[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