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Second Substitute S.B. 274

Senator Curtis S. Bramble proposes the following substitute bill:


             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, or
             16      online 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 occupation
             68      or profession licensed under this title to be used by another, except as permitted by law;
             69          (e) obtaining a passing score on a licensure examination, applying for or obtaining a
             70      license, or otherwise dealing with the division or a licensing board through the use of fraud,
             71      forgery, or intentional deception, misrepresentation, misstatement, or omission; or
             72          (f) (i) [unless Subsection (2)(m) or (4) applies,] issuing, or aiding and abetting in the
             73      issuance of, an order or prescription for a drug or device to a person located in this state:
             74          (A) without prescriptive authority conferred by a license issued under this title, or by
             75      an exemption to licensure under this title; or
             76          (B) with prescriptive authority conferred by an exception issued under this title or a
             77      multistate practice privilege recognized under this title, if the prescription was issued[: (I)]
             78      without first obtaining information, in the usual course of professional practice, that is
             79      sufficient to establish a diagnosis, to identify underlying conditions, and to identify
             80      contraindications to the proposed treatment; [or] and
             81          [(II) based on a questionnaire completed by the patient on the internet, or toll-free
             82      telephone number, when there exists no other bona fide patient-practitioner relationship; or]
             83          [(C) in violation of Subsection (2)(m), when the licensed person who issued, or aided
             84      and abetted another in the issuance of the prescription has violated Subsection (2)(m) on more
             85      than 100 prescriptions within a 30 day period of time; and]
             86          (ii) Subsection (1)(f)(i) does not apply to treatment rendered in an emergency, on-call
             87      or cross coverage situation, provided that the person who issues the prescription has


             88      prescriptive authority conferred by a license under this title, or is exempt from licensure under
             89      this title.
             90          (2) "Unprofessional conduct" means conduct, by a licensee or applicant, that is defined
             91      as unprofessional conduct under this title or under any rule adopted under this title and
             92      includes:
             93          (a) violating, or aiding or abetting any other person to violate, any statute, rule, or order
             94      regulating an occupation or profession under this title;
             95          (b) violating, or aiding or abetting any other person to violate, any generally accepted
             96      professional or ethical standard applicable to an occupation or profession regulated under this
             97      title;
             98          (c) engaging in conduct that results in conviction, a plea of nolo contendere, or a plea
             99      of guilty or nolo contendere which is held in abeyance pending the successful completion of
             100      probation with respect to a crime of moral turpitude or any other crime that, when considered
             101      with the functions and duties of the occupation or profession for which the license was issued
             102      or is to be issued, bears a reasonable relationship to the licensee's or applicant's ability to safely
             103      or competently practice the occupation or profession;
             104          (d) engaging in conduct that results in disciplinary action, including reprimand,
             105      censure, diversion, probation, suspension, or revocation, by any other licensing or regulatory
             106      authority having jurisdiction over the licensee or applicant in the same occupation or profession
             107      if the conduct would, in this state, constitute grounds for denial of licensure or disciplinary
             108      proceedings under Section 58-1-401 ;
             109          (e) engaging in conduct, including the use of intoxicants, drugs, narcotics, or similar
             110      chemicals, to the extent that the conduct does, or might reasonably be considered to, impair the
             111      ability of the licensee or applicant to safely engage in the occupation or profession;
             112          (f) practicing or attempting to practice an occupation or profession regulated under this
             113      title despite being physically or mentally unfit to do so;
             114          (g) practicing or attempting to practice an occupation or profession regulated under this
             115      title through gross incompetence, gross negligence, or a pattern of incompetency or negligence;
             116          (h) practicing or attempting to practice an occupation or profession requiring licensure
             117      under this title by any form of action or communication which is false, misleading, deceptive,
             118      or fraudulent;


             119          (i) practicing or attempting to practice an occupation or profession regulated under this
             120      title beyond the scope of the licensee's competency, abilities, or education;
             121          (j) practicing or attempting to practice an occupation or profession regulated under this
             122      title beyond the scope of the licensee's license;
             123          (k) verbally, physically, mentally, or sexually abusing or exploiting any person through
             124      conduct connected with the licensee's practice under this title or otherwise facilitated by the
             125      licensee's license;
             126          (l) acting as a supervisor without meeting the qualification requirements for that
             127      position that are defined by statute or rule;
             128          (m) [unless Subsection (4) applies,] issuing, or aiding and abetting in the issuance of,
             129      an order or prescription for a drug or device:
             130          (i) without first obtaining information in the usual course of professional practice, that
             131      is sufficient to establish a diagnosis, to identify conditions, and to identify contraindications to
             132      the proposed treatment; or
             133          [(ii) based on a questionnaire completed by the patient on the internet, or toll free
             134      telephone number when there exists no other bona fide patient-practitioner relationship or bona
             135      fide referral by a practitioner involved in an existing patient-practitioner relationship; or]
             136          (ii) with prescriptive authority conferred by an exception issued under this title, or a
             137      multi-state practice privilege recognized under this title, if the prescription was issued without
             138      first obtaining information, in the usual course of professional practice, that is sufficient to
             139      establish a diagnosis, to identify underlying conditions, and to identify contraindications to the
             140      proposed treatment; or
             141          (n) violating a provision of Section 58-1-501.5 .
             142          [(3) Subsection (2)(m) does not apply to treatment rendered in an emergency, on-call,
             143      or cross coverage situation.]
             144          [(4) Notwithstanding Subsections (1)(f) and (2)(m), the division may permit a person
             145      licensed to prescribe under this title to prescribe a legend drug to a person located in this state
             146      if the division in collaboration with the appropriate professional board has permitted the
             147      specific prescriptive practice of the legend drug by rule.]
             148          Section 2. Section 58-83-101 is enacted to read:
             149     
CHAPTER 83. ONLINE PRESCRIBING, DISPENSING,


             150     
AND FACILITATION LICENSING ACT

             151     
Part 1. General Provisions

             152          58-83-101. Title.
             153          This chapter is known as the "Online Prescribing, Dispensing, and Facilitation
             154      Licensing Act."
             155          Section 3. Section 58-83-102 is enacted to read:
             156          58-83-102. Definitions.
             157          In addition to the definitions in Section 58-1-102 , as used in this chapter:
             158          (1) "Board" means the Online Prescribing, Dispensing, and Facilitation Licensing
             159      Board created in Section 58-83-201 .
             160          (2) "Branching questionnaire" means an adaptive and progressive assessment tool
             161      approved by the board.
             162          (3) "Delivery of online pharmaceutical services" means the process in which a
             163      prescribing practitioner diagnoses a patient and prescribes one or more of the drugs authorized
             164      by Section 58-83-306 , using:
             165          (a) a branching questionnaire or other assessment tool approved by the division for the
             166      purpose of diagnosing and assessing a patient's health status;
             167          (b) an Internet contract pharmacy to:
             168          (i) dispense the prescribed drug; or
             169          (ii) transfer the prescription to another pharmacy; and
             170          (c) an Internet facilitator to facilitate the practices described in Subsections (3)(a) and
             171      (b).
             172          (4) "Division" means the Utah Division of Occupational and Professional Licensing.
             173          (5) "Internet facilitator" means a licensed provider of a web-based system for electronic
             174      communication between and among an online prescriber, the online prescriber's patient, and
             175      the online contract pharmacy.
             176          (6) "Online contract pharmacy" means a pharmacy licensed and in good standing under
             177      Chapter 17b, Pharmacy Practice Act, as either a Class A Retail Pharmacy or a Class B Closed
             178      Door Pharmacy and licensed under this chapter to fulfill prescriptions issued by an online
             179      prescriber through a specific Internet facilitator.
             180          (7) "Online prescriber" means a person:


             181          (a) licensed under another chapter of this title;
             182          (b) whose license under another chapter of this title includes assessing, diagnosing, and
             183      prescribing authority for humans; and
             184          (c) who has obtained a license under this chapter to engage in online prescribing.
             185          (8) "Unlawful conduct" is as defined in Sections 58-1-501 and 58-83-501 .
             186          (9) "Unprofessional conduct" is as defined in Sections 58-1-203 and 58-83-502 , and as
             187      further defined by the division in accordance with Title 63G, Chapter 3, Utah Administrative
             188      Rulemaking Act.
             189          Section 4. Section 58-83-201 is enacted to read:
             190     
Part 2. Board

             191          58-83-201. Board.
             192          (1) There is created the Online Prescribing, Dispensing, and Facilitation Licensing
             193      Board consisting of the following seven members:
             194          (a) two members who are licensed under either Chapter 67, Utah Medical Practices
             195      Act, or Chapter 68, Utah Osteopathic Medical Practices Act, of which:
             196          (i) one shall be engaged in the delivery of online pharmaceutical services; and
             197          (ii) one may not be an online prescriber licensed under this chapter;
             198          (b) two members who are licensed as a pharmacist under Chapter 17b, Pharmacy
             199      Practice Act, of which:
             200          (i) one shall be associated with an online contract pharmacy; and
             201          (ii) one may not be associated with an online contract pharmacy;
             202          (c) two members of the general public who are not associated with:
             203          (i) an online prescriber;
             204          (ii) an online contract pharmacy; or
             205          (iii) an Internet facilitator; and
             206          (d) one member who is licensed under this chapter as an Internet facilitator.
             207          (2) Notwithstanding any other requirement for membership on the board, no more than
             208      one member of the board may be associated in any of the following ways with the same
             209      Internet facilitator:
             210          (a) as an owner;
             211          (b) as an employee;


             212          (c) as an officer;
             213          (d) as a director;
             214          (e) contracted with;
             215          (f) as an agent of; or
             216          (g) having any direct or indirect financial interest.
             217          (3) The board shall be appointed and serve in accordance with Section 58-1-201 .
             218          (4) (a) The duties and responsibilities of the board shall be in accordance with Sections
             219      58-1-202 and 58-1-203 , and as otherwise provided in this chapter.
             220          (b) The board may designate one of its members on a permanent or rotating basis to:
             221          (i) assist the division in reviewing complaints concerning the unlawful or
             222      unprofessional conduct of a licensee; and
             223          (ii) advise the division in its investigation of a complaint.
             224          (5) A board member who has, under Subsection (4), reviewed a complaint or advised
             225      in its investigation may be disqualified from participating with the board when the board serves
             226      as a presiding officer of an administrative proceeding concerning the complaint.
             227          Section 5. Section 58-83-301 is enacted to read:
             228     
Part 3. Licensing

             229          58-83-301. Licensure required -- Issuance of licenses.
             230          (1) Beginning July 1, 2010, and except as provided in Section 58-1-307 :
             231          (a) a physician licensed under Chapter 67, Utah Medical Practice Act, or Chapter 68,
             232      Utah Osteopathic Medical Practice Act, shall be licensed under this chapter to engage in the
             233      delivery of online pharmaceutical services;
             234          (b) an online contract pharmacy shall be licensed under this chapter to engage in the
             235      delivery of online pharmaceutical services; and
             236          (c) an Internet facilitator shall be licensed under this chapter to engage in the delivery
             237      of online pharmaceutical services.
             238          (2) The division shall issue, to any person who qualifies under this chapter, a license:
             239          (a) to prescribe online;
             240          (b) to operate as an online contract pharmacy; or
             241          (c) to operate as an Internet facilitator.
             242          (3) (a) A license under this chapter is not required to engage in electronic prescribing


             243      under Chapter 82, Electronic Prescribing Act; and
             244          (b) nothing in this chapter shall prohibit a physician licensed under Chapter 67, Utah
             245      Medical Practice Act, or Chapter 68, Utah Osteopathic Medical Practice Act, from electronic
             246      prescribing or Internet prescribing as permitted by Chapter 67 or 68, or other law.
             247          Section 6. Section 58-83-302 is enacted to read:
             248          58-83-302. Qualifications for licensure.
             249          (1) Each applicant for licensure as an online prescriber under this chapter shall:
             250          (a) submit an application in a form prescribed by the division;
             251          (b) pay a fee determined by the department under Section 63J-1-504 ;
             252          (c) be of good moral character;
             253          (d) document that the applicant holds a Utah license that is active and in good standing
             254      and authorizes the licensee to engage in the assessment, diagnosis, and treatment of human
             255      ailments and the prescription of medications;
             256          (e) document that any other professional license the applicant possesses from other
             257      jurisdictions is in good standing;
             258          (f) (i) submit to the division an outline of the applicant's proposed online assessment,
             259      diagnosis, and prescribing tool, such as a branching questionnaire; and
             260          (ii) demonstrate the proposed online assessment, diagnosis, and prescribing tool to the
             261      board and establish to the board's satisfaction that the utilization of that assessment tool to
             262      facilitate the prescription of the drugs approved for online prescribing under Section 58-83-305
             263      does not compromise the public's health, safety, or welfare;
             264          (g) submit policies and procedures that address patient confidentiality, including
             265      measures that will be taken to ensure that the age and other identifying information of the
             266      person completing the online branching questionnaire are accurate;
             267          (h) describe the mechanism by which the online prescriber and patient will
             268      communicate with one another, including electronic and telephonic communication;
             269          (i) describe how the online prescriber/patient relationship will be established and
             270      maintained;
             271          (j) submit the name, address, and contact person of the Internet facilitator with whom
             272      the online prescriber has contracted to provide services that the online prescriber will use to
             273      engage in online assessment, diagnosis, and prescribing; and


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


             305          (h) demonstrate to the division that the applicant has satisfied any background check
             306      required by Section 58-17b-307 , and each owner, officer, or manager of the applicant online
             307      contract pharmacy has not engaged in any act, practice, or omission, which when considered
             308      with the duties and responsibilities of a licensee under this chapter indicates there is cause to
             309      believe that issuing a license under this chapter is inconsistent with the public's health, safety,
             310      or welfare.
             311          (4) Each applicant for licensure as an Internet facilitator under this chapter shall:
             312          (a) submit a written application in the form prescribed by the division;
             313          (b) pay a fee as determined by the department under Section 63J-1-504 ;
             314          (c) submit any contract between the applicant and the following with which the
             315      applicant will be affiliated:
             316          (i) each online prescriber; and
             317          (ii) the single online contract pharmacy;
             318          (d) submit written policies and procedures satisfactory to the division that:
             319          (i) address patient privacy, including compliance with 45 C.F.R. Parts 160, 162, and
             320      164, Health Insurance Portability and Accountability Act of 1996;
             321          (ii) ensure compliance with all applicable laws by health care personnel and the online
             322      prescriber who will process patient communications;
             323          (iii) list the hours of operation;
             324          (iv) describe the types of services that will be permitted electronically;
             325          (v) describe the required patient information to be included in the communication, such
             326      as patient name, identification number, and type of transaction;
             327          (vi) establish procedures for archiving and retrieving information; and
             328          (vii) establish quality oversight mechanisms;
             329          (e) submit written documentation of the applicant's security measures to ensure the
             330      confidentiality and integrity of any user-identifiable medical information;
             331          (f) submit a description of the mechanism for:
             332          (i) patients to access, supplement, and amend patient-provided personal health
             333      information;
             334          (ii) back-up regarding the Internet facilitator electronic interface;
             335          (iii) the quality of information and services provided via the interface; and


             336          (iv) patients to register complaints regarding the Internet facilitator, the online
             337      prescriber, or the online contract pharmacy;
             338          (g) submit a copy of the Internet facilitator's website;
             339          (h) sign an affidavit attesting that:
             340          (i) the applicant will not access any medical records or information contained in the
             341      medical record except as necessary to administer the website and the branching questionnaire;
             342      and
             343          (ii) the applicant and its principals, and any entities affiliated with them, will only use
             344      the services of a single online contract pharmacy named on the license approved by the
             345      division; and
             346          (i) submit any other information required by the division.
             347          Section 7. Section 58-83-303 is enacted to read:
             348          58-83-303. Term of license -- Expiration -- Renewal.
             349          (1) The online prescriber's license shall be associated with the online prescriber's
             350      primary professional license and may be renewed at the time the primary license is renewed in
             351      accordance with Subsection 58-1-308 (1).
             352          (2) The online contract pharmacy license shall be associated with the online contract
             353      pharmacy's primary professional license and may be renewed at the time the primary license is
             354      renewed in accordance with Subsection 58-1-308 (1).
             355          (3) The Internet facilitator license shall be renewed in accordance with Section
             356      58-1-308 .
             357          (4) Each licensee shall, at the time of applying for renewal, demonstrate compliance
             358      with this chapter.
             359          (5) Each license shall automatically expire on the expiration date shown on the license
             360      unless the licensee renews it in accordance with Section 58-1-308 .
             361          Section 8. Section 58-83-304 is enacted to read:
             362          58-83-304. Existing written agreements for online prescribing -- Pending
             363      applications.
             364          (1) (a) Subject to the provisions of this section, and until December 31, 2010, an entity
             365      or individual not licensed by the division to engage in the delivery of online pharmaceutical
             366      services under this chapter may nevertheless engage in the delivery of online pharmaceutical


             367      services if permitted by the division to do so prior to December 31, 2009, under either:
             368          (i) a non-disciplinary stipulation and consent order with the division; or
             369          (ii) a letter agreement with the division.
             370          (b) An entity or individual subject to Subsection (1)(a) shall only be permitted to
             371      engage in the delivery of online pharmaceutical services after December 31, 2010, if, on or
             372      before that date, it has obtained a license in accordance with the provisions of this chapter.
             373          (2) An entity or individual engaged in the delivery of online pharmaceutical services
             374      under the provisions of Subsection (1), may continue to operate in accordance with the terms
             375      and conditions of the written consent or agreement subject to the following:
             376          (a) On or before June 1, 2010, the entity or individual shall file an application with the
             377      division in accordance with this chapter for:
             378          (i) an online prescriber license;
             379          (ii) an online contract pharmacy license; or
             380          (iii) an Internet facilitator license.
             381          (b) After the application for a license under this chapter is filed in accordance with
             382      Subsection (2)(a), the applicant may continue to operate under the terms and conditions of the
             383      written consent agreement under Subsection (1)(a) until the division has issued its decision on
             384      the application.
             385          (c) If the application is approved and a license is issued, the licensee:
             386          (i) shall operate under the terms of the license under this chapter; and
             387          (ii) may not operate under the terms and conditions of the prior written consent or
             388      agreement of the division.
             389          (d) If the application for license under this chapter is denied, the applicant may not
             390      operate under the prior written consent or agreement with the division after the date the
             391      application for a license under this chapter is denied by the division.
             392          (3) (a) The following provisions apply to any application for authorization to engage in
             393      the delivery of online pharmaceutical services that was pending with the division on the
             394      effective date of this chapter:
             395          (i) the applicant shall:
             396          (A) no later than June 30, 2010, provide supplemental documentation to the division to
             397      correct any deficiency in the application; and


             398          (B) notify the division in writing that the application is ready to be acted upon by the
             399      division; or
             400          (ii) the applicant may rely upon the existing application submitted to the division
             401      without any supplementation under Subsection (1)(a)(i), if the applicant notifies the division in
             402      writing that the application is ready to be acted upon by the division.
             403          (b) The division shall not, prior to June 30, 2010, act on an application pending with
             404      the division on the effective date of this chapter unless the division prior to June 30, 2010,
             405      receives a notification from the applicant that the application is ready to be acted upon by the
             406      division.
             407          Section 9. Section 58-83-305 is enacted to read:
             408          58-83-305. Duties and responsibilities.
             409          (1) The online prescriber shall:
             410          (a) be held to the same standards of appropriate practice as those applicable in
             411      traditional settings which, for purposes of this chapter, include the delivery of online
             412      pharmaceutical services;
             413          (b) conduct an assessment and diagnosis based upon a comprehensive health history
             414      and an assessment tool such as a branching questionnaire;
             415          (c) ensure that a comprehensive health history, assessment, and diagnosis have been
             416      made before prescribing any medication;
             417          (d) conduct the online assessment and diagnosis only through the approved Internet
             418      facilitator identified in the online prescriber's application;
             419          (e) comply with all applicable state and federal laws, rules, regulations, and orders;
             420          (f) inform the patient electronically of the benefits and risks of appropriate treatment;
             421          (g) guide the patient regarding the optimal course of action;
             422          (h) treat the patient with courtesy, respect, dignity, responsiveness, and timely attention
             423      to the patient's needs;
             424          (i) comply with the requirements for confidentiality as required by this title and
             425      applicable federal law;
             426          (j) continue to provide the user with reasonable assistance and sufficient opportunity to
             427      make alternative arrangements for care;
             428          (k) be available for ongoing consultation with the patient through e-mail or other forms


             429      of communication;
             430          (l) not delegate to a third party the professional responsibility to:
             431          (i) review and evaluate the results of the branching questionnaire;
             432          (ii) consult with the patient electronically or through other means about the patient's
             433      medical condition; and
             434          (iii) diagnose and prescribe medications to the patient;
             435          (m) conduct the online assessment and diagnosis and the electronic communication
             436      between the online prescriber and the patient only through the approved Internet facilitator;
             437          (n) (i) maintain the online medical records of the patient; and
             438          (ii) if maintenance of the records is delegated by the online prescriber, delegate that
             439      authority only to the approved Internet facilitator;
             440          (o) inform a patient of the patient's freedom of choice to select the pharmacy to
             441      dispense the patient's prescription by providing the patient with the phone number of the online
             442      contract pharmacy so that the patient may contact the online contract pharmacy and request a
             443      transfer of the prescription to another pharmacy; and
             444          (p) authorize the Internet facilitator to provide the online contract pharmacy with the
             445      patient's:
             446          (i) full name;
             447          (ii) current address and telephone number;
             448          (iii) date of birth or age and gender;
             449          (iv) height, weight, and vital signs (if known);
             450          (v) medication allergies or drug reactions; and
             451          (vi) current medications, including over-the-counter products, and any additional
             452      comments relevant to the patient's drug use.
             453          (2) The online contract pharmacy shall:
             454          (a) only dispense prescription drugs that:
             455          (i) are approved by the division in accordance with Section 58-83-306 ; and
             456           (ii) were prescribed by an online prescriber who is using the Internet facilitator that is
             457      under contract with the online contract pharmacy;
             458          (b) maintain a toll-free number with a pharmacist available for patients using the
             459      services of the online contract pharmacy to receive medications prescribed online;


             460          (c) use a tracking identification number system when shipping medications prescribed
             461      for patients by an online prescriber; and
             462          (d) provide to the division a quarterly report of all drugs dispensed in accordance with
             463      this chapter.
             464          (3) The Internet facilitator shall:
             465          (a) provide services that the online prescriber will use in implementing the branching
             466      questionnaire;
             467          (b) provide electronic or telephonic communication between the online prescriber and
             468      the patient that:
             469          (i) is secure and confidential;
             470          (ii) allows the online prescriber to be directly accessible to a patient to answer
             471      questions regarding the patient's treatment plan; and
             472          (iii) provides privacy and security that complies with the provisions of 45 C.F.R. Parts
             473      160, 162, and 164, Health Insurance Portability and Accountability Act of 1996;
             474          (c) facilitate secure and confidential communication of the prescription issued by the
             475      online prescriber to the online contract pharmacy in accordance with Subsection (1)(p);
             476          (d) disclose on its website:
             477          (i) the owner of the website;
             478          (ii) the specific services provided by any associated online prescribers; and
             479          (iii) other information the division may require by rule; and
             480          (e) (i) only facilitate the delivery of online pharmaceutical services for the specific
             481      legend drugs approved by the division in accordance with Section 58-83-306 ; or
             482          (ii) not facilitate, directly or indirectly, through related entities or affiliates, the
             483      dispensing or online prescribing of any drug whether controlled or legend that is not
             484      specifically approved under Section 58-83-306 .
             485          Section 10. Section 58-83-306 is enacted to read:
             486          58-83-306. Drugs approved for online prescribing, dispensing, and facilitation.
             487          (1) An online prescriber may only prescribe, an online contract pharmacy may only
             488      dispense, and an Internet facilitator may only facilitate the prescribing and dispensing of,
             489      non-controlled, legend drugs that have been:
             490          (a) approved by the Food and Drug Administration;


             491          (b) prescribed to treat the condition for which the drug was approved; and
             492          (c) specifically approved by the division for online prescribing by administrative rule
             493      adopted in accordance with Title 63G, Chapter 3, Utah Administrative Rulemaking Act.
             494          (2) If, after January 1, 2010, the Food and Drug Administration issues a clinical black
             495      box warning with respect to any drug approved by the board under Subsection (1), the division
             496      shall determine what action, if any, is necessary to protect the public health or welfare as a
             497      result of the black box warning.
             498          Section 11. Section 58-83-307 is enacted to read:
             499          58-83-307. Approval of additional drugs -- Request to facilitate.
             500          (1) An Internet facilitator licensed under this chapter may seek the division's approval
             501      to facilitate the online prescribing and dispensing of prescriptions for additional drugs.
             502          (2) The Internet facilitator shall make a request for approval of additional drugs by
             503      petitioning for an amendment to the administrative rule adopted by the division in accordance
             504      with Section 58-83-306 and Title 63G, Chapter 3, Utah Administrative Rulemaking Act.
             505          Section 12. Section 58-83-308 is enacted to read:
             506          58-83-308. Audits.
             507          (1) Each licensee under this chapter shall allow and facilitate an audit by the division
             508      regarding the licensee's delivery of online pharmaceutical services to ensure compliance with
             509      state and federal statutes, rules, and regulations including ensuring that:
             510          (a) a comprehensive history and assessment have been obtained and a diagnosis has
             511      been made for a patient before any medications are prescribed; and
             512          (b) only the approved medications are being prescribed and dispensed.
             513          (2) The division shall be provided with the following, in the manner that allows access
             514      from the division's office for the purpose of conducting an audit:
             515          (a) full remote, read-only access rights to the data related to the online prescribing and
             516      dispensing of a drug under this chapter and that is used and stored in the Internet facilitator's
             517      system; and
             518          (b) the information available to the online prescriber.
             519          (3) An Internet facilitator licensed under this chapter shall provide to the division, at
             520      the times designated by the division by administrative rule, a report containing the following
             521      information:


             522          (a) the number of prescriptions issued by the online prescribers associated with the
             523      Internet facilitator by drug name;
             524          (b) the number of comprehensive histories/assessments received by the Internet
             525      facilitator;
             526          (c) the number of comprehensive histories/assessments reviewed by an online
             527      prescriber;
             528          (d) the demographic data of the patients receiving prescriptions through the Internet
             529      facilitator;
             530          (e) the number of prescriptions:
             531          (i) dispensed by the online contract pharmacy; or
             532          (ii) transferred to a different pharmacy at the patient's request; and
             533          (f) any other information specified by the division by administrative rule.
             534          (4) The division's authority to conduct an audit pursuant to this chapter shall survive
             535      any termination or expiration of any prescriptive authority for online prescribing, dispensing, or
             536      facilitation.
             537          Section 13. Section 58-83-401 is enacted to read:
             538     
Part 4. License Denial and Discipline

             539          58-83-401. Grounds for denial of license -- Disciplinary proceedings --
             540      Termination of authority to prescribe -- Immediate and significant danger.
             541          (1) Grounds for refusing to issue a license to an applicant, for refusing to renew the
             542      license of a licensee, for revoking, suspending, restricting, or placing on probation the license
             543      of a licensee, for issuing a public or private reprimand to a licensee, and for issuing a cease and
             544      desist order:
             545          (a) shall be in accordance with Section 58-1-401 ; and
             546          (b) includes:
             547          (i) prescribing, dispensing, or facilitating the prescribing or dispensing of a drug not
             548      approved by the board under Section 58-83-306 ; or
             549          (ii) any other violation of this chapter.
             550          (2) The termination or expiration of a license under this chapter for any reason does not
             551      limit the division's authority to start or continue any investigation or adjudicative proceeding.
             552          (3) Because of the working business relationship between and among the online


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


             584          (ii) records of the online prescriber, the Internet facilitator, or the online contract
             585      pharmacy.
             586          Section 14. Section 58-83-501 is enacted to read:
             587     
Part 5. Unlawful and Unprofessional Conduct - Penalties

             588          58-83-501. Unlawful conduct.
             589          "Unlawful conduct" includes, in addition to the definition in Section 58-1-501 ,
             590      engaging in the practice of Internet prescribing without a license under this chapter.
             591          Section 15. Section 58-83-502 is enacted to read:
             592          58-83-502. Unprofessional conduct.
             593          "Unprofessional conduct" includes, in addition to the definition in Section 58-1-501 and
             594      as may be further defined by administrative rule:
             595          (1) online prescribing, dispensing, or facilitation with respect to a person under the age
             596      of 18 years;
             597          (2) using the name or official seal of the state, the Utah Department of Commerce, or
             598      the Utah Division of Occupational and Professional Licensing, or their boards, in an
             599      unauthorized manner;
             600          (3) failing to respond promptly to a request by the division for information including:
             601          (a) an audit of the website; or
             602          (b) records of the online prescriber, the Internet facilitator, or the online contract
             603      pharmacy;
             604          (4) using an online prescriber, online contract pharmacy, or Internet facilitator without
             605      approval of the division;
             606          (5) failing to inform a patient of the patient's freedom of choice in selecting who will
             607      dispense a prescription in accordance with Subsection 58-83-305 (1)(n); and
             608          (6) failing to keep the division informed of the name and contact information of the
             609      Internet facilitator or online contract pharmacy.
             610          Section 16. Section 58-83-503 is enacted to read:
             611          58-83-503. Unlawful conduct.
             612          Unlawful conduct includes, in addition to the definition in Section 58-1-501 :
             613          (1) online prescribing, dispensing or facilitating of a legend drug not authorized by the
             614      division in accordance with Section 58-83-306 ; or


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


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