[Federal Register Volume 59, Number 114 (Wednesday, June 15, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-14470]


[[Page Unknown]]

[Federal Register: June 15, 1994]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1301

 

Exemption of Agents and Employees; Affiliated Practitioners

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Proposed rule.

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SUMMARY: DEA proposes to amend the language under title 21, Code of 
Federal Regulations (21 CFR) regarding the exemption of agents and 
employees from the requirement for individual registration when 
administering, dispensing, or prescribing controlled substances in the 
course of their official duties or business. The amendments will make 
the exemption granted to agents and employees of a registrant more 
consistent with the recent regulatory changes involving Mid-Level 
Practitioners (MLP) and the fee exemption for practitioners employed by 
Federal, state and local government hospitals or other institutions.

DATES: Written comments or objections must be received on or before 
August 15, 1994.

ADDRESSES: Comments and objections should be submitted in quintuplicate 
to the Deputy Assistant Administrator, Office of Diversion Control, 
Drug Enforcement Administration, Washington, DC 20537, Attention: DEA 
Federal Register Representative/CCR.

FOR FURTHER INFORMATION CONTACT: G. Thomas Gitchel, Chief, Liaison and 
Policy Section, Office of Diversion Control, Drug Enforcement 
Administration, Washington, DC 20537, Telephone (202) 307-7297.

SUPPLEMENTARY INFORMATION: DEA is proposing to amend the language under 
21 CFR, Sec. 1301.24 regarding the circumstances under which agents or 
employees of a DEA registrant may administer, dispense, or prescribe 
controlled substances in the course of their official duties or 
business without being required to obtain an individual registration. 
Specifically, Sec. 1301.24(b) is proposed to be amended to allow that 
an individual practitioner who acts as an agent or employee of another 
individual practitioner, other than a mid-level practitioner (MLP), may 
administer and dispense (other than by prescription) controlled 
substances in the normal course of his/her official duties or business 
under the registration of the employer or principal practitioner.
    Section 1301.24(c) is proposed to be amended to allow an individual 
practitioner who is an agent or employee of a hospital or other 
institution to administer, dispense, or prescribe controlled substances 
under the registration of the hospital or other institution in lieu of 
becoming individually registered. The provisions outlined under 
Sec. 1301.24(c)(1) through (c)(6) set forth the procedures under which 
an individual practitioner could prescribe utilizing the hospital or 
other institution's registration number.
    These changes are being proposed to make the circumstances under 
which agents or employees of a DEA registrant may administer, dispense, 
or prescribe controlled substances more consistent with recent 
developments with respect to MLPs and Federal, state or local 
government practitioners. During and immediately following the 
development of regulatory revisions concerning MLPs and persons exempt 
from the registration or reregistration application fees, DEA received 
a number of comments and questions from both individual practitioners 
and associations regarding the exemption of agents and employees of 
other DEA registrants. The comments and questions made it apparent that 
the current language in Sec. 1301.24 is not entirely consistent with 
the intent of the new developments. The proposed revisions to 
Sec. 1301.24 will allow that, (1) an individual practitioner who acts 
as an agent or employee of another individual registered practitioner 
(other than an MLP) may administer or dispense controlled substances, 
to the extent authorized under the laws of the jurisdiction in which he 
or she practices, under the registration of the principal practitioner, 
in lieu of being registered him/himself; and (2) an individual 
practitioner who is an agent or employee of a hospital or other 
institution which is registered with DEA may administer, dispense, or 
prescribe controlled substances under the registration of the hospital 
or other institution in lieu of being registered individually, provided 
that the requirements regarding prescribing as set forth in 
Sec. 1301.24(c)(1) through (c)(6) are complied with.
    The Deputy Assistant Administrator, Office of Diversion Control, 
hereby certifies that this proposed rulemaking will have no significant 
impact upon entities whose interests must be considered under the 
Regulatory Flexibility Act, 5 U.S.C. 601 et seq. This proposed rule 
expands an existing regulatory provision to accommodate recent changes 
regarding MLPs and government practitioners. This proposed rule is not 
a significant regulatory action and therefore has not been reviewed by 
the Office of Management and Budget pursuant to Executive Order 12866.
    This action has been analyzed in accordance with the principles and 
criteria in Executive Order 12612, and it has been determined that the 
proposed rule does not have sufficient federalism implications to 
warrant the preparation of a Federalism Assessment.

List of Subjects in 21 CFR Part 1301

    Administrative practice and procedure, Drug Enforcement 
Administration, Drug Traffic Control, Security measures.

    For reasons set out above, it is proposed that 21 CFR part 1301 be 
amended as follows:

PART 1301--[AMENDED]

    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.

    2. Section 1301.24 is proposed to be amended by revising paragraphs 
(b), (c) introductory text and (c)(5) to read as follows:


Sec. 1301.24  Exemption of agents and employees; affiliated 
practitioners.

* * * * *
    (b) An individual practitioner, as defined in Sec. 1304.02 of this 
chapter, who is an agent or employee of another individual practitioner 
(other than a mid-level practitioner) registered to dispense controlled 
substances may, when acting in the normal course of business or 
employment, administer or dispense (other than by issuance of 
prescription) controlled substances if and to the extent that such 
individual practitioner is authorized or permitted to do so by the 
jurisdiction in which he or she practices, under the registration of 
the employer or principal practitioner in lieu of being registered him/
herself.
    (c) An individual practitioner, as defined in Section 1304.02 of 
this chapter, who is an agent or employee of a hospital or other 
institution may, when acting in the normal course of business or 
employment, administer, dispense, or prescribe controlled substances 
under the registration of the hospital or other institution which is 
registered in lieu of being registered him/herself, provided that:
* * * * *
    (5) The hospital or other institution authorizes the individual 
practitioner to dispense or prescribe under the hospital registration 
and designates a specific internal code number for each individual 
practioner so authorized. The code number shall consist of numbers, 
letters, or a combination thereof and shall be a suffix to the 
institution's DEA registration number, preceded by a hyphen (e.g., 
AP0123456-10 or AP0123456-A12; and
* * * * *
    Dated: June 6, 1994.
Gene R. Haislip,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 94-14470 Filed 6-14-94; 8:45 am]
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