reglab/statecodes huggingface dataset:
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 35 - Pharmacy Technicians › Section 35-4 - Qualifications

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-18
Sec. 4.
To be eligible to perform the functions and duties of a
				  pharmacy technician, an individual must possess the following qualifications,
				  which shall be ascertained and documented in a reasonably retrievable manner by
				  the pharmacist that qualifies the pharmacy permit:
(1) The individual has not been convicted of
				a crime that has a direct bearing on the individual's ability to work with
				legend drugs or controlled substances.
(2) The individual must be a high school
				graduate or have successfully completed a General Education Development program
				or have been judged to be competent by the qualifying pharmacist.
(3) The individual must have successfully
				completed or be enrolled in and successfully complete within twelve (12) months
				of being hired as a technician one (1) of the following board-approved
				programs:
(A) A comprehensive curricular-based
				education and training program conducted by a pharmacy or educational
				organization.
(B) A technician
				training program utilized by the employer that includes specific training in
				the duties required to assist the pharmacist in the technical functions
				associated with the practice of pharmacy. The contents of the training program
				shall include, at a minimum, the following:
(i) Understanding of the duties and
				responsibilities of the technician and the pharmacist, including the standards
				of patient confidentiality and ethics governing pharmacy practice.
(ii) Tasks and technical skills, policies,
				and procedures related to the technician's position.
(iii) Working knowledge of
				pharmaceutical-medical terminology, abbreviations, and symbols commonly used in
				prescriptions and drug orders.
(iv)
				Working knowledge of the general storage, packaging, and labeling requirements
				of drugs, prescriptions, or drug orders.
(v) Ability to perform the arithmetic
				calculations required for the usual dosage determinations.
(vi) Working knowledge and understanding of
				the essential functions related to drug purchasing and inventory
				control.
(vii) The record keeping
				functions associated with prescriptions or drug orders.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 35 - Pharmacy Technicians › Section 35-5 - Duties that a pharmacy technician may not perform

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-18
Sec. 5.
A pharmacy technician may perform many technical functions
				  associated with the practice of pharmacy. However, even under the immediate and
				  direct supervision of a pharmacist, the pharmacy technician is prohibited from
				  performing the following functions:
(1) Any duty required by law, regulation, or
				rule to be performed by a pharmacist.
(2) The provision of advice or consultation
				with the prescriber or other licensed health care provider regarding the
				patient or the interpretation and application of information contained in the
				prescription or drug order, medical record, or patient profile.
(3) The provision of advice or consultation
				with the patient regarding the interpretation of the prescription or the
				application of information contained in the patient profile or medical
				record.
(4) Dispensing of
				prescription drug information to the patient as required in IC
				25-26-13-4.
(5) Receipt of a verbal prescription, other
				than a refill approval or denial, from a prescriber.
(6) Final check on all aspects of the
				completed prescription and assumption of the responsibility for the filled
				prescription, including, but not limited to, accuracy of the:
(A) drug;
(B) strength; and
(C) labeling.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 35 - Pharmacy Technicians › Section 35-7 - Identification

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-18
Sec. 7.
(a) The
				public shall be able to identify a pharmacist from a pharmacy technician while
				engaged in the provision of pharmaceutical care.
(b) A pharmacy technician shall:
(1) wear identification clearly stating that
				the person is a pharmacy technician while on duty; and
(2) identify himself or herself verbally in
				any telephonic or electronic communication as a pharmacy technician.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 36 - Temporary Variances › Section 36-1 - Exceptions

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13
Sec. 1.
A person subject to the regulations of the board may request
				  that the board grant a temporary variance from any rule adopted by the board,
				  except rules concerning examinations, experience hours, and requirements for
				  licensure.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 36 - Temporary Variances › Section 36-2 - Submission of a request for temporary variance

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13
Sec. 2.
A request for a temporary variance must be submitted to the
				  board in writing. Each request must contain the following information:
(1) The name, address, and license or permit
				number of the applicant.
(2) The
				name of the responsible pharmacist and the specific location at which
				activities will be conducted under the temporary variance.
(3) The citation to the specific rule from
				which the applicant seeks a temporary variance.
(4) A detailed explanation of the purpose of
				the temporary variance.
(5) An
				assessment of the impact on the public if the variance is granted.
(6) A statement of the conditions which would
				cause the applicant to apply for renewal of the temporary variance.
(7) The beginning, midpoint, and ending dates
				of the proposed demonstration project.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 36 - Temporary Variances › Section 36-3 - Positive impact on delivery of pharmaceutical care

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13
Sec. 3.
Temporary variances shall only be granted for demonstration
				  projects which are expected to have a positive impact on the delivery of
				  pharmaceutical care. Justification for that expectation shall be fully
				  explained. The board shall not grant any temporary variance which threatens
				  public health, safety, or welfare.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 36 - Temporary Variances › Section 36-4 - Period of time

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13
Sec. 4.
The board shall grant a temporary variance for a period of
				  no more than six (6) months. Any person who receives a temporary variance shall
				  submit to the board a written report of the effects of the demonstration
				  project at the midpoint and at the conclusion of the temporary variance.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 36 - Temporary Variances › Section 36-5 - Renewal

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13
Sec. 5.
A temporary variance may be renewed by the Indiana board of
				  pharmacy (board) for an additional six (6) months. A temporary variance shall
				  not be renewed more than five (5) times. Requests for renewal of a variance
				  shall be submitted in writing to the board not less than thirty (30) days prior
				  to the expiration of the variance and shall contain at least the information
				  required by section 2 of this rule.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 36 - Temporary Variances › Section 36-6 - Revocation

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13
Sec. 6.
The board may revoke any temporary variance for cause,
				  including, but not limited to, a finding that the temporary variance poses or
				  may pose a threat to public health, safety, or welfare. The person requesting
				  the temporary variance has the obligation to report any such potential threat
				  to the board immediately upon the discovery of such potential threat, or as
				  soon as possible after such discovery.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 36 - Temporary Variances › Section 36-7 - Public notice

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13
Sec. 7.
The board shall give public notice of requests for temporary
				  variances at not less than two (2) consecutive regular meetings before voting
				  to grant or deny a request for a temporary variance.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 36 - Temporary Variances › Section 36-8 - Justification of denial

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13
Sec. 8.
The board shall set forth in writing its reasons for
				  granting or denying a temporary variance.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 36 - Temporary Variances › Section 36-9 - Copies of requests

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-5
Sec. 9.
The executive director shall retain copies of all requests
				  for temporary variances and the board's reasons for granting or denying
				  requests as part of the record of it proceedings maintained under IC
				  25-26-13-5.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 37 - Central Fill or Processing, or Both, of Prescriptions and Drug Orders › Section 37-1 - "Central fill or processing, or both, of prescriptions and drug orders" defined

Current through July 10, 2024
Authority: IC 25-26-13-4
Affected: IC 25-26-13
Sec. 1.
"Central fill or processing, or both, of prescriptions and
				  drug orders" means, to the extent permissible by law, the filling or processing
				  by a pharmacy of a request from another pharmacy, provider, payor, pharmacy
				  benefit manager, or patient to do the following according to IC
				  25-26-13:
(1) Fill or dispense, or
				both, a new or refillable prescription or drug order.
(2) Perform processing or professional, or
				both, functions, including any of the following:
(A) Drug utilization review.
(B) Data entry and evaluation.
(C) Claims adjudication.
(D) Refill authorizations.
(E) Therapeutic interventions.
(F) Counseling.
(G) Any other cognitive services as defined
				under 856 IAC 1-41.
(H) Other functions as determined or approved
				by the board on an individual basis that do not adversely impact positive
				patient outcomes or patient safety.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 37 - Central Fill or Processing, or Both, of Prescriptions and Drug Orders › Section 37-1.1 - Central fill or processing, or both, facilities

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC 25-26
Sec. 1.1.
A pharmacy that performs centralized functions may
				  perform:
(1) either processing or
				filling functions; and
(2) both
				functions out of the same facility in accordance with this article and the
				documented policies and procedures manual discussed in this rule.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 37 - Central Fill or Processing, or Both, of Prescriptions and Drug Orders › Section 37-1.2 - Central fill or processing, or both, supervision

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13
Sec. 1.2.
Central fill or processing, or both, activities must occur
				  in a permitted pharmacy environment under the supervision of a qualifying
				  pharmacist as defined in IC
				  25-26-13.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 37 - Central Fill or Processing, or Both, of Prescriptions and Drug Orders › Section 37-1.3 - Central fill or processing, or both, remote practice

Current through July 10, 2024
Authority: IC 25-26-13-4
Affected: IC 25-26
Sec. 1.3.
Permitted central fill or central processing pharmacies may
				  engage in remote practice and supervision, but only to the extent that the
				  remote practice and supervision relates to the processing functions discussed
				  in this rule or the delivery of cognitive services defined in
				  856 IAC 1-41, or both. Those
				  facilities that choose to engage in remote practice shall comply with the
				  following:
(1)
									856 IAC 1-42-4.
(2)
									856 IAC 1-42-5.
(3)
									856 IAC 1-42-6.
(4)
									856 IAC 1-42-7.
Those facilities that utilize remote practice pharmacy are
				  also required to keep an active record of transactions and individuals that
				  perform remote work that is available for inspection or review.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 37 - Central Fill or Processing, or Both, of Prescriptions and Drug Orders › Section 37-2 - Contracting for central fill or processing, or both

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC 25-26
Sec. 2.
A permitted pharmacy may outsource and contract for central
				  fill or processing, or both, functions provided the involved parties
				  have:
(1) the same owner or are
				employed by the same organization; or
(2) a written contract outlining the:
(A) services to be provided; and
(B) responsibilities and accountabilities of
				each party in fulfilling the terms of the contract in compliance with federal
				and state laws and regulations and the provisions discussed in section 1 of
				this rule;
and share a common electronic database or have appropriate
				  technology to allow access to sufficient information necessary or required to
				  process, fill, or refill a prescription or drug order or provide cognitive
				  services, or both.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 37 - Central Fill or Processing, or Both, of Prescriptions and Drug Orders › Section 37-2.1 - Contracting for central fill or processing, or both, policies and procedures

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC 25-26
Sec. 2.1.
The pharmacy shall maintain as part of its documented
				  policies and procedures a section addressing its contractual relationship
				  regarding any outsourced or contractually provided services that are performed
				  by another entity.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 37 - Central Fill or Processing, or Both, of Prescriptions and Drug Orders › Section 37-3 - Policy and procedures manual

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC 25-26
Sec. 3.
The parties performing or contracting for central fill or
				  processing, or both, services shall maintain a policy and procedures manual and
				  documentation that implementation is occurring in a manner that shall be made
				  available to the board for review, upon request, and that includes, but it is
				  not limited to, the following:
(1) A
				description of how the parties will comply with federal and state laws and
				regulations.
(2) The maintenance of
				the following:
(A) Appropriate records to
				identify the responsible pharmacist or pharmacists in the dispensing and
				counseling processes.
(B) A
				mechanism for tracking the prescription or drug order during each step in the
				processing or dispensing, or both, process.
(C) A mechanism to identify all pharmacies or
				licensed persons, or both, involved in:
(i)
				processing;
(ii) filling and
				dispensing; or
(iii) providing
				cognitive services.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 38 - Credit for Returned Expired Drugs › Section 38-1 - Applicability

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13
Sec. 1.
(a) This rule
				establishes the standards and procedures concerning the return of expired
				legend drugs by an individual or entity licensed to receive legend drugs to
				either of the following:
(1) A drug
				manufacturer.
(2) A designated
				agent of a drug manufacturer.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 38 - Credit for Returned Expired Drugs › Section 38-2 - "Board" defined

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-2
Sec. 2.
As used in this rule, "board" has the meaning set forth in
				  IC 25-26-13-2.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 38 - Credit for Returned Expired Drugs › Section 38-3 - "Designated agent" defined

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13
Sec. 3.
As used in this rule, "designated agent" means an individual
				  or entity that contracts with a drug manufacturer to administer the
				  manufacturer's drug return policy for expired legend drugs.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 38 - Credit for Returned Expired Drugs › Section 38-4 - Application of return of expired drugs

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13
Sec. 4.
Effective with all drug orders placed after December 31,
				  2005, all drug manufacturers or their designated agents shall make adequate
				  provisions for the return of expired legend drugs.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 38 - Credit for Returned Expired Drugs › Section 38-5 - Record keeping

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13
Sec. 5.
Drug manufacturers or their designated agents shall do the
				  following:
(1) Maintain records of all
				credits made under this rule for a period of two (2) years.
(2) Make the records available to the board
				or its agent upon request.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 38 - Credit for Returned Expired Drugs › Section 38-6 - Compliance with other relevant law

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13
Sec. 6.
The return of expired legend drugs under this rule shall
				  also be consistent with all other applicable federal, state, and local laws and
				  regulations.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 39 - Home Medical Equipment Service Providers › Section 39-1 - "Board" defined

Current through July 10, 2024
Authority: IC
				  25-26-21-7
Affected: IC
				  25-26-21-1
Sec. 1.
As used in this rule, "board" has the meaning set forth in
				  IC 25-26-21-1.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 39 - Home Medical Equipment Service Providers › Section 39-2 - "DMEPOS" defined

Current through July 10, 2024
Authority: IC
				  25-26-21-7
Affected: IC
				  25-26-21
Sec. 2.
As used in this rule, "DMEPOS" means durable medical
				  equipment, prosthetics, orthotics, and supplies.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 39 - Home Medical Equipment Service Providers › Section 39-3 - "Home medical equipment" defined

Current through July 10, 2024
Authority: IC
				  25-26-21-7
Affected: IC
				  25-26-21-2
Sec. 3.
As used in this rule, "home medical equipment" has the
				  meaning set forth in IC
				  25-26-21-2. The term also includes
				  the following:
(1) Continuous passive
				motion (CPM) machines.
(2) Patient
				lift devices.
(3)
				Defibrillators.
(4) Manual
				wheelchairs.
(5) Hospital bed
				accessories.
(6) Electronically
				controlled or computerized wheel chairs and seating systems that are
				sold.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 39 - Home Medical Equipment Service Providers › Section 39-4 - "Home medical equipment services" defined

Current through July 10, 2024
Authority: IC
				  25-26-21-7
Affected: IC
				  25-26-21-3
Sec. 4.
As used in this rule, "home medical equipment services" has
				  the meaning set forth in IC
				  25-26-21-3.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 39 - Home Medical Equipment Service Providers › Section 39-5 - "Licensee" defined

Current through July 10, 2024
Authority: IC
				  25-26-21-7
Affected: IC
				  25-26-21
Sec. 5.
As used in this rule, "licensee" means the holder of a home
				  medical equipment service provider license issued under IC
				  25-26-21 and this
				  title.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 39 - Home Medical Equipment Service Providers › Section 39-6 - "Provider" defined

Current through July 10, 2024
Authority: IC
				  25-26-21-7
Affected: IC
				  25-26-21-4
Sec. 6.
As used in this rule, "provider" has the meaning set forth
				  in IC 25-26-21-4.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 39 - Home Medical Equipment Service Providers › Section 39-7 - Fees

Current through July 10, 2024
Authority: IC
				  25-1-8-2; IC
				  25-26-21-7
Affected: IC
				  25-26-21
Sec. 7.
(a) The fee
				for an original licensure application shall be:
(1) one hundred fifty dollars ($150);
				and
(2) paid at the time of filing
				the initial application.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 39 - Home Medical Equipment Service Providers › Section 39-8 - Renewal

Current through July 10, 2024
Authority: IC
				  25-1-8-2; IC
				  25-26-21-7
Affected: IC
				  25-26-21
Sec. 8.
Home medical equipment service provider licenses shall
				  expire on December 31 of each odd-numbered year.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 39 - Home Medical Equipment Service Providers › Section 39-9 - Proof of insurance

Current through July 10, 2024
Authority: IC
				  25-1-8-2; IC
				  25-26-21-7
Affected: IC
				  25-26-21
Sec. 9.
Before being issued a license, each home medical equipment
				  service provider shall obtain and maintain comprehensive business and liability
				  insurance, consistent with minimum Medicare DMEPOS Supplier
				  Standards.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 39 - Home Medical Equipment Service Providers › Section 39-10 - Oxygen and related respiratory services

Current through July 10, 2024
Authority: IC
				  25-26-21-7
Affected: IC
				  25-26-21; IC 25-34.5
Sec. 10.
In order to provide oxygen and related respiratory services,
				  each licensee shall employ or contract with:
(1) a respiratory care practitioner licensed
				under IC 25-34.5; or
(2) another
				duly licensed health professional with education and training in oxygen and
				related respiratory services.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 39 - Home Medical Equipment Service Providers › Section 39-11 - Training

Current through July 10, 2024
Authority: IC
				  25-26-21-7
Affected: IC
				  25-26-21
Sec. 11.
(a) Each
				licensee shall conduct and document training for each employee:
(1) at the time of hire; and
(2) annually.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 39 - Home Medical Equipment Service Providers › Section 39-12 - Patient records

Current through July 10, 2024
Authority: IC
				  25-26-21-7
Affected: IC
				  25-26-21
Sec. 12.
Each licensee shall maintain patient records, relevant to
				  services rendered, in accordance with state and federal
				  guidelines.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 39 - Home Medical Equipment Service Providers › Section 39-13 - Equipment maintenance

Current through July 10, 2024
Authority: IC
				  25-26-21-7
Affected: IC
				  25-26-21
Sec. 13.
Each licensee shall maintain documentation of the
				  maintenance of equipment according to industry standards.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 39 - Home Medical Equipment Service Providers › Section 39-14 - Personnel policies and procedures

Current through July 10, 2024
Authority: IC
				  25-26-21-7
Affected: IC
				  25-26-21
Sec. 14.
Each licensee shall maintain employee personnel records and
				  policies consistent with the following:
(1) The scope of services provided.
(2) State and federal requirements.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 39 - Home Medical Equipment Service Providers › Section 39-15 - Safety and quality of home medical equipment services

Current through July 10, 2024
Authority: IC
				  25-26-21-7
Affected: IC
				  25-26-21
Sec. 15.
Each licensee shall:
(1) clean;
(2) repair;
(3) store;
(4) segregate; and
(5) identify;
all equipment in a manner that makes the equipment safe for
				  use by the public, according to industry standards.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 39 - Home Medical Equipment Service Providers › Section 39-16 - Licenses

Current through July 10, 2024
Authority: IC
				  25-26-21-7
Affected: IC
				  25-26-21
Sec. 16.
Each licensee shall ensure that each employee is
				  appropriately licensed or credentialed, or both, for the services provided.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 39 - Home Medical Equipment Service Providers › Section 39-17 - Physical location

Current through July 10, 2024
Authority: IC
				  25-26-21-7
Affected: IC
				  25-26-21
Sec. 17.
Each licensee shall have a physical location from which home
				  medical equipment services are provided.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 39 - Home Medical Equipment Service Providers › Section 39-18 - Availability of licensee

Current through July 10, 2024
Authority: IC
				  25-26-21-7
Affected: IC
				  25-26-21
Sec. 18.
Each licensee shall provide twenty-four (24) hours a day,
				  seven (7) days a week availability to their clients consistent with the nature
				  of the services the licensee provides.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 39 - Home Medical Equipment Service Providers › Section 39-19 - Medicare DMEPOS supplier standards

Current through July 10, 2024
Authority: IC 25-26-21-7
Affected: IC 25-26-21
Sec. 19.
The board hereby incorporates by reference the Medicare
				  supplier standards titled Special Payment Rules for Items Furnished by DMEPOS
				  Suppliers and Issuance of DMEPOS Supplier Billing Privileges found at
				  42 CFR
				  424.57(c), effective
				  December 11, 2000.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 40 - Electronic Prescribing › Section 40-1 - "Board" defined

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-2
Sec. 1.
"Board" has the meaning set forth in IC
				  25-26-13-2.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 40 - Electronic Prescribing › Section 40-2 - "Electronically transmitted" or "electronic transmission" defined

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  16-18-2-106.4; IC
				  25-26-13-2
Sec. 2.
"Electronically transmitted" or "electronic transmission"
				  has the meaning set forth in IC
				  16-18-2-106.4 and IC
				  25-26-13-2.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 40 - Electronic Prescribing › Section 40-3 - "Electronic data intermediary" or "EDI" defined

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-2
Sec. 3.
"Electronic data intermediary" or "EDI" has the meaning set
				  forth in IC
				  25-26-13-2.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 40 - Electronic Prescribing › Section 40-4 - "Practitioner" defined

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-2
Sec. 4.
"Practitioner" has the meaning set forth in IC
				  25-26-13-2.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 40 - Electronic Prescribing › Section 40-5 - "Prescription" defined

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-2
Sec. 5.
"Prescription" has the meaning set forth in IC
				  25-26-13-2.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 40 - Electronic Prescribing › Section 40-6 - Equipment

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13
Sec. 6.
All electronic equipment for receipt of prescription drug
				  orders communicated by way of electronic transmission shall be maintained so as
				  to ensure against the following:
(1)
				Unauthorized access.
(2) Changes to
				the prescription.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 40 - Electronic Prescribing › Section 40-7 - Electronic transmission

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13
Sec. 7.
Each electronic data intermediary shall ensure that the
				  prescription electronically transmitted to the pharmacy:
(1) contains:
(A) no alterations to the:
(i) prescription;
(ii) order entry;
(iii) drug selection; or
(iv) intended drug selection;
by any electronic data
				  intermediary;
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 40 - Electronic Prescribing › Section 40-8 - Electronic data intermediary requirements

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13
Sec. 8.
An applicant for approval as an electronic data intermediary
				  shall do the following:
(1) File an
				application provided by the board.
(2) Submit information regarding how the EDI
				shall do the following:
(A) Guarantee the
				security of the following:
(i) The
				prescription.
(ii) The
				practitioner's identity and privacy.
(iii) The patient's identity, privacy, and
				confidentiality.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 40 - Electronic Prescribing › Section 40-9 - Electronic data intermediary standards

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13
Sec. 9.
Each electronic data intermediary shall do the
				  following:
(1) Maintain policies and
				procedures regarding the security of the following:
(A) The prescription.
(B) The practitioner's identity and
				privacy.
(C) The patient's
				identity, privacy, and confidentiality.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 40 - Electronic Prescribing › Section 40-10 - Electronic prescription prohibitions

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13
Sec. 10.
An electronic prescription does not include a prescription
				  that is as follows:
(1) Transmitted
				via:
(A) electronic mail, without the use of
				an electronic data intermediary; or
(B) facsimile.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 41 - Cognitive Services › Section 41-1 - "Cognitive services" defined

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13
Sec. 1.
(a) As used
				in this rule, "cognitive services" means those services provided by a licensed
				pharmacist (or registered pharmacist intern under the supervision of a licensed
				pharmacist) that involve the delivery of patient care, counseling, or
				professional advice that may facilitate pharmaceutical care. The term includes,
				but is not limited to, the following functions:
(1) Medication therapy management.
(2) Prospective drug review.
(3) Drug utilization review.
(4) Drug interaction review.
(5) Collaborative practice with eligible
				prescribers.
(6) Pharmacist
				prescribing where permissible under collaborative practice.
(7) Patient counseling (whether in person or
				via technology that allows the pharmacist to have real-time access to patient
				data and real-time visual or vocal contact with the patient).
(8) Patient education and outreach designed
				to improve patient outcomes.
(9)
				Facilitating patient medication compliance and adherence.
(10) Facilitating preventative health or
				disease state management programs.
(11) Reducing medication errors.
(12) Review and analysis of records of
				continuous quality improvement programs or protocols.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 41 - Cognitive Services › Section 41-2 - Delivery of cognitive services

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13
Sec. 2.
The delivery of cognitive services occurs between a licensed
				  pharmacist (or a registered pharmacist intern under the supervision of a
				  licensed pharmacist) and:
(1) a
				patient;
(2) a group of
				patients;
(3) another pharmacist or
				pharmacists;
(4) a prescriber or
				prescribers; or
(5) other eligible
				health care provider regarding the provision of pharmaceutical care as defined
				in this article.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 41 - Cognitive Services › Section 41-3 - Licensure requirement

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13
Sec. 3.
In order to provide or deliver cognitive services, an
				  individual must have an active license in good standing in a state that has at
				  least the same minimum standards for licensure as the state of Indiana
				  including, but not limited to, passage of the North American Pharmacist
				  Licensure Examination (NAPLEX).
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 42 - Remote Pharmacy Practice › Section 42-1 - "Remote pharmacy practice" defined

Current through July 10, 2024
Authority: IC 25-26-13-4
Affected: IC 25-26-13
Sec. 1.
"Remote pharmacy practice" means the provision of
				  pharmaceutical services not related to physically handling or dispensing
				  pharmaceutical drugs or devices. This rule is intended to govern the practice
				  of licensed pharmacists acting as independent contractors whether or not
				  directly employed or affiliated with an entity that is licensed by the board to
				  practice pharmacy into or out of the state of Indiana. This service also does
				  not include the provision of pharmaceutical care that is conducted within the
				  physical confines or premises of a permitted in-state pharmacy or a registered
				  nonresident pharmacy. This rule is not intended to overrule or supersede the
				  provisions, practices, and requirements listed in
				  856 IAC 1-37.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 42 - Remote Pharmacy Practice › Section 42-2 - Permissible activities

Current through July 10, 2024
Authority: IC 25-26-13-4
Affected: IC 25-26-13
Sec. 2.
The following are permissible activities covered by the
				  remote practice pharmacy:
(1) Perform
				processing functions.
(2)
				Consulting services by contract with a dispensing pharmacy.
(3) Claims adjudication.
(4) Remote order/entry.
(5) Remote order review and
				approval.
(6) Other cognitive
				services as defined in
				856 IAC
				1-41.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 42 - Remote Pharmacy Practice › Section 42-3 - Requirements for licensure

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13
Sec. 3.
Individuals who wish to engage in the remote practice of
				  pharmacy in or into the state of Indiana as provided in this rule must satisfy
				  the following licensure requirements:
(1) Have an active Indiana pharmacist
				license.
(2) Provide evidence, upon
				board request, of continuing education and any other relevant training for
				services provided.
(3) Have a
				license in good standing with no current or pending discipline (that is,
				ongoing probation) in this state or any other state in which the individual is
				licensed, unless otherwise approved by the board following a personal
				appearance.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 42 - Remote Pharmacy Practice › Section 42-4 - System, access, security, and privacy requirements

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13
Sec. 4.
Pharmacists that provide or engage in remote practice of
				  pharmacy services must employ security and privacy standards and protocols that
				  adequately protect patient privacy and health. Accordingly, a pharmacist must
				  satisfy the following requirements:
(1) Utilize a system that is capable of the
				following:
(A) Real-time access and exchange
				of live patient data.
(B) Secure
				and encrypted mediums of exchange.
(C) Limited access portals with rigorous
				authentication and identification protocols.
(D) Providing back-up or disaster recovery
				capability in the event of failure or loss of service.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 42 - Remote Pharmacy Practice › Section 42-5 - Record keeping requirements and notice

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13
Sec. 5.
Pharmacists that engage in remote practice of pharmacy
				  services are required to:
(1) maintain
				appropriate records; and
(2) make
				the records available for inspection and review upon board request.
Retention requirements shall be documented in a pharmacist's
				  policies and procedures and also made available for review by the board. Length
				  of retention stipulated in the policy should reflect any applicable state or
				  federal, or both, requirements.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 42 - Remote Pharmacy Practice › Section 42-6 - Work environment for remote practice of pharmacy

Current through July 10, 2024
Authority: IC 25-26-13-4
Affected: IC 25-26-13
Sec. 6.
Remote pharmacy practice shall be conducted in a work
				  environment that is conducive to providing quality patient treatment decisions,
				  private counseling, or other health care related activities permissible under
				  856 IAC 1-41 but that do not
				  include dispensing. Individuals that practice remotely are prohibited from
				  practicing in a space that serves as their primary living, household, or family
				  space. For example, if working out of a home environment, the individual should
				  perform this work in a dedicated office space that is not actively used as a
				  bedroom, living room, or other miscellaneous family space. This space should be
				  open and accessible for an inspection by board staff if required. Work product
				  or equipment in this space should be capable of being properly secured to
				  protect patient privacy.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 42 - Remote Pharmacy Practice › Section 42-7 - Policies and procedures

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13
Sec. 7.
A pharmacist that is providing remote practice of pharmacy
				  services shall develop, implement, review, revise, and comply with policies and
				  procedures for the services they provide. These policies and procedures should
				  reflect the nature and extent of the services they perform. In the event a
				  pharmacist is performing services via a contract with another service provider,
				  dispensing pharmacy, or other institution, their contract shall stipulate or
				  designate, or both, whose policies and procedures control for the services
				  being performed. At a minimum, the policies and procedures shall include the
				  following:
(1) A policy or statement
				concerning the services being provided or performed.
(2) A policy outlining the responsibilities
				of each of the parties involved.
(3) A policy or list that documents the
				names, addresses, telephone numbers, and all license and permit numbers of the
				parties involved in the services to be performed.
(4) A policy that documents the protection,
				confidentiality, and integrity of patient information.
(5) A policy that addresses record
				maintenance.
(6) A policy that
				addresses any necessary additional mechanisms or controls for compliance with
				other federal and state laws.
(7) A
				policy for operating and maintaining a continuous quality improvement program
				for remote practice of pharmacy services, designed to objectively and
				systematically monitor and evaluate the quality and appropriateness of patient
				care, pursue opportunities to improve patient care, and resolve identified
				problems.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 1 - Definitions › Section 1-1 - Definitions

Current through July 10, 2024
Authority: IC 35-48-3-1
Affected: IC 4-21.5; IC 35-48-2-1
Sec. 1.
Definitions. As used herein, the following terms shall have
				  the meanings specified:
(a) The term
				"Act" means the Indiana Uniform Controlled Substances Act of 1973. IC 1971,
				35-24.1
[Repealed by Acts 1976,
				P.L.
				148,
				SECTION
				24; Acts 1977,
				P.L.
				26,
				SECTION
				25. See
IC 35-48.] as
				amended.
(b) The term "basic class"
				means, as to controlled substances listed in Schedules I and II
[856 IAC 2-2-2 and
				856 IAC 2-2-3]
:
(1) Each of the opiates, including its
				isomers, esters, ethers, salts, and salts of isomers, esters, and ethers
				whenever the existence of such isomers, esters, ethers, and salts is possible
				within the specific chemical designation, listed in Section 2.11(b)
[856 IAC
				2-2-2(b)]
of this
				chapter;
(2) Each of the opium
				derivatives, including its salts, isomers, and salts of isomers whenever the
				existence of such salts, isomers, and salts of isomers is possible within the
				specific chemical designation, listed in Section 2.11(c)
[856 IAC
				2-2-2(c)]
of this
				part;
(3) Each of the
				hallucinogenic substances, including its salts, isomers, and salts of isomers
				whenever the existence of such salts, isomers, and salts of isomers is possible
				within the specific chemical designation, listed in Section 2.11(d)
[856 IAC
				2-2-2(d)]
of this
				part;
(4) Each of the following
				substances whether produced directly or indirectly by extraction from
				substances of vegetable origin, or independently by means of chemical
				synthesis, or by a combination of extraction and chemical synthesis:
(i) Opium, including raw opium, opium
				extracts, opium fluid extracts, powdered opium, granulated opium, deodorized
				opium and tincture of opium;
(ii)
				Apomorphine;
(iii)
				Codeine;
(iv)
				Ethylmorphine;
(v)
				Hydrocodone;
(vi)
				Hydromorphone;
(vii)
				Metopon;
(viii) Morphine;
(ix) Oxycodone;
(x) Oxymorphone;
(xi) Thebaine;
(xii) Mixed alkaloids of opium listed in
				Section 2.12(b)(2)
[856 IAC
				2-2-3(b)(2)]
of this
				part;
(xiii) Cocaine; and
(xiv) Ecgonine;
(5) Each of the opiates, including its
				isomers, esters, ethers, salts, and salts of isomers, esters, and ethers
				whenever the existence of such isomers, esters, ethers and salts is possible
				within the specific chemical designation, listed in Section 2.12(c)
[856 IAC
				2-2-3(c)]
as amended, of
				this part;
(6) Methamphetamine,
				including salts, isomers, and salts of isomers.
(7) Amphetamine, its salts, optical isomers
				and salts of its optical isomers;
(8) Phenmetrazine and its salts;
				and
(9)
				Methylphenidate.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 1 - Definitions › Section 1-2 - Controlled substances advisory committee; function; hearings

Current through July 10, 2024
Authority: IC
				  35-48-3-1
Affected: IC 4-21.5; IC
				  35-48-2-1
Sec. 2.
Function. The Controlled Substances Advisory Committee shall
				  serve as a consultative and advisory body to the Board in all matters relative
				  to additions, deletions and transfers of substances to or among schedules of
				  control established by IC 1971, 35-24.1
[Repealed by Acts 1976,
				  P.L.
				  148,
				  SECTION
				  24; Acts 1977,
				  P.L.
				  26,
				  SECTION
				  25. See
IC 35-48.] as
				  amended.
In addition, the advisory committee may, as representatives
				  of the Board, conduct hearings regarding control of substances, and it shall,
				  as representatives of the Board, conduct hearings and make recommended findings
				  in matters affecting the denial, suspension, or revocation of registrations.
				  All adjudicatory hearings shall be conducted in a manner consistent with the
				  provision of IC 1971,
				  35-24.1-3-4 through IC 1971,
				  35-24.1-3-5
[Repealed by
				  Acts 1976, P.L.
				  148,
				  SECTION
				  24; Acts 1977,
				  P.L.
				  26,
				  SECTION
				  25. See
IC 35-48], and IC 1971,
				  4-22-1
[Repealed by
				  P.L.
				  18-1986,
				  SECTION
				  2. See
IC 4-21.5.] as
				  amended.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 2 - CONTROLLED SUBSTANCES › Rule 1 - Definitions › Section 1-3 - Meetings; organization

Current through July 10, 2024
Authority: IC
				  35-48-3-1
Affected: IC
				  35-48-2-1
Sec. 3.
Meetings and Organization. The controlled substances
				  advisory committee shall meet not later than sixty (60) days after the
				  appointment of their entire membership and thereafter shall meet upon the
				  request of the Board. The committees shall select, from among their members, a
				  chairman, vice-chairman, and secretary who shall serve terms of one year from
				  the date of selection. In any case in which a committee officer shall be unable
				  to serve a full term, the committee shall select another to serve in his own
				  right a full term.