Commerce, Occupational and Professional Licensing

Section R156-83-306

Drugs Approved for Online Prescribing, Dispensing, and Facilitation

Notice of Proposed Rule

(Amendment)

DAR File No.: 34237
Filed: 11/15/2010 10:10:35 AM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The purpose of this rule filing is to first, implement what the Division and the Board believe to have been the legislative intent regarding adding Chantix (varenicline) to the list of drugs approved for online prescribing, dispensing, and facilitation; and second, to more specifically address hormonal contraceptive methods of administration.

Summary of the rule or change:

Section R156-83-306 is amended by adding a parenthetical limiting hormonal contraceptive methods. Specifically, injectable and implantable methods are excluded. Additionally, the drug varenicline (Chantix), a smoking-cessation drug, is added to the list of approved drugs for online prescribing, dispensing, and facilitation.

State statutory or constitutional authorization for this rule:

• Subsection 58-1-106(1)(a)
• Subsection 58-1-202(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:

This proposed amendment will not result in direct, measurable costs, and/or benefits for local governments.

small businesses:

The proposed amendments will result in a monetary impact upon the anticipated planning and cash flow for affected licensed online contract pharmacies, prescribing physicians for licensed contractor pharmacies and internet facilitators. However, the aggregate impact of the proposed amendments cannot be quantified. It should be noted however that this is a new licensing act and no one has been licensed under the act to date.

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

The proposed amendments will result in a monetary impact upon the anticipated planning and cash flow for affected licensed online contract pharmacies, prescribing physicians for licensed contract pharmacies and internet facilitators. It should be noted however that this is a new licensing act and no one has been licensed under the act to date. The proposed amendments will also affect the method of delivery and potentially the cost to consumers. However, the aggregate impact of the proposed amendments cannot be quantified.

Compliance costs for affected persons:

The proposed amendments will result in a monetary impact upon the anticipated planning and cash flow for affected licensed online contract pharmacies, prescribing physicians for licensed contract pharmacies and internet facilitators. It should be noted however that this is a new licensing act and no one has been licensed under the act to date. The proposed amendments will also affect the method of delivery and potentially the cost to consumers. However, the individual impact of the proposed amendments cannot be quantified.

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

Pursuant to authority granted in statute, the Division amends the list of approved online prescriptions to exclude injectable and implantable hormonal based contraceptives and to add the drug cessation medication varenicline. The fiscal impact to businesses from this amendments is difficult to ascertain as there are yet no licensees under this new law.

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
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 ntaxin@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:

12/31/2010

Interested persons may attend a public hearing regarding this rule:

• 12/07/2010 09:00 AM, Heber Wells Bldg, 160 E 300 S, Conference Room 474 (fourth floor), Salt Lake City, UT

This rule may become effective on:

01/07/2011

Authorized by:

Mark Steinagel, Director

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 hydrochlorid;[ and]

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

(6) varenicline.

 

KEY: licensing, online prescribing, internet facilitators

Date of Enactment or Last Substantive Amendment: [July 8, 2010]2011

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