Federal
Register Notices > Rules
- 2006 > Proposed Rule: Issuance
of Multiple Prescriptions for Schedule II Controlled Substances
FR Doc E6-14520 [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]]
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.
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
[[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
[[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
NOTICE: This is an
unofficial version. An official version of these publications may be obtained
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