DAR File No. 37202

Commerce, Occupational and Professional Licensing

Rule R156-82

Electronic Prescribing Act Rule

Notice of Proposed Rule

(New Rule)

DAR File No.: 37202
Filed: 01/15/2013 08:34:59 AM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The Division needs to establish a rule which clarifies provisions in Title 58, Chapter 82, the Electronic Prescribing Act.

Summary of the rule or change:

Section R156-82-101 establishes the title for the rule. Section R156-82-103 establishes the authority of the Division to enact the rule. Section R156-82-201 explains the security requirements to transmit and receive electronic prescriptions. Section R156-82-202 describes the practitioner's requirements to inform their patients of their rights, restrictions, and responsibilities. Section R156-82-203 explains that the Division may grant waivers.

State statutory or constitutional authorization for this rule:

• Subsection 58-1-106(1)(a)
• Section 58-82-101

This rule or change incorporates by reference the following material:

• Adds 21 CFR Part 1311, published by United States Government Printing Office, April 1, 2012

Anticipated cost or savings to:

the state budget:

The Division will incur minimal costs of approximately $50 to print and distribute the new rule once the proposed amendments are made effective. Any costs incurred will be absorbed in the Division's current budget.

local governments:

The proposed new rule only applies to licensees who prescribe drugs in the normal course of their employment, licensed pharmacists who fill said prescriptions, and applicants in those license classifications. As a result, the proposed new rule does not apply to local governments.

small businesses:

The proposed new rule only applies to licensees who prescribe drugs in the normal course of their employment., licensed pharmacists who fill said prescriptions, and applicants in those license classifications. Those who are affected have the right to request a waiver for financial hardship with the Division. Any costs associated with the implementation of the governing statute, Title 58, Chapter 82, would have been addressed when the statute was initially passed by the Legislature in 2009 in HB 128.

persons other than small businesses, businesses, or local governmental entities:

The proposed new rule only applies to licensees who prescribe drugs in the normal course of their employment., licensed pharmacists who fill said prescriptions, and applicants in those license classifications. Those who are affected have the right to request a waiver for financial hardship with the Division. Any costs associated with the implementation of the governing statute, Title 58, Chapter 82, would have been addressed when the statute was initially passed by the Legislature in 2009 in HB 128.

Compliance costs for affected persons:

The proposed new rule only applies to licensees who prescribe drugs in the normal course of their employment., licensed pharmacists who fill said prescriptions, and applicants in those license classifications. Those who are affected have the right to request a waiver for financial hardship with the Division. Any costs associated with the implementation of the governing statute, Title 58, Chapter 82, would have been addressed when the statute was initially passed by the Legislature in 2009 in HB 128.

Comments by the department head on the fiscal impact the rule may have on businesses:

Many businesses have the software and other technology in place that is required to facilitate electronic prescribing. These businesses will not experience any fiscal impact from this rule filing. Businesses that do not have the necessary technology will incur costs if they choose to implement electronic prescribing. Those costs will vary and cannot be estimated. Any business that does not wish to incur such costs may obtain a waiver from the Division and continue to prescribe according to its current practice. Therefore, any fiscal impact will be incurred voluntarily, if at all.

Francine A. Giani, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Division of Administrative Rules, or at:

Commerce
Occupational and Professional Licensing
HEBER M WELLS BLDG
160 E 300 S
SALT LAKE CITY, UT 84111-2316

Direct questions regarding this rule to:

• Mark Steinagel at the above address, by phone at 801-530-6292, by FAX at 801-530-6511, or by Internet E-mail at msteinagel@utah.gov

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

03/04/2013

Interested persons may attend a public hearing regarding this rule:

• 02/25/2013 11:00 PM, Heber Wells Bldg, 160 E 300 S, Conference Room 474, Salt Lake City, UT

This rule may become effective on:

03/11/2013

Authorized by:

Mark Steinagel, Director

R156. Commerce, Occupational and Professional Licensing.

R156-1. Electronic Prescribing Act Rule.

R156-1-101. Title.

This rule is known as the "Electronic Prescribing Act Rule."

 

R156-1-103. Authority - Purpose.

This rule is adopted by the Division under the authority of Subsection 58-1-106(1)(a) to enable the Division to administer Title 58, Chapter 82.

 

R156-82-201. Security.

(1) Practitioners and pharmacies who transmit and receive controlled substance prescriptions shall comply with 21 CFR 1311, dated April 1, 2012, which is adopted and incorporated by reference.

(2) Electronic prescribing for non-controlled substances shall be conducted in a secure manner, consistent with industry standards.

 

R156-82-202. Informing Patients.

(1) Practitioners shall fully inform their patients of their:

(a) rights;

(b) restrictions; and

(c) obligations pertaining to electronic prescribing.

 

R156-82-203. Waiver.

The Division may grant an exemption from the requirements in accordance with Subsection 58-82-201(6).

 

KEY: licensing, electronic prescribing

Date of Enactment or Last Substantive Amendment: 2013

Authorizing, and Implemented or Interpreted Law: 58-1-106(1)(a); 58-82-101