Section 856 IAC 2-3-13 - Application forms; reregistration formsAuthority: 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.Indiana Board of Pharmacy; Reg 28,Ch III,Sec 3.32; filed Jul 9, 1974, 9:29 a.m.: Unpublished; readopted filed Nov 30, 2001, 11:00 a.m.: 25 IR 1342; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed November 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFAReadopted filed 2/15/2024, 1:16 p.m.: 20240313-IR-856230795RFA