Kan. Admin. Regs. § 68-20-10 - Requirements of registration
(a) Persons
required to register. Every person who manufactures, distributes, or dispenses
any controlled substances within this state, or who proposes to engage in the
manufacture, distribution, or dispensing of any controlled substance in this
state shall obtain annually a registration unless exempted by law or pursuant
to subsections (d) through (g) of this regulation. Only persons actually
engaged in these activities in this state shall be required to obtain a
registration.
(b) Separate
registration for independent activ-ities.
(1)
The following six groups of activities shall be deemed to be independent of
each other:
(A) Manufacturing controlled
substances;
(B) distributing
controlled substances;
(C)
dispensing, conducting research, other than research described in paragraph
(b)(1)(D), with, and conducting instructional activities with, controlled
substances listed in schedules II through V;
(D) conducting research with narcotic drugs
listed in schedules II through V for the purpose of continuing the dependence
on these drugs of a narcotic drug-dependent person in the course of conducting
an authorized clinical investigation in the development of a narcotic addict
rehabilitation program pursuant to a notice of claimed investigational
exemption for a new drug approved by the food and drug administration;
(E) conducting research and
instructional activities with controlled substances listed in schedule I; and
(F) conducting chemical analysis
with controlled substances listed in any schedule.
(2) Every person who engages in more than one
group of independent activities shall obtain a separate registration for each
group of activities, except as provided in this subsection (b). Any person,
when registered to engage in the group of activities described in each
paragraph in this subsection, shall be authorized to engage in the coincident
activities described in that paragraph without obtaining a registration to
engage in such coincident activities if, unless specifically exempted, the
person complies with all requirements and duties prescribed by law for the
following persons registered to engage in the coincident activities:
(A) A person registered to manufacture any
controlled substance or basic class of controlled substance shall be authorized
to distribute that substance or class, but no other substance or class that the
person is not registered to manufacture.
(B) A person registered to manufacture any
controlled substance listed in schedules II through V shall be authorized to
conduct chemical analysis and preclinical research, including quality control
analysis, with narcotic and nonnarcotic controlled substances listed in those
schedules in which the person is authorized to manufacture.
(C) A person registered to conduct research
with a basic class of controlled substances listed in schedule I shall be
authorized to manufacture this class if and to the extent that the manufacture
is set forth in the research protocol filed with the application for
registration and to distribute this class to other persons registered to
conduct research with this class or to conduct chemical analysis.
(D) A person registered to conduct chemical
analysis with controlled substances shall be authorized to perform the
following:
(i) Manufacture and import these
substances for analytical or instructional purposes;
(ii) distribute these substances to other
persons registered to conduct chemical analysis or instructional activities, to
persons registered or authorized to conduct research with these substances, and
to persons exempted from registration pursuant to subsection (c);
(iii) export these substances to persons in
other countries performing chemical analysis or enforcing laws relating to
controlled substances or drugs in those countries; and
(iv) conduct instructional activities with
controlled substances.
(E) A person registered or authorized to
conduct research, other than the research described in paragraph (b)(2)(C),
with controlled substances listed in schedules II through V shall be authorized
to perform the following:
(i) Conduct
chemical analysis with controlled substances listed in those schedules in which
the person is authorized to conduct research to manufacture is set forth in a
statement filed with the application for registration;
(ii) distribute these substances to other
persons registered or authorized to conduct chemical analysis, instructional
activities, or research with these substances and to persons exempted from
registration pursuant to subsection (c); and
(iii) conduct instructional activities with
controlled substances.
(F) A person registered to dispense under the
pharmacy act, or to conduct research, other than research described in
paragraph (b)(2)(D), with controlled substances listed in schedules II through
V shall be authorized to dispense and to conduct research and to conduct
instructional research with those substances.
(3) A single registration to engage in any
group of independent activities may include one or more controlled substances
listed in the schedules authorized in that group of independent activities. A
person registered to conduct research with controlled substances listed in
schedule I may conduct research with any substance listed in schedule I for
which the person has filed and had approved a research protocol.
(c) Separate registrations for
separate locations.
(1) A separate
registration shall be required for each principal place of business or
professional practice at one general physical location where controlled
substances are manufactured, distributed, or dispensed by a person.
(2) The following locations shall be deemed
not to be places where controlled substances are manufactured, distributed, or
dispensed:
(A) A warehouse where controlled
substances are stored by or on behalf of a registered person, unless these
substances are distributed directly from the warehouse to registered locations
other than the registered location from which the substances were delivered or
to persons not required to register by virtue of the pharmacy act,
K.S.A.
65-4116 and amendments thereto;
(B) an office used by agents of a registrant
where sales of controlled substances are solicited, made, or supervised but
which neither contains these substances, other than substances for display
purposes only, nor serves as a distribution point for filling sales orders; and
(C) an office used by a
practitioner or mid-level practitioner who is registered at another location
where controlled substances are prescribed but neither administered nor
otherwise dispensed as a regular part of the professional practice of the
practitioner or mid-level practitioner at this office, and where no supplies of
controlled substances are maintained.
(d) Exemption of agents and employees;
affiliated practitioners.
(1) Practitioners,
mid-level practitioners, pharmacists, and other persons required to register
under this act shall not be exempt from registration because of their status as
an agent or employee of a person who is already registered to engage in any
group of independent activities. The requirements of registration, however,
shall be waived for any agent or employee of a person who is registered to
engage in any group of independent activities, if the agent or employee is
acting in the usual course of his business or employment.
(2) A practitioner who is an intern,
resident, or foreign physician or medical graduate may dispense and prescribe
controlled substances under the registration of the hospital or other
institution that is registered and by whom the person is employed if all of the
following conditions are met:
(A) The
practitioner is authorized or permitted to do so by the laws of the state of
Kansas.
(B) The dispensing or
prescribing is done in the usual course of the practitioner's professional
practice.
(C) The hospital or
other institution by whom the person is employed has determined that the
practitioner is permitted to dispense or prescribe drugs by the state of
Kansas.
(D) The practitioner is
acting only within the scope of employment in the hospital or institution.
(E) The hospital or other
institution authorizes the intern, resident, or foreign physician or medical
graduate to dispense or prescribe under the hospital registration and
designates a specific internal registration code number for each intern,
resident, or foreign physician or medical graduate so authorized. The code
number shall consist of numbers, letters, or a combination of both and shall be
a suffix to the institution's drug enforcement administration registration
number, preceded by a hyphen.
(F)
A current list of internal codes and the corresponding practitioners is kept by
the hospital or other institution, and an updated copy is on file with the
state board of pharmacy of the state of Kansas for the purposes of verifying
the authority of the prescribing practitioner.
(e) Exemption of certain military and other
personnel.
(1) The requirement of
registration shall be waived for any official of the U.S. army, navy, marine
corps, air force, coast guard, or public health service who is authorized to
prescribe, dispense, or administer, but not to procure or purchase, controlled
substances in the course of official duties. These officials shall follow the
procedures set forth in K.A.R. 68-20-18, 68-20-19, 68-20-20, and 68-20-21, but
shall state the branch of service or agency and the service identification
number of the issuing official in lieu of the registration number required on
prescription forms. The service identification number for a public health
service employee is the person's social security identification number.
(2) If any official exempted by
this subsection also engages as a private individual in any activity or group
of activities for which registration is required, the official shall obtain a
registration for these private activities.
(f) Exemption of law enforcement officials.
(1) The requirement of registration shall be
waived for the following persons in the circumstances described in this
subsection:
(A) Any officer or employee of
the bureau, any officer of the U.S. bureau of customs, any officer or employee
of the United States food and drug administration, and any other federal
officer who is lawfully engaged in the enforcement of any federal law relating
to controlled substances, drugs, or customs, and is duly authorized to possess
controlled substances in the course of official duties; and
(B) any officer or employee of the state of
Kansas, or any political subdivision or agency thereof, who is engaged in the
enforcement of Kansas law or local law relating to controlled substances and is
duly authorized to possess controlled substances in the course of official
duties.
(2) Any
official exempted by this subsection may, when acting in the course of official
duties, possess any controlled substance and distribute any such substance to
any other official who is also exempted by this subsection and acting in the
course of official duties.
(3) Any
official exempted by this subsection may procure any controlled substance in
the course of an inspection, in accordance with the controlled substances act,
K.S.A.
65-4131(c) and amendments
thereto, or in the course of any criminal investigation involving the person
from whom the substance was procured.
(4) In order to enable law enforcement agency
laboratories to obtain and transfer controlled substances for use as standards
in chemical analysis, these laboratories shall obtain annually a registration
to conduct chemical analysis. These laboratories shall be exempted from payment
of a fee for registration. Laboratory personnel, when acting in the scope of
their official duties, shall be deemed to be officials exempted by this
subsection and within the activities described in the controlled substances
act, K.S.A. 65-4115 and amendments
thereto. For purposes of this subsection, laboratory activities shall not
include field or other preliminary chemical tests by officials exempted by this
subsection.
(g)
Exemption of civil defense officials.
(1) The
requirement of registration shall be waived for any official of a civil defense
or disaster relief organization who, in the course of official duties, is
authorized to perform either of the following:
(A) Maintain, and distribute for maintenance,
controlled substances held for emergency use; or
(B) procure controlled substances for the
purposes of maintaining supplies for emergency use, if all procurement is from
the U.S. general services administration and in accordance with the rules of
the U.S. office of emergency preparedness.
(2) The requirement of registration shall be
waived for any official of a civil defense or disaster relief organization
during a state of emergency or disaster within the official's jurisdiction
proclaimed by the president or by a concurrent resolution of the congress,
which official, in the course of official duties during this emergency or
disaster, is authorized to perform either of the following:
(A) Dispense controlled substances; or
(B) procure or distribute
controlled substances, if all procurement is on a special "civil defense
emergency order form," as described in this subsection.
(3) Civil defense emergency order forms shall
be furnished by the U.S. office of emergency preparedness and shall contain the
name of the civil defense or disaster relief organization. These forms may be
used and shall be valid only during a state of emergency disaster proclaimed by
the president or by a concurrent resolution of the congress for the area in
which the organization using the forms has civil defense or disaster relief
jurisdiction, who shall state the position and the nature and legal designation
of the emergency or disaster. These forms may be filled by any person
registered under the controlled substances act. The organization shall, upon
the execution of a civil defense emergency order form, be deemed to be
registered under the controlled substances act for purposes of record keeping
pursuant to K.A.R. 68-20-16.
Notes
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No prior version found.