[Federal Register: August 26, 2005 (Volume 70, Number 165)]
[Notices]
[Page 50408-50409]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26au05-139]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-271N]
Clarification of Existing Requirements Under the Controlled
Substances Act for Prescribing Schedule II Controlled Substances
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Clarification.
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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 the
agency received indicate that there is a need to issue a clarification
regarding certain aspects of the prescription requirements for schedule
II controlled substances. This document provides such clarification.
DATES: August 26, 2005.
FOR FURTHER INFORMATION CONTACT: Patricia M. Good, Chief, Liaison and
Policy Section, Office of Diversion Control, Drug Enforcement
Administration, Washington, DC 20537; Telephone: (202) 307-7297.
SUPPLEMENTARY INFORMATION: On January 18, 2005, the Drug Enforcement
Administration (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. Most of the comments that the agency
received sought clarification on the legal requirements governing the
prescribing of schedule II controlled substances by physicians in view
of DEA's November 16, 2004, Interim Policy Statement. 69 FR 67170.
Given these comments, DEA wishes to reiterate the following principles
under the Controlled Substances Act (CSA) and DEA regulations.
1. As the Interim Policy Statement states, ``For a physician to
prepare multiple prescriptions [for a schedule II controlled substance]
on the same day with instructions to fill on different dates is
tantamount to writing a prescription authorizing refills of a schedule
II controlled substance.'' To do so conflicts with the provision of the
CSA which provides: ``No prescription for a controlled substance in
schedule II may be refilled.''
2. Many of the comments that DEA received were from patients who
said they have been receiving prescriptions for schedule II controlled
substances for several years (for example, for the treatment of severe
pain or attention deficit hyperactivity disorder) and have gotten into
a routine of seeing their physician once every three months. Many such
commenters were under the mistaken impression that, because of the
Interim Policy Statement, they now must begin seeing their physician
every month. DEA wishes to make clear that the Interim Policy did not
state that such patients must visit their physician's office every
month to pick up a new prescription. There is no such requirement in
the CSA or DEA regulations. 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. 21
CFR 1306.04(a); United States v. Moore, 423 U.S. 122 (1975).
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. 21 U.S.C. 812(b). Physicians must, therefore, use 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. Physicians must also abide by any requirements imposed by their
state medical boards with respect to proper prescribing practices and
what constitutes a bona fide physician-patient relationship. 21 U.S.C.
823(f)(1), (4).
3. Under the circumstances described in paragraph 2, in those
instances where the physician (who regularly sees a patient) issues a
prescription for a
[[Page 50409]]
schedule II controlled substance for a legitimate medical purpose
without seeing the patient in person, the physician may mail the
prescription to the patient or pharmacy. In addition, as the DEA
regulations state: ``A prescription for a schedule II controlled
substance may be transmitted by the practitioner or the practitioner's
agent to a pharmacy via facsimile equipment, provided that the original
written, signed prescription is presented to the pharmacist for review
prior to the actual dispensing of the controlled substance, except as
noted [elsewhere in this section of the regulations].'' 21 CFR
1306.11(a). Thus, as this provision of the regulations provides, faxing
may be used to facilitate the filling of a schedule II prescription,
but only if the pharmacy receives the original written, signed
prescription prior to dispensing the drug to the patient.
4. The CSA and DEA regulations contain no specific limit on the
number of days worth of a schedule II controlled substance that a
physician may authorize per prescription. Some states, however, do
impose specific limits on the amount of a schedule II controlled
substance that may be prescribed. Any limitations imposed by state law
apply in addition to the corresponding requirements under Federal law,
so long as the state requirements do not conflict with or contravene
the Federal requirements. 21 U.S.C. 903. Again, the essential
requirement under Federal law is that the prescription for a controlled
substance be issued for a legitimate medical purpose in the usual
course of professional practice. In addition, physicians and pharmacies
have a duty as DEA registrants to ensure that their prescribing and
dispensing of controlled substances occur in a manner consistent with
effective controls against diversion and misuse, taking into account
the nature of the drug being prescribed. 21 U.S.C. 823(f).
Finally, as stated in the Solicitation of Comments, once DEA has
completed its review of the comments, the agency plans to issue a new
Federal Register document, which will provide a recitation of the
pertinent legal principles relating to the dispensing of controlled
substances for the treatment of pain.
Dated: August 19, 2005.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 05-16954 Filed 8-25-05; 8:45 am]
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