DAR File No. 44108 NOTICES OF PROPOSED RULES
(b)   for  each  renewal  cycle  after  the  initial  training,  
successfully  complete  a  minimum  of  two  hours  of  continuing  
education  related  to  dispensing  a  self-administered  hormonal  
contraceptive, in accordance with Section R156-17b-309.
(3)   The  Utah  Hormonal  Contraceptive  Self-screening  
Risk  Assessment  Questionnaire,  adopted  September  18,  2018,  
posted  on  the  Division's  website,  is  the  self-screening  risk  
assessment questionnaire to be used for pharmacist and pharmacy  
intern dispensing of self-administered hormonal contraceptives.
R156-17b-622.  Standards - Dispensing Training Program.
(1)   In  accordance  with  Subsection  R156-17b-102  
([17]18),  a  formal  or  on-the-job  dispensing  training  program  
completed by a DMP designee is one that covers the following  
topics to the extent that the topics are relevant and current to the  
DMP practice where the DMP designee is employed:
(a)  role of the DMP designee;
(b)  laws affecting prescription drug dispensing;
(c)  pharmacology including the identification of drugs by  
trade and generic names, and therapeutic classifications;
(d)   pharmaceutical  terminology,  abbreviations  and  
symbols;
(e)  pharmaceutical calculations;
(f)  drug packaging and labeling;
(g)  computer applications in the pharmacy;
(h)  sterile and non-sterile compounding;
(i)  medication errors and safety;
(j)  prescription and order entry and fill process;
(k)  pharmacy inventory management; and
(l)  pharmacy billing and reimbursement.
(2)  Documentation demonstrating successful completion  
of a formal or on-the-job dispensing training program shall include  
the following information:
(a)  name of individual trained;
(b)  name of individual or entity that provided training;
(c)  list of topics covered during the training program; and
(d)  training completion date.
R156-17b-623.   Standards  -  Approved  Cosmetic  Drugs  and  
Injectable  Weight  Loss  Drugs  for  Dispensing  Medical  
Practitioners.
[(1)  A cosmetic]The drugs that may be dispensed by a  
DMP in accordance with Subsection 58-17b-802(1) and Section 58-
17b-803 [is]are limited to:
                 (1)  the following cosmetic drugs:  
                 (a)    Latisse; and
                 (b)   the  injectable  weight  loss  drug  human  chorionic   
gonadotropin; and
                 (2)   the  legend,  non-controlled  drugs  approved  under   
Section R156-83-306 for prescribing by an online prescriber .[
               (2)  An injectable weight loss drug that may be dispensed  
by a DMP in accordance with Section 58-17b-803 is limited to  
human chorionic gonadotropin. ]
KEY:  pharmacists, licensing, pharmacies
Date  of  Enactment  or  Last  Substantive  Amendment:  
[December 27,  2018]2019
Notice of Continuation: January 5, 2015Authorizing, and Implemented or Interpreted Law:  58-17b-
101; 58-17b-601(1); 58-37-1; 58-1-106(1)(a); 58-1-202(1)(a)
Health, Disease Control and  
Prevention, Health Promotion
R384-415
Electronic-Cigarette Substance  
Standards
NOTICE OF PROPOSED RULE
(Amendment)
DAR FILE NO.:  44114
FILED:  10/01/2019
RULE ANALYSIS
PURPOSE  OF  THE  RULE  OR  REASON  FOR  THE  
CHANGE:   Outdated  dates  in  Sections  R384-415-7  and  
R384-415-8 that reference requirements for tobacco retailers  
to comply with as of 08/08/2019 that need to align better with  
the  FDA's  changed  timeline  on  regulating  electronic  
cigarettes.  When this rule was originally written, the FDA  
published timeline to approve electronic cigarette substance  
standards  was  planned  to  be  on  or  before  08/08/2019.  
However the FDA's original timeline was delayed until August  
2022 and then changed to May 2021 by court ruling.  This  
timeline could change again.  As a result, this administrative  
rule is out of date and should be updated so it no longer  
states a specific date in both Sections R384-415-7 and R384-
415-8.
SUMMARY OF THE RULE OR CHANGE:  In Section R384-
415-7,  the  change  modifies  the  date  language  and  adds  
language  that  will  better  align  with  the  FDA's  electronic  
cigarette  pre-market  product  process  which  has  changed  
multiple  times  and  is  not  a  set  date  and  eliminating  the  
08/08/2019  date  from  this  administrative  rule.   In  Section  
R384-415-8,  the  change  modifies  the  date  language  for  
consistency in Subsection R384-415-8(1)(c) and instead adds  
language  that  will  better  align  with  the  FDA's  electronic  
cigarette  pre-market  product  process  which  has  changed  
multiple  times  and  is  not  a  set  date  and  eliminating  the  
08/08/2019 date from this administrative rule.
STATUTORY OR CONSTITUTIONAL AUTHORIZATION FOR  
THIS RULE:  Section 26-57-103
ANTICIPATED COST OR SAVINGS TO:
♦ THE STATE BUDGET:  These proposed rule changes are  
not expected to have any fiscal impact on the state budget  
because these changes do not affect the implementation of  
this rule; they simply clarify the process.
♦ LOCAL GOVERNMENTS:  These proposed rule changes  
are  not  expected  to  have  any  fiscal  impact  on  local  
governments  because  these  changes  do  not  affect  the  
implementation of this rule; they simply clarify the process.
UTAH STATE BULLETIN , October 15, 2019, V ol. 2019, No. 20 45NOTICES OF PROPOSED RULES DAR File No. 44114
♦ SMALL BUSINESSES:  These proposed rule changes are  
not expected to have any fiscal impact on small businesses  
because these changes do not affect the implementation of  
this rule; they simply clarify the process.
♦  PERSONS  OTHER  THAN  SMALL  BUSINESSES,  
BUSINESSES,  OR  LOCAL  GOVERNMENTAL  ENTITIES:  
These proposed rule changes are not expected to have any  
fiscal impact on other persons because these changes do not  
affect the implementation of this rule; they simply clarify the  
process.
COMPLIANCE COSTS FOR AFFECTED PERSONS:  There  
are no potential costs for updating this rule because these  
changes do not affect the implementation of this rule; they  
simply clarify the process.
COMMENTS  BY  THE  DEPARTMENT  HEAD  ON  THE  
FISCAL IMPACT THE RULE MAY HAVE ON BUSINESSES:  
There is no fiscal impact on businesses because these rule  
changes do not change requirements for businesses.
THE  FULL TEXT  OF  THIS  RULE  MAY BE  INSPECTED,  
DURING REGULAR BUSINESS HOURS, AT:
HEALTH
DISEASE CONTROL AND PREVENTION,
HEALTH PROMOTION
CANNON HEALTH BLDG
288 N 1460 W
SALT LAKE CITY , UT 84116-3231
or at the Office of Administrative Rules.
DIRECT QUESTIONS REGARDING THIS RULE TO:
♦ Heather Borski by phone at 801-538-9998, by FAX at 801-
538-9495, or by Internet E-mail at hborski@utah.gov or mail  
at PO Box 142107, Salt Lake City, UT 84114-2107
INTERESTED PERSONS MAY PRESENT THEIR VIEWS ON  
THIS RULE BY SUBMITTING WRITTEN COMMENTS NO  
LATER THAN AT 5:00 PM ON 11/14/2019
INTERESTED  PERSONS  MAY  ATTEND  A  PUBLIC  
HEARING REGARDING THIS RULE:
♦ 11/07/2019 01:00 PM, UDOH Cannon Building, 288 N 1460  
W, Room 125, Salt Lake City, UT
THIS RULE MAY BECOME EFFECTIVE ON:  11/22/2019
AUTHORIZED BY:  Joseph Miner, MD, Executive Director
Appendix 1: Regulatory Impact Summary Table*
Fiscal CostsFY 2020FY 2021FY 2022
State Government$0$0$0
Local Government$0$0$0
Small Businesses$0$0$0
Non-Small Businesses$0$0$0Other Person$0$0$0
Total Fiscal Costs:$0$0$0
Fiscal Benefits
State Government$0$0$0
Local Government$0$0$0
Small Businesses$0$0$0
Non-Small Businesses$0$0$0
Other Persons$0$0$0
Total  Fiscal Benefits:$0$0$0
Net Fiscal Benefits:$0$0$0
*This table only includes fiscal impacts that could be measured.  If  there are inestimable fiscal impacts, they will not be included in  this  table.   Inestimable  impacts  for  State  Government,  Local  Government, Small Businesses and Other Persons are described in the  narrative.  Inestimable impacts for Non -Small Businesses are described  in Appendix 2.
Appendix 2: Regulatory Impact to Non -Small BusinessesAs of January 1, 2019, according to the Utah Department of Health's  (UDOH) combined local health department tobacco retail compliance  check logs, there are approximately 835 non -small businesses tobacco retailers operating in Utah under the NAICS codes of 453991 and  424940.  These businesses will likely not experience a direct cost or  benefit because these rule changes will allow them to continue to sell  non-manufacturer sealed electronic cigarette substances until the  United States Food and Drug Administration (FDA) institutes its  process to regulate standards for electronic cigarette substances.
The head of the Department of Health, Joseph Miner, MD, has reviewed  and approved this fiscal analysis .
R384.  Disease Control and Prevention, Health Promotion.
R384-415.  Electronic-Cigarette Substance Standards.
R384-415-1.  Authority and Purpose.
(1)   This  rule  is  authorized  by  Section  26-57-103  and  
Subsection 59-14-803(5).
(2)  This rule establishes standards for labeling, nicotine  
content,  packaging,  and  product  quality  for  electronic-cigarette  
substances for the regulation of electronic-cigarettes.
(3)   This  rule  does  not  apply  to  a  manufacturer-sealed  
electronic-cigarette substance.
(4)  A product in compliance with this rule is not endorsed as  
safe.
R384-415-2.  Definitions.
As used in this rule:
(1)  "Business" means any sole proprietorship, partnership,  
joint venture, corporation, association, or other entity formed for profit  
or non-profit purposes.
(2)  "Child resistant" means the same as the term "special  
packaging" is defined in 16 C.F.R 1700.1(a)(4) (January 1, 2015) and  
46 UTAH STATE BULLETIN , October 15, 2019, V ol. 2019, No. 20DAR File No. 44114 NOTICES OF PROPOSED RULES
is tested in accordance with the method described in 16 C.F.R. 1700.20  
(January 1, 2015).
(3)  "Department" means the Utah Department of Health.
(4)  "Electronic-cigarette" means the same as the term is  
defined in Subsections 26-38-2(1) and 59-14-802(2).
(5)  "Electronic-cigarette Product" means the same as the  
term is defined in Subsection 59-14-802(3).
(6)  "Electronic-cigarette substance" means the same as the  
term is defined in Subsection 59-14-802(4).
(7)  "Local health department" means the same as the term is  
defined in Subsection 26A-1-102(5).
(8)  "Manufacture" means the same as the term is defined in  
Subsection 26-57-102(5).
(9)  "Manufacturer" means the same as the term is defined in  
Subsection 26-57-102(6).
(10)  "Mg/mL" means milligrams per milliliter, a ratio for  
measuring an ingredient, in liquid form, where accuracy is measured in  
milligrams per milliliter, or a percentage equivalent.
(11)  "Nicotine" means the same as the term is defined in the  
Federal Food, Drug, and Cosmetic Act, 21 U.S.C. Sec. 387(12) (2013).
(12)  "Manufacturer-sealed electronic-cigarette substance"  
means the same as the term defined is in Subsection 26-57-102(6).
(13)  "Package "or "packaging" means a pack, box, carton,  
or container of any kind, or if no other container, any wrapping, in  
which an electronic cigarette substance is offered for sale, sold, or  
otherwise distributed to consumers.
(14)  "Retailer" means any person who sells, offers for sale,  
or offers to exchange for any form of consideration, an electronic-
cigarette substance to a consumer. This definition is without regard to  
the quantity of an electronic-cigarette substance sold, offered for sale,  
exchanged, or offered for exchange.
(15)  "Retailing" means involvement in any of the activities  
listed in Subsection R384-415-2(14). This definition is without regard  
to the quantity of an electronic-cigarette substance sold, offered for  
sale, exchanged, or offered for exchange.
(16)  "Transaction statement" means a statement, in paper or  
electronic form, which the manufacturer transferring ownership of the  
product  certifies  that  the  electronic-cigarette  substance  is  in  
compliance with the standards in this rule.
R384-415-3.  Labeling.
(1)   The  retailer  shall  ensure  that  nicotine  containing  
electronic-cigarette substance offered for sale to the consumer features  
on  the  product  package  label  the  required  safety  warning  stating  
"WARNING":   This  product  contains  nicotine.   Nicotine  is  an  
addictive chemical."
(2)  The retailer shall ensure that an electronic-cigarette  
substance  marketed  as  nicotine-free  and  offered  for  sale  to  the  
consumer features a safety warning stating "WARNING:  Keep away  
from children and pets."
(3)  The retailer shall ensure that the required safety warning  
appear directly on the package and must be visible underneath any  
cellophane or other clear wrapping as follows:
(a)  be located in a conspicuous and prominent place on the  
two principle display panels of the package and the warning area must  
comprise at least 30 percent of each of the principal display panels;
(b)  is capitalized and punctuated as indicated in Subsection  
(1) or (2) of this Section;(c)  be printed in at least 12-point font size and ensure that  
the  required  warning  statement  occupies  the  greatest  possible  
proportion of the warning area set aside for the required text;
(d)  uses a conspicuous and legible Helvetica, Arial, or other  
san serif font;
(e)  uses either a black font on a white background or a white  
font on a black background; and
(f)  is centered in the warning area in which the text is  
required to be printed and positions such that the text of the required  
warning statement and the other information on the principal display  
panel have the same orientation.
(4)  A retailer of an electronic-cigarette substance will not be  
in violation of this Section when packaging:
(a)  contains a health warning;
(b)  is supplied to the retailer by a manufacturer, importer, or  
distributor, who has the required state, local, or tobacco tax license or  
permit, if applicable; and
(c)  is not altered by the retailer in a way that is material to  
the requirements of this Section.
(5)  An electronic-cigarette substance package that would be  
required to bear the warning in Subsection (1) or (2) of this Section but  
is too small or otherwise unable to accommodate a warning label with  
sufficient space to bear such information is exempt from compliance  
with the requirement provided:
(a)   the  information  and  specifications  required  in  
Subsection (1) and (2) of this Section appear on the carton or other  
outer container or wrapper if the carton, outer container, or wrapper  
has sufficient space to bear the information; or
(b)  appear on a tag firmly and permanently affixed to the  
packaged electronic-cigarette substance.
(c)  In the case of Subsection (5)(a) or (b), the carton, outer  
container, wrapper, or tag will serve as the location of the principal  
display panels.
R384-415-4.  Prohibited Sales.
(1)   The  retailer  shall  be  prohibited  from  selling  an  
electronic-cigarette substance to the public that is labeled to the public  
as containing:
(a)  additives that create the impression that an electronic-
cigarette substance has a health benefit;
(b)  additives that are associated with energy and vitality;
(c)  illegal or controlled substances as identified in Section  
58-37-3; and
(d)  additives having coloring properties for emissions.
R384-415-5.  Nicotine Content.
The retailer shall sell an electronic-cigarette substance to the  
consumer that is limited to 360 mg nicotine per container, and does not  
exceed a 24mg/mL concentration of nicotine.
R384-415-6.  Packaging.
The retailer shall ensure that the packaging of an electronic-
cigarette substance intended for sale to a consumer is certified as child  
resistant, and compliant with federal standards and law concerning  
child nicotine poisoning prevention.
R384-415-7.  Product Quality.
[As of August 8, 2019,]When the United States Food and  
Drug  Administration  instituting  its  process  to  approve  electronic  
UTAH STATE BULLETIN , October 15, 2019, V ol. 2019, No. 20 47NOTICES OF PROPOSED RULES DAR File No. 44114
cigarettes, the retailer shall only sell an electronic-cigarette substance  
that has been approved for regulatory sale by the United States Food  
and Drug Administration through a Pre-Market Tobacco application or  
Substantial Equivalent application.
R384-415-8.  Record Keeping and Testing.
(1)   The  retailer  shall  provide  the  electronic-cigarette  
substances transaction statement to the Department or the local health  
department within five working days of a request. The retailer shall  
ensure  that  the  transaction  statement  includes  manufacturer  
certifications that:
(a)  the nicotine content of an electronic-cigarette substance  
is compliant with Section R384-415-5;
(b)  the packaging of an electronic cigarette-substance is  
child-resistant; and
(c)  [United States Food and Drug Administration Approval  
after August 8, 2019.]An electronic cigarette substance that has been  
approved for regulatory sale by the United States Food and Drug  
Administration  through  a  Pre-Market  Tobacco  application  or  
Substantial Equivalent application.   
(2)  The retailer shall provide evidence that supports the  
documents described in Subsection R384-415-8(1) to the Department  
or the local health department within 5 working days of a request.
(3)   The  retailer  shall  have  access  to  the  documents  
described  in  Subsections  R384-415-8(1)  and  R384-415-8(2)  for  a  
period of two years after the retailer purchases the electronic-cigarette  
substance.
R384-415-9.  Enforcement.
(1)  The Department may enforce and seek penalties for the  
violation of public health rules including, the standards for electronic  
cigarettes  set  forth  in  this  rule  as  prescribed  in  Sections  26-23-1  
through 26-23-10.
(2)   A local  health  department  may  enforce  and  seek  
penalties for the violation of the standards for electronic cigarettes set  
forth in this rule.  A local health department shall have authority to  
enforce and seek penalties for violations of public health law including  
this rule as is found in Sections 26-23-1 through 26-23-10, 26A-1-108,  
26A-1-114(1) and 26A-1-123.
(3)   The  Department  or  local  health  department  is  
responsible to make a determination as to if a person holding a Utah  
State Tax Commission license to sell electronic cigarettes has violated  
the standards of this rule. If the Department or local health department  
makes  such  a  determination  it  shall  notify  the  Utah  State  Tax  
Commission to revoke the person's license as provided in Subsection  
59-14-803(5).
(4)  Administrative or civil enforcement of this rule by the  
Department or local health departments does not preclude criminal  
enforcement by a law enforcement agency and prosecution of any  
violation of the standards in this rule that can constitute a criminal  
offense under state law.
KEY:   electronic  cigarettes,  nicotine,  standards,  Electronic  
Cigarette Regulation Act
Date of Enactment or Last Substantive Amendment:  [ December 
29, 2016]2019  
Authorizing, and Implemented or Interpreted Law:  26-57-103;  
59-14-803(5)Health, Disease Control and  
Prevention, Epidemiology
R386-80
Local Public Health Emergency  
Funding Protocols
NOTICE OF PROPOSED RULE
(Amendment)
DAR FILE NO.:  44112
FILED:  10/01/2019
RULE ANALYSIS
PURPOSE  OF  THE  RULE  OR  REASON  FOR  THE  
CHANGE:   The  purpose  of  this  amendment  is  to  update  
language  to  match  statutory  changes.   The  report  
requirement referenced in Section R386-80-4 was repealed  
during the 2013 General Session (S.B. 207).
SUMMARY  OF  THE  RULE  OR  CHANGE:   This  rule  
establishes a local health emergency assistance program to  
be  administered  by the Utah  Department  of  Health.   The  
purpose of this amendment is to update language to match  
statutory  changes.   The  report  requirement  referenced  in  
Section R386-80-4 was repealed in S.B. 207 (2013).
STATUTORY OR CONSTITUTIONAL AUTHORIZATION FOR  
THIS RULE:  Section 26-1-38
ANTICIPATED COST OR SAVINGS TO:
♦ THE STATE BUDGET:  These rule changes will not have  
any  cost  or  savings  to  the  state  budget,  because  these  
amendments only remove reference  to a legislative report  
that hasn't been required since 2012.
♦  LOCAL GOVERNMENTS:   These  rule  changes  will  not  
have  any  cost  or  savings  to  local  governments,  because  
these  amendments  only remove  reference  to  a  legislative  
report that hasn't been required since 2012.
♦ SMALL BUSINESSES:  These rule changes will not have  
any cost or savings to small businesses, because this rule  
only applies to state and local governments.
♦  PERSONS  OTHER  THAN  SMALL  BUSINESSES,  
BUSINESSES,  OR  LOCAL  GOVERNMENTAL  ENTITIES:  
This rule change will not have any cost or savings to persons  
other than small businesses, businesses, or local government  
entities,  because  this  rule  only  applies  to  state  and  local  
governments.
COMPLIANCE COSTS FOR AFFECTED PERSONS:  There  
are no compliance costs for affected persons.
COMMENTS  BY  THE  DEPARTMENT  HEAD  ON  THE  
FISCAL IMPACT THE RULE MAY HAVE ON BUSINESSES:  
There is no fiscal impact on businesses because this rule  
only applies to state and local governments.
48 UTAH STATE BULLETIN , October 15, 2019, V ol. 2019, No. 20