Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

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###### Department of Justice

###### Drug Enforcement Administration

          - 21 CFR PART 1306
          - [DEA-190F]
          - RIN 1117-AA54

# AGENCY:

Drug Enforcement Administration (DEA), Justice.

# ACTION:

 Final rule.

# 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                           ( print 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]

BILLING CODE 4410-09-P