[Federal Register Volume 66, Number 8 (Thursday, January 11, 2001)]
[Rules and Regulations]
[Pages 2214-2215]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-545]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR PART 1306

[DEA-190F]
RIN 1117-AA54


Facsimile Transmission of Prescriptions for Patients Enrolled in 
Hospice Programs

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION:  Final rule.

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SUMMARY:  DEA is finalizing, without change, the interim rule with 
request for comment published in the Federal Register on July 25, 2000 
(65 FR 45712). The interim rule amended Title 21, Code of Federal 
Regulations (CFR) 1306.11(g) to clearly articulate that prescriptions 
for Schedule II narcotic substances for patients enrolled in hospice 
care certified by Medicare under Title XVIII or licensed by the state 
may be transmitted by facsimile. No comments to the interim rule were 
received. This final rule makes the clarification permanent.

EFFECTIVE DATE:  February 12, 2001.

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:

What Does This Final Rule Accomplish?

    On July 25, 2000 DEA published an interim rule with request for 
comment (65 FR 45712) amending 21 CFR 1306.11(g) to clearly articulate 
that prescriptions for Schedule II narcotic substances for patients 
enrolled in hospice care certified by Medicare under Title XVIII or 
licensed by the state, regardless of whether the patient resides in a 
hospice facility or other care setting, may be transmitted by 
facsimile. This final rule makes the clarification permanent.

Why Was Clarification of the Regulation Necessary?

    Section 1306.11(g) of the regulations originally provided that a 
pharmacy could dispense a Schedule II narcotic substance pursuant to a 
prescription transmitted to the pharmacy via facsimile for a patient 
residing in a hospice certified by Medicare under Title XVIII or 
licensed by the state. The use of the language ``residing in a hospice 
certified by Medicare under Title XVIII or licensed by the state'' was 
perceived by the regulated industry as requiring that the patient 
reside in a hospice facility to the exclusion of other care settings, 
such as home hospice care. DEA regulations were meant to cover all 
patients enrolled in hospice programs certified by Medicare under Title 
XVIII or licensed by the state, regardless of where the patient 
resides.
    The interim rule amended Section 1306.11(g) to refer to ``* * * a 
patient enrolled in a hospice care program certified and/or paid for by 
Medicare under Title XVIII or a hospice program which is licensed by 
the state'' to clarify that prescriptions for Schedule II narcotic 
substances for patients enrolled in recognized hospice programs, 
regardless of where the patients reside, may be transmitted via 
facsimile.

What Comments Were Received Regarding the Interim Rule?

    No comments were submitted regarding this interim rulemaking. 
Accordingly, the interim rule amending 21 CFR part 1306, which was 
published in the Federal Register on July 25, 2000, at 65 FR 45712 is 
adopted as a final rule.

Regulatory Certifications

Regulatory Flexibility Act

    The Deputy Assistant Administrator hereby certifies that this 
rulemaking has been drafted in a manner consistent with the principles 
of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). It will not 
have a significant economic impact on a substantial number of small 
business entities. This rulemaking clarifies the regulations regarding 
the facsimile transmission of prescriptions for Schedule II narcotic 
substances for patients enrolled in hospice programs.

Executive Order 12866

    The Deputy Assistant Administrator further certifies that this 
rulemaking has been drafted in accordance with the principles in 
Executive Order 12866, Section 1(b). DEA has determined that this is 
not a significant rulemaking action. This rulemaking clarifies the 
regulations regarding the facsimile transmission of prescriptions for 
Schedule II narcotic substances for patients enrolled in hospice 
programs. Therefore, this action has not been

[[Page 2215]]

reviewed by the Office of Management and Budget.

Executive Order 12988

    This regulation meets the applicable standards set forth in 
Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice 
Reform.

Executive Order 13132

    This rulemaking 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 rulemaking does not have federalism implications 
warranting the application of Executive Order 13132.

Unfunded Mandates Reform Act of 1995

    This rule will not result in the expenditure by state, local, and 
tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more in any one year, and will not significantly or 
uniquely affect small governments. Therefore, no actions were deemed 
necessary under the provisions of the Unfunded Mandates Reform Act of 
1995.

Small Business Regulatory Enforcement Fairness Act of 1996

    This rule is not a major rule as defined by section 804 of the 
Small Business Regulatory Enforcement Fairness Act of 1996. This rule 
will not result in an annual effect on the economy of $100,000,000 or 
more; a major increase in costs or prices; or significant adverse 
effects on competition, employment, investment, productivity, 
innovation, or on the ability of United States-based companies to 
compete with foreign-based companies in domestic and export markets.

Plain Language Instructions

    The Drug Enforcement Administration makes every effort to write 
clearly. If you have suggestions as to how to improve the clarity of 
this regulation, call or write Patricia M. Good, Chief, Liaison and 
Policy Section, Office of Diversion Control, Drug Enforcement 
Administration, Washington, DC 20537, telephone (202) 307-7297.
    The interim rule amending 21 CFR part 1306, which was published in 
the Federal Register on July 25, 2000, at 65 FR 45712, is adopted as a 
final rule without change.

    Dated: December 28, 2000.
John H. King,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 01-545 Filed 1-10-01; 8:45 am]
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