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First Substitute S.B. 274
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7 LONG TITLE
8 General Description:
9 This bill creates an Online Prescribing, Dispensing, and Facilitation Licensing Act.
10 Highlighted Provisions:
11 This bill:
12 . amends unlawful conduct provisions;
13 . defines terms;
14 . requires licenses with the state to engage in online prescribing, online dispensing, or
15 online facilitation;
16 . establishes requirements for the licenses;
17 . allows certain online prescribers, online contract pharmacies, and Internet
18 facilitators to continue delivering online pharmaceutical services while their
19 applications for licensure are pending with the division;
20 . establishes duties for a licensed online prescriber, online contract pharmacy, and
21 Internet facilitator;
22 . limits the type of drugs that can be prescribed online;
23 . requires the use of an Internet facilitator and an online contract pharmacy to
24 prescribe online; and
25 . provides enforcement mechanisms for the division.
26 Monies Appropriated in this Bill:
27 None
28 Other Special Clauses:
29 None
30 Utah Code Sections Affected:
31 AMENDS:
32 58-1-501, as last amended by Laws of Utah 2007, Chapter 162
33 ENACTS:
34 58-83-101, Utah Code Annotated 1953
35 58-83-102, Utah Code Annotated 1953
36 58-83-201, Utah Code Annotated 1953
37 58-83-301, Utah Code Annotated 1953
38 58-83-302, Utah Code Annotated 1953
39 58-83-303, Utah Code Annotated 1953
40 58-83-304, Utah Code Annotated 1953
41 58-83-305, Utah Code Annotated 1953
42 58-83-306, Utah Code Annotated 1953
43 58-83-307, Utah Code Annotated 1953
44 58-83-308, Utah Code Annotated 1953
45 58-83-401, Utah Code Annotated 1953
46 58-83-501, Utah Code Annotated 1953
47 58-83-502, Utah Code Annotated 1953
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49 Be it enacted by the Legislature of the state of Utah:
50 Section 1. Section 58-1-501 is amended to read:
51 58-1-501. Unlawful and unprofessional conduct.
52 (1) "Unlawful conduct" means conduct, by any person, that is defined as unlawful
53 under this title and includes:
54 (a) practicing or engaging in, representing oneself to be practicing or engaging in, or
55 attempting to practice or engage in any occupation or profession requiring licensure under this
56 title if the person is:
57 (i) not licensed to do so or not exempted from licensure under this title; or
58 (ii) restricted from doing so by a suspended, revoked, restricted, temporary,
59 probationary, or inactive license;
60 (b) impersonating another licensee or practicing an occupation or profession under a
61 false or assumed name, except as permitted by law;
62 (c) knowingly employing any other person to practice or engage in or attempt to
63 practice or engage in any occupation or profession licensed under this title if the employee is
64 not licensed to do so under this title;
65 (d) knowingly permitting the person's authority to practice or engage in any occupation
66 or profession licensed under this title to be used by another, except as permitted by law;
67 (e) obtaining a passing score on a licensure examination, applying for or obtaining a
68 license, or otherwise dealing with the division or a licensing board through the use of fraud,
69 forgery, or intentional deception, misrepresentation, misstatement, or omission; or
70 (f) (i) [
71 issuance of, an order or prescription for a drug or device to a person located in this state:
72 (A) without prescriptive authority conferred by a license issued under this title, or by
73 an exemption to licensure under this title; or
74 (B) with prescriptive authority conferred by an exception issued under this title or a
75 multistate practice privilege recognized under this title, if the prescription was issued[
76 without first obtaining information, in the usual course of professional practice, that is
77 sufficient to establish a diagnosis, to identify underlying conditions, and to identify
78 contraindications to the proposed treatment; [
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84 (ii) Subsection (1)(f)(i) does not apply to treatment rendered in an emergency, on-call
85 or cross coverage situation, provided that the person who issues the prescription has
86 prescriptive authority conferred by a license under this title, or is exempt from licensure under
87 this title.
88 (2) "Unprofessional conduct" means conduct, by a licensee or applicant, that is defined
89 as unprofessional conduct under this title or under any rule adopted under this title and
90 includes:
91 (a) violating, or aiding or abetting any other person to violate, any statute, rule, or order
92 regulating an occupation or profession under this title;
93 (b) violating, or aiding or abetting any other person to violate, any generally accepted
94 professional or ethical standard applicable to an occupation or profession regulated under this
95 title;
96 (c) engaging in conduct that results in conviction, a plea of nolo contendere, or a plea
97 of guilty or nolo contendere which is held in abeyance pending the successful completion of
98 probation with respect to a crime of moral turpitude or any other crime that, when considered
99 with the functions and duties of the occupation or profession for which the license was issued
100 or is to be issued, bears a reasonable relationship to the licensee's or applicant's ability to safely
101 or competently practice the occupation or profession;
102 (d) engaging in conduct that results in disciplinary action, including reprimand,
103 censure, diversion, probation, suspension, or revocation, by any other licensing or regulatory
104 authority having jurisdiction over the licensee or applicant in the same occupation or profession
105 if the conduct would, in this state, constitute grounds for denial of licensure or disciplinary
106 proceedings under Section 58-1-401 ;
107 (e) engaging in conduct, including the use of intoxicants, drugs, narcotics, or similar
108 chemicals, to the extent that the conduct does, or might reasonably be considered to, impair the
109 ability of the licensee or applicant to safely engage in the occupation or profession;
110 (f) practicing or attempting to practice an occupation or profession regulated under this
111 title despite being physically or mentally unfit to do so;
112 (g) practicing or attempting to practice an occupation or profession regulated under this
113 title through gross incompetence, gross negligence, or a pattern of incompetency or negligence;
114 (h) practicing or attempting to practice an occupation or profession requiring licensure
115 under this title by any form of action or communication which is false, misleading, deceptive,
116 or fraudulent;
117 (i) practicing or attempting to practice an occupation or profession regulated under this
118 title beyond the scope of the licensee's competency, abilities, or education;
119 (j) practicing or attempting to practice an occupation or profession regulated under this
120 title beyond the scope of the licensee's license;
121 (k) verbally, physically, mentally, or sexually abusing or exploiting any person through
122 conduct connected with the licensee's practice under this title or otherwise facilitated by the
123 licensee's license;
124 (l) acting as a supervisor without meeting the qualification requirements for that
125 position that are defined by statute or rule;
126 (m) [
127 an order or prescription for a drug or device:
128 (i) without first obtaining information in the usual course of professional practice, that
129 is sufficient to establish a diagnosis, to identify conditions, and to identify contraindications to
130 the proposed treatment; or
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134 (ii) with prescriptive authority conferred by an exception issued under this title, or a
135 multi-state practice privilege recognized under this title, if the prescription was issued without
136 first obtaining information, in the usual course of professional practice, that is sufficient to
137 establish a diagnosis, to identify underlying conditions, and to identify contraindications to the
138 proposed treatment; or
139 (n) violating a provision of Section 58-1-501.5 .
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146 Section 2. Section 58-83-101 is enacted to read:
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150 58-83-101. Title.
151 This chapter is known as the "Online Prescribing, Dispensing, and Facilitation License
152 Act."
153 Section 3. Section 58-83-102 is enacted to read:
154 58-83-102. Definitions.
155 In addition to the definitions in Section 58-1-102 , as used in this chapter:
156 (1) "Board" means the Online Prescribing, Dispensing, and Facilitation Licensing
157 Board created in Section 58-83-201 .
158 (2) "Branching questionnaire" means an adaptive and progressive assessment tool
159 approved by the board.
160 (3) "Delivery of online pharmaceutical services" means the process in which a
161 prescribing practitioner diagnoses a patient and prescribes one or more of the drugs authorized
162 by Section 58-83-306 , using:
163 (a) a branching questionnaire or other assessment tool approved by the division for the
164 purpose of diagnosing and assessing a patient's health status;
165 (b) an Internet contract pharmacy to:
166 (i) dispense the prescribed drug; or
167 (ii) transfer the prescription to another pharmacy; and
168 (c) an Internet facilitator to facilitate the practices described in Subsections (6)(a) and
169 (b).
170 (4) "Division" means the Utah Division of Occupational and Professional Licensing.
171 (5) "Internet facilitator" means a licensed provider of a web-based system for electronic
172 communication between and among an online prescriber, the online prescriber's patient, and
173 the online contract pharmacy.
174 (6) "Online prescriber" means a person:
175 (a) licensed under another chapter of this title;
176 (b) whose license under another chapter of this title includes assessing, diagnosing, and
177 prescribing authority for humans; and
178 (c) who has obtained a license under this chapter to engage in online prescribing.
179 (7) "Online contract pharmacy" means a pharmacy licensed and in good standing under
180 Chapter 17b, Pharmacy Practice Act, as either a Class A Retail Pharmacy or a Class B Closed
181 Door Pharmacy and licensed under this chapter to fulfill prescriptions issued by an online
182 prescriber through a specific Internet facilitator.
183 (8) "Unlawful conduct" is as defined in Sections 58-1-501 and 58-83-501 .
184 (9) "Unprofessional conduct" is as defined in Sections 58-1-203 and 58-83-502 , and as
185 further defined by the division in accordance with Title 63G, Chapter 3, Utah Administrative
186 Rulemaking Act.
187 Section 4. Section 58-83-201 is enacted to read:
188
189 58-83-201. Board.
190 (1) There is created the Online Prescribing, Dispensing, and Facilitation Licensing
191 Board consisting of the following seven members:
192 (a) (i) two members who are licensed under either Chapter 67, Utah Medical Practices
193 Act, or Chapter 68, Utah Osteopathic Medical Practices Act; and
194 (ii) of the two members appointed under Subsection (1)(a)(i):
195 (A) one shall be engaged in the delivery of online pharmaceutical services; and
196 (B) one may not be an online prescriber licensed under this chapter;
197 (b) (i) two members who are licensed as a pharmacist under Chapter 17b, Pharmacy
198 Practice Act; and
199 (ii) of the two members appointed under Subsection (1)(b)(i):
200 (A) one shall be associated with an online contract pharmacy; and
201 (B) 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) an owner;
211 (b) an employer;
212 (c) an officer;
213 (d) a director;
214 (e) contracted with;
215 (f) an agent of; or
216 (g) have 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
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 license under this chapter is not required to engage in electronic prescribing
243 under Chapter 82, Electronic Prescribing Act.
244 Section 6. Section 58-83-302 is enacted to read:
245 58-83-302. Qualifications for licensure.
246 (1) Each applicant for licensure as an online prescriber under this chapter shall:
247 (a) submit an application in a form prescribed by the division;
248 (b) pay a fee determined by the department under Section 63J-1-504 ;
249 (c) be of good moral character;
250 (d) document that the applicant holds a Utah license that is active and in good standing
251 and authorizes the licensee to engage in the assessment, diagnosis, and treatment of human
252 ailments and the prescription of medications;
253 (e) document that any other professional license the applicant possesses from other
254 jurisdictions is in good standing;
255 (f) (i) submit to the division an outline of the applicant's proposed online assessment,
256 diagnosis, and prescribing tool, such as a branching questionnaire; and
257 (ii) demonstrate the proposed online assessment, diagnosis, and prescribing tool to the
258 board and establish to the board's satisfaction that the utilization of that assessment tool to
259 facilitate the prescription of the drugs approved for online prescribing under Section 58-83-306
260 does not compromise the public's health, safety, or welfare;
261 (g) submit policies and procedures that address patient confidentiality, including
262 measures that will be taken to ensure that the age and other identifying information of the
263 person completing the online branching questionnaire are accurate;
264 (h) describe the mechanism by which the online prescriber and patient will
265 communicate with one another, including electronic and telephonic communication;
266 (i) describe how the online prescriber/patient relationship will be established and
267 maintained;
268 (j) submit the name, address, and contact person of the Internet facilitator with whom
269 the online prescriber has contracted to provide services that the online prescriber will use to
270 engage in online assessment, diagnosis, and prescribing; and
271 (k) submit documentation satisfactory to the board regarding public health, safety, and
272 welfare demonstrating:
273 (i) how the online prescriber will comply with the requirements of Section 58-83-303 ;
274 (ii) the contractual services arrangement between the online prescriber and:
275 (A) the Internet facilitator; and
276 (B) the online contract pharmacy; and
277 (iii) how the online prescriber will allow and facilitate the division's ability to conduct
278 audits in accordance with Section 58-83-308 .
279 (2) An online prescriber may not use the services of an Internet facilitator or online
280 contract pharmacy whose license is not active and in good standing.
281 (3) Each applicant for licensure as an online contract pharmacy under this chapter
282 shall:
283 (a) be licensed in good standing in Utah as a Class A Retail Pharmacy or a Class B
284 Closed Door Pharmacy;
285 (b) submit a written application in the form prescribed by the division;
286 (c) pay a fee as determined by the department under Section 63J-1-504 ;
287 (d) submit any contract between the applicant and the Internet facilitator with which
288 the applicant is or will be affiliated;
289 (e) submit proof of liability insurance acceptable to the division that expressly covers
290 all activities the online contract pharmacy will engage in under this chapter, which coverage
291 shall be in a minimum amount of $1,000,000 per occurrence with a policy limit of not less than
292 $3,000,000;
293 (f) submit a signed affidavit to the division attesting that the online contract pharmacy
294 will not dispense a drug that is prescribed by an online prescriber engaged in the delivery of
295 online pharmaceutical services under the provisions of this chapter unless:
296 (i) the drug is specifically approved by the division under Section 58-83-306 ; and
297 (ii) both the prescribing and the dispensing of the drug were facilitated by the Internet
298 facilitator with whom the Internet contract pharmacy is associated under Subsection
299 58-83-302 (3)(d);
300 (g) document that any other professional license the applicant possesses from other
301 jurisdictions is active and in good standing; and
302 (h) demonstrate to the division that the applicant has satisfied any background check
303 required by Section 58-17b-307 , and each owner, officer or manager of the applicant online
304 contract pharmacy has not engaged in any act, practice, or omission, which when considered
305 with the duties and responsibilities of a licensee under this chapter indicates there is cause to
306 believe that issuing a license under this chapter is inconsistent with the public's health safety or
307 welfare.
308 (4) Each applicant for licensure as an Internet facilitator under this chapter shall:
309 (a) submit a written application in the form prescribed by the division;
310 (b) pay a fee as determined by the department under Section 63J-1-504 ;
311 (c) submit any contract between the applicant and the following with which the
312 applicant will be affiliated:
313 (i) each online prescriber; and
314 (ii) the single online contract pharmacy;
315 (d) submit written policies and procedures satisfactory to the division that:
316 (i) address patient privacy;
317 (ii) ensure compliance with all applicable laws by health care personnel and the online
318 prescriber who will process patient communications;
319 (iii) list the hours of operation;
320 (iv) describe the types of services that will be permitted electronically;
321 (v) describe the required patient information to be included in the communication, such
322 as patient name, identification number, and type of transaction;
323 (vi) establish procedures for archiving and retrieving information; and
324 (vii) establish quality oversight mechanisms;
325 (e) submit written documentation of the applicant's security measures to ensure the
326 confidentiality and integrity of any user-identifiable medical information;
327 (f) submit a description of the mechanism for:
328 (i) patients to access, supplement, and amend patient-provided personal health
329 information;
330 (ii) back-up regarding the Internet facilitator electronic interface;
331 (iii) the quality of information and services provided via the interface; and
332 (iv) patients to register complaints regarding the Internet facilitator, the online
333 prescriber, or the online contract pharmacy;
334 (g) submit a copy of the Internet facilitator's website;
335 (h) sign an affidavit attesting that:
336 (i) the applicant will not access any medical records or information contained in the
337 medical record except as necessary to administer the website and the branching questionnaire;
338 and
339 (ii) the applicant and its principals, and any entities affiliated with them, will only use
340 the services of a single online contract pharmacy named on the license approved by the
341 division; and
342 (i) submit any other information required by the division.
343 Section 7. Section 58-83-303 is enacted to read:
344 58-83-303. Term of license -- Expiration -- Renewal.
345 (1) The online prescriber's license shall be associated with the online prescriber's
346 primary professional license and may be renewed at the time the primary license is renewed in
347 accordance with Subsection 58-1-308 (1).
348 (2) The online contract pharmacy license shall be associated with the online contract
349 pharmacy's primary professional license and may be renewed at the time the primary license is
350 renewed in accordance with Subsection 58-1-308 (1).
351 (3) The Internet facilitator license shall be renewed in accordance with Section
352 58-1-308 .
353 (4) Each licensee shall, at the time of applying for renewal, demonstrate compliance
354 with this chapter.
355 (5) Each license shall automatically expire on the expiration date shown on the license
356 unless the licensee renews it in accordance with Section 58-1-308 .
357 Section 8. Section 58-83-304 is enacted to read:
358 58-83-304. Existing written agreements for online prescribing -- Pending
359 applications.
360 (1) (a) Subject to the provisions of this section, and until December 31, 2010, an entity
361 or individual not licensed by the division to engage in the delivery of online pharmaceutical
362 services under this chapter may nevertheless engage in the delivery of online pharmaceutical
363 services if permitted by the division to do so prior to December 31, 2009, under either:
364 (i) a non-disciplinary stipulation and consent order with the division; or
365 (ii) a letter agreement with the division.
366 (b) An entity or individual subject to Subsection (1)(a) shall only be permitted to
367 engage in the delivery of online pharmaceutical services after December 31, 2010, if, on or
368 before that date, it has obtained a license in accordance with the provisions of this chapter.
369 (2) An entity or individual engaged in the delivery of online pharmaceutical services
370 under the provisions of Subsection (1), may continue to operate in accordance with the terms
371 and conditions of the written consent or agreement subject to the following:
372 (a) On or before June 1, 2010, the entity or individual shall file an application with the
373 division in accordance with this chapter for:
374 (i) an online prescriber license;
375 (ii) an online contract pharmacy license; or
376 (iii) an Internet facilitator license.
377 (b) After the application for a license under this chapter is filed in accordance with
378 Subsection (2)(a), the applicant may continue to operate under the terms and conditions of the
379 written consent agreement under Subsection (1)(a) until the division has issued its decision on
380 the application.
381 (c) If the application is approved and a license is issued, the licensee:
382 (i) shall operate under the terms of the license under this chapter; and
383 (ii) may not operate under the terms and conditions of the prior written consent or
384 agreement of the division.
385 (d) If the application for license under this chapter is denied, the applicant may not
386 operate under the prior written consent or agreement with the division after the date the
387 application for a license under this chapter is denied by the division.
388 (3) (a) The following provisions apply to any application for authorization to engage in
389 the delivery of online pharmaceutical services that was pending with the division on the
390 effective date of this chapter:
391 (i) the applicant shall:
392 (A) no later than June 30, 2010, provide supplemental documentation to the division to
393 correct any deficiency in the application; and
394 (B) notify the division in writing that the application is ready to be acted upon by the
395 division; or
396 (ii) the applicant may rely upon the existing application submitted to the division
397 without any supplementation under Subsection (1)(a)(i), if the applicant notifies the division in
398 writing that the application is ready to be acted upon by the division.
399 (b) The division shall not, prior to June 30, 2010, act on an application pending with
400 the division on the effective date of this chapter unless the division prior to June 30, 2010,
401 receives a notification from the applicant that the application is ready to be acted upon by the
402 division.
403 Section 9. Section 58-83-305 is enacted to read:
404 58-83-305. Duties and responsibilities.
405 (1) The online prescriber shall:
406 (a) be held to the same standards of appropriate practice as those applicable in
407 traditional settings which, for purposes of this chapter, include the delivery of online
408 pharmaceutical services;
409 (b) conduct an assessment and diagnosis based upon a comprehensive health history
410 and an assessment tool such as a branching questionnaire;
411 (c) ensure that a comprehensive health history, assessment, and diagnosis have been
412 made before prescribing any medication;
413 (d) conduct the online assessment and diagnosis only through the approved Internet
414 facilitator identified in the online prescriber's application;
415 (e) comply with all applicable state and federal laws, rules, regulations, and orders;
416 (f) inform the patient electronically of the benefits and risks of appropriate treatment;
417 (g) guide the patient regarding the optimal course of action;
418 (h) treat the patient with courtesy, respect, dignity, responsiveness and timely attention
419 to the patient's needs;
420 (i) comply with the requirements for confidentiality as required by this title and
421 applicable federal law;
422 (j) continue to provide the user with reasonable assistance and sufficient opportunity to
423 make alternative arrangements for care;
424 (k) be available for ongoing consultation with the patient through e-mail or other forms
425 of communication;
426 (l) not delegate to a third party the professional responsibility to:
427 (i) review and evaluate the results of the branching questionnaire;
428 (ii) consult with the patient electronically or through other means about the patient's
429 medical condition; and
430 (iii) diagnose and prescribe medications to the patient;
431 (m) conduct the online assessment and diagnosis, the electronic communication
432 between the online prescriber and the patient, and the maintenance of online medical records if
433 delegated by the online prescriber, only through the approved Internet facilitator;
434 (n) inform a patient of the patient's freedom of choice to select the pharmacy to
435 dispense the patient's prescription by providing the patient with the phone number of the online
436 contract pharmacy so that the patient may contact the online contract pharmacy and request a
437 transfer of the prescription to another pharmacy; and
438 (o) authorize the Internet facilitator to provide the online contract pharmacy with the
439 patient's:
440 (i) full name;
441 (ii) current address and telephone number;
442 (iii) date of birth or age and gender;
443 (iv) height, weight, and vital signs (if known);
444 (v) medication allergies or drug reactions; and
445 (vi) current medications, including over-the-counter products, and any additional
446 comments relevant to the patient's drug use.
447 (2) The online contract pharmacy shall:
448 (a) only dispense prescription drugs that:
449 (i) are approved by the division in accordance with Section 58-83-306 ; and
450 (ii) were prescribed by an online prescriber who is using the Internet facilitator that is
451 under contract with the online contract pharmacy;
452 (b) maintain a toll-free number with a pharmacist available for patients using the
453 services of the online contract pharmacy to receive medications prescribed online;
454 (c) use a tracking identification number system when shipping medications prescribed
455 for patients by an online prescriber; and
456 (d) provide to the division a quarterly report of all drugs dispensed in accordance with
457 this chapter.
458 (3) The Internet facilitator shall:
459 (a) provide services that the online prescriber will use in implementing the branching
460 questionnaire;
461 (b) provide electronic or telephonic communication between the online prescriber and
462 the patient that:
463 (i) is secure and confidential;
464 (ii) allows the online prescriber to be directly accessible to a patient to answer
465 questions regarding the patient's treatment plan; and
466 (iii) provides security that complies with the provisions of 42 C.F.R. Parts 160, 162,
467 and 164, Health Insurance Portability and Accountability Act of 1996;
468 (c) facilitate secure and confidential communication of the prescription issued by the
469 online prescriber to the online contract pharmacy in accordance with Subsection (1)(o);
470 (d) disclose on its website:
471 (i) the owner of the website;
472 (ii) the specific services provided by any associated online prescribers; and
473 (iii) other information the division may require by rule; and
474 (e) (i) only facilitate the delivery of online pharmaceutical services for the specific
475 legend drugs approved by the division in accordance with Section 58-83-306 ; or
476 (ii) not facilitate, directly or indirectly, through related entities or affiliates, the
477 dispensing, or online prescribing of any drug whether controlled or legend that is not
478 specifically approved under Section 58-83-306 .
479 Section 10. Section 58-83-306 is enacted to read:
480 58-83-306. Drugs approved for online prescribing, dispensing, and facilitation.
481 (1) An online prescriber may only prescribe, an online contract pharmacy may only
482 dispense, and an Internet facilitator may only facilitate the prescribing and dispensing of,
483 non-controlled, legend drugs that have been:
484 (a) approved by the Food and Drug Administration;
485 (b) prescribed to treat the condition for which the drug was approved; and
486 (c) specifically approved by the division for online prescribing by administrative rule
487 adopted in accordance with Title 63G, Chapter 3, Utah Administrative Rulemaking Act.
488 (2) If, after January 1, 2010, the Food and Drug Administration issues a clinical black
489 box warning with respect to any drug approved by the board under Subsection (1), the division
490 shall determine what action, if any, is necessary to protect the public health or welfare as a
491 result of the black box warning.
492 Section 11. Section 58-83-307 is enacted to read:
493 58-83-307. Approval of additional drugs -- Request to facilitate.
494 (1) An Internet facilitator licensed under this chapter may seek the division's approval
495 to facilitate the online prescribing and dispensing of prescriptions for additional drugs.
496 (2) The Internet facilitator shall make a request for approval of additional drugs by
497 petitioning for an amendment to the administrative rule adopted by the division in accordance
498 with Section 58-83-306 and Title 63G, Chapter 3, Utah Administrative Rulemaking Act.
499 Section 12. Section 58-83-308 is enacted to read:
500 58-83-308. Audits.
501 (1) Each licensee under this chapter shall allow and facilitate an audit by the division
502 regarding the licensee's delivery of online pharmaceutical services to ensure compliance with
503 state and federal statutes, rules, and regulations including:
504 (a) ensuring that a comprehensive history and assessment have been obtained and a
505 diagnosis has been made for a patient before any medications are prescribed; and
506 (b) ensuring that only the approved medications are being prescribed and dispensed.
507 (2) The division shall be provided with the following, in the manner that allows access
508 from the division's office for the purpose of conducting an audit:
509 (a) full remote, read-only access rights to the data related to the online prescribing and
510 dispensing of a drug under this chapter and that is used and stored in the Internet facilitator's
511 system; and
512 (b) the information available to the online prescriber.
513 (3) An Internet facilitator licensed under this chapter shall provide to the division, at
514 the times designated by the division by administrative rule, a report containing the following
515 information:
516 (a) number of prescriptions issued by the online prescribers associated with the Internet
517 facilitator by drug name;
518 (b) number of comprehensive histories/assessments received by the Internet facilitator;
519 (c) number of comprehensive histories/assessments reviewed by an online prescriber;
520 (d) the demographic data of the patients receiving prescriptions through the Internet
521 facilitator;
522 (e) the number of prescriptions:
523 (i) dispensed by the online contract pharmacy; or
524 (ii) transferred to a different pharmacy at the patient's request; and
525 (f) any other information specified by the division by administrative rule.
526 (4) The division's authority to conduct an audit pursuant to this chapter shall survive
527 any termination or expiration of any prescriptive authority for online prescribing, dispensing, or
528 facilitation.
529 Section 13. Section 58-83-401 is enacted to read:
530
531 58-83-401. Grounds for denial of license -- Disciplinary proceedings --
532 Termination of authority to prescribe -- Immediate and significant danger.
533 (1) Grounds for refusing to issue a license to an applicant, for refusing to renew the
534 license of a licensee, for revoking, suspending, restricting, or placing on probation the license
535 of a licensee, for issuing a public or private reprimand to a licensee, and for issuing a cease and
536 desist order:
537 (a) shall be in accordance with Section 58-1-401 ; and
538 (b) includes:
539 (i) prescribing, dispensing, or facilitating the prescribing or dispensing of a drug not
540 approved by the board under Section 58-83-306 ; or
541 (ii) any other violation of this chapter.
542 (2) The termination or expiration of a license under this chapter for any reason does not
543 limit the division's authority to start or continue any investigation or adjudicative proceeding.
544 (3) Because of the working business relationship between and among the online
545 prescriber, the Internet facilitator, and the online contract pharmacy, each entity's ability to
546 comply with this chapter may depend in some respects on the actions of the others. It is
547 possible that a particular action or inaction by the online prescriber, the Internet facilitator, or
548 the online contract pharmacy could have the effect of causing the other licensed entities to be
549 out of compliance with this chapter, and each entity may therefore be held accountable for any
550 related party's non-compliance, if the party knew or reasonably should have known of the other
551 person's non-compliance.
552 (4) An online prescriber may lose the practitioner's professional license to prescribe
553 any drug under this title if the online prescriber knew or reasonably should have known that the
554 provisions of this chapter were violated by the online prescriber, the Internet facilitator, or the
555 online contract pharmacy. It is not a defense to an alleged violation under this chapter that the
556 alleged violation was a result of an action or inaction not by the charged party but by the related
557 online prescriber, the online contract pharmacy or the Internet facilitator.
558 (5) The following actions may result in an immediate suspension of the online
559 prescriber's license, the online contract pharmacy's license, or the Internet facilitator's license,
560 and each is considered an immediate and significant danger to the public health, safety, or
561 welfare requiring immediate action by the division pursuant to Section 63G-4-502 to terminate
562 the delivery of online pharmaceutical services by the licensee:
563 (a) online prescribing, dispensing, or facilitation with respect to:
564 (i) a person under the age of 18 years;
565 (ii) a legend drug not authorized by the division in accordance with Section 58-83-306 ;
566 and
567 (iii) any controlled substance;
568 (b) violating this chapter after having been given reasonable opportunity to cure the
569 violation;
570 (c) using the name or official seal of the state of Utah, the Utah Department of
571 Commerce, the Utah Division of Occupational and Professional Licensing, or its boards in an
572 unauthorized manner; or
573 (d) failing to respond to a request from the division within the time frame requested
574 for:
575 (i) an audit of the website; or
576 (ii) records of the online prescriber, the Internet facilitator, or the online contract
577 pharmacy.
578 Section 14. Section 58-83-501 is enacted to read:
579
580 58-83-501. Unlawful conduct.
581 "Unlawful conduct" includes, in addition to the definition in Section 58-1-501 ,
582 engaging in the practice of Internet prescribing without a license under this chapter.
583 Section 15. Section 58-83-502 is enacted to read:
584 58-83-502. Unprofessional conduct.
585 "Unprofessional conduct" includes, in addition to the definition in Section 58-1-501 and
586 as may be further defined by administrative rule:
587 (1) online prescribing, dispensing, or facilitation with respect to:
588 (a) a person under the age of 18 years;
589 (b) a legend drug not authorized by the division in accordance with Section 58-83-306 ;
590 and
591 (c) any controlled substance;
592 (2) using the name or official seal of the state, the Utah Department of Commerce, the
593 Utah Division of Occupational and Professional Licensing, or its boards in an unauthorized
594 manner;
595 (3) failing to respond promptly to a request by the division for information including:
596 (a) an audit of the website; or
597 (b) records of the online prescriber, the Internet facilitator, or the online contract
598 pharmacy;
599 (4) using an online prescriber, online contract pharmacy, or Internet facilitator without
600 approval of the division;
601 (5) failing to inform a patient of the patient's freedom of choice in selecting who will
602 dispense a prescription in accordance with Subsection 58-83-305 (1)(n); and
603 (6) failing to keep the division informed of the name and contact information of the
604 Internet facilitator or online contract pharmacy.
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