856 IAC 2-3-13 - Application forms; reregistration forms
Authority: IC 35-48-3-1
Affected: IC 35-48-3-5
Sec. 13.
(a) If any
person is required to be registered, and is not so registered and is applying
for registration, the following apply:
(1) To
manufacture and perform other coincident activities (see
856 IAC 2-3-3(b)(7)
[section 3(b)(7) of this
rule]) with controlled substances, he or she shall apply on Form
CSR-1A.
(2) To dispense, or to
conduct research (other than research described in
856 IAC 2-3-3(a)(6)
[section 3(a)(6) of this
rule]) with, or to conduct instructional activities with, controlled
substances listed in Schedules II through V under
856 IAC 2-2-3 through
856 IAC 2-2-6, he or she shall
apply on Form CSR-1.
(3) To conduct
research with narcotic drugs listed in Schedules II through V under
856 IAC 2-2-3 through
856 IAC 2-2-6, as described in
856 IAC 2-3-3(a)(6)
[section 3(a)(6) of this
rule], he or she shall apply on Form CSR-1.
(4) To conduct research with controlled
substances listed in Schedule I under
856 IAC 2-2-2, he or she shall
apply on Form CSR-1 in accordance with an approved Schedule I under
856 IAC 2-2-2 research protocol.
Such protocol shall be subject to inspection by the Indiana board of
pharmacy.
(5) To conduct
instructional activities with controlled substances listed in Schedule I under
856 IAC 2-2-2, he or she shall
apply as a researcher on Form CSR-1 with two (2) copies of a statement
describing the nature, extent, and duration of such instructional activities
attached to the form.
(6) To
conduct chemical analysis with controlled substances listed in any schedule, he
or she shall apply on Form CSR-1.
(7) To distribute controlled substances, he
or she shall apply on Form CSR-1.
(b) If any person is registered and is
applying for reregistration, the following apply:
(1) To manufacture and perform other
coincident activities (see
856 IAC 2-3-3(b)(7)
[section 3(b)(7)
of this rule]), with controlled substances, he or she shall apply on
Form CSRII-A.
(2) To dispense, or
to conduct research (other than research described in
856 IAC 2-3-3(a)(6)
[section 3(a)(6)
of this rule]) with, or to conduct instructional activities with,
controlled substances listed in Schedules II through V under
856 IAC 2-2-3 through
856 IAC 2-2-6, he or she shall
apply on Form CSR-II.
(3) To
conduct research with narcotic drugs listed in Schedules II through V under
856 IAC 2-2-3 through
856 IAC 2-2-6, as described in
856 IAC 2-3-3(a)(6)
[section 3(a)(6) of this
rule], he or she shall apply on Form CSR-II.
(4) To continue to conduct research with
controlled substances listed in Schedule I under
856 IAC 2-2-2 under one (1) or
more approved research protocols, by the Drug Enforcement Administration, he or
she shall apply on Form CSR-II.
(5)
To continue to conduct instructional activities with controlled substances
listed in Schedule I under
856 IAC 2-2-2 under one (1) or
more approved instructional statements, he or she shall apply as a researcher
on Form CSR-II.
(6) To conduct
chemical analysis with controlled substances listed in any schedule, he or she
shall apply on Form CSR-II.
(7) To
distribute controlled substances, he or she shall apply on Form
CSR-II.
(c) Applications
for registration may be obtained by writing to the controlled substance
division of the Indiana board of pharmacy. Applications for reregistration will
be mailed, as applicable, to each registered person approximately sixty (60)
days before the expiration date of his or her registration; if any registered
person does not receive such forms within forty-five (45) days before the
expiration date of his or her registration, he or she must promptly give notice
of such fact and request such forms by writing to the controlled substance
division of the Indiana board of pharmacy.
(d) Each application for registration to
handle any basic class of controlled substance listed in Schedule I under
856 IAC 2-2-2 (except to conduct
chemical analysis with such classes), and each application for registration to
manufacture a basic class of controlled substance listed in Schedule II under
856 IAC 2-2-3, or to conduct
research with any narcotic controlled substance listed in Schedule II under
856 IAC 2-2-3, shall include the
controlled substances code number, as set forth in Part I
[856 IAC 2-1] , for each
basic class or substance to be covered by such registration.
(e) Each application shall include all
information called for on the form unless the item is not applicable, in which
case this fact shall be indicated.
(f) Each application, attachment, or other
document filed as part of an application shall be signed by:
(1) the applicant, if an
individual;
(2) a partner of the
applicant, if a partnership; or
(3)
an officer or authorized representative of the applicant, if a corporation,
corporate division, association, trust, or other entity.
Notes
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