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TITLE 856 INDIANA BOARD OF PHARMACY

Economic Impact Statement
LSA Document #20-455


IC 4-22-2.1-5 Statement Concerning Rules Affecting Small Businesses
The proposed rule does impose requirements or costs on small businesses under IC 4-22-2.1-5. Small businesses affected are ambulance service providers.

I. Estimate of number of small businesses.
This rule applies to all ambulance service providers in Indiana that store, handle, or administer controlled substances apart from a hospital or medical director registration. There are approximately 222 such providers in Indiana.

II. Estimate of average annual reporting, record keeping, and other administrative costs that small businesses will incur.
This rule does not require any annual reporting and requires minimal record keeping, aside from IC 35-48 and 856 IAC 2.

III. Estimate of total annual economic impact that compliance with the rule will have on all small businesses.
The cost to obtain a registration is $100. The biannual cost to renew the registration is $60. The total annual economic impact for obtaining registration should be minimal and does not exceed $22,200. It is assumed that there is no financial cost to determine if it is a legitimate need for registration.

IV. Justification of Costs and Requirements not expressly required by statute.
All costs and requirements are mandated by the Indiana Administrative Code in 856 IAC 2-3-9.

V. Alternative regulatory methods.
Less stringent compliance or reporting requirements
There are no alternatives for less stringent compliance due to a new federal law that will allow EMS provider organizations to become DEA registrants. The DEA has confirmed that each EMS provider organization in Indiana would be required to obtain a controlled substance registration (CSR) prior to applying for a DEA registration.
Less stringent schedules or deadlines for compliance or reporting requirements
Registrants are required to comply with record keeping requirements as found in IC 35-48 and 856 IAC 2.
Consolidation or simplification of compliance or reporting requirements
There are no reporting requirements, and consolidation or simplification is not feasible, as the requirements are mandated by statute.
Establishment of performance standards for small businesses instead of design or operational standards
There are no design or operational standards imposed by this rule.
Exemption of small businesses from part or all of the requirements of this rule.
The requirements of this rule are mandated by statute and apply to all of those who hold a CSR in Indiana.

Posted: 11/18/2020 by Legislative Services Agency

DIN: 20201118-IR-856200455EIA
Composed: Feb 03,2023 8:10:14AM EST
A PDF version of this document.