(Amendment)
DAR File No.: 38638
Filed: 06/23/2014 12:21:19 PMRULE ANALYSIS
Purpose of the rule or reason for the change:
The Division and the Board of Pharmacy reviewed the rule and determined it is necessary to make the following amendments: 1) adding definitions "prepackaged" or "prepackaging" and updating dates for incorporation by reference documents; 2) renumbering of subsections; 3) modifying internship standards for graduates of foreign pharmacy schools; 4) establishing a deadline for pharmacist license applicants to pass required exams; 5) removing unnecessary language; 6) clarifying subsections describing administrative penalties and unprofessional conduct; 7) clarifying direct supervision requirements for a pharmacy technician-in-training; 8) clarifying pharmacy inventory requirements; 9) allowing a pharmacist acting as a preceptor to supervise up to five pharmacy interns in various public outreach program settings; 10) establishing standards for common carrier delivery; 11) clarifying patient counseling standards; 12) requiring compliance with compounding standards when engaging in simple compounding; 13) further defining of pharmacy security system standards; 14) modifying standards for Class D out-of-state mail order pharmacies; 15) modifying standards for Class E pharmacies to address animal immobilization; and (16) correcting typographical errors. The Division and Board of Pharmacy are also proposing the amendments as a result of S.B. 77 from the 2014 General Legislative Session.
Summary of the rule or change:
The following rule amendments are made throughout Rule R156-17b: renumbering of subsections, correcting rule citations, and correcting grammatical and typographical errors. Subsection R156-17b-102(1) is added to allow students graduating from pharmacy technician training programs in American Society of Health System Pharmacists (ASHP) candidate status to satisfy the pharmacy technician license education requirement. Subsection R156-17b-102(4) is added to allow use of an acronym throughout the rule. Subsection R156-17b-102(39) is added because the terms "prepackaged" or "prepackaging" are used in Subsection R156-17b-614b (3)(d) and Subsection 58-17b-610(2)(b) and definition of these terms was necessary for enforcement and education purposes. Subsection R156-17b-102(53) was updated to reflect the most current versions of the United States Pharmacopeia (USP)-National Formulary (NF) books which are incorporated by reference. The sponsor of this year's legislation was consulted to ensure the definition conforms to his understanding. In Subsection R156-17b-302(5), an amendment was necessary due to amendments to Section R156-17b-617c in this filing. Subsection R156-17b-303a(3), Pharmacy Technicians University is added as a program satisfying the pharmacy technician license education requirement because it has acceptable standards, tuition that is cheaper than most other programs, and is accepted in several jurisdictions. In Subsection R156-17b-303a(5)(a), the last date that programs without ASHP accreditation may enroll new students is extended for an additional three years until 12/31/2018. This grants current pharmacy technician education programs without ASHP accreditation additional time to decide whether to pursue accreditation while still enrolling students. The last two sentences of Subsection R156-17b-303a(5)(a) are removed because they are no longer necessary. Subsection R156-17b-303a(5)(b) is necessary to establish an application deadline for students in a program that is exempt under Subsection R156-17b-303a(5)(a). Subsections R156-17b-303a(5)(c) and R156-17b-303a(5)(d) are necessary to ensure that a non-ASHP accredited program informs potential students, enrolled students, and student practice sites of the program's application status with ASHP accreditation. In Section R156-17b-303b, the proposed amendment establishes a separate pharmacy internship standard for graduates of foreign pharmacy schools. A separate standard is necessary because it is impossible for foreign graduates to gather experience in the U.S. that meets the standards in Subsection R156-17b-303b(1)(a). Proposed amendment references 02/14/2011 as the effective date of the Accreditation Council for Pharmacy Education (ACPE) Accreditation Standards and Guidelines for the Professional Program in Pharmacy Leading to the Doctor of Pharmacy Degree Guidelines Version 2.0. February 14, 2001 is not the correct effective date. In Section R156-17b-303c, the proposed amendment adds Subsection R156-17b-303c(4) to require that a pharmacist license applicant pass the North American Pharmacy Licensing Examination (NAPLEX) and Multistate Jurisprudence Examination (MPJE) within six months of the date the Division approved them to take the exams. This amendment is necessary because some information, such as information disclosed in the application qualifying questionnaire, may no longer be accurate six months after the applicant submitted the application. Subsection R156-17b-303c(4)(a) is removed because it was determined that the Utah Pharmacy Technician Law and Rule Examination was unnecessary. It is a true or false take-home exam included within the license application. There is no evidence that other states have a similar exam for initial applicants or that the exam helps protect the public. In Subsection R156-17b-402(36), the proposed amendment adds a phrase to clarify that self-inspection reports must be returned to the Division by the deadline established by the Division. In Subsection R156-17b-502(8), the proposed amendment adds a phrase to clarify that self-inspection reports must be returned to the Division by the deadline established by the Division. Subsection R156-17b-601(4) is added to clarify that a pharmacy technician-in-training may practice only under the direct supervision of a pharmacist. Subsection R156-17b-605(2)(d) is amended to clarify that it is acceptable for a pharmacy to have handwritten inventory records. In Section R156-17b-606, the proposed amendments allow a pharmacist acting as a preceptor to supervise up to five pharmacy interns in various public outreach program settings. This is allowed under conditions outlined in the rule. In Section R156-17b-608, the proposed amendments establish standards for a pharmacy's delivery of filled prescriptions when they are delivered via common carrier such as the United States Postal Service. These standards are needed because delivery of filled prescriptions via common carrier is becoming more common. The proposed amendment incorporates delivery standards accepted by the industry. In Section R156-17b-610, the proposed amendments modify patient counseling standards to better support the statutory standards established in Section 58-17b-613. Unnecessary language is removed. In Subsection R156-17b-614a(1), the proposed amendment further defines security system standards for a pharmacy. The Board and Division are concerned that the current rule does not require that a pharmacy have a security system that provides notice of unauthorized entry to an individual. In Subsection R156-17b-614a(3), compliance with compounding standards when engaging in simple compounding is required. This corrects an unintended error in a previous rule filing. In Section R156-17b-616, the proposed amendment modifies a license requirement for licensure as a Class D out-of-state mail order pharmacy. Under the amendment, an inspection completed by National Association of Boards of Pharmacy (NAPB) as part of the NABP Verified Pharmacy Program (VPP) may be accepted in lieu of a state specific inspection. This requirement is necessary because in some cases, NABP conducts inspections on Class D pharmacies more frequently than state regulatory board inspectors. In Section R156-17b-617c, the proposed amendment modifies the title of a license subcategory and expands operating standards to apply to animal control facilities that perform immobilization services, such as the Utah Division of Wildlife Resources.
State statutory or constitutional authorization for this rule:
- Subsection 58-17b-601(1)
- Section 58-17b-101
- Subsection 58-1-106(1)(a)
- Section 58-37-1
- Subsection 58-1-202(1)(a)
This rule or change incorporates by reference the following material:
- Updates United States Pharmacoepia-National Formulary USP 37-NF 32 through Supplement 1, published by United States Pharmacoepia, May 1, 2014
- Updates Accreditation Standards and Guidelines for the Professional Program in Pharmacy Leading to the Doctor of Pharmacy Degree Guidelines Version 2.0, published by Accreditation Council for Pharmacy Education, February 14, 2011
Anticipated cost or savings to:
the state budget:
The Division will incur minimal costs of approximately $100 to print and distribute the rule once the proposed amendments are made effective. Any costs incurred will be absorbed in the Division's current budget. The Division has also paid approximately $1,800 for two subscriptions to the United States Pharmacopeia (USP)-National Formulary (NF) books; one copy maintained by the Division and one copy sent to the Division of Administrative Rules.
local governments:
The proposed amendments only apply to pharmacies, pharmacy programs, pharmacists, pharmacy technicians, pharmacy interns, and applicants for licensure in the pharmacy profession. As a result, the proposed amendments do not apply to local governments.
small businesses:
Adding Subsection (1) to Section R156-17b-102 enables an individual who completed a program in ASHP candidate status to satisfy the pharmacy technician education program requirement. The current rule does not allow these individuals to become licensed. As a result of this proposed amendment, some individuals seeking licensure and some pharmacy technician training programs will experience cost savings. The Division is unable to estimate the potential cost savings. In Subsection (5) of Section R156-17b-303a, an individual is provided until 12/31/2018 to enroll in a program that was approved by the Division prior to 04/30/2014 but is without ASHP accreditation. This proposed amendment may result in a cost savings for pharmacy technician training programs that may continue to enroll students until 12/31/2018; however, the Division is unable to estimate the potential cost. Adding standards for common carrier delivery of medications in Section 608 may result in some pharmacies having to modify their current standards. If a pharmacy has to make modifications in order to comply with the proposed standards, they would experience some cost impact. The Division is unable to estimate the potential cost impact because the details regarding the modifications required to comply with the proposed standards are unknown. Section R156-17b-614a adds details regarding security system standards applicable to Class A and B pharmacies. Under the proposed amendment, pharmacies are required to have a security system that provides notice of unauthorized entry to an individual who is able to respond quickly and reasonably assess the entry and resolve the matter. A pharmacy that has to make modifications to their current security system to comply with the proposed standards would experience some cost impact. The Division does not know how many pharmacies need to modify their security system to comply with the proposed rule. The cost of security equipment that provides notice of unauthorized entry to a third party ranges from $200 to $300. Notification service fees range from $15 to $43 per month. However, most existing alarm systems likely meet the new standards.
persons other than small businesses, businesses, or local governmental entities:
Adding Subsection (1) to Section R156-17b-102 enables an individual who completed a program in ASHP candidate status to satisfy the pharmacy technician education program requirement. The current rule does not allow these individuals to become licensed. As a result of this proposed amendment, some individuals seeking licensure and pharmacy technician training programs will experience cost savings. The Division is unable to estimate the potential cost savings. In Subsection (3) of Section R156-17b-303a, Pharmacy Technicians University (PTU) is added as a possible program satisfying the pharmacy technician license education requirement. This amendment will result in cost savings for many students because other approved programs are more expensive. For example, PTU's tuition is $99 compared to the $2,240 tuition fee of the National Pharmacy Technician Association Online Program. In Subsection (5) of Section R156-17b-303a, an individual has until 12/31/2018 to enroll in a program that was approved by the Division prior to 04/30/2014 but is without ASHP accreditation. An individual must apply for a pharmacy technician license within two years after they enroll in the program unless otherwise approved by the Division in collaboration with the Board. Under the proposed amendment, their license application must be submitted no later than 12/31/2021. These proposed amendments may result in a cost savings for pharmacy technician training programs that may continue to enroll students until 12/31/2018. The Division is unable to estimate the potential cost savings. In Section R156-17b-303b, the proposed rule creates a pharmacy internship track specific to foreign-educated applicants. This rule change is a cost savings to foreign-educated students because it is very difficult for them to comply with the current standard. The Division is unable to estimate the potential cost savings.
Compliance costs for affected persons:
Adding Subsection (1) to Section R156-17b-102 enables an individual who completed a program in ASHP candidate status to satisfy the pharmacy technician education program requirement. The current rule does not allow these individuals to become licensed. As a result of this proposed amendment, some individuals seeking licensure and pharmacy technician training programs will experience cost savings. The Division is unable to estimate the potential cost savings. In Subsection (3) of Section R156-17b-303a, Pharmacy Technicians University (PTU) is added as a possible program satisfying the pharmacy technician license education requirement. This amendment will result in cost savings for many students because other approved programs are more expensive. For example, PTU's tuition is $99 compared to the $2,240 tuition fee of the National Pharmacy Technician Association Online Program. In Subsection (5) of Section R156-17b-303a, an individual has until 12/31/2018 to enroll in a program that was approved by the Division prior to 04/30/2014 but is without ASHP accreditation. An individual must apply for a pharmacy technician license within two years after they enroll in the program unless otherwise approved by the Division in collaboration with the Board. Under the proposed amendment, their license application must be submitted no later than 12/31/2021. These proposed amendments may result in a cost savings for pharmacy technician training programs that may continue to enroll students until 12/31/2018. The Division is unable to estimate the potential cost savings. In Section R156-17b-303b, the proposed rule creates a pharmacy internship track specific to foreign-educated applicants. This rule change is a cost savings to foreign-educated students because it is very difficult for them to comply with the current standard. The Division is unable to estimate the potential cost savings.
Comments by the department head on the fiscal impact the rule may have on businesses:
This comprehensive filing makes nonsubstantive corrections; clarifies licensing requirements regarding education, testing, and internships; and clarifies circumstances in which a licensee may be found to have engaged in unprofessional conduct. These amendments affect individuals and will therefore have no fiscal impact on businesses. In addition, the filing updates and clarifies requirements that attach to a pharmacy's supervision of technicians-in-training, use of a common carrier for drug delivery, obligation to provide patient counseling, simple compounding, animal immobilization, and security when the pharmacy is closed for business. Businesses that are out of compliance with these requirements might experience costs to modify their practices and systems to meet the standards. Such costs will vary and cannot be estimated.
Francine A. Giani, Executive Director
The full text of this rule may be inspected, during regular business hours, at the Division of Administrative Rules, or at:
Commerce
Occupational and Professional Licensing
HEBER M WELLS BLDG
160 E 300 S
SALT LAKE CITY, UT 84111-2316Direct questions regarding this rule to:
- Rich Oborn at the above address, by phone at 801-530-6767, by FAX at 801-530-6511, or by Internet E-mail at roborn@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:
08/14/2014
Interested persons may attend a public hearing regarding this rule:
- 07/22/2014 08:30 AM, Heber Wells Bldg, 160 E 300 S, Conference Room 474 (fourth floor), Salt Lake City, UT
This rule may become effective on:
08/21/2014
Authorized by:
Mark Steinagel, Director
RULE TEXT
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 on which the applicant for licensure completed the program; or
(b) was in ASHP candidate status on the day on which the applicant for licensure completed the program.
([
1]2) "ACPE" means the American Council on Pharmaceutical Education or Accreditation Council for Pharmacy Education.([
2]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.
([
3]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.([
4]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.([
5]7) "Centralized Prescription Filling" means the filling by a pharmacy of a request from another pharmacy to fill or refill a prescription drug order.([
6]8) "Centralized Prescription Processing" means the processing by a pharmacy of a request from another pharmacy to fill or refill a prescription drug order or to perform processing functions such as dispensing, drug utilization review (DUR), claims adjudication, refill authorizations, and therapeutic interventions.([
7]9) "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]10) "Co-licensed partner or product" means an instance where two or more parties have the right to engage in the manufacturing and/or marketing of a prescription drug, consistent with FDA's implementation of the Prescription Drug Marketing Act.([
9]11) "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.([
10]12) "Counterfeit prescription drug" has the meaning given that term in 21 USC 321(g)(2), including any amendments thereto.([
11]13) "Counterfeiting" means engaging in activities that create a counterfeit prescription drug.([
12]14) "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.([
13]15) "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."([
14]16) "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.
([
15]17) "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.([
16]18) "Drugs", as used in this rule, means drugs or devices.([
17]19) "Durable medical equipment" or "DME" means equipment that:(a) can withstand repeated use;
(b) is primarily and customarily used to serve a medical purpose;
(c) generally is not useful to a person in the absence of an illness or injury;
(d) is suitable for use in a health care facility or in the home; and
(e) may include devices and medical supplies.
([
18]20) "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.([
19]21) "Entities under common ownership" means entity assets are held indivisibly rather than in the names of individual members.([
20]22) "ExCPT", as used in this rule, means the Exam for the Certification of Pharmacy Technicians.([
21]23) "FDA" means the United States Food and Drug Administration and any successor agency.([
22]24) "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.([
23]25) "Hospice facility pharmacy" means a pharmacy that supplies drugs to patients in a licensed healthcare facility for terminal patients.([
24]26) "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.
([
25]27) "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
(c) "Rx only".
([
26]28) "Maintenance medications" means medications the patient takes on an ongoing basis.([
27]29) "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".([
28]30) "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.([
29]31) "MPJE" means the Multistate Jurisprudence Examination.([
30]32) "NABP" means the National Association of Boards of Pharmacy.([
31]33) "NAPLEX" means North American Pharmacy Licensing Examination.([
32]34) "Normal distribution channel" means a chain of custody for a prescription drug that goes directly, by drop shipment as defined in Subsection ([14]16), 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.
([
33]35) "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).([
34]36) "Parenteral" means a method of drug delivery injected into body tissues but not via the gastrointestinal tract.([
35]37) "Pedigree" means a document or electronic file containing information that records each distribution of any given prescription drug.([
36]38) "PIC", as used in this rule, means the pharmacist-in-charge.(39) "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 in which the prepackaging occurred.
([
37]40) "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.([
38]41) "PTCB" means the Pharmacy Technician Certification Board.([
39]42) "Qualified continuing education", as used in this rule, means continuing education that meets the standards set forth in Section R156-17b-309.([
40]43) "Refill" means to fill again.([
41]44) "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 responsible for dispensing the product to a patient.([
42]45) "Research facility" means a facility in which research takes place that has policies and procedures describing such research.([
43]46) "Reverse distributor" means a person or company that retrieves unusable or outdated drugs from a pharmacy or pharmacist for the purpose of removing those drugs from stock and destroying them.([
44]47) "Sterile products preparation facility" means any facility, or portion of the facility, that compounds sterile products using aseptic technique.([
45]48) "Supervisor" means a licensed pharmacist in good standing with the Division.([
46]49) "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. Such third party logistics provider 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".([
47]50) "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.([
48]51) "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.([
49]52) "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.([
50]53) "USP-NF" means the United States Pharmacopeia-National Formulary (USP [36]37-NF [31]32), [2013]2014 edition, which is official from May 1, [2013]2014 through Supplement [2]1, dated [December 1, 2013]August 1, 2014, which is hereby adopted and incorporated by reference.([
51]54) "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.([
52]55) "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;
(c) the sale, purchase, or trade of a drug pursuant to a prescription;
(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-302. Pharmacy Licensure Classifications - Pharmacist-in-Charge Requirements.
In accordance with Subsection 58-17b-302(4), the classification of pharmacies holding licenses are clarified as:
(1) Class A pharmacy includes all retail operations located in Utah and requires a PIC.
(2) Class B pharmacy includes an institutional pharmacy that provides services to a target population unique to the needs of the healthcare services required by the patient. All Class B pharmacies require a PIC except for pharmaceutical administration facilities and methadone clinics. Examples of Class B pharmacies include:
(a) closed door;
(b) hospital clinic pharmacy;
(c) methadone clinics;
(d) nuclear;
(e) branch;
(f) hospice facility pharmacy;
(g) veterinarian pharmaceutical facility;
(h) pharmaceutical administration facility; and
(i) sterile product preparation facility.
(j) A retail pharmacy that prepares sterile products does not require a separate license as a Class B pharmacy.
(3) Class C pharmacy includes pharmacies located in Utah that are involved in:
(a) manufacturing;
(b) producing;
(c) wholesaling;
(d) distributing; and
(e) reverse distributing.
(4) Class D pharmacy includes pharmacies located outside the [
s]State of Utah. Class D pharmacies require a PIC licensed in the state where the pharmacy is located and include [O]out-of-state mail order pharmacies. Facilities that have multiple locations must have licenses for each facility and every component part of a facility.(5) Class E pharmacy includes those pharmacies that do not require a PIC and include:
(a) analytical laboratory;
(b) animal [
euthanasia]control;(c) durable medical equipment provider;
(d) human clinical investigational drug research facility; and
(e) medical gas provider.
(6) All pharmacy licenses will be converted to the appropriate classification by the Division as identified in Section 58-17b-302.
(7) Each Class A and each Class B pharmacy required to have a PIC shall have one PIC who is employed on a full-time basis as defined by the employer, who acts as a PIC for one pharmacy. However, the PIC may be the PIC of more than one Class A or Class B pharmacy, if the additional Class A or Class B pharmacies are not open to provide pharmacy services simultaneously.
(8) The PIC shall comply with the provisions of Section R156-17b-603.
R156-17b-303a. Qualifications for Licensure - Education Requirements.
(1) In accordance with Subsections 58-17b-303(2) and 58-17b-304(7)(b), the credentialing agency recognized to provide certification and evaluate equivalency of a foreign educated pharmacy graduate is the Foreign Pharmacy Graduate Examination Committee (FPGEC) of the National Association of Boards of Pharmacy Foundation.
(2) In accordance with Subsection 58-17b-304(7), an applicant for a pharmacy intern license shall demonstrate that he meets one of the following education criteria:
(a) current admission in a College of Pharmacy accredited by the ACPE by written verification from the Dean of the College;
(b) a graduate degree from a school or college of pharmacy which is accredited by the ACPE; or
(c) a graduate degree from a foreign pharmacy school as established by a certificate of equivalency from an approved credentialing agency defined in Subsection (1).
(3) In accordance with Subsection 58-17b-305(1)(f), a pharmacy technician shall complete a training program that is :
(a) accredited [
or conducted by the American Society of Health System Pharmacists,]by ASHP; or(b) conducted by:
(i) the National Pharmacy Technician Association[
,];(ii) Pharmacy Technicians University; or
(iii) a branch of the Armed Forces of the United States, and
(c) meets the following standards:
([
a]i) completion of at least 180 hours of directly supervised practical training in a licensed pharmacy as determined appropriate by a licensed pharmacist in good standing; and([
b]ii) written protocols and guidelines for the teaching pharmacist outlining the utilization and supervision of pharmacy technicians in training that address:([
i]A) the specific manner in which supervision will be completed; and([
ii]B) an evaluative procedure to verify the accuracy and completeness of all acts, tasks and functions performed by the pharmacy technician in training.(4) An individual shall complete a pharmacy technician training program and successfully pass the required examinations as listed in Subsection R156-17b-303c[
(a) An individual who fails to apply for and obtain a pharmacy technician license within the two-year time frame or within six months after completion of a pharmacy technician training program, whichever comes first:
(i) is no longer eligible for employment as a technician-in-training and shall work in the pharmacy only as supportive personnel; and
(ii) shall repeat a pharmacy technician training program in its entirety if the individual pursues licensure as a pharmacy technician.
(5) (a) Pharmacy technician training programs that receive d Division approval on or before April 30, 2014 are exempt from satisfying standards established in Subsection R156-17b-303a(3) for students enrolled on or before December 31, 2018[
until January 1, 2016].[The Division will accept and review applications for approval of pharmacy technician training programs submitted on or before March 31, 2014. The criteria used by the Division to determine whether a pharmacy technician program is approved shall be the criteria established in Subsection R156-17b-303a(2) of the rule effective immediately prior to this rule.](b) A student in a program described in Subsection (5)(a) shall comply with the program completion deadline and testing requirements in Subsection (4), except that the license application shall be submitted to the Division no later than December 31, 2021.
(c) A program in ASHP candidate status shall notify a student prior to enrollment that if the program is denied accreditation status while the student is enrolled in the program, the student will be required to complete education in another program with no assurance of how many credits will transfer to the new program.
(d) A program in ASHP candidate status that is denied accreditation shall immediately notify the Division, enrolled students and student practice sites, of the denial. The notice shall instruct each student and practice site that:
(i) the program no longer satisfies the pharmacy technician license education requirement in the State of Utah; and
(ii) enrollment in a different program meeting requirements established in Subsection R156-17b-303a(3) is necessary for the student to complete training and to satisfy the pharmacy technician license education requirement in the State of Utah.
(6) An applicant for licensure as a pharmacy technician is deemed to have met the qualifications for licensure in Subsection 58-17b-305(1)(f) and 58-17b-305(1)(g) if the applicant:
(a) is currently licensed and in good standing in another state and has not had any adverse action taken on that license;
(b) has engaged in the practice as a pharmacy technician for a minimum of 1,000 hours in that state within the past two years or equivalent experience as approved by the Division in collaboration with the Board; and
(c) has passed and maintained current PTCB or ExCPT certification[
; and(d) has passed the Utah Pharmacy Technician Law and Rule Examination].R156-17b-303b. Licensure - Pharmacist - Pharmacy Internship Standards.
(1) In accordance with Subsection 58-17b-303(1)(g), the standards are established as one of the following for the pharmacy internship required for licensure as a pharmacist:
(a) [
f]For graduates of all U.S. [and foreign]pharmacy schools[, include the following]:([
a]i) 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 for the Professional Program in Pharmacy Leading to the Doctor of Pharmacy Degree Guidelines Version 2.0 Effective February 14, [2001]2011, which is hereby incorporated by reference.(ii) Introductory pharmacy practice experiences (IPPE) shall account for not less than 300 hours over the first three professional years.
(iii) A minimum of 150 hours shall be balanced between community pharmacy and institutional health system settings.
([
iii]iv) 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.([
i]v) Required experiences shall:(A) include primary, acute, chronic, and preventive care among patients of all ages; and
(B) develop pharmacist-delivered patient care competencies in the community pharmacy, hospital or health-system pharmacy, ambulatory care, inpatient/acute care, and general medicine settings.
(vi) 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.
([
b]vii) 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.([
c]viii) Pharmacy interns participating in internships may be credited no more than 50 hours per week of internship experience.([
d]ix) No credit will be awarded for didactic experience.([
2]x) 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.([
3]xi) 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.(b) For graduates of all foreign pharmacy schools, at least 1,440 hours of supervised pharmacy practice in the United States.
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 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) Applicants taking the NAPLEX or MPJE examination shall pass the exams within six months from the date of the Division's approval for the applicant to take the exam. If the applicant does not pass the required exam within six months, the pending license application shall be denied.
([
4]5) In accordance with Subsection 58-17b-305(1)(g), [the examinations which shall be passed by]an applicant applying for licensure as a pharmacy technician [are:(a) the Utah Pharmacy Technician Law and Rule Examination, taken as part of the application for licensure, with a minimum passing score of 88 percent; and(b)]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]6) A graduate of a foreign pharmacy school shall obtain a passing score on the Foreign Pharmacy Graduate Examination Committee (FPGEC) examination.R156-17b-303d. Qualifications for Licensure - Meet with the Board.
In accordance with Subsections 58-1-202(1)(d) and 58-1-301(3), an applicant for licensure under Title 58, Chapter 17b may be required to meet with the [
State]Board of Pharmacy for the purpose of evaluating the applicant's qualifications for licensure.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 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 which 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 which 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 which 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 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, or pharmacy technician, 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 or technicians 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, including compounding a prescription drug, for sale to another pharmacist or pharmaceutical facility, in violation of Subsection 58-17b-502(13):
initial offense: $100 - $500
subsequent offense(s): $500 - $1,000
(27) preparing a prescription drug in a dosage form which is regularly and commonly available from a manufacturer in quantities and strengths prescribed by a practitioner, in violation of Subsection 58-17b-502(14):
initial offense: $500 - $1,000
subsequent offense(s): $2,500 - $5,000
(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
(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
(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
(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
(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
(33) defaulting on a student loan, in violation of Subsection R156-17b-502(5):
initial offense: $100 - $200
subsequent offense(s): $200 - $500
(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
(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
(36) failing to return [
or providing false information on]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
(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
(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
(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
(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
(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
(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
(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
(44) failing to comply with the PIC 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
(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
(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
(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
(48) failing to provide PIC information to the Division within 30 days of a change in PIC, in violation of Subsection R156-17b-502(20):
initial offense: $100 - $500
subsequent offense: $200 - $1,000
(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
(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
(51) practicing or attempting to practice as a pharmacist, pharmacist intern, or pharmacy technician 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
(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
(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
(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
(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
(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
(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
(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
(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
(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
(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
(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 or pharmacy technician, in violation of Subsection 58-1-501(2)(e):
initial offense: $100 - $500
subsequent offense(s): $200 - $1,000
(63) practicing or attempting to practice as a pharmacist, pharmacy intern or pharmacy technician 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
(64) practicing or attempting to practice as a pharmacist, pharmacy intern, or pharmacy technician 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
(65) practicing or attempting to practice as a pharmacist, pharmacy intern or pharmacy technician by any form of action or communication which 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
(66) practicing or attempting to practice as a pharmacist, pharmacy intern or pharmacy technician 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
(67) practicing or attempting to practice as a pharmacist, pharmacy intern or pharmacy technician beyond the scope of licensure, in violation of Subsection 58-1-501(2)(j):
initial offense: $100 - $500
subsequent offense(s): $200 - $1,000
(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
(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
(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
(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
(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
(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 "L.td." 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
(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
(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
(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
(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
(78) self-prescribing or self-administering by a licensee of any Schedule II or Schedule III controlled substance which 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
(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
(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
(81) failing to deliver to the Division all controlled substance certificates issued by the Division, to the Division, upon an action which 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
(82) failing to maintain controls over controlled substances which 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
(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
(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
(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
(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
(87) any other conduct which constitutes unprofessional or unlawful conduct:
initial offense: $100 - $500
subsequent offense(s): $200 - $1,000
R156-17b-502. Unprofessional Conduct.
"Unprofessional conduct" includes:
(1) violating any provision of the American Pharmaceutical Association (APhA) Code of Ethics for Pharmacists, October 27, 1994, which is hereby incorporated by reference;
(2) failing to comply with the USP-NF Chapters 795 and 797;
(3) failing to comply with the continuing education requirements set forth in these rules;
(4) failing to provide the Division with a current mailing address within a 10 business day period of time following any change of address;
(5) defaulting on a student loan;
(6) failing to abide by all applicable federal and state law regarding the practice of pharmacy;
(7) failing to comply with administrative inspections;
(8) failing to return according to the deadline established by the Division, or providing false information on a self-inspection report;
(9) violating the laws and rules regulating operating standards in a pharmacy discovered upon inspection by the Division;
(10) abandoning a pharmacy or leaving prescription drugs accessible to the public;
(11) failing to identify licensure classification when communicating by any means;
(12) practicing pharmacy with an inappropriate pharmacist to pharmacy intern ratio established by Subsection R156-17b-606(1)(d) or pharmacist to pharmacy technician ratio as established by Subsection R156-17b-601(3);
(13) allowing any unauthorized persons in the pharmacy;
(14) failing to offer to counsel any person receiving a prescription medication;
(15) failing to pay an administrative fine that has been assessed in the time designated by the Division;
(16) failing to comply with the PIC standards as established in Section R156-17b-603;
(17) failing to adhere to institutional policies and procedures related to technician checking of medications when technician checking is utilized;
(18) failing to take appropriate steps to avoid or resolve identified drug therapy management problems as referenced in Subsection R156-17b-611(3);
(19) dispensing medication that has been discontinued by the FDA;
(20) failing to keep or report accurate records of training hours;
(21) failing to provide PIC information to the Division within 30 days of a change in PIC;
(22) requiring a pharmacy, PIC, or any other pharmacist to operate the pharmacy or allow operation of the pharmacy with a ratio of supervising pharmacist to pharmacy technician/pharmacy intern/support personnel which, under the circumstances of the particular practice setting, results in, or reasonably would be expected to result in, an unreasonable risk of harm to public health, safety, and welfare;
(23) 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; and
(24) effective November 30, 2014, failing to comply with prescription container label standards established in USP-NF Chapter 17.
R156-17b-601. Operating Standards - Pharmacy Technician.
In accordance with Subsection 58-17b-102(53), practice as a licensed pharmacy technician is defined as follows:
(1) The pharmacy technician may perform any task associated with the physical preparation and processing of prescription and medication orders including:
(a) receiving written prescriptions;
(b) taking refill orders;
(c) entering and retrieving information into and from a database or patient profile;
(d) preparing labels;
(e) retrieving medications from inventory;
(f) counting and pouring into containers;
(g) placing medications into patient storage containers;
(h) affixing labels;
(i) compounding;
(j) counseling for over-the-counter drugs and dietary supplements under the direction of the supervising pharmacist as referenced in Subsection 58-17b-102 (53 );
(k) accepting new prescription drug orders left on voicemail for a pharmacist to review;
(l) performing checks of certain medications prepared for distribution filled or prepared by another technician within a Class B hospital pharmacy, such as medications prepared for distribution to an automated dispensing cabinet, cart fill, crash cart medication tray, or unit dosing from a prepared stock bottle, in accordance with the following operating standards:
(i) technicians authorized by a hospital to check medications shall have at least one year of experience working as a pharmacy technician and at least six months experience at the hospital where the technician is authorized to check medications;
(ii) technicians shall only check steps in the medication distribution process that do not require the professional judgment of a pharmacist and that are supported by sufficient automation or technology to ensure accuracy (e.g. barcode scanning, drug identification automation, checklists, visual aids);
(iii) hospitals that authorize technicians to check medications shall have a training program and ongoing competency assessment that is documented and retrievable for the duration of each technician's employment and at least three years beyond employment, and shall maintain a list of technicians on staff that are allowed to check medications;
(iv) hospitals that authorize technicians to check medications shall have a medication error reporting system in place and shall be able to produce documentation of its use;
(v) a supervising pharmacist shall be immediately available during all times that a pharmacy technician is checking medications;
(vi) hospitals that authorize technicians to check medications shall have comprehensive policies and procedures that guide technician checking that include the following:
(A) process for technician training and ongoing competency assessment and documentation;
(B) process for supervising technicians who check medications;
(C) list of medications, or types of medications that may or may not be checked by a technician;
(D) description of the automation or technology that will be utilized by the institution to augment the technician check;
(E) process for maintaining a permanent log of the unique initials or identification codes which identify each technician responsible for checked medications by name; and
(F) description of processes used to track and respond to medication errors; and
(m) additional tasks not requiring the judgment of a pharmacist.
(2) The pharmacy technician shall not receive new prescriptions or medication orders as described in Subsection 58-17b-102(53)(b)(iv), clarify prescriptions or medication orders nor perform drug utilization reviews. A new prescription, as used in Subsection 58-17b-102(53)(b)(iv), does not include authorization of a refill of a legend drug.
(3) Pharmacy technicians[
, including no more than one pharmacy technician-in-training per shift,] shall have general supervision by a pharmacist in accordance with Subsection R156-17b-603(2)(s).(4) No more than one pharmacy technician-in-training per shift shall practice in a pharmacy. A pharmacy technician-in-training shall practice only under the direct supervision of a pharmacist.
R156-17b-605. Operating Standards - Inventory Requirements.
(1) All out of date legend drugs and controlled substances shall be removed from the inventory at regular intervals and in correlation to the beyond use date imprinted on the label.
(2) General requirements for inventory of a pharmacy shall include the following:
(a) the PIC shall be responsible for taking all required inventories, but may delegate the performance of the inventory to another person or persons;
(b) the inventory records shall be maintained for a period of five years and be readily available for inspection;
(c) the inventory records shall be filed separately from all other records;
(d) the inventory records shall be in a written, typewritten, or printed form and include all stocks of controlled substances on hand on the date of the inventory including any that are out of date drugs and drugs in automated pharmacy systems. An inventory taken by use of a verbal recording device shall be promptly transcribed;
(e) the inventory may be taken either as the opening of the business or the close of business on the inventory date;
(f) the person taking the inventory and the PIC shall indicate the time the inventory was taken and shall sign and date the inventory with the date the inventory was taken. The signature of the PIC and the date of the inventory shall be documented within 72 hours or three working days of the completed initial, annual, change of ownership and closing inventory;
(g) the person taking the inventory shall make an exact count or measure all controlled substances listed in Schedule I or II;
(h) the person taking the inventory shall make an estimated count or measure of all Schedule III, IV or V controlled substances, unless the container holds more than 1,000 tablets or capsules in which case an exact count of the contents shall be made;
(i) the inventory of Schedule I and II controlled substances shall be listed separately from the inventory of Schedule III, IV and V controlled substances;
(j) if the pharmacy maintains a perpetual inventory of any of the drugs required to be inventories, the perpetual inventory shall be reconciled on the date of the inventory.
(3) Requirements for taking the initial controlled substances inventory shall include the following:
(a) all pharmacies having any stock of controlled substances shall take an inventory on the opening day of business. Such inventory shall include all controlled substances including any out-of-date drugs and drugs in automated pharmacy systems;
(b) in the event a pharmacy commences business with no controlled substances on hand, the pharmacy shall record this fact as the initial inventory. An inventory reporting no Schedule I and II controlled substances shall be listed separately from an inventory reporting no Schedule III, IV, and V controlled substances;
(c) the initial inventory shall serve as the pharmacy's inventory until the next completed inventory as specified in Subsection (4) of this section; and
(d) when combining two pharmacies, each pharmacy shall:
(i) conduct a separate closing pharmacy inventory of controlled substances on the date of closure; and
(ii) conduct a combined opening inventory of controlled substances for the new pharmacy prior to opening.
(4) Requirement for annual controlled substances inventory shall be within 12 months following the inventory date of each year and may be taken within four days of the specified inventory date and shall include all stocks including out-of-date drugs and drugs in automated pharmacy systems.
(5) Requirements for change of ownership shall include the following:
(a) a pharmacy that changes ownership shall take an inventory of all legend drugs and controlled substances including out-of-date drugs and drugs in automated pharmacy systems on the date of the change of ownership;
(b) such inventory shall constitute, for the purpose of this section, the closing inventory for the seller and the initial inventory for the buyer; and
(c) transfer of Schedule I and II controlled substances shall require the use of official DEA order forms (Form 222).
(6) Requirement for taking inventory when closing a pharmacy includes the PIC, owner, or the legal representative of a pharmacy that ceases to operate as a pharmacy shall forward to the Division, within ten days of cessation of operation, a statement attesting that an inventory has been conducted, the date of closing and a statement attesting the manner by which legend drugs and controlled substances possessed by the pharmacy were transferred or disposed.
(7) All pharmacies shall maintain a perpetual inventory of all Schedule II controlled substances which shall be reconciled according to facility policy.
R156-17b-606. Operating Standards - Approved Preceptor.
In accordance with Subsection 58-17b-601(1), the operating standards for a pharmacist acting as a preceptor include:
(1) meeting the following criteria:
(a) hold a Utah pharmacist license that is active and in good standing;
(b) document engaging in active practice as a licensed pharmacist for not less than two years in any jurisdiction;
(c) not be under any sanction which, when considered by the Division and Board, would be of such a nature that the best interests of the intern and the public would not be served;
(d) provide direct, on-site supervision to :
(i) no more than two pharmacy interns during a working shift except as provided in Subsection (ii);[
and](ii) up to five pharmacy interns at public-health outreach programs such as informational health fairs, chronic disease state screening and education programs, and immunization clinics, provided:
(A) the totality of the circumstances are safe and appropriate according to generally recognized industry standards of practice; and
(B) the preceptor has obtained written approval from the pharmacy interns' schools of pharmacy for the intern's participation; and
(e) refer to the intern training guidelines as outlined in the Pharmacy Coordinating Council of Utah Internship Competencies, October 12, 2004, as information about a range of best practices for training interns;
(2) maintaining adequate records to document the number of internship hours completed by the intern and evaluating the quality of the intern's performance during the internship;
(3) completing the preceptor section of a Utah Pharmacy Intern Experience Affidavit found in the application packet at the conclusion of the preceptor/intern relationship regardless of the time or circumstances under which that relationship is concluded; and
(4) being responsible for the intern's actions related to the practice of pharmacy while practicing as a pharmacy intern under supervision.
R156-17b-608. [
Reserved]Common Carrier Delivery.A pharmacy that employs the United States Postal Service or other common carrier to deliver a filled prescription directly to a patient shall, under the direction of the pharmacist-in-charge or other responsible employee:
(1) use adequate storage or shipping containers and shipping processes to ensure drug stability and potency. The shipping processes shall include the use of appropriate packaging material and devices, according to the recommendations of the manufacturer or the United States Pharmacopeia Chapter 1079, in order to ensure that the drug is kept at appropriate storage temperatures throughout the delivery process to maintain the integrity of the medication;
(2) use shipping containers that are sealed in a manner to detect evidence of opening or tampering;
(3) develop and implement policies and procedures to ensure accountability, safe delivery, and compliance with temperature requirements. The policies and procedures shall address when drugs do not arrive at their destination in a timely manner or when there is evidence that the integrity of a drug was compromised during shipment. In these instances, the pharmacy shall make provisions for the replacement of the drugs;
(4) provide for an electronic, telephonic, or written communication mechanism for a pharmacist, or a pharmacy intern working under the direct supervision of a pharmacist, to offer counseling to the patient as defined in Section 58-17b-613, including documentation of such counseling; and
(5) provide information to the patient indicating what the patient should do if the integrity of the packaging or drug was compromised during shipment.
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.
([
1]3) Based upon the pharmacist's or pharmacy intern's professional judgment, patient counseling may be discussed to 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;
(c) intended use of the drug, when known, and expected action;
(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.[
(2) Patient counseling shall not be required for inpatients of a hospital or institution where other licensed health care professionals are authorized to administer the drugs.(3) A pharmacist shall not be required to counsel a patient or patient's agent when the patient or patient's agent refuses such consultation.](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) Counseling shall be:(a) provided with each new prescription drug order, once yearly on maintenance medications, and if the pharmacist deems appropriate with prescription drug refills;(b) provided for any prescription drug order dispensed by the pharmacy on the request of the patient or patient's agent; and(c) communicated verbally in person unless the patient or the patient's agent is not at the pharmacy or a specific communication barrier prohibits such verbal communication.]([
6]5) Only a pharmacist or pharmacy intern may [verbally]orally provide [drug information]counseling to a patient or patient's agent and answer questions concerning prescription drugs.[(7) In addition to the requirements of Subsections (1) through (6) of this section, if a prescription drug order is delivered to the patient at the pharmacy, a filled prescription may not be delivered to a patient unless a pharmacist is in the pharmacy. However, an agent of the pharmacist may deliver a prescription drug order to the patient or the patient's agent if the pharmacist is absent for ten minutes or less and provided a record of the delivery is maintained and contains the following information:(a) date of the delivery;(b) unique identification number of the prescription drug order;(c) patient's name;(d) patient's phone number or the phone number of the person picking up the prescription; and(e) signature of the person picking up the prescription.]([
8]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 (1) 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 (8)(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.
R156-17b-614a. Operating Standards - General Operating Standards, Class A and B Pharmacy.
(1) In accordance with Subsection 58-17b-601(1), the following operating standards apply to all Class A and Class B pharmacies, which may be supplemented by additional standards defined in this rule applicable to specific types of Class A and B pharmacies. The general operating standards include:
(a) shall be well lighted, well ventilated, clean and sanitary;
(b) the dispensing area, if any, shall have a sink with hot and cold culinary water separate and apart from any restroom facilities. This does not apply to clean rooms where sterile products are prepared. Clean rooms should not have sinks or floor drains that expose the area to an open sewer. All required equipment shall be clean and in good operating condition;
(c) be equipped to permit the orderly storage of prescription drugs and durable medical equipment in a manner to permit clear identification, separation and easy retrieval of products and an environment necessary to maintain the integrity of the product inventory;
(d) be equipped to permit practice within the standards and ethics of the profession as dictated by the usual and ordinary scope of practice to be conducted within that facility;
(e) be stocked with the quality and quantity of product necessary for the facility to meet its scope of practice in a manner consistent with the public health, safety and welfare; and
(f) be equipped with a security system to :
(i) permit detection of entry at all times when the facility is closed ; and
(ii) provide notice of unauthorized entry to an individual who is able to respond quickly and reasonably assess the entry and resolve the matter.
(2) The temperature of the pharmacy shall be maintained within a range compatible with the proper storage of drugs. The temperature of the refrigerator and freezer shall be maintained within a range compatible with the proper storage of drugs requiring refrigeration or freezing.
(3) Facilities engaged in simple, moderate or complex non-sterile or any level of sterile compounding activities shall be required to maintain proper records and procedure manuals and establish quality control measures to ensure stability, equivalency where applicable and sterility. The following requirements shall be met:
(a) shall follow USP-NF Chapter 795, compounding of non-sterile preparations, and USP-NF Chapter 797 if compounding sterile preparations;
(b) may compound in anticipation of receiving prescriptions in limited amounts;
(c) bulk active ingredients shall:
(i) be procured from a facility registered with the federal Food and Drug Administration; and
(ii) not be listed on the federal Food and Drug Administration list of drug products withdrawn or removed from the market for reasons of safety or effectiveness;
(d) a master worksheet sheet shall be developed and approved by a pharmacist for each batch of sterile or non-sterile pharmaceuticals to be prepared. Once approved, a duplicate of the master worksheet sheet shall be used as the preparation worksheet sheet from which each batch is prepared and on which all documentation for that batch occurs. The master worksheet sheet shall contain at a minimum:
(i) the formula;
(ii) the components;
(iii) the compounding directions;
(iv) a sample label;
(v) evaluation and testing requirements;
(vi) sterilization methods, if applicable;
(vii) specific equipment used during preparation such as specific compounding device; and
(viii) storage requirements;
(e) a preparation worksheet sheet for each batch of sterile or non-sterile pharmaceuticals shall document the following:
(i) identity of all solutions and ingredients and their corresponding amounts, concentrations, or volumes;
(ii) manufacturer lot number for each component;
(iii) component manufacturer or suitable identifying number;
(iv) container specifications (e.g. syringe, pump cassette);
(v) unique lot or control number assigned to batch;
(vi) beyond use date of batch prepared products;
(vii) date of preparation;
(viii) name, initials or electronic signature of the person or persons involved in the preparation;
(ix) names, initials or electronic signature of the responsible pharmacist;
(x) end-product evaluation and testing specifications, if applicable; and
(xi) comparison of actual yield to anticipated yield, when appropriate;
(f) the label of each batch prepared of sterile or non-sterile pharmaceuticals shall bear at a minimum:
(i) the unique lot number assigned to the batch;
(ii) all solution and ingredient names, amounts, strengths and concentrations, when applicable;
(iii) quantity;
(iv) beyond use date and time, when applicable;
(v) appropriate ancillary instructions, such as storage instructions or cautionary statements, including cytotoxic warning labels where appropriate; and
(vi) device-specific instructions, where appropriate;
(g) the beyond use date assigned shall be based on currently available drug stability information and sterility considerations or appropriate in-house or contract service stability testing;
(i) sources of drug stability information shall include the following:
(A) references can be found in Trissel's "Handbook on Injectable Drugs", 17th Edition, October 31, 2012;
(B) manufacturer recommendations; and
(C) reliable, published research;
(ii) when interpreting published drug stability information, the pharmacist shall consider all aspects of the final sterile product being prepared such as drug reservoir, drug concentration and storage conditions; and
(iii) methods for establishing beyond use dates shall be documented; and
(h) there shall be a documented, ongoing quality control program that monitors and evaluates personnel performance, equipment and facilities that follows the USP-NF Chapters 795 and 797 standards.
(4) The facility shall have current and retrievable editions of the following reference publications in print or electronic format and readily available and retrievable to facility personnel:
(a) Title 58, Chapter 1, Division of Occupational and Professional Licensing Act'
(b) R156-1, General Rule of the Division of Occupational and Professional Licensing;
(c) Title 58, Chapter 17b, Pharmacy Practice Act;
(d) R156-17b, Utah Pharmacy Practice Act Rule;
(e) Title 58, Chapter 37, Utah Controlled Substances Act;
(f) R156-37, Utah Controlled Substances Act Rule;
(g) Title 58, Chapter 37f, Controlled Substance Database Act;
(h) R156-37f, Controlled Substance Database Act Rule;
(i) Code of Federal Regulations (CFR) 21, Food and Drugs, Part 1300 to end or equivalent such as the USP DI Drug Reference Guides;
(j) current FDA Approved Drug Products (orange book); and
(k) any other general drug references necessary to permit practice dictated by the usual and ordinary scope of practice to be conducted within that facility.
(5) The facility shall post the license of the facility and the license or a copy of the license of each pharmacist, pharmacy intern and pharmacy technician who is employed in the facility, but may not post the license of any pharmacist, pharmacy intern or pharmacy technician not actually employed in the facility.
(6) Facilities shall have a counseling area to allow for confidential patient counseling, where applicable.
(7) If the pharmacy is located within a larger facility such as a grocery or department store, and a licensed Utah pharmacist is not immediately available in the facility, the pharmacy shall not remain open to pharmacy patients and shall be locked in such a way as to bar entry to the public or any non-pharmacy personnel. All pharmacies located within a larger facility shall be locked and enclosed in such a way as to bar entry by the public or any non-pharmacy personnel when the pharmacy is closed.
(8) Only a licensed Utah pharmacist or authorized pharmacy personnel shall have access to the pharmacy when the pharmacy is closed.
(9) The facility or parent company shall maintain a permanent log of the initials or identification codes which identify each dispensing pharmacist by name. The initials or identification code shall be unique to ensure that each pharmacist can be identified; therefore identical initials or identification codes shall not be used.
(10) The pharmacy facility shall maintain copy 3 of DEA order form (Form 222) which has been properly dated, initialed and filed and all copies of each unaccepted or defective order form and any attached statements or other documents.
(11) If applicable, a hard copy of the power of attorney authorizing a pharmacist to sign DEA order forms (Form 222) shall be available to the Division whenever necessary.
(12) Pharmacists or other responsible individuals shall verify that controlled substances are listed on the suppliers' invoices and were actually received by clearly recording their initials and the actual date of receipt of the controlled substances.
(13) The pharmacy facility shall maintain a record of suppliers' credit memos for controlled substances.
(14) A copy of inventories required under Section R156-17b-605 shall be made available to the Division when requested.
(15) The pharmacy facility shall maintain hard copy reports of surrender or destruction of controlled substances and legend drugs submitted to appropriate state or federal agencies.
(16) If the pharmacy includes a drop/false ceiling, the pharmacy's perimeter walls shall extend to the hard deck, or other measures shall be taken to prevent unauthorized entry into the pharmacy.
R156-17b-615. Operating Standards - Class C Pharmacy - Pharmaceutical Wholesaler/Distributor and Pharmaceutical Manufacturer in Utah.
In accordance with Subsections 58-17b-102(44) and 58-17b-601(1), the operating standards for Class C pharmacies designated as pharmaceutical wholesaler/distributor and pharmaceutical manufacturer licensees includes the following:
(1) Every pharmaceutical wholesaler or manufacturer that engages in the wholesale distribution and manufacturing of drugs or medical devices located in this state shall be licensed by the Division. A separate license shall be obtained for each separate location engaged in the distribution or manufacturing of prescription drugs. Business names cannot be identical to the name used by another unrelated wholesaler licensed to purchase drugs and devices in Utah.
(2) Manufacturers distributing only their own FDA-approved prescription drugs or co-licensed product shall satisfy this requirement by registering their establishment with the Federal Food and Drug Administration pursuant to 21 CFR Part 207 and submitting the information required by 21 CFR Part 205, including any amendments thereto, to the Division.
(3) An applicant for licensure as a pharmaceutical wholesale distributor shall provide the following minimum information:
(a) All trade or business names used by the licensee (including "doing business as" and "formerly known as");
(b) Name of the owner and operator of the license as follows:
(i) if a person, the name, business address, social security number and date of birth;
(ii) if a partnership, the name, business address, and social security number and date of birth of each partner, and the partnership's federal employer identification number;
(iii) if a corporation, the name, business address, social security number and date of birth, and title of each corporate officer and director, the corporate names, the name of the state of incorporation, federal employer identification number, and the name of the parent company, if any, but if a publicly traded corporation, the social security number and date of birth for each corporate officer shall not be required;
(iv) if a sole proprietorship, the full name, business address, social security number and date of birth of the sole proprietor and the name and federal employer identification number of the business entity;
(v) if a limited liability company, the name of each member, social security number of each member, the name of each manager, the name of the limited liability company and federal employer identification number, and the name of the state in which the limited liability company was organized; and
(c) any other relevant information required by the Division.
(4) The licensed facility need not be under the supervision of a licensed pharmacist, but shall be under the supervision of a designated representative who meets the following criteria:
(a) is at least 21 years of age;
(b) has been employed full time for at least three years in a pharmacy or with a pharmaceutical wholesaler in a capacity related to the dispensing and distribution of, and recordkeeping related to prescription drugs;
(c) is employed by the applicant full time in a managerial level position;
(d) is actively involved in and aware of the actual daily operation of the pharmaceutical wholesale distribution;
(e) is physically present at the facility during regular business hours, except when the absence of the designated representative is authorized, including but not limited to, sick leave and vacation leave; and
(f) is serving in the capacity of a designated representative for only one licensee at a time.
(5) The licensee shall provide the name, business address, and telephone number of a person to serve as the designated representative for each facility of the pharmaceutical wholesaler that engages in the distribution of drugs or devices.
(6) Each facility that engages in pharmaceutical wholesale distribution and manufacturing facilities shall undergo an inspection by the Division for the purposes of inspecting the pharmaceutical wholesale distribution or manufacturing operation prior to initial licensure and periodically thereafter with a schedule to be determined by the Division.
(7) All pharmaceutical wholesalers and manufacturer shall publicly display or have readily available all licenses and the most recent inspection report administered by the Division.
(8) All Class C pharmacies shall:
(a) be of suitable size and construction to facilitate cleaning, maintenance and proper operations;
(b) have storage areas designed to provide adequate lighting, ventilation, sanitation, space, equipment and security conditions;
(c) have the ability to control temperature and humidity within tolerances required by all prescription drugs and prescription drug precursors handled or used in the distribution or manufacturing activities of the applicant or licensee;
(d) provide for a quarantine area for storage of prescription drugs and prescription drug precursors that are outdated, damaged, deteriorated, misbranded, adulterated, opened or unsealed containers that have once been appropriately sealed or closed or in any other way unsuitable for use or entry into distribution or manufacturing;
(e) be maintained in a clean and orderly condition; and
(f) be free from infestation by insects, rodents, birds or vermin of any kind.
(9) Each facility used for wholesale drug distribution or manufacturing of prescription drugs shall:
(a) be secure from unauthorized entry;
(b) limit access from the outside to a minimum in conformance with local building codes, life and safety codes and control access to persons to ensure unauthorized entry is not made;
(c) limit entry into areas where prescription drugs, prescription drug precursors, or prescription drug devices are held to authorized persons who have a need to be in those areas;
(d) be well lighted on the outside perimeter;
(e) be equipped with an alarm system to permit detection of entry and notification of appropriate authorities at all times when the facility is not occupied for the purpose of engaging in distribution or manufacturing of prescription drugs; and
(f) be equipped with security measures, systems and procedures necessary to provide reasonable security against theft and diversion of prescription drugs or alteration or tampering with computers and records pertaining to prescription drugs or prescription drug precursors.
(10) Each facility shall provide the storage of prescription drugs, prescription drug precursors, and prescription drug devices in accordance with the following:
(a) all prescription drugs and prescription drug precursors shall be stored at appropriate temperature, humidity and other conditions in accordance with labeling of such prescription drugs or prescription drug precursors or with requirements in the USP-NF;
(b) if no storage requirements are established for a specific prescription drug, prescription drug precursor, or prescription drug devices, the products shall be held in a condition of controlled temperature and humidity as defined in the USP-NF to ensure that its identity, strength, quality and purity are not adversely affected; and
(c) there shall be established a system of manual, electromechanical or electronic recording of temperature and humidity in the areas in which prescription drugs, prescription drug precursors, and prescription drug devices are held to permit review of the record and ensure that the products have not been subjected to conditions which are outside of established limits.
(11) Each person who is engaged in pharmaceutical wholesale distribution of prescription drugs for human use that leave, or have ever left, the normal distribution channel shall, before each pharmaceutical wholesale distribution of such drug, provide a pedigree to the person who receives such drug. A retail pharmacy or pharmacy warehouse shall comply with the requirements of this section only if the pharmacy engages in pharmaceutical wholesale distribution of prescription drugs. The pedigree shall:
(a) include all necessary identifying information concerning each sale in the chain of distribution of the product from the manufacturer, through acquisition and sale by any pharmaceutical wholesaler, until sale to a pharmacy or other person dispensing or administering the prescription drug. At a minimum, the necessary chain of distribution information shall include:
(i) name, address, telephone number, and if available, the email address of each owner of the prescription drug, and each pharmaceutical wholesaler of the prescription drug;
(ii) name and address of each location from which the product was shipped, if different from the owner's;
(iii) transaction dates;
(iv) name of the prescription drug;
(v) dosage form and strength of the prescription drug;
(vi) size of the container;
(vii) number of containers;
(viii) lot number of the prescription drug;
(ix) name of the manufacturer of the finished dose form; and
(x) National Drug Code (NDC) number.
(b) be maintained by the purchaser and the pharmaceutical wholesaler for five years from the date of sale or transfer and be available for inspection or use upon a request of an authorized officer of the law.
(12) Each facility shall comply with the following requirements:
(a) in general, each person who is engaged in pharmaceutical wholesale distribution of prescription drugs shall establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of the prescription drugs. These records shall include pedigrees for all prescription drugs that leave the normal distribution channel;
(b) upon receipt, each outside shipping container containing prescription drugs, prescription drug precursors, or prescription drug devices shall be visibly examined for identity and to prevent the acceptance of prescription drugs, prescription drug precursors, or prescription drug devices that are contaminated, reveal damage to the containers or are otherwise unfit for distribution:
(i) prescription drugs, prescription drug precursors, or prescription drug devices that are outdated, damaged, deteriorated, misbranded, adulterated or in any other way unfit for distribution or use in manufacturing shall be quarantined and physically separated from other prescription drugs, prescription drug precursors or prescription drug devices until they are appropriately destroyed or returned to their supplier; and
(ii) any prescription drug or prescription drug precursor whose immediate sealed or outer secondary sealed container has been opened or in any other way breached shall be identified as such and shall be quarantined and physically separated from other prescription drugs and prescription drug precursors until they are appropriately destroyed or returned to their supplier;
(c) each outgoing shipment shall be carefully inspected for identity of the prescription drug products or devices and to ensure that there is no delivery of prescription drugs or devices that have been damaged in storage or held under improper conditions:
(i) if the conditions or circumstances surrounding the return of any prescription drug or prescription drug precursor cast any doubt on the product's safety, identity, strength, quality or purity, then the drug shall be appropriately destroyed or returned to the supplier, unless examination, testing or other investigation proves that the product meets appropriate and applicable standards related to the product's safety, identity, strength, quality and purity;
(ii) returns of expired, damaged, recalled, or otherwise non-saleable prescription drugs shall be distributed by the receiving pharmaceutical wholesale distributor only to the original manufacturer or a third party returns processor that is licensed as a pharmaceutical wholesale distributor under this chapter;
(iii) returns or exchanges of prescription drugs (saleable or otherwise), including any redistribution by a receiving pharmaceutical wholesaler, shall not be subject to the pedigree requirements, so long as they are exempt from the pedigree requirement under the FDA's Prescription Drug Marketing Act guidance or regulations; and
(d) licensee under this Act and pharmacies or other persons authorized by law to dispense or administer prescription drugs for use by a patient shall be accountable for administering their returns process and ensuring that all aspects of their operation are secure and do not permit the entry of adulterated and counterfeit prescription drugs.
(13) A manufacturer or pharmaceutical wholesaler shall furnish prescription drugs only to a person licensed by the Division or to another appropriate state licensing authority to possess, dispense or administer such drugs for use by a patient.
(14) Prescription drugs furnished by a manufacturer or pharmaceutical wholesaler shall be delivered only to the business address of a person described in Subsections R156-17b-102([
14]16)(c) and R156-17b-615(13), or to the premises listed on the license, or to an authorized person or agent of the licensee at the premises of the manufacturer or pharmaceutical wholesaler if the identity and authority of the authorized agent is properly established.(15) Each facility shall establish and maintain records of all transactions regarding the receipt and distribution or other disposition of prescription drugs and prescription drug precursors and shall make inventories of prescription drugs and prescription drug precursors and required records available for inspection by authorized representatives of the federal, state and local law enforcement agencies in accordance with the following:
(a) there shall be a record of the source of the prescription drugs or prescription drug precursors to include the name and principal address of the seller or transferor and the address of the location from which the drugs were shipped;
(b) there shall be a record of the identity and quantity of the prescription drug or prescription drug precursor received, manufactured, distributed or shipped or otherwise disposed of by specific product and strength;
(c) there shall be a record of the dates of receipt and distribution or other disposal of any product;
(d) there shall be a record of the identity of persons to whom distribution is made to include name and principal address of the receiver and the address of the location to which the products were shipped;
(e) inventories of prescription drugs and prescription drug precursors shall be made available during regular business hours to authorized representatives of federal, state and local law enforcement authorities;
(f) required records shall be made available for inspection during regular business hours to authorized representatives of federal, state and local law enforcement authorities and such records shall be maintained for a period of two years following disposition of the products; and
(g) records that are maintained on site or immediately retrievable from computer or other electronic means shall be made readily available for authorized inspection during the retention period; or if records are stored at another location, they shall be made available within two working days after request by an authorized law enforcement authority during the two year period of retention.
(16) Each facility shall establish, maintain and adhere to written policies and procedures which shall be followed for the receipt, security, storage, inventory, manufacturing, distribution or other disposal of prescription drugs or prescription drug precursors, including policies and procedures for identifying, recording and reporting losses or thefts, and for correcting all errors and inaccuracies in inventories. In addition, the policies shall include the following:
(a) a procedure whereby the oldest approved stock of a prescription drug or precursor product is distributed or used first with a provision for deviation from the requirement if such deviation is temporary and appropriate;
(b) a procedure to be followed for handling recalls and withdrawals of prescription drugs adequate to deal with recalls and withdrawals due to:
(i) any action initiated at the request of the FDA or other federal, state or local law enforcement or other authorized administrative or regulatory agency;
(ii) any voluntary action to remove defective or potentially defective drugs from the market; or
(iii) any action undertaken to promote public health, safety or welfare by replacement of existing product with an improved product or new package design;
(c) a procedure to prepare for, protect against or handle any crisis that affects security or operation of any facility in the event of strike, fire, flood or other natural disaster or other situations of local, state or national emergency;
(d) a procedure to ensure that any outdated prescription drugs or prescription drug precursors shall be segregated from other drugs or precursors and either returned to the manufacturer, other appropriate party or appropriately destroyed;
(e) a procedure for providing for documentation of the disposition of outdated, adulterated or otherwise unsafe prescription drugs or prescription drug precursors and the maintenance of that documentation available for inspection by authorized federal, state or local authorities for a period of five years after disposition of the product;
(f) a procedure for identifying, investigating and reporting significant drug inventory discrepancies (involving counterfeit drugs suspected of being counterfeit, contraband, or suspect of being contraband) and reporting of such discrepancies within three (3) business days to the Division and/or appropriate federal or state agency upon discovery of such discrepancies; and
(g) a procedure for reporting criminal or suspected criminal activities involving the inventory of drugs and devices to the Division, FDA and if applicable, Drug Enforcement Administration (DEA), within three (3) business days.
(17) Each facility shall establish, maintain and make available for inspection by authorized federal, state and local law enforcement authorities, lists of all officers, directors, managers and other persons in charge which lists shall include a description of their duties and a summary of their background and qualifications.
(18) Each facility shall comply with laws including:
(a) operating within applicable federal, state and local laws and regulations;
(b) permitting the state licensing authority and authorized federal, state and local law enforcement officials, upon presentation of proper credentials, to enter and inspect their premises and delivery vehicles and to audit their records and written operating policies and procedures, at reasonable times and in a reasonable manner, to the extent authorized by law; and
(c) obtaining a controlled substance license from the Division and registering with the Drug Enforcement Administration (DEA) if they engage in distribution or manufacturing of controlled substances and shall comply with all federal, state and local regulations applicable to the distribution or manufacturing of controlled substances.
(19) Each facility shall be subject to and shall abide by applicable federal, state and local laws that relate to the salvaging or reprocessing of prescription drug products.
(20) A person who is engaged in the wholesale distribution or manufacturing of prescription drugs but does not have a facility located within Utah in which prescription drugs are located, stored, distributed or manufactured is exempt from Utah licensure as a Class C pharmacy, if said person is currently licensed and in good standing in each state of the United States in which that person has a facility engaged in distribution or manufacturing of prescription drugs entered into interstate commerce.
(21) No facility located at the same address shall be dually licensed as both a Class C pharmacy and any other classification of Class A or B pharmacy. Nothing within this section prevents a facility from obtaining licensure for a secondary address which operates separate and apart from any other facility upon obtaining proper licensure.
R156-17b-616. Operating Standards - Class D Pharmacy - Out of State Mail Order Pharmacies.
(1) In accordance with Subsections 58-1-301(3) and 58-17b-306(2), an application for licensure as a Class D pharmacy shall include:
(a) a pharmacy care protocol that includes the operating standards established in Subsections R156-17b-610(1) and (8) and R156-17b-612(1) through (4);
(b) a copy of the pharmacist's license for the PIC; and
(c) a copy of the most recent state inspection or NABP inspection completed as part of the NABP Verified Pharmacy Program (VPP) showing the status of compliance with the laws and regulations for physical facility, records and operations.
(2) An out of state mail order pharmacy that compounds must follow the USP-NF Chapter 795 Compounding of non-sterile preparations and Chapter 797 Compounding of sterile preparations.
R156-17b-617c. Class E Pharmacy Operating Standards -- Animal [
Euthanasia]Control.(1) In accordance with Section 58-17b-302 and Subsection 58-17b-601(1), an animal [
euthanasia]control facility shall:(a) maintain for immediate retrieval a perpetual inventory of all drugs including controlled substances that are purchased, stored, processed and administered;
(b) maintain for immediate retrieval a current list of authorized employees and their training with regards to the handling and use of legend drugs and/or controlled substances in relation to euthanasia or immobilization of animals;
(c) maintain, for immediate retrieval documentation of all required materials pertaining to legitimate animal scientific drug research, guidance policy and other relevant documentation from the agency's Institutional Review Board, if applicable;
(d) maintain stocks of legend drugs and controlled substances to the smallest quantity needed for efficient operation to conduct animal euthanasia or immobilization purposes;
(e) maintain all legend drugs and controlled substances in an area within a building having perimeter security which limits access during working hours, provides adequate security after working hours, and has the following security controls:
(i) a permanently secured safe or steel cabinet substantially constructed with self-closing and self-locking doors employing either multiple position combination or key lock type locking mechanisms; and
(ii) requisite key control, combination limitations, and change procedures;
(f) have a responsible party who is the only person authorized to purchase and reconcile legend drugs and controlled substances and is responsible for the inventory of the animal [
euthanasia]control facility pharmacy;(g) ensure that only defined and approved individuals pursuant to the written facility protocol have access to legend drugs and controlled substances; and
(h) develop and maintain written policies and procedures for immediate retrieval which include the following:
(i) the type of activity conducted with regards to legend drugs and/or controlled substances;
(ii) how medications are purchased, inventoried, prepared and used in relation to euthanasia or immobilization of animals;
(iii) the type, form and quantity of legend drugs and/or controlled substances handled;
(iv) the type of safe or equally secure enclosures or other storage system used for the storage and retrieval of legend drugs and/or controlled substances;
(v) security measures in place to protect against theft or loss of legend drugs and controlled substances;
(vi) adequate supervision of employees having access to manufacturing and storage areas;
(vii) maintenance of records documenting the initial and ongoing training of authorized employees with regard to all applicable protocols;
(viii) maintenance of records documenting all approved and trained authorized employees who may have access to the legend drugs and controlled substances; and
(ix) procedures for allowing the presence of business guests, visitors, maintenance personnel, and non-employee service personnel.
(2) In accordance with Section 58-37-6 and Subsection R156-37-305(1), individuals employed by an agency of the State or any of its political subdivisions who are specifically authorized in writing by their employer to possess specified controlled substances in specified reasonable and necessary quantities for the purpose of euthanasia or immobilization upon animals, shall be exempt from having a controlled substance license if the employing agency or jurisdiction has obtained a controlled substance license and a DEA registration number, and uses the controlled substances according to a written protocol in performing animal euthanasia or immobilization.
KEY: pharmacists, licensing, pharmacies
Date of Enactment or Last Substantive Amendment: [
December 23, 2013]2014Notice of Continuation: February 23, 2010
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)
Document Information
- Hearing Meeting:
- 07/22/2014 08:30 AM, Heber Wells Bldg, 160 E 300 S, Conference Room 474 (fourth floor), Salt Lake City, UT
- Effective Date:
- 8/21/2014
- Publication Date:
- 07/15/2014
- Filed Date:
- 06/23/2014
- Agencies:
- Commerce,Occupational and Professional Licensing
- Rulemaking Authority:
Subsection 58-17b-601(1)
Section 58-17b-101
Subsection 58-1-106(1)(a)
Section 58-37-1
Subsection 58-1-202(1)(a)
- Authorized By:
- Mark Steinagel, Director
- DAR File No.:
- 38638
- Related Chapter/Rule NO.: (1)
- R156-17b. Pharmacy Practice Act Rules.