[Federal Register Volume 71, Number 172 (Wednesday, September 6, 2006)]
[Proposed Rules]
[Pages 52724-52726]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-14520]



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

[[Page 52724]]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1306

[Docket No. DEA-287N]
RIN 1117-AB01


Issuance of Multiple Prescriptions for Schedule II Controlled 
Substances

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of proposed rulemaking.

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SUMMARY: DEA is hereby proposing to amend its regulations to allow 
practitioners to provide individual patients with multiple 
prescriptions, to be filled sequentially, for the same schedule II 
controlled substance, with such multiple prescriptions having the 
combined effect of allowing a patient to receive over time up to a 90-
day supply of that controlled substance. DEA is requesting public 
comment on this proposed rule.

DATES: Written comments must be postmarked, and electronic comments 
must be sent, on or before November 6, 2006.

ADDRESSES: Please submit comments, identified by ``Docket No. DEA-
287N,'' by one of the following methods:
    1. Regular mail: Deputy Administrator, Drug Enforcement 
Administration, Washington, DC 20537, Attention: DEA Federal Register 
Representative/ODL.
    2. Express mail: DEA Headquarters, Attention: DEA Federal Register 
Representative/ODL, 2401 Jefferson-Davis Highway, Alexandria, VA 22301.
    3. E-mail comments directly to agency: 
[email protected].
    4. Federal eRulemaking portal: http://www.regulations.gov. Follow 
the on-line instructions for submitting comments.
    Anyone planning to comment should be aware that all comments 
received before the close of the comment period will be made available 
in their entirety for public inspection, including any personal 
information submitted. For those submitting comments electronically, 
DEA will accept attachments only in the following formats: Microsoft 
Word; WordPerfect; Adobe PDF; or Excel.

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: 

I. Background

    On August 26, 2005, DEA published in the Federal Register a 
``Clarification Of Existing Requirements Under The Controlled 
Substances Act For Prescribing Schedule II Controlled Substances.'' 70 
FR 50408. That document addressed the situation of patients who have 
been receiving prescriptions for schedule II controlled substances for 
legitimate medical purposes (for example, for the treatment of severe 
pain or attention deficit hyperactivity disorder (ADHD)) and have 
settled into a routine of seeing their physician once every three 
months. The document was intended to address the concerns of many such 
patients who were under the mistaken impression that, because of DEA's 
November 16, 2004, Interim Policy Statement (69 FR 67170), they had to 
begin seeing their physicians every month to obtain their schedule II 
prescriptions. As the August 26, 2005, clarification document noted: 
``DEA wishes to make clear that the Interim Policy Statement did not 
state that such patients must visit their physician's office every 
month to pick up a new prescription.'' The clarification document 
further explained some of the possible ways in which, under appropriate 
circumstances, patients can continue to receive schedule II 
prescriptions without visiting their physicians' offices every 
month.\1\
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    \1\ The clarification document stated, among other things, that 
a lawfully issued prescription may be mailed by the physician to the 
patient or pharmacy.
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    Following the publication of the clarification document, DEA 
received further comments from the public indicating that many 
physicians, patients, and pharmacists believe it would still be 
beneficial to allow physicians to provide individual patients with 
multiple prescriptions for the same schedule II controlled substance at 
a single office visit. Those who have commented in favor of allowing 
this practice suggest that under this approach, the physician would 
write instructions on each prescription indicating the earliest date on 
which it could be filled. In this manner, these commenters suggested, a 
physician should be allowed to authorize up to a 90-day supply of 
schedule II controlled substances at a single office visit. Other 
physicians who commented indicated that they do typically see their 
patients at least once every 30 days for the treatment of pain but that 
they too believe they should be permitted to issue multiple 
prescriptions over a shorter time frame (for example, three 
prescriptions each for a 10-day supply). Physicians who sought to issue 
multiple prescriptions in this latter manner suggested that doing so 
would facilitate greater physician oversight and minimize the 
likelihood of diversion and abuse.

II. Legal Considerations

    Whether it is legally permissible for a physician to provide a 
patient with multiple prescriptions for a schedule II controlled 
substance in the manner described above depends on the interpretation 
given the provision of the Controlled Substances Act (CSA) governing 
prescriptions, 21 U.S.C. 829. Subsection 829(a) states: ``No 
prescription for a controlled substance in schedule II may be 
refilled.'' By comparison, subsection 829(b) states that, for a 
schedule III or IV controlled substance, a prescription may be refilled 
up to five times within six months after the date the prescription was 
issued. Thus, Congress clearly mandated greater prescription controls 
for schedule II substances than for schedule III and IV substances. For 
example, a physician may--consistent with the statute--issue a 
prescription for a schedule III or IV controlled substance and circle 
on the prescription a certain number of refills. In this manner, a 
physician may provide a patient with up to a six-month supply of 
schedule III or IV controlled substance with a single prescription 
indicating five refills. The same cannot be done with a schedule II 
controlled substance since section 829(a) prohibits refills. The 
statute requires a separate prescription if the physician wishes to 
authorize a continuation of the patient's use of a schedule II drug 
beyond the amount specified on the first prescription.
    Because the statute does not permit refill prescriptions for 
schedule II drugs, some physicians began over the last decade or so to 
provide patients with several prescriptions at once, writing ``do not 
fill until [a specified date]'' on the additional prescriptions. As 
noted above, among those physicians who have used this multiple 
prescription approach, the most common practice has been to give the 
patient three prescriptions, each for a thirty-day supply, writing on 
the second prescription ``do not fill until [30 days later]'' and 
writing on the third prescription ``do not fill until [60 days 
later].''
    Section 829 does not specifically address the practice of issuing 
multiple schedule II prescriptions. Nor is this practice addressed 
elsewhere in the

[[Page 52725]]

CSA.\2\ In such situations (when faced with a provision of a statute 
that does not address the precise question at issue), the agency that 
administers the statute must interpret it consistent with the text, 
structure, and purposes of the Act as a whole. The Supreme Court has 
recently characterized section 829 as a provision that ``ensures 
patients use controlled substances under the supervision of a doctor so 
as to prevent addiction and recreational abuse''.\3\
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    \2\ That the CSA does not address the issuance of multiple 
schedule II prescriptions is not surprising, since it appears that 
no physician employed this practice in 1970, when the CSA was 
enacted. The practice of issuing multiple schedule II prescriptions 
appears to have begun in approximately 1995.
    \3\ Gonzales v. Oregon, 126 S.Ct. 904, 925 (2006).
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    Many of the comments that DEA received suggested that the issuance 
of multiple schedule II prescriptions, under appropriate circumstances, 
can be beneficial to the practice of medicine and does not promote 
addiction or recreational abuse. In fact, as discussed above, many 
commenters asserted that a physician can issue multiple prescriptions 
in a manner that allows for a greater level of control and supervision 
to prevent diversion and abuse than if the physician had authorized the 
same total amount of controlled substances with a single prescription. 
For example, some commenters said, issuing three ten-day prescriptions 
with specific instructions on when each should be filled provides for 
greater control by the physician than a single 30-day prescription for 
the same total amounts of drugs.
    The Supreme Court has held that the administering agency, in order 
``to engage in informed rulemaking, must consider varying 
interpretations and the wisdom of its policy on a continuing 
basis''.\4\ DEA has undertaken this task since publishing the Interim 
Policy Statement. The agency received numerous public comments on this 
issue. Upon consideration of these comments, DEA is hereby proposing 
that the issuance of multiple prescriptions in a single visit may be 
undertaken in a manner consistent with the text, structure, and 
purposes of the CSA, provided the procedures set forth in this proposed 
rule are followed.
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    \4\ Chevron, U.S.A. v. Natural Resources Defense Council, 467 
U.S. 837, 863-864 (1984).
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    Before setting forth the proposed rule, it is important to 
reiterate some additional basic principles:
    For those patients who have written to DEA stating that they have 
been receiving prescriptions for schedule II controlled substances for 
several years (for example, for the treatment of severe pain or ADHD) 
and have adopted a routine of seeing their physician once every three 
months, it should be underscored that there is no requirement under the 
CSA or DEA regulations that such patients must visit their physician's 
office every month to pick up a new prescription. What is required, in 
each instance where a physician issues a prescription for any 
controlled substance, is that the physician properly determine there is 
a legitimate medical purpose for the patient to be prescribed that 
controlled substance and that the physician be acting in the usual 
course of professional practice.\5\
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    \5\ 21 CFR 1306.04(a); United States v. Moore, 423 U.S. 122 
(1975).
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    At the same time, schedule II controlled substances, by definition, 
have the highest potential for abuse, and are the most likely to cause 
dependence, of all the controlled substances that have an approved 
medical use.\6\ Physicians must, therefore, employ the utmost care in 
determining whether their patients for whom they are prescribing 
schedule II controlled substances should be seen in person each time a 
prescription is issued or whether seeing the patient in person at 
somewhat less frequent intervals is consistent with sound medical 
practice and appropriate safeguards against diversion and misuse. Some 
physicians who submitted comments to DEA indicated that they treat 
patients for pain or ADHD and believe it is medically appropriate to 
see the patient in person in every instance where they issue a 
prescription for a schedule II controlled substance. No physician 
should view the rule being proposed here as encouragement to see his/
her patients (those who are being prescribed schedule II controlled 
substances) on a less frequent basis; nor should any physician view 
this document as signal to be less vigilant for the signs of diversion 
or abuse. To the contrary, DEA shares the concerns of those physicians 
whose comments reflect that, in view of the increasingly alarming 
levels of schedule II drug abuse in the United States, the sound 
judgment and continuous vigilance of physicians are crucial components 
in preventing diversion and abuse.
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    \6\ 21 U.S.C. 812(b).
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    Finally, nothing in this proposed rule changes the requirement that 
physicians must also abide by the laws of the states in which they 
practice and any additional requirements imposed by their state medical 
boards with respect to proper prescribing practices and what 
constitutes a bona fide physician-patient relationship.\7\ As set forth 
in this proposed rule, the issuance of multiple schedule II 
prescriptions in the manner described will only be permissible if doing 
so is also permissible under applicable state laws. Thus, 
notwithstanding this proposed rule, individual states may disallow the 
practice of issuing multiple schedule II prescriptions.
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    \7\ 21 U.S.C. 823(f)(1), (4).
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Regulatory Certifications

Regulatory Flexibility Act

    The Deputy Administrator hereby certifies that this proposed rule 
will not have a significant impact on a substantial number of small 
entities within the meaning of the Regulatory Flexibility Act (5 U.S.C. 
605(b)). This proposed rule would merely provide an additional option 
that practitioners may utilize when prescribing schedule II controlled 
substances under certain circumstances. The proposed rule would not 
mandate any new procedures. Therefore, an initial regulatory 
flexibility analysis is not required for this proposed rule.

Executive Order 12866

    This proposed rule has been drafted and reviewed in accordance with 
Executive Order 12866, Regulatory Planning and Review, section 1(b), 
Principles of Regulation. This proposed rule has been determined not to 
be a ``significant regulatory action'' under Executive Order 12866, 
section 3(f). Accordingly, this proposed rule has not been reviewed by 
the Office of Management and Budget for purposes of Executive Order 
12866.

Executive Order 13132

    This proposed rule 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 proposed rule does not have federalism 
implications warranting the application of Executive Order 13132.

Executive Order 12988--Civil Justice Reform

    This proposed rule meets the applicable standards set forth in 
sections 3(a) and 3(b)(2) of Executive Order 12988.

Unfunded Mandates Reform Act of 1995

    This proposed rule will not result in the expenditure by State, 
local, and tribal governments, in the aggregate, or by the private 
sector, of $115,000,000 or more in any one year. Therefore, no

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actions are necessary under the Unfunded Mandates Reform Act of 1995.

Small Business Regulatory Enforcement Fairness Act of 1996

    This proposed rule is not likely to result in any of the following: 
an annual effect on the economy of $100,000,000 or more; a major 
increase in costs or prices for consumers, individual industries, 
Federal, state, or local government agencies, or geographic regions; or 
significant adverse effects on competition, employment, investment, 
productivity, innovation, or on the ability of United States-based 
enterprises to compete with foreign-based enterprises in domestic and 
export markets. This proposed rule is not a major rule under the Small 
Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 
804. Therefore, the provisions of SBREFA relating to major rules are 
inapplicable to this proposed rule. However, a copy of this proposed 
rule is being submitted to each House of the Congress and to the 
Comptroller General in accordance with SBREFA (5 U.S.C. 801).

List of Subjects in 21 CFR Part 1306

    Administrative practice and procedure, Drug traffic control, 
Narcotics, Prescription drugs.

Proposed Rule

    Pursuant to the authority vested in the Attorney General under 
sections 201, 202, and 501(b) of the CSA (21 U.S.C. 811, 812, and 
871(b)), delegated to the Deputy Administrator pursuant to section 
501(a) (21 U.S.C. 871(a)) and as specified in 28 CFR 0.100 and 0.104, 
Appendix to Subpart R, the Deputy Administrator hereby proposes that 
Title 21 of the Code of Federal Regulations, part 1306, be amended as 
follows:

PART 1306--[AMENDED]

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

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

    2. Section 1306.12 is revised to read as follows:


Sec.  1306.12  Refilling prescriptions; issuance of multiple 
prescriptions.

    (a) The refilling of a prescription for a controlled substance 
listed in Schedule II is prohibited.
    (b)(1) An individual practitioner may issue multiple prescriptions 
authorizing the patient to receive a total of up to a 90-day supply of 
a Schedule II controlled substance provided the following conditions 
are met:
    (i) The individual practitioner properly determines there is a 
legitimate medical purpose for the patient to be prescribed that 
controlled substance and the individual practitioner is acting in the 
usual course of professional practice;
    (ii) The individual practitioner writes instructions on each 
prescription (other than the first prescription, if the prescribing 
practitioner intends for that prescription to be filled immediately) 
indicating the earliest date on which a pharmacy may fill the 
prescription;
    (iii) The individual practitioner concludes that providing the 
patient with multiple prescriptions in this manner does not create an 
undue risk of diversion or abuse;
    (iv) The issuance of multiple prescriptions as described in this 
section is permissible under the applicable state laws; and
    (v) The individual practitioner complies fully with all other 
applicable requirements under the Act and these regulations as well as 
any additional requirements under state law.
    (2) Nothing in this paragraph (b) shall be construed as mandating 
or encouraging individual practitioners to issue multiple prescriptions 
or to see their patients only once every 90 days when prescribing 
Schedule II controlled substances. Rather, individual practitioners 
must determine on their own, based on sound medical judgment, and in 
accordance with established medical standards, whether it is 
appropriate to issue multiple prescriptions and how often to see their 
patients when doing so.

    3. Section 1306.14 is amended by adding a new paragraph (e) to read 
as follows:


Sec.  1306.14  Labeling of substances and filling of prescriptions.

* * * * *
    (e) Where a prescription that has been prepared in accordance with 
Sec.  1306.12(b) contains instructions from the prescribing 
practitioner indicating that the prescription shall not be filled until 
a certain date, no pharmacist may fill the prescription before that 
date.

    Dated: August 28, 2006.
Michele M. Leonhart,
Deputy Administrator.
 [FR Doc. E6-14520 Filed 9-5-06; 8:45 am]
BILLING CODE 4410-09-P