No. 33638 (New Rule): Rule R156-83. Online Prescribing, Dispensing, and Facilitation Licensing Act Rule

(New Rule)

DAR File No.: 33638
Filed: 05/13/2010 01:52:57 PM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The purpose of this rule filing is to implement S.B. 274 which was passed during the 2010 Legislative Session. The proposed rule provides for the licensure and regulation of online prescribers, online contract pharmacies, and Internet facilitators. (DAR NOTE: S.B. 274 (2010) is found at Chapter 180, Laws of Utah 2010, and was effective 05/11/2010.)

Summary of the rule or change:

Section R156-83-101 establishes the title of the rule. Section R156-83-102 defines the following terms "active and in good standing", "licensed in good standing", "submit a copy of the internet facilitator's website", and "unprofessional conduct". Section R156-83-103, provides the statutory basis for establishing the rule. Section R156-83-104 references the rule section which explains the organization and relationship between this rule and Rule R156-1. Section R156-83-302 establishes the process by which an Internet facilitator documents minimum liability insurance. Section R156-83-303 includes Division model rule language referencing other Division rules which establish the renewal cycle for licensees under this chapter. Section R156-83-306 adds five legend, non-controlled drugs that can be prescribed by a licensed online prescriber. Section R156-83-308 requires Internet facilitators to submit reports to the Division on a quarterly basis. Section R156-83-502 provides three additional types of conduct that would be unprofessional and the basis for administrative disciplinary action.

State statutory or constitutional authorization for this rule:

• Subsection 58-1-106(1)(a)
• Section 58-83-101
• Subsection 58-1-202(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. Also, according to the fiscal note for S.B. 274, the enactment of the bill will generate $1,200 in revenue to the General Fund annually. One FTE (full time employee) and a new board are estimated to cost $80,800 per year from the Commerce Service Fund. License fee revenue is estimated at $82,000 per year. There will be a $40 pass through fee to BCI (Bureau of Criminal Investigation) to conduct criminal background checks for each owner, officer, or manager of the applicant online contract pharmacy.

local governments:

As was indicated on the fiscal note for S.B. 274, the regulation of online prescribing will not likely result in direct, measurable costs and/or benefits for local governments.

small businesses:

Individuals and businesses that are eligible for licensure will need to pay the application/renewal fee for that license. Proposed fees are as follows: 1) online prescribers: $200/initial application, $183/renewal; 2) online contract pharmacies: $200/initial application, $183/renewal; and 3) Internet facilitators: $7,000/initial application, $7,000/renewal. However, the ability to prescribe online will allow prescribing practitioners to broaden their patient base thus increasing the revenue of the practice. This would also be true for the online contract pharmacy. The Division is unable to determine how many new applicants to expect in each of the license classifications, thus precise estimates are unavailable. The start up costs for an online Internet facilitator are unknown but would be significant; however, those who have been involved in online prescription services have indicated the Internet facilitator is able to recoup their costs as the client base grows. Again, the Division is unable to determine precise estimates of those start up costs due to a wide degree of circumstances.

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

Individuals and businesses that are eligible for licensure will need to pay the fees for that license as outlined above.

Compliance costs for affected persons:

Individuals and businesses that are eligible for licensure will need to pay the fees for that license as outlined above.

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

This filing adopts a rule to administer the Online Prescribing, Dispensing, and Facilitation Licensing Act passed in the 2010 Legislative Session. No fiscal impact to businesses is anticipated beyond those addressed in the passage of the statute.

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:

• Laura Poe at the above address, by phone at 801-530-6789, 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:

07/01/2010

Interested persons may attend a public hearing regarding this rule:

• 06/15/2010 09:00 AM, Heber Wells Bldg, 160 E 300 S, Conference Room 475, Salt Lake City, UT

This rule may become effective on:

07/08/2010

Authorized by:

Mark Steinagel, Director

RULE TEXT

R156. Commerce, Occupational and Professional Licensing.

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

R156-83-101. Title.

This rule is known as the "Online Prescribing, Dispensing, and Facilitation Licensing Act".

 

R156-83-102. Definitions.

In addition to the definitions in Title 58, Chapters 1 and 83, as used in this rule:

(1) "Active and in good standing", as used in Subsections 58-83-302(1)(d), 58-83-302(2) and 58-83-302(3)(g), and "licensed in good standing", as used in Subsection 58-83-302(3)(a), is as defined in Subsection R156-1-102(1) and also includes that the license has not been subject to disciplinary action in the past three years.

(2) "Submit a copy of the internet facilitator's website", as used in Subsection 58-83-302(4)(g), means submitting the URL for the Internet facilitator's website, a site map, and a printout of the main pages.

(3) "Unprofessional conduct" is further defined, in accordance with Subsections 58-1-203(1)(e) and 58-83-102(9), in Section R156-83-502.

 

R156-83-103. 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 83.

 

R156-83-104. Organization - Relationship to Rule R156-1.

The organization of this rule and its relationship to Rule R156-1 is as described in Section R156-1-107.

 

R156-83-302. Qualifications for Licensure - Liability Insurance Requirements.

In accordance with the provisions of Subsection 58-83-302(3)(e), an applicant who is approved for licensure as an online contract pharmacy shall submit proof of public liability insurance in coverage amounts of at least $1,000,000 per occurrence with a policy limit of not less than $3,000,000 by means of a certificate of insurance naming the Division as a certificate holder.

 

R155-83-303. Renewal Cycle - Procedures.

(1) In accordance with Subsection 58-1-308(1), the renewal date for the two-year renewal cycle applicable to licensees under Title 58, Chapter 83 is established by rule in Subsection R156-1-308a(1).

(2) Renewal procedures shall be in accordance with Section R156-1-308c.

 

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.

 

R156-83-308. Audit Reports.

In accordance with Subsection 58-83-308(3), an Internet facilitator licensed under this chapter shall provide quarterly reports to the Division containing the information listed in Subsection 58-83-308(3). The report is due on the fifteenth day of each quarter, i.e. January 15, April 15, July 15, and October 15.

 

R156-83-502. Unprofessional Conduct.

"Unprofessional conduct" includes:

(1) failing as an online facilitator to timely submit quarterly reports to the Division as established in Section R156-83-308;

(2) prescribing any medication to a patient while engaged in practice as an online prescriber without first reviewing a comprehensive health history, making an assessment, or establishing a diagnosis; and

(3) prescribing a drug listed in Section R156-83-306 for diagnosis that is not recognized by the Federal Food and Drug Administration to be treated by that prescribed drug.

 

KEY: licensing, online prescribing, internet facilitators

Date of Enactment or Last Substantive Amendment: 2010

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

 

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