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S.B. 274 Enrolled

             1     

ONLINE PHARMACY AMENDMENTS

             2     
2010 GENERAL SESSION

             3     
STATE OF UTAH

             4     
Chief Sponsor: Curtis S. Bramble

             5     
House Sponsor: Rebecca D. Lockhart

             6      Cosponsor:Peter C. Knudson              7     
             8      LONG TITLE
             9      General Description:
             10          This bill creates an Online Prescribing, Dispensing, and Facilitation Licensing Act.
             11      Highlighted Provisions:
             12          This bill:
             13          .    amends unlawful conduct provisions;
             14          .    defines terms;
             15          .    requires licenses with the state to engage in online prescribing, online dispensing,
             16      or Internet facilitation;
             17          .    establishes requirements for the licenses;
             18          .    allows certain online prescribers, online contract pharmacies, and Internet
             19      facilitators to continue delivering online pharmaceutical services while their
             20      applications for licensure are pending with the division;
             21          .    establishes duties for a licensed online prescriber, online contract pharmacy, and
             22      Internet facilitator;
             23          .    limits the type of drugs that can be prescribed online;
             24          .    requires the use of an Internet facilitator and an online contract pharmacy to
             25      prescribe online; and
             26          .    provides enforcement mechanisms for the division.
             27      Monies Appropriated in this Bill:
             28          None
             29      Other Special Clauses:


             30          None
             31      Utah Code Sections Affected:
             32      AMENDS:
             33          58-1-501, as last amended by Laws of Utah 2007, Chapter 162
             34      ENACTS:
             35          58-83-101, Utah Code Annotated 1953
             36          58-83-102, Utah Code Annotated 1953
             37          58-83-201, Utah Code Annotated 1953
             38          58-83-301, Utah Code Annotated 1953
             39          58-83-302, Utah Code Annotated 1953
             40          58-83-303, Utah Code Annotated 1953
             41          58-83-304, Utah Code Annotated 1953
             42          58-83-305, Utah Code Annotated 1953
             43          58-83-306, Utah Code Annotated 1953
             44          58-83-307, Utah Code Annotated 1953
             45          58-83-308, Utah Code Annotated 1953
             46          58-83-401, Utah Code Annotated 1953
             47          58-83-501, Utah Code Annotated 1953
             48          58-83-502, Utah Code Annotated 1953
             49          58-83-503, Utah Code Annotated 1953
             50     
             51      Be it enacted by the Legislature of the state of Utah:
             52          Section 1. Section 58-1-501 is amended to read:
             53           58-1-501. Unlawful and unprofessional conduct.
             54          (1) "Unlawful conduct" means conduct, by any person, that is defined as unlawful
             55      under this title and includes:
             56          (a) practicing or engaging in, representing oneself to be practicing or engaging in, or
             57      attempting to practice or engage in any occupation or profession requiring licensure under this


             58      title if the person is:
             59          (i) not licensed to do so or not exempted from licensure under this title; or
             60          (ii) restricted from doing so by a suspended, revoked, restricted, temporary,
             61      probationary, or inactive license;
             62          (b) impersonating another licensee or practicing an occupation or profession under a
             63      false or assumed name, except as permitted by law;
             64          (c) knowingly employing any other person to practice or engage in or attempt to
             65      practice or engage in any occupation or profession licensed under this title if the employee is
             66      not licensed to do so under this title;
             67          (d) knowingly permitting the person's authority to practice or engage in any
             68      occupation or profession licensed under this title to be used by another, except as permitted by
             69      law;
             70          (e) obtaining a passing score on a licensure examination, applying for or obtaining a
             71      license, or otherwise dealing with the division or a licensing board through the use of fraud,
             72      forgery, or intentional deception, misrepresentation, misstatement, or omission; or
             73          (f) (i) [unless Subsection (2)(m) or (4) applies,] issuing, or aiding and abetting in the
             74      issuance of, an order or prescription for a drug or device to a person located in this state:
             75          (A) without prescriptive authority conferred by a license issued under this title, or by
             76      an exemption to licensure under this title; or
             77          (B) with prescriptive authority conferred by an exception issued under this title or a
             78      multistate practice privilege recognized under this title, if the prescription was issued[: (I)]
             79      without first obtaining information, in the usual course of professional practice, that is
             80      sufficient to establish a diagnosis, to identify underlying conditions, and to identify
             81      contraindications to the proposed treatment; [or] and
             82          [(II) based on a questionnaire completed by the patient on the internet, or toll-free
             83      telephone number, when there exists no other bona fide patient-practitioner relationship; or]
             84          [(C) in violation of Subsection (2)(m), when the licensed person who issued, or aided
             85      and abetted another in the issuance of the prescription has violated Subsection (2)(m) on more


             86      than 100 prescriptions within a 30 day period of time; and]
             87          (ii) Subsection (1)(f)(i) does not apply to treatment rendered in an emergency, on-call
             88      or cross coverage situation, provided that the person who issues the prescription has
             89      prescriptive authority conferred by a license under this title, or is exempt from licensure under
             90      this title.
             91          (2) "Unprofessional conduct" means conduct, by a licensee or applicant, that is
             92      defined as unprofessional conduct under this title or under any rule adopted under this title and
             93      includes:
             94          (a) violating, or aiding or abetting any other person to violate, any statute, rule, or
             95      order regulating an occupation or profession under this title;
             96          (b) violating, or aiding or abetting any other person to violate, any generally accepted
             97      professional or ethical standard applicable to an occupation or profession regulated under this
             98      title;
             99          (c) engaging in conduct that results in conviction, a plea of nolo contendere, or a plea
             100      of guilty or nolo contendere which is held in abeyance pending the successful completion of
             101      probation with respect to a crime of moral turpitude or any other crime that, when considered
             102      with the functions and duties of the occupation or profession for which the license was issued
             103      or is to be issued, bears a reasonable relationship to the licensee's or applicant's ability to
             104      safely or competently practice the occupation or profession;
             105          (d) engaging in conduct that results in disciplinary action, including reprimand,
             106      censure, diversion, probation, suspension, or revocation, by any other licensing or regulatory
             107      authority having jurisdiction over the licensee or applicant in the same occupation or
             108      profession if the conduct would, in this state, constitute grounds for denial of licensure or
             109      disciplinary proceedings under Section 58-1-401 ;
             110          (e) engaging in conduct, including the use of intoxicants, drugs, narcotics, or similar
             111      chemicals, to the extent that the conduct does, or might reasonably be considered to, impair
             112      the ability of the licensee or applicant to safely engage in the occupation or profession;
             113          (f) practicing or attempting to practice an occupation or profession regulated under


             114      this title despite being physically or mentally unfit to do so;
             115          (g) practicing or attempting to practice an occupation or profession regulated under
             116      this title through gross incompetence, gross negligence, or a pattern of incompetency or
             117      negligence;
             118          (h) practicing or attempting to practice an occupation or profession requiring licensure
             119      under this title by any form of action or communication which is false, misleading, deceptive,
             120      or fraudulent;
             121          (i) practicing or attempting to practice an occupation or profession regulated under
             122      this title beyond the scope of the licensee's competency, abilities, or education;
             123          (j) practicing or attempting to practice an occupation or profession regulated under
             124      this title beyond the scope of the licensee's license;
             125          (k) verbally, physically, mentally, or sexually abusing or exploiting any person through
             126      conduct connected with the licensee's practice under this title or otherwise facilitated by the
             127      licensee's license;
             128          (l) acting as a supervisor without meeting the qualification requirements for that
             129      position that are defined by statute or rule;
             130          (m) [unless Subsection (4) applies,] issuing, or aiding and abetting in the issuance of,
             131      an order or prescription for a drug or device:
             132          (i) without first obtaining information in the usual course of professional practice, that
             133      is sufficient to establish a diagnosis, to identify conditions, and to identify contraindications to
             134      the proposed treatment; or
             135          [(ii) based on a questionnaire completed by the patient on the internet, or toll free
             136      telephone number when there exists no other bona fide patient-practitioner relationship or
             137      bona fide referral by a practitioner involved in an existing patient-practitioner relationship; or]
             138          (ii) with prescriptive authority conferred by an exception issued under this title, or a
             139      multi-state practice privilege recognized under this title, if the prescription was issued without
             140      first obtaining information, in the usual course of professional practice, that is sufficient to
             141      establish a diagnosis, to identify underlying conditions, and to identify contraindications to the


             142      proposed treatment; or
             143          (n) violating a provision of Section 58-1-501.5 .
             144          [(3) Subsection (2)(m) does not apply to treatment rendered in an emergency, on-call,
             145      or cross coverage situation.]
             146          [(4) Notwithstanding Subsections (1)(f) and (2)(m), the division may permit a person
             147      licensed to prescribe under this title to prescribe a legend drug to a person located in this state
             148      if the division in collaboration with the appropriate professional board has permitted the
             149      specific prescriptive practice of the legend drug by rule.]
             150          Section 2. Section 58-83-101 is enacted to read:
             151     
CHAPTER 83. ONLINE PRESCRIBING, DISPENSING,

             152     
AND FACILITATION LICENSING ACT

             153     
Part 1. General Provisions

             154          58-83-101. Title.
             155          This chapter is known as the "Online Prescribing, Dispensing, and Facilitation
             156      Licensing Act."
             157          Section 3. Section 58-83-102 is enacted to read:
             158          58-83-102. Definitions.
             159          In addition to the definitions in Section 58-1-102 , as used in this chapter:
             160          (1) "Board" means the Online Prescribing, Dispensing, and Facilitation Licensing
             161      Board created in Section 58-83-201 .
             162          (2) "Branching questionnaire" means an adaptive and progressive assessment tool
             163      approved by the board.
             164          (3) "Delivery of online pharmaceutical services" means the process in which a
             165      prescribing practitioner diagnoses a patient and prescribes one or more of the drugs authorized
             166      by Section 58-83-306 , using:
             167          (a) a branching questionnaire or other assessment tool approved by the division for the
             168      purpose of diagnosing and assessing a patient's health status;
             169          (b) an Internet contract pharmacy to:


             170          (i) dispense the prescribed drug; or
             171          (ii) transfer the prescription to another pharmacy; and
             172          (c) an Internet facilitator to facilitate the practices described in Subsections (3)(a) and
             173      (b).
             174          (4) "Division" means the Utah Division of Occupational and Professional Licensing.
             175          (5) "Internet facilitator" means a licensed provider of a web-based system for
             176      electronic communication between and among an online prescriber, the online prescriber's
             177      patient, and the online contract pharmacy.
             178          (6) "Online contract pharmacy" means a pharmacy licensed and in good standing
             179      under Chapter 17b, Pharmacy Practice Act, as either a Class A Retail Pharmacy or a Class B
             180      Closed Door Pharmacy and licensed under this chapter to fulfill prescriptions issued by an
             181      online prescriber through a specific Internet facilitator.
             182          (7) "Online prescriber" means a person:
             183          (a) licensed under another chapter of this title;
             184          (b) whose license under another chapter of this title includes assessing, diagnosing,
             185      and prescribing authority for humans; and
             186          (c) who has obtained a license under this chapter to engage in online prescribing.
             187          (8) "Unlawful conduct" is as defined in Sections 58-1-501 and 58-83-501 .
             188          (9) "Unprofessional conduct" is as defined in Sections 58-1-203 and 58-83-502 , and
             189      as further defined by the division in accordance with Title 63G, Chapter 3, Utah
             190      Administrative Rulemaking Act.
             191          Section 4. Section 58-83-201 is enacted to read:
             192     
Part 2. Board

             193          58-83-201. Board.
             194          (1) There is created the Online Prescribing, Dispensing, and Facilitation Licensing
             195      Board consisting of the following seven members:
             196          (a) two members who are licensed under either Chapter 67, Utah Medical Practices
             197      Act, or Chapter 68, Utah Osteopathic Medical Practices Act, of which:


             198          (i) one shall be engaged in the delivery of online pharmaceutical services; and
             199          (ii) one may not be an online prescriber licensed under this chapter;
             200          (b) two members who are licensed as a pharmacist under Chapter 17b, Pharmacy
             201      Practice Act, of which:
             202          (i) one shall be associated with an online contract pharmacy; and
             203          (ii) one may not be associated with an online contract pharmacy;
             204          (c) two members of the general public who are not associated with:
             205          (i) an online prescriber;
             206          (ii) an online contract pharmacy; or
             207          (iii) an Internet facilitator; and
             208          (d) one member who is licensed under this chapter as an Internet facilitator.
             209          (2) Notwithstanding any other requirement for membership on the board, no more
             210      than one member of the board may be associated in any of the following ways with the same
             211      Internet facilitator:
             212          (a) as an owner;
             213          (b) as an employee;
             214          (c) as an officer;
             215          (d) as a director;
             216          (e) contracted with;
             217          (f) as an agent of; or
             218          (g) having any direct or indirect financial interest.
             219          (3) The board shall be appointed and serve in accordance with Section 58-1-201 .
             220          (4) (a) The duties and responsibilities of the board shall be in accordance with
             221      Sections 58-1-202 and 58-1-203 , and as otherwise provided in this chapter.
             222          (b) The board may designate one of its members on a permanent or rotating basis to:
             223          (i) assist the division in reviewing complaints concerning the unlawful or
             224      unprofessional conduct of a licensee; and
             225          (ii) advise the division in its investigation of a complaint.


             226          (5) A board member who has, under Subsection (4), reviewed a complaint or advised
             227      in its investigation may be disqualified from participating with the board when the board
             228      serves as a presiding officer of an administrative proceeding concerning the complaint.
             229          Section 5. Section 58-83-301 is enacted to read:
             230     
Part 3. Licensing

             231          58-83-301. Licensure required -- Issuance of licenses.
             232          (1) Beginning July 1, 2010, and except as provided in Section 58-1-307 :
             233          (a) a physician licensed under Chapter 67, Utah Medical Practice Act, or Chapter 68,
             234      Utah Osteopathic Medical Practice Act, shall be licensed under this chapter to engage in the
             235      delivery of online pharmaceutical services;
             236          (b) an online contract pharmacy shall be licensed under this chapter to engage in the
             237      delivery of online pharmaceutical services; and
             238          (c) an Internet facilitator shall be licensed under this chapter to engage in the delivery
             239      of online pharmaceutical services.
             240          (2) The division shall issue, to any person who qualifies under this chapter, a license:
             241          (a) to prescribe online;
             242          (b) to operate as an online contract pharmacy; or
             243          (c) to operate as an Internet facilitator.
             244          (3) (a) A license under this chapter is not required to engage in electronic prescribing
             245      under Chapter 82, Electronic Prescribing Act; and
             246          (b) nothing in this chapter shall prohibit a physician licensed under Chapter 67, Utah
             247      Medical Practice Act, or Chapter 68, Utah Osteopathic Medical Practice Act, from electronic
             248      prescribing or Internet prescribing as permitted by Chapter 67 or 68, or other law.
             249          Section 6. Section 58-83-302 is enacted to read:
             250          58-83-302. Qualifications for licensure.
             251          (1) Each applicant for licensure as an online prescriber under this chapter shall:
             252          (a) submit an application in a form prescribed by the division;
             253          (b) pay a fee determined by the department under Section 63J-1-504 ;


             254          (c) be of good moral character;
             255          (d) document that the applicant holds a Utah license that is active and in good
             256      standing and authorizes the licensee to engage in the assessment, diagnosis, and treatment of
             257      human ailments and the prescription of medications;
             258          (e) document that any other professional license the applicant possesses from other
             259      jurisdictions is in good standing;
             260          (f) (i) submit to the division an outline of the applicant's proposed online assessment,
             261      diagnosis, and prescribing tool, such as a branching questionnaire; and
             262          (ii) demonstrate the proposed online assessment, diagnosis, and prescribing tool to the
             263      board and establish to the board's satisfaction that the utilization of that assessment tool to
             264      facilitate the prescription of the drugs approved for online prescribing under Section
             265      58-83-305 does not compromise the public's health, safety, or welfare;
             266          (g) submit policies and procedures that address patient confidentiality, including
             267      measures that will be taken to ensure that the age and other identifying information of the
             268      person completing the online branching questionnaire are accurate;
             269          (h) describe the mechanism by which the online prescriber and patient will
             270      communicate with one another, including electronic and telephonic communication;
             271          (i) describe how the online prescriber/patient relationship will be established and
             272      maintained;
             273          (j) submit the name, address, and contact person of the Internet facilitator with whom
             274      the online prescriber has contracted to provide services that the online prescriber will use to
             275      engage in online assessment, diagnosis, and prescribing; and
             276          (k) submit documentation satisfactory to the board regarding public health, safety, and
             277      welfare demonstrating:
             278          (i) how the online prescriber will comply with the requirements of Section 58-83-305 ;
             279          (ii) the contractual services arrangement between the online prescriber and:
             280          (A) the Internet facilitator; and
             281          (B) the online contract pharmacy; and


             282          (iii) how the online prescriber will allow and facilitate the division's ability to conduct
             283      audits in accordance with Section 58-83-308 .
             284          (2) An online prescriber may not use the services of an Internet facilitator or online
             285      contract pharmacy whose license is not active and in good standing.
             286          (3) Each applicant for licensure as an online contract pharmacy under this chapter
             287      shall:
             288          (a) be licensed in good standing in Utah as a Class A Retail Pharmacy or a Class B
             289      Closed Door Pharmacy;
             290          (b) submit a written application in the form prescribed by the division;
             291          (c) pay a fee as determined by the department under Section 63J-1-504 ;
             292          (d) submit any contract between the applicant and the Internet facilitator with which
             293      the applicant is or will be affiliated;
             294          (e) submit proof of liability insurance acceptable to the division that expressly covers
             295      all activities the online contract pharmacy will engage in under this chapter, which coverage
             296      shall be in a minimum amount of $1,000,000 per occurrence with a policy limit of not less
             297      than $3,000,000;
             298          (f) submit a signed affidavit to the division attesting that the online contract pharmacy
             299      will not dispense a drug that is prescribed by an online prescriber engaged in the delivery of
             300      online pharmaceutical services under the provisions of this chapter unless:
             301          (i) the drug is specifically approved by the division under Section 58-83-306 ; and
             302          (ii) both the prescribing and the dispensing of the drug were facilitated by the Internet
             303      facilitator with whom the Internet contract pharmacy is associated under Subsection
             304      58-83-302 (3)(d);
             305          (g) document that any other professional license the applicant possesses from other
             306      jurisdictions is active and in good standing; and
             307          (h) demonstrate to the division that the applicant has satisfied any background check
             308      required by Section 58-17b-307 , and each owner, officer, or manager of the applicant online
             309      contract pharmacy has not engaged in any act, practice, or omission, which when considered


             310      with the duties and responsibilities of a licensee under this chapter indicates there is cause to
             311      believe that issuing a license under this chapter is inconsistent with the public's health, safety,
             312      or welfare.
             313          (4) Each applicant for licensure as an Internet facilitator under this chapter shall:
             314          (a) submit a written application in the form prescribed by the division;
             315          (b) pay a fee as determined by the department under Section 63J-1-504 ;
             316          (c) submit any contract between the applicant and the following with which the
             317      applicant will be affiliated:
             318          (i) each online prescriber; and
             319          (ii) the single online contract pharmacy;
             320          (d) submit written policies and procedures satisfactory to the division that:
             321          (i) address patient privacy, including compliance with 45 C.F.R. Parts 160, 162, and
             322      164, Health Insurance Portability and Accountability Act of 1996;
             323          (ii) ensure compliance with all applicable laws by health care personnel and the online
             324      prescriber who will process patient communications;
             325          (iii) list the hours of operation;
             326          (iv) describe the types of services that will be permitted electronically;
             327          (v) describe the required patient information to be included in the communication,
             328      such as patient name, identification number, and type of transaction;
             329          (vi) establish procedures for archiving and retrieving information; and
             330          (vii) establish quality oversight mechanisms;
             331          (e) submit written documentation of the applicant's security measures to ensure the
             332      confidentiality and integrity of any user-identifiable medical information;
             333          (f) submit a description of the mechanism for:
             334          (i) patients to access, supplement, and amend patient-provided personal health
             335      information;
             336          (ii) back-up regarding the Internet facilitator electronic interface;
             337          (iii) the quality of information and services provided via the interface; and


             338          (iv) patients to register complaints regarding the Internet facilitator, the online
             339      prescriber, or the online contract pharmacy;
             340          (g) submit a copy of the Internet facilitator's website;
             341          (h) sign an affidavit attesting that:
             342          (i) the applicant will not access any medical records or information contained in the
             343      medical record except as necessary to administer the website and the branching questionnaire;
             344      and
             345          (ii) the applicant and its principals, and any entities affiliated with them, will only use
             346      the services of a single online contract pharmacy named on the license approved by the
             347      division; and
             348          (i) submit any other information required by the division.
             349          Section 7. Section 58-83-303 is enacted to read:
             350          58-83-303. Term of license -- Expiration -- Renewal.
             351          (1) The online prescriber's license shall be associated with the online prescriber's
             352      primary professional license and may be renewed at the time the primary license is renewed in
             353      accordance with Subsection 58-1-308 (1).
             354          (2) The online contract pharmacy license shall be associated with the online contract
             355      pharmacy's primary professional license and may be renewed at the time the primary license is
             356      renewed in accordance with Subsection 58-1-308 (1).
             357          (3) The Internet facilitator license shall be renewed in accordance with Section
             358      58-1-308 .
             359          (4) Each licensee shall, at the time of applying for renewal, demonstrate compliance
             360      with this chapter.
             361          (5) Each license shall automatically expire on the expiration date shown on the license
             362      unless the licensee renews it in accordance with Section 58-1-308 .
             363          Section 8. Section 58-83-304 is enacted to read:
             364          58-83-304. Existing written agreements for online prescribing -- Pending
             365      applications.


             366          (1) (a) Subject to the provisions of this section, and until December 31, 2010, an entity
             367      or individual not licensed by the division to engage in the delivery of online pharmaceutical
             368      services under this chapter may nevertheless engage in the delivery of online pharmaceutical
             369      services if permitted by the division to do so prior to December 31, 2009, under either:
             370          (i) a non-disciplinary stipulation and consent order with the division; or
             371          (ii) a letter agreement with the division.
             372          (b) An entity or individual subject to Subsection (1)(a) shall only be permitted to
             373      engage in the delivery of online pharmaceutical services after December 31, 2010, if, on or
             374      before that date, it has obtained a license in accordance with the provisions of this chapter.
             375          (2) An entity or individual engaged in the delivery of online pharmaceutical services
             376      under the provisions of Subsection (1), may continue to operate in accordance with the terms
             377      and conditions of the written consent or agreement subject to the following:
             378          (a) On or before June 1, 2010, the entity or individual shall file an application with the
             379      division in accordance with this chapter for:
             380          (i) an online prescriber license;
             381          (ii) an online contract pharmacy license; or
             382          (iii) an Internet facilitator license.
             383          (b) After the application for a license under this chapter is filed in accordance with
             384      Subsection (2)(a), the applicant may continue to operate under the terms and conditions of the
             385      written consent agreement under Subsection (1)(a) until the division has issued its decision on
             386      the application.
             387          (c) If the application is approved and a license is issued, the licensee:
             388          (i) shall operate under the terms of the license under this chapter; and
             389          (ii) may not operate under the terms and conditions of the prior written consent or
             390      agreement of the division.
             391          (d) If the application for license under this chapter is denied, the applicant may not
             392      operate under the prior written consent or agreement with the division after the date the
             393      application for a license under this chapter is denied by the division.


             394          (3) (a) The following provisions apply to any application for authorization to engage
             395      in the delivery of online pharmaceutical services that was pending with the division on the
             396      effective date of this chapter:
             397          (i) the applicant shall:
             398          (A) no later than June 30, 2010, provide supplemental documentation to the division
             399      to correct any deficiency in the application; and
             400          (B) notify the division in writing that the application is ready to be acted upon by the
             401      division; or
             402          (ii) the applicant may rely upon the existing application submitted to the division
             403      without any supplementation under Subsection (1)(a)(i), if the applicant notifies the division
             404      in writing that the application is ready to be acted upon by the division.
             405          (b) The division shall not, prior to June 30, 2010, act on an application pending with
             406      the division on the effective date of this chapter unless the division prior to June 30, 2010,
             407      receives a notification from the applicant that the application is ready to be acted upon by the
             408      division.
             409          Section 9. Section 58-83-305 is enacted to read:
             410          58-83-305. Duties and responsibilities.
             411          (1) The online prescriber shall:
             412          (a) be held to the same standards of appropriate practice as those applicable in
             413      traditional settings which, for purposes of this chapter, include the delivery of online
             414      pharmaceutical services;
             415          (b) conduct an assessment and diagnosis based upon a comprehensive health history
             416      and an assessment tool such as a branching questionnaire;
             417          (c) ensure that a comprehensive health history, assessment, and diagnosis have been
             418      made before prescribing any medication;
             419          (d) conduct the online assessment and diagnosis only through the approved Internet
             420      facilitator identified in the online prescriber's application;
             421          (e) comply with all applicable state and federal laws, rules, regulations, and orders;


             422          (f) inform the patient electronically of the benefits and risks of appropriate treatment;
             423          (g) guide the patient regarding the optimal course of action;
             424          (h) treat the patient with courtesy, respect, dignity, responsiveness, and timely
             425      attention to the patient's needs;
             426          (i) comply with the requirements for confidentiality as required by this title and
             427      applicable federal law;
             428          (j) continue to provide the user with reasonable assistance and sufficient opportunity
             429      to make alternative arrangements for care;
             430          (k) be available for ongoing consultation with the patient through e-mail or other
             431      forms of communication;
             432          (l) not delegate to a third party the professional responsibility to:
             433          (i) review and evaluate the results of the branching questionnaire;
             434          (ii) consult with the patient electronically or through other means about the patient's
             435      medical condition; and
             436          (iii) diagnose and prescribe medications to the patient;
             437          (m) conduct the online assessment and diagnosis and the electronic communication
             438      between the online prescriber and the patient only through the approved Internet facilitator;
             439          (n) (i) maintain the online medical records of the patient; and
             440          (ii) if maintenance of the records is delegated by the online prescriber, delegate that
             441      authority only to the approved Internet facilitator;
             442          (o) inform a patient of the patient's freedom of choice to select the pharmacy to
             443      dispense the patient's prescription by providing the patient with the phone number of the
             444      online contract pharmacy so that the patient may contact the online contract pharmacy and
             445      request a transfer of the prescription to another pharmacy; and
             446          (p) authorize the Internet facilitator to provide the online contract pharmacy with the
             447      patient's:
             448          (i) full name;
             449          (ii) current address and telephone number;


             450          (iii) date of birth or age and gender;
             451          (iv) height, weight, and vital signs (if known);
             452          (v) medication allergies or drug reactions; and
             453          (vi) current medications, including over-the-counter products, and any additional
             454      comments relevant to the patient's drug use.
             455          (2) The online contract pharmacy shall:
             456          (a) only dispense prescription drugs that:
             457          (i) are approved by the division in accordance with Section 58-83-306 ; and
             458           (ii) were prescribed by an online prescriber who is using the Internet facilitator that is
             459      under contract with the online contract pharmacy;
             460          (b) maintain a toll-free number with a pharmacist available for patients using the
             461      services of the online contract pharmacy to receive medications prescribed online;
             462          (c) use a tracking identification number system when shipping medications prescribed
             463      for patients by an online prescriber; and
             464          (d) provide to the division a quarterly report of all drugs dispensed in accordance with
             465      this chapter.
             466          (3) The Internet facilitator shall:
             467          (a) provide services that the online prescriber will use in implementing the branching
             468      questionnaire;
             469          (b) provide electronic or telephonic communication between the online prescriber and
             470      the patient that:
             471          (i) is secure and confidential;
             472          (ii) allows the online prescriber to be directly accessible to a patient to answer
             473      questions regarding the patient's treatment plan; and
             474          (iii) provides privacy and security that complies with the provisions of 45 C.F.R. Parts
             475      160, 162, and 164, Health Insurance Portability and Accountability Act of 1996;
             476          (c) facilitate secure and confidential communication of the prescription issued by the
             477      online prescriber to the online contract pharmacy in accordance with Subsection (1)(p);


             478          (d) disclose on its website:
             479          (i) the owner of the website;
             480          (ii) the specific services provided by any associated online prescribers; and
             481          (iii) other information the division may require by rule; and
             482          (e) (i) only facilitate the delivery of online pharmaceutical services for the specific
             483      legend drugs approved by the division in accordance with Section 58-83-306 ; or
             484          (ii) not facilitate, directly or indirectly, through related entities or affiliates, the
             485      dispensing or online prescribing of any drug whether controlled or legend that is not
             486      specifically approved under Section 58-83-306 .
             487          Section 10. Section 58-83-306 is enacted to read:
             488          58-83-306. Drugs approved for online prescribing, dispensing, and facilitation.
             489          (1) An online prescriber may only prescribe, an online contract pharmacy may only
             490      dispense, and an Internet facilitator may only facilitate the prescribing and dispensing of,
             491      non-controlled, legend drugs that have been:
             492          (a) approved by the Food and Drug Administration;
             493          (b) prescribed to treat the condition for which the drug was approved; and
             494          (c) specifically approved by the division for online prescribing by administrative rule
             495      adopted in accordance with Title 63G, Chapter 3, Utah Administrative Rulemaking Act.
             496          (2) If, after January 1, 2010, the Food and Drug Administration issues a clinical black
             497      box warning with respect to any drug approved by the board under Subsection (1), the division
             498      shall determine what action, if any, is necessary to protect the public health or welfare as a
             499      result of the black box warning.
             500          Section 11. Section 58-83-307 is enacted to read:
             501          58-83-307. Approval of additional drugs -- Request to facilitate.
             502          (1) An Internet facilitator licensed under this chapter may seek the division's approval
             503      to facilitate the online prescribing and dispensing of prescriptions for additional drugs.
             504          (2) The Internet facilitator shall make a request for approval of additional drugs by
             505      petitioning for an amendment to the administrative rule adopted by the division in accordance


             506      with Section 58-83-306 and Title 63G, Chapter 3, Utah Administrative Rulemaking Act.
             507          Section 12. Section 58-83-308 is enacted to read:
             508          58-83-308. Audits.
             509          (1) Each licensee under this chapter shall allow and facilitate an audit by the division
             510      regarding the licensee's delivery of online pharmaceutical services to ensure compliance with
             511      state and federal statutes, rules, and regulations including ensuring that:
             512          (a) a comprehensive history and assessment have been obtained and a diagnosis has
             513      been made for a patient before any medications are prescribed; and
             514          (b) only the approved medications are being prescribed and dispensed.
             515          (2) The division shall be provided with the following, in the manner that allows access
             516      from the division's office for the purpose of conducting an audit:
             517          (a) full remote, read-only access rights to the data related to the online prescribing and
             518      dispensing of a drug under this chapter and that is used and stored in the Internet facilitator's
             519      system; and
             520          (b) the information available to the online prescriber.
             521          (3) An Internet facilitator licensed under this chapter shall provide to the division, at
             522      the times designated by the division by administrative rule, a report containing the following
             523      information:
             524          (a) the number of prescriptions issued by the online prescribers associated with the
             525      Internet facilitator by drug name;
             526          (b) the number of comprehensive histories/assessments received by the Internet
             527      facilitator;
             528          (c) the number of comprehensive histories/assessments reviewed by an online
             529      prescriber;
             530          (d) the demographic data of the patients receiving prescriptions through the Internet
             531      facilitator;
             532          (e) the number of prescriptions:
             533          (i) dispensed by the online contract pharmacy; or


             534          (ii) transferred to a different pharmacy at the patient's request; and
             535          (f) any other information specified by the division by administrative rule.
             536          (4) The division's authority to conduct an audit pursuant to this chapter shall survive
             537      any termination or expiration of any prescriptive authority for online prescribing, dispensing,
             538      or facilitation.
             539          Section 13. Section 58-83-401 is enacted to read:
             540     
Part 4. License Denial and Discipline

             541          58-83-401. Grounds for denial of license -- Disciplinary proceedings --
             542      Termination of authority to prescribe -- Immediate and significant danger.
             543          (1) Grounds for refusing to issue a license to an applicant, for refusing to renew the
             544      license of a licensee, for revoking, suspending, restricting, or placing on probation the license
             545      of a licensee, for issuing a public or private reprimand to a licensee, and for issuing a cease
             546      and desist order:
             547          (a) shall be in accordance with Section 58-1-401 ; and
             548          (b) includes:
             549          (i) prescribing, dispensing, or facilitating the prescribing or dispensing of a drug not
             550      approved by the board under Section 58-83-306 ; or
             551          (ii) any other violation of this chapter.
             552          (2) The termination or expiration of a license under this chapter for any reason does
             553      not limit the division's authority to start or continue any investigation or adjudicative
             554      proceeding.
             555          (3) Because of the working business relationship between and among the online
             556      prescriber, the Internet facilitator, and the online contract pharmacy, each entity's ability to
             557      comply with this chapter may depend in some respects on the actions of the others. It is
             558      possible that a particular action or inaction by the online prescriber, the Internet facilitator, or
             559      the online contract pharmacy could have the effect of causing the other licensed entities to be
             560      out of compliance with this chapter, and each entity may, therefore, be held accountable for
             561      any related party's non-compliance, if the party knew or reasonably should have known of the


             562      other person's non-compliance.
             563          (4) An online prescriber may lose the practitioner's professional license to prescribe
             564      any drug under this title if the online prescriber knew or reasonably should have known that
             565      the provisions of this chapter were violated by the online prescriber, the Internet facilitator, or
             566      the online contract pharmacy. It is not a defense to an alleged violation under this chapter that
             567      the alleged violation was a result of an action or inaction not by the charged party but by the
             568      related online prescriber, the online contract pharmacy, or the Internet facilitator.
             569          (5) The following actions may result in an immediate suspension of the online
             570      prescriber's license, the online contract pharmacy's license, or the Internet facilitator's license,
             571      and each is considered an immediate and significant danger to the public health, safety, or
             572      welfare requiring immediate action by the division pursuant to Section 63G-4-502 to terminate
             573      the delivery of online pharmaceutical services by the licensee:
             574          (a) online prescribing, dispensing, or facilitation with respect to:
             575          (i) a person under the age of 18 years;
             576          (ii) a legend drug not authorized by the division in accordance with Section
             577      58-83-306 ; and
             578          (iii) any controlled substance;
             579          (b) violating this chapter after having been given reasonable opportunity to cure the
             580      violation;
             581          (c) using the name or official seal of the state, the Utah Department of Commerce, or
             582      the Utah Division of Occupational and Professional Licensing, or their boards, in an
             583      unauthorized manner; or
             584          (d) failing to respond to a request from the division within the time frame requested
             585      for:
             586          (i) an audit of the website; or
             587          (ii) records of the online prescriber, the Internet facilitator, or the online contract
             588      pharmacy.
             589          Section 14. Section 58-83-501 is enacted to read:


             590     
Part 5. Unlawful and Unprofessional Conduct - Penalties

             591          58-83-501. Practice without a license.
             592          "Unlawful conduct" includes, in addition to the definition in Section 58-1-501 ,
             593      engaging in the practice of Internet prescribing without a license under this chapter.
             594          Section 15. Section 58-83-502 is enacted to read:
             595          58-83-502. Unprofessional conduct.
             596          "Unprofessional conduct" includes, in addition to the definition in Section 58-1-501
             597      and as may be further defined by administrative rule:
             598          (1) online prescribing, dispensing, or facilitation with respect to a person under the
             599      age of 18 years;
             600          (2) using the name or official seal of the state, the Utah Department of Commerce, or
             601      the Utah Division of Occupational and Professional Licensing, or their boards, in an
             602      unauthorized manner;
             603          (3) failing to respond promptly to a request by the division for information including:
             604          (a) an audit of the website; or
             605          (b) records of the online prescriber, the Internet facilitator, or the online contract
             606      pharmacy;
             607          (4) using an online prescriber, online contract pharmacy, or Internet facilitator without
             608      approval of the division;
             609          (5) failing to inform a patient of the patient's freedom of choice in selecting who will
             610      dispense a prescription in accordance with Subsection 58-83-305 (1)(n); and
             611          (6) failing to keep the division informed of the name and contact information of the
             612      Internet facilitator or online contract pharmacy.
             613          Section 16. Section 58-83-503 is enacted to read:
             614          58-83-503. Unlawful conduct.
             615          Unlawful conduct includes, in addition to the definition in Section 58-1-501 :
             616          (1) online prescribing, dispensing or facilitating of a legend drug not authorized by the
             617      division in accordance with Section 58-83-306 ; or


             618          (2) online prescribing, dispensing or facilitating of a controlled substance.


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