DAR File No. 38031

Commerce, Occupational and Professional Licensing

Section R156-37f-102

Definitions

Notice of Proposed Rule

(Amendment)

DAR File No.: 38031
Filed: 09/30/2013 10:58:30 AM

RULE ANALYSIS

Purpose of the rule or reason for the change:

H.B. 270 which was passed during the 2013 General Legislative Session of the Legislature requires the Division to define the term "research facility" in Subsection 58-37f-301(2)(d)(ii)(D). Designation as a research facility as defined is one of the requirements necessary for an individual conducting scientific studies in conjunction with the Department of Health to access information from the Controlled Substance Database (CSD) or from other state or federal prescription monitoring programs by means of the CSD.

Summary of the rule or change:

The definition of "research facility" in Subsection R156-37f-102(6) is consistent with the definition to be used in a proposed revision of the Pharmacy Practice Act Rule, Subsection R156-17b-102(42). Although loosely defined in this rule, when combined with the other requirements of this section, effectively limits access to CSD information to researchers affiliated with the Department of Health and whose scientific studies have been approved by an institutional review board.

State statutory or constitutional authorization for this rule:

• Subsection 58-37f-301(1)
• Subsection 58-1-106(1)(a)

Anticipated cost or savings to:

the state budget:

The Division will incur minimal costs of approximately $50 to print and distribute the rule once the proposed amendments are made effective. Any costs incurred will be absorbed in the Division's current budget. Research conducted under agreements with the Department of Health may increase as a result of this legislation which may increase the workloads of various state agencies that are conducting research with the Department of Health as research collaborator.

local governments:

The proposed amendment only applies to research facilities working in conjunction with the Utah Department of Health and as a result, the amendment does not apply to local governments.

small businesses:

The proposed amendment only applies to research facilities working in conjunction with the Utah Department of Health. Research facilities working in conjunction with the Utah Department of Health may qualify as a small business, but the Division does not anticipate any costs as a result of this proposed rule filing beyond those considered in the fiscal note for H.B. 270 (2013).

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

The proposed amendment only applies to research facilities working in conjunction with the Utah Department of Health. The Division does not anticipate any costs as a result of this proposed rule filing beyond those considered in the fiscal note for H.B. 270 (2013).

Compliance costs for affected persons:

State agencies and the Utah Department of Health may experience increased research activity as a result of this amendment and the provisions in H.B. 270 (2013). However, the Division is unable to quantify state agency costs that may be associated with this increased research activity.

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

This rule filing responds to H.B. 270 (2013) which requires that the term "research facility" be defined. No fiscal impact to businesses is anticipated beyond that contemplated by the Legislature in determining to pass the bill.

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:

• Debra Hobbins at the above address, by phone at 801-530-6789, by FAX at 801-530-6511, or by Internet E-mail at dhobbins@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:

11/14/2013

This rule may become effective on:

11/21/2013

Authorized by:

Mark Steinagel, Director

R156. Commerce, Occupational and Professional Licensing.

R156-37f. Controlled Substance Database Act Rule.

R156-37f-102. Definitions.

In addition to the definitions in Sections 58-17b-102, 58-37-2 and 58-37f-102, as used in this chapter:

(1) "ASAP" means the American Society for Automation in Pharmacy system.

(2) "DEA" means Drug Enforcement Administration.

(3) "NABP" means the National Association of Boards of Pharmacy.

(4) "NCPDP" means National Council for Prescription Drug Programs.

(5) "NDC" means National Drug Code.

(6) "Research facility" means a facility in which research takes place that has policies and procedures describing such research.

([6]7) "Rx" means a prescription.

 

KEY: controlled substance database, licensing

Date of Enactment or Last Substantive Amendment: [January 8, ]2013

Authorizing, and Implemented or Interpreted Law: 58-1-106(1)(a); 58-37f-301(1)