reglab/statecodes huggingface dataset:
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 1 - Definitions › Section 1-4 - Duties of officers

Current through July 10, 2024
Authority: IC
				  35-48-3-1
Affected: IC
				  35-48-2-1
Sec. 4.
Duties of Officers. The chairman of the committee, or the
				  vice-chairman in the absence of the chairman, shall preside at all meetings of
				  the committee. In addition, the chairman or his designee shall preside over all
				  hearings conducted by the committee on behalf of the Board.
The secretary of the committee shall be responsible for
				  keeping the minutes of all meetings and he shall further be charged with the
				  responsibility of assuring that a complete and accurate record is made of all
				  hearings conducted before the committee. To this end, he may, with the consent
				  of the Board, arrange for the attendance of such stenographers or court
				  reporters as are necessary for the recording of such
				  hearings.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 1 - Definitions › Section 1-5 - Rulemaking powers

Current through July 10, 2024
Authority: IC
				  35-48-3-1
Affected: IC
				  4-22-2; IC
				  35-48-2-1
Sec. 5.
Rules of Conduct. The advisory committee may, with the
				  approval of the Board, make such other rules regulating its conduct and
				  procedure as are necessary and proper for the orderly conduct of its
				  business.
All such rules, when they may affect procedure or substance
				  of matters which may come before the Board for adjudication, after promulgation
				  in accordance with IC 1971,
				  4-22-2 as amended, shall be in
				  writing and shall be made available upon request to parties appearing before
				  the committee.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 1 - Definitions › Section 1-6 - Recommendations and findings

Current through July 10, 2024
Authority: IC
				  35-48-3-1
Affected: IC
				  35-48-2-1
Sec. 6.
Recommendations and findings. Recommendations and findings
				  to be in writing. Whenever, in the discharge of its duties, the advisory
				  committee shall be required to make recommendations or findings upon matters
				  heard before the committee, such recommendations to the Board shall be in
				  writing and shall include a summary of relevant evidence, opinions, and laws
				  upon which such recommendations or findings are based.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 2 - Controlled Substances Code Number-Schedules I through IV › Section 2-1 - Controlled substances code numbers

Current through July 10, 2024
Authority: IC 35-48-3-1
Affected: IC 35-48-3-1
Sec. 1.
Controlled Substances Code Number.
(a) Each controlled substance, or basic class
				thereof, listed in Schedules I through IV
[856 IAC
				2-2-2 -
				856 IAC 2-2-5]
has been
				assigned a "Controlled Substances Code Number" for purposes of identification
				of the substances or class on certain Certificates of Registration issued by
				the Indiana State Board of Pharmacy pursuant to Section 3.42
[856 IAC 2-3-19]
of the
				Chapter. Certain applicants for registration must include the appropriate
				numbers on the application as required in Section 3.32(d)
[856 IAC
				2-3-13(d)]
of this
				Chapter.
(b) Except as stated in
				paragraph (a) of this section, no applicant or registrant is required to use
				the Controlled Substances Code Number for any purpose.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 2 - Controlled Substances Code Number-Schedules I through IV › Section 2-6 - Schedule V

Current through July 10, 2024
Authority: IC
				  35-48-3-1
Affected: IC
				  35-48-2-12
Sec. 6.
(a) Schedule
				V shall consist of the drugs and other substances, by whatever official name,
				common or usual name, chemical name, or brand name designated, listed in this
				section.
(b) Narcotic drugs
				containing nonnarcotic active medicinal ingredients. Any compound, mixture, or
				preparation containing any of the following limited quantities of narcotic
				drugs or salts thereof, which shall include one or more nonnarcotic active
				medicinal ingredients in sufficient proportion to confer upon the compound,
				mixture, or preparation valuable medicinal qualities other than those possessed
				by the narcotic drug alone:
(1) Not more than
				200 milligrams of codeine, per 100 milliliters or per 100 grams.
(2) Not more than 100 milligrams of
				dihydrocodeine, per 100 milliliters or per 100 grams.
(3) Not more than 100 milligrams of
				ethylmorphine, per 100 milliliters or per 100 grams.
(4) Not more than 2.5 milligrams of
				diphenoxylate and not less than 25 micrograms of atropine sulfate per dosage
				unit.
(5) Not more than 100
				milligrams of opium per 100 milliliters or per 100 grams.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 2 - Controlled Substances Code Number-Schedules I through IV › Section 2-7 - Application for exception of stimulant or depression compound; revocation

Current through July 10, 2024
Authority: IC 35-48-3-1
Affected: IC 35-48-2-1
Sec. 7.
Application for exception of a stimulant or depressant
				  compound.
(a) Any person seeking to
				have any compound, mixture, or preparation containing any depressant or
				stimulant substance listed in Chapter 2, Section 2.13(b) or (c)
[856 IAC 2-2-4(b) or
				(c)]
or in Section 2.14
[856 IAC 2-2-5]
excepted
				from the application of all or any part of the Act
[
IC 35-48]
				pursuant to IC 1971,
				35-24.1-2-8(e) 
				or 10(c)
[Repealed by Acts 1976,
				P.L.
				148,
				SECTION
				24; Acts 1977,
				P.L.
				26,
				SECTION
				25. See
IC 35-48.] as amended, may
				apply to the Indiana Board of Pharmacy for such exception.
(b) An application for an exception under
				this section shall be approved by the Board, provided that such application
				shall contain a copy of the Administration's approval for such request for an
				exception from the Federal Controlled Substances Act.
(c) Within a reasonable period of time after
				the receipt of an application for an exception under this section, the Indiana
				State Board of Pharmacy shall notify the applicant of its acceptance or
				non-acceptance of the application, and if not accepted, the reason therefor.
				The Indiana State Board of Pharmacy need not accept an application for filing
				if any of the requirements prescribed in paragraph (b) of this section is
				lacking or is not set forth so as to be readily understood. If the applicant
				desires, he may amend the application to meet the requirements of paragraph (b)
				of this section.
(d) The Indiana
				Board of Pharmacy may at any time revoke any exception granted pursuant to IC
				1971, 35-24.1-2-8(e) 
				or 10(c)
[Repealed by Acts 1976,
				P.L.
				148,
				SECTION
				24; Acts 1977,
				P.L.
				26,
				SECTION
				25. See
IC 35-48.], as amended, upon
				a finding that such exception from the Federal Controlled Substances Act was
				terminated, suspended or revoked. The revocation of the exception granted under
				this Act
[
IC 35-48] shall become effective upon the Board's
				notifying the person to whom such exception was granted by certified mail of
				such revocation.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 2 - Controlled Substances Code Number-Schedules I through IV › Section 2-8 - Excepted stimulant or depressant compounds

Current through July 10, 2024
Authority: IC 35-48-3-1
Affected: IC 35-48-2-8; IC 35-48-2-10
Sec. 8.
The Indiana Board of Pharmacy may except any compound,
				  mixture, or preparation containing any depressant or stimulant substance listed
				  in Section 2.13(b) or (c)
[856 IAC 2-2-4(b)
				  or (c)]
, or in Section 2.14
[856 IAC 2-2-5]
from the
				  application of all or any part of the Act pursuant to IC 1971, 35-24.1-2-8(e)
				  or 10(c)
[Repealed by Acts 1976,
				  P.L.
				  148,
				  SECTION
				  24; Acts 1977,
				  P.L.
				  26,
				  SECTION
				  25. See
IC 35-48.] as amended, the
				  drugs which were excepted by the Bureau or Administration on April 1, 1973
				  under section 202(d) of the Federal Controlled Substances Act (21 U.S.C.
				  812(d)) have been excepted
				  by the Indiana State Board of Pharmacy from the application of IC 1971,
				  25-24.1-3, 6 and 8
[Repealed by Acts 1976,
				  P.L.
				  148,
				  SECTION
				  24; Acts 1977,
				  P.L.
				  26,
				  SECTION
				  25. See
IC 35-48.] as amended, and
				  the application of Section 3.74(d)
[856 IAC
				  2-3-33(d)]
(rule) for
				  administrative purposes only. The excepting of these drugs by the Indiana State
				  Board of Pharmacy should not be construed as an adoption or rejection of the
				  criteria by which these drugs were originally excepted. Any deviation from the
				  quantitative composition of any of the listed drugs shall require a petition
				  for exception in order for that drug to be excepted.
The following is a list of the excepted stimulant or
				  depressant compounds under these regulations
[856 IAC
				  2-2]
.
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Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 2 - Controlled Substances Code Number-Schedules I through IV › Section 2-9 - Application for exclusion of stimulant or depression compound; revocation

Current through July 10, 2024
Authority: IC
				  35-48-3-1
Affected: IC
				  35-48-2-1
Sec. 9.
Application for exclusion of a stimulant or depressant
				  compound.
(a) Any person seeking to
				have any non-narcotic substance which may, under the Federal Food, Drug, and
				Cosmetic Act or state law, be lawfully sold over-the-counter without a
				prescription, excluded from any schedule, pursuant to IC 1971,
				35-24.1-2-1(g)
[Repealed by Acts 1976,
				P.L.
				148,
				SECTION
				24; Acts 1977,
				P.L.
				26,
				SECTION
				25. See
IC 35-48.] as amended, may
				apply to the Indiana Board of Pharmacy for such exclusion.
(b) An application for an exclusion under
				this section shall be approved by the Board, provided that such application
				shall contain a copy of the Administration's approval for such request for an
				exclusion from the Federal Controlled Substances Act.
(c) Within a reasonable period of time after
				the receipt of an application for an exclusion under this section, the Indiana
				State Board of Pharmacy shall notify the applicant of its acceptance or
				non-acceptance of the application, and if not accepted, the reason therefor.
				The Indiana State Board of Pharmacy need not accept an application for filing
				if any of the requirements prescribed in paragraph (b) of this section is
				lacking or is not set forth so as to be readily understood. If the applicant
				desires, he may amend the application to meet the requirements of paragraph (b)
				of this section.
(d) The Indiana
				State Board of Pharmacy may at any time revoke any exclusion granted pursuant
				to IC 1971,
				35-24.1-2-1(g)
[Repealed by Acts 1976,
				P.L.
				148,
				SECTION
				24; Acts 1977,
				P.L.
				26,
				SECTION
				25. See
IC 35-48.], as amended, upon
				a finding that such exclusion from the Federal Controlled Substances Act was
				terminated, suspended or revoked. The revocation of the exclusion granted under
				this Act
[
IC 35-48] shall become effective upon the board's
				notifying the person to whom such exclusion was granted by certified mail of
				such revocation.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 2 - Controlled Substances Code Number-Schedules I through IV › Section 2-10 - Excluded nonnarcotic substances, stimulant or depressant compounds

Current through July 10, 2024
Authority: IC
				  35-48-3-1
Affected: IC
				  35-48-2-1
Sec. 10.
Excluded non-narcotic substances, stimulant, or depressant
				  compounds.
(a) The Indiana Board of
				Pharmacy may exclude any non-narcotic substance from a schedule if such
				substance may, under the Federal Food, Drug and Cosmetic Act or state law, be
				lawfully sold over-the-counter without a prescription pursuant to IC 1971,
				35-24.1-2-1(g)
[Repealed by Acts 1976,
				P.L.
				148,
				SECTION
				24; Acts 1977,
				P.L.
				26,
				SECTION
				25. See
IC 35-48.] as amended, the
				drugs which were excluded by the Bureau or Administration on January 1, 1974
				under section 201(g)(1) of the Federal Controlled Substances Act (21 U.S.C. 811(g)
				(1)) have been excluded by the Indiana State
				Board of Pharmacy from the schedules of IC 1971,
				35-24.1-2-4, 6, 8, 10, and 12
[Repealed by Acts 1976,
				P.L.
				148,
				SECTION
				24; Acts 1977,
				P.L.
				26,
				SECTION
				25. See
IC 35-48.], as amended. The
				exclusion of these drugs by the Indiana State Board of Pharmacy should not be
				construed as an adoption or rejection of the criteria by which these drugs were
				originally excluded. Any deviation from the quantitative composition of any of
				the listed drugs shall require a petition for exclusion in order for that drug
				to be excluded. The following is a list of the presently excluded non-narcotic
				substances under these regulations.
Click here to
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Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 2 - Controlled Substances Code Number-Schedules I through IV › Section 2-11 - Exempt chemical preparations

Current through July 10, 2024
Authority: IC
				  35-48-3-1
Affected: IC
				  35-48-2-1
Sec. 11.
Exempt Chemical Preparations.
(a) The chemical preparations and mixtures
				specifically listed in subparagraph (b) of this Section have been exempted by
				the Indiana Board of Pharmacy from the application of IC 1971,
				35-24.1-3-2, 3, 6 and 8
[Repealed by Acts 1976,
				P.L.
				148,
				SECTION
				24; Acts 1977,
				P.L.
				26,
				SECTION
				25. See
IC 35-48.] as amended, which
				preparation or mixture is intended for laboratory, industrial, educational or
				special research purposes and not for general administration to a human being
				or other animal. The exemption to be valid must be in strict compliance with
				the requirements imposed for the preparation or mixture prescribed in Part
				1308, Section 1308.24 of Title 21 of the Code of Federal Regulations, effective
				January 1, 1973, and no exemption granted pursuant to this Section affects the
				criminal liability for illegal manufacture, distribution, or possession of
				controlled substances contained in the exempt chemical preparation.
				Distribution, possession and use of an exempt chemical preparation are lawful
				for registrants and non-registrants only as long as such distribution,
				possession or use is intended for laboratory, industrial or educational
				purposes and not for immediate or subsequent administration to a human being or
				other animal.
(b) The following
				preparations and mixtures in the form and quantity listed in the application
				submitted (indicated as the "date of application") are designated as exempt
				chemical preparations for the purposes set forth in this Section.
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Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 2 - Controlled Substances Code Number-Schedules I through IV › Section 2-12 - Rulemaking hearings

Current through July 10, 2024
Authority: IC
				  35-48-3-1
Affected: IC
				  4-22-2; IC
				  35-48-3-1
Sec. 12.
Hearings for rule making. In any case where the Indiana
				  Board of Pharmacy shall hold a hearing on the issuance, amendment, or repeal of
				  rules pursuant to IC 1971,
				  35-24.1-2
[Repealed by
				  Acts 1976, P.L.
				  148,
				  SECTION
				  24; Acts 1977,
				  P.L.
				  26,
				  SECTION
				  25. See
IC 35-48.] as amended, the
				  procedures for such hearing and accompanying proceedings shall be governed
				  generally by the rule making procedures set forth in IC 1971,
				  4-22-2 as amended, and such
				  procedures, if relating to standards and schedules, be of record in accordance
				  with IC 1971,
				  35-24.1-2-1
[Repealed by
				  Acts 1976, P.L.
				  148,
				  SECTION
				  24; Acts 1977,
				  P.L.
				  26,
				  SECTION
				  25. See
IC 35-48.] as
				  amended.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 2 - Controlled Substances Code Number-Schedules I through IV › Section 2-13 - Purpose of public hearings

Current through July 10, 2024
Authority: IC
				  35-48-3-1
Affected: IC
				  35-48-3-1
Sec. 13.
Purpose of hearing. Whenever proceedings are initiated
				  pursuant to IC 1971,
				  35-24.1-2
[Repealed by
				  Acts 1976, P.L.
				  148,
				  SECTION
				  24; Acts 1977,
				  P.L.
				  26,
				  SECTION
				  25. See
IC 35-48.] as amended, of
				  this chapter, the Indiana Board of Pharmacy shall hold a hearing of record for
				  the purpose of receiving factual evidence and expert opinion regarding the
				  issues involved in the issuance, amendment or repeal of a rule issuable
				  pursuant to IC 1971,
				  35-24.1-2
[Repealed by
				  Acts 1976, P.L.
				  148,
				  SECTION
				  24; Acts 1977,
				  P.L.
				  26,
				  SECTION
				  25. See
IC 35-48.] as
				  amended.
On the date set for hearing any interested party in person or
				  by attorney shall be afforded an adequate opportunity to participate in the
				  formulation of the proposed rule or rules through the presentation of facts or
				  argument or the submission of written data or views. All relevant matter
				  presented shall be given full consideration by the Board.
The Board may adopt procedures in addition to those required
				  by this Act
[
IC 35-48] including the holding of conferences
				  and inviting and permitting the submission of suggestions, facts, argument and
				  views of interested persons in advance of the drafting of the proposed rule or
				  rules.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 3 - Registration Information-Special Instructions › Section 3-1 - Registration information furnished upon request

Current through July 10, 2024
Authority: IC
				  35-48-3-1
Affected: IC
				  35-48-3-1
Sec. 1.
Information; special instructions. Information regarding
				  procedures under these rules and instructions supplementing these rules will be
				  furnished upon request by writing to the Indiana State Board of
				  Pharmacy.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 3 - Registration Information-Special Instructions › Section 3-2 - Persons required to register

Current through July 10, 2024
Authority: IC 35-48-3-1
Affected: IC 35-48-3-3
Sec. 2.
Persons required to register. Every person who manufactures,
				  distributes, or dispenses any controlled substance or who proposes to engage in
				  the manufacture, distribution, or dispensing of any controlled substance shall
				  obtain annually a registration unless exempted by law or pursuant to sections
				  3.14T3.17
[856 IAC 2-3-5 T
				  856 IAC 2-3-8]
of this
				  chapter. Only persons actually engaged in such activities are required to
				  obtain registration; related or affiliated persons who are not engaged in such
				  activities are not required to be registered. (For example, a stockholder or
				  parent corporation of a corporation manufacturing controlled substances is not
				  required to obtain a registration).
As soon after the effective date of these rules as is
				  practicable, the Board shall issue a provisional certificate to all persons
				  when in possession of a valid State of Indiana or Federal certificate of
				  registration authorizing such persons to manufacture, distribute, dispense,
				  prescribe or possess controlled substances. The provisional certificates shall
				  be valid until the Board shall declare that applications for annual renewals
				  shall begin and until such applications have been acted upon by the Board.
				  During the first renewal period, when it is instituted, applications shall be
				  required from all prospective registrants in alphabetically ordered increments
				  according to a schedule to be adopted by the Board.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 3 - Registration Information-Special Instructions › Section 3-3 - Independent activities; separate registration required; exceptions

Current through July 10, 2024
Authority: IC 35-48-3-1
Affected: IC 35-48-3-3; IC 35-48-3-4
Sec. 3.
Separate registration for independent activities.
(a) The following groups of activities are
				deemed to be independent of each other:
(1)
				Manufacturing controlled substances;
(2) Distributing controlled
				substances;
(3) Dispensing
				controlled substances listed in Schedules II through V
[856 IAC
				2-2-3 T
				856 IAC 2-2-6]
;
(4) Conducting research
				(other than research described in sub-paragraph (6) of this paragraph) with
				controlled substances listed in Schedules II through V
[856 IAC
				2-2-3 T
				856 IAC 2-2-6]
;
(5) Conducting
				instructional activities with controlled substances listed in Schedules II
				through V
[856 IAC 2-2-3 T
				856 IAC 2-2-6]
;
(6) Conducting research
				with narcotic drugs listed in Schedules II through V
[856 IAC
				2-2-3 T
				856 IAC 2-2-6]
for the
				purpose of continuing the dependence on such 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;
(7) Conducting
				research and instructional activities with controlled substances listed in
				Schedule I
[856 IAC 2-2-2]
;
				and
(8) Conducting chemical
				analysis with controlled substances listed in any Schedule.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 3 - Registration Information-Special Instructions › Section 3-4 - Separate registrations for separate locations; exceptions

Current through July 10, 2024
Authority: IC
				  35-48-3-1
Affected: IC
				  35-48-3-3
Sec. 4.
(a) A
				separate registration is required for each principal place of business or
				professional practice at one (1) general physical location where controlled
				substances are manufactured, distributed, dispensed, or possessed by a
				person.
(b) The following locations
				shall be deemed not to be places where controlled substances are manufactured,
				distributed, or dispensed:
(1) A warehouse
				where controlled substances are stored by or on behalf of a registered person,
				unless such substances are distributed directly from such warehouse to
				registered locations other than the registered location from which the
				substances were delivered or to persons not required to register under IC
				35-48-3-3.
(2) An office used by agents of a registrant
				where sales of controlled substances are solicited, made, or supervised but
				which neither contains such substances (other than substances for display
				purposes or lawful distribution as samples only) nor serves as a distribution
				point for filling sales orders.
(3)
				An office used by a 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 at
				such office, and where no supplies of controlled substances are
				maintained.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 3 - Registration Information-Special Instructions › Section 3-4.5 - Registration of ambulance service providers

Current through July 10, 2024
Authority: IC 35-48-3-1
Affected: IC 16-18-2; IC 35-48
Sec. 4.5.
(a) The
				following definitions apply throughout this section:
(1) "Advanced emergency medical technician"
				has the meaning set forth in IC 16-18-2-6.5.
(2) "Ambulance" has the meaning set forth in
				IC 16-18-2-13.
(3) "Ambulance
				service provider" has the meaning set forth in
				836 IAC 1-1-1.
(4) "Contracting hospital" means a licensed
				hospital pharmacy that has a written agreement with one (1) or more ambulance
				service providers to provide stocks of controlled substances to such
				providers.
(5) "Health care
				practitioner" means a licensed physician, physician assistant, or advanced
				nurse practitioner.
(6) "Medical
				director" has the meaning set forth in
				836 IAC 1-1-1.
(7) "Paramedic" has the meaning set forth in
				IC 16-18-2-266.
(8) "Stock" means
				the controlled substances that are held by an ambulance service
				provider.
(9) "Sub-stock" means the
				controlled substances that are stored on a specific ambulance, or those
				controlled substances that are stored by an ambulance service provider that is
				owned or operated by, or utilizing a contract with, a hospital
				pharmacy.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 3 - Registration Information-Special Instructions › Section 3-5 - Exemption of agents or employees; affiliated practitioners; paramedics

Current through July 10, 2024
Authority: IC
				  35-48-3-1
Affected: IC
				  35-48-3-3
Sec. 5.
(a) The
				requirement of registration is waived for any agent or employee of a person who
				is registered to engage in any group of independent activities, if such agent
				or employee is acting in the usual course of his or her business or
				employment.
(b) An individual
				practitioner (other than an intern, a resident, or a foreign-trained physician)
				who is an agent or employee of another practitioner registered to dispense
				controlled substances may, when acting in the usual course of his or her
				employment, administer and 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 himself or herself. For example, a pharmacist employed
				by a pharmacy need not be registered individually to fill a prescription for
				controlled substances in a pharmacy if so registered.
(c) An individual practitioner who is an
				intern, a resident, or a foreign-trained physician may dispense, administer,
				and prescribe controlled substances as follows under the registration of the
				hospital or other institution that is registered and by whom he or she is
				employed in lieu of being registered himself or herself, provided that:
(1) Such dispensing or prescribing is done in
				the usual course of his professional practice.
(2) Such individual practitioner is
				authorized or permitted to do so by the jurisdiction in which he or she is
				practicing.
(3) The hospital or
				other institution by whom he is employed has determined that the individual
				practitioner is so permitted to dispense, administer, or prescribe drugs by the
				jurisdiction.
(4) Such individual
				practitioner is acting only within the scope of his employment with the
				hospital or institution.
(5) The
				hospital or other institution authorizes the intern, resident, or
				foreign-trained physician to dispense or prescribe under the hospital
				registration and designates a specific internal code number for each intern,
				resident, or foreign-trained physician so authorized. The code number shall
				consist of numbers, letters, or a combination thereof and shall be a suffix to
				the institution's Drug Enforcement Agency (DEA) registration number, preceded
				by a hyphen (e.g., AP 0123456-10 or AP 0123456-A12).
(6) A current list of internal codes and the
				corresponding individual practitioner is kept by the hospital or other
				institution and is made available to the public upon request for the purpose of
				verifying the authority of the prescribing individual
				practitioner.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 3 - Registration Information-Special Instructions › Section 3-6 - Exemption of military or public health service personnel

Current through July 10, 2024
Authority: IC 35-48-3-1
Affected: IC 35-48-3-3
Sec. 6.
Exemption of certain military and other personnel.
(a) The requirement of registration is 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 his official duties. Such officials shall follow procedures set forth in
				Part 6
[856 IAC 2-6]
of this
				chapter regarding prescriptions, but shall state the branch of service or
				agency (e.g., "U.S. Army" or "Public Health Service") 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 his Social Security identification
				number.
(b) If any official
				exempted by this section also engages as a private individual in any activity
				or group of activities for which registration is required, such official shall
				obtain a registration for such private activities.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 3 - Registration Information-Special Instructions › Section 3-7 - Exemption of law enforcement officers; registration of law enforcement laboratories

Current through July 10, 2024
Authority: IC
				  35-48-3-1
Affected: IC
				  35-48-3-3
Sec. 7.
Exemption of law enforcement officials.
(a) The requirement of registration is waived
				for the following persons in the circumstances described in this section:
(1) Any officer or employee of the Drug
				Enforcement Administration, 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 his official duties;
				and
(2) Any officer or employee of
				any State, or any political subdivision or agency thereof, who is engaged in
				the enforcement of any State or local law relating to controlled substances and
				is duly authorized to possess controlled substances in the course of his
				official duties.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 3 - Registration Information-Special Instructions › Section 3-8 - Exemption of civil defense officials

Current through July 10, 2024
Authority: IC 35-48-3-1
Affected: IC 35-48-3-3
Sec. 8.
Exemption of civil defense officials.
(a) The requirement of registration is waived
				for any offical of a civil defense or disaster relief organization who, in the
				course of his official duties, is authorized to:
(1) Maintain, and distribute for such
				maintenance, controlled substances held for emergency use; or
(2) Procure controlled substances for the
				purpose of maintaining supplies for emergency use, provided that all of such
				procurement is from the U.S. General Services Administration and in accordance
				with the rules of the U.S. Office of Emergency
				Preparedness.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 3 - Registration Information-Special Instructions › Section 3-9 - Registration fees

Current through July 10, 2024
Authority: IC 25-26-13-4
Affected: IC 25-26-13-4
Sec. 9.
(a) For each
				registration or reregistration to manufacture controlled substances, the
				registrant shall pay a fee of one hundred dollars ($100).
(b) For each registration or reregistration
				to distribute controlled substances, the registrant shall pay a fee of one
				hundred dollars ($100).
(c) For
				each registration or reregistration to dispense or to conduct research or
				instructional activities with controlled substances listed in
				856 IAC 2-2-3 through
				856 IAC 2-2-6, the registrant
				shall pay a fee of one hundred dollars ($100).
(d) For each registration or reregistration
				to conduct research or instructional activities with controlled substances
				listed in
				856 IAC 2-2-2, the registrant
				shall pay a fee of one hundred dollars ($100).
(e) For each registration or reregistration
				to conduct chemical analysis with controlled substances listed in any schedule,
				the registrant shall pay a fee of one hundred dollars ($100).
(f) For each registration or reregistration
				for a practitioner seeking to prescribe, administer, or dispense controlled
				substances, the registrant shall pay a fee of sixty dollars ($60).
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 3 - Registration Information-Special Instructions › Section 3-11 - Persons exempt from fee

Current through July 10, 2024
Authority: IC
				  35-48-3-1
Affected: IC
				  35-48-3-1
Sec. 11.
Persons exempt from fee.
(a) The Indiana State Board of Pharmacy shall
				exempt from payment of a fee for registration or re-registration the following
				persons:
(1) Any official or agency of the
				U.S. Army, Navy, Marine Corps, Air Force, Coast Guard, Veterans' Administration
				or Public Health Service who or which is authorized to procure or purchase
				controlled substances for official use; and
(2) Any official, employee, or other civil
				officer or agency of the United States, or any State, or any political
				subdivision or agency thereof, who or which is authorized to purchase
				controlled substances, to obtain such substances from official stocks, to
				dispense or administer such substances, to conduct research, instructional
				activities, or chemical analysis with such substances, or any combination
				thereof, in the course of his or its official duties or
				employment.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 3 - Registration Information-Special Instructions › Section 3-12 - Time for registration or re-registration application

Current through July 10, 2024
Authority: IC
				  35-48-3-1
Affected: IC
				  35-48-3-5
Sec. 12.
Time for application for registration; expiration
				  date.
(a) Any person who is required
				to be registered and who is not so registered may apply for registration at any
				time. No person required to be registered shall engage in any activity for
				which registration is required until the application for registration is
				granted by the Indiana Board of Pharmacy.
(b) Any person who is registered may apply to
				be re-registered not more than 60 days, before the expiration date his
				registration.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 3 - Registration Information-Special Instructions › Section 3-13 - Application forms; reregistration forms

Current through July 10, 2024
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.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 3 - Registration Information-Special Instructions › Section 3-16 - Additional information; failure to supply

Current through July 10, 2024
Authority: IC
				  35-48-3-1
Affected: IC
				  35-48-3-5
Sec. 16.
Additional information. The Indiana State Board of Pharmacy
				  may require an applicant to submit such documents or written statements of fact
				  relevant to the application as the Board deems necessary and as provided by IC
				  1971, 35-24.1-3-3(a)
[Repealed by Acts 1976,
				  P.L.
				  148,
				  SECTION
				  24; Acts 1977,
				  P.L.
				  26,
				  SECTION
				  25. See
IC 35-48.] as amended, to
				  determine whether the application should be granted. The failure of the
				  applicant to provide such documents or statements within a reasonable period of
				  time after being requested to do so shall be deemed to be a waiver by the
				  applicant of an opportunity to present such documents or facts for
				  consideration by the Indiana State Board of Pharmacy in granting or denying the
				  application.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 3 - Registration Information-Special Instructions › Section 3-17 - Amendment or withdrawal of application

Current through July 10, 2024
Authority: IC
				  35-48-3-1
Affected: IC
				  35-48-3-5
Sec. 17.
Amendments to and withdrawal of applications. An application
				  may be amended or withdrawn without permission of the Indiana Board of Pharmacy
				  at any time.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 3 - Registration Information-Special Instructions › Section 3-18 - Inspection and review of application by board

Current through July 10, 2024
Authority: IC
				  35-48-3-1
Affected: IC
				  35-48-3-5
Sec. 18.
Administrative review generally. The Indiana Board of
				  Pharmacy may inspect, or cause to be inspected, the establishment of an
				  applicant or registrant, pursuant to IC 1971,
				  35-24.1-5-2
[Repealed by
				  Acts 1976, P.L.
				  148,
				  SECTION
				  24; Acts 1977,
				  P.L.
				  26,
				  SECTION
				  25. See
IC 35-48.] as amended. The
				  Indiana Board of Pharmacy shall review the application for registration and
				  other information regarding an applicant in order to determine whether the
				  applicable standards of IC 1971,
				  35-24.1-3
[Repealed by
				  Acts 1976, P.L.
				  148,
				  SECTION
				  24; Acts 1977,
				  P.L.
				  26,
				  SECTION
				  25. See
IC 35-48.] as amended, have
				  been met by the applicant.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 3 - Registration Information-Special Instructions › Section 3-19 - Certificate of registration; denial of registration

Current through July 10, 2024
Authority: IC 35-48-3-1
Affected: IC 35-48-3-5
Sec. 19.
Certificate of registration; denial of registration.
(a) The Indiana State Board of Pharmacy shall
				issue a Certificate of Registration Form CSR-3 to an applicant if the issuance
				of registration or re-registration is required under the applicable provisions
				of IC 1971, 35-24.1-3
[Repealed by Acts 1976,
				P.L.
				148,
				SECTION
				24; Acts 1977,
				P.L.
				26,
				SECTION
				25. See
IC 35-48.] as amended. In
				the event that the issuance of registration or re-registration is not required,
				the Indiana State Board of Pharmacy may deny the application. Before denying
				any application, the Indiana State Board of Pharmacy shall issue an order to
				show cause pursuant to Section 3.46
[856 IAC
				2-3-23]
and, if requested by the applicant,
				shall hold a hearing on the application pursuant to Section 3.51, through
				Section 3.53
[856 IAC 2-3-24 T
				856 IAC 2-3-26]
.
(b) The Certificate of
				Registration shall contain the name, address, and registration number of the
				registrant, the activity authorized by the registration, the schedules and/or
				Controlled Substances Code Number (as set forth in Part 2
[856 IAC 2-2]
of this
				Act) of the controlled substances which the registrant is authorized to handle,
				the amount of fee paid (or exemption), and the expiration date of the
				registration. The registrant shall maintain the Certificate of Registration in
				a readily retrievable manner and shall permit inspection of the Certificate of
				Registration and shall permit inspection of the certificate by any official,
				agent, or employee of the Board or any agency engaged in enforcement of laws
				relating to controlled substances.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 3 - Registration Information-Special Instructions › Section 3-20 - Suspension or revocation of registration

Current through July 10, 2024
Authority: IC 35-48-3-1
Affected: IC 35-48-3-5
Sec. 20.
Suspension or revocation of registration.
(a) The Indiana Board of Pharmacy may suspend
				any registration pursuant to IC 1971, 35-24.1-3-4
[Repealed by Acts
				1976, P.L.
				148,
				SECTION
				24; Acts 1977,
				P.L.
				26,
				SECTION
				25. See
IC 35-48.] as amended, for
				any period of time he determines.
(b) The Indiana Board of Pharmacy may revoke
				any registration pursuant to IC 1971, 35-24.1-3-4
[Repealed by Acts
				1976, P.L.
				148,
				SECTION
				24; Acts 1977,
				P.L.
				26,
				SECTION
				25. See
IC 35-48.] as
				amended.
(c) Before revoking or
				suspending any registration, the Indiana Board of Pharmacy shall issue an order
				to show cause, such order shall be sent by certified mail to address of the
				registrant, advising registrant of his rights to a hearing, Form CSR-4,
				pursuant to section 3.46
[856 IAC 2-3-23]
. Notwithstanding the requirements of this section, however, the
				Indiana Board of Pharmacy may suspend any registration pending a final order
				pursuant to section 3.44
[856 IAC 2-3-21]
.
(d) Upon service of the
				final order of the Indiana Board of Pharmacy following a hearing or waiver
				thereof suspending or revoking registration, the registrant shall immediately
				deliver his Certificate of Registration to the Indiana Board of Pharmacy. Also,
				upon service of the final order of the Indiana Board of Pharmacy suspending or
				revoking registration, the registrant shall, as instructed by the Indiana Board
				of Pharmacy:
(1) Deliver all controlled
				substances in his possession to the Indiana Board of Pharmacy or to authorized
				agents of the Indiana Board of Pharmacy; or
(2) Place all controlled substances in his
				possession under seal as described in IC 1971,
				35-24.1-3-4(c)
[Repealed by Acts 1976,
				P.L.
				148,
				SECTION
				24; Acts 1977,
				P.L.
				26,
				SECTION
				25. See
IC 35-48.] as
				amended.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 3 - Registration Information-Special Instructions › Section 3-21 - Suspension pending final order

Current through July 10, 2024
Authority: IC 35-48-3-1
Affected: IC 35-48-3-5
Sec. 21.
Suspension of registration pending final order.
(a) The Indiana Board of Pharmacy may suspend
				any registration simultaneously with or at any time subsequent to the service
				upon the registrant of an order to show cause why such registration should not
				be revoked or suspended, in any case where it finds that there is an imminent
				danger to the public health or safety. If the Indiana Board of Pharmacy so
				suspends, it shall serve with the order to show cause pursuant to section 3.46
[856 IAC 2-3-23]
an
				order of immediate suspension which shall contain a statement of its findings
				regarding the danger to public health or safety.
(b) Upon service of the order of immediate
				suspension, the registrant shall promptly return his Certificate of
				Registration to the Indiana Board of Pharmacy. Also, upon service of the order
				of the Indiana Board of Pharmacy immediately suspending registration, the
				registrant shall, as instructed by the Indiana Board of Pharmacy:
(1) Deliver all affected controlled
				substances in his possession to the Indiana Board of Pharmacy or to authorized
				agents of the Indiana Board of Pharmacy; or
(2) Place all of such substances under seal
				as described in IC 1971, 35-24.1-3-4(c)
[Repealed by Acts 1976,
				P.L.
				148,
				SECTION
				24; Acts 1977,
				P.L.
				26,
				SECTION
				25. See
IC 35-48.] as
				amended.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 3 - Registration Information-Special Instructions › Section 3-22 - Extension of registration pending re-registration order

Current through July 10, 2024
Authority: IC
				  35-48-3-1
Affected: IC
				  35-48-3-5
Sec. 22.
Extension of registration pending final order. In the event
				  that an applicant for re-registration (who is doing business under a
				  registration previously granted and not revoked or suspended) has applied for
				  re-registration at least 30 days before the date on which the existing
				  registration is due to expire, the existing registration of the applicant shall
				  automatically be extended and continue in effect until the date on which the
				  Indiana Board of Pharmacy so issues its final order. The Indiana Board of
				  Pharmacy may extend any other existing registration under the circumstances
				  contemplated in this section even though the registrant failed to apply for
				  re-registration at least 30 days before expiration of the existing
				  registration, with or without request by the registrant, if the Indiana Board
				  of Pharmacy finds that such extension is not inconsistent with the public
				  health and safety.