[Federal Register Volume 70, Number 165 (Friday, August 26, 2005)]
[Notices]
[Pages 50408-50409]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-16954]


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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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