HaCKeRz KrOnIcKLeZ 3/HaCKeRz_KrOnIcKLeZ.iso/drugs/60.fr.36640

Text File | 1996-05-06 | 14KB | 304 lines

<ARTICLE>
Date="07/18/95"
Citation="60 FR 36640"
Group="legal"
Type="RULE"
Department="DEPARTMENT OF JUSTICE"
Agency="DRUG ENFORCEMENT ADMINISTRATION (DEA), JUSTICE"
Subject="Exemption of Agents and Employees; Affiliated Practitioners"
<HEADER>

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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.
</HEADER>

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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 [phone].

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


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The Contents entry for this article reads as follows:

Manufacturers, distributors, and dispensers of controlled substances;
    registration, etc.:
  Agents and employees, exemptions; affiliated practitioners, 36640
</ARTICLE>

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