[Federal Register Volume 60, Number 137 (Tuesday, July 18, 1995)]
[Rules and Regulations]
[Pages 36639-36641]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-17515]
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[[Page 36640]]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Parts 1301 and 1306
[DEA No. 109F]
RIN 1117-AA20
Exemption of Agents and Employees; Affiliated Practitioners
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Final rule.
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SUMMARY: DEA amends its regulations to allow for the exemption of
agents and employees of a registered individual practitioner, hospital,
or institution from the requirement for individual registration when
administering, dispensing, or prescribing controlled substances in the
course of their official duties or business. The amendments 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.
DEA is also amending, without prior notice, its regulations concerning
the manner of issuance of prescriptions to make the language of that
section consistent with the amended language set forth herein.
EFFECTIVE DATE: September 18, 1995.
FOR FURTHER INFORMATION CONTACT:
G. Thomas Gitchel, Chief, Liaison and Policy Section, Office of
Diversion Control, Drug Enforcement Administration, Washington, D.C.
20537, Telephone (202) 307-7297.
SUPPLEMENTARY INFORMATION: On June 15, 1994, DEA published a Notice of
Proposed Rulemaking (NPRM) in the Federal Register (59 FR 30738)
proposing to amend the language under 21 CFR 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) was 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) was also 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 may administer, dispense and prescribe
controlled substances utilizing the hospital or other institution's
registration number.
DEA received two written comments on the proposed amendments.
The first commentor questioned whether the amended regulation would
continue to allow hospital or institution residents and non-private
practice staff physicians, in the course of inpatient and outpatient
treatment of patients, to prescribe controlled substances under that
hospital or institution's DEA registration number. The specific concern
was with the potential financial impact on the institution if the
proposed amendments required individual registration numbers for a
hospital or institution's staff.
The intent of the amendments is to expand the existing exemption
from the registration requirement to include a greater population of
practitioners. The language of Sec. 1301.24(c) deletes the restriction
of an individual practitioner ``who is an intern, resident, mid-level
practitioner, etc.'' and replaces that language with ``[a]n individual
practitioner''. The amendments will not affect the authority of those
individual practitioners, i.e., interns, residents, mid-level
practitioners, foreign trained physicians, etc., already authorized to
dispense controlled substances under a hospital or institution
registration number.
The first commentor additionally wished to ensure that
prescriptions issued by agents or employees of a registered hospital or
institution would be valid at community pharmacies in the event that
patients choose not to use the prescribing institution's pharmacy.
Prescriptions issued by agents or employees, consistent with the
exemption, are legitimate prescriptions that may be filled at any local
registered pharmacy. The regulations do not restrict dispensing of
prescriptions to the prescribing hospital or institution.
The second commentor raised three separate concerns. The first
inquired as to who has the oversight responsibility for determining
whether a given agent or employee, while operating in the usual course
of his/her duties, is authorized to handle controlled substances in the
jurisdiction in which the registrant practices.
The responsibility for determining whether a registrant's agents
and/or employees are authorized by state law to handle controlled
substances lies with the registrant. As a threshold matter, DEA cannot
register an applicant to handle controlled substances unless that
individual practitioner, hospital or other institution has the
necessary state authorization or permission to engage in such
activities. DEA registration does not convey to a practitioner,
hospital or institution any specific authority or permission to engage
in controlled substances activities beyond such state authority. Title
21 CFR 1307.02 states ``Nothing in parts 1301-1308, 1311, 1312, or 1316
of this chapter shall be construed as authorizing or permitting any
person to do any act which such person is not authorized or permitted
to do under other Federal laws or obligations under international
treaties, conventions or protocols, or under the law of the State in
which he desires to do such act nor shall compliance with such parts be
construed as compliance with other Federal or State laws unless
expressly provided in such other laws.''
DEA registrants are responsible for ensuring that any controlled
substance activities carried out pursuant to their DEA registrations
are in full compliance with all applicable Federal and State laws
governing controlled substances. Section 1301.24(c)(3) spells out the
requirement that a hospital or other institution must verify that
individual practitioners who will administer, dispense or prescribe
controlled substances under the facility's registration, are authorized
to do so under state law. If a controlled substances activity is not
authorized or permitted under other Federal or State laws, then the
registrant may not allow the activity to be carried out under its
registration.
The second commentor also expressed concern with a perceived
inconsistency in the language set forth in Sec. 1301.24(c) introductory
text and, by reference, in Sec. 1301.24(c)(5), in that paragraph (c)
introductory text permits the individual practitioner to ``administer,
dispense or prescribe'' under the hospital registration, but paragraph
(c)(5) requires only that the registered hospital authorize such
practitioner to ``dispense or prescribe''. The technical definition of
dispense, as set forth in 21 U.S.C. 802(10), includes the
administration of a controlled substance; therefore, an individual
[[Page 36641]]
practitioner authorized to dispense a controlled substance would also
be authorized to administer a controlled substance. However, in order
to avoid further confusion and to maintain consistency, paragraph
(c)(5) will be amended to read ``administer, dispense or prescribe.''
The second commentor additionally requested that DEA provide
estimates of any financial or other impact on affected entities,
including any increased risk or liability. With regard to this request,
it must be noted that the provisions set forth under Sec. 1301.24 are
not mandatory. If an individual practitioner, hospital or other
institution chooses to use the exemptions, however, it is that
registrant's responsibility to assess any potential benefits, as well
as any risks or liabilities and determine whether the advantages
outweigh the disadvantages in using the exemption provisions.
DEA is also amending the language of Sec. 1306.05(b) without prior
notice, in order to make the language of that section consistent with
the new language in Sec. 1301.24(c). Section 1306.05(b) relates to the
manner of issuance of prescriptions issued by persons exempted from the
registration requirement under Sec. 1301.24(c). The language is being
amended by deleting the reference to ``An intern, resident, or foreign-
trained physician, or physician on the staff of a Veterans
Administration facility, * * *'' and inserting ``An individual
practitioner * * * ''
The Deputy Assistant Administrator, Office of Diversion Control,
hereby certifies that this 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 final rule expands an
existing exception to the registration requirements to provide
regulatory relief to a greater population of practitioners. This final
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
final rule does not have sufficient federalism implications to warrant
the preparation of a Federalism Assessment.
List of Subjects
21 CFR Part 1301
Administrative practice and procedure, Drug traffic control,
Security measures.
21 CFR Part 1306
Drug traffic control, Prescription drugs.
For reasons set out above, 21 CFR part 1301 is 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 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 section 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 Sec. 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 administer, dispense or prescribe under the hospital
registration and designates a specific internal code number for each
individual practitioner 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
* * * * *
PART 1306 [AMENDED]
1. The authority citation for part 1306 continues to read as
follows:
Authority: 21 U.S.C. 821, 829, 871(b), unless otherwise noted.
2. Section 1306.05 is amended by revising paragraph (b) to read as
follows:
Sec. 1306.05 Manner of issuance of prescriptions.
* * * * *
(b) An individual practitioner exempted from registration under
Sec. 1301.24(c) of this chapter shall include on all prescriptions
issued by him or her the registration number of the hospital or other
institution and the special internal code number assigned to him or her
by the hospital or other institution as provided in Sec. 1301.24(c) of
this chapter, in lieu of the registration number of the practitioner
required by this section. Each written prescription shall have the name
of the physician stamped, typed, or handprinted on it, as well as the
signature of the physician.
* * * * *
Dated: June 16, 1995.
Gene R. Haislip,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 95-17515 Filed 7-17-95; 8:45 am]
BILLING CODE 4410-09-M