                                     practitioner would
                                                     have to prove that
                                                     he was not
                                                     responsible for the
                                                     prescriptions. Such
                                                     legal action
                                                     against the
                                                     practitioner could
                                                     include criminal
                                                     prosecution, civil
                                                     fine proceedings,
                                                     and administrative
                                                     proceedings to
                                                     revoke the
                                                     practitioner's DEA
                                                     registration.
------------------------------------------------------------------------

    Under M-04-04, the overall rating is driven by the highest rating 
assigned. Therefore, the potential impact of not being able to limit 
authentication credentials to DEA registrants is rated as high, which 
means that without mitigating factors, DEA should impose requirements 
that meet Assurance Level 4 under NIST SP 800-63-1.
    Mitigating Factors:
    DEA included a number of elements in the interim final rule that 
mitigate the risks of unauthorized access to the electronic 
prescription application and reduce the potential for diversion. While 
some of these relate to authentication to the application, others 
relate to use of the application itself.
    Separation of duties. DEA's premise for its requirements regarding 
the access to any electronic prescription application to prescribe 
controlled substances rests on the principle of separation of duties. 
The interim final rule requires that practitioners wishing to prescribe 
controlled substances undergo identity proofing by an independent 
third-party credential service provider (CSP) or certification 
authority (CA) that is recognized by a Federal agency as conducting 
identity proofing at the basic assurance level (Assurance Level 3 for 
CAs) or greater. The CSP or CA will then issue the credential. This 
approach removes the electronic prescription application provider from 
the process of issuing the credential, which limits the ability of 
individuals at the application provider to steal identities and 
ensures, to as great an extent as possible, that a person will not be 
issued a credential using someone else's identity.
    Access control. The possession of a credential by the practitioner, 
while necessary to legally sign controlled substance prescriptions, is 
not sufficient to do so. After the practitioner has obtained the 
credential, a person in the practitioner's office (assuming that the 
practitioner is in private practice in an office setting) must enter 
information into the electronic prescription application identifying 
the practitioner as a person authorized to prescribe controlled 
substances. A second person in that office, who must be a DEA 
registrant, must approve the information entered and grant the 
practitioner access to the electronic prescription application for the 
purpose of signing controlled substance prescriptions using the 
practitioner's credential. (Note that a similar system involving 
separation of duties is being implemented for

[[Page 16291]]

institutional practitioners, i.e., hospitals and clinics. That system 
has similar conceptual requirements, but involves different people in 
the physical processes.)
    This separation of duties ensures that even if someone is able to 
impersonate a practitioner and obtain a credential from an independent 
third-party CSP or CA, that impersonator will not be able to gain 
access to the electronic prescription application to sign controlled 
substance prescriptions unless the impersonator also has the assistance 
of two persons (one of whom is a DEA registrant) within a 
practitioner's office. In this way, it will be significantly more 
difficult for impersonators to gain access to sign controlled substance 
prescriptions, reducing the possibility of authentication errors and 
lessening the potential for diversion.
    Use of two-factor authentication. DEA is requiring the use of two-
factor authentication. Assurance Level 4 requires a hard token that is 
separate from the computer to which the person is gaining access, but 
also imposes more stringent requirements on the cryptographic module 
and the token. DEA has determined that combining the requirements for 
Assurance Level 3 tokens (i.e., FIPS 140-2 Security Level 1 tokens used 
in combination with another factor to reach Assurance Level 3) with the 
requirement that the token be separate from the computer will provide 
sufficient security to mitigate the risk of misuse. Keeping the token 
separate from the computer being accessed makes it much easier for the 
practitioner to control access to his credential. A person would have 
to obtain both the token and the second factor to gain access. (Note 
that DEA is also permitting the use of biometrics as one of the factors 
that may be used for authentication; the biometric could replace either 
the hard token or the knowledge factor.)
    Application requirements. In addition to the requirements discussed 
above, DEA is also imposing the following requirements on the 
electronic prescription application that will mitigate the risks:
     The application must have the ability to set logical 
access controls as discussed above and limit access to indicating that 
prescriptions are ready for signing and signing prescriptions to DEA 
registrants or those exempted from registration.
     The application must require the use of the two-factor 
credential to sign the prescription and digitally sign and archive the 
record when the two-factor authentication protocol is executed. This 
step ensures that there is a record of the prescription as signed and 
allows other people in the practice or facility to add information not 
required by DEA, (e.g., pharmacy URLs) or review the prescription 
before transmission.
     The application must not allow a practitioner to sign a 
prescription if his credential is not linked to the DEA number listed 
on the prescription.
     The application must undergo a third-party audit to 
determine whether it complies with the requirements of the interim 
final rule.
    In addition, as part of their approval by the Federal Government, 
CSPs and CAs issuing credentials undergo third-party audits to ensure 
compliance with Federal Government standards.
    Conclusion:
    Consistent with M-04-04, DEA believes that it is appropriate for 
the agency to accept lower level credentials in view of the mitigating 
factors discussed above. M-04-04 states, in pertinent part (in Section 
2.5):

    Agencies may also decrease reliance on identity credentials 
through increased risk-mitigation controls. For example, an agency 
business process rated for Level 3 identity assertion assurance may 
lower its profile to accept Level 2 credentials by increasing system 
controls or `second level authentication' activities.

    Following this approach, DEA has concluded that, even though the 
agency rates overall identity assurance for electronic prescribing of 
controlled substances at Assurance Level 4, the agency believes that 
Level 3 credentials are acceptable in view of the system controls that 
are mandated by this interim final rule. Specifically, DEA believes 
that the requirements that the interim final rule imposes for identity 
proofing, logical access controls, the separation of the hard token 
from the computer being accessed, and the application requirements 
lower the potential for a nonregistrant to steal an identity or gain 
access to a registrant's credential and issue illegal prescriptions 
sufficiently to render acceptable remote identity proofing, consistent 
with NIST SP 800-63-1 Assurance Level 3 requirements, and the use of 
FIPS 140-2 Security Level 1 hard tokens that in combination with a 
second factor provided that the token is not stored on the computer to 
which the person is gaining access. With these requirements in place, 
the potential for diversion through misuse of a credential will be 
limited, which supports the closed system of control DEA is mandated to 
maintain, protect practitioners from misuse of their identity, and 
protects the public from the harm of drug abuse. (Note that DEA is not 
imposing any requirements on the security of the transmission.)
    As has been discussed previously, it is important to note that the 
electronic prescribing of controlled substances is voluntary--
practitioners may still dispense controlled substances through the use 
of written prescriptions, regardless of whether they choose to write 
controlled substances prescriptions electronically. Also, the 
compromise of an authentication protocol through loss, credential 
invalidation, or other cause, does not invalidate the practitioner's 
authority to write controlled substances prescriptions. Practitioners 
may continue to write controlled substances prescriptions on paper or 
generate a prescription electronically to be printed and signed 
manually even if their authentication credential has been compromised, 
so long as the practitioner continues to possess a DEA registration.

B. Executive Order 12866

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), DEA 
must determine whether a regulatory action is ``significant'' and, 
therefore, subject to Office of Management and Budget review and the 
requirements of the Executive Order. The Order defines ``significant 
regulatory action'' as one that is likely to result in a rule that may:
    (1) Have an annual effect on the economy of $100 million or more or 
adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local, or tribal government or communities.
    (2) Create a serious inconsistency or otherwise interfere with an 
action taken or planned by another agency.
    (3) Materially alter the budgetary impact of entitlements, grants, 
user fees, or loan programs or the rights and obligations of recipients 
thereof.
    (4) Raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in 
the Executive Order.
    A copy of the Economic Impact Analysis of the Electronic 
Prescriptions for Controlled Substances Rule can be obtained by 
contacting the Liaison and Policy Section, Office of Diversion Control, 
Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, 
VA 22152, Telephone (202) 307-7297. The initial analysis is also 
available on DEA's Diversion Control Program Web site at http://
www.deadiversion.usdoj.gov.
    Comments:

[[Page 16292]]

    DEA conducted an initial economic analysis of the proposed rule and 
sought comments. DEA received several comments regarding the estimates 
provided in the NPRM.
    Comments. A practitioner organization stated that DEA 
underestimated the costs for registration, hard token hardware and 
software, software upgrades, annual system audits, and, especially, for 
separate prescribing workflows for controlled drugs. The commenter 
asserted that the analysis did not include the added costs for each 
prescriber every time a controlled substance prescription is written. 
The commenter believed that the comparison should not be with the 
current system where controlled substance prescriptions require a 
separate workflow, but rather with a commenter-preferred system where 
all prescribing takes place in a single workflow. The commenter 
asserted that the costs of prosecutions are dwarfed by the potential 
benefits offered by a single, manageable electronic prescribing system. 
The commenter stated that DEA acknowledged in the analysis it did not 
have valid data on all costs to society from diversion of controlled 
substances. Without valid estimates of the cost of the problem, the 
commenter asserted, it is impossible to justify the expense of the 
proposed solution.
    DEA Response. DEA disagrees with this comment, but notes that the 
revisions to the interim final rule reduce the costs and the additional 
keystrokes. The only change to the usual workflow will be the use of 
the two-factor authentication credential to sign the prescription. 
Wherever possible, in the economic analysis of the interim final rule, 
DEA has used estimates based on current prices.
    DEA's concern is not simply or primarily with the costs of 
prosecutions, but with the diversion of controlled substances and the 
societal harm caused by abuse of these drugs. The cost of emergency 
room treatment alone for people using prescription controlled 
substances for nonmedical reasons is far higher than the cost of this 
rule. Without appropriate security measures, electronic prescriptions 
could facilitate increased drug abuse, with a concomitant increase in 
deaths, medical treatment, and other societal costs associated with 
drug dependency.
    Although DEA supports electronic prescribing and shares the hope 
that it will reduce adverse drug events and improve the efficiency of 
the healthcare system, there is little, if any, evidence that 
electronic prescribing is achieving this goal. The limited studies that 
have examined the impacts of electronic prescribing have found that the 
primary benefit is improved formulary compliance. DEA has not found any 
studies that quantify the number of adverse drug events associated with 
illegible prescriptions. The data often cited regarding medication 
errors are based primarily on inpatient hospital and long-term care 
facility adverse drug events and include ``errors'' that are unrelated 
to legibility (e.g., administering a drug to the wrong patient, 
dispensing the wrong drug); some of the errors cited may not result in 
adverse drug events (e.g., failing to include all of the label 
information or the insert). In addition, as discussed below in the 
Benefits section, studies of pharmacy experiences with electronic 
prescriptions have found that there may be an increase in errors with 
these prescriptions. DEA notes that although illegible handwritten 
prescriptions are unquestionably a problem, in most cases the 
pharmacists resolve the problem by calling the practitioner to clarify 
the prescription rather than risk dispensing the wrong drug.
    Comments. A pharmacy organization asserted that unless there is a 
compelling law enforcement need, DEA must eliminate provisions that 
increase the burden and costs on prescribers and pharmacies. The 
commenter claimed that these burdens and costs will fall 
disproportionately on independent, rural and small primary care and 
physician practices, pharmacies and health care facilities and 
programs. State pharmacy associations stated that DEA should perform an 
economic analysis that details the financial impact on safety-net 
clinics using appropriate metrics (net revenue) and actual fees, and 
that DEA should consider options that reduce these identified costs. 
One organization indicated that the analysis did not adequately address 
the cost of storage, technology, staff resources, and oversight.
    DEA Response. DEA disagrees that the costs fall disproportionately 
on small or rural practices. Most of the costs of the rule will be 
borne by practitioners, to obtain identity proofing, and the 
application providers. DEA has revised the process for identity 
proofing to reduce the burden on rural practitioners. The primary cost 
will be to complete an application for a credential or digital 
certificate and to pay for the credential. The frequency with which a 
practitioner must do this will be determined by the credential service 
provider or certification authority.
    Although the application providers will have to recover their costs 
from their customers, the incremental costs for any single customer 
will be low, particularly when compared to the cost of an electronic 
health record application. DEA has revised the rule to reduce the costs 
to application providers by both lengthening the time between audits/
certifications and allowing them to substitute certification by an 
approved organization, where one exists, for a third-party audit. 
Because the American Recovery and Reinvestment Act requires that an 
application be certified before a practitioner will be eligible for an 
incentive payment, it is reasonable to assume that all electronic 
prescription application providers will be seeking certification and 
incurring those costs regardless of DEA's rules. On the pharmacy 
application side, the third-party audit will only need to address 
compliance with DEA's requirements, most of which existing pharmacy 
applications already meet.
    DEA has removed the requirement for offsite storage. As for the 
costs for technology, staff resources, and oversight, these apply to 
acquisition of the application, not to DEA's requirements. DEA is not 
requiring any registrant to issue or accept electronic prescriptions 
for controlled substances. Any registrant that purchases an application 
will incur these costs whether they use the application for controlled 
substance prescriptions or not.
    Comments. An organization representing dentists stated that the 
number of dentists used in the calculations in the economic analysis 
was high; the commenter noted that the Bureau of Labor Statistics lists 
161,000 dentists as opposed to DEA's estimate of 170,969. The commenter 
also asserted that DEA did not include potential practitioner 
reprogramming cost(s) in this figure. The commenter believed that the 
addition of any reprogramming costs will make this figure much greater 
and create additional burden for practicing dentists who wish to 
transmit prescriptions for controlled substances electronically.
    DEA Response. In the interim final Economic Impact Analysis, DEA 
used the organization's estimate for the number of dentists, adjusted 
to account for growth. DEA has estimated the cost for reprogramming, 
but notes that this will be done by the application provider, not at 
the practice level. Unless an individual practice decides to implement 
biometrics as part of their two-factor authentication credentials, 
there should not be additional hardware or software needed; the 
software needed to use a biometric can be relatively

[[Page 16293]]

inexpensive. DEA expects that there will be considerable variation in 
the extent of reprogramming an application provider needs to do based 
on the degree to which an application already meets the requirements 
being implemented in this rule. Application providers, however, 
routinely reprogram their software to add new features, upgrade 
functions, and fix problems. Reprogramming to meet the interim final 
rule is likely to occur as part of this routine process.
    Comments. A pharmacy organization asserted that the cost of 
dispensing for the average independent community pharmacy is already 
high. The commenter believed that the regulation would necessitate the 
purchase of new technology, generating more reports at the end of the 
day, and then storing those corresponding reports for five years. The 
commenter claimed that these processes will only add to the monetary 
costs and time constraints that pharmacists have to abide by to 
responsibly consult with and serve their patients. The commenter 
asserted that such gains from electronic prescribing are relatively 
minimal when compared to such costs, considering that independent 
community pharmacies already connected for electronic prescribing only 
receive around 2 percent of their prescriptions through such 
technology.
    DEA Response. DEA is not requiring any pharmacy to accept 
electronic prescriptions for controlled substances. Based on industry 
comments, the existing pharmacy applications already have most, if not 
all, of the functions that DEA is requiring. It is unlikely, therefore, 
that any pharmacy will have to replace its existing application. Where 
additional functionality is needed, it can be added as an upgrade or 
patch, as occurs routinely with most widely used software applications. 
The only reports that will be generated are on security incidents, 
which should be rare events. Pharmacies should not have daily reports 
to review. DEA has revised the record retention period to two years. 
DEA also notes that in allowing electronic prescriptions, it is 
relieving pharmacies of the burden of storing paper prescriptions.
    Comments. A pharmacy organization asserted that costs of several 
cents per prescription will be significant to some pharmacies.
    DEA Response. DEA estimates that the average cost of the rule will 
be less than one cent per controlled substance prescription, which as 
some commenters noted is far less than the $0.30 per prescription fee 
some commenters stated they are paying intermediaries.
    Comments. A healthcare system stated that PDAs may not be able to 
function as tokens and thumb drives would require software changes and 
take too much time to connect. The commenter believed that other 
solutions would be more expensive. The commenter also noted that mid-
level practitioners would be likely to use the same kind of tokens as 
practitioners, which differed from the assumptions DEA made in its 
initial analysis. That commenter and a second healthcare system also 
stated that the initial Economic Impact Analysis did not include staff 
time for audits.
    DEA Response. DEA has not included PDAs in its cost analysis of the 
interim final rule although some practitioners may use them. The range 
of possible tokens is considerable and the costs associated with them 
wide. For example, one-time-password (OTP) devices are slightly more 
expensive than smart cards or tap-and-go cards, but do not require a 
separate reader. Where readers are needed, they may exist on keyboards, 
or can be separate devices. Because it has no basis for estimating how 
many computers would need readers, DEA has based its cost estimates on 
OTP devices, recognizing that practices may find other options more 
suitable.
    DEA has not estimated staff time for application providers for 
audits in part because the interim final rule limits the audit to 
determining whether the application meets DEA's requirements. An 
auditor will usually make this determination by testing the 
application, which will not involve provider staff time. In addition, 
DEA assumes that once a certification organization is ready to make 
this determination as part of its certification process, application 
providers will not need audits. They will obtain the certification for 
reasons other than compliance with DEA rules.
    Comments. An application provider stated that financial incentives 
may speed adoption more quickly than assumed in the initial Economic 
Impact Analysis. It further stated that the average salary of a primary 
care physician is $104,000, but provided no sourcing for this 
assertion.
    DEA Response. DEA has increased (i.e., shortened) the 
implementation rate to account for the financial incentives that may be 
available to practitioners. According to the Bureau of Labor Statistics 
the average salary rate for a physician in family practice is $167,970 
(May of 2008). Some hospital-based physicians have lower salary rates, 
but their costs are likely to be borne by the institutional 
practitioner.
    Comments. An application provider estimated that cost per unit for 
two-factor authentication at $329 to $349, comprising a hand-held 
reader at $300, a desktop reader at $20, and a smart card ($29). The 
commenter estimated support costs between $300 to $400 a year per 
prescriber to deal with malfunctions. The commenter asserted that it 
would take 3 to 7 days to replace the smart card. The commenter further 
indicated that its current support metrics indicate 7 trouble tickets 
per year per prescriber, 10 percent of which require an office visit. 
The commenter claimed that the average prescriber writes six controlled 
substance prescriptions a week and would not pay as much as DEA 
indicated the costs would be to write controlled substances 
prescriptions electronically. It noted that these costs would 
disproportionately burden stand-alone electronic prescription 
applications because they represent a higher proportion of the annual 
fee. The commenter indicated that the first year cost of $629-749 would 
be a 35 percent increase in the $2000 first year fee. Subsequent year 
costs ($300-400) would be a 58% increase in the $600 charge. The costs 
represent a much smaller percentage of EHR costs. The commenter 
asserted that these costs would deter practitioners from adopting 
electronic prescribing.
    DEA Response. DEA notes that most of the costs the commenter 
estimated relate to a hand-held reader, but the commenter failed to 
explain why this was needed. It also failed to explain why the smart 
card would cost so much, when many are available for a tenth the amount 
listed, and why it would take days to replace the card. If the 
practitioner acquires the card locally, then registers or activates the 
credential, replacement would take little time. The commenter appears 
to be incurring the support costs for problems already. It is unclear 
to DEA, based on the commenter's comments, why the commenter believes 
this would change or increase. Under the interim final rule, the 
application provider is not involved in providing the authentication 
credential. If its application has problems after it has been 
programmed, that is not a cost that accrues to the interim final rule. 
DEA recognizes that any incremental costs will represent a higher 
proportion of the annual fee for stand-alone electronic prescription 
applications. DEA notes, however, that the Federal incentive payments 
available under the American Recovery and Reinvestment Act are for EHR

[[Page 16294]]

applications, not electronic prescription applications. It is likely, 
therefore, that the trend toward EHRs rather than stand-alone 
electronic prescription applications will accelerate.
    The Interim Final Rule Analysis:
    DEA has determined that this interim final rule is an economically 
significant regulatory action; therefore, DEA has conducted an analysis 
of the options. The following sections summarize the economic analysis 
conducted in support of this rule. DEA is seeking further comments on 
the assumptions used in this revised economic analysis and is 
especially interested in any data or information that commenters can 
provide that would reduce the many uncertainties in the estimates as 
discussed below and improve the options considered in the analysis of a 
final rule.
    Options Considered:
    DEA considered three options for the electronic prescribing of 
controlled substances:
    Option 1: The interim final rule as described in this preamble.
    Option 2: The interim final rule with the requirement that one of 
the factors used to authenticate to the application must be a 
biometric.
    Option 3: No additional requirements for electronic prescription or 
pharmacy applications, but a callback for each controlled substance 
electronic prescription.
    Universe of Affected Entities:
    The entities directly affected by this rule are the following:
     DEA individual practitioner registrants who issue 
controlled substance prescriptions or individual practitioners who are 
exempt from registration and who are authorized to issue controlled 
substance prescriptions under an institutional practitioner's 
registration.
     Hospitals and clinics where practitioners may issue 
controlled substance prescriptions.
     Pharmacies.
    In addition, application providers are indirectly affected because 
their applications must meet DEA's requirements before a registrant may 
use them to create or process controlled substance prescriptions. The 
practitioners who prescribe controlled substances are primarily 
physicians, dentists, and mid-level practitioners. Hospitals and 
clinics will be affected if practitioners working for or affiliated 
with the hospital or clinic use the institutional practitioner's 
application to issue prescriptions for persons leaving the institution 
(inpatient medical orders are not subject to these rules). Several 
thousand institutional practitioner registrants (e.g., prisons, jails, 
veterinarians, medical practices, and Federal facilities) are not 
included either because they are unlikely to have staff issuing 
prescriptions, are already counted in the practitioner total, or, in 
the case of Federal facilities, already comply with more stringent 
standards. Table 4 presents the estimates of entities directly affected 
and estimated growth rates, which are based on recent trends. As the 
number of hospitals and retail pharmacies have been declining, DEA did 
not project growth (or decline) for these sectors.

                                 Table 4--Universe of Directly Affected Entities
----------------------------------------------------------------------------------------------------------------
                                            In offices/ in
                                               hospitals                         Growth rate
----------------------------------------------------------------------------------------------------------------
Physicians................................         328,772  ....................................................
                                                   169,337  2.1 percent.\1\
Mid-levels................................          82,579  ....................................................
                                                    48,841  2.2 percent.
Dentists..................................         171,328  ....................................................
                                                     (\2\)  1.3 percent.
Total Practitioner........................        582,729/
                                                   218,178  1.9 percent.
Hospitals and Clinics.....................          12,412  DEA assumes no future growth.
Pharmacies................................          65,421  DEA assumes no future growth.
----------------------------------------------------------------------------------------------------------------
\1\ This rate does not include physicians in hospitals.
\2\ Not applicable.

    The number of application providers is based on the number of 
providers currently certified by SureScripts/RxHub or CCHIT. For 
practitioners, that number is about 170, which DEA assumes will 
increase to 200 by the third year and then begin declining. Pharmacy 
application providers are estimated to be about 40; the actual number 
is lower but DEA increased the number to account for pharmacy chains 
that may have developed their own applications.
    The number of controlled substance prescriptions written is 
relevant to the estimate of cost-savings. DEA estimates the number of 
prescriptions based on the assumption that the percentage of controlled 
substance prescriptions in the top 200 brand name and top 200 generic 
drug prescriptions is the same as it is for the remainder of the 
prescriptions.\41\ According to data from SDI/Verispan, in 2008, 
controlled substances represented about 12 percent of prescriptions for 
the top 400 drugs.\42\ IMS Health data reported a total of 3.8431 
billion prescriptions in 2008.\43\ Based on these data, DEA estimates 
that, with a three percent growth rate for prescriptions, there will be 
about 475 million controlled substance prescriptions in Year 1 of the 
analysis. IMS Health data indicate that about 86 percent of 
prescriptions are filled at retail outlets, which is relevant to 
estimating public wait time as long-term care prescriptions and mail 
order prescriptions will not be affected. Previous DEA analysis has 
indicated that 75 percent of controlled substance prescriptions are 
original prescriptions or 356 million prescriptions in Year 1. DEA has 
previously estimated that about 19 percent of prescriptions are 
currently faxed or phoned into pharmacies. Applying both the 86 percent 
and 19 percent to the number of original prescriptions results in an 
estimate of 247 million prescriptions that may have reduced public wait 
time as electronic prescriptions for controlled substances is 
implemented.
---------------------------------------------------------------------------

    \41\ The top 400 drugs represent about 87% of all prescriptions 
dispensed at retail.
    \42\ See http://www.drugtopics.com for the top 200 generic and 
top 200 brand name drugs.
    \43\ See http://www.imshealth.com. IMS Health data are used for 
total prescriptions because the data include prescriptions for long-
term care and mail order.
---------------------------------------------------------------------------

Unit Costs

    For the interim final Economic Impact Analysis, DEA based all labor 
costs on May 2008 BLS data, inflated to 2009

[[Page 16295]]

dollars and loaded with fringe and overhead. Using BLS data provides a 
consistent source of data. For the NPRM, DEA used other estimates for 
physician and dentist costs, but these were based on salary surveys 
that may be weighted toward larger practices and were not clearly wage 
as opposed to compensation figures. The effect of the change is to 
lower the wage rates for these practitioners.
    Practitioners will have to complete an application to apply for 
identity proofing and a credential. As these applications generally ask 
for standard information that practitioners will be able to fill in 
without needing to collect documents that they would not carry with 
them (e.g., credit cards, driver's licenses), DEA estimates that it 
will take them 10 minutes to complete the form. Credential providers 
generally require subscribers to renew the credential periodically. 
This renewal can take the form of an e-mail request that is signed with 
the credential. To be conservative, DEA estimates that it will take 5 
minutes to renew.
    For hospitals and clinics, DEA estimates that practitioners and 
someone at the credentialing office will spend 2 minutes to verify the 
identity document presented. Practitioners are assumed to take 30 
minutes total for this process because they will need to go to the 
credentialing office. This review will occur only when the hospital or 
clinic first implements controlled substance electronic prescribing and 
will involve only those practitioners that already work at or have 
privileges at the hospital or clinic. All practitioners that are hired 
or gain privileges later will have this step done as part of their 
regular initial credentialing.
    Prior to granting access, someone at each office must verify that 
each practitioner has a valid DEA registration and State authorization 
to practice and, where applicable, dispense controlled substances. As 
this requires nothing more than checking the expiration dates of these 
documents, which are often visibly displayed, DEA estimates that this 
will take an average of one minute. In small practices, which are the 
majority of offices, it may take no time because the registrant will be 
one of the people granting access and the status of every registrant 
will be known. Checking registrations and State authorizations is done 
as part of credentialing at hospitals and clinics and is, therefore, 
not a cost of the rule. Similarly, once the rule is implemented at 
offices, it should not be a cost because credentials should be checked 
before a person is hired.
    Prior to granting access, those who will be given this 
responsibility will need to be trained to do so. DEA estimates the time 
at one hour per person at practices. This estimate may be high, 
particularly for smaller offices. It may also be the case that in some 
larger practices, people already perform this task for other reasons 
and training may be unnecessary. Because it is likely that in larger 
pharmacies, access controls are already being set, DEA estimates that 
the training time will be five minutes.
    DEA estimates that it will take, on average, five minutes to enter 
the data to grant access for the first time at a practice or a 
pharmacy. The approval of the data entry is estimated to take one 
minute. The actual approval may take only a few seconds, but the 
approver may take time away from some other work, but would presumably 
do it when using the computer for other tasks.
    DEA has not estimated the cost of setting logical access controls 
at hospitals because hospital applications should already do this. The 
CCHIT criteria for in-patient applications include logical access 
controls; the HL7 standard used by most hospitals includes logical 
access controls. In addition, an application used by as many different 
departments as exist at hospitals necessarily will impose limits on who 
can carry out certain functions. Consequently, DEA's requirements 
should not entail any actions not already being performed.
    Auditable events reported on security incident logs should be rare 
once the application has been implemented and staff understand their 
permission levels. Because of the size of hospitals and clinics and the 
volume of controlled substance prescriptions at pharmacies, DEA 
estimates that each of them will review security incident logs monthly; 
DEA estimates that the review will take hospitals ten minutes per month 
and pharmacies five minutes per month. Because of the smaller size of 
private practices and the much lower volume of controlled substance 
prescriptions issued, DEA estimates that a review will be needed only 
once a quarter. The review time remains at 5 minutes.
    DEA estimates that reprogramming for electronic prescription 
applications will take, on average, 2,000 hours, an estimate based on 
industry information obtained during the development of DEA's 
Controlled Substances Ordering System rule.\44\ The requirements for 
pharmacy applications are simpler and include functionalities that the 
industry has indicated it already has, so DEA assumes an average of 
1,000 hours of reprogramming for pharmacy applications.
---------------------------------------------------------------------------

    \44\ ``Electronic Orders for Controlled Substances'' 70 FR 
16901, April 1, 2005; Economic Impact Analysis of the Electronic 
Orders Rule available at http://www.DEAdiversion.usdoj.gov/fed_regs/rules/2005/index.html
---------------------------------------------------------------------------

    To estimate the cost of obtaining identity proofing from a 
credential service provider, DEA used the fee SAFE BioPharma charges 
for a three-year digital certificate and a hard token using remote 
identity proofing ($110). This figure may be high because it assumes a 
medium rather than the basic assurance level that DEA is requiring. 
Based on standard industry practice for digital certificates, DEA 
estimates that the credential will need to be renewed every three 
years, but that a complete reapplication will not be required until the 
ninth year. These assumptions are based on the standards incorporated 
in the Federal PKI Policy Authority Common Policy. The cost for the 
three-year renewal is estimated to be $35.00, which is what SAFE 
charges for a three-year digital certificate at the basic assurance 
level. Hospitals and clinics are assumed to use or adapt their existing 
access cards to store the credential and, therefore, incur no 
additional costs for the credential.
    In the initial years, application providers may have to obtain a 
third-party audit to determine whether the application meets the 
requirements of the rule. DEA estimates the cost of this audit at 
$15,000. This estimated cost is about 50 percent of the application fee 
for CCHIT testing and certification of a full ambulatory electronic 
health record application ($29,000). DEA chose to use the CCHIT fees as 
a basis because the interim final rule narrows the scope of the third-
party audit and allows a larger number of auditors to conduct the 
audit. The higher cost estimates in the NPRM were based on obtaining 
particular types of audits and having the audits cover functions that 
will not be subject to auditing for installed applications. In 
addition, the one commenter that already obtained the third-party 
audits specified in the NPRM stated that the costs were much lower than 
DEA had estimated. DEA estimates that within five years, all electronic 
prescription application providers will obtain certification from an 
approved certification organization; because the providers already seek 
these certifications for other reasons, the cost of continuing to 
obtain certifications will not accrue to the rule after that point.

[[Page 16296]]

    Table 5 presents the unit costs for both labor-based costs and 
fees.

                                               Table 5--Unit Costs
----------------------------------------------------------------------------------------------------------------
                Requirement                                  Item, or labor, required                  Unit cost
----------------------------------------------------------------------------------------------------------------
                                                 Non-Labor Costs
----------------------------------------------------------------------------------------------------------------
Identity proofing and credential...........  Remote identity proofing and downloadable code for          $110.00
                                              registrant (includes hard token).
Renewal of credential......................  Three-year renewal.....................................       35.00
                                             Nine-year renewal......................................      110.00
Initial audit of application...............  Certification that application meets DEA requirements..   15,000.00
Reaudit of application.....................  Certification that application still meets DEA            15,000.00
                                              requirements.
----------------------------------------------------------------------------------------------------------------
                                                   Labor Costs
----------------------------------------------------------------------------------------------------------------
Application for identity proofing and        Registrant must fill out form; 10 minutes required.....       28.23
 credential.
Renewal application for credential.........  Registrant must only fill out parts where information         14.12
                                              has changed; 5 minutes needed.
Registration check.........................  Requires one minute for a non-registrant...............
                                             Physician office--nurse................................        1.12
                                             Dental office--dental assistant........................        0.57
Access control--training (practice office).  One hour per person; one is a registrant...............  ..........
Physician plus nurse.......................  .......................................................      259.35
Mid-level plus nurse.......................  .......................................................      151.49
Dentist plus dental assistant..............  .......................................................      201.01
Access control--granting (practice office).  Requires one minute for registrant, five minutes for
                                              non-registrant (nurse).
                                             Physician plus nurse...................................        8.66
                                             Mid-level plus nurse...................................        7.00
                                             Dentist plus dental assistant..........................        5.64
Access control--training (pharmacy)........  Requires five minutes for pharmacy technician..........        2.33
Access control--granting (pharmacy)........  Requires five minutes for pharmacy technician..........        2.33
Review of security logs (practice office)..  Requires five minutes per quarter; 20 minutes per year        22.39
                                              for nurse.
Review of security logs (pharmacy).........  Requires five minutes per quarter; 20 minutes per year        11.43
                                              for pharmacy tech.
Review of security logs (hospital).........  Requires ten minutes per month per year for system           136.64
                                              administrator.
ID check, face to face (hospital only).....  Requires two minutes for HR person AND.................        1.20
                                             30 minutes per hospital practitioner OR................       55.22
                                             30 minutes per private physician.......................       96.08
Reprogramming applications for practices...  Requires 2,000 hours of application provider engineer's     184,197
                                              time.
Reprogramming pharmacy applications........  Requires 1,000 hours of application provider engineer's      92,099
                                              time.
----------------------------------------------------------------------------------------------------------------

Total Costs

    To proceed from unit costs to total costs, it is necessary to 
establish the frequency of occurrence of cost items and the 
distribution of those occurrences, and thus of costs, over time. DEA 
assumes that all application providers will reprogram their 
applications in the first year and that after the fifth year they will 
be able to substitute certification for the third-party audit. DEA 
assumes that pharmacies will be able to accept electronic prescriptions 
in the first year and set initial access controls in that year, but 
that they will incur ongoing costs for checking security incident logs. 
Hospitals and clinics are assumed to adopt applications within five 
years; identity proofing costs occur only in the first year of 
adoption. Practitioners are assumed to adopt electronic prescribing 
over seven years; after that point implementation for practitioners 
basically covers new practitioners and offices as well as ongoing 
costs. Practitioners incur ongoing costs for renewal of the credential, 
reviewing security incident logs, and adding new staff to the access 
list. DEA estimates costs for 15 years. Table 6 presents the 
implementation rate for practitioners.

             Table 6--Implementation Rates for Practitioners
------------------------------------------------------------------------
                                            Implementation
                                                 rate         Cumulative
                                             (percentage)     percentage
------------------------------------------------------------------------
YEAR 1...................................               6.0          6.0
YEAR 2...................................              10.0         16.0
YEAR 3...................................              20.0         36.0
YEAR 4...................................              20.0         56.0
YEAR 5...................................              20.0         76.0
YEAR 6...................................              10.0         86.0
YEAR 7...................................               5.0         91.0
YEAR 8...................................               2.0         93.0
YEAR 9...................................               1.0         94.0
YEAR 10..................................               1.0         95.0
YEAR 11..................................               1.0         96.0
YEAR 12..................................               1.0         97.0
YEAR 13..................................               1.0         98.0
YEAR 14..................................               1.0         99.0
YEAR 15..................................               1.0        100.0
------------------------------------------------------------------------

    Total costs are calculated by multiplying the unit cost for an item 
or activity by the number of entities that will incur the cost in each 
year. Tables 7 and 8 present the Option 1 annualized costs by item and 
regulated entity at both a 7 percent and 3 percent discount rate.

[[Page 16297]]



                      Table 7--Option 1 Annualized Costs by Item and by Sector--7.0 Percent
----------------------------------------------------------------------------------------------------------------
                                 Practitioners'                                     Application
                                     offices         Hospitals      Pharmacies       providers        Totals
----------------------------------------------------------------------------------------------------------------
Credential....................       $14,669,488  ..............  ..............  ..............     $14,669,488
Credential application........         3,844,882  ..............  ..............  ..............       3,844,882
Registration check............            30,405  ..............  ..............  ..............          30,405
Granting access...............           303,086  ..............         $16,752  ..............         319,838
Training for granting.........         7,147,886  ..............          50,255  ..............       7,198,142
Review security logs..........         4,248,868      $1,524,079       1,959,040  ..............       7,731,986
ID verification...............  ................       4,717,580  ..............  ..............       4,717,580
Reprogram applications........  ................  ..............  ..............      $3,842,530       3,842,530
Obtain certification..........  ................  ..............  ..............         391,021         391,021
Audit of applications.........  ................  ..............  ..............         583,957         583,957
                               ---------------------------------------------------------------------------------
    Totals....................        30,244,615       6,241,658       2,026,046       4,817,509      43,329,829
----------------------------------------------------------------------------------------------------------------


                      Table 8--Option 1 Annualized Costs by Item and by Sector--3.0 Percent
----------------------------------------------------------------------------------------------------------------
                                 Practitioners'                                     Application
                                     offices         Hospitals      Pharmacies       providers        Totals
----------------------------------------------------------------------------------------------------------------
Credential....................       $14,761,504  ..............  ..............  ..............     $14,761,504
Credential application........         3,817,785  ..............  ..............  ..............       3,817,785
Registration check............            27,259  ..............  ..............  ..............          27,259
Granting access...............           281,572  ..............         $12,781  ..............         294,353
Training for granting.........         6,315,405  ..............          38,342  ..............       6,353,747
Review security logs..........         4,399,243      $1,518,215       1,885,804  ..............       7,803,262
ID verification...............  ................       3,834,522  ..............  ..............       3,834,522
Reprogram applications........  ................  ..............  ..............      $3,842,530       3,842,530
Obtain certification..........  ................  ..............  ..............         393,356         393,356
Audit of applications.........  ................  ..............  ..............         650,592         650,592
                               ---------------------------------------------------------------------------------
    Totals....................        29,602,769       5,352,737       1,936,927       4,886,478      41,778,910
----------------------------------------------------------------------------------------------------------------

Option 2

    Option 2 is the same as Option 1, except that the two-factor 
authentication credential requires a biometric identifier and a hard 
token. Passwords would not be permitted as an authentication factor. 
The cost items are:
     Biometric readers for practitioners' offices, hospitals, 
and clinics.
     Software packages for practitioners' offices and clinics.
     Reprogramming of applications for hospitals.
    A biometric reader would be needed for every practitioner's 
computer. DEA estimates that hospitals would need one for every 15 
beds, and each clinic would need an average of two readers. Based on 
American Hospital Association data, DEA estimates the number of 
community hospital beds to be 802,658. The number of clinics is 
estimated to be 7,485. There are 20 firms providing applications to 
hospitals, and their number is not expected to change.\45\ All of these 
firms would reprogram their applications in YEAR 1. Costs of readers 
and software packages would be incurred as hospitals and clinics adopt 
electronic prescriptions for controlled substances. Hospital beds and 
clinics are phased in as shown in Table 9.
---------------------------------------------------------------------------

    \45\ The estimate is based on the number of application 
providers that have obtained CCHIT certification for inpatient EHRs.

             Table 9--Phase-in of Hospital Beds and Clinics
------------------------------------------------------------------------
                                                       Beds     Clinics
------------------------------------------------------------------------
YEAR 1............................................    200,665      1,871
YEAR 2............................................    200,665      1,871
YEAR 3............................................    160,532      1,497
YEAR 4............................................    160,532      1,497
YEAR 5............................................     80,266        749
------------------------------------------------------------------------

    There are no costs for hospitals and clinics after YEAR 5. All 
reprogramming costs are in YEAR 1. Costs for practitioners' offices and 
registrants extend over 15 years following the projected start-up of 
electronic prescriptions for controlled substances in practitioners' 
offices and number of registrants in practitioners' offices starting 
electronic prescriptions for controlled substances.
    A biometric reader that meets the requirements costs $114.00.\46\ 
The software package for clinics and offices is $86.00. Reprogramming 
of applications for hospitals would require 200 hours for an 
application provider's engineer at $92.10 per hour. Cost is $18,420 per 
application provider. Table 10 presents the annualized costs of adding 
the biometric.
---------------------------------------------------------------------------

    \46\ Based on the cost of BioTouch 500, which is a separate 
reader. Where the reader is part of a keyboard, the bundled reader 
and software is available for $200. The software cost was derived 
from this price.

                       Table 10--Cost of Option 2
------------------------------------------------------------------------
                                            7.0 percent     3.0 percent
------------------------------------------------------------------------
YEAR 1..................................      $8,037,011      $8,037,011
YEAR 2..................................      10,862,145      11,283,976
YEAR 3..................................      18,424,735      19,883,569
YEAR 4..................................      17,750,891      19,900,309
YEAR 5..................................      16,454,640      19,163,490
YEAR 6..................................       8,085,656       9,782,458
YEAR 7..................................       4,387,114       5,513,892
YEAR 8..................................       2,278,677       2,975,149
YEAR 9..................................       1,570,416       2,130,037
YEAR 10.................................       1,502,772       2,117,445
YEAR 11.................................       1,437,996       2,104,861
YEAR 12.................................       1,375,970       2,092,286
YEAR 13.................................       1,316,578       2,079,722
YEAR 14.................................       1,259,712       2,067,171
YEAR 15.................................       1,205,265       2,054,634
                                         -------------------------------
    Total...............................      95,949,579     111,186,009
------------------------------------------------------------------------


 
------------------------------------------------------------------------
                                               7.0 percent   3.0 percent
------------------------------------------------------------------------
Annualized..................................   $10,534,748    $9,313,672

[[Page 16298]]

 
Annualized plus Option 1....................    53,864,576    51,092,582
------------------------------------------------------------------------

    The cost of the biometrics requirement is additive to the interim 
final rule cost, since no other requirements are eliminated.

Option 3

    Under this option the security requirements of the interim final 
rule are set aside and sole reliance for security is placed on a 
requirement that, on receipt of an electronic prescription for a 
controlled substance, a pharmacy must call the practitioner's office 
for verification of the prescription. For the sake of simplicity, DEA 
has not included in this option estimates of the time that will be 
required to reprogram existing applications to conform to the basic 
information included on every controlled substance prescription. DEA 
has no basis for determining how many existing applications do not 
include or do not transmit all of this information. Similarly, there 
may be some pharmacy applications that will require reprogramming to 
incorporate the requirements for annotations. The costs of 
reprogramming, however, will be relatively small compared with the 
primary cost of this option.
    The cost of this option depends on the number of prescriptions to 
be verified. There were 461,172,000 controlled substance prescriptions 
in 2008.\47\ Annual growth rate has been 3.0 percent. Therefore, DEA 
expects 475,007,160 prescriptions in YEAR 1 and growth thereafter at 
3.0 percent annually. Of these prescriptions, 75.0 percent will be 
original prescriptions, requiring verification if electronic; the 
remainder are refills that are authorized on the original prescription 
and require no contact between the pharmacy and practitioner.
---------------------------------------------------------------------------

    \47\ In 2008, controlled substances represented 12.15% of the 
top 400 brand name and generic drugs sold at retail. The estimated 
number of controlled substance prescriptions is based on the 
assumption that 12% of all prescriptions (3.8431 billion according 
to IMS Health data) are for controlled substances.
---------------------------------------------------------------------------

    Industry estimates indicate that 30 percent of original 
prescriptions generate callbacks to deal with formulary issues, 
requests to change to generic forms of the prescribed drug, 
illegibility, and other problems. Based on data from a 2004 Medical 
Group Management Association survey, 34 percent of callbacks on 
original prescriptions were for formulary issues, 31 percent were about 
generic drugs, and 35 percent were on other issues.\48\ The callback 
rate for controlled substance prescriptions is likely to be lower than 
30 percent because more than 85 percent of controlled substance 
prescriptions are for generic drugs. Adjusting for a lower number of 
calls related to generic drugs, DEA estimates that currently 22 percent 
of controlled substance prescriptions require callbacks. The callback 
option applies only to new calls that would need to be placed, or 78 
percent of the original prescriptions: 277,879,189 (0.78 x 0.75 x 
475,007,160). For the 22 percent of prescriptions that already require 
callbacks, the confirmation would simply be part of a call that is 
being made anyway and, therefore, is not an additional cost. The number 
of electronic prescriptions each year requiring calls will be 
determined by the rate of adoption of electronic prescriptions for 
controlled substances. Because these are callbacks simply to confirm 
the legitimacy of the prescription, DEA assumes that each call would 
require three minutes of a pharmacy technician's time, three minutes of 
a medical assistant's time, and one minute of the practitioner's time. 
Table 11 presents the present value and annualized costs of Option 3.
---------------------------------------------------------------------------

    \48\ http://www.mgma.com/WorkArea/DownloadAsset.aspx?id=19248, 
accessed 08/06/09.

          Table 11--Present Value and Annualized Cost Option 3
------------------------------------------------------------------------
                                         7.0 percent       3.0 percent
------------------------------------------------------------------------
YEAR 1..............................      $100,904,733      $100,904,733
YEAR 2..............................       259,020,250       269,079,289
YEAR 3..............................       561,008,812       605,428,399
YEAR 4..............................       840,056,809       941,777,510
YEAR 5..............................     1,097,457,393     1,278,126,621
YEAR 6..............................     1,195,435,021     1,446,301,176
YEAR 7..............................     1,217,649,690     1,530,388,454
YEAR 8..............................     1,197,891,176     1,564,023,365
YEAR 9..............................     1,165,509,232     1,580,840,821
YEAR 10.............................     1,133,874,313     1,597,658,276
YEAR 11.............................     1,102,975,819     1,614,475,732
YEAR 12.............................     1,072,802,902     1,631,293,187
YEAR 13.............................     1,043,344,493     1,648,110,643
YEAR 14.............................     1,014,589,338     1,664,928,098
YEAR 15.............................       986,526,025     1,681,745,554
                                     -----------------------------------
    Total...........................    13,989,046,006    19,155,081,859
        Annualized..................     1,535,922,056     1,604,555,706
------------------------------------------------------------------------


               Table 12--Total Annualized Costs of Options
------------------------------------------------------------------------
                                         7.0 percent       3.0 percent
------------------------------------------------------------------------
Option 1............................       $43,329,829       $41,778,910
Option 2--Required Use of Biometrics        53,864,576        51,092,582
Option 3--Callbacks.................     1,535,922,056     1,604,555,706
------------------------------------------------------------------------


[[Page 16299]]

Benefits:

    Electronic prescriptions are widely expected to reduce errors in 
medication dispensing because they will eliminate illegible written 
prescriptions and misunderstood oral prescriptions. They are also 
expected to reduce the number of callbacks from pharmacy to 
practitioner to address legibility, formulary, and contraindication 
issues. Electronic prescriptions may also reduce processing time at the 
pharmacy and wait time for patients. These benefits are likely to be 
mitigated to some extent. As a Rand study suggested, practitioners may 
fail to review the prescription and notice errors that occur when the 
wrong item is selected from one or more drop-down menus; pharmacists 
may be less likely to question a legible electronic prescription.\49\ 
The formulary and contraindication checks are functions that 
practitioners sometimes disable because they do not work as they should 
or take too much time.\50\ In addition, recent studies indicate that 
electronic prescriptions sometimes are missing information, 
particularly directions for use and dosing errors.\51\ \52\ 
Nonetheless, electronic prescriptions may provide benefits in avoided 
medication errors, reduced processing time, and reduced callbacks. 
These benefits of electronic prescriptions are not directly 
attributable to this rule because they accrue to electronic 
prescribing, not the incremental changes being required in this rule.
---------------------------------------------------------------------------

    \49\ Bell, D.S. et al., ``Recommendations for Comparing 
Electronic Prescribing Systems: Results of An Expert Consensus 
Process,'' Health Affairs, May 25, 2004, W4-305-317.
    \50\ Grossman, J.M. et al., ``Physicians' Experiences Using 
Commercial E-Prescribing Systems,'' Health Affairs, 26, no. 3 
(2007), w393-w404.
    \51\ Warholak, T.L. and M.T. Rupp. ``Analysis of community chain 
pharmacists' interventions on electronic prescriptions.'' Journal of 
American Pharm Association, 2009, Jan-Feb; 49(1): 59-64.
    \52\ Astrand, B. et al., ``Assessment of ePrescription Quality: 
an observational study at three mail order pharmacies.'' BMC Med 
Inform Decis Mak, 2009 Jan 26; 9:8.
---------------------------------------------------------------------------

    DEA has quantified three types of benefits: reduced number of 
callbacks to clarify prescriptions, the reduction in wait time for 
patients picking up prescriptions, and the cost-savings pharmacies will 
realize from eliminating storage of paper records. One of the greatest 
burdens in the paper system is the need for callbacks to clarify 
prescriptions. Clarifications and changes may be required for several 
reasons: the prescription is not legible; required information is not 
included on the prescription; the prescribed dosage unit does not 
exist; the particular medication is not approved by the patient's 
health insurance; and the drug prescribed is contraindicated because it 
reacts with other medications the patient is taking or because it 
negatively affects other conditions from which the patient suffers. 
Each callback involves the pharmacy staff and one or more staff at the 
practitioner's office, often including the practitioner. Electronic 
prescriptions will eliminate illegible prescriptions and could 
eliminate those with missing information or unavailable dosage units or 
forms. The recent studies cited above indicate that at least some 
prescription applications do not prevent practitioners from 
transmitting electronic prescriptions that are incomplete. At present, 
the field for directions for use in the NCPDP SCRIPT has not been 
standardized; when it is, the issues cited in the studies related to 
these directions may be resolved. Whether formulary and 
contraindication callbacks are eliminated will depend on the functions 
of the electronic prescription applications and the accuracy of the 
drug databases that they use.
    The public is also affected by the current system. For the majority 
of controlled substance prescriptions, the patient (or someone acting 
for the patient) presents a paper prescription to the pharmacy and then 
waits for the pharmacy to fill it. The time between the point when the 
prescription is handed to the pharmacist and the point when it is ready 
for pick-up is a cost to the public.
    The percentage of callbacks that will be eliminated by electronic 
prescribing is unclear. The Centers for Medicare and Medicaid Services, 
in its November 16, 2007, proposed rule on formulary and generic 
transactions, estimated a 25 percent reduction in time spent on 
callbacks.\53\ DEA similarly assumes that callbacks will be reduced by 
25 percent. For these callbacks, which require more effort than the 
simple confirmation required for Option 3, DEA used the time estimates 
from the MGMA survey (6.9 minutes of staff time per call and 4.2 
minutes of practitioner time).\54\ Assuming that electronic controlled 
substance prescriptions phase in over 15 years, as described above, the 
annualized time-saving for eliminating 25 percent of these callbacks 
would be $420 million (at 7% discount) or $439 million (at 3% 
discount).
---------------------------------------------------------------------------

    \53\ 72 FR 64900, November 16, 2007.
    \54\ http://www.mgma.com/WorkArea/DownloadAsset.aspx?id=19248, 
accessed 08/06/09.
---------------------------------------------------------------------------

    Electronic prescriptions could also reduce the patient's wait time 
at the pharmacy. The number of original controlled substance 
prescriptions that could require public wait time is based on the 
estimated number of original prescriptions (approximately 356 million 
in 2009), reduced by 19 percent, to account for those prescriptions 
phoned to the pharmacy \55\ plus another 14 percent to remove those 
that are currently filled by mail order pharmacies or long-term care 
facilities.\56\ Assuming the average wait time is 15 minutes for the 81 
percent of original prescriptions that are presented on paper to retail 
pharmacies (not mail order or long-term care prescriptions), if those 
waiting times are eliminated, at the current United States average 
hourly wage ($20.49), the annualized savings over 15 years would be $1 
billion (at 7% discount) or $1.03 billion (at 3% discount).
---------------------------------------------------------------------------

    \55\ A 1999 Drugtopics.com survey indicated that 36% of all 
prescriptions were phoned in; because refills are usually authorized 
on the original prescription and do not require second calls, and 
slightly less than half of prescriptions are refills, the analysis 
uses 19% for phoned in prescriptions.
    \56\ Based on IMS Health 2008 channel distribution by U.S. 
dispensed prescriptions. http://imshealth.com, accessed June 16, 
2009.
---------------------------------------------------------------------------

    The estimate for public wait time is an upper bound, as such it is 
not included in the primary estimate for the benefits of this interim 
final rule. It assumes that the practitioner will transmit the 
prescription and that the pharmacist will open the record and fill it 
before the patient arrives at the pharmacy. Recent research on 
electronic prescriptions found that 28 percent of electronic 
prescriptions transmitted were never picked up by patients; for 
painkillers, more than 50 percent were not picked up.\57\ If pharmacies 
prepared electronic prescriptions before the patient arrives, the 
pharmacy will have spent time for which it will not be reimbursed if 
the patient does not pick up the prescription and will spend further 
time returning the drugs to stock and correcting records. It is 
possible, therefore, that pharmacies will not be willing to fill 
electronic prescriptions for controlled substances until they are 
certain that the patient wants to fill the prescription. The primary 
estimate for public wait time, therefore, is zero.
---------------------------------------------------------------------------

    \57\ Solomon, M., and S.R. Majumdar. ``Primary Non-Adherence of 
Medications: Lifting the Veil on Prescription-filling Behavior'' 
Journal of General Internal Medicine, March 2, 2010.
---------------------------------------------------------------------------

    Table 13 presents the annualized gross benefits at a 7.0 percent 
and 3.0 percent discount rate.

[[Page 16300]]



                   Table 13--Annualized Gross Benefits
------------------------------------------------------------------------
                                                7%              3%
------------------------------------------------------------------------
Callbacks Avoided......................     $419,745,516    $438,502,110
------------------------------------------------------------------------

    These benefits are gross rather than net benefits, but it is not 
possible to compare these cost-savings to the costs of the rule or to 
estimate net benefits. These savings will accrue to any electronic 
prescription application. The only way to assess net benefits is to 
compare them with the costs of the full application and its 
implementation, not the incremental costs of DEA's requirements.
    Pharmacies are required to retain all original controlled substance 
prescriptions, including oral prescriptions that the pharmacist reduces 
to writing, on paper for two years. As electronic prescriptions replace 
paper records, pharmacies will be able to eliminate file cabinets, 
freeing up space for other uses. The annualized cost of a prescription 
file cabinet is $78.50 ($715 annualized over 15 years at 7%); the cost 
of the floor space is $55.34 per cabinet (2.77 square feet times $20/
square feet rental price for retail space). The annualized cost-savings 
for pharmacies are $1.38 million at 7 percent and $1.4 million at 3 
percent.

Other Benefits

    DEA has not attempted to quantify or monetize the benefits of the 
rule that relate to diversion because of a lack of data on the extent 
of diversion of controlled substances through forged or altered 
prescriptions and alteration of pharmacy records. Electronic 
prescriptions for controlled substances will directly affect the 
following types of diversion:
     Stealing prescription pads or printing them, and writing 
non-legitimate prescriptions.
     Altering a legitimate prescription to obtain a higher dose 
or more dosage units (e.g., changing a ``10'' to a ``40'').
     Phoning in non-legitimate prescriptions late in the day 
when it is difficult for a pharmacy to complete a confirmation call to 
the practitioner's office.
     Altering a prescription record at the pharmacy to hide 
diversion from pharmacy stock.
    These are examples of prescription forgery that contribute 
significantly to the overall problem of drug diversion. DEA expects 
this rule to reduce significantly these types of forgeries because only 
practitioners with secure prescription-writing applications will be 
able to issue electronic prescriptions for controlled substances and 
because any alteration of the prescription at the pharmacy will be 
discernible from the audit log and a comparison of the digitally signed 
records. DEA expects that over time, as electronic prescribing becomes 
the norm, practitioners issuing paper prescriptions for controlled 
substances may find that their prescriptions are examined more closely.
    The Substance Abuse and Mental Health Services Administration 
(SAMHSA) runs the Drug Abuse Warning Network (DAWN), a public health 
surveillance system that monitors drug-related visits to hospital 
emergency departments and drug-related deaths investigated by medical 
examiners and coroners. SAMHSA reported that in 2003, in six States 
(Maine, Maryland, New Hampshire, New Mexico, Utah, and Vermont) there 
were 352 deaths from misuse of oxycodone and hydrocodone, both 
prescription controlled substances. SAMHSA data for 2006 show that 
195,000 emergency department visits involved nonmedical use of 
benzodiazepines (Schedule IV) and 248,000 involved nonmedical use of 
opioids (Schedule II and III). Of all visits involving nonmedical use 
of pharmaceuticals, about 224,000 resulted in admission to the 
hospital; about 65,000 of those individuals were admitted to critical 
care units; 1,574 of the visits ended with the death of the patient. 
More than half of the visits involved patients 35 and older. Using a 
value per life of $5.8 million, the costs of the 2003 deaths from 
misuse of prescription controlled substances in the six States is more 
than $2 billion.\58\ The cost of the 2006 emergency room visits is 
above $350 million (at $1,000 per visit), not including the cost of 
further in-patient care for those admitted. These costs are some 
fraction of the total cost to the Nation. DEA has no basis for 
estimating what percentage of these costs could be addressed by the 
rule. If, however, the rule prevents even a small fraction of the 
deaths and emergency care the benefits will far exceed the costs.
---------------------------------------------------------------------------

    \58\ The DAWN mortality data from 2005 indicate that almost 
4,900 people died with prescription opioids in their bloodstream; 
about 600 were not using any other drug or alcohol. These numbers, 
however, do not indicate how many of the people were using the drugs 
for nonmedical purposes.
---------------------------------------------------------------------------

    These costs also do not represent all of the costs of drug abuse to 
society. Drug abuse is associated with crime and lost productivity. 
Crime imposes costs on the victims as well as on government. DEA does 
not track information on controlled substance prescription drug 
diversion because enforcement is generally handled by State and local 
authorities. The cost of enforcement is, however, considerable. In 
2007, DEA spent between $2,700 for a small case and $147,000 for a 
large diversion case just for the primary investigators; adjudication 
costs and support staff are additional. It is reasonable to assume that 
State and local law enforcement agencies are spending similar sums per 
case. Some cases involve multiple jurisdictions, all of which bear 
costs for collecting data and deposing witnesses. The rule could reduce 
the number of cases and, therefore, reduce the costs to governments at 
all levels. A reduction in forgeries will also benefit practitioners 
who will be less likely to be at risk of being accused of diverting 
controlled substances and of then having to prove that they were not 
responsible.
    Adverse drug events that result from medication errors are 
frequently cited as a benefit of electronic prescriptions. Illegible 
prescriptions and misunderstood oral prescriptions can result in the 
dispensing of the wrong drug, which may cause medical problems and, at 
the very least, fail to provide the treatment a practitioner has 
determined is necessary. Once a practitioner has access to a patient's 
complete medication list, electronic prescription applications hold the 
promise of identifying contraindication problems so that a patient is 
not prescribed drugs that taken together cause health problems or 
cancel the benefits. Allergy alerts will also warn practitioners of 
potential medication concerns.
    DEA has not attempted to estimate the extent of these benefits for 
two reasons. First, there are few data that indicate the extent of the 
problem as it relates to prescriptions. The data most frequently cited 
on medication errors and adverse drug events (1.5 million preventable 
adverse drug events) are from two literature reviews conducted by the

[[Page 16301]]

Institute of Medicine.\59\ These reviews and the estimate are based on 
studies that looked at medication errors that occur in hospitals, 
nursing homes, clinics, and ambulatory settings. Similarly, a 2008 
review of studies found fewer errors with electronic medication orders, 
but at least 24 of the 27 studies reviewed covered only inpatient 
medication orders, which DEA does not regulate.60 61 Many of 
the studies cover errors that will not be addressed by electronic 
prescribing, such as inpatient administration errors (i.e., either the 
chart was incorrect or the chart was correct, but the wrong drug or 
dosage was administered or the drug was given to the wrong patient), 
pharmacy dispensing errors (i.e., the prescription was correct, but the 
wrong drug was given to the patient), failure to include the dosage or 
other information on the label, and failure to include informational 
inserts with the dispensed drug. All of these may cause adverse drug 
events, but will not be addressed by electronic prescribing. Other 
errors, such as the practitioner's selection of the wrong dose, wrong 
drug, or wrong frequency of use, may or may not be addressed by 
electronic prescribing. DEA has no basis to determine what number of 
adverse drug events could be prevented by the use of an electronic 
prescription application. Although illegible prescriptions have caused 
adverse drug events when the wrong drug or dosage was dispensed, most 
often pharmacies contact the practitioner to decipher prescriptions 
rather than guess at the drug or dosage intended. In addition, the 
assumption that the use of electronic prescription applications will 
alert practitioners to contraindications and allergies is based on the 
assumption that the patient's medical record will be complete. Although 
this may be the case when every patient has an EHR and all of the 
applications are interoperable so that a practitioner can access 
pharmacy records, until that time the medical record will be only as 
complete as the patient is willing or able to make it, which will limit 
the ability of the application to alert the practitioner to potential 
problems. Similarly, until EHRs have databases that link drug names to 
diagnostic codes and dosage units to age and weight, the applications 
will have no way to prevent a practitioner from issuing a prescription 
with an inappropriate drug name or dosage.
---------------------------------------------------------------------------

    \59\ ``To Err is Human: Building a Safer Health System,'' IOM 
2000; ``Preventing Medication Errors,'' IOM 2007. http://www.nap.edu.
    \60\ Ammenwerth, E. et al. ``The Effect of Electronic 
Prescribing on Medication Errors and Adverse Drug Events: A 
Systematic Review.'' Jour. Am. Medical Informatics Assn., June 25, 
2008.
    \61\ Most of the studies label all medical orders as 
prescriptions, whether they are included on a patient's chart in a 
hospital or LTCF or are written and given to a patient to fill at a 
pharmacy.
---------------------------------------------------------------------------

    Second, the use of electronic prescription applications and 
transmission systems may introduce errors. Keystroke and data entry 
errors may replace some of the errors that occur with illegible 
handwriting. A comment on the proposed rule from a State pharmacy board 
indicated that, at least at this early stage of implementation, the 
translation of the electronic data file to the pharmacies has caused 
data to be placed in the wrong fields and, in some cases, in the wrong 
patient's file. Similarly, a 2006 survey of chain pharmacy experience 
with electronic prescribing noted both positive experiences (improved 
clarity and speed) and negative, prescribing errors, particularly those 
with wrong drugs or directions.\62\
---------------------------------------------------------------------------

    \62\ Rupp, M.T. and T.L. Warholack. ``Evaluation of e-
prescribing in chain community pharmacy: best-practice 
recommendations.'' J. Am. Pharm. Assoc. 2008 May-Jun; 48(3):364-370.
---------------------------------------------------------------------------

    DEA believes that electronic prescribing will reduce the number of 
prescription errors, but it has no basis for estimating the scope of 
the problem or the extent of reduction that will occur and the speed at 
which it will occur. Some of the problems will not be solved until EHRs 
are common and linked; others could be addressed more easily by 
programming applications to require all of the fields to be completed 
before transmission. Even the best system is unlikely to be able to 
eliminate human errors.
    Uncertainties:
    Any economic analysis involves some level of uncertainty about 
elements of the analysis. This is particularly true for this analysis, 
which must estimate costs for implementation of a new technology and 
project voluntary adoption rates. This section discusses the elements 
that have the greatest level of uncertainty associated with them.
    The American Recovery and Reinvestment Act (Pub. L. 111-5) provides 
incentives for practitioners to adopt electronic health record 
applications; the incentives are scheduled to end after 2016. The 
analysis assumes that practitioners will adopt electronic prescribing 
by that time; after that point all of the implementation occurs with 
new entrants. Whether adoption is, in fact, that rapid will depend on a 
number of factors unrelated to this rulemaking. The barriers to 
adoption continue to be the high cost of the applications, which may be 
greater than the subsidies; the disruption that implementation creates 
in a practice; and uncertainty about the applications themselves.\63\ 
The pattern with software applications is that a large number of firms 
enter a market, but the vast majority of them fail, leaving a very few 
dominant providers.\64\ The health IT market is still in the early 
phases of this process. DEA has no basis for estimating when dominant 
players will emerge. The 7-year implementation period projected may be 
too conservative or too optimistic.
---------------------------------------------------------------------------

    \63\ California HealthCare Foundation, Snapshot: The State of 
Health Information Technology in California, 2008.
    \64\ Bergin, T.J., ``The Proliferation and Consolidation of Word 
Processing Software: 1985-1995.'' IEEE Annals of the History of 
Computing. Volume 28, Issue 4, Oct.-Dec. 2006 Page(s):48-63.
---------------------------------------------------------------------------

    The time for reprogramming existing applications is estimated to be 
between 1,000 hours and 2,000 hours. DEA based the upper estimate on 
information provided by the industry for DEA's rulemaking regarding 
electronic orders for controlled substances. The actual cost to 
existing application providers is likely to vary widely. Some providers 
may meet all or virtually all of the requirements and need little 
reprogramming. Many of the requirements are standard practice for 
software (e.g., logical access controls for hospitals) and should need 
minimal adjustments. Most electronic prescription applications appear 
to present the data DEA will require on prescriptions. Any software 
firm that uses the Internet for any transaction will have digital 
signature capability. Electronic health record applications must 
control access to gain Certification Commission for Healthcare 
Information Technology certification. Nonetheless, DEA expects that for 
some existing providers, the requirements may take more than the 
estimated time. The extent to which this requires additional time will 
also depend on whether the changes are incorporated into other updates 
to the application or are done on a different schedule.
    Another uncertainty of application provider costs relates to the 
third-party audit and the time that will elapse before a certification 
organization is able to certify compliance with DEA's requirements. If 
the Certification Commission for Healthcare Information Technology 
includes DEA's requirements in its criteria, the costs for third-party 
audits may be eliminated sooner than estimated. The interim final rule 
provides more options for obtaining a third-party audit, which should 
reduce its cost. DEA has not assumed

[[Page 16302]]

that any organization will certify pharmacy applications because no 
organization currently does so except for determining whether the 
pharmacy application can read a SCRIPT format.
    The single largest cost for practitioners is obtaining identity 
proofing and an authentication credential. DEA used the cost of a 
three-year digital certificate at a medium assurance level from the 
SAFE BioPharma Certification Authority for the cost estimate. SAFE 
meets the criteria set in the rule. Other firms that meet the criteria 
provide digital certificates and other credentials for more and for 
less. The actual cost will not be known until the rule is implemented 
and practitioners and providers decide on the type of credential they 
will use. Some commenters on the proposed rule stated that remote 
identity proofing, which is allowable, can be done very quickly, which 
could lower the cost. The firms providing the service, however, may 
impose other requirements beyond those of DEA, which could increase the 
cost.
    There will also be costs associated with lost or compromised 
credentials. DEA has not attempted to estimate those costs because the 
frequency with which this will occur and the requirements that 
credential providers will impose is not known. Some practitioners will 
never incur these costs while others may incur them multiple times. 
Credential providers may require a practitioner to go through identity 
proofing or may impose lesser requirements. If one of the two factors 
is a password, credential providers may deal with password resets as 
they do now; password resets do not usually involve issuing a new token 
or a fee.

C. Regulatory Flexibility Act

    Under the Regulatory Flexibility Act of 1980 (5 U.S.C. 601-612) 
(RFA), Federal agencies must evaluate the impact of rules on small 
entities and consider less burdensome alternatives. In its Economic 
Impact Analysis, DEA has evaluated the cost of the rule on individual 
practitioners and small pharmacies. The initial costs to the smallest 
practitioner office will be about $400 ($110 for identity proofing 
including the authentication credential, and $290 in labor costs to 
complete the application, receive access control training, and set 
logical access controls). The main ongoing costs for the rule will be 
the renewal of the credential ($49 every three years) and checking 
security logs ($22 per year) plus any incremental cost of the software 
or application. The initial costs for the basic rule elements represent 
about 0.3 percent of the annual income of the lowest paid practitioner 
and 0.1 percent of average revenues. The ongoing costs are considerably 
lower. For practices with a physician and a mid-level practitioner, the 
costs would be lower because access control training would not need to 
involve the physician. (Mid-level practitioners, because they are 
generally employees, are not small entities under the Regulatory 
Flexibility Act.)
    Determining the incremental cost of the application requirements 
per practitioner is difficult because it depends on the number of 
application providers, the number of customers, the number of 
application requirements that an application provider does not already 
meet, and how costs are recovered (in the year in which the money is 
spent or over time). For example, an electronic health record 
application that had to reprogram to the full extent will have 
incremental application costs of $199,000 ($15,000 for the third-party 
audit and $184,000 for reprogramming). If the provider recovered the 
costs from 1,000 practitioners (charges are usually on a per 
practitioner, not per practice basis), the incremental cost to those 
customers will be $199 or about $17 a month. The costs for the 
application provider in the out years will be much lower ($15,000 every 
two years) because no further programming is needed. Even if the 
application provider did not add practitioners and continued to obtain 
a third-party audit rather than rely on certification, the incremental 
cost to practitioners will be less than a dollar a month.
    For pharmacies, the costs will be the incremental cost that their 
application provider charges to cover the costs of reprogramming and 
audits ($92,000 plus $15,000) plus the cost of reviewing the security 
log ($11.43 per year) and initial access control training and initial 
access control setting ($4.66). In the first year, if the application 
providers recover the programming costs and initial audit costs in a 
single year, the average incremental cost to a pharmacy for these two 
activities will be $65 ($4,284,900 first year cost divided by 65,421 
pharmacies). The total first year cost will, therefore, be less than 
$100. After that, the incremental charge to recover the cost of the 
third-party audit will be $9 per pharmacy every two years, assuming the 
cost is evenly distributed across all pharmacies. The pharmacy will 
have continuing labor costs for reviewing security logs ($11.43). The 
first year charge represents less than 0.01 percent of an independent 
pharmacy's annual sales. The annual cost is less than $0.01 per 
controlled substance prescription. It also represents a far lower cost 
than the pharmacy will pay its application provider to cover the fee 
charged by SureScripts/RxHub or another intermediary for processing the 
prescriptions. According to comments DEA received to its notice of 
proposed rulemaking, the application provider charges a transaction fee 
of $0.30 per electronic prescription to cover intermediary charges for 
routing and, where necessary converting, prescriptions to ensure that 
the pharmacy system will be able to capture the data electronically. 
Based on National Association of Chain Drug Stores data on the average 
price of prescriptions ($71.69) and the average value of prescription 
sales, an independent pharmacy processes about 36,000 prescriptions a 
year and will have to pay about $10,800 to cover the transaction 
fee.\65\
---------------------------------------------------------------------------

    \65\ http://www.nacds.org/wmspage.cfm?parm1=507, accessed 6/17/
09.
---------------------------------------------------------------------------

    The average annualized cost to hospitals and clinics is about $180, 
which does not represent a significant economic impact. Most of the 
hospital tasks are part of their routine business practices related to 
credentialing.
    Application providers are not directly regulated by the rule and, 
therefore, are not covered by the requirements of the RFA. DEA notes, 
however, that the costs of the rule are not so high that any of these 
firms will not be able to recover them from their customers. 
Reprogramming is a routine practice in the software industry; 
applications are updated with some frequency to add features and fix 
problems. The additional requirements of the rule can be incorporated 
during the update cycle. Many of these firms are already spending more 
than DEA has estimated to obtain CCHIT certification; in time, DEA 
expects that this certification (or a similar certification) will 
replace the third-party audit, further reducing their costs.
    Based on the above analysis, DEA has determined that although the 
rule will impact a substantial number of small entities, it will not 
impose a significant economic impact on any small entity directly 
subject to the rule.

D. Congressional Review Act

    It has been determined that this rule is a major rule as defined by 
Section 804 of the Small Business Regulatory Enforcement Fairness Act 
of 1996 (Congressional Review Act). This rule is voluntary and could 
result in a net reduction in costs. This rule will not result in a 
major increase in costs or

[[Page 16303]]

prices; or significant adverse effects on competition, employment, 
investment, productivity, innovation, or on the ability of United 
States-based companies to compete with foreign-based companies in 
domestic and export markets.

E. Paperwork Reduction Act

    As part of its NPRM, DEA included a discussion of the hour burdens 
associated with the proposed rule. DEA did not receive any comments 
specific to the information collection aspects of the NPRM.
    The Department of Justice, Drug Enforcement Administration, has 
submitted the following information collection request to the Office of 
Management and Budget for review and clearance in accordance with 
review procedures of the Paperwork Reduction Act of 1995.
    All suggestions or questions regarding additional information, to 
include obtaining a copy of the information collection instrument with 
instructions, should be directed to Mark W. Caverly, Chief, Liaison and 
Policy Section, Office of Diversion Control, Drug Enforcement 
Administration, 8701 Morrissette Drive, Springfield, VA 22152.
    Overview of information collection 1117-0049:
    (1) Type of Information Collection: New collection.
    (2) Title of the Form/Collection: Recordkeeping for electronic 
prescriptions for controlled substances.
    (3) Agency form number, if any, and the applicable component of the 
Department of Justice sponsoring the collection:
    Form number: None.
    Office of Diversion Control, Drug Enforcement Administration, 
Department of Justice.
    (4) Affected public who will be asked or required to respond, as 
well as a brief abstract:
    Primary: business or other for-profit.
    Other: non-profit healthcare facilities.
    Abstract: DEA is requiring that each registered practitioner apply 
to a credential service provider approved by the Federal government to 
obtain identity proofing and a credential. Hospitals and other 
institutional practitioners may conduct this process in-house as part 
of their credentialing. For practitioners currently working at or 
affiliated with a registered hospital or clinic, the hospital/clinic 
will have to check a government-issued photographic identification. In 
the future, this will be done when the hospital/clinic issues 
credentials to new hires or newly affiliated physicians. At 
practitioner offices, two people will need to enter logical access 
control data into the electronic prescription application to grant 
permissions for individual practitioner registrants to approve and sign 
controlled substance prescriptions. For larger offices (more than two 
registrants), DEA registrations will be checked prior to granting 
access. Similarly pharmacies will have to enter permissions for access 
to prescription records. Finally, practitioners, hospitals/clinics, and 
pharmacies will have to check security logs periodically to determine 
if security incidents have occurred.
    (5) An estimate of the total number of respondents and the amount 
of time estimated for an average respondent to respond:
    DEA estimates in the first three years of implementation 217,740 
practitioners, 8,688 hospitals and clinics, and 65,421 pharmacies will 
adopt electronic prescribing for a total of 291,849 respondents. The 
average practitioner is expected to spend 0.17 hours, the average 
hospital or clinic, 2.23 hours, and the average pharmacy 0.36 hours 
annually or an average across all respondents of 0.27 hours per year. 
Table 14 presents the burden hours by activity, registrant type, and 
year.

                          Table 14--Burden Hours by Activity, Registrant Type, and Year
----------------------------------------------------------------------------------------------------------------
                     Year 1                        Practitioner      Hospitals      Pharmacies      Total hours
----------------------------------------------------------------------------------------------------------------
Application.....................................           5,827  ..............  ..............           5,827
Registration check..............................             264  ..............  ..............             264
Access control..................................           1,826  ..............           5,452           7,277
Security log....................................           6,086           6,206          21,807          34,099
ID check........................................  ..............          27,712  ..............          27,712
                                                 ---------------------------------------------------------------
    Total.......................................          14,003          33,918          27,259          75,180
----------------------------------------------------------------------------------------------------------------
Year 2                                             Practitioner      Hospitals      Pharmacies      Total hours
----------------------------------------------------------------------------------------------------------------
Application.....................................          10,004  ..............  ..............          10,004
Registration check..............................             454  ..............  ..............             454
Access control..................................           3,101  ..............  ..............           3,101
Security log....................................          16,423          12,412          21,807          50,642
ID check........................................  ..............          28,887  ..............          28,887
                                                 ---------------------------------------------------------------
    Total.......................................          29,983          41,299          21,807          93,089
----------------------------------------------------------------------------------------------------------------
Year 3                                             Practitioner      Hospitals      Pharmacies       Total hours
----------------------------------------------------------------------------------------------------------------
Application.....................................          20,459  ..............  ..............          20,459
Registration check..............................             931  ..............  ..............             931
Access control..................................           6,292  ..............               0           6,292
Security log....................................          37,395           9,120          21,807          68,322
ID check........................................  ..............          24,319  ..............          24,319
                                                 ---------------------------------------------------------------
    Total.......................................          65,076          41,696          21,807         128,579
----------------------------------------------------------------------------------------------------------------

     (6) An estimate of the total public burden (in hours) associated 
with the collection:
    The three year burden hours are estimated to be 296,848 or 98,949 
hours annually.
    If additional information is required contact: Lynn Bryant, 
Department Clearance Officer, Information Management and Security 
Staff, Justice

[[Page 16304]]

Management Division, Department of Justice, Patrick Henry Building, 
Suite 1600, 601 D Street NW., Washington, DC 20530.

F. Executive Order 12988

    This regulation meets the applicable standards set forth in 
Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice 
Reform.

G. Executive Order 13132

    This rulemaking does not preempt or modify any provision of State 
law; nor does it impose enforcement responsibilities on any State; nor 
does it diminish the power of any State to enforce its own laws. 
Accordingly, this rulemaking does not have federalism implications 
warranting the application of Executive Order 13132.

H. Unfunded Mandates Reform Act of 1995

    This rule will not result in the net expenditure by State, local, 
and tribal governments, in the aggregate, or by the private sector, of 
$120,000,000 or more (adjusted for inflation) in any one year and will 
not significantly or uniquely affect small governments. Because this 
rule will not affect other governments, no actions were deemed 
necessary under the provisions of the Unfunded Mandates Reform Act of 
1995. The economic impact on private entities is analyzed in the 
Economic Impact Analysis of the Electronic Prescription Rule.

List of Subjects

21 CFR Part 1300

    Chemicals, Drug traffic control.

21 CFR Part 1304

    Drug traffic control, Reporting and recordkeeping requirements

21 CFR Part 1306

    Drug traffic control, Prescription drugs.

21 CFR Part 1311

    Administrative practice and procedure, Certification authorities, 
Controlled substances, Digital certificates, Drug traffic control, 
Electronic signatures, Incorporation by reference, Prescription drugs, 
Reporting and recordkeeping requirements.

0
For the reasons set out above, 21 CFR parts 1300, 1304, 1306, and 1311 
are amended as follows:

PART 1300--DEFINITIONS

0
1. The authority citation for part 1300 continues to read as follows:

    Authority:  21 U.S.C. 802, 821, 829, 871(b), 951, 958(f).


0
2. Section 1300.03 is added to read as follows:


Sec.  1300.03  Definitions relating to electronic orders for controlled 
substances and electronic prescriptions for controlled substances.

    For the purposes of this chapter, the following terms shall have 
the meanings specified:
    Application service provider means an entity that sells electronic 
prescription or pharmacy applications as a hosted service, where the 
entity controls access to the application and maintains the software 
and records on its servers.
    Audit trail means a record showing who has accessed an information 
technology application and what operations the user performed during a 
given period.
    Authentication means verifying the identity of the user as a 
prerequisite to allowing access to the information application.
    Authentication protocol means a well specified message exchange 
process that verifies possession of a token to remotely authenticate a 
person to an application.
    Biometric authentication means authentication based on measurement 
of the individual's physical features or repeatable actions where those 
features or actions are both distinctive to the individual and 
measurable.
    Biometric subsystem means the hardware and software used to 
capture, store, and compare biometric data. The biometric subsystem may 
be part of a larger application. The biometric subsystem is an 
automated system capable of:
    (1) Capturing a biometric sample from an end user.
    (2) Extracting and processing the biometric data from that sample.
    (3) Storing the extracted information in a database.
    (4) Comparing the biometric data with data contained in one or more 
reference databases.
    (5) Determining how well the stored data matches the newly captured 
data and indicating whether an identification or verification of 
identity has been achieved.
    Cache means to download and store information on a local server or 
hard drive.
    Certificate policy means a named set of rules that sets forth the 
applicability of the specific digital certificate to a particular 
community or class of application with common security requirements.
    Certificate revocation list (CRL) means a list of revoked, but 
unexpired certificates issued by a certification authority.
    Certification authority (CA) means an organization that is 
responsible for verifying the identity of applicants, authorizing and 
issuing a digital certificate, maintaining a directory of public keys, 
and maintaining a Certificate Revocation List.
    Certified information systems auditor (CISA) means an individual 
who has been certified by the Information Systems Audit and Control 
Association as qualified to audit information systems and who performs 
compliance audits as a regular ongoing business activity.
    Credential means an object or data structure that authoritatively 
binds an identity (and optionally, additional attributes) to a token 
possessed and controlled by a person.
    Credential service provider (CSP) means a trusted entity that 
issues or registers tokens and issues electronic credentials to 
individuals. The CSP may be an independent third party or may issue 
credentials for its own use.
    CSOS means controlled substance ordering system.
    Digital certificate means a data record that, at a minimum--
    (1) Identifies the certification authority issuing it;
    (2) Names or otherwise identifies the certificate holder;
    (3) Contains a public key that corresponds to a private key under 
the sole control of the certificate holder;
    (4) Identifies the operational period; and
    (5) Contains a serial number and is digitally signed by the 
certification authority issuing it.
    Digital signature means a record created when a file is 
algorithmically transformed into a fixed length digest that is then 
encrypted using an asymmetric cryptographic private key associated with 
a digital certificate. The combination of the encryption and algorithm 
transformation ensure that the signer's identity and the integrity of 
the file can be confirmed.
    Digitally sign means to affix a digital signature to a data file.
    Electronic prescription means a prescription that is generated on 
an electronic application and transmitted as an electronic data file.
    Electronic prescription application provider means an entity that 
develops or markets electronic prescription software either as a stand-
alone application or as a module in an electronic health record 
application.
    Electronic signature means a method of signing an electronic 
message that

[[Page 16305]]

identifies a particular person as the source of the message and 
indicates the person's approval of the information contained in the 
message.
    False match rate means the rate at which an impostor's biometric is 
falsely accepted as being that of an authorized user. It is one of the 
statistics used to measure biometric performance when operating in the 
verification or authentication task. The false match rate is similar to 
the false accept (or acceptance) rate.
    False non-match rate means the rate at which a genuine user's 
biometric is falsely rejected when the user's biometric data fail to 
match the enrolled data for the user. It is one of the statistics used 
to measure biometric performance when operating in the verification or 
authentication task. The false match rate is similar to the false 
reject (or rejection) rate, except that it does not include the rate at 
which a biometric system fails to acquire a biometric sample from a 
genuine user.
    FIPS means Federal Information Processing Standards. These Federal 
standards, as incorporated by reference in Sec.  1311.08 of this 
chapter, prescribe specific performance requirements, practices, 
formats, communications protocols, etc., for hardware, software, data, 
etc.
    FIPS 140-2, as incorporated by reference in Sec.  1311.08 of this 
chapter, means the National Institute of Standards and Technology 
publication entitled ``Security Requirements for Cryptographic 
Modules,'' a Federal standard for security requirements for 
cryptographic modules.
    FIPS 180-2, as incorporated by reference in Sec.  1311.08 of this 
chapter, means the National Institute of Standards and Technology 
publication entitled ``Secure Hash Standard,'' a Federal secure hash 
standard.
    FIPS 180-3, as incorporated by reference in Sec.  1311.08 of this 
chapter, means the National Institute of Standards and Technology 
publication entitled ``Secure Hash Standard (SHS),'' a Federal secure 
hash standard.
    FIPS 186-2, as incorporated by reference in Sec.  1311.08 of this 
chapter, means the National Institute of Standards and Technology 
publication entitled ``Digital Signature Standard,'' a Federal standard 
for applications used to generate and rely upon digital signatures.
    FIPS 186-3, as incorporated by reference in Sec.  1311.08 of this 
chapter, means the National Institute of Standards and Technology 
publication entitled ``Digital Signature Standard (DSS),'' a Federal 
standard for applications used to generate and rely upon digital 
signatures.
    Hard token means a cryptographic key stored on a special hardware 
device (e.g., a PDA, cell phone, smart card, USB drive, one-time 
password device) rather than on a general purpose computer.
    Identity proofing means the process by which a credential service 
provider or certification authority validates sufficient information to 
uniquely identify a person.
    Installed electronic prescription application means software that 
is used to create electronic prescriptions and that is installed on a 
practitioner's computers and servers, where access and records are 
controlled by the practitioner.
    Installed pharmacy application means software that is used to 
process prescription information and that is installed on a pharmacy's 
computers or servers and is controlled by the pharmacy.
    Intermediary means any technology system that receives and 
transmits an electronic prescription between the practitioner and 
pharmacy.
    Key pair means two mathematically related keys having the 
properties that:
    (1) One key can be used to encrypt a message that can only be 
decrypted using the other key; and
    (2) Even knowing one key, it is computationally infeasible to 
discover the other key.
    NIST means the National Institute of Standards and Technology.
    NIST SP 800-63-1, as incorporated by reference in Sec.  1311.08 of 
this chapter, means the National Institute of Standards and Technology 
publication entitled ``Electronic Authentication Guideline,'' a Federal 
standard for electronic authentication.
    NIST SP 800-76-1, as incorporated by reference in Sec.  1311.08 of 
this chapter, means the National Institute of Standards and Technology 
publication entitled ``Biometric Data Specification for Personal 
Identity Verification,'' a Federal standard for biometric data 
specifications for personal identity verification.
    Operating point means a point chosen on a receiver operating 
characteristic (ROC) curve for a specific algorithm at which the 
biometric system is set to function. It is defined by its corresponding 
coordinates--a false match rate and a false non-match rate. An ROC 
curve shows graphically the trade-off between the principal two types 
of errors (false match rate and false non-match rate) of a biometric 
system by plotting the performance of a specific algorithm on a 
specific set of data.
    Paper prescription means a prescription created on paper or 
computer generated to be printed or transmitted via facsimile that 
meets the requirements of part 1306 of this chapter including a manual 
signature.
    Password means a secret, typically a character string (letters, 
numbers, and other symbols), that a person memorizes and uses to 
authenticate his identity.
    PDA means a Personal Digital Assistant, a handheld computer used to 
manage contacts, appointments, and tasks.
    Pharmacy application provider means an entity that develops or 
markets software that manages the receipt and processing of electronic 
prescriptions.
    Private key means the key of a key pair that is used to create a 
digital signature.
    Public key means the key of a key pair that is used to verify a 
digital signature. The public key is made available to anyone who will 
receive digitally signed messages from the holder of the key pair.
    Public Key Infrastructure (PKI) means a structure under which a 
certification authority verifies the identity of applicants; issues, 
renews, and revokes digital certificates; maintains a registry of 
public keys; and maintains an up-to-date certificate revocation list.
    Readily retrievable means that certain records are kept by 
automatic data processing applications or other electronic or 
mechanized recordkeeping systems in such a manner that they can be 
separated out from all other records in a reasonable time and/or 
records are kept on which certain items are asterisked, redlined, or in 
some other manner visually identifiable apart from other items 
appearing on the records.
    SAS 70 Audit means a third-party audit of a technology provider 
that meets the American Institute of Certified Public Accountants 
(AICPA) Statement of Auditing Standards (SAS) 70 criteria.
    Signing function means any keystroke or other action used to 
indicate that the practitioner has authorized for transmission and 
dispensing a controlled substance prescription. The signing function 
may occur simultaneously with or after the completion of the two-factor 
authentication protocol that meets the requirements of part 1311 of 
this chapter. The signing function may have different names (e.g., 
approve, sign, transmit), but it serves as the practitioner's final 
authorization that he intends to issue the prescription for a

[[Page 16306]]

legitimate medical reason in the normal course of his professional 
practice.
    SysTrust means a professional service performed by a qualified 
certified public accountant to evaluate one or more aspects of 
electronic systems.
    Third-party audit means an independent review and examination of 
records and activities to assess the adequacy of system controls, to 
ensure compliance with established policies and operational procedures, 
and to recommend necessary changes in controls, policies, or 
procedures.
    Token means something a person possesses and controls (typically a 
key or password) used to authenticate the person's identity.
    Trusted agent means an entity authorized to act as a representative 
of a certification authority or credential service provider in 
confirming practitioner identification during the enrollment process.
    Valid prescription means a prescription that is issued for a 
legitimate medical purpose by an individual practitioner licensed by 
law to administer and prescribe the drugs concerned and acting in the 
usual course of the practitioner's professional practice.
    WebTrust means a professional service performed by a qualified 
certified public accountant to evaluate one or more aspects of Web 
sites.

PART 1304--RECORDS AND REPORTS OF REGISTRANTS

0
3. The authority citation for part 1304 continues to read as follows:

    Authority:  21 U.S.C. 821, 827, 831, 871(b), 958(e), 965, unless 
otherwise noted.


0
4. Section 1304.03 is amended by revising paragraph (c) and adding 
paragraph (h) to read as follows:


Sec.  1304.03  Persons required to keep records and file reports.

* * * * *
    (c) Except as provided in Sec.  1304.06, a registered individual 
practitioner is not required to keep records of controlled substances 
in Schedules II, III, IV, and V that are prescribed in the lawful 
course of professional practice, unless such substances are prescribed 
in the course of maintenance or detoxification treatment of an 
individual.
* * * * *
    (h) A person is required to keep the records and file the reports 
specified in Sec.  1304.06 and part 1311 of this chapter if they are 
either of the following:
    (1) An electronic prescription application provider.
    (2) An electronic pharmacy application provider.


0
5. Section 1304.04 is amended by revising paragraph (b) introductory 
text, paragraph (b)(1), and paragraph (h) to read as follows:


Sec.  1304.04  Maintenance of records and inventories.

* * * * *
    (b) All registrants that are authorized to maintain a central 
recordkeeping system under paragraph (a) of this section shall be 
subject to the following conditions:
    (1) The records to be maintained at the central record location 
shall not include executed order forms and inventories, which shall be 
maintained at each registered location.
* * * * *
    (h) Each registered pharmacy shall maintain the inventories and 
records of controlled substances as follows:
    (1) Inventories and records of all controlled substances listed in 
Schedule I and II shall be maintained separately from all other records 
of the pharmacy.
    (2) Paper prescriptions for Schedule II controlled substances shall 
be maintained at the registered location in a separate prescription 
file.
    (3) Inventories and records of Schedules III, IV, and V controlled 
substances shall be maintained either separately from all other records 
of the pharmacy or in such form that the information required is 
readily retrievable from ordinary business records of the pharmacy.
    (4) Paper prescriptions for Schedules III, IV, and V controlled 
substances shall be maintained at the registered location either in a 
separate prescription file for Schedules III, IV, and V controlled 
substances only or in such form that they are readily retrievable from 
the other prescription records of the pharmacy. Prescriptions will be 
deemed readily retrievable if, at the time they are initially filed, 
the face of the prescription is stamped in red ink in the lower right 
corner with the letter ``C'' no less than 1 inch high and filed either 
in the prescription file for controlled substances listed in Schedules 
I and II or in the usual consecutively numbered prescription file for 
noncontrolled substances. However, if a pharmacy employs a computer 
application for prescriptions that permits identification by 
prescription number and retrieval of original documents by prescriber 
name, patient's name, drug dispensed, and date filled, then the 
requirement to mark the hard copy prescription with a red ``C'' is 
waived.
    (5) Records of electronic prescriptions for controlled substances 
shall be maintained in an application that meets the requirements of 
part 1311 of this chapter. The computers on which the records are 
maintained may be located at another location, but the records must be 
readily retrievable at the registered location if requested by the 
Administration or other law enforcement agent. The electronic 
application must be capable of printing out or transferring the records 
in a format that is readily understandable to an Administration or 
other law enforcement agent at the registered location. Electronic 
copies of prescription records must be sortable by prescriber name, 
patient name, drug dispensed, and date filled.


0
6. Section 1304.06 is added to read as follows:


Sec.  1304.06  Records and reports for electronic prescriptions.

    (a) As required by Sec.  1311.120 of this chapter, a practitioner 
who issues electronic prescriptions for controlled substances must use 
an electronic prescription application that retains the following 
information:
    (1) The digitally signed record of the information specified in 
part 1306 of this chapter.
    (2) The internal audit trail and any auditable event identified by 
the internal audit as required by Sec.  1311.150 of this chapter.
    (b) An institutional practitioner must retain a record of identity 
proofing and issuance of the two-factor authentication credential, 
where applicable, as required by Sec.  1311.110 of this chapter.
    (c) As required by Sec.  1311.205 of this chapter, a pharmacy that 
processes electronic prescriptions for controlled substances must use 
an application that retains the following:
    (1) All of the information required under Sec.  1304.22(c) and part 
1306 of this chapter.
    (2) The digitally signed record of the prescription as received as 
required by Sec.  1311.210 of this chapter.
    (3) The internal audit trail and any auditable event identified by 
the internal audit as required by Sec.  1311.215 of this chapter.
    (d) A registrant and application service provider must retain a 
copy of any security incident report filed with the Administration 
pursuant to Sec. Sec.  1311.150 and 1311.215 of this chapter.
    (e) An electronic prescription or pharmacy application provider 
must retain third party audit or certification reports as required by 
Sec.  1311.300 of this chapter.
    (f) An application provider must retain a copy of any notification 
to the

[[Page 16307]]

Administration regarding an adverse audit or certification report filed 
with the Administration on problems identified by the third-party audit 
or certification as required by Sec.  1311.300 of this chapter.
    (g) Unless otherwise specified, records and reports must be 
retained for two years.

PART 1306--PRESCRIPTIONS

0
7. The authority citation for part 1306 continues to read as follows:

    Authority: 21 U.S.C. 821, 829, 831, 871(b), unless otherwise 
noted.

0
8. Section 1306.05 is revised to read as follows:


Sec.  1306.05  Manner of issuance of prescriptions.

    (a) All prescriptions for controlled substances shall be dated as 
of, and signed on, the day when issued and shall bear the full name and 
address of the patient, the drug name, strength, dosage form, quantity 
prescribed, directions for use, and the name, address and registration 
number of the practitioner.
    (b) A prescription for a Schedule III, IV, or V narcotic drug 
approved by FDA specifically for ``detoxification treatment'' or 
``maintenance treatment'' must include the identification number issued 
by the Administrator under Sec.  1301.28(d) of this chapter or a 
written notice stating that the practitioner is acting under the good 
faith exception of Sec.  1301.28(e) of this chapter.
    (c) Where a prescription is for gamma-hydroxybutyric acid, the 
practitioner shall note on the face of the prescription the medical 
need of the patient for the prescription.
    (d) A practitioner may sign a paper prescription in the same manner 
as he would sign a check or legal document (e.g., J.H. Smith or John H. 
Smith). Where an oral order is not permitted, paper prescriptions shall 
be written with ink or indelible pencil, typewriter, or printed on a 
computer printer and shall be manually signed by the practitioner. A 
computer-generated prescription that is printed out or faxed by the 
practitioner must be manually signed.
    (e) Electronic prescriptions shall be created and signed using an 
application that meets the requirements of part 1311 of this chapter.
    (f) A prescription may be prepared by the secretary or agent for 
the signature of a practitioner, but the prescribing practitioner is 
responsible in case the prescription does not conform in all essential 
respects to the law and regulations. A corresponding liability rests 
upon the pharmacist, including a pharmacist employed by a central fill 
pharmacy, who fills a prescription not prepared in the form prescribed 
by DEA regulations.
    (g) An individual practitioner exempted from registration under 
Sec.  1301.22(c) of this chapter shall include on all prescriptions 
issued by him the registration number of the hospital or other 
institution and the special internal code number assigned to him by the 
hospital or other institution as provided in Sec.  1301.22(c) of this 
chapter, in lieu of the registration number of the practitioner 
required by this section. Each paper prescription shall have the name 
of the practitioner stamped, typed, or handprinted on it, as well as 
the signature of the practitioner.
    (h) An official exempted from registration under Sec.  1301.23(a) 
of this chapter must include on all prescriptions issued by him his 
branch of service or agency (e.g., ``U.S. Army'' or ``Public Health 
Service'') and his service identification number, in lieu of the 
registration number of the practitioner required by this section. The 
service identification number for a Public Health Service employee is 
his Social Security identification number. Each paper prescription 
shall have the name of the officer stamped, typed, or handprinted on 
it, as well as the signature of the officer.

0
9. Section 1306.08 is added to read as follows:


Sec.  1306.08  Electronic prescriptions.

    (a) An individual practitioner may sign and transmit electronic 
prescriptions for controlled substances provided the practitioner meets 
all of the following requirements:
    (1) The practitioner must comply with all other requirements for 
issuing controlled substance prescriptions in this part;
    (2) The practitioner must use an application that meets the 
requirements of part 1311 of this chapter; and
    (3) The practitioner must comply with the requirements for 
practitioners in part 1311 of this chapter.
    (b) A pharmacy may fill an electronically transmitted prescription 
for a controlled substance provided the pharmacy complies with all 
other requirements for filling controlled substance prescriptions in 
this part and with the requirements of part 1311 of this chapter.
    (c) To annotate an electronic prescription, a pharmacist must 
include all of the information that this part requires in the 
prescription record.
    (d) If the content of any of the information required under Sec.  
1306.05 for a controlled substance prescription is altered during the 
transmission, the prescription is deemed to be invalid and the pharmacy 
may not dispense the controlled substance.

0
10. In Sec.  1306.11, paragraphs (a), (c), (d)(1), and (d)(4) are 
revised to read as follows:


Sec.  1306.11  Requirement of prescription.

    (a) A pharmacist may dispense directly a controlled substance 
listed in Schedule II that is a prescription drug as determined under 
section 503 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
353(b)) only pursuant to a written prescription signed by the 
practitioner, except as provided in paragraph (d) of this section. A 
paper prescription for a Schedule II controlled substance may be 
transmitted by the practitioner or the practitioner's agent to a 
pharmacy via facsimile equipment, provided that the original manually 
signed prescription is presented to the pharmacist for review prior to 
the actual dispensing of the controlled substance, except as noted in 
paragraph (e), (f), or (g) of this section. The original prescription 
shall be maintained in accordance with Sec.  1304.04(h) of this 
chapter.
* * * * *
    (c) An institutional practitioner may administer or dispense 
directly (but not prescribe) a controlled substance listed in Schedule 
II only pursuant to a written prescription signed by the prescribing 
individual practitioner or to an order for medication made by an 
individual practitioner that is dispensed for immediate administration 
to the ultimate user.
    (d) * * *
    (1) The quantity prescribed and dispensed is limited to the amount 
adequate to treat the patient during the emergency period (dispensing 
beyond the emergency period must be pursuant to a paper or electronic 
prescription signed by the prescribing individual practitioner);
* * * * *
    (4) Within 7 days after authorizing an emergency oral prescription, 
the prescribing individual practitioner shall cause a written 
prescription for the emergency quantity prescribed to be delivered to 
the dispensing pharmacist. In addition to conforming to the 
requirements of Sec.  1306.05, the prescription shall have written on 
its face ``Authorization for Emergency Dispensing,'' and the date of 
the oral order. The paper prescription may be delivered to the 
pharmacist in person or by mail, but if delivered by mail it must be 
postmarked within the 7-day period.

[[Page 16308]]

Upon receipt, the dispensing pharmacist must attach this paper 
prescription to the oral emergency prescription that had earlier been 
reduced to writing. For electronic prescriptions, the pharmacist must 
annotate the record of the electronic prescription with the original 
authorization and date of the oral order. The pharmacist must notify 
the nearest office of the Administration if the prescribing individual 
practitioner fails to deliver a written prescription to him; failure of 
the pharmacist to do so shall void the authority conferred by this 
paragraph to dispense without a written prescription of a prescribing 
individual practitioner.
* * * * *

0
11. In Sec.  1306.13, paragraph (a) is revised to read as follows:


Sec.  1306.13  Partial filling of prescriptions.

    (a) The partial filling of a prescription for a controlled 
substance listed in Schedule II is permissible if the pharmacist is 
unable to supply the full quantity called for in a written or emergency 
oral prescription and he makes a notation of the quantity supplied on 
the face of the written prescription, written record of the emergency 
oral prescription, or in the electronic prescription record. The 
remaining portion of the prescription may be filled within 72 hours of 
the first partial filling; however, if the remaining portion is not or 
cannot be filled within the 72-hour period, the pharmacist shall notify 
the prescribing individual practitioner. No further quantity may be 
supplied beyond 72 hours without a new prescription.
* * * * *

0
12. In Sec.  1306.15, paragraph (a)(1) is revised to read as follows:


Sec.  1306.15  Provision of prescription information between retail 
pharmacies and central fill pharmacies for prescriptions of Schedule II 
controlled substances.

* * * * *
    (a) * * *
    (1) Write the words ``CENTRAL FILL'' on the face of the original 
paper prescription and record the name, address, and DEA registration 
number of the central fill pharmacy to which the prescription has been 
transmitted, the name of the retail pharmacy pharmacist transmitting 
the prescription, and the date of transmittal. For electronic 
prescriptions the name, address, and DEA registration number of the 
central fill pharmacy to which the prescription has been transmitted, 
the name of the retail pharmacy pharmacist transmitting the 
prescription, and the date of transmittal must be added to the 
electronic prescription record.
* * * * *

0
13. In Sec.  1306.21, paragraphs (a) and (c) are revised to read as 
follows:


Sec.  1306.21  Requirement of prescription.

    (a) A pharmacist may dispense directly a controlled substance 
listed in Schedule III, IV, or V that is a prescription drug as 
determined under section 503(b) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 353(b)) only pursuant to either a paper prescription 
signed by a practitioner, a facsimile of a signed paper prescription 
transmitted by the practitioner or the practitioner's agent to the 
pharmacy, an electronic prescription that meets the requirements of 
this part and part 1311 of this chapter, or an oral prescription made 
by an individual practitioner and promptly reduced to writing by the 
pharmacist containing all information required in Sec.  1306.05, except 
for the signature of the practitioner.
* * * * *
    (c) An institutional practitioner may administer or dispense 
directly (but not prescribe) a controlled substance listed in Schedule 
III, IV, or V only pursuant to a paper prescription signed by an 
individual practitioner, a facsimile of a paper prescription or order 
for medication transmitted by the practitioner or the practitioner's 
agent to the institutional practitioner-pharmacist, an electronic 
prescription that meets the requirements of this part and part 1311 of 
this chapter, or an oral prescription made by an individual 
practitioner and promptly reduced to writing by the pharmacist 
(containing all information required in Sec.  1306.05 except for the 
signature of the individual practitioner), or pursuant to an order for 
medication made by an individual practitioner that is dispensed for 
immediate administration to the ultimate user, subject to Sec.  
1306.07.

0
14. Section 1306.22 is revised to read as follows:


Sec.  1306.22  Refilling of prescriptions.

    (a) No prescription for a controlled substance listed in Schedule 
III or IV shall be filled or refilled more than six months after the 
date on which such prescription was issued. No prescription for a 
controlled substance listed in Schedule III or IV authorized to be 
refilled may be refilled more than five times.
    (b) Each refilling of a prescription shall be entered on the back 
of the prescription or on another appropriate document or electronic 
prescription record. If entered on another document, such as a 
medication record, or electronic prescription record, the document or 
record must be uniformly maintained and readily retrievable.
    (c) The following information must be retrievable by the 
prescription number:
    (1) The name and dosage form of the controlled substance.
    (2) The date filled or refilled.
    (3) The quantity dispensed.
    (4) The initials of the dispensing pharmacist for each refill.
    (5) The total number of refills for that prescription.
    (d) If the pharmacist merely initials and dates the back of the 
prescription or annotates the electronic prescription record, it shall 
be deemed that the full face amount of the prescription has been 
dispensed.
    (e) The prescribing practitioner may authorize additional refills 
of Schedule III or IV controlled substances on the original 
prescription through an oral refill authorization transmitted to the 
pharmacist provided the following conditions are met:
    (1) The total quantity authorized, including the amount of the 
original prescription, does not exceed five refills nor extend beyond 
six months from the date of issue of the original prescription.
    (2) The pharmacist obtaining the oral authorization records on the 
reverse of the original paper prescription or annotates the electronic 
prescription record with the date, quantity of refill, number of 
additional refills authorized, and initials the paper prescription or 
annotates the electronic prescription record showing who received the 
authorization from the prescribing practitioner who issued the original 
prescription.
    (3) The quantity of each additional refill authorized is equal to 
or less than the quantity authorized for the initial filling of the 
original prescription.
    (4) The prescribing practitioner must execute a new and separate 
prescription for any additional quantities beyond the five-refill, six-
month limitation.
    (f) As an alternative to the procedures provided by paragraphs (a) 
through (e) of this section, a computer application may be used for the 
storage and retrieval of refill information for original paper 
prescription orders for controlled substances in Schedule III and IV, 
subject to the following conditions:
    (1) Any such proposed computerized application must provide online 
retrieval (via computer monitor or hard-copy printout) of original 
prescription order information for those prescription orders that are 
currently authorized for refilling. This shall include, but is not 
limited to, data such as the original prescription number; date of 
issuance of

[[Page 16309]]

the original prescription order by the practitioner; full name and 
address of the patient; name, address, and DEA registration number of 
the practitioner; and the name, strength, dosage form, quantity of the 
controlled substance prescribed (and quantity dispensed if different 
from the quantity prescribed), and the total number of refills 
authorized by the prescribing practitioner.
    (2) Any such proposed computerized application must also provide 
online retrieval (via computer monitor or hard-copy printout) of the 
current refill history for Schedule III or IV controlled substance 
prescription orders (those authorized for refill during the past six 
months). This refill history shall include, but is not limited to, the 
name of the controlled substance, the date of refill, the quantity 
dispensed, the identification code, or name or initials of the 
dispensing pharmacist for each refill and the total number of refills 
dispensed to date for that prescription order.
    (3) Documentation of the fact that the refill information entered 
into the computer each time a pharmacist refills an original paper, 
fax, or oral prescription order for a Schedule III or IV controlled 
substance is correct must be provided by the individual pharmacist who 
makes use of such an application. If such an application provides a 
hard-copy printout of each day's controlled substance prescription 
order refill data, that printout shall be verified, dated, and signed 
by the individual pharmacist who refilled such a prescription order. 
The individual pharmacist must verify that the data indicated are 
correct and then sign this document in the same manner as he would sign 
a check or legal document (e.g., J.H. Smith, or John H. Smith). This 
document shall be maintained in a separate file at that pharmacy for a 
period of two years from the dispensing date. This printout of the 
day's controlled substance prescription order refill data must be 
provided to each pharmacy using such a computerized application within 
72 hours of the date on which the refill was dispensed. It must be 
verified and signed by each pharmacist who is involved with such 
dispensing. In lieu of such a printout, the pharmacy shall maintain a 
bound log book, or separate file, in which each individual pharmacist 
involved in such dispensing shall sign a statement (in the manner 
previously described) each day, attesting to the fact that the refill 
information entered into the computer that day has been reviewed by him 
and is correct as shown. Such a book or file must be maintained at the 
pharmacy employing such an application for a period of two years after 
the date of dispensing the appropriately authorized refill.
    (4) Any such computerized application shall have the capability of 
producing a printout of any refill data that the user pharmacy is 
responsible for maintaining under the Act and its implementing 
regulations. For example, this would include a refill-by-refill audit 
trail for any specified strength and dosage form of any controlled 
substance (by either brand or generic name or both). Such a printout 
must include name of the prescribing practitioner, name and address of 
the patient, quantity dispensed on each refill, date of dispensing for 
each refill, name or identification code of the dispensing pharmacist, 
and the number of the original prescription order. In any computerized 
application employed by a user pharmacy the central recordkeeping 
location must be capable of sending the printout to the pharmacy within 
48 hours, and if a DEA Special Agent or Diversion Investigator requests 
a copy of such printout from the user pharmacy, it must, if requested 
to do so by the Agent or Investigator, verify the printout transmittal 
capability of its application by documentation (e.g., postmark).
    (5) In the event that a pharmacy which employs such a computerized 
application experiences system down-time, the pharmacy must have an 
auxiliary procedure which will be used for documentation of refills of 
Schedule III and IV controlled substance prescription orders. This 
auxiliary procedure must ensure that refills are authorized by the 
original prescription order, that the maximum number of refills has not 
been exceeded, and that all of the appropriate data are retained for 
online data entry as soon as the computer system is available for use 
again.
    (g) When filing refill information for original paper, fax, or oral 
prescription orders for Schedule III or IV controlled substances, a 
pharmacy may use only one of the two applications described in 
paragraphs (a) through (e) or (f) of this section.
    (h) When filing refill information for electronic prescriptions, a 
pharmacy must use an application that meets the requirements of part 
1311 of this chapter.

0
15. Section 1306.25 is revised to read as follows:


Sec.  1306.25  Transfer between pharmacies of prescription information 
for Schedules III, IV, and V controlled substances for refill purposes.

    (a) The transfer of original prescription information for a 
controlled substance listed in Schedule III, IV, or V for the purpose 
of refill dispensing is permissible between pharmacies on a one-time 
basis only. However, pharmacies electronically sharing a real-time, 
online database may transfer up to the maximum refills permitted by law 
and the prescriber's authorization.
    (b) Transfers are subject to the following requirements:
    (1) The transfer must be communicated directly between two licensed 
pharmacists.
    (2) The transferring pharmacist must do the following:
    (i) Write the word ``VOID'' on the face of the invalidated 
prescription; for electronic prescriptions, information that the 
prescription has been transferred must be added to the prescription 
record.
    (ii) Record on the reverse of the invalidated prescription the 
name, address, and DEA registration number of the pharmacy to which it 
was transferred and the name of the pharmacist receiving the 
prescription information; for electronic prescriptions, such 
information must be added to the prescription record.
    (iii) Record the date of the transfer and the name of the 
pharmacist transferring the information.
    (3) For paper prescriptions and prescriptions received orally and 
reduced to writing by the pharmacist pursuant to Sec.  1306.21(a), the 
pharmacist receiving the transferred prescription information must 
write the word ``transfer'' on the face of the transferred prescription 
and reduce to writing all information required to be on a prescription 
pursuant to Sec.  1306.05 and include:
    (i) Date of issuance of original prescription.
    (ii) Original number of refills authorized on original 
prescription.
    (iii) Date of original dispensing.
    (iv) Number of valid refills remaining and date(s) and locations of 
previous refill(s).
    (v) Pharmacy's name, address, DEA registration number, and 
prescription number from which the prescription information was 
transferred.
    (vi) Name of pharmacist who transferred the prescription.
    (vii) Pharmacy's name, address, DEA registration number, and 
prescription number from which the prescription was originally filled.
    (4) For electronic prescriptions being transferred electronically, 
the

[[Page 16310]]

transferring pharmacist must provide the receiving pharmacist with the 
following information in addition to the original electronic 
prescription data:
    (i) The date of the original dispensing.
    (ii) The number of refills remaining and the date(s) and locations 
of previous refills.
    (iii) The transferring pharmacy's name, address, DEA registration 
number, and prescription number for each dispensing.
    (iv) The name of the pharmacist transferring the prescription.
    (v) The name, address, DEA registration number, and prescription 
number from the pharmacy that originally filled the prescription, if 
different.
    (5) The pharmacist receiving a transferred electronic prescription 
must create an electronic record for the prescription that includes the 
receiving pharmacist's name and all of the information transferred with 
the prescription under paragraph (b)(4) of this section.
    (c) The original and transferred prescription(s) must be maintained 
for a period of two years from the date of last refill.
    (d) Pharmacies electronically accessing the same prescription 
record must satisfy all information requirements of a manual mode for 
prescription transferal.
    (e) The procedure allowing the transfer of prescription information 
for refill purposes is permissible only if allowable under existing 
State or other applicable law.

PART 1311--REQUIREMENTS FOR ELECTRONIC ORDERS AND PRESCRIPTIONS

0
16. The authority citation for part 1311 continues to read as follows:

    Authority:  21 U.S.C. 821, 828, 829, 871(b), 958(e), 965, unless 
otherwise noted.


0
17. The heading for part 1311 is revised to read as set forth above.

0
18. Section 1311.01 is revised to read as follows:


Sec.  1311.01  Scope.

    This part sets forth the rules governing the creation, 
transmission, and storage of electronic orders and prescriptions.

0
19. Section 1311.02 is revised to read as follows:


Sec.  1311.02  Definitions.

    Any term contained in this part shall have the definition set forth 
in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.

0
20. Section 1311.08 is revised to read as follows:


Sec.  1311.08  Incorporation by reference.

    (a) These incorporations by reference were approved by the Director 
of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies may be inspected at the Drug Enforcement 
Administration, 600 Army Navy Drive, Arlington, VA 22202 or at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at the Drug Enforcement 
Administration, call (202) 307-1000. For information on the 
availability of this material at NARA, call (202) 741-6030 or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
    (b) These standards are available from the National Institute of 
Standards and Technology, Computer Security Division, Information 
Technology Laboratory, National Institute of Standards and Technology, 
100 Bureau Drive, Gaithersburg, MD 20899-8930, (301) 975-6478 or TTY 
(301) 975-8295, [email protected], and are available at http://csrc.nist.gov/. The following standards are incorporated by reference:
    (1) Federal Information Processing Standard Publication (FIPS PUB) 
140-2, Change Notices (12-03-2002), Security Requirements for 
Cryptographic Modules, May 25, 2001 (FIPS 140-2) including Annexes A 
through D; incorporation by reference approved for Sec. Sec.  
1311.30(b), 1311.55(b), 1311.115(b), 1311.120(b), 1311.205(b).
    (i) Annex A: Approved Security Functions for FIPS PUB 140-2, 
Security Requirements for Cryptographic Modules, September 23, 2004.
    (ii) Annex B: Approved Protection Profiles for FIPS PUB 140-2, 
Security Requirements for Cryptographic Modules, November 4, 2004.
    (iii) Annex C: Approved Random Number Generators for FIPS PUB 140-
2, Security Requirements for Cryptographic Modules, January 31, 2005.
    (iv) Annex D: Approved Key Establishment Techniques for FIPS PUB 
140-2, Security Requirements for Cryptographic Modules, February 23, 
2004.
    (2) Federal Information Processing Standard Publication (FIPS PUB) 
180-2, Secure Hash Standard, August 1, 2002, as amended by change 
notice 1, February 25, 2004 (FIPS 180-2); incorporation by reference 
approved for Sec. Sec.  1311.30(b) and 1311.55(b).
    (3) Federal Information Processing Standard Publication (FIPS PUB) 
180-3, Secure Hash Standard (SHS), October 2008 (FIPS 180-3); 
incorporation by reference approved for Sec. Sec.  1311.120(b) and 
1311.205(b).
    (4) Federal Information Processing Standard Publication (FIPS PUB) 
186-2, Digital Signature Standard, January 27, 2000, as amended by 
Change Notice 1, October 5, 2001 (FIPS 186-2); incorporation by 
reference approved for Sec. Sec.  1311.30(b) and 1311.55(b).
    (5) Federal Information Processing Standard Publication (FIPS PUB) 
186-3, Digital Signature Standard (DSS), June 2009 (FIPS 186-3); 
incorporation by reference approved for Sec. Sec.  1311.120(b), 
1311.205(b), and 1311.210(c).
    (6) Draft NIST Special Publication 800-63-1, Electronic 
Authentication Guideline, December 8, 2008 (NIST SP 800-63-1); Burr, W. 
et al.; incorporation by reference approved for Sec.  1311.105(a).
    (7) NIST Special Publication 800-76-1, Biometric Data Specification 
for Personal Identity Verification, January 2007 (NIST SP 800-76-1); 
Wilson, C. et al.; incorporation by reference approved for Sec.  
1311.116(d).

0
21. Subpart C, consisting of Sec. Sec.  1311.100 through 1311.305, is 
added to read as follows:
Subpart C--Electronic Prescriptions
Sec.
1311.100 General.
1311.102 Practitioner responsibilities.
1311.105 Requirements for obtaining an authentication credential--
Individual practitioners.
1311.110 Requirements for obtaining an authentication credential--
Individual practitioners eligible to use an electronic prescription 
application of an institutional practitioner.
1311.115 Additional requirements for two-factor authentication.
1311.116 Additional requirements for biometrics.
1311.120 Electronic prescription application requirements.
1311.125 Requirements for establishing logical access control--
Individual practitioner.
1311.130 Requirements for establishing logical access control--
Institutional practitioner.
1311.135 Requirements for creating a controlled substance 
prescription.
1311.140 Requirements for signing a controlled substance 
prescription.
1311.145 Digitally signing the prescription with the individual 
practitioner's private key.
1311.150 Additional requirements for internal application audits.
1311.170 Transmission requirements.
1311.200 Pharmacy responsibilities.
1311.205 Pharmacy application requirements.
1311.210 Archiving the initial record.
1311.215 Internal audit trail.

[[Page 16311]]

1311.300 Application provider requirements--Third-party audits or 
certifications.
1311.302 Additional application provider requirements.
1311.305 Recordkeeping.

Subpart C--Electronic Prescriptions


Sec.  1311.100  General.

    (a) This subpart addresses the requirements that must be met to 
issue and process Schedule II, III, IV, and V controlled substance 
prescriptions electronically.
    (b) A practitioner may issue a prescription for a Schedule II, III, 
IV, or V controlled substance electronically if all of the following 
conditions are met:
    (1) The practitioner is registered as an individual practitioner or 
exempt from the requirement of registration under part 1301 of this 
chapter and is authorized under the registration or exemption to 
dispense the controlled substance;
    (2) The practitioner uses an electronic prescription application 
that meets all of the applicable requirements of this subpart; and
    (3) The prescription is otherwise in conformity with the 
requirements of the Act and this chapter.
    (c) An electronic prescription for a Schedule II, III, IV, or V 
controlled substance created using an electronic prescription 
application that does not meet the requirements of this subpart is not 
a valid prescription, as that term is defined in Sec.  1300.03 of this 
chapter.
    (d) A controlled substance prescription created using an electronic 
prescription application that meets the requirements of this subpart is 
not a valid prescription if any of the functions required under this 
subpart were disabled when the prescription was indicated as ready for 
signature and signed.
    (e) A registered pharmacy may process electronic prescriptions for 
controlled substances only if all of the following conditions are met:
    (1) The pharmacy uses a pharmacy application that meets all of the 
applicable requirements of this subpart; and
    (2) The prescription is otherwise in conformity with the 
requirements of the Act and this chapter.
    (f) Nothing in this part alters the responsibilities of the 
practitioner and pharmacy, specified in part 1306 of this chapter, to 
ensure the validity of a controlled substance prescription.


Sec.  1311.102  Practitioner responsibilities.

    (a) The practitioner must retain sole possession of the hard token, 
where applicable, and must not share the password or other knowledge 
factor, or biometric information, with any other person. The 
practitioner must not allow any other person to use the token or enter 
the knowledge factor or other identification means to sign 
prescriptions for controlled substances. Failure by the practitioner to 
secure the hard token, knowledge factor, or biometric information may 
provide a basis for revocation or suspension of registration pursuant 
to section 304(a)(4) of the Act (21 U.S.C. 824(a)(4)).
    (b) The practitioner must notify the individuals designated under 
Sec.  1311.125 or Sec.  1311.130 within one business day of discovery 
that the hard token has been lost, stolen, or compromised or the 
authentication protocol has been otherwise compromised. A practitioner 
who fails to comply with this provision may be held responsible for any 
controlled substance prescriptions written using his two-factor 
authentication credential.
    (c) If the practitioner is notified by an intermediary or pharmacy 
that an electronic prescription was not successfully delivered, as 
provided in Sec.  1311.170, he must ensure that any paper or oral 
prescription (where permitted) issued as a replacement of the original 
electronic prescription indicates that the prescription was originally 
transmitted electronically to a particular pharmacy and that the 
transmission failed.
    (d) Before initially using an electronic prescription application 
to sign and transmit controlled substance prescriptions, the 
practitioner must determine that the third-party auditor or 
certification organization has found that the electronic prescription 
application records, stores, and transmits the following accurately and 
consistently:
    (1) The information required for a prescription under Sec.  
1306.05(a) of this chapter.
    (2) The indication of signing as required by Sec.  1311.120(b)(17) 
or the digital signature created by the practitioner's private key.
    (3) The number of refills as required by Sec.  1306.22 of this 
chapter.
    (e) If the third-party auditor or certification organization has 
found that an electronic prescription application does not accurately 
and consistently record, store, and transmit other information required 
for prescriptions under this chapter, the practitioner must not create, 
sign, and transmit electronic prescriptions for controlled substances 
that are subject to the additional information requirements.
    (f) The practitioner must not use the electronic prescription 
application to sign and transmit electronic controlled substance 
prescriptions if any of the functions of the application required by 
this subpart have been disabled or appear to be functioning improperly.
    (g) If an electronic prescription application provider notifies an 
individual practitioner that a third-party audit or certification 
report indicates that the application or the application provider no 
longer meets the requirements of this part or notifies him that the 
application provider has identified an issue that makes the application 
non-compliant, the practitioner must do the following:
    (1) Immediately cease to issue electronic controlled substance 
prescriptions using the application.
    (2) Ensure, for an installed electronic prescription application at 
an individual practitioner's practice, that the individuals designated 
under Sec.  1311.125 terminate access for signing controlled substance 
prescriptions.
    (h) If an electronic prescription application provider notifies an 
institutional practitioner that a third-party audit or certification 
report indicates that the application or the application provider no 
longer meets the requirements of this part or notifies it that the 
application provider has identified an issue that makes the application 
non-compliant, the institutional practitioner must ensure that the 
individuals designated under Sec.  1311.130 terminate access for 
signing controlled substance prescriptions.
    (i) An individual practitioner or institutional practitioner that 
receives a notification that the electronic prescription application is 
not in compliance with the requirements of this part must not use the 
application to issue electronic controlled substance prescriptions 
until it is notified that the application is again compliant and all 
relevant updates to the application have been installed.
    (j) The practitioner must notify both the individuals designated 
under Sec.  1311.125 or Sec.  1311.130 and the Administration within 
one business day of discovery that one or more prescriptions that were 
issued under a DEA registration held by that practitioner were 
prescriptions the practitioner had not signed or were not consistent 
with the prescriptions he signed.
    (k) The practitioner has the same responsibilities when issuing 
prescriptions for controlled substances via electronic means as when 
issuing a paper or oral prescription. Nothing in this subpart relieves 
a practitioner of his responsibility to dispense controlled substances 
only for a legitimate medical purpose while acting in the usual course

[[Page 16312]]

of his professional practice. If an agent enters information at the 
practitioner's direction prior to the practitioner reviewing and 
approving the information and signing and authorizing the transmission 
of that information, the practitioner is responsible in case the 
prescription does not conform in all essential respects to the law and 
regulations.


Sec.  1311.105  Requirements for obtaining an authentication 
credential--Individual practitioners.

    (a) An individual practitioner must obtain a two-factor 
authentication credential from one of the following:
    (1) A credential service provider that has been approved by the 
General Services Administration Office of Technology Strategy/Division 
of Identity Management to conduct identity proofing that meets the 
requirements of Assurance Level 3 or above as specified in NIST SP 800-
63-1 as incorporated by reference in Sec.  1311.08.
    (2) For digital certificates, a certification authority that is 
cross-certified with the Federal Bridge certification authority and 
that operates at a Federal Bridge Certification Authority basic 
assurance level or above.
    (b) The practitioner must submit identity proofing information to 
the credential service provider or certification authority as specified 
by the credential service provider or certification authority.
    (c) The credential service provider or certification authority must 
issue the authentication credential using two channels (e.g., e-mail, 
mail, or telephone call). If one of the factors used in the 
authentication protocol is a biometric, or if the practitioner has a 
hard token that is being enabled to sign controlled substances 
prescriptions, the credential service provider or certification 
authority must issue two pieces of information used to generate or 
activate the authentication credential using two channels.


Sec.  1311.110  Requirements for obtaining an authentication 
credential--Individual practitioners eligible to use an electronic 
prescription application of an institutional practitioner.

    (a) For any registrant or person exempted from the requirement of 
registration under Sec.  1301.22(c) of this chapter who is eligible to 
use the institutional practitioner's electronic prescription 
application to sign prescriptions for controlled substances, the entity 
within a DEA-registered institutional practitioner that grants that 
individual practitioner privileges at the institutional practitioner 
(e.g., a hospital credentialing office) may conduct identity proofing 
and authorize the issuance of the authentication credential. That 
entity must do the following:
    (1) Ensure that photographic identification issued by the Federal 
Government or a State government matches the person presenting the 
identification.
    (2) Ensure that the individual practitioner's State authorization 
to practice and, where applicable, State authorization to prescribe 
controlled substances, is current and in good standing.
    (3) Either ensure that the individual practitioner's DEA 
registration is current and in good standing or ensure that the 
institutional practitioner has granted the individual practitioner 
exempt from the requirement of registration under Sec.  1301.22 of this 
chapter privileges to prescribe controlled substances using the 
institutional practitioner's DEA registration number.
    (4) If the individual practitioner is an employee of a health care 
facility that is operated by the Department of Veterans Affairs, 
confirm that the individual practitioner has been duly appointed to 
practice at that facility by the Secretary of the Department of 
Veterans Affairs pursuant to 38 U.S.C. 7401-7408.
    (5) If the individual practitioner is working at a health care 
facility operated by the Department of Veterans Affairs on a 
contractual basis pursuant to 38 U.S.C. 8153 and, in the performance of 
his duties, prescribes controlled substances, confirm that the 
individual practitioner meets the criteria for eligibility for 
appointment under 38 U.S.C. 7401-7408 and is prescribing controlled 
substances under the registration of such facility.
    (b) An institutional practitioner that elects to conduct identity 
proofing must provide authorization to issue the authentication 
credentials to a separate entity within the institutional practitioner 
or to an outside credential Service provider or certification authority 
that meets the requirements of Sec.  1311.105(a).
    (c) When an institutional practitioner is conducting identity 
proofing and submitting information to a credential service provider or 
certification authority to authorize the issuance of authentication 
credentials, the institutional practitioner must meet any requirements 
that the credential service provider or certification authority imposes 
on entities that serve as trusted agents.
    (d) An institutional practitioner that elects to conduct identity 
proofing and authorize the issuance of the authentication credential as 
provided in paragraphs (a) through (c) of this section must do so in a 
manner consistent with the institutional practitioner's general 
obligation to maintain effective controls against diversion. Failure to 
meet this obligation may result in remedial action consistent with 
Sec.  1301.36 of this chapter.
    (e) An institutional practitioner that elects to conduct identity 
proofing must retain a record of the identity-proofing. An 
institutional practitioner that elects to issue the two-factor 
authentication credential must retain a record of the issuance of the 
credential.


Sec.  1311.115  Additional requirements for two-factor authentication.

    (a) To sign a controlled substance prescription, the electronic 
prescription application must require the practitioner to authenticate 
to the application using an authentication protocol that uses two of 
the following three factors:
    (1) Something only the practitioner knows, such as a password or 
response to a challenge question.
    (2) Something the practitioner is, biometric data such as a 
fingerprint or iris scan.
    (3) Something the practitioner has, a device (hard token) separate 
from the computer to which the practitioner is gaining access.
    (b) If one factor is a hard token, it must be separate from the 
computer to which it is gaining access and must meet at least the 
criteria of FIPS 140-2 Security Level 1, as incorporated by reference 
in Sec.  1311.08, for cryptographic modules or one-time-password 
devices.
    (c) If one factor is a biometric, the biometric subsystem must 
comply with the requirements of Sec.  1311.116.


Sec.  1311.116  Additional requirements for biometrics.

    (a) If one of the factors used to authenticate to the electronic 
prescription application is a biometric as described in Sec.  1311.115, 
it must comply with the following requirements.
    (b) The biometric subsystem must operate at a false match rate of 
0.001 or lower.
    (c) The biometric subsystem must use matching software that has 
demonstrated performance at the operating point corresponding with the 
false match rate described in paragraph (b) of this section, or a lower 
false match rate. Testing to demonstrate performance must be conducted 
by the National Institute of Standards and Technology or another DEA-
approved

[[Page 16313]]

government or nongovernment laboratory. Such testing must comply with 
the requirements of paragraph (h) of this section.
    (d) The biometric subsystem must conform to Personal Identity 
Verification authentication biometric acquisition specifications, 
pursuant to NIST SP 800-76-1 as incorporated by reference in Sec.  
1311.08, if they exist for the biometric modality of choice.
    (e) The biometric subsystem must either be co-located with a 
computer or PDA that the practitioner uses to issue electronic 
prescriptions for controlled substances, where the computer or PDA is 
located in a known, controlled location, or be built directly into the 
practitioner's computer or PDA that he uses to issue electronic 
prescriptions for controlled substances.
    (f) The biometric subsystem must store device ID data at enrollment 
(i.e., biometric registration) with the biometric data and verify the 
device ID at the time of authentication to the electronic prescription 
application.
    (g) The biometric subsystem must protect the biometric data (raw 
data or templates), match results, and/or non-match results when 
authentication is not local. If sent over an open network, biometric 
data (raw data or templates), match results, and/or non-match results 
must be:
    (1) Cryptographically source authenticated;
    (2) Combined with a random challenge, a nonce, or a time stamp to 
prevent replay;
    (3) Cryptographically protected for integrity and confidentiality; 
and
    (4) Sent only to authorized systems.
    (h) Testing of the biometric subsystem must have the following 
characteristics:
    (1) The test is conducted by a laboratory that does not have an 
interest in the outcome (positive or negative) of performance of a 
submission or biometric.
    (2) Test data are sequestered.
    (3) Algorithms are provided to the testing laboratory (as opposed 
to scores or other information).
    (4) The operating point(s) corresponding with the false match rate 
described in paragraph (b) of this section, or a lower false match 
rate, is tested so that there is at least 95% confidence that the false 
match and non-match rates are equal to or less than the observed value.
    (5) Results of the testing are made publicly available.


Sec.  1311.120  Electronic prescription application requirements.

    (a) A practitioner may only use an electronic prescription 
application that meets the requirements in paragraph (b) of this 
section to issue electronic controlled substance prescriptions.
    (b) The electronic prescription application must meet the 
requirements of this subpart including the following:
    (1) The electronic prescription application must do the following:
    (i) Link each registrant, by name, to at least one DEA registration 
number.
    (ii) Link each practitioner exempt from registration under Sec.  
1301.22(c) of this chapter to the institutional practitioner's DEA 
registration number and the specific internal code number required 
under Sec.  1301.22(c)(5) of this chapter.
    (2) The electronic prescription application must be capable of the 
setting of logical access controls to limit permissions for the 
following functions:
    (i) Indication that a prescription is ready for signing and signing 
controlled substance prescriptions.
    (ii) Creating, updating, and executing the logical access controls 
for the functions specified in paragraph (b)(2)(i) of this section.
    (3) Logical access controls must be set by individual user name or 
role. If the application sets logical access control by role, it must 
not allow an individual to be assigned the role of registrant unless 
that individual is linked to at least one DEA registration number as 
provided in paragraph (b)(1) of this section.
    (4) The application must require that the setting and changing of 
logical access controls specified under paragraph (b)(2) of this 
section involve the actions of two individuals as specified in 
Sec. Sec.  1311.125 or 1311.130. Except for institutional 
practitioners, a practitioner authorized to sign controlled substance 
prescriptions must approve logical access control entries.
    (5) The electronic prescription application must accept two-factor 
authentication that meets the requirements of Sec.  1311.115 and 
require its use for signing controlled substance prescriptions and for 
approving data that set or change logical access controls related to 
reviewing and signing controlled substance prescriptions.
    (6) The electronic prescription application must be capable of 
recording all of the applicable information required in part 1306 of 
this chapter for the controlled substance prescription.
    (7) If a practitioner has more than one DEA registration number, 
the electronic prescription application must require the practitioner 
or his agent to select the DEA registration number to be included on 
the prescription.
    (8) The electronic prescription application must have a time 
application that is within five minutes of the official National 
Institute of Standards and Technology time source.
    (9) The electronic prescription application must present for the 
practitioner's review and approval all of the following data for each 
controlled substance prescription:
    (i) The date of issuance.
    (ii) The full name of the patient.
    (iii) The drug name.
    (iv) The dosage strength and form, quantity prescribed, and 
directions for use.
    (v) The number of refills authorized, if applicable, for 
prescriptions for Schedule III, IV, and V controlled substances.
    (vi) For prescriptions written in accordance with the requirements 
of Sec.  1306.12(b) of this chapter, the earliest date on which a 
pharmacy may fill each prescription.
    (vii) The name, address, and DEA registration number of the 
prescribing practitioner.
    (viii) The statement required under Sec.  1311.140(a)(3).
    (10) The electronic prescription application must require the 
prescribing practitioner to indicate that each controlled substance 
prescription is ready for signing. The electronic prescription 
application must not permit alteration of the DEA elements after the 
practitioner has indicated that a controlled substance prescription is 
ready to be signed without requiring another review and indication of 
readiness for signing. Any controlled substance prescription not 
indicated as ready to be signed shall not be signed or transmitted.
    (11) While the information required by paragraph (b)(9) of this 
section and the statement required by Sec.  1311.140(a)(3) remain 
displayed, the electronic prescription application must prompt the 
prescribing practitioner to authenticate to the application, using two-
factor authentication, as specified in Sec.  1311.140(a)(4), which will 
constitute the signing of the prescription by the practitioner for 
purposes of Sec.  1306.05(a) and (e) of this chapter.
    (12) The electronic prescription application must not permit a 
practitioner other than the prescribing practitioner whose DEA number 
(or institutional practitioner DEA number and extension data for the 
individual practitioner) is listed on the prescription as the 
prescribing practitioner and who has indicated that the prescription is 
ready to be signed to sign the prescription.
    (13) Where a practitioner seeks to prescribe more than one 
controlled substance at one time for a particular

[[Page 16314]]

patient, the electronic prescription application may allow the 
practitioner to sign multiple prescriptions for a single patient at one 
time using a single invocation of the two-factor authentication 
protocol provided the following has occurred: The practitioner has 
individually indicated that each controlled substance prescription is 
ready to be signed while the information required by paragraph (b)(9) 
of this section for each such prescription is displayed along with the 
statement required by Sec.  1311.140(a)(3).
    (14) The electronic prescription application must time and date 
stamp the prescription when the signing function is used.
    (15) When the practitioner uses his two-factor authentication 
credential as specified in Sec.  1311.140(a)(4), the electronic 
prescription application must digitally sign at least the information 
required by part 1306 of this chapter and electronically archive the 
digitally signed record. If the practitioner signs the prescription 
with his own private key, as provided in Sec.  1311.145, the electronic 
prescription application must electronically archive a copy of the 
digitally signed record, but need not apply the application's digital 
signature to the record.
    (16) The digital signature functionality must meet the following 
requirements:
    (i) The cryptographic module used to digitally sign the data 
elements required by part 1306 of this chapter must be at least FIPS 
140-2 Security Level 1 validated. FIPS 140-2 is incorporated by 
reference in Sec.  1311.08.
    (ii) The digital signature application and hash function must 
comply with FIPS 186-3 and FIPS 180-3, as incorporated by reference in 
Sec.  1311.08.
    (iii) The electronic prescription application's private key must be 
stored encrypted on a FIPS 140-2 Security Level 1 or higher validated 
cryptographic module using a FIPS-approved encryption algorithm. FIPS 
140-2 is incorporated by reference in Sec.  1311.08.
    (iv) For software implementations, when the signing module is 
deactivated, the application must clear the plain text password from 
the application memory to prevent the unauthorized access to, or use 
of, the private key.
    (17) Unless the digital signature created by an individual 
practitioner's private key is being transmitted to the pharmacy with 
the prescription, the electronic prescription application must include 
in the data file transmitted an indication that the prescription was 
signed by the prescribing practitioner.
    (18) The electronic prescription application must not transmit a 
controlled substance prescription unless the signing function described 
in Sec.  1311.140(a)(4) has been used.
    (19) The electronic prescription application must not allow 
alteration of any of the information required by part 1306 of this 
chapter after the prescription has been digitally signed. Any 
alteration of the information required by part 1306 of this chapter 
after the prescription is digitally signed must cancel the 
prescription.
    (20) The electronic prescription application must not allow 
transmission of a prescription that has been printed.
    (21) The electronic prescription application must allow printing of 
a prescription after transmission only if the printed prescription is 
clearly labeled as a copy not for dispensing. The electronic 
prescription application may allow printing of prescription information 
if clearly labeled as being for informational purposes. The electronic 
prescription application may transfer such prescription information to 
medical records.
    (22) If the transmission of an electronic prescription fails, the 
electronic prescription application may print the prescription. The 
prescription must indicate that it was originally transmitted 
electronically to, and provide the name of, a specific pharmacy, the 
date and time of transmission, and that the electronic transmission 
failed.
    (23) The electronic prescription application must maintain an audit 
trail of all actions related to the following:
    (i) The creation, alteration, indication of readiness for signing, 
signing, transmission, or deletion of a controlled substance 
prescription.
    (ii) Any setting or changing of logical access control permissions 
related to the issuance of controlled substance prescriptions.
    (iii) Notification of a failed transmission.
    (iv) Auditable events as specified in Sec.  1311.150.
    (24) The electronic prescription application must record within 
each audit record the following information:
    (i) The date and time of the event.
    (ii) The type of event.
    (iii) The identity of the person taking the action, where 
applicable.
    (iv) The outcome of the event (success or failure).
    (25) The electronic prescription application must conduct internal 
audits and generate reports on any of the events specified in Sec.  
1311.150 in a format that is readable by the practitioner. Such 
internal audits may be automated and need not require human 
intervention to be conducted.
    (26) The electronic prescription application must protect the 
stored audit records from unauthorized deletion. The electronic 
prescription application shall prevent modifications to the audit 
records.
    (27) The electronic prescription application must do the following:
    (i) Generate a log of all controlled substance prescriptions issued 
by a practitioner during the previous calendar month and provide the 
log to the practitioner no later than seven calendar days after that 
month.
    (ii) Be capable of generating a log of all controlled substance 
prescriptions issued by a practitioner for a period specified by the 
practitioner upon request. Prescription information available from 
which to generate the log must span at least the previous two years.
    (iii) Archive all logs generated.
    (iv) Ensure that all logs are easily readable or easily rendered 
into a format that a person can read.
    (v) Ensure that all logs are sortable by patient name, drug name, 
and date of issuance of the prescription.
    (28) Where the electronic prescription application is required by 
this part to archive or otherwise maintain records, it must retain such 
records electronically for two years from the date of the record's 
creation and comply with all other requirements of Sec.  1311.305.


Sec.  1311.125  Requirements for establishing logical access control--
Individual practitioner.

    (a) At each registered location where one or more individual 
practitioners wish to use an electronic prescription application 
meeting the requirements of this subpart to issue controlled substance 
prescriptions, the registrant(s) must designate at least two 
individuals to manage access control to the application. At least one 
of the designated individuals must be a registrant who is authorized to 
issue controlled substance prescriptions and who has obtained a two-
factor authentication credential as provided in Sec.  1311.105.
    (b) At least one of the individuals designated under paragraph (a) 
of this section must verify that the DEA registration and State 
authorization(s) to practice and, where applicable, State 
authorization(s) to dispense controlled substances of each registrant 
being granted permission to sign electronic prescriptions for 
controlled substances are current and in good standing.
    (c) After one individual designated under paragraph (a) of this 
section

[[Page 16315]]

enters data that grants permission for individual practitioners to have 
access to the prescription functions that indicate readiness for 
signature and signing or revokes such authorization, a second 
individual designated under paragraph (a) of this section must use his 
two-factor authentication credential to satisfy the logical access 
controls. The second individual must be a DEA registrant.
    (d) A registrant's permission to indicate that controlled 
substances prescriptions are ready to be signed and to sign controlled 
substance prescriptions must be revoked whenever any of the following 
occurs, on the date the occurrence is discovered:
    (1) A hard token or any other authentication factor required by the 
two-factor authentication protocol is lost, stolen, or compromised. 
Such access must be terminated immediately upon receiving notification 
from the individual practitioner.
    (2) The individual practitioner's DEA registration expires, unless 
the registration has been renewed.
    (3) The individual practitioner's DEA registration is terminated, 
revoked, or suspended.
    (4) The individual practitioner is no longer authorized to use the 
electronic prescription application (e.g., when the individual 
practitioner leaves the practice).


Sec.  1311.130  Requirements for establishing logical access control--
Institutional practitioner.

    (a) The entity within an institutional practitioner that conducts 
the identity proofing under Sec.  1311.110 must develop a list of 
individual practitioners who are permitted to use the institutional 
practitioner's electronic prescription application to indicate that 
controlled substances prescriptions are ready to be signed and to sign 
controlled substance prescriptions. The list must be approved by two 
individuals.
    (b) After the list is approved, it must be sent to a separate 
entity within the institutional practitioner that enters permissions 
for logical access controls into the application. The institutional 
practitioner must authorize at least two individuals or a role filled 
by at least two individuals to enter the logical access control data. 
One individual in the separate entity must authenticate to the 
application and enter the data to grant permissions to individual 
practitioners to indicate that controlled substances prescriptions are 
ready to be signed and to sign controlled substance prescriptions. A 
second individual must authenticate to the application to execute the 
logical access controls.
    (c) The institutional practitioner must retain a record of the 
individuals or roles that are authorized to conduct identity proofing 
and logical access control data entry and execution.
    (d) Permission to indicate that controlled substances prescriptions 
are ready to be signed and to sign controlled substance prescriptions 
must be revoked whenever any of the following occurs, on the date the 
occurrence is discovered:
    (1) An individual practitioner's hard token or any other 
authentication factor required by the practitioner's two-factor 
authentication protocol is lost, stolen, or compromised. Such access 
must be terminated immediately upon receiving notification from the 
individual practitioner.
    (2) The institutional practitioner's or, where applicable, 
individual practitioner's DEA registration expires, unless the 
registration has been renewed.
    (3) The institutional practitioner's or, where applicable, 
individual practitioner's DEA registration is terminated, revoked, or 
suspended.
    (4) An individual practitioner is no longer authorized to use the 
institutional practitioner's electronic prescription application (e.g., 
when the individual practitioner is no longer associated with the 
institutional practitioner.)


Sec.  1311.135  Requirements for creating a controlled substance 
prescription.

    (a) The electronic prescription application may allow the 
registrant or his agent to enter data for a controlled substance 
prescription, provided that only the registrant may sign the 
prescription in accordance with Sec. Sec.  1311.120(b)(11) and 
1311.140.
    (b) If a practitioner holds multiple DEA registrations, the 
practitioner or his agent must select the appropriate registration 
number for the prescription being issued in accordance with the 
requirements of Sec.  1301.12 of this chapter.
    (c) If required by State law, a supervisor's name and DEA number 
may be listed on a prescription, provided the prescription clearly 
indicates who is the supervisor and who is the prescribing 
practitioner.


Sec.  1311.140  Requirements for signing a controlled substance 
prescription.

    (a) For a practitioner to sign an electronic prescription for a 
controlled substance the following must occur:
    (1) The practitioner must access a list of one or more controlled 
substance prescriptions for a single patient. The list must display the 
information required by Sec.  1311.120(b)(9).
    (2) The practitioner must indicate the prescriptions that are ready 
to be signed.
    (3) While the prescription information required in Sec.  
1311.120(b)(9) is displayed, the following statement or its substantial 
equivalent is displayed: ``By completing the two-factor authentication 
protocol at this time, you are legally signing the prescription(s) and 
authorizing the transmission of the above information to the pharmacy 
for dispensing. The two-factor authentication protocol may only be 
completed by the practitioner whose name and DEA registration number 
appear above.''
    (4) While the prescription information required in Sec.  
1311.120(b)(9) and the statement required by paragraph (a)(3) of this 
section remain displayed, the practitioner must be prompted to complete 
the two-factor authentication protocol.
    (5) The completion by the practitioner of the two-factor 
authentication protocol in the manner provided in paragraph (a)(4) of 
this section will constitute the signing of the prescription by the 
practitioner for purposes of Sec.  1306.05(a) and (e) of this chapter.
    (6) Except as provided under Sec.  1311.145, the practitioner's 
completion of the two-factor authentication protocol must cause the 
application to digitally sign and electronically archive the 
information required under part 1306 of this chapter.
    (b) The electronic prescription application must clearly label as 
the signing function the function that prompts the practitioner to 
execute the two-factor authentication protocol using his credential.
    (c) Any prescription not signed in the manner required by this 
section shall not be transmitted.


Sec.  1311.145  Digitally signing the prescription with the individual 
practitioner's private key.

    (a) An individual practitioner who has obtained a digital 
certificate as provided in Sec.  1311.105 may digitally sign a 
controlled substance prescription using the private key associated with 
his digital certificate.
    (b) The electronic prescription application must require the 
individual practitioner to complete a two-factor authentication 
protocol as specified in Sec.  1311.140(a)(4) to use his private key.
    (c) The electronic prescription application must digitally sign at 
least all information required under part 1306 of this chapter.
    (d) The electronic prescription application must electronically 
archive the digitally signed record.
    (e) A prescription that is digitally signed with a practitioner's 
private key

[[Page 16316]]

may be transmitted to a pharmacy without the digital signature.
    (f) If the electronic prescription is transmitted without the 
digital signature, the electronic prescription application must check 
the certificate revocation list of the certification authority that 
issued the practitioner's digital certificate. If the digital 
certificate is not valid, the electronic prescription application must 
not transmit the prescription. The certificate revocation list may be 
cached until the certification authority issues a new certificate 
revocation list.
    (g) When the individual practitioner digitally signs a controlled 
substance prescription with the private key associated with his own 
digital certificate obtained as provided under Sec.  1311.105, the 
electronic prescription application is not required to digitally sign 
the prescription using the application's private key.


Sec.  1311.150  Additional requirements for internal application 
audits.

    (a) The application provider must establish and implement a list of 
auditable events. Auditable events must, at a minimum, include the 
following:
    (1) Attempted unauthorized access to the electronic prescription 
application, or successful unauthorized access where the determination 
of such is feasible.
    (2) Attempted unauthorized modification or destruction of any 
information or records required by this part, or successful 
unauthorized modification or destruction of any information or records 
required by this part where the determination of such is feasible.
    (3) Interference with application operations of the prescription 
application.
    (4) Any setting of or change to logical access controls related to 
the issuance of controlled substance prescriptions.
    (5) Attempted or successful interference with audit trail 
functions.
    (6) For application service providers, attempted or successful 
creation, modification, or destruction of controlled substance 
prescriptions or logical access controls related to controlled 
substance prescriptions by any agent or employee of the application 
service provider.
    (b) The electronic prescription application must analyze the audit 
trail at least once every calendar day and generate an incident report 
that identifies each auditable event.
    (c) Any person designated to set logical access controls under 
Sec. Sec.  1311.125 or 1311.130 must determine whether any identified 
auditable event represents a security incident that compromised or 
could have compromised the integrity of the prescription records. Any 
such incidents must be reported to the electronic prescription 
application provider and the Administration within one business day.


Sec.  1311.170  Transmission requirements.

    (a) The electronic prescription application must transmit the 
electronic prescription as soon as possible after signature by the 
practitioner.
    (b) The electronic prescription application may print a 
prescription that has been transmitted only if an intermediary or the 
designated pharmacy notifies a practitioner that an electronic 
prescription was not successfully delivered to the designated pharmacy. 
If this occurs, the electronic prescription application may print the 
prescription for the practitioner's manual signature. The printed 
prescription must include information noting that the prescription was 
originally transmitted electronically to [name of the specific 
pharmacy] on [date/time] and that transmission failed.
    (c) The electronic prescription application may print copies of the 
transmitted prescription if they are clearly labeled: ``Copy only--not 
valid for dispensing.'' Data on the prescription may be electronically 
transferred to medical records, and a list of prescriptions written may 
be printed for patients if the list indicates that it is for 
informational purposes only and not for dispensing.
    (d) The electronic prescription application must not allow the 
transmission of an electronic prescription if an original prescription 
was printed prior to attempted transmission.
    (e) The contents of the prescription required by part 1306 of this 
chapter must not be altered during transmission between the 
practitioner and pharmacy. Any change to the content during 
transmission, including truncation or removal of data, will render the 
electronic prescription invalid. The electronic prescription data may 
be converted from one software version to another between the 
electronic prescription application and the pharmacy application; 
conversion includes altering the structure of fields or machine 
language so that the receiving pharmacy application can read the 
prescription and import the data.
    (f) An electronic prescription must be transmitted from the 
practitioner to the pharmacy in its electronic form. At no time may an 
intermediary convert an electronic prescription to another form (e.g., 
facsimile) for transmission.


Sec.  1311.200  Pharmacy responsibilities.

    (a) Before initially using a pharmacy application to process 
controlled substance prescriptions, the pharmacy must determine that 
the third-party auditor or certification organization has found that 
the pharmacy application does the following accurately and 
consistently:
    (1) Import, store, and display the information required for 
prescriptions under Sec.  1306.05(a) of this chapter.
    (2) Import, store, and display the indication of signing as 
required by Sec.  1311.120(b)(17).
    (3) Import, store, and display the number of refills as required by 
Sec.  1306.22 of this chapter.
    (4) Import, store, and verify the practitioner's digital signature, 
as provided in Sec.  1311.210(c), where applicable.
    (b) If the third-party auditor or certification organization has 
found that a pharmacy application does not accurately and consistently 
import, store, and display other information required for prescriptions 
under this chapter, the pharmacy must not process electronic 
prescriptions for controlled substances that are subject to the 
additional information requirements.
    (c) If a pharmacy application provider notifies a pharmacy that a 
third-party audit or certification report indicates that the 
application or the application provider no longer meets the 
requirements of this part or notifies it that the application provider 
has identified an issue that makes the application non-compliant, the 
pharmacy must immediately cease to process controlled substance 
prescriptions using the application.
    (d) A pharmacy that receives a notification that the pharmacy 
application is not in compliance with the requirements of this part 
must not use the application to process controlled substance 
prescriptions until it is notified that the application is again 
compliant and all relevant updates to the application have been 
installed.
    (e) The pharmacy must determine which employees are authorized to 
enter information regarding the dispensing of controlled substance 
prescriptions and annotate or alter records of these prescriptions (to 
the extent such alterations are permitted under this chapter). The 
pharmacy must ensure that logical access controls in the pharmacy 
application are set so that only such employees are granted access to 
perform these functions.

[[Page 16317]]

    (f) When a pharmacist fills a prescription in a manner that would 
require, under part 1306 of this chapter, the pharmacist to make a 
notation on the prescription if the prescription were a paper 
prescription, the pharmacist must make the same notation electronically 
when filling an electronic prescription and retain the annotation 
electronically in the prescription record or in linked files. When a 
prescription is received electronically, the prescription and all 
required annotations must be retained electronically.
    (g) When a pharmacist receives a paper or oral prescription that 
indicates that it was originally transmitted electronically to the 
pharmacy, the pharmacist must check its records to ensure that the 
electronic version was not received and the prescription dispensed. If 
both prescriptions were received, the pharmacist must mark one as void.
    (h) When a pharmacist receives a paper or oral prescription that 
indicates that it was originally transmitted electronically to another 
pharmacy, the pharmacist must check with that pharmacy to determine 
whether the prescription was received and dispensed. If the pharmacy 
that received the original electronic prescription had not dispensed 
the prescription, that pharmacy must mark the electronic version as 
void or canceled. If the pharmacy that received the original electronic 
prescription dispensed the prescription, the pharmacy with the paper 
version must not dispense the paper prescription and must mark the 
prescription as void.
    (i) Nothing in this part relieves a pharmacy and pharmacist of the 
responsibility to dispense controlled substances only pursuant to a 
prescription issued for a legitimate medical purpose by a practitioner 
acting in the usual course of professional practice.


Sec.  1311.205  Pharmacy application requirements.

    (a) The pharmacy may only use a pharmacy application that meets the 
requirements in paragraph (b) of this section to process electronic 
controlled substance prescriptions.
    (b) The pharmacy application must meet the following requirements:
    (1) The pharmacy application must be capable of setting logical 
access controls to limit access for the following functions:
    (i) Annotation, alteration, or deletion of prescription 
information.
    (ii) Setting and changing the logical access controls.
    (2) Logical access controls must be set by individual user name or 
role.
    (3) The pharmacy application must digitally sign and archive a 
prescription on receipt or be capable of receiving and archiving a 
digitally signed record.
    (4) For pharmacy applications that digitally sign prescription 
records upon receipt, the digital signature functionality must meet the 
following requirements:
    (i) The cryptographic module used to digitally sign the data 
elements required by part 1306 of this chapter must be at least FIPS 
140-2 Security Level 1 validated. FIPS 140-2 is incorporated by 
reference in Sec.  1311.08.
    (ii) The digital signature application and hash function must 
comply with FIPS 186-3 and FIPS 180-3, as incorporated by reference in 
Sec.  1311.08.
    (iii) The pharmacy application's private key must be stored 
encrypted on a FIPS 140-2 Security Level 1 or higher validated 
cryptographic module using a FIPS-approved encryption algorithm. FIPS 
140-2 is incorporated by reference in Sec.  1311.08.
    (iv) For software implementations, when the signing module is 
deactivated, the pharmacy application must clear the plain text 
password from the application memory to prevent the unauthorized access 
to, or use of, the private key.
    (v) The pharmacy application must have a time application that is 
within five minutes of the official National Institute of Standards and 
Technology time source.
    (5) The pharmacy application must verify a practitioner's digital 
signature (if the pharmacy application accepts prescriptions that were 
digitally signed with an individual practitioner's private key and 
transmitted with the digital signature).
    (6) If the prescription received by the pharmacy application has 
not been digitally signed by the practitioner and transmitted with the 
digital signature, the pharmacy application must either:
    (i) Verify that the practitioner signed the prescription by 
checking the data field that indicates the prescription was signed; or
    (ii) Display the field for the pharmacist's verification.
    (7) The pharmacy application must read and retain the full DEA 
number including the specific internal code number assigned to 
individual practitioners authorized to prescribe controlled substances 
by the hospital or other institution as provided in Sec.  1301.22(c) of 
this chapter.
    (8) The pharmacy application must read and store, and be capable of 
displaying, all information required by part 1306 of this chapter.
    (9) The pharmacy application must read and store in full the 
information required under Sec.  1306.05(a) of this chapter. The 
pharmacy application must either verify that such information is 
present or must display the information for the pharmacist's 
verification.
    (10) The pharmacy application must provide for the following 
information to be added or linked to each electronic controlled 
substance prescription record for each dispensing:
    (i) Number of units or volume of drug dispensed.
    (ii) Date dispensed.
    (iii) Name or initials of the person who dispensed the 
prescription.
    (11) The pharmacy application must be capable of retrieving 
controlled substance prescriptions by practitioner name, patient name, 
drug name, and date dispensed.
    (12) The pharmacy application must allow downloading of 
prescription data into a database or spreadsheet that is readable and 
sortable.
    (13) The pharmacy application must maintain an audit trail of all 
actions related to the following:
    (i) The receipt, annotation, alteration, or deletion of a 
controlled substance prescription.
    (ii) Any setting or changing of logical access control permissions 
related to the dispensing of controlled substance prescriptions.
    (iii) Auditable events as specified in Sec.  1311.215.
    (14) The pharmacy application must record within each audit record 
the following information:
    (i) The date and time of the event.
    (ii) The type of event.
    (iii) The identity of the person taking the action, where 
applicable.
    (iv) The outcome of the event (success or failure).
    (15) The pharmacy application must conduct internal audits and 
generate reports on any of the events specified in Sec.  1311.215 in a 
format that is readable by the pharmacist. Such an internal audit may 
be automated and need not require human intervention to be conducted.
    (16) The pharmacy application must protect the stored audit records 
from unauthorized deletion. The pharmacy application shall prevent 
modifications to the audit records.
    (17) The pharmacy application must back up the controlled substance 
prescription records daily.
    (18) The pharmacy application must retain all archived records 
electronically for at least two years from the date of their receipt or 
creation and comply

[[Page 16318]]

with all other requirements of Sec.  1311.305.


Sec.  1311.210  Archiving the initial record.

    (a) Except as provided in paragraph (c) of this section, a copy of 
each electronic controlled substance prescription record that a 
pharmacy receives must be digitally signed by one of the following:
    (1) The last intermediary transmitting the record to the pharmacy 
must digitally sign the prescription immediately prior to transmission 
to the pharmacy.
    (2) The first pharmacy application that receives the electronic 
prescription must digitally sign the prescription immediately on 
receipt.
    (b) If the last intermediary digitally signs the record, it must 
forward the digitally signed copy to the pharmacy.
    (c) If a pharmacy receives a digitally signed prescription that 
includes the individual practitioner's digital signature, the pharmacy 
application must do the following:
    (1) Verify the digital signature as provided in FIPS 186-3, as 
incorporated by reference in Sec.  1311.08.
    (2) Check the validity of the certificate holder's digital 
certificate by checking the certificate revocation list. The pharmacy 
may cache the CRL until it expires.
    (3) Archive the digitally signed record. The pharmacy record must 
retain an indication that the prescription was verified upon receipt. 
No additional digital signature is required.


Sec.  1311.215  Internal audit trail.

    (a) The pharmacy application provider must establish and implement 
a list of auditable events. The auditable events must, at a minimum, 
include the following:
    (1) Attempted unauthorized access to the pharmacy application, or 
successful unauthorized access to the pharmacy application where the 
determination of such is feasible.
    (2) Attempted or successful unauthorized modification or 
destruction of any information or records required by this part, or 
successful unauthorized modification or destruction of any information 
or records required by this part where the determination of such is 
feasible.
    (3) Interference with application operations of the pharmacy 
application.
    (4) Any setting of or change to logical access controls related to 
the dispensing of controlled substance prescriptions.
    (5) Attempted or successful interference with audit trail 
functions.
    (6) For application service providers, attempted or successful 
annotation, alteration, or destruction of controlled substance 
prescriptions or logical access controls related to controlled 
substance prescriptions by any agent or employee of the application 
service provider.
    (b) The pharmacy application must analyze the audit trail at least 
once every calendar day and generate an incident report that identifies 
each auditable event.
    (c) The pharmacy must determine whether any identified auditable 
event represents a security incident that compromised or could have 
compromised the integrity of the prescription records. Any such 
incidents must be reported to the pharmacy application service 
provider, if applicable, and the Administration within one business 
day.


Sec.  1311.300  Application provider requirements--Third-party audits 
or certifications.

    (a) Except as provided in paragraph (e) of this section, the 
application provider of an electronic prescription application or a 
pharmacy application must have a third-party audit of the application 
that determines that the application meets the requirements of this 
part at each of the following times:
    (1) Before the application may be used to create, sign, transmit, 
or process controlled substance prescriptions.
    (2) Whenever a functionality related to controlled substance 
prescription requirements is altered or every two years, whichever 
occurs first.
    (b) The third-party audit must be conducted by one of the 
following:
    (1) A person qualified to conduct a SysTrust, WebTrust, or SAS 70 
audit.
    (2) A Certified Information System Auditor who performs compliance 
audits as a regular ongoing business activity.
    (c) An audit for installed applications must address processing 
integrity and determine that the application meets the requirements of 
this part.
    (d) An audit for application service providers must address 
processing integrity and physical security and determine that the 
application meets the requirements of this part.
    (e) If a certifying organization whose certification process has 
been approved by DEA verifies and certifies that an electronic 
prescription or pharmacy application meets the requirements of this 
part, certification by that organization may be used as an alternative 
to the audit requirements of paragraphs (b) through (d) of this 
section, provided that the certification that determines that the 
application meets the requirements of this part occurs at each of the 
following times:
    (1) Before the application may be used to create, sign, transmit, 
or process controlled substance prescriptions.
    (2) Whenever a functionality related to controlled substance 
prescription requirements is altered or every two years, whichever 
occurs first.
    (f) The application provider must make the audit or certification 
report available to any practitioner or pharmacy that uses the 
application or is considering use of the application. The electronic 
prescription or pharmacy application provider must retain the most 
recent audit or certification results and retain the results of any 
other audits or certifications of the application completed within the 
previous two years.
    (g) Except as provided in paragraphs (h) and (i) of this section, 
if the third-party auditor or certification organization finds that the 
application does not meet one or more of the requirements of this part, 
the application must not be used to create, sign, transmit, or process 
electronic controlled substance prescriptions. The application provider 
must notify registrants within five business days of the issuance of 
the audit or certification report that they should not use the 
application for controlled substance prescriptions. The application 
provider must also notify the Administration of the adverse audit or 
certification report and provide the report to the Administration 
within one business day of issuance.
    (h) For electronic prescription applications, the third-party 
auditor or certification organization must make the following 
determinations:
    (1) If the information required in Sec.  1306.05(a) of this 
chapter, the indication that the prescription was signed as required by 
Sec.  1311.120(b)(17) or the digital signature created by the 
practitioner's private key, if transmitted, and the number of refills 
as required by Sec.  1306.22 of this chapter, cannot be consistently 
and accurately recorded, stored, and transmitted, the third-party 
auditor or certification organization must indicate that the 
application does not meet the requirements of this part.
    (2) If other information required under this chapter cannot be 
consistently and accurately recorded, stored, and transmitted, the 
third-party auditor or certification organization must indicate that 
the application has failed to meet the requirements for the specific 
information and should not be used to create, sign, and transmit 
prescriptions that require the additional information.
    (i) For pharmacy applications, the third-party auditor or 
certification

[[Page 16319]]

organization must make the following determinations:
    (1) If the information required in Sec.  1306.05(a) of this 
chapter, the indication that the prescription was signed as required by 
Sec.  1311.205(b)(6), and the number of refills as required by Sec.  
1306.22 of this chapter, cannot be consistently and accurately 
imported, stored, and displayed, the third-party auditor or 
certification organization must indicate that the application does not 
meet the requirements of this part.
    (2) If the pharmacy application accepts prescriptions with the 
practitioner's digital signature, the third-party auditor or 
certification organization must indicate that the application does not 
meet the requirements of this part if the application does not 
consistently and accurately import, store, and verify the digital 
signature.
    (3) If other information required under this chapter cannot be 
consistently and accurately imported, stored, and displayed, the third-
party auditor or certification organization must indicate that the 
application has failed to meet the requirements for the specific 
information and should not be used to process electronic prescriptions 
that require the additional information.


Sec.  1311.302  Additional application provider requirements.

    (a) If an application provider identifies or is made aware of any 
issue with its application that make the application non-compliant with 
the requirements of this part, the application provider must notify 
practitioners or pharmacies that use the application as soon as 
feasible, but no later than five business days after discovery, that 
the application should not be used to issue or process electronic 
controlled substance prescriptions.
    (b) When providing practitioners or pharmacies with updates to any 
issue that makes the application non-compliant with the requirements of 
this part, the application provider must indicate that the updates must 
be installed before the practitioner or pharmacy may use the 
application to issue or process electronic controlled substance 
prescriptions.


Sec.  1311.305  Recordkeeping.

    (a) If a prescription is created, signed, transmitted, and received 
electronically, all records related to that prescription must be 
retained electronically.
    (b) Records required by this subpart must be maintained 
electronically for two years from the date of their creation or 
receipt. This record retention requirement shall not pre-empt any 
longer period of retention which may be required now or in the future, 
by any other Federal or State law or regulation, applicable to 
practitioners, pharmacists, or pharmacies.
    (c) Records regarding controlled substances prescriptions must be 
readily retrievable from all other records. Electronic records must be 
easily readable or easily rendered into a format that a person can 
read.
    (d) Records required by this part must be made available to the 
Administration upon request.
    (e) If an application service provider ceases to provide an 
electronic prescription application or an electronic pharmacy 
application or if a registrant ceases to use an application service 
provider, the application service provider must transfer any records 
subject to this part to the registrant in a format that the 
registrant's applications are capable of retrieving, displaying, and 
printing in a readable format.
    (f) If a registrant changes application providers, the registrant 
must ensure that any records subject to this part are migrated to the 
new application or are stored in a format that can be retrieved, 
displayed, and printed in a readable format.
    (g) If a registrant transfers its electronic prescription files to 
another registrant, both registrants must ensure that the records are 
migrated to the new application or are stored in a format that can be 
retrieved, displayed, and printed in a readable format.
    (h) Digitally signed prescription records must be transferred or 
migrated with the digital signature.

    Dated: March 22, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-6687 Filed 3-24-10; 4:15 pm]
BILLING CODE 4410-09-P