[Federal Register Volume 71, Number 172 (Wednesday, September 6, 2006)]
[Notices]
[Pages 52716-52723]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-14517]



[[Page 52715]]

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Part V





Department of Justice





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Drug Enforcement Administration



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21 CFR Part 1306



Dispensing Controlled Substances for the Treatment of Pain; Notice



Issuance of Multiple Prescriptions for Schedule II Controlled 
Substances; Proposed Rule

  Federal Register / Vol. 71, No. 172 / Wednesday, September 6, 2006 / 
Notices  

[[Page 52716]]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-286P]


Dispensing Controlled Substances for the Treatment of Pain

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Policy Statement.

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SUMMARY: On January 18, 2005, DEA published in the Federal Register a 
solicitation of comments on the subject of dispensing controlled 
substances for the treatment of pain. Many of the comments that DEA 
received asked the agency to elaborate on the legal requirements and 
agency policy relating to this subject. This document provides such 
information.

DATES: September 6, 2006.

FOR FURTHER INFORMATION CONTACT: Mark W. Caverly, Chief, Liaison and 
Policy Section, Office of Diversion Control, Drug Enforcement 
Administration, Washington, DC 20537; Telephone: (202) 307-7297.

SUPPLEMENTARY INFORMATION:

Background

    On January 18, 2005, the DEA published in the Federal Register a 
Solicitation of Comments on the subject of dispensing controlled 
substances for the treatment of pain. 70 FR 2883. Many of the comments 
sought further information about the legal requirements and agency 
policy relating to the prescribing of controlled substances for the 
treatment of pain. DEA stated in the Solicitation of Comments that it 
would be issuing a document providing such information after reviewing 
the comments. Accordingly, this policy statement provides practitioners 
with a recitation of the pertinent principles under the Controlled 
Substances Act (CSA) and DEA regulations relating to the dispensing of 
controlled substances for the treatment of pain.

Extent of Abuse in the United States of Controlled Prescription Drugs

    The abuse (nonmedical use) of prescription drugs is a serious and 
growing health problem in this country.\1\ As the Administration has 
announced, recent data indicate that prescription drug abuse, 
particularly of opioid pain killers, has increased at an alarming rate 
over the past decade.\2\ Statistics published in the National Survey on 
Drug Use and Health (NSDUH) by the Department of Health and Human 
Services, Substance Abuse and Mental Health Services Administration 
(SAMHSA), demonstrate that prescription drugs account for the second-
most commonly abused category of drugs, behind marijuana and ahead of 
cocaine, heroin, methamphetamine, and other drugs.\3\
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    \1\ National Institute on Drug Abuse Research Report: 
Prescription Drug Abuse and Addiction (revised August 2005). 
(available at http://www.drugabuse.gov/PDF/RRPrescription.pdf).
    \2\ Office of National Drug Control Policy (ONDCP) press 
release, March 1, 2004.
    \3\ 2006 Synthetic Drug Control Strategy (available at http://www.whitehousedrugpolicy.gov/publications/synthetic_drg_control_strat/synth_strat.pdf).
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    One of the areas of concern is the number of persons who have 
recently begun abusing prescription controlled substances. In its NSDUH 
Report published in June 2006,\4\ SAMHSA states: ``In 2004, among 
persons aged 12 or older, 2.4 million initiated nonmedical use of 
prescription pain relievers within the past year. This is more than the 
estimated number of initiates for marijuana (2.1 million) or cocaine 
(1.0 million).'' Overall, according to the NSDUH report: ``An estimated 
31.8 million Americans have used pain relievers nonmedically in their 
lifetimes, up from 29.6 million in 2002.''
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    \4\ The NSDUH report is available at http://www.oas.samhsa.gov/2k6/pain/pain.pdf. The report extracted data from the 2004 National 
Survey on Drug Use and Health.
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    Another source of data presented by SAMHSA is that collected by the 
Drug Abuse Warning Network (DAWN), which provides national estimates of 
drug related visits to hospital emergency departments. According to 
DAWN, for 2004:

     Nearly 1.3 million emergency department (ED) visits in 
2004 were associated with drug misuse/abuse. Nonmedical use of 
pharmaceuticals was involved in nearly half a million of these ED 
visits.
     Opiates/opioid analgesics (pain killers), such as 
hydrocodone, oxycodone, and methadone, and benzodiazepines, such as 
alprazolam and clonazepam, were present in more than 100,000 ED 
visits associated with nonmedical use of pharmaceuticals in 2004.\5\
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    \5\ http://dawninfo.samhsa.gov/files/TNDR07EDvisitsNonmedicalUseForWeb.pdf.

    A measure of the problem among young people is the 2005 Monitoring 
the Future (MTF) survey conducted by the University of Michigan.\6\ The 
MTF survey is funded by the National Institute on Drug Abuse (NIDA), a 
component of the National Institutes of Health (NIH), and measures drug 
abuse among 8th, 10th, and 12th graders. NIDA stated: ``While the 2005 
survey showed a continuing general decline in drug use, there are 
continued high rates of non-medical use of prescription medications, 
especially opioid pain killers. For example, in 2005, 9.5 percent of 
12th graders reported using Vicodin in the past year, and 5.5 percent 
of these students reported using OxyContin in the past year.'' \7\ In 
announcing the latest MTF survey results, NIH Director Dr. Elias 
Zerhouni said that ``the upward trend in prescription drug abuse is 
disturbing.'' \8\
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    \6\ http://monitoringthefuture.org.
    \7\ NIDA news release, December 19, 2005 (available at http://www.nida.nih.gov).
    \8\ Id.
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Purposes and Structure of This Document

    One of the chief purposes of this document is to make clear that 
the longstanding requirement under the law that physicians may 
prescribe controlled substances only for legitimate medical purposes in 
the usual course of professional practice should in no way interfere 
with the legitimate practice of medicine or cause any physician to be 
reluctant to provide legitimate pain treatment. DEA also wishes to 
dispel the mistaken notion among a small number of medical 
professionals that the agency has embarked on a campaign to ``target'' 
physicians who prescribe controlled substances for the treatment of 
pain (or that physicians must curb their legitimate prescribing of pain 
medications to avoid legal liability).
    To achieve these aims, this document begins with a general summary 
of the relevant legal principles and an explanation of the role of DEA 
with respect to regulation of controlled substances. The document then 
addresses specific issues and questions that have been raised on a 
recurring basis by physicians who seek guidance on the subject of 
dispensing controlled substances for the treatment of pain.
    It should be understood that the legal standard under the 
Controlled Substances Act (CSA) for prescribing controlled substances 
to treat pain is the same as that for prescribing controlled substances 
generally: The prescription must be issued for a legitimate medical 
purpose by a registered physician acting within the usual course of 
professional practice. The reason this document focuses on the 
prescribing of controlled substances for the treatment of pain is that 
there has been considerable interest among members of the public in 
having DEA address this specific issue.

[[Page 52717]]

The Statutory Role of DEA in Regulating the Prescribing of Controlled 
Substances

    DEA is the agency within the Department of Justice responsible for 
carrying out the functions assigned to the Attorney General under the 
CSA.\9\ These functions include enforcing and administering the CSA 
provisions governing the prescribing, administering, and dispensing of 
controlled substances. Thus, the scope of DEA's authority is delineated 
by the extent to which Congress itself regulated controlled substances 
through the enactment of the CSA and assigned certain functions under 
the Act to the Attorney General.
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    \9\ 21 U.S.C. 871(a); 28 CFR 0.100.
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    While the CSA is one component of the overall regulation of the 
practice of medicine in the United States,\10\ it bears emphasis that 
the CSA does not regulate the practice of medicine as a whole. 
Therefore, although DEA is the agency responsible for administering the 
CSA, DEA does not act as the Federal equivalent of a State medical 
board overseeing the general practice of medicine. State laws and State 
licensing bodies (such as medical licensing boards) collectively 
regulate the practice of medicine.\11\ In contrast, the scope of the 
CSA (and therefore role of DEA) is much narrower. The CSA regulates 
only the segment of medical practice involving the use of controlled 
substances, and DEA is correspondingly responsible for ensuring that 
controlled substances are used in compliance with Federal law.
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    \10\ As the United States Supreme Court stated in an early 
decision under the CSA, ``provisions throughout the Act reflect the 
intent of Congress to confine authorized medical practice within 
accepted limits.'' United States v. Moore, 423 U.S. 122, 141-142 
(1975). In Gonzales v. Oregon, 126 S.Ct. 904, 925 (2006), the Court 
continued to cite Moore with approval and for the proposition that 
the legitimate medical purpose requirement in the CSA ``ensures 
patients use controlled substances under the supervision of a doctor 
so as to prevent addiction and recreational abuse.'' The Court 
further stated: ``As a corollary, the provision also bars doctors 
from peddling to patients who crave the drugs for those prohibited 
uses.'' Id
    \11\ Medical specialty boards also play a crucial role in 
providing information to the public, the government, and the medical 
profession concerning issues involving specialization and 
certification in medicine. Specialty boards maintain the quality of 
medical care in the United States by developing and utilizing 
professional and educational standards for the evaluation and 
certification of physician specialists.
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    In particular, DEA's role under the CSA is to ensure that 
controlled substances are prescribed, administered, and dispensed only 
for legitimate medical purposes by DEA-registered practitioners acting 
in the usual course of professional practice and otherwise in 
accordance with the CSA and DEA regulations. Each State also has its 
own laws (administered by State agencies) requiring that a prescription 
for a controlled substance be issued only for a legitimate medical 
purpose by State-licensed practitioners acting in the usual course of 
professional practice.
    There is nothing new in this arrangement of responsibilities 
between the Federal and State governments. For more than 90 years 
(starting with the Harrison Narcotic Act of 1914, which was superseded 
by the CSA in 1970) Federal law has placed certain restrictions on the 
medical use of federally controlled substances while, at the same time, 
the States have regulated the practice of medicine generally. In this 
respect, there has long been a certain amount of overlap between the 
Federal and State oversight of controlled substances. Beginning in the 
1930s and through to the present, States have adopted uniform 
controlled substance laws that were designed to promote standards that 
are consistent from State to State and in harmony with Federal law.\12\ 
One such standard that has always been a fundamental part of these 
uniform State laws is the requirement that controlled substances be 
dispensed only for a legitimate medical purpose by a practitioner 
acting in the usual course of professional practice--a requirement 
first articulated in the Harrison Narcotic Act. Accordingly, it has 
been the case for more than 70 years that a practitioner who dispenses 
controlled substances for other than a legitimate medical purpose, or 
outside the usual course of professional practice, is subject to legal 
liability under both State and Federal law.\13\
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    \12\ The first such uniform act was the Uniform Narcotic Drug 
Act of 1932, which was eventually adopted by every state. That act 
was replaced in 1970 by the Uniform Controlled Substances Act, which 
has been adopted by all but two states (New Hampshire and Vermont).
    \13\ Congress expressly intended that there would be a dual 
system of Federal-state regulation of controlled substances by 
including in the CSA a preemption provision, 21 U.S.C. 903, which 
reflects that this field of regulation was to be shared by the 
Federal and state governments. Section 903 states: ``No provision of 
this subchapter shall be construed as indicating an intent on the 
part of Congress to occupy the field in which that provision 
operates, including criminal penalties, to the exclusion of any 
State law on the same subject matter which would otherwise be within 
the authority of the State * * * .'' At the same time, this 
provision reiterates what is inherent in the supremacy clause of the 
United States Constitution--that no state may enact a law relating 
to controlled substances that presents a ``positive conflict'' with 
the CSA.
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The Meaning of the ``Legitimate Medical Purpose'' Requirement

    As stated above, the core legal standard is that a controlled 
substance may only be prescribed, administered, or dispensed for a 
legitimate medical purpose by a physician acting in the usual course of 
professional practice. This requirement has been construed to mean that 
the prescription must be ``in accordance with a standard of medical 
practice generally recognized and accepted in the United States.'' \14\ 
However, Federal courts have long recognized that it is not possible to 
expand on the phrase ``legitimate medical purpose in the usual course 
of professional practice,'' in a way that will provide definitive 
guidelines that address all the varied situations physicians might 
encounter. As one court explained:
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    \14\ Moore, 423 U.S. at 139 (quoting jury instruction).

    There are no specific guidelines concerning what is required to 
support a conclusion that an accused acted outside the usual course 
of professional practice. Rather, the courts must engage in a case-
by-case analysis of evidence to determine whether a reasonable 
inference of guilt may be drawn from specific facts.\15\
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    \15\ United States v. August, 984 F.2d 705, 713 (6th Cir. 1992).

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    Similarly, another court stated:

    A majority of cases [in which physicians were alleged to have 
dispensed controlled substances without a legitimate medical 
purpose] have dealt with facts which were so blatant that a 
statement of clear-cut criteria in a form useful in other cases 
would have been superfluous to the decision. We are, however, able 
to glean from reported cases certain recurring concomitance of 
condemned behavior.\16\
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    \16\ United States v. Rosen, 582 F.2d 1032 (5th Cir. 1978).

    The foregoing quotation makes a particularly important point: that 
the types of cases in which physicians have been found to have 
dispensed controlled substances improperly under Federal law generally 
involve facts where the physician's conduct is not merely of 
questionable legality, but instead is a glaring example of illegal 
activity.

Specific Areas of Interest to the Commenters

    The comments DEA received covered a variety of issues related to 
the dispensing of controlled substances for the treatment of pain. 
While some of the viewpoints expressed in the comments were in sharp 
contrast with other viewpoints, taken as a whole, the comments indicate 
there is significant interest (among those physicians and members of 
the public who submitted comments) in having DEA address the following 
topics:

[[Page 52718]]

     The extent and consequences of the undertreatment of pain 
in the United States.
     The extent and consequences of excessive use of opioids to 
treat nonsevere pain.
     Providing medical and legal guidance on prescribing 
opioids for pain.
     Elaborating on DEA's policy regarding the investigation of 
physicians for improper prescribing of controlled substances for pain.
     Having DEA provide reassurance that it is not targeting 
physicians who prescribe controlled substances for pain.
    Each of these topics is addressed in this document.\17\
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    \17\ Also of chief concern to commenters was the issuance by 
physicians of multiple schedule II prescriptions. DEA addressed this 
issue in detail in the August 26, 2005, Federal Register document 
titled ``Clarification of Existing Requirements Under the Controlled 
Substances Act for Prescribing Schedule II Controlled Substances.'' 
70 FR 50403. In addition, DEA is today publishing in the Federal 
Register a notice of proposed rulemaking (Docket No. DEA-287N) that 
would revise the DEA regulations to allow for the issuance of 
multiple schedule II prescriptions under certain circumstances.
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Comments Regarding the Use of Opioids

    The comments reflect two distinct points of emphasis among 
physicians who specialize in the treatment of pain. For some, of 
paramount concern is what they describe as the undertreatment of acute 
and chronic pain. Illustrative of this viewpoint, one commenter has 
stated:

    The undertreatment of pain is recognized as a serious public 
health problem that results in a decrease in patients' functional 
status and quality of life and may be attributed to a myriad of 
social, economic, political, legal and educational factors, 
including inconsistencies and restrictions in State pain policies. 
Circumstances that contribute to the prevalence of undertreated pain 
include: (1) Lack of knowledge of medical standards, current 
research, and clinical guidelines for appropriate pain treatment; 
(2) the perception that prescribing adequate amounts of controlled 
substances will result in unnecessary scrutiny by regulatory 
authorities; (3) misunderstanding of addiction and dependence; and 
(4) lack of understanding of regulatory policies and processes.\18\
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    \18\ Federation of State Medical Boards of the United States, 
Model Policy for the Use of Controlled Substances for the Treatment 
of Pain (2004).

    One group representing several organizations of physicians who 
specialize in treating pain commented that it agrees with the following 
statement made by DEA in the November 16, 2004, Interim Policy 
Statement published in the Federal Register (69 FR 67170): ``[C]hronic 
pain is a serious problem for many Americans. It is crucial that 
physicians who are engaged in legitimate pain treatment not be 
discouraged from providing proper medication to patients as medically 
justified.'' However, this group expressed the view that the Interim 
Policy Statement would have ``the exact opposite effect'' by 
discouraging some practitioners from properly treating pain. The group 
therefore urged DEA to readdress the subject in a way that will promote 
proper dispensing of controlled substances for pain. Similar views were 
expressed in comments submitted by many other organizations whose 
missions relate to the treatment of pain. For example, an organization 
representing health care professionals and patient advocates for those 
with cancer pain stated: ``We respectfully request that the DEA 
reaffirm its support for areas of the law that support the appropriate 
use of opioid analgesics for pain control and thereby reduce the fears 
and uncertainties of health care professionals who treat patients in 
pain.'' With regard to this point, NIDA has stated in a recent report: 
``Many healthcare providers underprescribe opioid pain relievers, such 
as morphine and codeine, because they overestimate the potential for 
patients to become addicted.'' \19\
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    \19\ National Institute on Drug Abuse Research Report: 
Prescription Drug Abuse and Addiction (available at http://www.drugabuse.gov/PDF/RRPrescription.pdf).
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    A few other commenters focused primarily on what they believe is 
the overprescribing of opioids by some physicians to treat pain. For 
example, one physician who specializes in pain treatment stated that 
``the majority of high dose narcotic prescribing is for chronic `non-
malignant' pain,'' that ``the growth of this practice has been 
exponential,'' and that ``there have been many problems associated with 
this practice, including the tremendous rise in abuse of prescription 
drugs in all segments of the population, especially the youth.'' Along 
similar lines, another physician commented there has been an 
``epidemic'' of deaths and addiction resulting from the illicit use of 
prescription narcotics, which, according to this commenter, is due in 
large part to the prescribing of narcotics to ``a much wider class of 
chronic noncancer patients, including those with moderate subjective 
ailments such as bursitis, neuralgia, arthritis, headaches, and lower 
back pain.'' Another physician stated the large increase in the use of 
prescription narcotics and deaths related thereto ``seem to be 
coincident with growing advocacy for use of opioid pain medications in 
chronic benign pain syndromes'' and ``also coincide with the marketing 
of expensive new opioid drug preparations which are aggressively 
promoted by the drug manufacturers, and with the growth of professional 
and accrediting organizations that seem determined to promote the use 
of opioid pain medications.''
    The two distinct areas of emphasis reflected in the comments--the 
commenters' views about the undertreatment of pain and what some 
perceive as overprescribing of opioids for nonsevere ailments--are not 
necessarily mutually exclusive. To the contrary, the comments taken 
collectively suggest that there may be some physicians who 
``undertreat'' pain and others who improperly prescribe opioids 
ostensibly for the treatment of pain. (DEA presumes, however, that most 
physicians provide appropriate amounts of pain medication.) The 
comments also reflect that there is a lack of consensus among 
physicians as to all the circumstances that warrant the use of opioids 
to treat pain.\20\ On this latter point, one physician who specializes 
in pain treatment commented: ``The treatment of chronic nonmalignant 
pain syndromes with narcotic medications remains a controversial area 
with the mainstream medical community.'' This commenter suggested there 
is a need for randomized, double-blind, controlled clinical trials to 
fully evaluate this issue. As explained below, it is not DEA's role to 
issue medical guidelines specifying patient characteristics that 
warrant the selection of a particular opioid or other medication or 
regimen for the treatment of pain.
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    \20\ One indication of the lack of consensus among physicians on 
this point is the following. The American Medical Association, in a 
published policy statement (D-120.999) (``Use of opioids in chronic 
noncancer pain''), states: ``Further controlled trials [should] be 
conducted on opioid therapy in patients with chronic noncancer pain 
in an effort to identify best practice with regard to selection of 
both medication and treatment regimens [to] identify patient 
characteristics that predict opioid responsiveness [and to] provide 
support for guidelines on appropriate precautions, 
contraindications, and the degree of monitoring required in such 
patients.''
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Requests for Guidance on Treating Patients for Pain

    Many commenters expressed the view that it would be beneficial if 
physicians had a single document providing clear guidelines on the use 
of controlled substances for the treatment of pain. Some believe such a 
document would remedy their concerns about the undertreatment of pain 
by giving

[[Page 52719]]

physicians assurance that they can avoid scrutiny by Federal and State 
regulatory authorities as long as they follow those guidelines when 
prescribing opioids. More specifically, it has been suggested that 
these guidelines should take the form of a series of questions and 
answers to be adopted by DEA. Among the questions that have been 
proposed for inclusion in these guidelines are:
     What should be the goals of pain management?
     How can a clinician assess a patient's pain?
     When should a primary care physician turn to a pain 
medicine specialist to manage a patient's pain?
     How are opioids used to manage chronic pain?
    It is certainly appropriate for physicians and medical oversight 
boards to explore these types of questions. However, for the following 
reasons, it is not appropriate for DEA to address these questions in 
the form of a guidance document (or to endorse such a guidance document 
prepared by others).
    First, one cannot provide an exhaustive and foolproof list of ``dos 
and don'ts'' when it comes to prescribing controlled substances for 
pain or any other medical purpose. As discussed above, the fundamental 
principle under both Federal and State law is that a controlled 
substance must be dispensed by a physician for a legitimate medical 
purpose in the usual course of professional practice. Throughout the 90 
years that this requirement has been a part of United States law, the 
courts have recognized that there are no definitive criteria laying out 
precisely what is legally permissible, as each patient's medical 
situation is unique and must be evaluated based on the entirety of the 
circumstances. DEA cannot modify or expand upon this longstanding legal 
requirement through the publication or endorsement of guidelines.
    Second, as stated earlier in this document, DEA's authority under 
the CSA is not equivalent to that of a State medical board. DEA does 
not regulate the general practice of medicine. The responsibility for 
educating and training physicians so that they make sound medical 
decisions in treating pain (or any other ailment) lies primarily with 
medical schools, post-graduate training facilities, State accrediting 
bodies, and other organizations with medical expertise. Some states 
also have continuing medical education requirements for licensing. 
Physicians also keep abreast of the latest findings by reading peer-
reviewed articles published in medical and scientific journals. DEA, 
however, has neither the legal authority nor the expertise to provide 
medical training to physicians or issue guidelines that constitute 
advice on the general practice of medicine.\21\
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    \21\ As stated above, DEA does have the authority and the 
expertise to investigate and determine whether a prescription for a 
controlled substance was issued for a legitimate medical purpose in 
the usual course of professional practice within the meaning of the 
CSA and DEA regulations.
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    For these reasons, DEA is not proposing any medical guidelines on 
prescribing controlled substances for the treatment of pain.

Whether To Form an Advisory Committee

    Several members of the public have suggested that DEA form an 
advisory committee, panel, or working group to develop and publish 
guidelines on the use of controlled substances for the treatment of 
pain. An agency may not utilize an advisory committee (or panel or 
working group) to provide advice to the agency or prepare a document 
for (or in conjunction with) the agency unless all of the procedural 
requirements of the Federal Advisory Committee Act (FACA) are 
satisfied.\22\ Compliance with FACA ensures, among other things, that 
persons selected by the agency to serve on the committee constitute a 
balanced membership that represents a fair cross-section of viewpoints.
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    \22\ As set forth in FACA, a charter must be enacted before an 
advisory committee can meet. 5 U.S.C. App. 2 Sec.  9(c). For an 
agency committee, the charter must be filed with the head of the 
agency, the appropriate Senate and House of Representatives standing 
committees, the Library of Congress, and the General Services 
Administration Secretariat, 41 CFR 102-3.70. The charter must 
contain certain information, including, among other things, the 
following: the advisory committee's official designation; objectives 
and the scope of the advisory committee's activity; the time 
necessary to carry out the advisory committee's purposes; a 
description of the duties for which the advisory committee is 
responsible; the estimated annual costs; the estimated frequency of 
the advisory committee's meetings; and the planned termination date.
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    If DEA were to conclude that compelling considerations necessitated 
the formation of an advisory committee subject to FACA, the agency 
would seek to do so in accordance with the law and Executive Branch 
directives.\23\ At this time, DEA does not believe that such 
considerations exist warranting the formation of such an advisory 
committee to address the dispensing of controlled substances for the 
treatment of pain. However, there are other means available to an 
agency to obtain valuable public input. Within the bounds permissible 
by law, DEA remains firmly committed to obtaining the ongoing input of 
the medical community, law enforcement officials, and other interested 
members of the public. Toward this end, the agency welcomes written 
submissions from the public on this document and will continue to 
explore other legally appropriate means of hearing the views of 
interested members of the public.
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    \23\ See Executive Order 12838 (``Termination and Limitation of 
Federal Advisory Committees'').
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The Number of Physicians Who Prescribe Controlled Substances in 
Violation of the CSA Is Extremely Small and There Is No DEA 
``Crackdown'' on Physicians

    DEA recognizes that the overwhelming majority of American 
physicians who prescribe controlled substances do so for legitimate 
medical purposes. In fact, the overwhelming majority of physicians who 
prescribe controlled substances do so in a legitimate manner that will 
never warrant scrutiny by Federal or State law enforcement officials. 
Contrary to the impression of some commenters, DEA has not modified its 
criteria for investigating physicians or increased its emphasis on 
physicians as part of the agency's overall mission. In any given year, 
including 2005, fewer than one out of every 10,000 physicians in the 
United States (less than 0.01 percent) lose their controlled substance 
registrations based on a DEA investigation of improper prescribing.\24\ 
This figure alone should correct any mistaken notions about a supposed 
DEA ``crackdown'' on physicians. Moreover, as mentioned above, the 
responsibility for monitoring and preventing controlled substance abuse 
is shared by State and Federal governments. Even in the rare cases 
where a physician loses his/her DEA registration for improper 
prescribing, it is often State officials--not DEA--who initiate the 
investigations.
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    \24\ The majority of cases in which physicians lose their DEA 
registrations result from actions by state medical boards to revoke 
or suspend the physicians' state medical licenses.
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    DEA always had, and continues to have, a legal obligation to 
investigate the extremely small fraction of physicians who use their 
DEA registration to commit criminal acts or otherwise violate the CSA. 
DEA takes this obligation seriously because even just one physician who 
uses his/her DEA registration for criminal purposes can cause enormous 
harm. In the words of one commenter: ``It takes only a few untrained or 
unscrupulous physicians to create large pockets of addicts.'' But DEA 
takes just as seriously its obligation to ensure that there is no 
interference with the dispensing of controlled

[[Page 52720]]

substances to the American public in accordance with the sound medical 
judgment of their physicians. It would be a disservice to many patients 
if exaggerated statements regarding the likelihood of a DEA 
investigation resulted in physicians mistakenly concluding that they 
must scale back their patients' use of controlled substances to levels 
below that which is medically appropriate.
    Furthermore, DEA does not apply a greater level of scrutiny to the 
prescribing of controlled substances to treat pain as compared to other 
ailments. Regardless of the ailment, DEA applies evenhandedly the 
requirement that a controlled substance be prescribed for a legitimate 
medical purpose in the usual course of professional practice. The idea 
that prescribing opioids to treat pain will trigger special scrutiny by 
DEA is false.

Types of Cases in Which Physicians Have Been Found To Have Prescribed 
or Dispensed Controlled Substances for Other Than a Legitimate Medical 
Purpose or Outside the Usual Course of Professional Practice

    Bearing in mind that there are no criteria that will address every 
conceivable instance of prescribing, the following examples of cases 
are provided to explain how Federal courts and DEA have applied the 
requirement that a controlled substance be dispensed for a legitimate 
medical purpose in the usual course of professional practice.

Application of the Requirement by Federal Courts

    As noted above, the Supreme Court recently stated, in Gonzales v. 
Oregon, that the legitimate medical purpose requirement in the CSA 
``ensures patients use controlled substances under the supervision of a 
doctor so as to prevent addiction and recreational abuse.'' \25\ The 
Court further stated: ``As a corollary, the provision also bars doctors 
from peddling to patients who crave the drugs for those prohibited 
uses.'' \26\
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    \25\ 126 S.Ct. at 925.
    \26\ Id.
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    Consistent with those views, some years ago, the United States 
Court of Appeals for the Fifth Circuit summarized the reported cases in 
which physicians had been found to have violated the requirement that a 
prescription for a controlled substance be issued only for a legitimate 
medical purpose in the usual course of professional practice. In this 
decision, United States v. Rosen, 582 F.2d 1032 (5th Cir. 1978), the 
court looked at the case law and found the following recurring patterns 
indicative of diversion and abuse:

    (1) An inordinately large quantity of controlled substances was 
prescribed.
    (2) Large numbers of prescriptions were issued.
    (3) No physical examination was given.
    (4) The physician warned the patient to fill prescriptions at 
different drug stores.
    (5) The physician issued prescriptions knowing that the patient 
was delivering the drugs to others.
    (6) The physician prescribed controlled drugs at intervals 
inconsistent with legitimate medical treatment.
    (7) The physician involved used street slang rather than medical 
terminology for the drugs prescribed.
    (8) There was no logical relationship between the drugs 
prescribed and treatment of the condition allegedly existing.
    (9) The physician wrote more than one prescription on occasions 
in order to spread them out.

    The same fact patterns listed by the Rosen court remain prevalent 
today among the cases in which physicians have been found to have 
improperly prescribed controlled substances. This does not mean that 
the existence of any of the foregoing factors will automatically lead 
to the conclusion that the physician acted improperly. Rather, each 
case must be evaluated based on its own merits in view of the totality 
of circumstances particular to the physician and patient. For example, 
what constitutes ``an inordinately large quantity of controlled 
substances'' (factor (1) listed by the Rosen court) can vary greatly 
from patient to patient. A particular quantity of a powerful schedule 
II opioid might be blatantly excessive for the treatment of a 
particular patient's mild temporary pain, yet insufficient to treat the 
severe unremitting pain of a cancer patient.
    Again, rather than focusing on any particular factor, it is 
critical to bear in mind that (i) the entirety of circumstances must be 
considered, (ii) the cases in which physicians have been found to have 
prescribed controlled substances improperly typically involve facts 
that demonstrate blatant criminal conduct, and (iii) the percentage of 
physicians who prescribe controlled substances improperly (or are 
investigated for doing so) is extremely small.

Application of the Requirement by DEA

    Any final decision by DEA to revoke or deny a DEA registration is 
published in the Federal Register. The following are three examples 
from 2005 in which DEA revoked physicians' DEA registrations for 
unlawfully prescribing or dispensing controlled substances. (The 
complete final orders are published in the Federal Register and are 
available online.)
     Robert A. Smith, M.D. (70 FR 33207)--Dr. Smith gave one 
patient seven to ten prescriptions of OxyContin per visit on a weekly 
basis. The prescriptions were written in the patient's name as well as 
the names of the patient's father and her fianc[eacute]. Each visit, 
the patient paid Dr. Smith a $65 fee for the office visit plus an 
additional $100 for the fraudulent prescriptions. Dr. Smith also asked 
the patient for sexual favors during office visits. The patient 
declined, but, as a substitute, paid another woman $100 to perform a 
sexual act on Dr. Smith. Dr. Smith's office assistant also provided the 
patient with blank prescriptions, in return for which the office 
assistant demanded from the patient $40 and OxyContin tablets.
    Another patient would give Dr. Smith a list of fictitious names and 
types of controlled substances he desired, and Dr. Smith would issue 
three prescriptions under each name, usually for Percocet, OxyContin, 
and Xanax, at the same time. Dr. Smith issued between nine and fifteen 
fraudulent prescriptions per visit and received $100 for each set of 
three prescriptions. The patient then sold the prescriptions to a third 
party who, in turn, sold the drugs on the street, all with the 
knowledge of Dr. Smith.
    Another individual visited Dr. Smith three times in less than a 
three-week period, obtaining fraudulent prescriptions each time. The 
individual paid Dr. Smith $500 for 15 prescriptions for Xanax, 
OxyContin, and Percocet, which were written under five different 
fictitious patient names.
     James S. Bischoff, M.D. (70 FR 12734)--Dr. Bischoff took a 
16-year-old high school student to an out-of-town physician specialist 
for emergency medical treatment after the boy's hand was cut in an 
accident. When the specialist did not recommend treatment with a 
controlled substance, Dr. Bischoff wrote the boy a prescription for 100 
OxyContin, which Dr. Bischoff personally took to a pharmacy to be 
filled. Dr. Bischoff delivered only 20 tablets to the boy, unlawfully 
diverting the remaining 80 tablets. Around the same time, Dr. Bischoff 
wrote another prescription in the boy's name for 120 Adderall tablets. 
Dr. Bischoff also filled this prescription himself at a pharmacy but 
never delivered the tablets to the boy. Later, Dr. Bischoff wrote 
another prescription in the name of the boy for 120 Adderall tablets. 
The boy's stepmother learned that the boy was taking the medication 
only after she

[[Page 52721]]

discovered the bottle a couple of weeks later. She then checked with 
the pharmacy and discovered that Dr. Bischoff had written and 
personally filled multiple fraudulent prescriptions for controlled 
substances in the names of the boy's family members, telling 
pharmacists that he was a close friend and that the purported patients 
were too busy to get to the pharmacy. In addition, Dr. Bischoff ordered 
approximately 46,000 dosage units of schedule III and IV controlled 
substances from a supplier, and he was unable to account for 32,000 
dosage units.
     John S. Poulter, D.D.S. (70 FR 24628)--Local law 
enforcement authorities were called after Dr. Poulter was observed 
parked in front of a convenience store injecting himself with Demerol. 
Dr. Poulter failed a field sobriety test, admitted to injecting himself 
with Demerol, and later pleaded guilty to State felony charges of 
unlawful possession of a controlled substance. The plea was held in 
abeyance for three years pending Dr. Poulter's successful completion of 
a monitoring program for impaired professionals. In addition to the 
criminal proceedings, his State professional licensing board took 
action based on the Demerol incident and several instances of improper 
use of Fentanyl. Dr. Poulter entered into a five-year probationary 
agreement with the State board, agreeing to abstain from personal use 
of mood-altering substances. Before completing these probationary 
periods, Dr. Poulter was involved in an automobile accident in which he 
drove his car off the road after having injected himself with Fentanyl 
and Demerol. Responding officers and medical personnel found him 
``incoherent and very confused,'' and there were visible needle marks 
on his arm and hands. A search of the automobile revealed a used 
syringe and a plastic container holding Demerol and Fentanyl.
    These three recent cases provide illustrations of some of the most 
common behaviors that result in loss of DEA registration: Issuing 
prescriptions for controlled substances without a bona fide physician-
patient relationship; issuing prescriptions in exchange for sex; 
issuing several prescriptions at once for a highly potent combination 
of controlled substances; charging fees commensurate with drug dealing 
rather than providing medical services; issuing prescriptions using 
fraudulent names; and self-abuse by practitioners.
    In another recent case, United States v. Singh, 390 F.3d 168 (2d 
Cir. 2004), a physician who claimed to specialize in pain management 
was convicted following a jury trial of improperly prescribing a 
controlled substance in violation of the CSA. The court of appeals, 
which upheld the conviction, described the nature of the physician's 
prescribing practice as follows (id. at 176):

    Singh developed a scheme that enabled nurses to see patients 
alone, to issue prescriptions for schedule II controlled substances, 
and to bill for such services. He and the other physicians would 
pre-sign the triplicate forms and provide them to non-physician 
personnel to use during patient visits. These employees, although 
not trained or legally authorized to do so, filled in all the 
required prescription information--drug type, dosage, and quantity--
and provided the prescriptions to the patients.
    It appears that the physicians at the practice, including Singh, 
signed entire books of triplicate prescription forms in blank 
without even knowing the identities of the patients to whom the 
prescriptions would be issued or the nature or dosage of the drug to 
be prescribed. * * *
    Data extracted from Singh's office records revealed that the 
nurses issued prescriptions for at least 76,000 tablets of schedule 
II controlled substances when Singh was not present in the practice 
suite.

    Thus, Singh is another example of a prosecution based on blatant 
criminal conduct by a physician, and it should cause no concern for any 
legitimate pain specialist or other physician who properly prescribes 
controlled substances.

Commencement of Investigations

    On the subject of when DEA might commence an investigation of 
possible improper prescribing of controlled substances, several 
commenters sought elaboration on DEA's statements in the November 16, 
2004 Interim Policy Statement. In that document, DEA stated, among 
other things:

    [I]t is a longstanding legal principle that the Government ``can 
investigate merely on suspicion that the law is being violated, or 
even just because it wants assurance that it is not.'' United States 
v. Morton Salt Co., 338 U.S. 632, 642-643 (1950). It would be 
incorrect to suggest that DEA must meet some arbitrary standard or 
threshold evidentiary requirement to commence an investigation of a 
possible violation of the [CSA].

    The foregoing is a correct statement of the law, and DEA is not 
unique in this regard. All law enforcement agencies--Federal and 
State--have long been governed by this same principle. The reason DEA 
mentioned this longstanding maxim in the Interim Policy Statement was 
to correct an earlier publication attributed to DEA that embodied a 
contrary view.
    While those who commented on the subject of investigations 
generally acknowledged that DEA had properly stated the law, some 
asserted that, by doing so, the agency might have caused some 
physicians to fear the prospect of being investigated and thereby 
discouraged them from providing proper pain treatment. DEA believes, 
however, physicians will understand that correctly stating the legal 
standard which has historically applied to regulatory agencies is no 
cause for alarm. DEA does not use its investigatory authority in an 
arbitrary manner. Further, as DEA has repeatedly stated in this 
document and elsewhere, there is no ``crackdown'' or increased emphasis 
on investigating physicians, and the statistics bear that out. In 2005, 
as in prior years, only a tiny fraction of physicians (less than one in 
ten thousand) lost their registration based on a DEA investigation of 
improper prescribing of controlled substances.
    One commenter suggested DEA should announce it will only commence 
an investigation when it has evidence that the physician is prescribing 
in a manner outside of accepted medical standards. To adopt such a 
standard would conflict with longstanding law, as previously noted. In 
addition, from a practical perspective, such a standard would be 
impossible to apply because the agency cannot know--prior to commencing 
an investigation--whether the activity was proper or improper. 
Gathering preliminary information is essential to determining whether a 
full-scale investigation is--or is not--warranted. By stating the 
governing law, however, DEA is not suggesting that it investigates 
every instance of prescribing in order to rule out the possibility of 
illegal activity. To the contrary, the agency recognizes that nearly 
every prescription issued by a physician in the United States is for a 
legitimate medical purpose in the usual course of professional 
practice.

Other Recurring Questions

What is fueling the recent increase in prescription drug abuse?

    There are a variety of factors that may be contributing to the 
increase in prescription drug abuse. The Director of NIDA recently 
testified before Congress:

    The recent increase in the extent of prescription drug abuse in 
this country is likely the result of a confluence of factors, such 
as: Significant increases in the number of prescriptions; 
significant increases in drug availability; aggressive marketing by 
the pharmaceutical industry; the proliferation of illegal Internet 
pharmacies that dispense these medications without proper 
prescriptions and surveillance; and a greater

[[Page 52722]]

social acceptability for medicating a growing number of 
conditions.\27\
---------------------------------------------------------------------------

    \27\ The NIDA testimony, which was presented July 26, 2006, 
before the House Subcommittee on Criminal Justice, Drug Policy, and 
Human Resources, Committee on Government Reform, appears in full on 
NIDA's Web site at http://www.drugabuse.gov/Testimony/7-26-06Testimony.html.
---------------------------------------------------------------------------

     Increased availability of prescription drugs and sharing 
among family and friends--The United States Government Accountability 
Office (GAO) published a report in 2003 on the abuse of the most 
prescribed brand name narcotic medication for treating moderate-to-
severe pain.\28\ The report states: ``The large amount of [the drug] 
available in the marketplace may have increased opportunities for abuse 
and diversion. Both DEA and [the manufacturer of the drug] have stated 
that an increase in a drug's availability in the marketplace may be a 
factor that attracts interest by those who abuse and divert drugs.''
---------------------------------------------------------------------------

    \28\ The GAO report, ``Prescription Drugs OxyContin Abuse and 
Diversion and Efforts to Address the Problem,'' GAO-04-110 (December 
2003), is available at http://www.gao.gov/new.items/d04110.pdf.
---------------------------------------------------------------------------

    The 2006 Synthetic Drug Control Strategy states:

    Preliminary data suggest the most common way in which controlled 
substance prescriptions are diverted may be through friends and 
family. For example, a person with a lawful and medical need for 
some amount of a controlled substance uses only a portion of the 
prescribed amount. Then a family member complains of pain, and the 
former patient shares excess medication. Alternatively, for a family 
member addicted to controlled prescription drugs, the mere 
availability of unused controlled substance prescriptions in the 
house may prove to be an irresistible temptation.

     Ease of access via the Internet--It is becoming 
increasingly easy for persons of any age to obtain controlled 
substances illegally by means of the Internet. Numerous Web sites based 
in the United States and abroad sell controlled substances to anyone 
willing and able to provide a credit card number. Some of these Web 
sites do not require a prescription. Others will provide the buyer with 
an illegitimate prescription simply by having the buyer fill out an 
online questionnaire without seeing a physician. As the 2006 Synthetic 
Drug Control Strategy states, ``the anonymity of the Internet and the 
proliferation of Web sites that facilitate illicit transactions for 
controlled substance prescription drugs have given drug abusers the 
ability to circumvent the law as well as sound medical practice.''
     Improper prescribing--As the 2006 Synthetic Drug Control 
Strategy states: ``The overwhelming majority of prescribing in America 
is conducted responsibly, but the small number of physicians who 
overprescribe controlled substances--carelessly at best, knowingly at 
worst--help supply America's most widespread drug addiction problem. 
Although the problem exists, the number of physicians responsible for 
this problem is a very small fraction of those licensed to prescribe 
controlled substances in the United States.''
     Drug formulation and marketing--One of the recommendations 
in the 2006 Synthetic Drug Control Strategy is to ``[c]ontinue to 
support the efforts of firms that manufacture frequently diverted 
pharmaceutical products to reformulate their products so as to reduce 
diversion and abuse,'' and to ``[e]ncourage manufactures to explore 
methods to render * * * pain control products, such as OxyContin, less 
suitable for snorting or injection.'' Whether the marketing of certain 
opioids has contributed to abuse and diversion has also been an area of 
discussion.\29\
---------------------------------------------------------------------------

    \29\ A detailed discussion of this issue is contained in the 
above-referenced GAO report, ``Prescription Drugs OxyContin Abuse 
and Diversion and Efforts to Address the Problem.'' The 
manufacturer's statement to Congress in response to the GAO report 
is available at http://reform.house.gov/UploadedFiles/9-13-2005%20Purdue%20Testimony.pdf. In 2001, FDA announced that it had 
worked with the manufacturer of OxyContin to make changes to the 
drug's labeling, including a ``black box warning,'' which FDA states 
is ``intended to lessen the chance that OxyContin will be prescribed 
inappropriately for pain of lesser severity than the approved use or 
for other disorders or conditions inappropriate for a schedule II 
narcotic.'' FDA Talk Paper: ``FDA Strengthens Warnings for 
OxyContin'' (July 25, 2001), available at http://www.fda.gov/bbs/topics/ANSWERS/2001/ANS01091.html.
---------------------------------------------------------------------------

What are some of the common methods and sources of diversion?

    Diversion of prescription drugs containing controlled substances 
occurs on a variety of levels. Some controlled substances are stolen 
directly from manufacturers and distributors. Diversion also occurs at 
the retail level with thefts from, and robberies of, pharmacies. In one 
survey of over 1,000 pharmacists nationwide, 28.9 percent reported that 
they had experienced a theft or robbery at their pharmacies within the 
past five years.\30\ A very small percentage of physicians also 
contribute to the problem of diversion by intentionally, or 
unintentionally, providing controlled substances to those who are 
themselves drug abusers or who sell the drugs for profit.
---------------------------------------------------------------------------

    \30\ The survey was conducted by the National Center on 
Addiction and Substance Abuse at Columbia University, which 
published the results in a comprehensive report on prescription drug 
abuse entitled: ``Under the Counter: The Diversion and Abuse of 
Controlled Prescription Drugs in the U.S.'' (available at http://www.casacolumbia.org/absolutenm/articlefiles/380-under_the_counter_-_diversion.pdf).
---------------------------------------------------------------------------

    Prescription fraud is another common source of diversion. This 
occurs whenever prescriptions for controlled substances are obtained 
under false pretenses, including when prescriptions are forged or 
altered, or when someone falsely claiming to be a physician calls in 
the prescription to a pharmacy.
    ``Doctor shopping'' is another traditional method by which 
diversion occurs. Some drug abusers visit multiple physicians' offices 
and falsely present complaints in order to obtain controlled 
substances.

What are the potential signs to a physician that a patient might be 
seeking drugs for the purpose of abuse or diversion?

    Many physicians have requested a list of the possible indicators 
that a patient might be seeking controlled substances for the purpose 
of diversion or abuse. DEA has provided this type of list in various 
publications over the years. While not an exhaustive list, the 
following are some of the common behaviors that might be an indication 
the patient is seeking drugs for the purpose of diversion or abuse:

     Demanding to be seen immediately;
     Stating that s/he is visiting the area and is in need 
of a prescription to tide her/him over until returning to the local 
physician;
     Appearing to feign symptoms, such as abdominal or back 
pain, or pain from kidney stones or a migraine, in an effort to 
obtain narcotics;
     Indicating that nonnarcotic analgesics do not work for 
him/her;
     Requesting a particular narcotic drug;
     Complaining that a prescription has been lost or stolen 
and needs replacing;
     Requesting more refills than originally prescribed;
     Using pressure tactics or threatening behavior to 
obtain a prescription;
     Showing visible signs of drug abuse, such as track 
marks.

What are the general legal responsibilities of a physician to prevent 
diversion and abuse when prescribing controlled substances?

    In each instance where a physician issues a prescription for a 
controlled substance, the physician must properly determine there is a 
legitimate medical purpose for the patient to be prescribed that 
controlled substance and the physician must be acting in the usual 
course of professional practice.\31\ This is the basic legal 
requirement discussed

[[Page 52723]]

above, which has been part of American law for decades. Moreover, as a 
condition of being a DEA registrant, a physician who prescribes 
controlled substances has an obligation to take reasonable measures to 
prevent diversion.\32\ The overwhelming majority of physicians in the 
United States who prescribe controlled substances do, in fact, exercise 
the appropriate degree of medical supervision--as part of their routine 
practice during office visits--to minimize the likelihood of diversion 
or abuse. Again, each patient's situation is unique and the nature and 
degree of physician oversight should be tailored accordingly, based on 
the physician's sound medical judgment and consistent with established 
medical standards.
---------------------------------------------------------------------------

    \31\ 21 CFR 1306.04(a); United States v. Moore, supra.
    \32\ 21 U.S.C. 823(f).
---------------------------------------------------------------------------

What additional precaution should be taken when a patient has a history 
of drug abuse?

    As a DEA registrant, a physician has a responsibility to exercise a 
much greater degree of oversight to prevent diversion and abuse in the 
case of a known or suspected addict than in the case of a patient for 
whom there are no indicators of drug abuse. Under no circumstances may 
a physician dispense controlled substances with the knowledge they will 
be used for a nonmedical purpose or that they will be resold by the 
patient. Some physicians who treat patients having a history of drug 
abuse require each patient to sign a contract agreeing to certain terms 
designed to prevent diversion and abuse, such as periodic urinalysis. 
While such measures are not mandated by the CSA or DEA regulations, 
they can be very useful.

Can a physician be investigated solely on the basis of the number of 
tablets prescribed for an individual patient?

    The Supreme Court has long recognized that an administrative agency 
responsible for enforcing the law has broad investigative 
authority,\33\ and courts have recognized that prescribing an 
``inordinately large quantity of controlled substances'' can be 
evidence of a violation of the CSA.\34\ DEA therefore, as the agency 
responsible for administering the CSA, has the legal authority to 
investigate a suspicious prescription of any quantity.
---------------------------------------------------------------------------

    \33\ Morton Salt, 338 U.S. at 642-643 (``an administrative 
agency charged with seeing that the laws are enforced'' may 
``investigate merely on suspicion that the law is being violated, or 
even just because it wants assurance that it is not.'').
    \34\ United States v. Rosen, 582 F.2d at 1036.
---------------------------------------------------------------------------

    Nonetheless, the amount of dosage units per prescription will never 
be a basis for investigation for the overwhelming majority of 
physicians. As with every other profession, however, among the hundreds 
of thousands of physicians who practice medicine in this country in a 
manner that warrants no government scrutiny are a handful who engage in 
criminal behavior. In rare cases, it is possible that an aberrant 
physician could prescribe such an enormous quantity of controlled 
substances to a given patient that this alone will be a valid basis for 
investigation. For example, if a physician were to prescribe 1,600 
(sixteen hundred) tablets per day of a schedule II opioid to a single 
patient, this would certainly warrant investigation as there is no 
conceivable medical basis for anyone to ingest that quantity of such a 
powerful narcotic in a single day. Again, however, such cases are 
extremely rare. The overwhelming majority of physicians who conclude 
that use of a particular controlled substance is medically appropriate 
for a given patient should prescribe the amount of that controlled 
substance which is consistent with their sound medical judgment and 
accepted medical standards without concern that doing so will subject 
them to DEA scrutiny.

Can methadone be used for pain control?

    Methadone, a schedule II controlled substance, has been approved by 
the FDA as an analgesic. While a physician must have a separate DEA 
registration to dispense methadone for maintenance or detoxification, 
no separate registration is required to prescribe methadone for pain. 
However, in a document entitled ``Methadone-Associated Mortality: 
Report of a National Assessment,'' SAMHSA recently recommended that 
``physicians need to understand methadone's pharmacology and 
appropriate use, as well as specific indications and cautions to 
consider when deciding whether to use this medication in the treatment 
of pain.'' \35\ This recommendation was made in light of mortality 
rates associated with methadone.
---------------------------------------------------------------------------

    \35\ SAMHSA Publication No. 04-3904. Available at http://dpt.samhsa.gov/reports/index.htm.
---------------------------------------------------------------------------

Obtaining Further Input From Physicians and Other Health Care 
Professionals

    In developing policies and rules relating to the use of controlled 
substances in the treatment of pain, DEA is firmly committed to 
obtaining input on an ongoing basis from physicians and other health 
care professionals authorized to prescribe and dispense controlled 
substances, as well the views of Federal and State agencies, 
professional societies, and other interested members of the public. DEA 
welcomes the written comments that any such persons might wish to 
submit in response to this document. DEA will also continue to evaluate 
whether it would be beneficial to obtain the additional views of 
physicians through in-person meetings, to the extent permissible under 
FACA.

    Dated: August 28, 2006.
Michele M. Leonhart,
Deputy Administrator.
 [FR Doc. E6-14517 Filed 9-5-06; 8:45 am]
BILLING CODE 4410-09-P