Commerce, Occupational and Professional Licensing

Rule R156-1a

Limited Online Prescribing Permit Rule

Notice of Proposed Rule

(New Rule)

DAR File No.: 33228
Filed: 12/01/2009 10:38:13 AM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The purpose of this filing is to recodify the existing rule governing limited online prescribing as permitted under Subsection 58-1-501(4) from existing Rule R156-1 to this new Rule R156-1a. (DAR NOTE: The proposed amendment to Rule R156-1 is under DAR No. 33227 in this issue, December 15, 2009, of the Bulletin.)

Summary of the rule or change:

This new rule provides the following sections: R156-1a-101-Title; R156-1a-102-Definitions; R156-1a-301-Limited Online Prescribing Permit - This section specifies that a permit is required to engage in the practice of limited online prescribing under Subsection 58-1-501(4) and clarifies that a permit does not authorize online assessment, diagnosis, and prescribing for any person located outside the State of Utah; R156-1a-302-Application Requirements; R156-1a-303-Existing Written Agreements for Online Prescribing; R156-1a-304-Pending Applications; R156-1a-305-Duties and Responsibilities of a Limited Online Prescribing Practitioner; R156-1a-306-Drugs Approved to be Prescribed Online; R156-1a-307-Internet Facilitator: This section requires the limited online prescribing practitioner to have an Internet facilitator and specifies the required role and responsibilities of the Internet facilitator and the limited online prescribing practitioner in regard thereto; R156-1a-308-Contractual Pharmacy: This section permits the limited online prescribing practitioner to utilize the services of a contractual pharmacy and specifies the role and responsibilities of the contractual pharmacy and the roles of the limited online prescribing practitioner and Internet facilitator in regard thereto; R156-1a-309-Audits: This section specifies that the online prescribing practitioner is required to allow and facilitate Division audits of the website, as well as the records of the limited online prescribing practitioner, contractual pharmacy, and Internet facilitator to ensure compliance with governing authority. This section specifies that the Division shall be given full remote read only access to all of the data used and stored in the system to conduct its audits including all of the information available to the limited online prescribing practitioner. The section also requires a specified report on a quarterly basis or other basis directed by the Division; R156-1a-310-Renewal of Limited Online Prescribing Permit/Procedure; R156-1a-401-Termination of Authority/Relationship with Internet Facilitator and Contractual Pharmacy: This section addresses termination of authority to engage in limited online prescribing either by expiration or termination of the limited online prescribing permit. It addresses the fact that the limited online prescribing permit holder is responsible for the actions of the practitioner's Internet facilitator and contractual pharmacy and indicates that their actions may well place the limited online prescribing permit practitioner out of compliance with the requirements of Rule R156-1a; R156-1a-501-Unprofessional Conduct; R156-1a-502-Immediate and Significant Danger: This section specifies what actions by the limited prescribing practitioner constitutes an immediate and significant danger under the Utah Administrative Procedures Act and grounds for emergency action to terminate the prescriptive authority for online prescribing under Section 63G-4-502; and R156-1a-601-Effect of Governing Authority Changes on this Rule: This section addresses the effect of any governing authority after the effective date of the rule rendering unlawful in any respect the practice of online prescribing authorized by this rule.

State statutory or constitutional authorization for this rule:

• Subsection 58-1-106(1)(a)
• Subsection 58-1-501(4)

Anticipated cost or savings to:

the state budget:

The Division will incur minimal costs of approximately $100 to print and distribute the rule once the proposed new rule is made effective. Any costs incurred will be absorbed in the Division's current budget. The Division is already regulating the practice of limited online prescribing so the costs of this recodification should not be significant to the state budget. The recodification of the rule simply better defines the method of regulation. Initial applications for limited online prescribing permits are estimated to be ten or fewer with a review process that should be better defined and easier as compared to the former negotiation process of the loosely defined consent agreements, thus resulting in some cost savings that cannot be quantified. Primary professional licenses will have to be reprinted and mailed at a nominal cost.

local governments:

This proposed new rule only applies to companies or practitioners applying for limited online prescribing permits. As a result, the proposed new rule does not apply to local governments.

small businesses:

The proposed new rule only applies to companies or practitioners applying for limited online prescribing permits. Such companies may or may not qualify as a small business. The impact on small businesses is impossible to quantify. The new rule codifies existing practice in large part and therefore is not expected to be unduly burdensome and provides an enhanced business opportunity for limited online prescribing permit practitioners and their Internet facilitators and contractual pharmacies.

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

The new rule codifies existing practice in large part and therefore the compliance costs are not expected to be unduly burdensome to limited online prescribing permit practitioners and their internet facilitators and contractual pharmacies. This rule will likely result in a wider availability, as well as a cost savings to consumers who choose to use the services of a limited online prescribing permit practitioner.

Compliance costs for affected persons:

Any compliance costs for individuals is impossible to quantify. The new rule codifies existing practice in large part and therefore the compliance costs are not expected to be unduly burdensome to limited online prescribing permit practitioners and their Internet facilitators and contractual pharmacies. This rule will likely result in a wider availability as well as a cost savings to consumers who choose to use the services of a limited online prescribing permit practitioner.

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

No fiscal impact to businesses is anticipated beyond those addressed in detail in the rule summary.

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:

• 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:

01/14/2010

Interested persons may attend a public hearing regarding this rule:

• 01/11/2010 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:

01/21/2010

Authorized by:

Mark Steinagel, Director

R156. Commerce, Occupational and Professional Licensing.

R156-1a. Limited Online Prescribing Permit Rule.

R156-1a-101. Title.

This rule is known as the "Limited Online Prescribing Permit Rule".

 

R156-1a-102. Definitions.

In addition to the definitions in Title 58, Chapter 1, as used in this rule:

(1) "Active and in good standing", as used in this rule, is as defined in Subsection R156-1-102(1) and includes that the license has not been subject to disciplinary action in the past three years.

(2) "Branching questionnaire", as used in this rule for limited online prescribing, means an adaptive and progressive assessment tool completed by a patient, that requires the patient to provide answers to all the required questions and does not rely upon default answers.

(3) "Contractual Pharmacy" means a Utah licensed pharmacy that provides the services outlined in Section R156-1a-308.

(4) "Internet Facilitator" means a provider of a web-based system for electronic communication between a Limited Online Prescribing Practitioner and the Limited Online Prescribing Practitioner's patients in accordance with Section R156-1a-305.

(5) "Limited online prescribing" means the practice of prescribing medications listed in Section R156-1a-306 by a Limited Online Prescribing Practitioner to a patient, utilizing a branching questionnaire to obtain a comprehensive health history and assessment, which serves as the basis for a diagnosis and treatment plan for a specific patient.

(6) "Limited Online Prescribing Practitioner" means a person licensed in Utah with assessment, diagnosis, and prescribing authority within the scope of licensure, who has applied for and obtained a permit to prescribe specific legend drugs to persons located in the State of Utah based on an online comprehensive health history, assessment and diagnosis.

(7) "Unprofessional conduct" as defined in Title 58, Chapter 1, is further defined, in accordance with Subsection 58-1-203(1)(e), in Section R156-1a-502.

(8) "URL" means a uniform resource locator on the world wide web.

 

R156-1a-301. Limited Online Prescribing Permit.

(1) A written permit is required to engage in the practice of limited online prescribing in accordance with Subsection 58-1-501(4) and this rule.

(2) Each applicant for a limited online prescribing permit shall be licensed as required in Subsection R156-1a-302(1)(a), apply to the Division in writing upon forms available from the Division, and meet all the requirements established in this rule.

(3) Nothing in this rule shall be construed to authorize a Limited Online Prescribing Practitioner to engage in online assessment, diagnosis and prescribing for any person located outside the State of Utah.

 

R156-1a-302. Application Requirements.

(1) In accordance with Subsection 58-1-501(4) and this rule, to obtain an online prescribing permit a licensee shall:

(a) document that the applicant holds a Utah license that is active and in good standing that includes assessment, diagnosis and treatment of human ailments with prescription of medications within the scope of licensure;

(b) document that any other professional license the applicant for Limited Online Prescribing Practitioner possesses from other jurisdictions is in good standing;

(c)(i) submit an outline of the applicant's proposed online assessment, diagnosis and prescribing tool, such as a branching questionnaire; and

(ii) demonstrate the proposed online assessment, diagnosis and prescribing tool to the Division and appropriate board or boards, or board designee, and establish that the utilization of the assessment tool does not compromise the public's health, safety, or welfare;

(d) submit policies and procedures that address patient confidentiality, including measures that will be taken to ensure that the age and other identifying information of the person completing the online questionnaire are accurate;

(e) describe the mechanism by which the Limited Online Prescribing Practitioner and patient will communicate with one another, including electronic and telephonic communication;

(f) describe how the Limited Online Prescribing Practitioner/patient relationship will be established and maintained;

(g) submit the name, address, and contact person of the Internet Facilitator with whom the Limited Online Prescribing Practitioner has contracted to provide services which the Limited Online Prescribing Practitioner will use to engage in online assessment, diagnosis and prescribing;

(h) submit the name, address, license number and contact information of the contractual pharmacy with which the Limited Online Prescribing Practitioner contracts with to dispense medications or transfer prescription orders; and

(i) submit documentation satisfactory to the Division regarding public health, safety, and welfare documenting protections, including:

(i) how the Limited Online Prescribing Practitioner will comply with the requirements of Section R156-1a-303;

(ii) the contractual services arrangement between the Limited Online Prescribing Practitioner and Internet Facilitator, and the Limited Online Prescribing Practitioner and Contractual Pharmacy (if applicable); and

(iii) how the Limited Online Prescribing Practitioner will allow and facilitate the ability of the Division to conduct audits in accordance with R156-1a-309.

(2) A Limited Online Prescribing Practitioner may not utilize the services of an Internet Facilitator or Contractual Pharmacy that is engaging in or has engaged in unlawful or unprofessional conduct under Title 58 or R156 within the past three years.

(3) The application for a permit to engage in the practice of limited online prescribing is a public record. Should the applicant believe that any of the information contained in the application consists of trade secrets or commercial information that should not be released to the public, the applicant may provide to the Division a written claim of business confidentiality in accordance with Section 63G-2-309. In that event the Division shall act in compliance with the provisions of the Government Records Access and Management Act (Utah Code Ann. Sections 63G-2-101 through 901), and particularly with Section 63G-2-309 and Subsections 63G-2-305(1) and (2).

 

R156-1a-303. Existing Written Agreements for Online Prescribing.

(1) Any entity or other person not licensed by the Division who prior to December 31, 2009 has engaged in online prescribing with the written consent of the Division, whether such consent has been manifested by means of a stipulation, consent order, letter agreement, or otherwise, may continue to operate in accordance with the terms and conditions of such written consent until December 31, 2011, and shall discontinue such operations after that date.

(2) Any licensee who prior to June 30, 2009 has engaged in online prescribing with the written consent of the Division, whether such consent has been manifested by means of a stipulation, consent order, letter agreement, or otherwise, may continue to operate in accordance with the terms and conditions of such written consent subject to the following:

(a) On or before December 31, 2010, the licensee shall file an application with the Division in accordance with R156-1a-302 for a limited online prescribing permit.

(b) After that application is filed, the licensee may continue to operate under the terms and conditions of the prior written consent until the Division has issued its decision on the application.

(c) If the application is approved and a limited online prescribing permit is issued, the licensee may no longer operate under the terms and conditions of the prior written consent.

(d) The licensee may not operate under the prior written consent after the date an application filed in accordance with R156-1a-302 has been denied.

 

R156-1a-304. Pending Applications.

The following provisions shall apply to any application for authorization to engage in online prescribing that was pending on the effective date of this rule:

(1) The application shall comply with this rule.

(2) The applicant may by no later than June 30, 2010 provide supplemental documentation to the Division to correct any deficiency in the application. After any such supplemental documentation has been provided, the applicant shall notify the Division in writing that the application is ready to be acted upon by the Division.

(3) The applicant may rely upon the existing application, without any supplementation. In that event, the applicant shall notify the Division in writing that the application is ready to be acted upon by the Division.

(4) Unless the Division receives a notification from the applicant that the application is ready to be acted upon by the Division, the Division shall not act on the application until after June 30, 2010.

 

R156-1a-305. Duties and Responsibilities of a Limited Online Prescribing Practitioner.

(1) The Limited Online Prescribing Practitioner shall:

(a) conduct an assessment and diagnosis based upon a comprehensive health history and an assessment tool such as a branching questionnaire;

(b) ensure that a comprehensive health history, assessment and diagnosis have been made before prescribing any medications;

(c) conduct the online assessment and diagnosis only through the approved Internet Facilitator, as set forth in the Limited Online Prescribing Practitioner's application;

(d) only use the approved Internet Facilitator as the Limited Online Prescribing Practitioner's method for electronic communication between the Limited Online Prescribing Practitioner and patients;

(e) ensure that the Internet Facilitator uses only one URL address that does not link to any other sites; and

(f) comply with all governing state and federal laws, rules, regulations and orders.

(2) Medical records shall be readily available to the limited online prescribing practitioner and shall be maintained in accordance with the standards of the Limited Online Prescribing Practitioner's profession for each patient requesting a prescription, whether or not the Limited Online Prescribing Practitioner issues a prescription for the patient. The Limited Online Prescribing Practitioner may delegate the storage of these medical records to the Internet Facilitator only if the appropriate patient consent has been obtained. Only the Limited Online Prescribing Practitioner and the Division shall have access to all the patient records. A patient shall be able to view or obtain a copy of the patient's own records.

(3) The Limited Online Prescribing Practitioner shall be available for consultation with all of the online patients through secure electronic or other forms of communication. The Limited Online Prescribing Practitioner shall provide meaningful opportunities for patients to communicate their concerns or questions, and shall review and respond to those concerns or questions in a timely manner.

(4) The Limited Online Prescribing Practitioner shall not delegate to any person or third party the Limited Online Prescribing Practitioner's responsibility to:

(a) review and evaluate the patient comprehensive health history questionnaire;

(b) consult with the patient electronically or through other secure means regarding the patient's medical condition(s); and

(c) diagnose and prescribe medication to the patient.

(5) Decisions made by the Limited Online Prescribing Practitioner regarding patient care, including whether or not to prescribe particular drugs for a patient, shall be based solely on the professional judgment of the Limited Online Prescribing Practitioner. The health and welfare of the patient shall be the Limited Online Prescribing Practitioner's primary priority.

(6) The Limited Online Prescribing Practitioner's compensation for the services provided to patients may not be based on the issuance of a prescription by the Limited Online Prescribing Practitioner.

(7) The following information shall be conspicuously disclosed by the Limited Online Prescribing Practitioner on the URL that is submitted in the application:

(a) the owner of the site;

(b) the specific services provided by the Limited Online Prescribing Practitioner;

(c) the Limited Online Prescribing Practitioner's office address and contact information;

(d) the licensure and qualifications of the Limited Online Prescribing Practitioner;

(e) the financial interest of the Limited Online Prescribing Practitioner in the website or in any information, products, or services available through the website;

(f) the appropriate uses of the website and standards for operation of the site including providing health advice, and use and response times for e-mails, electronic messages and other communication transmitted via the website;

(g) the limitations of the website, including the inability to provide medical services electronically in emergency situations;

(h) an attestation that:

(i) no one associated with the website will sell or provide any confidential information;

(ii) the Limited Online Prescribing Practitioner, Internet Facilitator and Contractual Pharmacy will strictly adhere to HIPAA requirements; and

(iii) confidential information shall, upon request, be provided to the Division and to the patient to whom the information relates;

(i) a description of the rights of a patient with respect to obtaining the patient's own health information; and

(j) a list of risks and benefits of any of the drug therapies available on the site.

(8) A Limited Online Prescribing Practitioner shall have in place a method for communication between the patients and the Limited Online Prescribing Practitioner in the event the agreement between the Limited Online Prescribing Practitioner and Internet Facilitator is dissolved.

(9) The Limited Online Prescribing Practitioner shall follow the policies and procedures established by the approved Internet Facilitator to adequately safeguard patient confidentiality.

(10) The Limited Online Prescribing Practitioner shall keep the Division advised at all times regarding the name and contact information of the Contractual Pharmacy.

(11) The Limited Online Prescribing Practitioner shall maintain in good standing all of the Limited Online Prescribing Practitioner's professional licenses in the State of Utah and in all other jurisdictions in which the Limited Online Prescribing Practitioner is licensed. Any disciplinary action on the Limited Online Prescribing Practitioner's Utah license shall unless otherwise stated automatically have the same effect upon the Limited Online Prescribing Practitioner's permit for limited online prescribing.

(12) If a Limited Online Prescribing Practitioner is rendered unable to engage in online prescribing, the Limited Online Prescribing Practitioner shall recognize the existence of any previously established relationship with a patient to whom the Limited Online Prescribing Practitioner prescribed medication. The termination of such relationship shall be conducted only in accordance with the professional standards of the Limited Online Prescribing Practitioner's profession.

 

R156-1a-306. Drugs Approved to be Prescribed Online.

(1) In accordance with Subsection 58-1-501(4), only the following legend, non-controlled drugs that are approved by the Food and Drug Administration and prescribed to treat the condition for which the drug was approved, may be prescribed by a Limited Online Prescribing Practitioner in accordance with this rule:

(i) finasteride;

(ii) sildenafil citrate;

(iii) tadalafil;

(iv) vardenafil hydrochloride; and

(v) hormonal based contraception.

(2) Should the Food and Drug Administration issue an additional clinical black box warning on any drug listed in Subsection (1) after January 1, 2010, a Limited Online Prescribing Practitioner shall immediately cease to prescribe the drug and the Division shall consult with the appropriate board(s) to determine the warning's effect on Subsection (1).

(3) Any request to alter this list of approved drugs shall be directed to the Division Director in the form of a request to modify this rule. Any changes to this list shall be made in accordance with Title 63G, Chapter 3, Utah Administrative Rulemaking Act, and in consultation with the Utah State Board of Pharmacy, the Physicians Licensing Board, and the Osteopathic Physicians and Surgeons Licensing Board.

 

R156-1a-307. Internet Facilitator.

(1) The Limited Online Prescribing Practitioner shall have an Internet Facilitator to provide services which the Limited Online Prescribing Practitioner will use in implementing the online assessment, diagnosis and prescribing tool.

(2) The Internet Facilitator shall provide electronic or telephonic communication between the Limited Online Prescribing Practitioner and the patient which is secure and confidential, and allows the Limited Online Prescribing Practitioner to be directly accessible to a patient to answer questions regarding the patient's treatment plan. A secure and confidential electronic method of communication does not include common email usage.

(3) The Limited Online Prescribing Practitioner shall use only one Internet Facilitator, and one URL address/site unless otherwise approved by the Division.

(4) The Limited Online Prescribing Practitioner's online assessment and diagnosis, the electronic communication between the Limited Online Prescribing Practitioner and the patient, and the maintenance of online medical records if delegated by the Limited Online Prescribing Practitioner, shall be conducted only through the approved Internet Facilitator.

(5) Any change of the Internet Facilitator or URL address/site shall be approved by the Division prior to the change.

(6) To ensure patient confidentiality and security of data, any system used to communicate with a patient shall comply with all HIPAA requirements.

(7) The Internet Facilitator is prohibited from advertising to any pornographic sites or sites that promote any illegal activity, or allowing links to and from the approved URL by any such sites.

 

R156-1a-308. Contractual Pharmacy.

(1) The Limited Online Prescribing Practitioner may utilize the services of a Contractual Pharmacy. The Contractual Pharmacy shall be licensed in good standing in Utah as a Class A Retail Pharmacy or a Class B Closed Door Pharmacy.

(2) The patients' freedom of choice in selecting who will fill prescriptions shall be preserved at all times. As requested by the patient, the Contractual Pharmacy shall:

(a) dispense the medication to the patient;

(b) transfer the prescription to the patient's personal pharmacy for dispensing at no additional cost to the patient; or

(c) send the prescription directly to the patient at no additional cost to the patient.

(3) The Contractual Pharmacy shall maintain a toll-free number for patients utilizing the services of the Contractual Pharmacy to receive medications prescribed online.

(4) A Contractual Pharmacy shall utilize a tracking ID number system when shipping medications prescribed for patients by a Limited Online Prescribing Practitioner.

(5) Should a patient choose to utilize the services of a Contractual Pharmacy, the Limited Online Prescribing Practitioner shall authorize the Internet Facilitator to provide the following information to the Contractual Pharmacy:

(a) the patient's basic biographical information including:

(i) full name of patient;

(ii) patient's address and telephone number; and

(iii) patient's date of birth or age and gender;

(b) a summary of the patient's medical history including:

(i) the patient's height, weight, and vital signs (if known);

(ii) any medication allergies or drug reactions the patient has; and

(iii) current medications including over-the-counter products the patient is taking; and

(c) any additional comments relevant to the patient's drug use.

(6) Any agreement between a Contractual Pharmacy and a Limited Online Prescribing Practitioner shall include the following:

(i) a requirement that the Contractual Pharmacy shall provide the Division access to the records of patients who receive medications pursuant to this rule; and

(ii) a requirement that the Contractual Pharmacy shall provide to the Division a quarterly report of all the drugs dispensed in accordance with this rule.

 

R156-1a-309. Audits.

(1) The Limited Online Prescribing Practitioner shall allow and facilitate the ability of the Division to conduct audits of the operation of the website as well as the records of the Limited Online Prescribing Practitioner, Contractual Pharmacy and Internet Facilitator to ensure compliance with state and federal statutes, rules, and regulations including:

(a) ensuring that a comprehensive history and assessment have been obtained and a diagnosis has been made for a patient before any medications are prescribed; and

(b) ensuring that only the approved medications are being prescribed.

(2) The Division shall be given full remote read access only rights to all of the data used and stored in the system to conduct its audits. The Division shall be able to access and review all of the information available to the Limited Online Prescribing Practitioner. Access shall be provided in a manner that allows access from the Division's offices.

(3) The Limited Online Prescribing Practitioner shall provide to the Division on a quarterly basis or other basis as directed by the Division, a report containing the following information and other information as the Division may direct:

(a) number of prescriptions written by drug name;

(b) number of comprehensive histories/assessments received;

(c) number of comprehensive histories/assessments reviewed;

(d) the demographic data of the patients receiving prescriptions based on this rule; and

(e) the number of prescriptions:

(i) dispensed by the Contractual Pharmacy;

(ii) sent to a patient's pharmacy of choice; and

(iii) sent directly to a patient.

(4) The Division's authority to conduct an audit pursuant to this rule shall survive any termination or expiration of any prescriptive authority for online prescribing.

 

R156-1a-310. Renewal of Limited Online Prescribing Permit - Procedure.

(1) The limited online prescribing permit shall be associated with the Limited Online Prescribing Practitioner's primary professional license and may be renewed at the time the primary license is renewed in accordance with Subsection 58-1-308(1).

(2) The renewal requirements shall include continuous compliance with this rule and any other governing authority.

 

R156-1a-401. Termination of Authority - Relationship with Internet Facilitator and Contractual Pharmacy.

(1) The termination or expiration of a limited online prescribing permit for any reason does not limit the Division's authority to commence or continue any investigation or adjudicative proceeding.

(2) Because of the working business relationship between the Limited Online Prescribing Practitioner, the Internet Facilitator and the Contractual Pharmacy, the Limited Online Prescribing Practitioner's ability to comply with this rule may depend in some respects on the Internet Facilitator or Contractual Pharmacy. It is possible that a particular action or inaction by the Internet Facilitator or Contractual Pharmacy could have the effect of causing the Limited Online Prescribing Practitioner to be out of compliance with this rule, and the Limited Online Prescribing Practitioner may be held accountable for the non-compliance.

(3) This rule addresses the Limited Online Prescribing Practitioner's medical practice, and it is the Limited Online Prescribing Practitioner's professional licenses that will be at risk if the Limited Online Prescribing Practitioner violates this rule, whether or not an action or inaction by the Internet Facilitator or Contractual Pharmacy was a contributing factor in the Limited Online Prescribing Practitioner's violation. It shall not be a defense to an allegation that the Limited Online Prescribing Practitioner has failed to comply with this rule or to a disciplinary proceeding based on such an allegation, that failure to comply was a result of an action or inaction by the Internet Facilitator or Contractual Pharmacy.

 

R156-1a-501. Unprofessional Conduct.

"Unprofessional conduct" includes:

(1) online prescribing to a person under the age of 18 years;

(2) online prescribing of a legend drug not authorized in Section R156-1a-306;

(3) online prescribing of any controlled substance;

(4) using the name or official seal of the State of Utah, the Utah Department of Commerce, the Utah Division of Occupational and Professional Licensing or its boards in an unauthorized manner;

(5) failing to respond to a request from the Division within the timeframe requested for:

(a) an audit of the website;

(b) records of the Limited Online Prescribing Practitioner, Internet Facilitator or Contractual Pharmacy; or

(c) other information;

(6) engaging in online prescribing using an online comprehensive health history without a permit granted by the Division under this rule;

(7) utilizing an Internet Facilitator without approval from the Division;

(8) failing to inform a patient of the patient's freedom of choice in selecting who will dispense a prescription;

(9) failing to comply with Subsection R156-1a-308(2);

(10) failing to keep the Division informed of the name and contact information of the Internet Facilitator or Contractual Pharmacy;

(11) prescribing any medications to a patient while engaged in practice as a Limited Online Prescribing Practitioner without first reviewing a comprehensive health history, making an assessment, or establishing a diagnosis;

(12) prescribing a medication listed in Section R156-1a-306 for a diagnosis that is not recognized by the Federal Food and Drug Administration to be treated by the prescribed drug;

(13) online prescribing to a person not located in the State of Utah (unless such practice is authorized by a source of legal authority independent from this rule); and

(14) prescribing a drug listed in Subsection R156-1a-306(1) following the issuance of any additional clinical black box warning issued after January 1, 2010 by the Food and Drug Administration.

 

R156-1a-502. Immediate and Significant Danger.

(1) If the Limited Online Prescribing Practitioner violates this rule in any of the ways specified below, the violation shall be deemed to constitute (1) an immediate and significant danger to the public health, safety, or welfare, and (2) a threat requiring immediate action by the Division to terminate the prescriptive authority for online prescribing pursuant to Section 63G-4-502:

(a) online prescribing to a person under the age of 18 years;

(b) online prescribing of a legend drug not authorized in Section R156-1a-306;

(c) online prescribing of any controlled substance;

(d) violating this rule after having been given reasonable opportunity to cure the violation;

(e) using the name or official seal of the State of Utah, the Utah Department of Commerce, the Utah Division of Occupational and Professional Licensing or its boards in an unauthorized manner; or

(f) failing to respond to a request from the Division within the timeframe requested for:

(i) an audit of the website; or

(ii) records of the Limited Online Prescribing Practitioner, Internet Facilitator or Contractual Pharmacy.

 

R156-1a-601. Effect of Governing Authority Changes on this Rule.

If after the effective date of this rule any Utah or federal statute, regulation, rule, or amendment thereto becomes effective which renders unlawful in any respect the practice of online prescribing authorized by this rule, then this rule or any portion thereof shall terminate automatically on the effective date of the change in the law and the Limited Online Prescribing Practitioner shall immediately cease the prohibited practice of limited online prescribing.

 

KEY: licensing, limited online prescribing permit

Date of Enactment or Last Substantive Amendment: 2010

Authorizing, and Implemented or Interpreted Law: 58-1-106(1)(a); 58-1-501(4)