[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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