Clarification of Existing Requirements Under the Controlled Substances Act for Prescribing Schedule II Controlled Substances, 50408-50409 [05-16954]

Download as PDF 50408 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Notices Consortium, Inc. intends to file additional written notification disclosing all changes in membership. On November 19, 2004, Network Centric Operations Industry Consortium, Inc. filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the Federal Register pursuant to Section 6(b) of the Act on February 2, 2005 (70 FR 5486). The last notification was filed with the Department on May 11, 2005. A notice was published in the Federal Register pursuant to Section 6(b) of the Act on June 13, 2005 (70 FR 34150). Dorothy B. Fountain, Deputy Director of Operations, Antitrust Division. [FR Doc. 05–16961 Filed 8–25–05; 8:45 am] requirements for an enclosure controller slot that will support a variety of storage controllers from a variety of independent hardware vendors and independent software vendors. Any storage controller design based on this specification shall be able to fit, connect, and operate within any storage enclosure controller slot design based on the same specification. Dorothy B. Fountain, Deputy Director of Operations Antitrust Division. [FR Doc. 05–16959 Filed 8–25–05; 8:45 am] BILLING CODE 4410–11–M DEPARTMENT OF JUSTICE Drug Enforcement Administration BILLING CODE 4410–11–M [Docket No. DEA–271N] DEPARTMENT OF JUSTICE Antitrust Division Notice Pursuant to the National Cooperative Research and Production Act of 1993—Storage Bridge Bay Working Group, Inc. Notice is hereby given that, on August 9, 2005, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301 et. seq. (‘‘the Act’’), Storage Bridge Bay Working Group, Inc. (‘‘SBB’’) has filed written notifications simultaneously with the Attorney General and the Federal Trade Commission disclosing (1) the name and principal place of business of the standards development organization and (2) the nature and scope of its standards development activities. The notifications were filed for the purpose of invoking the Act’s provisions limiting the recovery of antitrust plaintiffs to actual damages under specified circumstances. Pursuant to Section 6(b) of the Act, the name and principal place of business of the Standards development organization is: Storage Bridge Bay Working Group, Inc., Redwood City, CA. The nature and scope of SBB’s standards development activities are: Promoting the computer industry by supporting and facilitating the development of interoperable and compatible storage components with reference to controller slot compatibility between and among storage solutions. These purposes include the objective of developing and publishing a ‘‘storage bridge bay’’ specification that will serve as a reference and guideline for defining physical, mechanical, electrical and low-level enclosure management VerDate jul<14>2003 16:18 Aug 25, 2005 Jkt 205001 Clarification of Existing Requirements Under the Controlled Substances Act for Prescribing Schedule II Controlled Substances Drug Enforcement Administration (DEA), Justice. ACTION: Clarification. AGENCY: 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. PO 00000 Frm 00118 Fmt 4703 Sfmt 4703 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 E:\FR\FM\26AUN1.SGM 26AUN1 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Notices 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] DEPARTMENT OF LABOR DEPARTMENT OF LABOR Employment and Training Administration Employment and Training Administration [TA–W–56,114] [TA–W–57,428] Americal Corporation, Henderson, NC; Notice of Termination of Investigation Pursuant to Section 221 of the Trade Act of 1974, as amended, an investigation was initiated on June 22, 2005 in response to a petition filed by a company official on behalf of workers at Americal Corporation, Henderson, North Carolina. The petitioner has requested that the petition be withdrawn. Consequently, the investigation has been terminated. Signed at Washington, DC, this 29th day of July, 2005. Linda G. Poole, Certifying Officer, Division of Trade Adjustment Assistance. [FR Doc. E5–4678 Filed 8–25–05; 8:45 am] BILLING CODE 4510–30–P DEPARTMENT OF LABOR Employment and Training Administration [TA–W–57,639 and TA-W–57,639A] Bernhardt Furniture Company, Plant # 9, Shelby, NC, and Bernhardt Furniture Company, Plant # 14, Cherryville, NC; Notice of Termination of Investigation Pursuant to Section 221 of the Trade Act of 1974, an investigation was initiated on July 28, 2005 in response to a petition filed by a company official on behalf of workers at Bernhardt Furniture Company, Plant #9, Shelby, North Carolina (TA–W–57,639) and Bernhardt Furniture Company, Plant #14, Cherryville, North Carolina (TA–W– 57,639A). The petitioner has requested that the petition be withdrawn. Consequently, the investigation has been terminated. Signed in Washington, DC, this 10th day of August, 2005. Elliott S. Kushner, Certifying Officer, Division of Trade Adjustment Assistance. [FR Doc. E5–4683 Filed 8–25–05; 8:45 am] BILLING CODE 4510–30–P BILLING CODE 4410–09–P VerDate jul<14>2003 16:18 Aug 25, 2005 Jkt 205001 50409 PO 00000 Frm 00119 Fmt 4703 Sfmt 4703 Bourns Microelectronics Modules, Inc., a Subsidiary of Bourns Inc., New Berlin, WI; Notice of Revised Determination on Remand On June 29, 2005, the United States Court of International Trade (USCIT) granted the Department of Labor’s motion for voluntary remand in Former Employees of Bourns Microelectronics Modules, Inc. v. U.S. Secretary of Labor (Court No. 045–00350). A petition, dated November 30, 2004, for Trade Adjustment Assistance (TAA) and Alternative Trade Adjustment Assistance (ATAA) was filed on behalf of workers and former workers of MMC Bidding, Inc., Division of Bourns, New Berlin, Wisconsin. The investigation revealed that the workers previously worked for Microelectronics Modules Corporation (MMC), New Berlin, Wisconsin and that the workers’ employment with MMC was terminated when Bourns acquired the assets of MMC on October 30, 2003. The investigation also revealed that the Department granted a certification for the former workers of MMC (TA–W– 42,217; expired December 6, 2004). On December 27, 2004, the investigation for the case at hand was terminated because it was believed that the workers were covered by the previous certification for MMC (TA–W– 42,217). (The Department had also terminated another investigation for a previous petition for the same location (TA–W–54,790) on June 4, 2004 because the Department found that the workers were covered by the certification for MMC (TA–W–42,217)). The Department’s Notice of Termination of Investigation for this case was published in the Federal Register (70 FR 3732). By letter dated January 14, 2005, the petitioner requested administrative reconsideration, stating that the workers were hired by and then separated from Bourns, that the petitioner helped ship machines and documentation to, and provided training to persons in Costa Rica, China and Taiwan, and that parts were being imported to satisfy customers’ demands. By letter dated March 10, 2005, the petitioner’s request for reconsideration was dismissed based on the finding that no new facts of a substantive nature which would bear importantly on the Department’s determination was provided by the petitioner. On March 11, 2005, the Dismissal of Application E:\FR\FM\26AUN1.SGM 26AUN1

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


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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]
BILLING CODE 4410-09-P

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