70576 Federal Register / Vol. 69, No. 234 / Tuesday, December 7, 2004 / Proposed Rules 

DEPARTMENT OF JUSTICE

Drug Enforcement Administration 

21 CFR Part 1301

[Docket No. DEA–244P] 

RIN 1117–AA89

Clarification of Registration 

Requirements for Individual 

Practitioners

AGENCY: Drug Enforcement 

Administration (DEA), Justice.

ACTION: Notice of proposed rulemaking.

SUMMARY: The Drug Enforcement 

Administration (DEA) proposes to 

amend its registration regulations to 

make it clear that when an individual 

practitioner who practices and is 

registered in one state seeks to practice 

and prescribe controlled substances in 

another state, he/she must obtain a 

separate DEA registration for the 

subsequent state. The current regulation 

was intended to apply to intrastate 

offices only, but has been 

misunderstood by some practitioners to 

apply to interstate offices. To avoid any 

further misinterpretation, DEA is 

proposing to modify its current 

regulation to indicate that it applies 

only to separate locations maintained 

within one state for which the 

practitioner possesses state licensure 

and DEA registration.

DATES: Written comments must be 

postmarked, and electronic comments 

must be sent, on or before February 7, 

2005.

ADDRESSES: To ensure proper handling 

of comments, please reference ‘‘Docket 

No. DEA–244’’ on all written and 

electronic correspondence. Written 

comments being sent via regular mail 

should be sent to the Deputy Assistant 

Administrator, Office of Diversion 

Control, Drug Enforcement 

Administration, Washington, DC 20537, 

Attention: DEA Federal Register 

Representative/CCD. Written comments 

sent via express mail should be sent to 

DEA Headquarters, Attention: DEA 

Federal Register Representative/CCD, 

2401 Jefferson-Davis Highway, 

Alexandria, VA 22301. Comments may 

be directly sent to DEA electronically by 

sending an electronic message to 

dea.diversion.policy@usdoj.gov.

Comments may also be sent 

electronically through http://

www.regulations.gov using the 

electronic comment form provided on 

that site. An electronic copy of this 

document is also available at the

http://www.regulations.gov Web site. 

DEA will accept electronic comments 

containing MS word, WordPerfect, 

Adobe PDF, or Excel file formats only. 

DEA will not accept any file format 

other than those specifically listed here.

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: 

Purpose of This Proposed Rule 

There is confusion regarding whether 

a practitioner who practices and is 

registered in one state and wishes to 

practice and prescribe in another state 

must register with DEA in the second 

state. DEA proposes to amend its 

regulations to make it clear that when 

an individual practitioner who practices 

and is registered in one state seeks to 

practice and prescribe controlled 

substances in another state, he/she must 

obtain a separate DEA registration for 

the subsequent state. 

Background 

The Controlled Substances Act (CSA) 

requires that a separate registration be 

obtained for each location at which 

controlled substances are manufactured, 

distributed, or dispensed (21 U.S.C. 

822(e)). Under this requirement, an 

individual practitioner must have a 

separate DEA registration, predicated on 

a separate state license, if he/she 

practices in offices that are located in 

different states and administers, 

dispenses directly, or prescribes 

controlled substances from both offices. 

However, DEA has provided in the 

regulations (21 CFR 1301.12(b)(3)) that 

‘‘an office used by a practitioner (who 

is registered at another location) where 

controlled substances are prescribed but 

neither administered nor otherwise 

dispensed as a regular part of the 

professional practice of the practitioner 

at such office, and where no supplies of 

controlled substances are maintained,’’

is not a location for which a registration 

must be obtained. This regulation is 

intended to apply only to secondary 

locations within the same state in which 

the practitioner maintains his/her DEA 

registration. However, because the 

language in Section 1301.12(b)(3) does 

not specify that it pertains to intrastate 

locations only, individual practitioners 

have been applying the regulation to 

interstate situations, which is contrary 

to the intent of the regulation, the CSA, 

and the underlying principles that apply 

to individual practitioner registration. 

State Licensure

The issuance by DEA of an individual 

practitioner registration is predicated, in 

part, on the practitioner being 

authorized (e.g. licensed) to dispense 

controlled substances by the state in 

which he/she practices (21 U.S.C. 

823(f)). Valid state authority to dispense 

controlled substances is a necessary, but 

not sufficient, condition for obtaining a 

DEA registration. DEA will not register 

a practitioner at a particular location 

within a state if the practitioner lacks 

valid state authority to dispense 

controlled substances in that state. DEA 

registration serves, in part, to reflect that 

the individual practitioner has been 

granted some level of controlled 

substances authority by the state. In 

light of the above, a DEA registration is 

considered to be related directly and 

exclusively to the license issued to the 

practitioner by the state in which he/she 

maintains the registration. 

Explanation of DEA Registration 

Predicated on State Authority 

There are problems associated with 

use of a single DEA registration in 

different states. For instance, if a 

practitioner licensed in the State of 

North Carolina and possessing a DEA 

registration predicated on that state 

license subsequently opened an office in 

Virginia, then any controlled substance 

prescriptions he/she wrote in Virginia 

would be invalid for the following 

reason. 

To be valid in a particular 

jurisdiction, a controlled substance 

prescription must be written by a 

practitioner who possesses valid state 

authority in that jurisdiction and, 

equally important, the practitioner must 

possess a DEA registration predicated 

upon valid state authority in that 

jurisdiction (or be exempted from the 

registration requirement) (21 CFR 

1306.03(a)). In the example cited above, 

the practitioner possesses valid state 

authority in North Carolina and a DEA 

registration based upon that state 

authority. Therefore, the practitioner’s 

controlled substance prescriptions 

would be valid in North Carolina. 

Because the practitioner lacks a DEA 

registration based on valid state 

authority in Virginia, the practitioner’s 

controlled substance prescriptions in 

Virginia would be invalid. 

Similarly, if an optometrist licensed 

in the State of Virginia and possessing 

a DEA registration predicated on said 

license subsequently opened an office in 

North Carolina prescribing oxycodone 

with acetaminophen (a Schedule II 

controlled substance) the prescription 

would be invalid. This is due to the fact 

that the DEA registration was issued 

pursuant to Virginia authority while the 

prescription was written based on North 

Carolina state licensure and authority. 

Federal Register / Vol. 69, No. 234 / Tuesday, December 7, 2004 / Proposed Rules 70577

North Carolina and Virginia authorize 

different levels of prescribing authority 

to optometrists. In Virginia, optometrists 

are only permitted to prescribe 

analgesics in Schedules III and IIIN, 

while in North Carolina optometrists are 

authorized to prescribe Schedules II 

through V controlled substances. 

Therefore, the prescription for 

oxycodone with acetaminophen would 

also be invalid due to the fact that 

Virginia authority is more restrictive 

than North Carolina’s and does not 

allow the prescribing of Schedule II 

controlled substances by optometrists. 

Title 21 U.S.C. 823(f) states that the 

Attorney General (as delegated to DEA) 

shall register practitioners to dispense 

controlled substances if the applicant is 

authorized to dispense the controlled 

substances under the laws of the state in 

which the applicant practices. Title 21 

U.S.C. 841(a) prohibits any person from 

knowingly or intentionally dispensing a 

controlled substance except as 

permitted by the CSA. As previously 

stated, controlled substances may not be 

dispensed without state authorization to 

do so. 

Reason for Modification of Existing 

Regulation 

To avoid any further 

misinterpretation, DEA is proposing to 

modify its current regulation found in 

21 CFR 1301.12(b)(3) by adding the 

words ‘‘in the same state or jurisdiction 

of the United States’’ to the 

parenthetical statement. This would 

make clear that the regulation applies 

only to separate locations maintained 

within one state for which the 

practitioner possesses state licensure 

and DEA registration. The practitioner 

must maintain separate state licensure 

and DEA registration for separate 

locations in a different state. 

Regulatory Certifications 

Regulatory Flexibility Act 

The Deputy Assistant Administrator 

hereby certifies that this rulemaking has 

been drafted in accordance with the 

Regulatory Flexibility Act (5 U.S.C. 

605(b)), has reviewed this regulation, 

and by approving it certifies that this 

regulation will not have a significant 

economic impact on a substantial 

number of small entities. This proposed 

rule merely clarifies existing regulations 

regarding the registration by individual 

practitioners conducting business in 

more than one state. 

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). This rule has been 

determined to be a significant regulatory 

action. Therefore, this action has been 

reviewed by the Office of Management 

and Budget. This proposed rule merely 

clarifies existing regulations regarding 

the registration by individual 

practitioners conducting business in 

more than one state.

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. 

Paperwork Reduction Act 

This Notice of Proposed Rulemaking 

merely clarifies that DEA registration 

must be obtained by practitioners for 

each state in which a practitioner 

conducts business, except under certain 

specific circumstances. While it is 

possible that the amendment of the 

regulations could cause certain persons 

who were not previously registered to 

register with the Administration, it is 

not possible for DEA to determine how 

many persons might be affected by this 

circumstance. It is important to note 

that this rule serves merely as a 

clarification; the Controlled Substances 

Act, which establishes the requirement 

of registration, has not been changed, 

and the requirement of registration 

addressed by this rulemaking remains 

consistent. Therefore, persons who 

would register as a result of publication 

of this clarification should have been 

previously registered with the 

Administration but were not registered 

due to confusion regarding registration 

requirements. Thus, at this time, as DEA 

is not able to determine the impact of 

this rulemaking on the registrant 

population, DEA will make any 

necessary revisions to the affected 

information collection at the time of 

renewal of the collection. 

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 foreignbased companies in domestic and 

export markets.

List of Subjects in 21 CFR Part 1301

Administrative practice and 

procedure, Drug traffic control, Security 

measures.

For the reasons set forth above, 21 

CFR 1301 is proposed to be amended as 

follows:

PART 1301—REGISTRATION OF 

MANUFACTURERS, DISTRIBUTORS, 

AND DISPENSERS OF CONTROLLED 

SUBSTANCES 

1. The authority citation for part 1301 

continues to read as follows:

Authority: 21 U.S.C. 821, 822, 823, 824, 

871(b), 875, 877, 951, 952, 953, 956, 957. 

2. Section 1301.12(b)(3) is proposed to 

be revised to read as follows:

§ 1301.12 Separate registrations for 

separate locations.

* * * * *

(b) * * *

(3) An office used by a practitioner 

(who is registered at another location in 

the same state or jurisdiction of the 

United States) where controlled 

substances are prescribed but neither 

administered nor otherwise dispensed 

as a regular part of the professional 

practice of the practitioner at such 

office, and where no supplies of 

controlled substances are maintained.

* * * * *

Dated: November 30, 2004. 

William J. Walker, 

Deputy Assistant Administrator, Office of 

Diversion Control.

[FR Doc. 04–26808 Filed 12–6–04; 8:45 am] 

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