reglab/statecodes huggingface dataset:
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 3 - Registration Information-Special Instructions › Section 3-23 - Order to show cause

Current through July 10, 2024
Authority: IC 35-48-3-1
Affected: IC 35-48-3-5
Sec. 23.
Order to show cause.
(a) If, upon examination of the application
				for registration from any applicant and other information regarding the
				applicant, the Indiana Board of Pharmacy is unable to make the determinations
				required by the applicable provisions of IC 1971, 35-24.1-3-3
[Repealed
				by Acts 1976, P.L.
				148,
				SECTION
				24; Acts 1977,
				P.L.
				26,
				SECTION
				25. See
IC 35-48.], as amended, to
				register the applicant, the Indiana Board of Pharmacy shall serve upon the
				applicant an order to show cause why the registration should not be
				denied.
(b) If, upon information
				regarding any registrant, the Indiana Board of Pharmacy determines that the
				registration of such registrant is subject to suspension or revocation 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[Repealed by Acts 1976,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, the
				Indiana Board of Pharmacy shall serve upon the registrant an order to show
				cause why a registration should not be revoked or suspended.
(c) The order to show cause shall call upon
				the applicant or registrant to appear before the Indiana Board of Pharmacy at a
				time and place stated in the order, which shall not be less than 30 days after
				the date of receipt of the order. The order to show cause shall also contain a
				statement of the legal basis for such hearing and for the denial, revocation,
				or suspension of registration and a summary of the matters of fact and law
				asserted.
(d) The Indiana Board of
				Pharmacy shall hold a hearing at the time and place stated in the order,
				pursuant to section 3.51
[856 IAC 2-3-24]
.
(e) When authorized by
				the section 3.51
[856 IAC 2-3-24]
any agent of the Indiana Board of Pharmacy may serve the order to
				show cause.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 3 - Registration Information-Special Instructions › Section 3-24 - Evidentiary hearing

Current through July 10, 2024
Authority: IC
				  35-48-3-1
Affected: IC
				  35-48-3-6
Sec. 24.
The controlled substances advisory committee shall hold a
				  hearing for the purpose of receiving factual evidence regarding the issues
				  involved in the denial, revocation, or suspension of any
				  registration.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 3 - Registration Information-Special Instructions › Section 3-25 - Hearing procedures

Current through July 10, 2024
Authority: IC 35-48-3-1
Affected: IC 4-21.5; IC 35-48-3-6
Sec. 25.
Hearing for granting, denial, revocation, or suspension of
				  application.
(a) In any case where the
				advisory committee shall hold a hearing on any registration or application
				therefor, the procedures for such hearing shall be governed generally by the
				adjudication procedures of IC 1971, 4-22-1-1 to 4-22-1-30
[Repealed by
				P.L.
				18-1986,
				SECTION
				2. See
IC 4-21.5.], as amended, and
				by sections 3.52-3.53
[this section and
				856 IAC 2-3-26]
.
(b) Any hearing under
				this part shall be independent of, and not in lieu of, criminal prosecutions or
				other proceedings under the Act
[
IC 35-48] or any other law of
				this State.
(c) At any such hearing
				the advisory committee shall designate one of its members as presiding
				officer.
(d) At any such hearing a
				quorum of the advisory committee consisting of a majority of its membership
				shall hear the evidence and the disputed issues of law and they shall after the
				conclusion of the hearing, prepare for the Board recommended findings, facts,
				and conclusions of law.
(e) The
				committee's recommended findings and facts and conclusions of law shall be
				acted on by the Board in the manner required by IC 1971,
				4-22-1
[Repealed by
				P.L.
				18-1986,
				SECTION
				2. See
IC 4-21.5.].
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 3 - Registration Information-Special Instructions › Section 3-26 - Modification or waiver of rules

Current through July 10, 2024
Authority: IC
				  35-48-3-1
Affected: IC
				  35-48-3-6
Sec. 26.
Waiver or modification of rules.The presiding officer at the
				  advisory committee hearings or of the Indiana Board of Pharmacy (with respect
				  to matters pending before him) may modify or waive any rule in this part by
				  notice in advance of the hearing, if he determines than no party in the hearing
				  will be unduly prejudiced and the ends of justice will thereby be served and if
				  all parties consent. Such notice of modification or waiver shall be made a part
				  of the record of the hearing.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 3 - Registration Information-Special Instructions › Section 3-27 - Modification of registration

Current through July 10, 2024
Authority: IC 35-48-3-1
Affected: IC 35-48-3-6
Sec. 27.
Modification in registration. Any registrant may apply to
				  modify his registration to authorize the handling of additional controlled
				  substances or to change his name or address by submitting a letter of request
				  to the Indiana Board of Pharmacy. The letter shall contain the registrant's
				  name, address, registration number, and the substances and/or schedule to be
				  added to his registration or the name or address and shall be signed by the
				  same person who signed the most recent application for registration or
				  re-registration. If the registrant is seeking to handle additional controlled
				  substances listed in Schedule I
[856 IAC
				  2-2-2]
for the purpose of research or
				  instructional activities, a Federally approved research protocol describing
				  each research project involving the additional substances shall be subject to
				  inspection by the Indiana Board of Pharmacy or he shall attach two copies of a
				  statement describing the nature, extent, and duration of such instructional
				  activities, as appropriate. No fee shall be required to be paid for the
				  modification. The request for modification shall be handled in the same manner
				  as an application for registration.
If the modification of registration is approved, the Indiana
				  Board of Pharmacy shall issue a new certificate of registration to the
				  registrant, who shall maintain it with the old certificate of registration
				  until the expiration date.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 3 - Registration Information-Special Instructions › Section 3-28 - Termination of registration; notice to board

Current through July 10, 2024
Authority: IC
				  35-48-3-1
Affected: IC
				  35-48-3-6
Sec. 28.
Termination of registration. The registration of any person
				  shall terminate if and when such person dies, ceases legal existence, or
				  discontinues business or professional practice. Any registrant who ceases legal
				  existence or discontinues business or professional practice shall notify the
				  Indiana Board of Pharmacy promptly of such fact.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 3 - Registration Information-Special Instructions › Section 3-29 - Transfer of registration

Current through July 10, 2024
Authority: IC
				  35-48-3-1
Affected: IC
				  35-48-3-6
Sec. 29.
Transfer of registration. No registration or any authority
				  conferred thereby shall be assigned or otherwise transferred except upon such
				  conditions as the Indiana Board of Pharmacy may specifically designate and then
				  only pursuant to its written consent.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 3 - Registration Information-Special Instructions › Section 3-31 - Storage areas; security controls for nonpractitioners

Current through July 10, 2024
Authority: IC 35-48-3-1
Affected: IC 35-48-3-7
Sec. 31.
Physical security controls for nonpractitioners: Storage
				  Areas.
(a) Schedules I and II
[856 IAC 2-2-2 and
				856 IAC 2-2-3]
. Raw
				materials, bulk materials awaiting further processing, and finished products
				which are controlled substances listed in Schedule I or II
[856 IAC 2-2-2 or
				856 IAC 2-2-3]
shall be
				stored in one of the following secure storage areas:
(1) Where small quantities permit, a safe or
				steel cabinet.
(i) Which safe or steel cabinet
				shall have the following specifications or the equivalent: 30 man-minutes
				against surreptitious entry, 10 man-minutes against forced entry, 20 man-hours
				against lock manipulation, and 20 man-hours against radiological
				techniques.
(ii) Which safe or
				steel cabinet, if it weighs less than 750 pounds, is bolted or cemented to the
				floor or wall in such a way that it cannot be readily removed; and
(iii) Which safe or steel cabinet, if
				necessary, depending upon the quantities and type of controlled substances
				stored, is equipped with an alarm system which, upon attempted unauthorized
				entry, shall transmit a signal directly to a central protection company or a
				local or State police agency which has a legal duty to respond, or a 24-hour
				control station operated by the registrant, or such other protection as the
				Indiana Board of Pharmacy or the Drug Enforcement Administration may
				approve.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 3 - Registration Information-Special Instructions › Section 3-32 - Manufacturing areas; security controls for nonpractitioners

Current through July 10, 2024
Authority: IC
				  35-48-3-1
Affected: IC
				  35-48-3-7
Sec. 32.
Physical security controls for nonpractitioners:
				  Manufacturing areas. All manufacturing activities (including processing,
				  packaging, and labeling) involving controlled substances listed in any schedule
				  shall be conducted in accordance with the following:
(a) All in-process substances shall be
				returned to the controlled substances storage area at the termination of the
				process. If the process is not terminated at the end of a workday (except where
				a continuous process or other normal manufacturing operation should not be
				interrupted), the processing area or tanks, vessels, bins or bulk containers
				containing such substances shall be securely locked, with adequate security for
				the area or building. If such security requires an alarm, such alarm, upon
				unauthorized entry, shall transmit a signal directly to a central station
				protection company, or a local or State Police agency which has a legal duty to
				respond, or a 24-hour control station operated by registrant.
(b) Manufacturing activities with controlled
				substances shall be conducted in an area or areas of clearly defined limited
				access which is under surveillance by an employee or employees designated in
				writing as responsible for the area. "Limited access" may be provided in the
				absence of physical dividers such as walls or partitions, by traffic control
				lines or restricted space designation. The employee designated as responsible
				for the area may be engaged in the particular manufacturing operation being
				conducted: Provided: that he is able to provide continuous surveillance of the
				area in order that unauthorized persons may not enter or leave the area without
				his knowledge.
(c) During the
				production of controlled substances, the manufacturing areas shall be
				accessible to only those employees required for efficient operation. When it is
				necessary for employee maintenance personnel, non-employee maintenance
				personnel, business guests, or visitors to be present in or pass through
				manufacturing areas during production of controlled substances, the registrant
				shall provide for adequate observation of the area by an employee specifically
				authorized in writing.
(d)
				Compliance with the requirements prescribed in Part 301, Section 301.73 of
				Title 21 of the Code of Federal Regulations, effective April 1, 1973, shall be
				deemed in compliance with this section.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 3 - Registration Information-Special Instructions › Section 3-34 - Storage; security controls for practitioners

Current through July 10, 2024
Authority: IC 35-48-3-1
Affected: IC 35-48-3-7
Sec. 34.
Physical security controls for practitioners.
(a) Controlled substances listed in Schedule
				I
[856 IAC 2-2-2]
shall be
				stored in a securely locked substantially constructed cabinet.
(b) Controlled substances listed in Schedules
				II, III, IV, and V
[856 IAC 2-2-3 T
				856 IAC 2-2-6]
shall be
				stored in a securely locked, substantially constructed cabinet. However,
				pharmacies and institutional practitioners (as defined) in Chapter I, 1.01
[856 IAC 2-1-1]
may
				disperse such substances throughout the stock of noncontrolled substances in
				such a manner as to obstruct the theft or diversion of the controlled
				substances.
Controlled substances (institutional practitionersTward and
				  floor stock) listed in Schedule II
[856 IAC
				  2-2-3]
and narcotic drugs in Schedule III
[856 IAC 2-2-4]
shall be
				  stored in a securely locked substantially constructed cabinet or device.
				  Controlled substances (institutional practitioners ward and floor stock) listed
				  in Schedules III, IV, and V
[856 IAC
				  2-2-4 T
				  856 IAC 2-2-6]
may be
				  dispersed in their ward or floor stock in such a manner as to obstruct theft or
				  diversion of these controlled substances.
(c) This section shall also apply to
				nonpractitioners authorized to conduct research or chemical analysis under
				another registration.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 3 - Registration Information-Special Instructions › Section 3-35 - Additional security controls for practitioners

Current through July 10, 2024
Authority: IC
				  35-48-3-1
Affected: IC
				  35-48-3-7
Sec. 35.
Other security controls for practitioners.
(a) The registrant shall not employ as an
				agent or employee who has access to controlled substances any person who has
				had an application for registration denied, or has had his registration
				revoked, or has been convicted of a violation of State or Federal law relative
				to the manufacture, distribution, dispensing or possession of controlled
				substances.
(b) The registrant
				shall notify the Indiana Board of Pharmacy of the theft or significant loss of
				any controlled substances upon discovery of such loss or theft.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 4 - Records and Inventories of Registrants › Section 4-1 - Records and inventories

Current through July 10, 2024
Authority: IC
				  35-48-3-1
Affected: IC
				  35-48-3-7
Sec. 1.
(a) Every
				registrant shall keep records and maintain inventories in conformance with the
				record keeping and inventorying requirements of federal law and
				regulation.
(b) For purposes of
				this article, "readily retrievable" means that certain records are kept by
				automatic data processing systems or other electronic or mechanized record
				keeping systems in such a manner that they can be separated out from all other
				records in a reasonable time and/or records are kept on which certain items are
				asterisked, red-lined, or in some manner visually identifiable apart from other
				items appearing on the records. Manufacturers, distributors, and research
				records or electronic data processing printouts shall be made available within
				five (5) working days after a request by the Indiana board of pharmacy for such
				records or information on controlled substances transactions.
(c) Each registered pharmacy shall maintain,
				for a period of two (2) years, its prescriptions of controlled substances by
				maintaining any of the following:
(1) Three
				(3) separate files as follows:
(A) A file for
				schedule II drugs dispensed.
(B) A
				file for schedules III, IV, and V drugs dispensed.
(C) A file for prescriptions for all other
				drugs dispensed.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 5 - Order Forms › Section 5-1 - Order form requirements

Current through July 10, 2024
Authority: IC
				  35-48-3-1
Affected: IC
				  35-48-3-8
Sec. 1.
Order Form Requirements Generally. Compliance with the
				  requirements prescribed in section 308 of the Federal Controlled Substances Act
				  (21 U.S.C.
				  828), and in Part 305 of Title 21 of the Code
				  of Federal Regulations, effective April 1, 1973 shall be deemed compliance with
				  the requirements of IC 1971,
				  35-24.1-3-7
[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 6 - Issuance, Filling and Filing Prescriptions › Section 6-1 - Scope of rules governing prescriptions

Current through July 10, 2024
Authority: IC
				  35-48-3-1
Affected: IC
				  35-48-3-9
Sec. 1.
Scope of Part 6. Rules governing the issuance, filling and
				  filing of prescriptions pursuant to IC 1971,
				  35-24.1-3-8
[Repealed by
				  Acts 1976, P.L.
				  148,
				  SECTION
				  24; Acts 1977,
				  P.L.
				  26,
				  SECTION
				  25. See
IC 35-48.] as amended, are
				  set forth generally in that section and specifically by the sections of this
				  part
[856 IAC 2]
.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 6 - Issuance, Filling and Filing Prescriptions › Section 6-1.5 - Signature requirements

Current through July 10, 2024
Authority: IC
				  35-48-3-1
Affected: IC
				  35-48-3-9
Sec. 1.5.
All references to "signed" in this rule shall include
				  either:
(1) manually written in pen or
				indelible pencil; or
(2)
				electronically signed in accordance with applicable federal
				regulations.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 6 - Issuance, Filling and Filing Prescriptions › Section 6-2 - Persons entitled to issue prescriptions

Current through July 10, 2024
Authority: IC 35-48-3-1
Affected: IC 35-48-3-9
Sec. 2.
(a) A
				prescription for a controlled substance may be issued only by an individual
				practitioner who is:
(1) authorized to
				prescribe controlled substances by the state; and
(2) either registered or exempted from
				registration pursuant to
				856 IAC 2-3-5(b)
				 or
				856 IAC
				2-3-6.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 6 - Issuance, Filling and Filing Prescriptions › Section 6-3 - Purpose of prescription; prohibitions

Current through July 10, 2024
Authority: IC
				  35-48-3-1
Affected: IC
				  35-48-3-9
Sec. 3.
Purpose of issue of prescription.
(a) A prescription for a controlled substance
				to be effective must be issued for a legitimate medical purpose in a reasonable
				quantity by an individual practitioner acting in the usual course of his
				professional practice. The responsibility for the proper prescribing and
				dispensing of controlled substances is upon the prescribing practitioner, but a
				corresponding responsibility rests with the pharmacist who fills the
				prescription. An order purporting to be a prescription issued not in the usual
				course of professional treatment or in legitimate and authorized research is
				not a prescription, within the meaning and intent of IC 1971,
				35-24.1-3-8
[Repealed by
				Acts 1976, P.L.
				148,
				SECTION
				24; Acts 1977,
				P.L.
				26,
				SECTION
				25. See
IC 35-48.] as amended, and
				the person knowingly filling such a purported prescription, as well as the
				person issuing it, shall be subject to the penalties provided for violations of
				the provisions of law relating to controlled substances.
(b) A prescription may not be issued in order
				for an individual practitioner to obtain controlled substances for supplying
				the individual practitioner for the purpose of general dispensing to
				patients.
(c) A prescription may
				not be issued for the dispensing of narcotic drugs listed in any schedule to a
				narcotic drug dependent person for the purpose of continuing his dependence
				upon such drugs in the course of conducting an authorized clinical
				investigation in the development of a narcotic addict rehabilitation
				program.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 6 - Issuance, Filling and Filing Prescriptions › Section 6-4 - Issuance of prescriptions; information required

Current through July 10, 2024
Authority: IC 35-48-3-1
Affected: IC 35-48-3-9
Sec. 4.
(a) All
				prescriptions for controlled substances shall be dated as of, and signed, the
				day when issued and shall bear the full name and address of the patient, and
				the name, address, and federal controlled substance registration number of the
				practitioner. A practitioner may sign a prescription either in writing or
				electronically in accordance with applicable federal regulations. Where an oral
				order is not permitted, prescriptions shall be:
(1) written with ink, indelible pencil,
				computer printer, or typewriter and manually signed by the practitioner;
				or
(2) electronically written,
				signed, and transmitted in accordance with applicable federal
				regulations.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 6 - Issuance, Filling and Filing Prescriptions › Section 6-5 - Persons entitled to fill prescriptions

Current through July 10, 2024
Authority: IC
				  35-48-3-1
Affected: IC
				  35-48-3-9
Sec. 5.
Persons entitled to fill prescriptions. A prescription for
				  controlled substances may only be filled by a pharmacist acting in the usual
				  course of his professional practice and either registered individually or
				  employed in a registered pharmacy or by a registered institutional
				  practitioner.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 6 - Issuance, Filling and Filing Prescriptions › Section 6-6 - Dispensing of narcotics for maintenance purposes

Current through July 10, 2024
Authority: IC
				  35-48-3-1
Affected: IC
				  35-48-3-9
Sec. 6.
Dispensing of narcotic drugs for maintenance purposes. The
				  administering or dispensing directly (but not prescribing) of narcotic drugs
				  listed in any schedule to a narcotic drug dependent person for the purpose of
				  treatment of his dependence upon such drugs in the course of conducting a
				  clinical investigation authorized by State or Federal law in the development of
				  a narcotic addict rehabilitation program shall be deemed to be within the
				  meaning of the term "in the course of his professional practice or research" in
				  IC 1971, 35-24.1-1-1(u)
[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 6 - Issuance, Filling and Filing Prescriptions › Section 6-8 - Schedule II controlled substances; refilling prescriptions

Current through July 10, 2024
Authority: IC 35-48-3-1
Affected: IC 35-48-3-9
Sec. 8.
Refilling prescriptionsTSchedule II
[856 IAC
				  2-2-3]
. The refilling of a prescription for
				  a controlled substance listed in Schedule II
[856 IAC
				  2-2-3]
is prohibited.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 6 - Issuance, Filling and Filing Prescriptions › Section 6-9 - Schedule II controlled substances; partial filling of prescriptions

Current through July 10, 2024
Authority: IC
				  35-48-3-1
Affected: IC
				  35-48-2-6; IC
				  35-48-3-9
Sec. 9.
(a) The
				partial filling of a prescription for a controlled substance listed in schedule
				II under IC
				35-48-2-6, as amended, is
				permissible if the pharmacist is unable to supply the full quantity called for
				in a prescription written either manually or electronically in accordance with
				applicable federal regulations, or emergency oral prescription and makes a
				notation of the quantity supplied on the face of the written prescription, on
				the written record of the emergency oral prescription or electronically
				recorded if electronically transmitted. The remaining portion of the
				prescription may be filled within seventy-two (72) hours of the first partial
				filling. However, if the remaining portion is not or cannot be filled within
				the seventy-two (72) hour period, the pharmacist shall so notify the
				prescribing individual practitioner. No further quantity may be supplied beyond
				seventy-two (72) hours without a new prescription.
(b) A prescription prescribed, either in
				writing or electronically in accordance with applicable federal regulations,
				for a schedule II controlled substance for patients in long-term care
				facilities may be filled in partial quantities to include individual dosage
				units. For each partial filling, the dispensing pharmacist shall record on the
				back of the prescription (or on another appropriate record, uniformly
				maintained, and readily retrievable) the:
(1)
				date of the partial filling;
(2)
				quantity dispensed;
(3) remaining
				quantity authorized to be dispensed; and
(4) identification of the dispensing
				pharmacist.
The total quantity of a schedule II controlled substance
				  dispensed in all partial fillings must not exceed the total quantity
				  prescribed. A schedule II prescription, for a patient in a long-term care
				  facility, shall be valid for a period not to exceed sixty (60) days from the
				  issue date unless sooner terminated by the discontinuance of
				  medication.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 6 - Issuance, Filling and Filing Prescriptions › Section 6-10 - Schedule II controlled substances; label information; exceptions

Current through July 10, 2024
Authority: IC 35-48-3-1
Affected: IC 35-48-3-9
Sec. 10.
(a) The
				pharmacist filling a written prescription, an electronically transmitted
				prescription, or an emergency oral prescription for a controlled substance
				listed in
				856 IAC 2-2-3, Schedule II, shall
				affix to the package a label showing the following:
(1) The date of filling.
(2) The pharmacy name and address.
(3) The serial number of the
				prescription.
(4) The name of the
				patient.
(5) The name of the
				prescribing practitioner.
(6)
				Directions for use.
(7) The
				cautionary statement, "Federal law prohibits the transfer of this drug to any
				person other than the patient for whom it was prescribed".
(8) Any others if any, contained in the
				prescription or required by law.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 6 - Issuance, Filling and Filing Prescriptions › Section 6-12 - Schedules III and IV controlled substances

Current through July 10, 2024
Authority: IC 35-48-3-1
Affected: IC 35-48-3-9
Sec. 12.
(a) A
				pharmacist may dispense a controlled substance listed in schedule III or IV
				under 856 IAC 2-2-4 or
				856 IAC 2-2-5, which is a
				prescription drug as determined under the federal Food, Drug, and Cosmetic Act,
				only pursuant to either a prescription signed by a prescribing individual
				practitioner or an oral prescription made by a prescribing individual
				practitioner or a practitioner's authorized agent and promptly reduced to
				writing by the pharmacist containing all information required in section 4 of
				this rule, except for the signature of the prescribing individual
				practitioner.
(b) An individual
				practitioner may administer or dispense a controlled substance listed in
				schedule III or IV under
				856 IAC 2-2-4 or
				856 IAC 2-2-5 in the course of
				his or her professional practice without a prescription, subject to section 6
				of this rule.
(c) An institutional
				practitioner may administer or dispense directly (but not prescribe) a
				controlled substance listed in schedule III or IV under
				856 IAC 2-2-4 or
				856 IAC 2-2-5 pursuant to a
				prescription signed by a prescribing individual practitioner, or pursuant to an
				oral prescription made by a prescribing individual practitioner and promptly
				reduced to writing by the pharmacist (containing all information required in
				section 4 of this rule, except for the signature of the prescribing individual
				practitioner), or pursuant to an order for medication made by an individual
				practitioner that is dispensed for immediate administration to the ultimate
				user, subject to section 6 of this rule.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 6 - Issuance, Filling and Filing Prescriptions › Section 6-13 - Schedules III, IV, and V controlled substances; refilling prescriptions; retrievable information

Current through July 10, 2024
Authority: IC
				  35-48-3-1
Affected: IC
				  35-48-2; IC
				  35-48-3-9
Sec. 13.
(a) No
				prescription for a controlled substance listed in schedule III ( IC
				35-48-2-8), schedule IV ( IC
				35-48-2-10), or schedule V ( IC
				35-48-2-12) shall be filled or
				refilled more than six (6) months after the date on which such prescription was
				issued, and no such prescription shall be authorized to be refilled more than
				five (5) times.
(b) Each refill of
				a prescription shall be recorded by one (1) of the following methods:
(1) On the back of the original prescription,
				an electronically transmitted record in accordance with applicable federal
				regulations, or a uniformly maintained, readily retrievable record.
(2) In the storage memory of an electronic
				data processing system if such board approved system is used in the
				pharmacy.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 6 - Issuance, Filling and Filing Prescriptions › Section 6-14 - Schedules III, IV and V controlled substances; partial filling of prescriptions

Current through July 10, 2024
Authority: IC
				  35-48-3-1
Affected: IC
				  35-48-3-9
Sec. 14.
The partial filling of a prescription for a controlled
				  substance listed in Schedule III, IV, or V in the Controlled Substance Act, IC
				  35-48 as amended is permissible, provided that:
(a) each partial filling is recorded in the
				same manner as a refilling,
(b) the
				total quantity dispensed pursuant to an individual prescription including the
				original and all subsequent partial refills does not exceed the total quantity
				prescribed, and
(c) no dispensing
				occurs more than six (6) months after the date on which the prescription was
				issued.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 6 - Issuance, Filling and Filing Prescriptions › Section 6-15 - Schedules III and IV controlled substances; label information; exceptions

Current through July 10, 2024
Authority: IC 35-48-3-1
Affected: IC 35-48-3-9
Sec. 15.
Labeling of substances.
(a) The pharmacist filling a prescription for
				a controlled substance listed in Schedule III or IV
[856 IAC
				2-2-4 or
				856 IAC 2-2-5]
shall
				affix to the package a label showing the pharmacy name and address, the serial
				number and date of initial filling, the name of the patient, the name of the
				practitioner issuing the prescription, and directions for use and cautionary
				statement, "Federal Law prohibits the transfer of this drug to any person other
				than the patient for whom it was prescribed", and other if any, contained in
				such prescription as required by law.
(b) The requirements of paragraph (a) of this
				section do not apply when a controlled substance listed in Schedule III or IV
[856 IAC 2-2-4 or
				856 IAC 2-2-5]
is
				prescribed for administration to an ultimate user who is institutionalized:
				Provided, That:
(1) Not more than a 34-day
				supply or 100 dosage units, whichever is less, of the controlled substance
				listed in Schedule III or IV
[856 IAC
				2-2-4 or
				856 IAC 2-2-5]
is
				dispensed at one time;
(2) The
				controlled substance listed in schedule III or IV
[856 IAC
				2-2-4 or
				856 IAC 2-2-5]
is not
				in the possession of the ultimate user prior to administration;
(3) The institution maintains appropriate
				safeguards and records, the proper administration, control, dispensing, and
				storage of the controlled substance listed in Schedule III or IV
[856 IAC 2-2-4 or
				856 IAC 2-2-5]
;
				and
(4) The system employed by the
				pharmacist in filling a prescription is adequate to identify the supplier, the
				product and the patient, and to set forth the directions for use and cautionary
				statements, if any, contained in the prescription or required by
				law.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 6 - Issuance, Filling and Filing Prescriptions › Section 6-16 - Schedules III and IV controlled substances; retention of prescriptions

Current through July 10, 2024
Authority: IC 35-48-3-1
Affected: IC 35-48-3-9
Sec. 16.
Filing prescriptions. All prescriptions for controlled
				  substances listed in Schedules III and IV
[856 IAC
				  2-2-4 or
				  856 IAC 2-2-5]
shall be
				  kept in accordance with section 4.01
[856 IAC
				  2-4-1]
of these
				  regulations.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 6 - Issuance, Filling and Filing Prescriptions › Section 6-17 - Schedule V controlled substances; prescription requirements; refilling; exceptions

Current through July 10, 2024
Authority: IC 35-48-3-1
Affected: IC 35-48-3-9
Sec. 17.
(a) A
				pharmacist may dispense a controlled substance listed in
				856 IAC 2-2-6, Schedule V,
				pursuant to a prescription as required for controlled substances listed in
				856 IAC 2-2-4 and
				856 IAC 2-2-5, Schedules III and
				IV, in section 12 of this rule. A prescription for a controlled substance
				listed in
				856 IAC 2-2-6, Schedule V, may be
				refilled only as expressly authorized by the prescribing individual
				practitioner on the prescription. If no such authorization is given, the
				prescription may not be refilled. A pharmacist dispensing such substance
				pursuant to a prescription shall label the substance in accordance with section
				15 of this rule and file the prescription in accordance with
[section]
16 of this rule.
(b) An individual practitioner may administer
				or dispense a controlled substance listed in
				856 IAC 2-2-6, Schedule V, in the
				course of his or her professional practice without a prescription, subject to
				section 15 of this rule.
(c) An
				institutional practitioner may administer or dispense directly (but not
				prescribe) a controlled substance listed in
				856 IAC 2-2-6, Schedule V, only
				pursuant to:
(1) a prescription signed by the
				prescribing individual practitioner;
(2) an oral prescription made by a
				prescribing individual practitioner and promptly reduced to writing by the
				pharmacist (containing all information required in section 4 of this rule
				except for the signature of the prescribing individual practitioner);
				or
(3) an order for medication made
				by an individual practitioner that is dispensed for immediate administration to
				the ultimate user, subject to section 15 of this rule.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 6 - Issuance, Filling and Filing Prescriptions › Section 6-18 - Dispensing without prescription; delivery of devices

Current through July 10, 2024
Authority: IC 35-48-3-1
Affected: IC 35-48-3-9
Sec. 18.
(a) A
				controlled substance listed in schedule V in the Controlled Substance Act, IC
				35-48, that does not require a prescription under federal, state, or local law
				or a device known as a hypodermic syringe or needle, or both, for human use may
				be dispensed only by a pharmacist or a pharmacist intern under the direct
				supervision of a pharmacist without a prescription to a purchaser at retail,
				provided the following:
(1) Not more than:
(A) two hundred forty (240) cubic centimeters
				(cc) (eight (8) ounces) or forty-eight (48) dosage units of any substance
				containing opium may be dispensed at retail to the same purchaser in any given
				forty-eight (48) hour period; or
(B) one hundred twenty (120) cc (four (4)
				ounces) or twenty-four (24) dosage units of any other substance nor more than
				forty-eight (48) dosage units may be dispensed at retail to the same purchaser
				in any given forty-eight (48) hour period.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 7 - Limited Permits › Section 7-1 - Application

Current through July 10, 2024
Authority: IC
				  35-48-3-2
Affected: IC
				  35-48-3-2
Sec. 1.
(a) A humane
				society, animal control agency, or governmental entity that intends to operate
				an animal shelter or other animal impounding facility for the purpose of
				buying, possessing, and using drugs authorized by IC
				35-48-3-2 shall apply for a
				limited permit in the form and manner required by the board.
(b) The applicant shall provide the
				following:
(1) Name and address of the
				facility.
(2) Type of
				facility.
(3) Documentation
				describing the ownership of the facility.
(4) Fees set by the board in this
				rule.
(5) Information about the
				substances that the facility intends to administer.
(6) Written policies relating to storage,
				security, and procedures for access, handling, and administration of
				drugs.
(7) Proof that the employees
				of the applicant who will handle a controlled substance are sufficiently
				trained to use and administer the controlled substance.
(8) Proof that a licensed Indiana
				veterinarian holding a valid Indiana controlled substances registration and
				federal DEA registration has been retained to provide technical advice to the
				facility.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 7 - Limited Permits › Section 7-2 - Permit fees

Current through July 10, 2024
Authority: IC
				  35-48-3-2
Affected: IC
				  35-48-3-2
Sec. 2.
The board shall charge and collect the following
				  fees:
(1) Application for a limited
				permit, fifty dollars ($50).
(2)
				Annual renewal of limited permit, twenty-five dollars ($25).
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 7 - Limited Permits › Section 7-3 - Renewal of permit

Current through July 10, 2024
Authority: IC
				  35-48-3-2
Affected: IC
				  35-48-3-2
Sec. 3.
The renewal of the limited permits issued under this section
				  shall be on the same schedule as other humane societies, animal control
				  agencies, or governmental entities that hold controlled substance registrations
				  issued by the board.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 7 - Limited Permits › Section 7-4 - Storage, handling, and use of controlled substances

Current through July 10, 2024
Authority: IC 35-48-3-2
Affected: IC 35-48-3-2
Sec. 4.
(a) Limited
				permit holders and their agents, representatives, and employees must comply
				with the requirements of this rule for the storage and handling of controlled
				substances.
(b) All facilities at
				which controlled substances are stored, handled, or used shall:
(1) be of suitable size and construction to
				facilitate cleaning, maintenance, and proper operations;
(2) have storage areas large enough to
				provide adequate lighting, ventilation, temperature, sanitation, humidity,
				space, equipment, and security conditions;
(3) have a quarantine area for storage of
				controlled substances that are:
(A) outdated,
				damaged, deteriorated, misbranded, or adulterated; or
(B) in immediate or sealed secondary
				containers that have been opened;
(4) be maintained in a clean and orderly
				condition; and
(5) be free from
				infestation by insects, rodents, birds, or vermin of any
				kind.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 7 - Limited Permits › Section 7-5 - Training of staff

Current through July 10, 2024
Authority: IC
				  35-48-3-2
Affected: IC
				  35-48-3-2
Sec. 5.
(a) Only
				employees of the limited permit holder are eligible for training to store,
				handle, and use controlled substances. Volunteers are prohibited from storing,
				handling, or using controlled substances.
(b) The following training is required:
(1) Completion of a comprehensive training
				program approved by the controlled substance advisory committee.
(2) Any additional training as required by
				the supervising veterinarian or site administrator.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 7 - Limited Permits › Section 7-6 - Protocol for administration of controlled substances

Current through July 10, 2024
Authority: IC
				  35-48-3-2
Affected: IC
				  35-48-3-2
Sec. 6.
In the event the consulting veterinarian is not physically
				  present during the administration of controlled substances by employees of the
				  limited permit holder, the veterinarian shall be available for consultation by
				  telephonic or other electronic device.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 7 - Limited Permits › Section 7-7 - Limitations on permit

Current through July 10, 2024
Authority: IC
				  35-48-3-2
Affected: IC
				  35-48-3-2
Sec. 7.
(a) Except as
				provided in subsection (b), only controlled substances for which the humane
				society, animal control agency, or governmental entity has received a permit
				may be stored, handled, and used at the facility.
(b) A licensed veterinarian who stores,
				handles, or uses controlled substances at the humane society, animal control
				agency, or governmental entity other than those authorized under the facility's
				limited permit, must apply for and obtain a controlled substance registration
				for the facility in the veterinarian's name.
(c) The veterinarian who holds the
				registration noted in subsection (b) is responsible for the proper storage,
				handling, and use of the controlled substances authorized for use under the
				veterinarian's controlled substance registration.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 3 - WHOLESALE LEGEND DRUGS › Rule 1 - Definitions › Section 1-1 - Definitions

Current through July 10, 2024
Authority: IC
				  25-26-14-13
Affected: IC
				  25-26-14
Sec. 1.
All terms which are defined in IC
				  25-26-14 shall have the same
				  meanings as they are so defined when used in this article.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 3 - WHOLESALE LEGEND DRUGS › Rule 1 - Definitions › Section 1-2 - "Chain drug warehouse" defined

Current through July 10, 2024
Authority: IC
				  25-26-14-13
Affected: IC
				  25-26-14
Sec. 2.
As used in IC
				  25-26-14 and in this article,
				  "chain drug warehouse" means a permanent physical location for drugs or
				  devices, or both, that:
(1) is
				licensed as a wholesale distributor;
(2) acts as a central warehouse;
				and
(3) primarily performs
				intracompany sales and transfers of legend drugs or devices to chain pharmacies
				that are members of the same affiliated group under common ownership and
				control.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 3 - WHOLESALE LEGEND DRUGS › Rule 1 - Definitions › Section 1-3 - "Statement" defined

Current through July 10, 2024
Authority: IC
				  25-26-14-13
Affected: IC
				  25-26-14
Sec. 3.
"Statement" means the specific unit of the specific legend
				  drug that was purchased directly from the manufacturer.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 3 - WHOLESALE LEGEND DRUGS › Rule 2 - Licensing and Operational Requirements › Section 2-2 - Fees

Current through July 10, 2024
Authority: IC
				  25-26-14-13
Affected: IC
				  25-26-14-14
Sec. 2.
(a) The fee
				for original licensure and biennial renewal shall be one hundred dollars ($100)
				for in-state applicants. The fee for original licensure and biennial renewal
				shall be one hundred dollars ($100) for out-of-state applicants.
(b) Licensure fees shall be paid at the time
				when the application for licensure or renewal of a license is filed.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 3 - WHOLESALE LEGEND DRUGS › Rule 2 - Licensing and Operational Requirements › Section 2-3 - Application forms; renewal forms

Current through July 10, 2024
Authority: IC
				  25-26-14-13
Affected: IC
				  25-26-14-14
Sec. 3.
(a)
				Applications for licensure may be obtained by writing to the Indiana Board of
				Pharmacy, Indiana Professional Licensing Agency, 402 West Washington Street,
				Room W072, Indianapolis, Indiana 46204.
(b) Wholesale drug distributor licenses shall
				expire on September 30 of each even-numbered year. Applications for renewal
				shall be mailed to the licensee.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 3 - WHOLESALE LEGEND DRUGS › Rule 2 - Licensing and Operational Requirements › Section 2-4 - Inspection and review of application

Current through July 10, 2024
Authority: IC
				  25-26-14-13
Affected: IC
				  25-26-14-17; IC
				  25-26-14-19
Sec. 4.
The board may inspect, or cause to be inspected, the
				  establishment of an applicant or licensee pursuant to IC 25-26 14-19. The board
				  shall review the application for licensure and other information regarding an
				  applicant to determine whether the applicable standards of IC
				  25-26-14-17 have been met by the
				  applicant.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 3 - WHOLESALE LEGEND DRUGS › Rule 2 - Licensing and Operational Requirements › Section 2-5 - Wholesale drug distributor license

Current through July 10, 2024
Authority: IC
				  25-26-14-13
Affected: IC
				  25-26-14
Sec. 5.
(a) The board
				shall issue a wholesale drug distributor license to applicants that qualify
				under IC 25-26-14.
(b) The wholesale drug distributor license
				shall contain the name, address, and license number of the licensee, the amount
				of fee paid, and the expiration date of the license. The licensee shall
				maintain the wholesale drug distributor license in a readily retrievable manner
				and shall permit inspection of the license by any official, agent, or employee
				of the board.