No. 37942 (Amendment): Rule R156-83. Online Prescribing, Dispensing, and Facilitation Licensing Act Rule

(Amendment)

DAR File No.: 37942
Filed: 08/27/2013 10:52:26 AM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The Division and the Online Prescribing, Dispensing and Facilitation Licensing Board are proposing amendments to the rule to add a new erectile dysfunction drug, Avanafil, to the approved drug list and to amend audit report requirements to accommodate licensees who are in compliance.

Summary of the rule or change:

In Section R156-83-306, the proposed amendment adds Avanafil, an erectile dysfunction drug, to the approved list. In Section R156-83-308, the proposed amendments allow for an Internet facilitator who has been licensed for two years to request the audit reports to be due biannually.

State statutory or constitutional authorization for this rule:

• Subsection 58-1-202(1)(a)
• Subsection 58-1-106(1)(a)
• Section 58-83-101

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.

local governments:

The proposed amendments only apply to licensed online prescribers, licensed Internet facilitators, and persons who may receive prescriptions via online methods. As a result, the proposed amendments do not apply to local governments.

small businesses:

The proposed amendments may affect online dispensing/facilitation small businesses by increasing revenue if the business sells the approved drug Avanafil. An exact amount of increased revenue cannot be determined by the Division due to a wide range of circumstances. Licensed Internet facilitators, who have been licensed in this state for at least two years and who may qualify as a small business, may also see a slight decrease in their costs relating to required audit reports that need to be submitted to the Division as a result of the proposed amendment with respect to the required audit reports. However, the Division is not able to determine an exact amount of potential decreased costs relating to audit reports due to a wide range of circumstances.

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

The proposed amendments may affect other persons who are involved in online dispensing/facilitation by increasing revenue if the person sells the approved drug Avanafil. An exact amount of increased revenue cannot be determined by the Division due to a wide range of circumstances. Licensed Internet facilitators who have been licensed in this state for at least two years may also see a slight decrease in their costs relating to required audit reports that need to be submitted to the Division as a result of the proposed amendment with respect to the required audit reports. However, the Division is not able to determine an exact amount of potential decreased costs relating to audit reports due to a wide range of circumstances. Additionally, the proposed amendment adding the approved drug Avanafil increases the options of obtaining the approved erectile dysfunction drug for patients who utilize licensed online prescribing and dispensing companies which may result in lower costs than obtaining the drug through a pharmacy. The Division, however, is not able to determine the amount of potential lower costs in obtaining the newly approved drug.

Compliance costs for affected persons:

The proposed amendments may affect other persons who are involved in online dispensing/facilitation by increasing revenue if the person sells the approved drug Avanafil. An exact amount of increased revenue cannot be determined by the Division due to a wide range of circumstances. Licensed Internet facilitators who have been licensed in this state for at least two years may also see a slight decrease in their costs relating to required audit reports that need to be submitted to the Division as a result of the proposed amendment with respect to the required audit reports. However, the Division is not able to determine an exact amount of potential decreased costs relating to audit reports due to a wide range of circumstances. Additionally, the proposed amendment adding the approved drug Avanafil increases the options of obtaining the approved erectile dysfunction drug for patients who utilize licensed online prescribing and dispensing companies which may result in lower costs than obtaining the drug through a pharmacy. The Division, however, is not able to determine the amount of potential lower costs in obtaining the newly approved drug.

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

As stated in the rule analysis, no fiscal impact to business is anticipated from this rule filing, which adds a new drug to the list of medications that are approved for online prescribing, dispensing and facilitation; and allows an online facilitator that has been licensed for at least two years to request that its audit reports be due biannually rather than quarterly.

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:

• Noel Taxin at the above address, by phone at 801-530-6621, by FAX at 801-530-6511, or by Internet E-mail at [e-mail]

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:

10/15/2013

This rule may become effective on:

10/22/2013

Authorized by:

Mark Steinagel, Director

RULE TEXT

R156. Commerce, Occupational and Professional Licensing.

R156-83. Online Prescribing, Dispensing, and Facilitation Licensing Act Rule.

R156-83-306. Drugs Approved for Online Prescribing, Dispensing, and Facilitation.

In accordance with Subsection 58-83-306(1)(c), the following legend, non-controlled drugs are approved for prescribing by an online prescriber:

(1) finasteride;

(2) sildenafil citrate;

(3) tadalafil;

(4) vardenafil hydrochloride;

(5) hormonal based contraception (except injectable or implantable methods);[ and]

(6) varenicline;

(7) hydroquinone up to 4%;[ and]

(8) tretinoin up to 0.1%; and

(9) avanafil.

 

R156-83-308. Audit Reports.

In accordance with Subsection 58-83-308(3), an initially licensed Internet facilitator licensed under this chapter shall provide quarterly reports to the Division containing the information listed in Subsection 58-83-308(3). The reports are [is ]due on the fifteenth day of each quarter, i.e. January 15, April 15, July 15, and October 15.  If the Internet facilitator has been licensed for two years, the Board and Division may reduce the audit reports to be due biannually, January 15 and July 15.

 

KEY: licensing, online prescribing, internet facilitators

Date of Enactment or Last Substantive Amendment: [February 21, 2012]2013

Authorizing, and Implemented or Interpreted Law: 58-1-106(1)(a); 58-1-202(1)(a), 58-83-101

 

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