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Notice of Intent to Adopt a Rule
LSA Document #12-619

Under IC 4-22-2-23, the Indiana Board of Pharmacy intends to adopt a rule concerning the following:

OVERVIEW: Amends 856 IAC 1-1.1-3 to update the definition of in personal attendance. Adds 856 IAC 1-1.1-4 to define reasonable visual and vocal distance. Adds 856 IAC 1-1.1-5 to define supervision. Adds 856 IAC 1-1.1-6 to define pharmaceutical care. Adds 856 IAC 1-1.1-7 to define real-time online database. Adds 856 IAC 1-1.1-8 concerning unlicensed person. Adds 856 IAC 1-1.1-9 to define electronic database. Adds 856 IAC 1-1.1-10 to define electronic record or image. Amends 856 IAC 1-29-1 concerning the approval of electronic data processing system. Amends 856 IAC 1-29-3 to update the hard-copy of daily dispensing, verification and retention, and back-up capability requirements. Amends 856 IAC 1-29-6 to update data entry and supervision requirements. Amends 856 IAC 1-29-9 to update the applicability of 856 IAC 1-29. Amends 856 IAC 1-31-1 to update facsimile machines requirements. Amends 856 IAC 1-31-2 to update the requirements for the use of a facsimile machine to electronically transmit a prescription or drug order. Adds 856 IAC 1-31-3 concerning facsimile prescription or drug order maintenance. Amends 856 IAC 1-32-2 to update the requirements for noncontrolled and controlled substance prescription transfers. Amends 856 IAC 1-32-4 to update the responsibilities of pharmacists. Adds 856 IAC 1-32-5 concerning electronic transfers. Amends 856 IAC 1-34-2 to update security feature requirements. Amends 856 IAC 1-37-1 to update the requirements for central fill or processing, or both, of prescriptions and drug orders. Adds 856 IAC 1-37-1.1 regarding central fill or processing, or both, facilities. Adds 856 IAC 1-37-1.2 concerning central fill or processing, or both, supervision. Adds 856 IAC 1-37-1.3 concerning central fill or processing, or both, remote practice. Amends 856 IAC 1-37-2 to update the contracting for central fill or processing, or both, requirements. Adds 856 IAC 1-37-2.1 concerning contracting for central fill or processing, or both, policies and procedures. Amends 856 IAC 1-37-3 to update policy and procedures manual requirements. Amends 856 IAC 1-40-8 to update electronic data intermediary requirements. Adds 856 IAC 1-41 concerning cognitive services. Adds 856 IAC 1-42 concerning remote pharmacy practice. Amends 856 IAC 2-4-1 to update records and inventories requirements. Adds 856 IAC 2-6-1.5 concerning signature requirements. Amends 856 IAC 2-6-7 to update schedule II controlled substances, prescription required, and exception requirements. Amends 856 IAC 2-6-9 to update schedule II controlled substances partial filling of prescriptions requirements. Amends 856 IAC 2-6-10 to update schedule II controlled substances, label information, and exceptions requirements. Amends 856 IAC 2-6-12 to update schedules III and IV controlled substances requirements. Amends 856 IAC 2-6-13 to update schedules III, IV, and V controlled substances, refilling prescriptions, retrievable information requirements. Amends 856 IAC 2-6-17 to update schedule V controlled substances, prescription requirements, refilling, exceptions requirements. Amends 856 IAC 2-6-18 to update dispensing without a prescription, delivery of devices requirements. Repeals 856 IAC 1-35-2 and 856 IAC 1-35-3. Statutory authority: IC 25-26-13-4; IC 35-48-3-1.

For purposes of IC 4-22-2-28.1, the Small Business Regulatory Coordinator for this rule is:
Gregory Pachmayr, Director
Indiana Board of Pharmacy
Indiana Government Center South
402 W. Washington St., RM W072
Indianapolis, IN 46204
(317) 234-2067

For purposes of IC 4-22-2-28.1, the Small Business Ombudsman designated by IC 5-28-17-5 is:
Eric P. Shields
Indiana Economic Development Corporation
One North Capitol, Suite 700
Indianapolis, IN 46204
(317) 234-3997
Resources available to regulated entities through the small business ombudsman include the ombudsman's duties stated in IC 5-28-17-5, specifically IC 5-28-17-5(9), investigating and attempting to resolve any matter regarding compliance by a small business with a law, rule, or policy administered by a state agency, either as a party to a proceeding or as a mediator.

Posted: 12/05/2012 by Legislative Services Agency

DIN: 20121205-IR-856120619NIA
Composed: Mar 24,2018 2:02:43PM EDT
A PDF version of this document.