DAR File No. 43334

This rule was published in the November 15, 2018, issue (Vol. 2018, No. 22) of the Utah State Bulletin.

Commerce, Occupational and Professional Licensing

Rule R156-17b

Pharmacy Practice Act Rule

Notice of Proposed Rule

(Amendment)

DAR File No.: 43334
Filed: 10/30/2018 10:12:48 AM

RULE ANALYSIS

Purpose of the rule or reason for the change:

Summary of the rule or change:

Section R156-17b-102: Definitions are added as follows: 1) define the term "self-administered hormonal contraceptive" by reference to Section 26-62-102(9); 2) define the new "Utah Hormonal Contraceptive Self-Screening Risk Assessment Questionnaire" as the self-screening risk assessment questionnaire that is approved by the Division pursuant to Section 26-62-106; 3) define the "professional entry degree" required for licensure under Subsection 58-17b-303(1)(f) as the professional entry degree that was offered by the applicant's Accreditation Council on Pharmacy Education (ACPE) accredited school or college of pharmacy in the applicant's year of graduation, either a baccalaureate in Pharmacy (BSPharm) or a doctorate in pharmacy (PharmD); and 4)update the United States Pharmacopeia-National Formulary to USP 41-NF 36 and incorporate it into rule by reference. Section R156-17b-303b: These proposed amendments delete duplicative provisions, and update and clarify pharmacy internship standards required for licensure as a pharmacist, in accordance with the ACPE's current 2016 Standards. Section R156-17b-303c: This proposed amendment increases from two to three the number of North American Pharmacy Licensing Exam (NAPLEX) or Multistate Jurisprudence Exam (MPJE) failures allowed to an applicant, before the applicant must meet with the Board to request an additional authorization to test. Section R156-17b-304: These proposed amendments make non-substantive formatting changes for clarity and provide consistency for temporary licenses with licensure examination requirements. Section R156-17b-308: These proposed amendments clarify and update renewal and reinstatement procedures. In particular, as allowed by Subsection 58-1-308(5)(a)(ii)(B) and Section 58-17b-506, these proposed amendments will allow former Utah licensees whose licenses expired while active and in good standing, easier re-entry into practice by extending their permissible reinstatement period from two years to eight years. This means that if these former licensees meet continuing education and certain other requirements, they may apply for reinstatement instead of being required to submit a new application for licensure complete with all supporting documents as is required of an individual making an initial application for license and demonstrating they meet all current qualifications for licensure. Section R156-17b-309: These proposed amendments clarify and update continuing education requirements as follows: 1) make non-substantive formatting changes throughout for clarity; 2) for pharmacists, update continuing education standards and topics by deleting the old topics of "drug therapy or patient management", and substituting the current topics of "disease state management/drug therapy, AIDS/HIV therapy, or patient safety"; 3) for pharmacy technicians, reduce the eight-hour "live or technology-enabled participation" requirement to six hours; 4) for pharmacists, clarify existing continuing education requirements regarding individual licensee practices (such as requiring two continuing education hours in topics related to long-acting injectables if the licensee will be providing administration of long-acting injectable drug therapy, and requiring two hours in topics related to hormonal contraceptive therapy if the licensee will be prescribing and dispensing a self-administered hormonal contraceptive); 5) add additional options for fulfilling continuing education requirements, including allowing one "live" continuing education (CE) hour for attending one Utah State Board of Pharmacy meeting, up to a maximum of two CE hours during each two-year period, and allowing two CE hours for each hour of lecturing or instructing a CE course or teaching in the licensee's profession, up to a maximum of ten CE hours during each two-year period; 6) require licensees to prove compliance with their continuing education requirements through registration with the free National Association of Boards of Pharmacy (NABP) e-profile CPE Monitor plan, or the NABP CPE Monitor Plus plan, and by maintaining a certificate of completion or other adequate documentation for CE that cannot be tracked by the NABP plan. Section R156-17b-402: These proposed amendments add to the fine and citation schedule "failing to act in accordance with Title 26, Chapter 62, Family Planning Access Act, when dispensing a self-administered hormonal contraceptive under a standing order, in violation of 58-17b-502(14)". Section R156-17b-610: These proposed amendments provide guidelines for patient counseling by a pharmacist or pharmacy intern who dispenses a self-administered hormonal contraceptive. The guidelines require the pharmacist or pharmacy intern to obtain a completed Utah Hormonal Contraceptive Self-Screening Risk Assessment Questionnaire, and provide the written information and counseling described in Section 26-62-106. Section R156-17b-621b: This proposed amendment establishes the operating standards for pharmacist and pharmacy intern dispensing of a self-administered hormonal contraceptive. These standards require special initial training and continuing education, and use of the new Utah Hormonal Contraceptive Self-Screening Risk Assessment Questionnaire adopted by the Division in collaboration with the Board.

Statutory or constitutional authorization for this rule:

Section 58-17b-101
Subsection 58-17b-601(1)
Section 58-37-1
Subsection 58-1-106(1)(a)
Subsection 58-1-202(1)(a)

This rule or change incorporates by reference the following material:

Updates ACPE Accreditation Standards and Key Elements for the Professional Program in Pharmacy Leading to the Doctor of Pharmacy Degree (Standards 2016), published by Accreditation Council for Pharmacy Education (ACPE), July 1, 2016
Updates United States Pharmacopeia-National Formulary (USP 41-NF 36) and First Supplement, dated August 1, 2018, and Second Supplement, dated December 1, 2018, published by United States Pharmacopeia, 2018

Anticipated cost or savings to:

the state budget:

Sections R156-17b-102, R156-17b-303b, and R156-17b-304: Definition R156-17b-102(64) updates the United States Pharmacopeia-National Formulary (USP-NF) to USP 41-NF 36 and incorporates it into rule by reference. The Division budgets for and incurs a yearly cost of $950 to maintain the USP Formulary reference material. The other rule amendments and proposed changes are not expected to impact state government revenues or expenditures because the changes merely update the rules to establish definitions, clarify standards and encompass current requirements and practices in the profession, and make formatting changes for clarity. Section R156-17b-303c: These proposed amendments are not expected to have any impact on the state budget beyond a potential time savings for Division staff and Board members due to a reduction in requests from applicants for Board authorization to retake failed exams. The exact savings cannot be estimated as it will depend on cases of unforeseeable exam failures by applicants and the individuality of the requests that are made, and the relevant data is unavailable. Sections R156-17b-402, R156-17b-610, and R156-17b-621b: These proposed amendments will impact businesses in the pharmacy industry who employ pharmacists or pharmacy interns who dispense self-administered hormonal contraceptives, and this may include certain state government entities acting as businesses. However, because the amendments only carry out the mandates of the Utah Pharmacy Practice Act as amended by S.B. 184 (2018), Pharmacist Dispensing Authority Amendments, the Division estimates that these proposed amendments will have no impact on the state budget, as follows: Section R156-17b-402: This new administrative fine corresponds to new Section 58-17b-502(14) added by S.B. 184 (2018). It is similar to the other unprofessional conduct fines found in Section R156-17b-502. The goal of this rule is to provide a deterrent, such that there is a $0 net impact on all parties involved. Therefore, for the typical member of the affected party, this proposed rule amendment is expected to have no direct or indirect fiscal impacts. However, inestimable fiscal impacts of the underlying rule includes any money a person who is adjudicated as having violated the rule might have to pay to the state budget in the form of an administrative penalty. This amount is inestimable, both because it applies only in cases of unforeseeable violations, and because the penalty assessed may vary depending on the circumstances of the violation. Section R156-17b-610: These proposed amendments provide guidelines for patient counseling by a pharmacist or pharmacy intern who dispenses a self-administered hormonal contraceptive are not expected to have any fiscal impact beyond that imposed by S.B. 184 (2018) because they simply require the pharmacist or pharmacy intern to obtain the completed questionnaire and provide the written information and counseling described in Section 26-62-106. Section R156-17b-621b: These proposed amendments provide operating standards for pharmacist and pharmacy intern dispensing of a self-administered hormonal contraceptive are not expected to have any fiscal impact to the state budget beyond that imposed by S.B. 184 (2018), because in accordance with the guidance of S.B. 184 (2018), the required questionnaire has been adopted by the Division based on extensive collaboration with the Board and multiple medical industry participants so as to incorporate generally accepted professional standards, and the amendments only impose accredited initial training and continuing education requirements common in the industry. Section R156-17b-308: These proposed amendments may indirectly benefit state agencies acting as businesses who employ pharmacists, if these state agencies are able to more easily hire one or more experienced pharmacists who have been able to reinstate their license and enter into practice. The full fiscal and non-fiscal impacts on these state agencies cannot be estimated because the data necessary to determine how many such licensees might be hired is unavailable, and because the benefits the state agencies may experience from any resulting employment will vary widely depending on the requirements of the agencies and the individual characteristics of each pharmacist. Also, any increase in staff workload that may be caused by additional applications and individuals becoming licensed will be balanced by additional revenue and absorbed within the Division's existing budget. Section R156-17b-309: Most of these proposed amendments will not have any impact on the state budget because they will not change existing state practices or procedures. The amendment that will require licensees to prove compliance with their continuing education requirements through registration with the free NABP e-profile CPE Monitor plan or the NABP CPE Monitor Plus plan is expected to create a time savings for Division staff, due to improvement in the quantity and quality of licensee CE records provided to the Division and streamlining of the procedures for auditing licensees' continuing education. This will cause a corresponding financial benefit to the Division. However, the exact savings cannot be estimated as it will vary depending on the circumstances and the nature of each licensee's continuing education records, and the relevant data is unavailable. No other fiscal impact to the state is expected, beyond a minimal cost to the Division of approximately $75 to print and distribute this rule once the proposed amendments are made effective.

local governments:

Sections R156-17b-102, R156-17b-303b, and R156-17b-304: None of these proposed changes are expected to impact local governments' revenues or expenditures because these changes merely establish definitions, update this rule to clarify standards and encompass current requirements and practices in the profession, and make formatting changes for clarity. Sections R156-17b-303c and R156-17b-309: These proposed amendments are not expected to have any impact on local government because they do not apply to local government. Sections R156-17b-402, R156-17b-610, and R156-17b-621b: These proposed amendments will impact businesses in the pharmacy industry who employ pharmacists or pharmacy interns who dispense self-administered hormonal contraceptives, and this may potentially include certain local government entities acting as businesses. However, because these amendments only carry out the mandates of the Utah Pharmacy Practice Act as amended by S.B. 184 (2018), Pharmacist Dispensing Authority Amendments, the Division estimates that these proposed amendments will have no impact on local governments, as follows: Section R156-17b-402: This new administrative fine corresponds to new Section 58-17b-502(14) added by S.B. 184 (2018). It is similar to the other unprofessional conduct fines found in Section R156-17b-502. The goal of this rule is to provide a deterrent, such that there is a $0 net impact on all parties involved. Therefore, for the typical member of the affected party, these proposed amendments are expected to have no direct or indirect fiscal impacts. However, inestimable fiscal impacts of the underlying rule includes any money a person who is adjudicated as having violated this rule might have to pay in the form of an administrative penalty. This amount is inestimable, both because it applies only in cases of unforeseeable violations, and because the penalty assessed may vary depending on the circumstances of the violation. Section R156-17b-610: These proposed amendments provide guidelines for patient counseling by a pharmacist or pharmacy intern who dispenses a self-administered hormonal contraceptive are not expected to have any fiscal impact beyond that imposed by S.B. 184 (2018) because they simply require the pharmacist or pharmacy intern to obtain the completed questionnaire and provide the written information and counseling described in Section 26-62-106. Section R156-17b-621b: These proposed amendments provide operating standards for pharmacist and pharmacy intern dispensing of a self-administered hormonal contraceptive are not expected to have any fiscal impact beyond that imposed by S.B. 184 (2018), because in accordance with the guidance of S.B. 184 (2018) the required questionnaire has been adopted by the Division based on extensive collaboration with the Board and multiple medical industry participants, so as to incorporate generally accepted professional standards, and the amendments only impose accredited initial training and continuing education requirements common in the industry. Section R156-17b-308: These proposed amendments may indirectly benefit local government entities acting as businesses who employ pharmacists, if these entities are able to more easily hire one or more experienced pharmacists who have been able to reinstate their license and enter into practice. The full fiscal and non-fiscal impacts on these local government entities cannot be estimated because the data necessary to determine how many such licensees might be hired is unavailable, and because the benefits the local government entities may experience from any resulting employment will vary widely depending on the requirements of the entities and the individual characteristics of each pharmacist.

small businesses:

Sections R156-17b-102, R156-17b-303b, and R156-17b-304: Definition R156-17b-102(64) updates the United States Pharmacopeia-National Formulary to USP 41-NF 36 and incorporates it into rule by reference; the renewal price for the formulary is $950, however the formulary is available online at no cost. It is unknown whether any of the small businesses would purchase the formulary or simply utilize the free resource. None of the other proposed changes are expected to impact small businesses revenues or expenditures because the changes will not alter the price or quantity of any exchanges between any parties. These changes merely establish definitions, update the rules to clarify standards and encompass current requirements and practices in the profession, and make formatting changes for clarity. Section R156-17b-303c: These proposed amendments are not expected to have any impact on small businesses beyond a potential small indirect benefit from being able to more quickly hire a licensee who became licensed earlier because the licensee did not need to seek Board approval to retake the exam. The exact savings cannot be estimated as it will vary substantially based on the characteristics of the employer and of each individual applicant. Section R156-17b-402, R156-17b-610, and R156-17b-621b: There are approximately 511 small-business Class A retail pharmacies in Utah that may be impacted by these amendments (NAICS 446110). These proposed amendments may impact these small businesses in the pharmacy industry if they choose to employ pharmacists or pharmacy interns who dispense self-administered hormonal contraceptives. However, these proposed amendments are not expected to have an estimable fiscal impact on these small businesses beyond that imposed by the mandates of the Utah Pharmacy Practice Act as amended by S.B. 184 (2018), as follows: Section R156-17b-402: This new administrative fine corresponds to new Section 58-17b-502(14) added by S.B. 184 (2018). It is similar to the other unprofessional conduct fines found in Section R156-17b-502. The goal of this rule is to provide a deterrent, such that there is a $0 net impact on all parties involved. Therefore, for the licensee that will be the typical member of the affected party, these proposed amendments are expected to have no direct or indirect fiscal impacts. However, inestimable fiscal impacts of the underlying rule includes any money a licensee who is adjudicated as having violated the rule might have to pay in the form of an administrative penalty. This amount is inestimable both because it applies only in cases of unforeseeable violations, and because the penalty assessed may vary depending on the circumstances of the violation. Section R156-17b-610: These proposed amendments providing guidelines for patient counseling by a pharmacist or pharmacy intern who dispenses a self-administered hormonal contraceptive are not expected to have any fiscal impact beyond that imposed by S.B. 184 (2018) because they simply require the pharmacist or pharmacy intern to obtain the completed questionnaire and provide the written information and counseling as described in Section 26-62-106. Section R156-17b-621b: These proposed amendments provide operating standards for pharmacist and pharmacy intern dispensing of a self-administered hormonal contraceptive are not expected to have any fiscal impact beyond that imposed by S.B. 184 (2018), because in accordance with the mandates and guidance of S.B. 184 (2018) the required questionnaire has been adopted by the Division based on extensive collaboration with the Board and multiple medical industry participants, so as to incorporate generally accepted professional standards, and these amendments only impose accredited initial training and continuing education requirements common in the industry. Section R156-17b-308: These proposed amendments may directly benefit small businesses in this pharmacy industry that are owned by experienced pharmacists re-entering into practice, who may operate as private or group practices in their own offices (e.g., centers, clinics) or in the facilities of others. These proposed amendments may also indirectly benefit small businesses offering pharmacy services if they are able to more easily hire one or more experienced pharmacists or pharmacy technicians. The Division estimates that there are approximately 511 small-business Class A retail pharmacies, 270 small-business Class B pharmacies, 1,065 small-business Class C pharmacies, 714 small-business Class D pharmacies, and 564 small-business Class E pharmacies licensed in Utah. There are also currently 3,935 licensed pharmacists, many of which are (or may become) owners of small businesses. (For a complete listing of the NAICS Codes used in this analysis, please contact the Division.) The full fiscal and non-fiscal benefits to these small businesses cannot be estimated because the data necessary to determine how many of the licensees returning to practice might operate small businesses of their own or might be hired by small businesses is unavailable; further, the resulting employment will vary widely depending on the characteristics and scope of practice of each small business, as well as the individual characteristics of each licensee. Sections R156-17b-309: These proposed amendments are not expected to have any impact on small businesses because they do not apply to small businesses.

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

Sections R156-17b-102, R156-17b-303b, and R156-17b-304: Definition R156-17b-102(64) updates the United States Pharmacopeia-National Formulary to USP 41-NF 36 and incorporates it into rule by reference; the renewal price for the formulary is $950, however the formulary is available online at no cost. It is unknown whether any of the other persons would purchase the formulary or simply utilize the free resource. None of the other proposed changes are expected to impact other persons because the changes will not alter the price or quantity of any exchanges between any parties. These changes merely establish definitions, update the rule to clarify standards and encompass current requirements and practices in the profession, and make formatting changes for clarity. Section R156-17b-303c: This proposed amendment will benefit some applicants for licensure who have failed an exam twice, and will now not need to seek Board authorization to retake the exam (unless and until they fail the exam a third time). These applicants will avoid the need to take time to appear before the Board, and they may be able to become licensed earlier and employed earlier (or retain their current employment). The exact savings to these persons cannot be estimated as it will vary substantially based on the characteristics of each individual applicant. Sections R156-17b-402, R156-17b-610, and R156-17b-621b: These proposed amendments will impact pharmacists or pharmacy interns who choose to dispense self-administered hormonal contraceptives, and will affect members of the public who choose to purchase self-administered hormonal contraceptives. However, the Division estimates that these proposed amendments will have no impact on these persons beyond the mandates of the Utah Pharmacy Practice Act as amended by S.B. 184 (2018), as follows: Section R156-17b-402: This new administrative fine corresponds to new Section 58-17b-502(14) added by S.B. 184 (2018). It is similar to the other unprofessional conduct fines found in Section R156-17b-502. The goal of this rule is to provide a deterrent, such that there is a $0 net impact on all parties involved. Therefore, for the licensee who will be the typical member of the affected party, the proposed amendment is expected to have no direct or indirect fiscal impacts. However, inestimable fiscal impacts of the underlying rule includes any money a licensee who is adjudicated as having violated the rule might have to pay in the form of an administrative penalty. This amount is inestimable, both because it applies only in cases of unforeseeable violations, and because the penalty assessed may vary depending on the circumstances of the violation. Section R156-17b-610: These proposed amendments provide guidelines for patient counseling by a pharmacist or pharmacy intern who dispenses a self-administered hormonal contraceptive are not expected to have any fiscal impact on either the licensees or pharmacy customers beyond that imposed by S.B. 184 (2018), because they simply require the pharmacist or pharmacy intern to obtain the completed questionnaire and provide the written information and counseling as described in Section 26-62-106. Section R156-17b-621b: These proposed amendments provide operating standards for pharmacist and pharmacy intern dispensing of a self-administered hormonal contraceptive are not expected to have any fiscal impact on the licensees or the pharmacy customers beyond the fiscal impact already imposed by S.B. 184 (2018), because in accordance with the mandates and guidance of S.B. 184 (2018) the required Questionnaire has been adopted by the Division based on extensive collaboration with the Board and multiple medical industry participants, so as to incorporate generally accepted professional standards, and the amendments only impose accredited initial training and continuing education requirements common in the industry. Section R156-17ba-308: These proposed amendments will allow easier re-entry into practice for persons formerly licensed as a pharmacist or pharmacy technician in Utah whose license expired while active and in good standing. These amendments will benefit these and future experienced pharmacists and pharmacy technicians who have left practice and choose to re-enter into practice. However, the full fiscal and non-fiscal benefits for these persons cannot be estimated because the resulting employment will vary substantially depending on the individual choices and characteristics of each pharmacist and pharmacy technician. Section R156-17b-309: Most of these proposed amendments will have no impact on other persons because they only clarify and update the rule regarding current continuing education requirements. The amendment for pharmacy technicians reducing the eight-hour "live or technology-enabled participation" requirement to six hours is expected to save some licensees the cost of traveling to a central location to obtain these two CE hours. This will be especially beneficial to licensees in remote, rural locations. However, the amount of savings is inestimable as it will depend entirely on the CE courses chosen and the location of each licensee. The amendment for all licensees that will add additional options for fulfilling continuing education requirements, including allowing one "live" CE hour for attending one Utah State Board of Pharmacy meeting, up to a maximum of two CE hours during each two-year period, and allowing two CE hours for each hour of lecturing or instructing a CE course or teaching in the licensee's profession, up to a maximum of ten CE hours during each two-year period, is expected to benefit some licensees who are able and willing to earn this CE credit, but the amount of savings is again inestimable as it will be based on individual licensee characteristics and choices. Finally, the amendment that will require all licensees to prove compliance with their continuing education requirements through registration with the free NABP e-profile CPE Monitor plan or the NABP CPE Monitor Plus plan, and by maintaining a certificate of completion or other adequate documentation for CE that cannot be tracked by the NABP plan, is expected to have little to no net impact on licensees. There will be no cost to licensees for registering for CE monitoring unless they choose the CPE Monitor Plus plan. There may be a potential time savings and corresponding financial savings for licensees due to the streamlining of their CE reporting requirements, but there may also be a potential cost to some of these persons due to the need for obtaining and providing better documentation of their CE. In sum, the amount of the net impact to licensees from the potential savings or cost from these amendments is inestimable, as it will vary substantially depending on individual licensee characteristics and choices, and the relevant data is unavailable.

Compliance costs for affected persons:

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

S.B. 184, passed during the 2018 Legislative General Session, amended the Pharmacy Practice Act to permit a pharmacist to dispense a self-administered hormonal contraceptive under a standing prescription order. As required by S.B. 184 (2018), this rule filing provides necessary definitions and establishes and clarifies the requirements for such dispensing. The Board of Pharmacy (Board) proposes the remaining amendments to establish and clarify certain internship requirements and continuing education requirements, and to provide easier practice re-entry into the pharmacy professions by adding a license reinstatement option for certain previously licensed pharmacists and pharmacy technicians. Sections R156-17b-102, R156-17b-303b, R156-17b-304 and Section R156-37-602: Definition R156-17b-102(64) updates the United States Pharmacopeia-National Formulary to USP 41-NF 36 and incorporates it into rule by reference; the renewal price for the formulary is $950. However, the formulary is available online at no cost. It is unknown whether any of the small businesses would purchase the formulary or simply utilize the free resource. None of the other proposed changes are expected to impact small businesses' revenues or expenditures because the changes will not alter the price or quantity of any exchanges between any parties. These changes merely establish definitions, update the rules to clarify standards and encompass current requirements and practices in the profession, and make formatting changes for clarity. Section R156-17b-303c: These proposed amendments are not expected to have any impact on small businesses beyond a potential small indirect benefit from being able to more quickly hire a licensee who became licensed earlier because the licensee did not need to seek Board approval to retake the exam. The exact savings cannot be estimated as it will vary substantially based on the characteristics of the employer and of each individual applicant. Section R156-17b-402, R156-17b-610 and R156-17b-621b: There are approximately 511 small-business Class A retail pharmacies in Utah that may be impacted by these amendments (NAICS 446110). These proposed amendments may impact these small businesses in the pharmacy industry if they choose to employ pharmacists or pharmacy interns who dispense self-administered hormonal contraceptives. However, these proposed amendments are not expected to have an estimable fiscal impact on these small businesses beyond that imposed by the mandates of the Utah Pharmacy Practice Act as amended by S.B. 184 (2018), as follows: Section R156-17b-402: This new administrative fine corresponds to new Section 58-17b-502(14) added by S.B. 184 (2018). It is similar to the other unprofessional conduct fines found in Section R156-17b-502. The goal of this rule is to provide a deterrent, such that there is a $0 net impact on all parties involved. Therefore, for the licensee that will be the typical member of the affected group, this proposed amendment is expected to have no direct or indirect fiscal impacts. However, inestimable fiscal impacts of the underlying rule includes any money a licensee who is adjudicated as having violated the rule might have to pay in the form of an administrative penalty. This amount is inestimable both because it applies only in cases of unforeseeable violations, and because the penalty assessed may vary depending on the circumstances of the violation. Section R156-17b-610: These proposed amendments providing guidelines for patient counseling by a pharmacist or pharmacy intern who dispenses a self-administered hormonal contraceptive are not expected to have any fiscal impact beyond that imposed by S.B. 184 (2018) because they simply require the pharmacist or pharmacy intern to obtain the completed questionnaire and provide the written information and counseling as described in Section 26-62-106. Section R156-17b-621b: These proposed amendments providing operating standards for pharmacist and pharmacy intern dispensing of a self-administered hormonal contraceptive are not expected to have any fiscal impact beyond that imposed by S.B. 184 (2018), because (in accordance with the mandates and guidance of S.B. 184 (2018) the required questionnaire has been adopted by the Division based on extensive collaboration with the Board and multiple medical industry participants, so as to incorporate generally accepted professional standards. Further, the amendments only impose accredited initial training and continuing education requirements common in the industry. Section R156-17b-308: These proposed amendments may directly benefit small businesses in the pharmacy industry that are owned by experienced pharmacists re-entering into practice, who may operate as private or group practices in their own offices (e.g., centers, clinics) or in the facilities of others. These proposed amendments may also indirectly benefit small businesses offering pharmacy services, if they are able to more easily hire one or more experienced pharmacists or pharmacy technicians. The Division estimates that there are approximately 511 small-business Class A retail pharmacies, 270 small-business Class B pharmacies, 1,065 small-business Class C pharmacies, 714 small-business Class D pharmacies, and 564 small-business Class E pharmacies licensed in Utah. There are also currently 3,935 licensed pharmacists, many of whom are (or may become) owners of small businesses. The full fiscal and non-fiscal benefits to these small businesses cannot be estimated because the data necessary to determine how many of the licensees returning to practice might operate small businesses of their own or might be hired by small businesses is unavailable; further, the resulting employment will vary widely depending on the characteristics and scope of practice of each small business, as well as the individual characteristics of each licensee. Sections R156-17b-309: These proposed amendments are not expected to have any impact on small businesses. Non-Small Business: The Division estimates that there are approximately 10 non-small Class A retail pharmacies, 5 non-small Class B pharmacies, 22 non-small Class C pharmacies, 15 non-small Class D pharmacies, and 12 non-small Class E pharmacies licensed in Utah. There are also currently 3,935 licensed pharmacists, some of whom may be (or may become) owners of non-small businesses. The fiscal impact of each of these rule amendments addressed in these comments on non-small businesses is the same as described above with regard to small businesses.

Francine A. Giani, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Office of Administrative Rules, or at:

Commerce
Occupational and Professional Licensing
HEBER M WELLS BLDG
160 E 300 S
SALT LAKE CITY, UT 84111-2316

Direct questions regarding this rule to:

Jennifer Zaelit at the above address, by phone at 801-530-7632, by FAX at , or by Internet E-mail at jzaelit@utah.gov

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

12/17/2018

Interested persons may attend a public hearing regarding this rule:

11/27/2018 08:30 AM, 160 East 300 South, North Conference Room (1st floor), Salt Lake City, Utah

This rule may become effective on:

12/24/2018

Authorized by:

Mark Steinagel, Director

RULE TEXT

Appendix 1: Regulatory Impact Summary Table*

Fiscal Costs	FY 2019	FY 2020	FY 2021
State Government	$0	$0	$0
Local Government	$0	$0	$0
Small Businesses	$0	$0	$0
Non-Small Businesses	$0	$0	$0
Other 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 above. Inestimable impacts for Non-Small Businesses are described below.

Appendix 2: Regulatory Impact to Non-Small Businesses (50 or more employees)

Section R156-17b-303c: These proposed amendments are not expected to have any impact on non-small business beyond a potential small indirect benefit from being able to more quickly hire a licensee who became licensed earlier because the licensee did not need to seek Board approval to retake the exam. The exact savings cannot be estimated as it will vary substantially based on the characteristics of the employer and of each individual applicant.

Section R156-17b-402, R156-17b-610, and R156-17b-621b: There are approximately 10 non-small business Class A retail pharmacies in Utah that may be impacted by these amendments (NAICS 446110). These proposed amendments may impact these non-small businesses in the pharmacy industry if they choose to employ pharmacists or pharmacy interns who dispense self-administered hormonal contraceptives. However, these proposed amendments are not expected to have an estimable fiscal impact on these non-small businesses beyond that imposed by the mandates of the Utah Pharmacy Practice Act as amended by S.B. 184 (2018), as follows:

Section R156-17b-402: This new administrative fine corresponds to new Section 58-17b-502(14) added by S.B. 184 (2018). It is similar to the other unprofessional conduct fines found in Section R156-17b-502. The goal of this rule is to provide a deterrent, such that there is a $0 net impact on all parties involved. Therefore, for the licensee who will be the typical member of the affected party, the proposed rule is expected to have no direct or indirect fiscal impacts. However, inestimable fiscal impacts of the underlying rule includes any money a licensee who is adjudicated as having violated the rule might have to pay in the form of an administrative penalty. This amount is inestimable, both because it applies only in cases of unforeseeable violations, and because the penalty assessed may vary depending on the circumstances of the violation.

Section R156-17b-610: These proposed amendments providing guidelines for patient counseling by a pharmacist or pharmacy intern who dispenses a self-administered hormonal contraceptive are not expected to have any fiscal impact beyond that imposed by S.B. 184 (2018) because they simply require the pharmacist or pharmacy intern to obtain the completed questionnaire and provide the written information and counseling as described in Section 26-62-106.

Section R156-17b-621b: These proposed amendments providing operating standards for pharmacist and pharmacy intern dispensing of a self-administered hormonal contraceptive are not expected to have any fiscal impact beyond that imposed by S.B. 184 (2018), because in accordance with the mandates and guidance of S.B. 184 (2018) the required Questionnaire has been adopted by the Division based on extensive collaboration with the Board and multiple medical industry participants, so as to incorporate generally accepted professional standards, and the amendments only impose accredited initial training and continuing education requirements common in the industry.

Section R156-17b-308: These proposed amendments may directly benefit any non-small businesses in the pharmacy industry that are owned by experienced pharmacists re-entering into practice, and may also indirectly benefit non-small businesses offering pharmacy services if they are able to more easily hire one or more experienced pharmacists or pharmacy technicians. The Division estimates that there are approximately 10 non-small Class A retail pharmacies, 5 non-small Class B pharmacies, 22 non-small class C pharmacies, 15 non-small class D pharmacies and 12 non-small class E pharmacies licensed in Utah. There are also currently 3,935 licensed pharmacists, some of which may be (or become) owners of non-small businesses. (For a complete listing of the NAICS Codes used in this analysis, please contact the Division.) The full fiscal and non-fiscal benefits to these non-small businesses cannot be estimated because the data necessary to determine how many of the licensees returning to practice might operate non-small businesses of their own or might be hired by non-small businesses is unavailable; further, the resulting employment will vary widely depending on the characteristics and scope of practice of each non-small business as well as the individual characteristics of each licensee.

Sections R156-17b-309: These proposed amendments are not expected to have any impact on non-small business because they do not apply to non-small business.

Agency sign off: The head of the Department of Commerce, Francine A. Giani, has reviewed and approved this fiscal analysis.

R156. Commerce, Occupational and Professional Licensing.

R156-17b. Pharmacy Practice Act Rule.

R156-17b-102. Definitions.

In addition to the definitions in Title 58, Chapters 1 and 17b, as used in Title 58, Chapters 1 and 17b or this rule:

(1) "Accredited by ASHP" means a program that:

(a) was accredited by the ASHP on the day the applicant for licensure completed the program; or

(b) was in ASHP candidate status on the day the applicant for licensure completed the program.

(2) "ACPE" means the American Council on Pharmaceutical Education or Accreditation Council for Pharmacy Education.

(3) "Analytical laboratory":

(a) means a facility in possession of prescription drugs for the purpose of analysis; and

(b) does not include a laboratory possessing prescription drugs used as standards and controls in performing drug monitoring or drug screening analysis if the prescription drugs are pre-diluted in a human or animal body fluid, human or animal body fluid components, organic solvents, or inorganic buffers at a concentration not exceeding one milligram per milliliter when labeled or otherwise designated as being for in-vitro diagnostic use.

(4) "ASHP" means the American Society of Health System Pharmacists.

(5) "Authorized distributor of record" means a pharmaceutical wholesaler with whom a manufacturer has established an ongoing relationship to distribute the manufacturer's prescription drugs. An ongoing relationship is deemed to exist between such pharmaceutical wholesaler and a manufacturer, as defined in Section 1504 of the Internal Revenue Code, when the pharmaceutical wholesaler has a written agreement currently in effect with the manufacturer evidencing such ongoing relationship, and the pharmaceutical wholesaler is listed on the manufacturer's current list of authorized distributors of record.

(6) "Authorized personnel" means any person who is a part of the pharmacy staff who participates in the operational processes of the pharmacy and contributes to the natural flow of pharmaceutical care.

(7) "Chain pharmacy warehouse" means a physical location for prescription drugs that acts as a central warehouse and performs intracompany sales or transfers of the prescription drugs to a group of chain pharmacies that have the same common ownership and control.

(8) "Clinic" as used in Subsection 58-17b-625(3)(b) means a class B pharmacy, or a facility which provides out-patient health care services whose primary practice includes the therapeutic use of drugs related to a specific patient for the purpose of:

(a) curing or preventing the patient's disease;

(b) eliminating or reducing the patient's disease;

(9) "Co-licensed partner" means a person that has the right to engage in the manufacturing or marketing of a co-licensed product.

(10) "Co-licensed product" means a device or prescription drug for which two or more persons have the right to engage in the manufacturing, marketing, or both consistent with FDA's implementation of the Prescription Drug Marketing Act as applicable.

(11) "Community pharmacy" as used in Subsection 58-17b-625(3)(b) means a class A pharmacy as defined in Subsection 58-17b-102(10).

(12) "Cooperative pharmacy warehouse" means a physical location for drugs that acts as a central warehouse and is owned, operated or affiliated with a group purchasing organization (GPO) or pharmacy buying cooperative and distributes those drugs exclusively to its members.

(13) "Counterfeit prescription drug" has the meaning given that term in 21 USC 321(g)(2), including any amendments thereto.

(14) "Counterfeiting" means engaging in activities that create a counterfeit prescription drug.

(15) "Dispense", as defined in Subsection 58-17b-102(22), does not include transferring medications for a patient from a legally dispensed prescription for that particular patient into a daily or weekly drug container to facilitate the patient taking the correct medication.

(16) "Device" means an instrument, apparatus, implement, machine, contrivance, implant, or other similar or related article, including any component part or accessory, which is required under Federal law to bear the label, "Caution: Federal or State law requires dispensing by or on the order of a physician."

(17) "DMP" means a dispensing medical practitioner licensed under Section 58-17b, Part 8.

(18) "DMP designee" means an individual, acting under the direction of a DMP, who:

(a)(i) holds an active health care professional license under one of the following chapters:

(A) Chapter 67, Utah Medical Practice Act;

(B) Chapter 68, Utah Osteopathic Medical Practice Act;

(D) Chapter 31b, Nurse Practice Act;

(E) Chapter 16a, Utah Optometry Practice Act;

(F) Chapter 44a, Nurse Midwife Practice Act; or

(G) Chapter 17b, Pharmacy Practice Act; or

(ii) is a medical assistant as defined in Subsection 58-67-102 (9);

(b) meets requirements established in Subsection 58-17b-803 (4)(c); and

(c) can document successful completion of a formal or on-the-job dispensing training program that meets standards established in Section R156-17b-622.

(19) "DMPIC" means a dispensing medical practitioner licensed under Section 58-17b, Part 8 who is designated by a dispensing medical practitioner clinic pharmacy to be responsible for activities of the pharmacy.

(20) "Drop shipment" means the sale of a prescription drug to a pharmaceutical wholesaler by the manufacturer of the drug; by the manufacturer's co-licensed product partner, third party logistics provider, or exclusive distributor; or by an authorized distributor of record that purchased the product directly from the manufacturer or from one of these entities; whereby:

(a) the pharmaceutical wholesale distributor takes title to but not physical possession of such prescription drug;

(b) the pharmaceutical wholesale distributor invoices the pharmacy, pharmacy warehouse, or other person authorized by law to dispense to administer such drug; and

(c) the pharmacy, pharmacy warehouse, or other person authorized by law to dispense or administer such drug receives delivery of the prescription drug directly from the manufacturer; from the co-licensed product partner, third party logistics provider, or exclusive distributor; or from an authorized distributor of record that purchases the product directly from the manufacturer or from one of these entities.

(21) "Drug therapy management" means the review of a drug therapy regimen of a patient by one or more pharmacists for the purpose of evaluating and rendering advice to one or more practitioners regarding adjustment of the regimen.

(22) "Drugs", as used in this rule, means drugs or devices.

(23) "Durable medical equipment" or "DME" means equipment that:

(a) can withstand repeated use;

(b) is primarily and customarily used to serve a medical purpose;

(d) is suitable for use in a health care facility or in the home; and

(e) may include devices and medical supplies.

(24) "Entities under common administrative control" means an entity holds the power, actual as well as legal to influence the management, direction, or functioning of a business or organization.

(25) "Entities under common ownership" means entity assets are held indivisibly rather than in the names of individual members.

(26) "ExCPT", as used in this rule, means the Exam for the Certification of Pharmacy Technicians.

(27) "FDA" means the United States Food and Drug Administration and any successor agency.

(28) "FDA-approved" means the federal Food, Drug, and Cosmetic Act, 21 U.S.C.A. Section 301 et seq. and regulations promulgated thereunder permit the subject drug or device to be lawfully manufactured, marketed, distributed, and sold.

(29) "High-risk, medium-risk, and low-risk drugs" refers to the risk to a patient's health from compounding sterile preparations, as referred to in USP-NF Chapter 797, for details of determining risk level.

(30) "Hospice facility pharmacy" means a pharmacy that supplies drugs to patients in a licensed healthcare facility for terminal patients.

(31) "Hospital clinic pharmacy" means a pharmacy that is located in an outpatient treatment area where a pharmacist or pharmacy intern is compounding, admixing, or dispensing prescription drugs, and where:

(a) prescription drugs or devices are under the control of the pharmacist, or the facility for administration to patients of that facility;

(b) prescription drugs or devices are dispensed by the pharmacist or pharmacy intern; or

(c) prescription drugs are administered in accordance with the order of a practitioner by an employee or agent of the facility.

(32) "Legend drug" or "prescription drug" means any drug or device that has been determined to be unsafe for self-medication or any drug or device that bears or is required to bear the legend:

(a) "Caution: federal law prohibits dispensing without prescription";

(b) "Caution: federal law restricts this drug to use by or on the order of a licensed veterinarian"; or

(33) "Long-term care facility" as used in Section 58-17b-610.7 means the same as the term is defined in Section 58-31b-102.

(34) "Maintenance medications" means medications the patient takes on an ongoing basis.

(35) "Manufacturer's exclusive distributor" means an entity that contracts with a manufacturer to provide or coordinate warehousing, distribution, or other services on behalf of a manufacturer and who takes title to that manufacturer's prescription drug, but who does not have general responsibility to direct the drug's sale or disposition. Such manufacturer's exclusive distributor shall be licensed as a pharmaceutical wholesaler under this chapter and be an "authorized distributor of record" to be considered part of the "normal distribution channel".

(36) "Medical supplies" means items for medical use that are suitable for use in a health care facility or in the home and that are disposable or semi-disposable and are non-reusable.

(37) "MPJE" means the Multistate Jurisprudence Examination.

(38) "NABP" means the National Association of Boards of Pharmacy.

(39) "NAPLEX" means North American Pharmacy Licensing Examination.

(40) "Non drug or device handling central prescription processing pharmacy" means a central prescription processing pharmacy that does not engage in compounding, packaging, labeling, dispensing, or administering of drugs or devices.

(41) "Normal distribution channel" means a chain of custody for a prescription drug that goes directly, by drop shipment as defined in Subsection (19), or via intracompany transfer from a manufacturer; or from the manufacturer's co-licensed partner, third-party logistics provider, or the exclusive distributor to:

(a) a pharmacy or other designated persons authorized under this chapter to dispense or administer prescription drugs to a patient;

(b) a chain pharmacy warehouse that performs intracompany sales or transfers of such drugs to a group of pharmacies under common ownership and control;

(c) a cooperative pharmacy warehouse to a pharmacy that is a member of the pharmacy buying cooperative or GPO to a patient;

(d) an authorized distributor of record, and then to either a pharmacy or other designated persons authorized under this chapter to dispense or administer such drug for use by a patient;

(e) an authorized distributor of record, and then to a chain pharmacy warehouse that performs intracompany sales or transfers of such drugs to a group of pharmacies under common ownership and control; or

(f) an authorized distributor of record to another authorized distributor of record to a licensed pharmaceutical facility or a licensed healthcare practitioner authorized under this chapter to dispense or administer such drug for use by a patient.

(42) "Other health care facilities" means any entity as defined in Utah Code Subsection 26-21-2(13)(a) or Utah Administrative Code R432-1-3(55).

(43) "Parenteral" means a method of drug delivery injected into body tissues but not via the gastrointestinal tract.

(44) "Patient's agent" means a:

(a) relative, friend or other authorized designee of the patient involved in the patient's care; or

(b) if requested by the patient or the individual under Subsection (40)(a), one of the following facilities:

(i) an office of a licensed prescribing practitioner in Utah;

(ii) a long-term care facility where the patient resides; or

(iii) a hospital, office, clinic or other medical facility that provides health care services.

(45) "Pedigree" means a document or electronic file containing information that records each distribution of any given prescription drug.

(46) "PIC", as used in this rule, means the pharmacist-in-charge.

(47) "Prepackaged" or "Prepackaging" means the act of transferring a drug, manually or by use of an automated pharmacy system, from a manufacturer's or distributor's original container to another container in advance of receiving a prescription drug order or for a patient's immediate need for dispensing by a pharmacy or practitioner authorized to dispense in the establishment where the prepackaging occurred.

(48) "Prescription files" means all hard-copy and electronic prescriptions that includes pharmacist notes or technician notes, clarifications or information written or attached that is pertinent to the prescription.

(49) "Professional entry degree", as used in Subsection 58-17b-303(1)(f), means the professional entry degree offered by the applicant's ACPE-accredited school or college of pharmacy in the applicant's year of graduation, either a baccalaureate in pharmacy (BSPharm) or a doctorate in pharmacy (PharmD).

([49]50) "PTCB" means the Pharmacy Technician Certification Board.

([50]51) "Qualified continuing education", as used in this rule, means continuing education that meets the standards set forth in Section R156-17b-309.

([51]52) "Refill" means to fill again.

([52]53) "Repackage" means repackaging or otherwise changing the container, wrapper, or labeling to further the distribution of a prescription drug, excluding that completed by the pharmacist or DMP responsible for dispensing the product to a patient.

([53]54) "Research facility" means a facility where research takes place that has policies and procedures describing such research.

([54]55) "Reverse distributor" means a person or company that retrieves unusable or outdated drugs from a pharmacy for the purpose of removing those drugs from stock and destroying them.

(56) "Self-administered hormonal contraceptive" means the same as defined in Subsection 26-62-102(9).

([55]57) "Sterile products preparation facility" means any facility, or portion of the facility, that compounds sterile products using aseptic technique.

([56]58) "Supervisor" means a licensed pharmacist or DMP in good standing with the Division.

([57]59) "Third party logistics provider" means anyone who contracts with a prescription drug manufacturer to provide or coordinate warehousing, distribution, or other similar services on behalf of a manufacturer, but does not take title to the prescription drug or have any authoritative control over the prescription drug's sale.

([58]60) "Unauthorized personnel" means any person who is not participating in the operational processes of the pharmacy who in some way would interrupt the natural flow of pharmaceutical care.

([59]61) "Unit dose" means the ordered amount of a drug in a dosage form prepared for a one-time administration to an individual and indicates the name, strength, lot number and beyond use date for the drug.

([60]62) "Unprofessional conduct", as defined in Title 58, Chapters 1 and 17b, is further defined, in accordance with Subsection 58-1-203(1)(e), in Section R156-17b-502.

(63) The "Utah Hormonal Contraceptive Self-screening Risk Assessment Questionnaire", adopted September 18, 2018, by the Division in collaboration with the Utah State Board of Pharmacy and Physicians Licensing Board, as posted on the Division's website, is the self-screening risk assessment questionnaire approved by the Division pursuant to Section 26-62-106.

([61]64) "USP-NF" means the United States Pharmacopeia-National Formulary (USP [40]41-NF [35]36), either First Supplement, dated August 1, [~~2017~~]2018, or Second Supplement, dated December 1, [~~2017~~]2018, which is hereby adopted and incorporated by reference.

([62]65) "Wholesaler" means a wholesale distributor who supplies or distributes drugs or medical devices that are restricted by federal law to sales based on the order of a physician to a person other than the consumer or patient.

([63]66) "Wholesale distribution" means the distribution of drugs to persons other than consumers or patients, but does not include:

(a) intracompany sales or transfers;

(b) the sale, purchase, distribution, trade, or other transfer of a prescription drug for emergency medical reasons, as defined under 21 CFR 203.3(m), including any amendments thereto;

(d) the distribution of drug samples;

(e) the return or transfer of prescription drugs to the original manufacturer, original wholesale distributor, reverse distributor, or a third party returns processor;

(f) the sale, purchase, distribution, trade, or transfer of a prescription drug from one authorized distributor of record to one additional authorized distributor of record during a time period for which there is documentation from the manufacturer that the manufacturer is able to supply a prescription drug and the supplying authorized distributor of record states in writing that the prescription drug being supplied had until that time been exclusively in the normal distribution channel;

(g) the sale, purchase or exchange of blood or blood components for transfusions;

(h) the sale, transfer, merger or consolidation of all or part of the business of a pharmacy;

(i) delivery of a prescription drug by a common carrier; or

(j) other transactions excluded from the definition of "wholesale distribution" under 21 CFR 203.3 (cc), including any amendments thereto.

R156-17b-303b. Licensure - Pharmacist - Pharmacy Internship Standards.

In accordance with Subsection 58-17b-303(1)(g), the following standards are established for the pharmacy internship required for licensure as a pharmacist:

(1) For graduates of all U.S. pharmacy schools:

(a) At least 1,740 hours of practice supervised by a pharmacy preceptor shall be obtained [~~in Utah or another state or territory of the United States, or a combination of both~~ ]according to the Accreditation Council for Pharmacy Education (ACPE), Accreditation Standards and [~~Guidelines~~]Key Elements for the Professional Program in Pharmacy Leading to the Doctor of Pharmacy Degree , effective July 1, 2016 ("Standards 2016")[~~Guidelines Version 2.0 Effective February 14, 2011~~], which is hereby incorporated by reference.

(b) [~~Introductory pharmacy practice experiences (IPPE) shall account for not less than 300 hours over the first three professional years.~~

~~(c) A minimum of 150 hours shall be balanced between community pharmacy and institutional health system settings.~~

~~(d) Advanced pharmacy practice experiences (APPE) shall include at least 1,440 hours (i.e., 36 weeks) during the last academic year and after all IPPE requirements are completed.~~

~~(e) Required experiences shall:~~

~~(i) include primary, acute, chronic, and preventive care among patients of all ages; and~~

~~(ii) develop pharmacist-delivered patient care competencies in the community pharmacy, hospital or health-system pharmacy, ambulatory care, inpatient/acute care, and general medicine settings.~~

(f) Internship hours completed in another state or territory of the United States shall be accepted based on the approval of the hours by the pharmacy board in the jurisdiction where the hours were obtained.

~~(g) Evidence of completed internship hours shall be documented to the Division by the pharmacy intern at the time application is made for a Utah pharmacist license.~~

~~(h) Pharmacy interns participating in internships may be credited no more than 50 hours per week of internship experience.~~

~~(i) No credit will be awarded for didactic experience.~~

~~(j)~~ ]If a pharmacy intern is suspended or dismissed from an approved College of Pharmacy, the intern shall notify the Division within 15 days of the suspension or dismissal.

([k]c) If a pharmacy intern ceases to meet all requirements for intern licensure, the pharmacy intern shall surrender the pharmacy intern license to the Division within 60 days unless an extension is requested and granted by the Division in collaboration with the Board.

(2) For graduates of all foreign pharmacy schools, at least 1,440 hours of supervised pharmacy practice in the United States.

(3) Up to 500 hours towards the requirements of Subsections (1)(a) or (2) may be granted, at the discretion of the Division in collaboration with the Board, for other experience substantially related to the practice of pharmacy.

R156-17b-303c. Qualifications for Licensure - Examinations.

(1) In accordance with Subsection 58-17b-303(1)(h), the examinations that shall be successfully passed by an applicant for licensure as a pharmacist are:

(a) the NAPLEX with a passing score as established by NABP; and

(b) the Multistate Pharmacy Jurisprudence Examination (MPJE) with a minimum passing score as established by NABP.

(2) An individual who has failed either examination [~~twice~~]three times shall meet with the Board to request an additional authorization to test. The Division, in collaboration with the Board, may require additional training as a condition for approval of an authorization to retest.

(3) In accordance with Subsection 58-17b-303(3)(j), an applicant applying by endorsement is required to pass the MPJE.

(4) In accordance with Subsection 58-17b-305(1)(g), an applicant applying for licensure as a pharmacy technician shall pass the PTCB or ExCPT with a passing score as established by the certifying body. The certificate shall exhibit a valid date and that the certification is active.

(5) A graduate of a foreign pharmacy school shall obtain a passing score on the Foreign Pharmacy Graduate Examination Committee (FPGEC) examination.

R156-17b-304. Temporary Licensure.

(1) In accordance with Subsection 58-1-303(1), the Division may issue a temporary pharmacist license to a person who meets all qualifications for licensure as a pharmacist in Utah except for the passing of the required examination, if the applicant:

(a) (i) is a graduate of an ACPE accredited pharmacy school within two months immediately preceding application for licensure[,];

(ii) enrolled in a pharmacy graduate residency or fellowship program[,]; or

(iii) licensed[,] in good standing[,] to practice pharmacy in another state or territory of the United States;

(b) submit s a complete application for licensure as a pharmacist except the passing of the NAPLEX and MJPE examinations;

(c) submits evidence of having secured employment conditioned upon issuance of the temporary license, and the employment is under the direct, on-site supervision of a pharmacist with an active, non-temporary license that may or may not include a controlled substance license; and

(d) has registered to take the required licensure examinations.

(2) A temporary pharmacist license issued under Subsection (1) expires the earlier of:

(a) six months from the date of issuance;

(b) the date upon which the Division receives notice from the examination agency that the individual has failed either examination [~~twice~~]three times; or

(3) An individual who has failed either examination [~~twice~~]three times shall meet with the Board to request an additional authorization to test. The Division, in collaboration with the Board, may require additional training as a condition for approval of an authorization to retest.

(4) A pharmacist temporary license issued in accordance with this section cannot be renewed , but may be [or ]extended up to six months, as approved by the Division in collaboration with the Board.

R156-17b-308. [~~Renewal Cycle - Procedures~~]Term, Expiration, Renewal, and Reinstatement of License - Application Procedures.

In accordance with Sections 58-1-308 and 58-17b-506:

(1) [~~In accordance with Subsection 58-1-308(1), t~~]The renewal date for the two-year renewal cycle applicable to licensees under Title 58, Chapter 17b is established [~~by rule~~ ]in Section R156-1-308a.

(2) Renewal and reinstatement procedures shall be in accordance with Section s R156-1-308[c]a through R156-1-308l, except as provided in Subsection (3).

(3) An applicant whose license was active and in good standing at the time of expiration may apply for reinstatement between two years and eight years after the date of expiration, in accordance with the following practice re-entry requirements:

(a) Each applicant shall:

(i) submit a reinstatement application demonstrating compliance with all requirements and conditions of license renewal;

(ii) pay all license renewal and reinstatement fees for the current renewal period; and

(iii) comply with any additional licensure requirements or conditions considered necessary by the Division in collaboration with the Board to protect the public and ensure the applicant is currently competent to engage in the profession, such as:

(A) a background check;

(B) conditional licensure;

(D) licensure exams;

(E) supervised practice requirements;

(F) fitness for duty/competency evaluations; or

(G) any other licensure requirements or conditions determined necessary by the Division in collaboration with the Board.

(b) An applicant applying between two and five years after expiration shall also:

(i) if requested, meet with the Board for evaluation of the applicant's qualifications for licensure; and

(ii) submit evidence that the applicant has successfully completed:

(A) all continuing education for each preceding renewal period in which the license was expired; or

(B) a refresher or practice re-entry program approved by the Division in collaboration with the Board.

(i) meet with the Board for evaluation of the applicant's qualifications for licensure;

(ii) submit evidence that the applicant has:

(A) within five years preceding the application, passed the examinations required for licensure under Section R156-17b-303c (NABPLEX and MPJE for a pharmacist, or PTCB or ExCPT for a pharmacy technician); or

(B) successfully completed a refresher or practice re-entry program approved by the Division in collaboration with the Board; and

(iii) successfully practice under conditional licensure during a period of direct supervision by a pharmacist, for a period equal to at least 40 hours of supervision for each expired year.

([3]4) [An]The Division in collaboration with the Board may approve extension of an intern license [~~may be extended~~ ]upon the request of the licensee, if [~~and approval by the Division under the following conditions:~~

(a) the intern applied to the Division for a pharmacist license and to sit for the NAPLEX and MJPE examinations within three calendar months after obtaining full certification from the Foreign Pharmacy Graduate Equivalency Commission; or

~~(b)~~ ]the intern lacks the required number of internship hours for licensure.

R156-17b-309. Continuing Education.

[~~(1)~~ ]In accordance with Section 58-17b-310 and Subsections 58-1-203(1)(g) and 58-1-308(3)(b), [~~there is created a requirement for~~]the continuing education (CE) requirements [~~as a condition~~ ]for renewal or reinstatement of a pharmacist or pharmacy technician license for each two-year renewal cycle are established as follows:[~~issued under Title 58, Chapter 17b.~~

~~(2) Requirements shall consist of the following number of qualified continuing education hours in each preceding renewal period:~~

~~(a) 30 hours for a pharmacist; and~~

~~(b) 20 hours for a pharmacy technician.~~]

(1) A pharmacist shall complete at least 30 CE hours, which shall include at minimum:

(a) 12 hours of live or technology-enabled participation in lectures, seminars, or workshops;

(b) 15 hours of disease state management/drug therapy, AIDS/HIV therapy, or patient safety;

(d) if providing immunization administration as defined in R156-17b-621, two hours in immunization or vaccine-related topics;

(e) if providing administration of long-acting injectable drug therapy as defined in Section R156-17b-621a, two hours in topics related to long-acting injectables; and

(f) if dispensing a self-administered hormonal contraceptive in accordance with Title 26, Chapter 62, Family Planning Access Act, two hours in topics related to hormonal contraceptive therapy.

(2)(a) A pharmacy technician shall complete at least 20 CE hours, which shall include at minimum:

(i) six hours of live or technology-enabled participation at lectures, seminars, or workshops; and

(ii) one hour of pharmacy law or ethics.

(3) (a) If a licensee first becomes licensed during the two-year renewal cycle, the licensee's required number of CE hours shall be decreased proportionately according to the date of licensure.

(b) The Division may defer or waive CE requirements as provided in Section R156-1-308d.[The required number of hours of qualified continuing professional education for an individual who first becomes licensed during the two year renewal cycle shall be decreased in a pro-rata amount equal to any part of that two year period preceding the date on which that individual first became licensed.]

(4) [~~Qualified continuing professional education hours shall consist of the following~~]CE credit shall be recognized as follows:

(a) [~~for pharmacists:~~]One live CE hour for attending one Utah State Board of Pharmacy meeting, up to a maximum of two CE hours during each two-year period. These hours may count as "pharmacy law or ethics" hours.

(b) Two CE hours for each hour of lecturing or instructing a CE course or teaching in the licensee's profession, up to a maximum of ten CE hours during each two-year period. The licensee shall document the course's content and intended audience (e.g., pharmacists, pharmacy technicians, pharmacy interns, physicians, nurses). Public service programs, such as presentations to schoolchildren or service clubs, are not eligible for CE credit.

(i) institutes, seminars, lectures, conferences, workshops, various forms of mediated instruction, and programmed learning courses, presented by an ACPE-approved institution, individual, organization, association, corporation , or agency[~~that has been approved by ACPE~~];

(ii) programs approved by health-related [~~continuing education~~]CE approval organizations , provided the [~~continuing education~~]CE is nationally recognized by a healthcare accrediting agency and [~~the education~~ ]is related to the practice of pharmacy;

(iii) Division training or educational presentations;

(iv) educational meetings that meet ACPE criteria and are sponsored by the Utah Pharmacy Association, the Utah Society of Health-System Pharmacists, or other professional organization or association; and

(v) for pharmacists, programs of certification by qualified individuals, such as certified diabetes educator credentials, board certification in advanced therapeutic disease management or other certification as approved by the Division in [~~consultation~~]collaboration with the Board[~~; and~~

~~(iv) training or educational presentations offered by the Division.~~

~~(b) for pharmacy technicians:~~

(i) institutes, seminars, lectures, conferences, workshops, various forms of mediated instruction, and programmed learning courses, presented by an institution, individual, organization, association, corporation or agency that has been approved by ACPE;

(ii) programs approved by health-related continuing education approval organizations provided the continuing education is nationally recognized by a healthcare accrediting agency and the education is related to the practice of pharmacy; and

(iii) educational meetings that meet ACPE continuing education criteria sponsored by the Utah Pharmacist Association, the Utah Society of Health-System Pharmacists or other professional organization or association; and

~~(iv) training or educational presentations offered by the Division.~~

~~(5) Credit for qualified continuing professional education shall be recognized in accordance with the following:~~

~~(a) Pharmacists:~~

~~(i) a minimum of 12 hours shall be obtained through attendance at live or technology enabled participation lectures, seminars or workshops;~~

~~(ii) a minimum of 15 hours shall be in drug therapy or patient management; and~~

~~(iii) a minimum of one hour shall be in pharmacy law or ethics.~~

~~(b) Pharmacy Technicians:~~

~~(i) a minimum of eight hours shall be obtained through attendance at live or technology enabled participation at lectures, seminars or workshops; and~~

~~(ii) a minimum of one hour shall be in pharmacy law or ethics.~~

~~(iii) documentation of current PTCB or ExCPT certification will count as meeting the requirement for continuing education.~~

(6) A licensee shall be responsible for maintaining competent records of completed qualified continuing professional education for a period of four years after the close of the two year period to which the records pertain. It is the responsibility of the licensee to maintain such information with respect to qualified continuing professional education to demonstrate it meets the requirements under this section].

(5) A licensee shall maintain documentation sufficient to prove compliance with this section, for a period of four years after the end of the renewal cycle for which the CE is due, by:

(a) maintaining registration with the NABP e-Profile CPE Monitor plan or the NABP CPE Monitor Plus plan; and

(b) maintaining a certificate of completion or other adequate documentation for any CE that cannot be tracked by the licensee's NABP plan.

R156-17b-402. Administrative Penalties.

In accordance with Subsection 58-17b-401(6) and Sections 58-17b-501 and 58-17b-502, unless otherwise ordered by the presiding officer, the following fine and citation schedule shall apply:

(1) preventing or refusing to permit any authorized agent of the Division to conduct an inspection, in violation of Subsection 58-17b-501(1):

initial offense: $500 - $2,000

subsequent offense(s): $5,000

(2) failing to deliver the license or permit or certificate to the Division upon demand, in violation Subsection 58-17b-501(2):

initial offense: $100 - $1,000

subsequent offense(s): $500 - $2,000

(3) using the title pharmacist, druggist, pharmacy intern, pharmacy technician, pharmacy technician trainee or any other term having a similar meaning or any term having similar meaning when not licensed to do so, in violation of Subsection 58-17b-501(3)(a):

initial offense: $500 - $2,000

subsequent offense(s): $2,000 - $10,000

(4) conducting or transacting business under a name that contains as part of that name the words drugstore, pharmacy, drugs, medicine store, medicines, drug shop, apothecary, prescriptions or any other term having a similar meaning or in any manner advertising otherwise describing or referring to the place of the conducted business or profession when not licensed to do so, in violation of Subsection 58-17b-501(3)(b):

initial offense: $500 - $2,000

subsequent offense(s): $2,000 - $10,000

(5) buying, selling, causing to be sold, or offering for sale any drug or device that bears the inscription sample, not for resale, investigational purposes, or experimental use only or other similar words inspection, in violation of Subsection 58-17b-501(4):

initial offense: $1,000 - $5,000

subsequent offense(s): $10,000

(6) using to the licensee's own advantage or revealing to anyone other than the Division, Board or its authorized representatives, any information acquired under the authority of this chapter concerning any method or process that is a trade secret, in violation of Subsection 58-17b-501(5):

initial offense: $100 - $500

subsequent offense(s): $200 - $1,000

(7) illegally procuring or attempting to procure any drug for the licensee or to have someone else procure or attempt to procure a drug, in violation of Subsection 58-17b-501(6):

initial offense: $500 - $2,000

subsequent offense(s): $2,000 - $10,000

(8) filling, refilling or advertising the filling or refilling of prescription drugs when not licensed do to so, in violation of Subsection 58-17b-501(7):

initial offense: $500 - $2,000

subsequent offense(s): $2,000 - $10,000

(9) requiring any employed pharmacist, pharmacy intern, pharmacy technician, pharmacy technician trainee or authorized supportive personnel to engage in any conduct in violation of this chapter, in violation of Subsection 58-17b-501(8):

initial offense: $500 - $2,000

subsequent offense(s): $2,500 - $10,000

(10) being in possession of a drug for an unlawful purpose, in violation of Subsection 58-17b-501(9):

initial offense: $500 - $1,000

subsequent offense(s): $1,500 - $5,000

(11) dispensing a prescription drug to anyone who does not have a prescription from a practitioner or to anyone who is known or should be known as attempting to obtain drugs by fraud or misrepresentation, in violation of Subsection 58-17b-501(10):

initial offense: $500 - $2,000

subsequent offense(s): $2,500 - $10,000

(12) selling, dispensing or otherwise trafficking in prescription drugs when not licensed to do so or when not exempted from licensure, in violation of Subsection 58-17b-501(11):

initial offense: $1,000 - $5,000

subsequent offense(s): $10,000

(13) using a prescription drug or controlled substance for the licensee that was not lawfully prescribed for the licensee by a practitioner, in violation of Subsection 58-17b-501(12):

initial offense: $100 - $500

subsequent offense(s): $1,000 - $2,5000

(14) willfully deceiving or attempting to deceive the Division, the Board or its authorized agents as to any relevant matter regarding compliance under this chapter, in violation of Subsection 58-17b-502(1):

initial offense: $500 - $2,000

subsequent offense(s): $2,500 - $10,000

(15) paying rebates to practitioners or any other health care provider, or entering into any agreement with a medical practitioner or any other person for the payment or acceptance of compensation for recommending the professional services of either party, in violation of Subsection 58-17b-502(2):

initial offense:$2,500 - $5,000

subsequent offense(s):$5,500 - $10,000

(16) misbranding or adulteration of any drug or device or the sale, distribution or dispensing of any outdated, misbranded, or adulterated drugs or devices, in violation of Subsection 58-17b-502(3):

initial offense: $1,000 - $5,000

subsequent offense(s): $10,000

(17) engaging in the sale or purchase of drugs that are samples or packages bearing the inscription "sample" or "not for resale" or similar words or phrases, in violation of Subsection 58-17b-502(4):

initial offense: $500 - $2,000

subsequent offense(s): $2,500 - $10,000

(18) accepting back and redistributing any unused drugs, with the exception as provided in Section 58-17b-503, in violation of Subsection 58-17b-502(5):

initial offense: $1,000 - $5,000

subsequent offense(s): $10,000

(19) engaging in an act in violation of this chapter committed by a person for any form of compensation if the act is incidental to the person's professional activities, including the activities of a pharmacist, pharmacy intern, pharmacy technician, or pharmacy technician trainee in violation of Subsection 58-17b-502(6):

initial offense: $500 - $2,000

subsequent offense(s): $2,500 - $10,000

(20) violating Federal Title II, PL 91, Controlled Substances Act or Title 58, Chapter 37, Utah Controlled Substances Act, or rules and regulations adopted under either act, in violation of Subsection 58-17b-502(7):

initial offense: $500 - $2,000

subsequent offense(s): $2,500 - $10,000

(21) requiring or permitting pharmacy interns, pharmacy technicians, or pharmacy technician trainees to engage in activities outside the scope of practice for their respective license classifications, or beyond their scopes of training and ability, in violation of Subsection 58-17b-502(8):

initial offense: $100 - $500

subsequent offense(s): $500 - $1,000

(22) administering without appropriate training, guidelines, lawful order, or in conflict with a practitioner's written guidelines or protocol for administering, in violation of Subsection 58-17b-502(9):

initial offense: $500 - $2,000

subsequent offense(s): $2,000 - $10,000

(23) disclosing confidential patient information in violation of the provision of the Health Insurance Portability and Accountability Act of 1996 or other applicable law, in violation of Subsection 58-17b-502(10):

initial offense: $100 - $500

subsequent offense(s): $500 - $1,000

(24) engaging in the practice of pharmacy without a licensed pharmacist designated as the PIC, in violation of Subsection 58-17b-502(11):

initial offense: $100 - $500

subsequent offense(s): $2,000 - $10,000

(25) failing to report to the Division any adverse action taken by another licensing jurisdiction, government agency, law enforcement agency or court, in violation of Subsection 58-17b-502(12):

initial offense: $100 - $500

subsequent offense(s): $500 - $1,000

(26) preparing a prescription drug in a dosage form that is regularly and commonly available from a manufacturer in quantities and strengths prescribed by a practitioner, in violation of Subsection 58-17b-502(13):

initial offense: $500 - $1,000

subsequent offense(s): $2,500 - $5,000

(27) failing to act in accordance with Title 26, Chapter 62, Family Planning Access Act, when dispensing a self-administered hormonal contraceptive under a standing order, in violation of Subsection 58-17b-502(14):

initial offense: $100 - $500

subsequent offense(s): $500 - $1,000

([27]28) violating any ethical code provision of the American Pharmaceutical Association Code of Ethics for Pharmacists, October 27, 1994, in violation of Subsection R156-17b-502(1):

initial offense: $250 - $500

subsequent offense(s): $2,000 - $10,000

([28]29) failing to comply with USP-NF Chapter 795 guidelines, in violation of Subsection R156-17b-502(2):

initial offense: $250 - $500

subsequent offense(s): $500 - $750

([29]30) failing to comply with USP-NF Chapter 797 guidelines, in violation of Subsection R156-17b-502(2):

initial offense: $500 - $2,000

subsequent offense(s): $2,500 - $10,000

([30]31) failing to comply with the continuing education requirements set forth in this rule, in violation of Subsection R156-17b-502(3):

initial offense: $100 - $500

subsequent offense(s): $500 - $1,000

([31]32) failing to provide the Division with a current mailing address within 10 days following any change of address, in violation of Subsection R156-17b-502(4):

initial offense: $50 - $100

subsequent offense(s): $200 - $300

([32]33) defaulting on a student loan, in violation of Subsection R156-17b-502(5):

initial offense: $100 - $200

subsequent offense(s): $200 - $500

([33]34) failing to abide by all applicable federal and state law regarding the practice of pharmacy, in violation of Subsection R156-17b-502(6):

initial offense: $500 - $1,000

subsequent offense(s): $2,000 - $10,000

([34]35) failing to comply with administrative inspections, in violation of Subsection R156-17b-502(7):

initial offense: $500 - $2,000

subsequent offense(s): $2,000 - $10,000

([35]36) failing to return a self-inspection report according to the deadline established by the Division, or providing false information on a self-inspection report, in violation of Subsection R156-17b-502(8):

initial offense: $100 - $250

subsequent offense(s): $300 - $500

([36]37) violating the laws and rules regulating operating standards in a pharmacy discovered upon inspection by the Division, in violation of Subsection R156-17b-502(9):

initial violation: $50 - $100

failure to comply within determined time: $250 - $500

subsequent violations: $250 - $500

failure to comply within established time: $750 - $1,000

([37]38) abandoning a pharmacy and/or leaving drugs accessible to the public, in violation of Subsection R156-17b-502(10):

initial offense: $500 - $2,000

subsequent offense(s): $2,000 - $10,000

([38]39) failing to identify license classification when communicating by any means, in violation of Subsection R156-17b-502(11):

initial offense: $100 - $500

subsequent offense(s): $500 - $1,000

([39]40) failing to maintain an appropriate ratio of personnel, in violation of Subsection R156-17b-502(12):

Pharmacist initial offense: $100 - $250

Pharmacist subsequent offense(s): $500 - $2,500

Pharmacy initial offense: $250 - $1,000

Pharmacy subsequent offense(s): $500 - $5,000

([40]41) allowing any unauthorized persons in the pharmacy, in violation of Subsection R156-17b-502(13):

Pharmacist initial offense: $50 - $100

Pharmacist subsequent offense(s): $250 - $500

Pharmacy initial offense: $250 - $500

Pharmacy subsequent offense(s): $1,000 - $2,000

([41]42) failing to offer to counsel any person receiving a prescription medication, in violation of Subsection R156-17b-502(14):

Pharmacy personnel initial offense: $500 - $2,500

Pharmacy personnel subsequent offense(s): $5,000 - $10,000

Pharmacy: $2,000 per occurrence

([42]43) failing to pay an administrative fine within the time designated by the Division, in violation of Subsection R156-17b-502(15):

Double the original penalty amount up to $10,000

([43]44) failing to comply with the PIC or DMPIC standards as established in Section R156-17b-603, in violation of Subsection R156-17b-502(16):

initial offense: $500 - $2,000

subsequent offense(s) $2,000 - $10,000

([44]45) failing to take appropriate steps to avoid or resolve identified drug therapy management problems as referenced in Subsection R156-17b-611(3), in violation of Subsection R156-17b-502(17):

initial offense: $500 - $2,500

subsequent offense: $5,000 - $10,000

([45]46) dispensing a medication that has been discontinued by the FDA, in violation of Subsection R156-17b-502(18):

initial offense: $100 - $500

subsequent offense: $200 - $1,000

([46]47) failing to keep or report accurate records of training hours, in violation of Subsection R156-17b-502(19):

initial offense: $100 - $500

subsequent offense: $200 - $1,000

([47]48) failing to provide PIC or DMPIC information to the Division within 30 days of a change in PIC or DMPIC, in violation of Subsection R156-17b-502(20):

initial offense: $100 - $500

subsequent offense: $200 - $1,000

([48]49) requiring a pharmacy, PIC, or any other pharmacist to operate a pharmacy with unsafe personnel ratio, in violation of Subsection R156-17b-502(21):

initial offense: $500 - $2,000

subsequent offense: $2,000 - $10,000

([49]50) failing to update the Division within seven calendar days of any change in the email address designated for use in self-audits or pharmacy alerts, in violation of Subsection R156-17b-502(22):

Pharmacist initial offense: $100 - $300

Pharmacist subsequent offense(s): $500 - $1,000

Pharmacy initial offense: $250 - $500

Pharmacy subsequent offense(s): $500 - $1,250

([50]51) practicing or attempting to practice as a pharmacist, pharmacist intern, pharmacy technician, or pharmacy technician trainee or operating a pharmacy without a license, in violation of Subsection 58-1-501(1)(a):

initial offense: $500 - $2,000

subsequent offense(s): $2,000 - $10,000

([51]52) impersonating a licensee or practicing under a false name, in violation of Subsection 58-1-501(1)(b):

initial offense: $500 - $2,000

subsequent offense(s): $2,000 - $10,000

([52]53) knowingly employing an unlicensed person, in violation of Subsection 58-1-501(1)(c):

initial offense: $500 - $1,000

subsequent offense(s): $1,000 - $5,000

([53]54) knowingly permitting the use of a license by another person, in violation of Subsection 58-1-501(1)(d):

initial offense: $500 - $1,000

subsequent offense(s): $1,000 - $5,000

([54]55) obtaining a passing score, applying for or obtaining a license or otherwise dealing with the Division or Board through the use of fraud, forgery, intentional deception, misrepresentation, misstatement, or omission, in violation of Subsection 58-1-501(1)(e):

initial offense: $100 - $2,000

subsequent offense(s): $2,000 - $10,000

([55]56) issuing a prescription without prescriptive authority conferred by a license or an exemption to licensure, in violation of Subsection 58-1-501(1)(f)(i)(A)and 58-1-501(2)(m)(i):

initial offense: $500 - $2,000

subsequent offense(s): $2,000 - $10,000

([56]57) issuing a prescription without prescriptive authority conferred by a license or an exemption to licensure without obtaining information sufficient to establish a diagnosis, identify underlying conditions and contraindications to treatment in a situation other than an emergency or an on-call cross coverage situation, in violation of Subsection 58-1-501(1)(f)(i)(B)and 58-1-501(2)(m)(ii):

initial offense: $500 - $2,000

subsequent offense(s): $2,000 - $10,000

([57]58) violating or aiding or abetting any other person to violate any statute, rule or order regulating pharmacy, in violation of Subsection 58-1-501(2)(a):

initial offense: $100 - $2,000

subsequent offense(s): $2,000 - $10,000

([58]59) violating or aiding or abetting any other person to violate any generally accepted professional or ethical standard, in violation of Subsection 58-1-501(2)(b):

initial offense: $500 - $2,000

subsequent offense(s): $2,000 - $10,000

([59]60) engaging in conduct that results in conviction of, or a plea of nolo contendere, or a plea of guilty or nolo contendere held in abeyance to a crime, in violation of Subsection 58-1-501(2)(c):

initial offense: $500 - $2,000

subsequent offense(s): $2,000 - $10,000

([60]61) engaging in conduct that results in disciplinary action by any other jurisdiction or regulatory authority, that if the conduct had occurred in this state, would constitute grounds for denial of licensure or disciplinary action, in violation of Subsection 58-1-501(2)(d):

initial offense: $100 - $500

subsequent offense(s): $200 - $1,000

([61]62) engaging in conduct, including the use of intoxicants, drugs, or similar chemicals, to the extent that the conduct does or may impair the ability to safely engage in practice as a pharmacist, pharmacy intern, pharmacy technician, or pharmacy technician trainee, in violation of Subsection 58-1-501(2)(e):

initial offense: $100 - $500

subsequent offense(s): $200 - $1,000

([62]63) practicing or attempting to practice as a pharmacist, pharmacy intern, pharmacy technician, or pharmacy technician trainee when physically or mentally unfit to do so, in violation of Subsection 58-1-501(2)(f):

initial offense: $100 - $500

subsequent offense(s): $200 - $1,000

([63]64) practicing or attempting to practice as a pharmacist, pharmacy intern, pharmacy technician, or pharmacy technician trainee through gross incompetence, gross negligence or a pattern of incompetency or negligence, in violation of Subsection 58-1-501(2)(g):

initial offense: $500 - $2,000

subsequent offense(s): $2,000 - $10,000

([64]65) practicing or attempting to practice as a pharmacist, pharmacy intern, pharmacy technician, or pharmacy technician trainee by any form of action or communication that is false, misleading, deceptive or fraudulent, in violation of Subsection 58-1-501(2)(h):

initial offense: $100 - $500

subsequent offense(s): $200 - $1,000

([65]66) practicing or attempting to practice as a pharmacist, pharmacy intern, pharmacy technician, or pharmacy technician trainee beyond the individual's scope of competency, abilities or education, in violation of Subsection 58-1-501(2)(i):

initial offense: $100 - $500

subsequent offense(s): $200 - $1,000

([66]67) practicing or attempting to practice as a pharmacist, pharmacy intern, pharmacy technician, or pharmacy technician trainee beyond the scope of licensure, in violation of Subsection 58-1-501(2)(j):

initial offense: $100 - $500

subsequent offense(s): $200 - $1,000

([67]68) verbally, physically or mentally abusing or exploiting any person through conduct connected with the licensee's practice, in violation of Subsection 58-1-501(2)(k):

initial offense: $100 - $1,000

subsequent offense(s): $500 - $2,000

([68]69) acting as a supervisor without meeting the qualification requirements for that position as defined by statute or rule, in violation of Subsection 58-1-501(2)(l):

initial offense: $100 - $500

subsequent offense(s): $200 - $1,000

([69]70) violating a provision of Section 58-1-501.5, in violation of Subsection 58-1-501(2)(n):

initial offense: $500 - $2,000

subsequent offense(s): $2,000 - $10,000

([70]71) surrendering licensure to any other licensing or regulatory authority having jurisdiction over the licensee or applicant in the same occupation or profession while an investigation or inquiry into allegations of unprofessional or unlawful conduct is in progress or after a charging document has been filed against the applicant or licensee alleging unprofessional or unlawful conduct, in violation of Subsection R156-1-501(1):

initial offense: $500 - $2,000

subsequent offense(s): $2,500 - $10,000

([71]72) practicing a regulated occupation or profession in, through, or with a limited liability company that has omitted the words, "limited company," "limited liability company," or the abbreviation "L.C." or "L.L.C." in the commercial use of the name of the limited liability company, in violation of Subsection R156-1-501 (2):

initial offense: $500 - $2,000

subsequent offense(s): $2,500 - $10,000

([72]73) practicing a regulated occupation or profession in, through, or with a limited partnership that has omitted the words, "limited partnership," "limited," or the abbreviation "L.P." or "Ltd." in the commercial use of the name of the limited partnership, in violation of Subsection R156-1-501(3):

initial offense: $500 - $2,000

subsequent offense(s): $2,500 - $10,000

([73]74) practicing a regulated occupation or profession in, through, or with a professional corporation that has omitted the words "professional corporation" or the abbreviation "P.C." in the commercial use of the name of the professional corporation, in violation of Subsection R156-1-501(4):

initial offense: $500 - $2,000

subsequent offense(s): $2,500 - $10,000

([74]75) using a capitalized DBA (doing-business-as name) that has not been properly registered with the Division of Corporations and with the Division of Occupational and Professional Licensing, in violation of Subsection R156-1-501(5):

initial offense: $500 - $2,000

subsequent offense(s): $2,500 - $10,000

([75]76) failing, as a prescribing practitioner, to follow the "Model Policy for the Use of Controlled Substances for the Treatment of Pain," May 2004, established by the Federation of State Medical Boards of the United States, Inc., which is hereby adopted and incorporated by reference, in violation of R156-1-501(6):

initial offense: $500 - $2,000

subsequent offense(s): $2,500 - $10,000

([76]77) engaging in prohibited acts as defined in Section 58-37-8, in violation of Section 58-37-8:

initial offense: $1,000 - $5,000

subsequent offense(s) $5,000 - $10,000

([77]78) self-prescribing or self-administering by a licensee of any Schedule II or Schedule III controlled substance that is not prescribed by another practitioner having authority to prescribe the drug, in violation of Subsection R156-37-502(1)(a):

initial offense: $500 - $2,000

subsequent offense(s): $2,500 - $10,000

([78]79) prescribing or administering a controlled substance for a condition that the licensee is not licensed or competent to treat, in violation of Subsection R156-37-502(1)(b):

initial offense: $500 - $2,000

subsequent offense(s): $2,500 - $10,000

([79]80) violating any federal or state law relating to controlled substances, in violation of Subsection R156-37-502(2):

initial offense: $500 - $2,000

subsequent offense(s): $2,500 - $10,000

([80]81) failing to deliver to the Division all controlled substance certificates issued by the Division, to the Division, upon an action that revokes, suspends, or limits the license, in violation of R156-37-502(3):

initial offense: $500 - $2,000

subsequent offense(s): $2,500 - $10,000

([81]82) failing to maintain controls over controlled substances that would be considered by a prudent licensee to be effective against diversion, theft, or shortage of controlled substances, in violation of Subsection R156-37-502(4):

initial offense: $500 - $2,000

subsequent offense(s): $2,500 - $10,000

([82]83) being unable to account for shortages of controlled substances in any controlled substances inventory for which the licensee has responsibility, in violation of Subsection R156-37-502(5):

initial offense: $500 - $2,000

subsequent offense(s): $2,500 - $10,000

([83]84) knowingly prescribing, selling, giving away, or administering, directly or indirectly, or offering to sell, furnish, give away, or administer any controlled substance to a drug dependent person, as defined in Subsection 58-37-2(1)(s), except for legitimate medical purposes as permitted by law, in violation of Subsection R156-37-502(6):

initial offense: $500 - $2,000

subsequent offense(s): $2,500 - $10,000

([84]85) refusing to make available for inspection controlled substance stock, inventory, and records as required under this rule or other law regulating controlled substances and controlled substance records, in violation of Subsection R156-37-502(7):

initial offense: $500 - $2,000

subsequent offense(s): $2,500 - $10,000

([85]86) failing to submit controlled substance prescription information to the database manager after being notified in writing to do so, in violation of Subsection R156-37-502(8):

initial offense: $500 - $2,000

subsequent offense(s): $2,500 - $10,000

([86]87) any other conduct that constitutes unprofessional or unlawful conduct:

initial offense: $100 - $500

subsequent offense(s): $200 - $1,000

([87]88) if licensed as a DMP or DMP clinic pharmacy, delegating the dispensing of a drug to a DMP designee who has not completed a formal or on-the-job dispensing training program that meets standards established in Section R156-17b-622, in violation of Subsection R156-17b-502 (25):

initial offense: $500 - $2,000

subsequent offense: $2,500 - $10,000

R156-17b-610. Operating Standards - Patient Counseling.

In accordance with Subsection 58-17b-601(1), guidelines for providing patient counseling established in Section 58-17b-613 include the following:

(1) Counseling shall be offered orally in person unless the patient or patient's agent is not at the pharmacy or a specific communication barrier prohibits oral communication.

(2) A pharmacy facility shall orally offer to counsel but shall not be required to counsel a patient or patient's agent when the patient or patient's agent refuses such counseling.

(3) Based upon the professional judgment of the pharmacist, pharmacy intern, or DMP, patient counseling may include the following elements:

(a) the name and description of the prescription drug;

(b) the dosage form, dose, route of administration and duration of drug therapy;

(d) special directions and precautions for preparation, administration and use by the patient;

(e) common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur;

(f) techniques for self-monitoring drug therapy;

(g) proper storage;

(h) prescription refill information;

(i) action to be taken in the event of a missed dose;

(j) pharmacist comments relevant to the individual's drug therapy, including any other information specific to the patient or drug; and

(k) the date after which the prescription should not be taken or used, or the beyond use date.

(4) The offer to counsel shall be documented and said documentation shall be available to the Division. These records shall be maintained for a period of five years and be available for inspection within 7-10 business days.

(5) Only a pharmacist, pharmacy intern, or DMP may orally provide counseling to a patient or patient's agent and answer questions concerning prescription drugs.

(6) If a prescription drug order is delivered to the patient or the patient's agent at the patient's or other designated location, the following is applicable:

(a) the information specified in Subsection (3) of this section shall be delivered with the dispensed prescription in writing;

(b) if prescriptions are routinely delivered outside the area covered by the pharmacy's local telephone service, the pharmacist shall place on the prescription container or on a separate sheet delivered with the prescription container, the telephone number of the pharmacy and the statement "Written information about this prescription has been provided for you. Please read this information before you take this medication. If you have questions concerning this prescription, a pharmacist is available during normal business hours to answer these questions."; and

(c) written information provided in Subsection (6)(b) of this section shall be in the form of patient information leaflets similar to USP-NF patient information monographs or equivalent information.

(7) Patient counseling shall not be required for inpatients of a hospital or institution where other licensed health care professionals are authorized to administer the patient's drugs.

(8) A pharmacist or pharmacy intern who dispenses a self-administered hormonal contraceptive shall obtain a completed Utah Hormonal Contraceptive Self-Screening Risk Assessment Questionnaire and provide written information and counseling as described in Section 26-62-106.

R156-17b-621b. Operating Standards - Pharmacist and Pharmacy Intern Dispensing of a Self-Administered Hormonal Contraceptive - Training.

In accordance with Subsection 58-17b-502(14) and Section 26-62-106:

(1) Prior to dispensing a self-administered hormonal contraceptive, a pharmacist or pharmacy intern shall successfully complete a training program for dispensing self-administered hormonal contraceptives that is provided by an ACPE-accredited provider and approved by the Division in collaboration with the Board.

(2) A pharmacist or pharmacy intern who engages in the dispensing of a self-administered hormonal contraceptive shall:

(a) maintain documentation that the required training was obtained prior to any dispensing; and

(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.

KEY: pharmacists, licensing, pharmacies

Date of Enactment or Last Substantive Amendment: [~~December 12, 2017~~]2018

Notice of Continuation: January 5, 2015

Authorizing, 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)

Additional Information

More information about a Notice of Proposed Rule is available online.

The Portable Document Format (PDF) version of the Bulletin is the official version. The PDF version of this issue is available at https://rules.utah.gov/publicat/bull_pdf/2018/b20181115.pdf. The HTML edition of the Bulletin is a convenience copy. Any discrepancy between the PDF version and HTML version is resolved in favor of the PDF version.

Text to be deleted is struck through and surrounded by brackets ([~~example~~]). Text to be added is underlined (example). Older browsers may not depict some or any of these attributes on the screen or when the document is printed.

For questions regarding the content or application of this rule, please contact Jennifer Zaelit at the above address, by phone at 801-530-7632, by FAX at , or by Internet E-mail at jzaelit@utah.gov. For questions about the rulemaking process, please contact the Office of Administrative Rules.

Home / Publications / Utah State Bulletin / 11/15/2018 Contents / File No. 43334