[Federal Register: September 6, 2006 (Volume 71, Number 172)]
[Proposed Rules]
[Page 52724-52726]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06se06-43]
[[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:
dea.diversion.policy@usdoj.gov.
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
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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
[[Page 52726]]
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