DAR File No.: 27529
Filed: 11/04/2004, 12:50
Received by: NLRULE ANALYSIS
Purpose of the rule or reason for the change:
This new rule is being proposed to address changes and provide clarification to Title 58, Chapter 17b, Pharmacy Practice Act, which was rewritten in its entirety in S.B. 114, passed during the 2004 General Session of the Legislature and became effective on July 1, 2004. (DAR NOTE: S.B. 114 is found at UT L 2004 Ch 280, and was effective 07/01/2004.)
Summary of the rule or change:
This new rule provides the following sections: Title, Definitions, Authority, Organization, Licensure/Administrative Inspections, Pharmacy Licensure Classifications/Pharmacist-in-Charge Requirements, Licensure/Examinations, Licensure/Pharmacist by Endorsement, Licensure/Education Requirements, Licensure/Pharmacist/Pharmacy Internship Standards, Licensure/Meet with the Board, Renewal Cycle/Procedure, Disciplinary Proceedings, Administrative Penalties, Unprofessional Conduct; and Sections R156-17b-601 through R156-17b-620 deal with operating standards in the following areas: Pharmacy Technician/Scope of Practice, Pharmacy Intern/Scope of Practice, Pharmacist-in-Charge, Closing a Pharmacy, Inventory Requirements, Approved Preceptors, Supportive Personnel, Medication Profile System, Patient Counseling, Drug Therapy Management, Prescriptions, Issuing Prescription Orders by Electronic Means, Class A or B Pharmacy, Class B Pharmacy Designated as a Branch Pharmacy, Class B Sterile Pharmacy, Class B Pharmaceutical Administration Facility, Class B Nuclear Pharmacy, Class C Pharmacy Pharmaceutical Wholesaler/Distributor and Pharmaceutical Manufacturer in Utah, Class D Pharmacy Non-Residence Pharmacies, Class E Pharmacy, Class E Animal Euthanasia Agency, Class E Pharmaceutical Dog Trainer, Third Party Payors, Automated Pharmacy Systems, and Pharmacist Administration/Training.
State statutory or constitutional authorization for this rule:
Sections 58-17b-101 and 58-37-1; and Subsections 58-17b-601(1), 58-1-106(1)(a) and 58-1-202(1)(a)
This rule or change incorporates by reference the following material:Adds the following documents: United States Pharmacopeia-National Formulary (USP 28 - NF 23), 2004 edition, official from January 1, 2005; Pharmacy Coordinating Council of Utah Internship Competencies, October 12, 2004 American Pharmaceutical Association (APhA) Code of Ethics for Pharmacists, October 27, 1994; and VIPPS Criteria, as established by the National Association of Boards of Pharmacy (NABP), September 14, 2004
Anticipated cost or savings to:
the state budget:
The Division anticipates copying costs of approximately $100 - $150 to print the rule once it is made effective. The Division has also incurred costs of $1,364 to purchase two subscriptions to the United States Pharmacopeia/National Formulary (USP-NF), which is an incorporated by reference document in the rule. All costs involved will be absorbed in the Division's current budget. As allowed by Section 58-17b-504, the Division will be receiving the payment of fines as penalties for unlawful or unprofessional conduct. An exact amount of fines to be collected is unknown to the Division since the Division is unable to determine how many persons or licensees may engage in unlawful or unprofessional conduct and be subject to a fine.
local governments:
This proposed rule does not affect local governments. The rule only affects licensed pharmacists, pharmacy interns, pharmacy technicians and pharmacies. Therefore, there is no anticipated cost or savings to local government.
other persons:
The Division anticipates that prescribing practitioners will need to become familiar with and comply with the provisions of the new rule in their practice. Professional associations will need to be current on the newly enacted statute and the provisions of this new proposed rule. The Division anticipates that licensed pharmacists, pharmacy interns, pharmacy technicians, and pharmacies will need to obtain copies of the new rule to use in reference in their practice. The Division does not anticipate any costs to obtain a copy of the newly enacted statute (Title 58, Chapter 17b) and this rule once it is made effective since both items can be located on various state websites. Some professional associations may implement a statute and rule update training session that may have a cost associated with it to attend. However, this would be a voluntary cost since attendance at an update seminar would not be required for continued licensure. Additional reference texts may need to be purchased by any healthcare provider or pharmacy affected by this new rule if they don't already have the reference texts in their office or location. The Division is unable to determine any costs associated with the reference texts since we are unable to determine who will need what reference texts and what reference texts they already have in their office or location. Pharmacies will have to continue their annual subscription to the USP/NF book and supplements at a cost of $665. However, this will not be a new cost increase since pharmacies were required under the old pharmacy rules (Rule R156-17a) to maintain a copy of this reference book. Fines could present an increase in cost for those individuals who do not comply with the law. The Division is unable to determine how many persons or licensees may engage in unlawful or unprofessional conduct and be subject to a fine. Implementation of federal guidelines required for sterile and non-sterile compounding may add increased costs for those pharmacies that participate in compounding drugs if their current setup does not comply with the federal guidelines. The Division is unable to determine any exact costs due to the varying degrees of work that may be needed per pharmacy location. Some pharmacies that are involved in compounding drugs may already be in compliance with the federal guidelines while some pharmacies may require extensive remodeling to comply with the federal guidelines. Also, increased costs will be realized by licensed pharmacists and licensed pharmacy technicians due to the increase in continuing education hours required for each two year period. Presently, pharmacists are required to have 24 continuing education hours every two years and pharmacy technicians are required to have 8 continuing education hours. Under the new proposed rule, the continuing education hours increase to 30 hours for pharmacists and 20 hours for pharmacy technicians every 2 years. An exact cost due to the increased continuing education hours required for pharmacists and pharmacy technicians cannot be determined since some continuing education seminars may be free while some conferences may cost as much as $400.
Compliance costs for affected persons:
The Division anticipates that prescribing practitioners will need to become familiar with and comply with the provisions of the new rule in their practice. Professional associations will need to be current on the newly enacted statute and the provisions of this new proposed rule. The Division anticipates that licensed pharmacists, pharmacy interns, pharmacy technicians, and pharmacies will need to obtain copies of the new rule to use in reference in their practice. The Division does not anticipate any costs to obtain a copy of the newly enacted statute (Title 58, Chapter 17b) and this rule once it is made effective since both items can be located on various state websites. Some professional associations may implement a statute and rule update training session that may have a cost associated with it to attend. However, this would be a voluntary cost since attendance at an update seminar would not be required for continued licensure. Additional reference texts may need to be purchased by any healthcare provider or pharmacy affected by this new rule if they don't already have the reference texts in their office or location. The Division is unable to determine any costs associated with the reference texts since we are unable to determine who will need what reference texts and what reference texts they already have in their office or location. Pharmacies will have to continue their annual subscription to the USP/NF book and supplements at a cost of $665. However, this will not be a new cost increase since pharmacies were required under the old pharmacy rule (Rule R156-17a) to maintain a copy of this reference book. Fines could present an increase in cost for those individuals who do not comply with the law. The Division is unable to determine how many persons or licensees may engage in unlawful or unprofessional conduct and be subject to a fine. Implementation of federal guidelines required for sterile and non-sterile compounding may add increased costs for those pharmacies that participate in compounding drugs if their current setup does not comply with the federal guidelines. The Division is unable to determine any exact costs due to the varying degrees of work that may be needed per pharmacy location. Some pharmacies that are involved in compounding drugs may already be in compliance with the federal guidelines while some pharmacies may require extensive remodeling to comply with the federal guidelines. Also, increased costs will be realized by licensed pharmacists and licensed pharmacy technicians due to the increase in continuing education hours required for each two year period. Presently, pharmacists are required to have 24 continuing education hours every 2 years and pharmacy technicians are required to have 8 continuing education hours. Under the new proposed rule, the continuing education hours increase to 30 hours for pharmacists and 20 hours for pharmacy technicians every 2 years. An exact cost due to the increased continuing education hours required for pharmacists and pharmacy technicians cannot be determined since some continuing education seminars may be free while some conferences may cost as much as $400.
Comments by the department head on the fiscal impact the rule may have on businesses:
As required by S.B. 114, this rule filing establishes rules to administer the Pharmacy Practice Act. There will likely be a fiscal impact to pharmacies as they attempt to meet the new federal requirements for the sterile compounding of drugs, which requirements the Division has adopted in this rule pursuant to authority established in S.B. 114. The amount of such impact is difficult to determine, as it is not clear how many pharmacies deal in compounding of drugs and what their current facilities include. For example, hospital pharmacies likely already meet the new federal requirements because the national hospital accrediting agency (JCAHO) had previously enforced such sterile compounding requirements. Another cost to pharmacists and pharmacy technicians will be the increased continuing education requirements adopted in this rule filing. The amount of the cost is again difficult to ascertain and may depend on the courses the pharmacist or pharmacy technician chooses to take. Some continuing education courses are free, while some conferences may cost as much as $400. Klarice A. Bachman, 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:
Diana Baker at the above address, by phone at 801-530-6179, by FAX at 801-530-6511, or by Internet E-mail at dbaker@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:
01/03/2005
Interested persons may attend a public hearing regarding this rule:
12/21/2004 at 9:00 AM, Heber Wells Bldg, 160 E 300 S, Conference Room 4A (fourth floor), Salt Lake City, UT
This rule may become effective on:
01/04/2005
Authorized by:
J. Craig Jackson, Director
RULE TEXT
R156. Commerce, Occupational and Professional Licensing.
R156-17b. Pharmacy Practice Act Rules.
R156-17b-101. Title.
These rules are known as the "Pharmacy Practice Act Rules".
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 these rules:
(1) "ACPE" means the American Council on Pharmaceutical Education or Accreditation Council for Pharmacy Education.
(2) "Drugs", as used in these rules, means drugs or devices.
(3) "Dispense", as defined in Subsection 58-17b-102(23), 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.
(4) "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.
(5) "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.
(6) "Hospice facility pharmacy" means a pharmacy that supplies drugs to patients in a licensed healthcare facility for terminal patients.
(7) "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.
(8) "Legend 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".
(9) Maintenance medications" means medications the patient takes on an ongoing basis.
(10) "MPJE" means the Multistate Jurisprudence Examination.
(11) "NABP" means the National Association of Boards of Pharmacy.
(12) "NAPLEX" means North American Pharmacy Licensing Examination.
(13) "Parenteral" means a method of drug delivery injected into body tissues but not via the gastrointestinal tract.
(14) "PTCB" means the Pharmacy Technician Certification Board.
(15) "Qualified continuing education", as used in these rules, means continuing education that meets the standards set forth in Section R156-17b-309.
(16) "Sterile products preparation facility" means any facility, or portion of the facility, that compounds sterile products using aseptic technique.
(17) "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.
(18) "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 expiration date for the drug.
(19) "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.
(20) "USP-NF" means the United States Pharmacopeia-National Formulary (USP 28-NF 23), 2004 edition, which is official from January 1, 2005, which is hereby adopted and incorporated by reference.
(21) "VIPPS" means Verified Internet Pharmacy Practice Sites. Pharmacies displaying the VIPPS seal have demonstrated to NABP their compliance with VIPPS criteria including patient rights to privacy, authentication and security of prescription orders, adherence to a recognized quality assurance policy, and provision of meaningful consultation between patients and pharmacists. The VIPPS Criteria document, dated September 14, 2004, as established by NABP is adopted and incorporated by reference.
R156-17b-103. Authority - Purpose.
These rules are adopted by the Division under the authority of Subsection 58-1-106(1)(a) to enable the Division to administer Title 58, Chapter 17b.
R156-17b-104. Organization - Relationship to Rule R156-1.
The organization of this rule and its relationship to Rule R156-1 is as described in Section R156-1-107.
R156-17b-105. Licensure - Administrative Inspection.
In accordance with Subsection 58-17b-103(3)(e), the procedure for disposing of any drugs or devices seized by the Division during an administrative inspection will be handled as follows:
(1) Any legal drugs or devices found and temporarily seized by the Division and are found to be in compliance with this chapter will be returned to the pharmacist-in-charge of the pharmacy involved at the conclusion of any investigative or adjudicative proceedings and appeals.
(2) Any drugs or devices that are temporarily seized by the Division and are found to be unlawfully possessed, adulterated, misbranded, outdated, or otherwise in violation of this rule shall be destroyed by Division personnel at the conclusion of any investigative or adjudicative proceedings and appeals. The destruction of any seized controlled substance drugs will be witnessed by two Division individuals. A controlled substance destruction form will be completed and retained by the Division.
(3) An investigator may, upon determination that the violations observed are of a nature that pose an imminent peril to the public health, safety and welfare, recommend to the Division Director to issue an emergency licensure action, such as cease and desist.
R156-17b-301. 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, including in-state Internet pharmacies, and requires a pharmacist-in-charge.
(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 pharmacist-in-charge except for pharmaceutical administration facilities. Examples of Class B pharmacies include:
(a) closed door;
(b) hospital clinic pharmacy;
(c) nuclear;
(d) branch;
(e) hospice facility pharmacy;
(f) veterinarian pharmaceutical facility;
(g) pharmaceutical administration facility; and
(h) sterile product preparation facility.
(i) A retail pharmacy that prepares sterile products does not require a separate license as a Class B pharmacy.
(3) Class C pharmacy includes all pharmacies that are involved in:
(a) manufacturing;
(b) producing;
(c) wholesaling; and
(d) distributing
(4) Class D pharmacy includes non-resident pharmacies located outside the state of Utah. Class D pharmacies require a pharmacist-in-charge licensed in the state where the pharmacy is located. Class D pharmacies include:
(a) Out-of-state mail order pharmacies. Facilities that have multiple locations must have licenses for each facility and every component part of a facility; and
(b) Out-of-state Internet pharmacies. Internet pharmacies must meet VIPPS standard and criteria as established by NABP.
(5) Class E pharmacy include those pharmacies that do not require a pharmacist-in-charge and include:
(a) medical gases providers;
(b) analytical laboratory;
(c) dog trainers;
(d) animal euthanasia agency; and
(e) pharmaceutical research facility. Individual researchers who do not have prescriptive practice must have a controlled substances handler license.
(6) All pharmacy licenses will be converted to the appropriate classification by the Division and as identified in Section 58-17b-302.
(7) Each Class A and each Class B pharmacy required to have a pharmacist-in-charge shall have one pharmacist-in-charge who is employed on a full-time basis as defined by the employer, who acts as a pharmacist-in-charge for one pharmacy. However, the pharmacist-in-charge may be the pharmacist-in-charge of more than one Class A pharmacy, if the additional Class A pharmacies are not open to provide pharmacy services simultaneously.
(8) The pharmacist-in-charge shall comply with the provisions of Section R156-17b-603.
R156-17b-302. Licensure - Examinations.
(1) In accordance with Subsection 58-17b-303(1)(h), the examinations that must 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) In accordance with Subsection 58-17b-303(3)(j), an applicant applying by endorsement is required to pass the MPJE.
(3) In accordance with Subsection 58-17b-305(1)(g), the examinations which must be passed by an applicant applying for licensure as a pharmacy technician are:
(a) the Utah Pharmacy Technician Law and Rule Examination with a passing score of at least 75 and taken within six months prior to making application for licensure; and
(b) the National Pharmacy Technician Certification Board Examination with a passing score as established by the Pharmacy Technician Certification Board and taken within six months of completion of an approved education and training program.
R156-17b-303. Licensure - Pharmacist by Endorsement.
(1) In accordance with Subsections 58-17b-303(3) and 58-1-301(3), an applicant for licensure as a pharmacist by endorsement shall apply through the "Licensure Transfer Program" administered by NABP.
(2) An applicant for licensure as a pharmacist by endorsement does not need to provide evidence of intern hours if that applicant has:
(a) lawfully practiced as a licensed pharmacist a minimum of 2000 hours in the two years immediately preceding application in Utah;
(b) obtained sufficient continuing education credits required to maintain a license to practice pharmacy in the state of practice; and
(c) not had a pharmacist license suspended, revoked, canceled, surrendered, or otherwise restricted for any reason in any state for ten years prior to application in Utah, unless otherwise approved by the Division in collaboration with the Board.
R156-17b-304. Licensure - Education Requirements.
(1) In accordance with Subsections 58-17b-303(2) and 58-17b-304(7)(c), the credentialing agency recognized to provide certification and evaluate equivalency of a foreign educated pharmacy graduate is the Foreign Pharmacy Graduate Examination Committee of the National Association of Boards of Pharmacy Foundation, or an equivalent credentialing agency as approved by the Division.
(2) In accordance with Subsection 58-17b-304(6), the preliminary education qualification for licensure as a pharmacy intern include:
(a) a current pharmacy student who has completed at least 15 semester hours of pharmacy course work in a college or school of pharmacy accredited by the ACPE;
(b) a graduate who has received a degree from a school or college of pharmacy which is accredited by the ACPE; or
(c) a graduate of a foreign pharmacy school who has received 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 must complete an approved program of education and training that meets the following standards:
(a) The didactic training program must be approved by the Division in collaboration with the Board and must address, at a minimum, the following topics:
(i) legal aspects of pharmacy practice including federal and state laws and rules governing practice;
(ii) hygiene and aspectic techniques;
(iii) terminology, abbreviations and symbols;
(iv) pharmaceutical calculations;
(v) identification of drugs by trade and generic names, and therapeutic classifications;
(vi) filling of orders and prescriptions including packaging and labeling;
(vii) ordering, restocking, and maintaining drug inventory;
(viii) computer applications in the pharmacy; and
(ix) non-prescription products including, but not limited to, cough and cold, nutritional, analgesics, allergy, diabetic testing supplies, first aid, ophthalmic, family planning, foot, feminine hygiene, gastrointestinal preparations, and pharmacy care over-the-counter drugs.
(b) This training program's curriculum and a copy of the final examination shall be submitted to the Division for approval by the Board prior to staring any training session with a pharmacy technician in training. The final examination must include questions covering each of the topics listed in Subsection (3)(a) above.
(c) Approval must be granted by the Division in collaboration with the Board before a student may start a program of study. Specific guidelines include:
(i) an individual currently participating in a program of study that was approved prior to July 1, 2004, must complete the program by April 1, 2005 to be eligible for licensure.
(ii) a training program that accepts an individual into a program on or after January 1, 2005 must submit a copy of the curriculum no later than November 1, 2004 and have the program approved by the Division in collaboration with the Board.
(iii) an individual who completes a non-approved program is not eligible for licensure.
(d) The training program must require at least 180 hours of practical training supervised by a licensed pharmacist in good standing with the Division and must include written protocols and guidelines for the teaching pharmacist outlining the utilization and supervision of pharmacy technicians in training that includes:
(i) the specific manner in which supervision will be completed; and
(iii) an evaluative procedure to verify the accuracy and completeness of all acts, tasks and functions performed by the pharmacy technician in training.
(e) An individual must complete an approved training program and successfully pass the required examinations as listed in Subsection R156-17b-302(3) within one year from the date of the first day of the training program, unless otherwise approved by the Division in collaboration with the Board.
(4) An applicant for licensure as a pharmacy technician is deemed to have met the qualification for licensure in Subsection 58-17b-305(f) 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 or equivalent experience as approved by the Division in collaboration with the Board; and
(c) has passed and maintained current the PTCB certification and passed the Utah law exam.
R156-17b-306. Licensure - Pharmacist - Pharmacy Internship Standards.
(1) In accordance with Subsection 58-17b-303(1)(g), the standards for the pharmacy internship required for licensure as a pharmacist include the following:
(a) At least 1500 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.
(i) Internship hours completed in Utah shall include at least 360 hours but not more than 900 hours in a college coordinated practical experience program as an integral part of the curriculum which shall include a minimum of 120 hours in each of the following practices:
(A) community pharmacy;
(B) institutional pharmacy; and
(C) any clinical setting.
(ii) 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) 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) Pharmacy interns participating in internships may be credited no more than 50 hours per week of internship experience.
(d) No credit will be awarded for didactic experience.
(2) If a pharmacy intern is suspended or dismissed from an approved College of Pharmacy, the intern must notify the Division within 15 days of the suspension or dismissal.
(3) If a pharmacy intern ceases to meet all requirements for intern licensure, he shall surrender his pharmacy intern license to the Division within 60 days unless an extension is required and granted by the Division in collaboration with the Board.
(4) In accordance with Subsections 58-17b-102(51), to be an approved preceptor, a pharmacist must meet the following criteria:
(a) hold a Utah pharmacist license that is active and in good standing;
(b) have been engaged in active practice as a licensed pharmacist for not less than two years in any jurisdiction;
(c) is not currently under any sanction nor has been under any sanction at any time which when considered by the Division and the Board would be of such a nature that the best interests of the intern and the public would not be served.
(d) shall provide direct, on-site supervision to only one pharmacy intern during a working shift; and
(e) should follow internship training guidelines as outlined in the Pharmacy Coordinating Council of Utah Internship Competencies, October 12, 2004, which is hereby adopted and incorporated by reference.
R156-17b-307. Licensure - Meet with the Board.
In accordance with Subsections 58-1-202(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-308. Renewal Cycle - Procedures.
(1) In accordance with Subsection 58-1-308(1), the renewal date for the two-year renewal cycle applicable to licensees under Title 58, Chapter 17b is established by rule in Section R156-1-308.
(2) Renewal procedures shall be in accordance with Section R156-1-308.
(3) An intern license may be extended upon the request of the licensee and approval by the Division under the following conditions:
(a) have applied to the Division for a pharmacist license and to sit for the NAPLEX and MJPE examinations within three calendar months after obtaining full certification from the Foreign Pharmacy Graduate Equivalency Commission; or
(b) have passed the NAPLEX and MJPE examinations but lacks the required number of internship hours for licensure.
(4) The extended internship hours shall be under the direct supervision of a preceptor who meets the criteria established in R156-17b-306(4).
R156-17b-309. Continuing Education.
(1) In accordance with Section 58-17b-310 and Subsections 58-1-203(1)(g) and 58-1-308(3)(b), there is created a requirement for continuing education as a condition for renewal or reinstatement of a pharmacist or pharmacy technician license issued under Title 58, Chapter 17b.
(2) Requirements shall consist of the following number of qualified continuing education hours in each preceding renewal period:
(a) 30 hours for a pharmacist; and
(b) 20 hours for a pharmacy technician.
(3) The required number of hours of qualified continuing professional education for an individual who first becomes licensed during the two year renewal cycle shall be decreased in a pro-rata amount equal to any part of that two year period preceding the date on which that individual first became license.
(4) Qualified continuing professional education hours shall consist of the following:
(a) for pharmacists:
(i) institutes, seminars, lectures, conferences, workshops, various forms of mediated instruction, and programmed learning courses, presented by an institution, individual, organization, association, corporation or agency that has been approved by ACPE;
(ii) programs approved by health-related continuing education approval organizations provided the continuing education is nationally recognized by a healthcare accrediting agency and the education is related to the practice of pharmacy; and
(iii) programs of certification by qualified individuals, such as certified diabetes educator credentials, board certification in advanced therapeutic disease management or other certification as approved by the Division in consultation with the Board.
(b) for pharmacy technicians:
(i) institutes, seminars, lectures, conferences, workshops, various forms of mediated instruction, and programmed learning courses, presented by an institution, individual, organization, association, corporation or agency that has been approved by ACPE;
(ii) programs approved by health-related continuing education approval organizations provided the continuing education is nationally recognized by a healthcare accrediting agency and the education is related to the practice of pharmacy; and
(iii) educational meetings that meet ACPE continuing education criteria sponsored by the Utah Pharmaceutical Association, the Utah Society of Health-System Pharmacists or a pharmacy technician training program approved in accordance with Subsection R156-17b-304(3)(b).
(5) Credit for qualified continuing professional education shall be recognized in accordance with the following:
(a) Pharmacists:
(i) a minimum of 12 hours shall be obtained through attendance at live or technology enabled participation lectures, seminars or workshops;
(ii) a minimum of 15 hours shall be in drug therapy or patient management; and
(iii) a minimum of one hour shall be in pharmacy law and ethics.
(b) Pharmacy Technicians:
(i) a minimum of eight hours shall be obtained through attendance at live or technology enabled participation at lectures, seminars or workshops; and
(ii) a minimum of one hour shall be in pharmacy law and ethics.
(iii) documentation of current Pharmacy Technician Certification Board certification will count as meeting the requirement for continuing education.
(6) A licensee shall be responsible for maintaining competent records of completed qualified continuing professional education for a period of four years after the close of the two year period to which the records pertain. It is the responsibility of the licensee to maintain such information with respect to qualified continuing professional education to demonstrate it meets the requirements under this section.
R156-17b-401. Disciplinary Proceedings.
(1) An individual licensed as a pharmacy intern who is currently under disciplinary action and qualifies for licensure as a pharmacist may be issued a pharmacist license under the same restrictions as the pharmacy intern license.
(2) A pharmacist, pharmacy intern or pharmacy technician whose license or registration is suspended under Subsection 58-17b-701(6) may petition the Division at any time that he can demonstrate the ability to resume competent practice.
R156-17b-402. Administrative Penalties.
In accordance withe Subsection 58-17b-401(6), 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:
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:
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:
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:
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:
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:
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:
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:
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:
initial offense: $500 - $2,000
subsequent offense(s): $2,500 - $10,000
(10) Being in possession of a drug for an unlawful purpose:
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:
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:
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:
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:
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:
initial offense: $500 - $2,000
subsequent offense(s): $2,500 - $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:
initial offense: $1,000 - $5,000
subsequent offense(s): $10,000
(17) Accepting back and redistributing any unused drugs, with the exception as provided in Section 58-17b-503:
initial offense: $1,000 - $5,000
subsequent offense(s): $10,000
(18) 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:
initial offense: $500 - $2,000
subsequent offense(s): $2,500 - $10,000
(19) Failure to follow USP-NF Chapter 797 guidelines:
initial offense: $500 - $2,000
subsequent offense(s) $2,500 - $10,000
(20) Failure to follow USP-NF Chapter 795 guidelines:
initial offense: $250 - $500
subsequent offense(s): $500 - $750
(21) Administering without appropriate guidelines or lawful order:
initial offense: $500 - $2,000
subsequent offense(s): $2,000 - $10,000
(22) Disclosing confidential patient information in violation of the provision of the Health Insurance Portability and Accountability Act of 1996 or other applicable law:
initial offense: $100 - $500
subsequent offense(s): $500 - $1,000
(23) Engaging in the practice of pharmacy without a licensed pharmacist designated as the pharmacist in charge:
initial offense: $100 - $500
subsequent offense(s): $2,000 - $10,000
(24) Failing to report to the Division any adverse action taken by another licensing jurisdiction, government agency, law enforcement agency or court:
initial offense: $100 - $500
subsequent offense(s): $500 - $1,000
(25) Compounding a prescription drug for sale to another pharmaceutical facility:
initial offense: $100 - $500
subsequent offense(s): $500 - $1,000
(26) 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:
initial offense: $500 - $1,000
subsequent offense(s): $2,500 - $5,000
(27) Violating any ethical code provision of the American Pharmaceutical Association Code of Ethics for Pharmacists, October 27, 1994:
initial offense: $250 - $500
subsequent offense(s): $2,000 - $10,000
(29) Failing to comply with the continuing education requirements set forth in these rules:
initial offense: $100 - $500
subsequent offense(s): $500 - $1,000
(29) Failing to provide the Division with a current mailing address within 10 days following any change of address:
initial offense: $50 - $100
subsequent offense(s): $200 - $300
(30) Defaulting on a student loan:
initial offense: $100 - $200
subsequent offense(s): $200 - $500
(31) Failing to abide by all applicable federal and state law regarding the practice of pharmacy:
initial offense: $500 - $1,000
subsequent offense(s): $2,000 - $10,000
(32) Failing to comply with administrative inspections:
initial offense: $500 - $2,000
subsequent offense(s): $2,000 - $10,000
(33) Abandoning a pharmacy and/or leaving drugs accessible to the public:
initial offense: $500 - $2,000
subsequent offense(s): $2,000 - $10,000
(34) Failure to return or providing false information on a self-inspection report:
initial offense: $100 - $250
subsequent offense(s): $300 - $500
(35) Failure to pay an administrative fine:
Double the original penalty amount up to $10,000
(36) Any other conduct which constitutes unprofessional or unlawful conduct:
initial offense: $100 - $500
subsequent offense(s): $200 - $1,000
(37) Failure to wear a name tag:
Individual initial: $50
Subsequent offense: $100
Pharmacy any offense: $100 - $200
(38) Failure to maintain an appropriate ratio of personnel:
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
(39) Unauthorized people in the pharmacy:
Pharmacist initial offense: $50 - $100
Pharmacist subsequent offense(s): $250 - $500
Pharmacy initial offense: $250 - $500
Pharmacy subsequent offense(s): $1,000 - $2,000
(40) Failure to offer to counsel:
Pharmacy personnel initial offense: $500 - $2,500
Pharmacy personnel subsequent offense(s): $5,000 - $10,000
Pharmacy: $2,000 per occurrence
(41) Violations of the laws and rules regulating operating standards (security system, unkempt facility, no hot water, etc.) in a pharmacy discovered upon inspection by the Division:
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
(42) Practicing or attempting to practice as a pharmacist, pharmacist intern, or pharmacy technician or operating a pharmacy without a license:
initial offense: $500 - $2,000
subsequent offense(s): $2,000 - $10,000
(43) Impersonating a licensee or practicing under a false name:
initial offense: $500 - $2,000
subsequent offense(s): $2,000 - $10,000
(44) Knowingly employing an unlicensed person:
initial offense: $500 - $1,000
subsequent offense(s): $1,000 - $5,000
(45) Knowingly permitting the use of a license by another person:
initial offense: $500 - $1,000
subsequent offense(s): $1,000 - $5,000
(46) 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:
initial offense: $100 - $2,000
subsequent offense(s): $2,000 - $10,000
(47) Violating or aiding or abetting any other person to violate any statute, rule or order regulating pharmacy:
initial offense: $500 - $2,000
subsequent offense(s): $2,000 - $10,000
(48) Violating or aiding or abetting any other person to violate any generally accepted professional or ethical standard:
initial offense: $500 - $2,000
subsequent offense(s): $2,000 - $10,000
(49) Engaging in conduct that results in convictions of, or a plea of nolo contendere, or a plea of guilty or nolo contendere held in abeyance to a crime:
initial offense: $500 - $2,000
subsequent offense(s): $2,000 - $10,000
(50) Engaging in conduct that results in disciplinary action by any other jurisdiction or regulatory authority:
initial offense: $100 - $500
subsequent offense(s): $200 - $1,000
(51) Engaging in conduct, including the use of intoxicants or drugs, 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:
initial offense: $100 - $500
subsequent offense(s): $200 - $1,000
(52) Practicing or attempting to practice as a pharmacist, pharmacy intern or pharmacy technician when physically or mentally unfit to do so:
initial offense: $00 - $500
subsequent offense(s): $200 - $1,000
(53) 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:
initial offense: $500 - $2,000
subsequent offense(s): $2,000 - $10,000
(54) 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:
initial offense: $100 - $500
subsequent offense(s): $200 - $1,000
(55) Practicing or attempting to practice as a pharmacist, pharmacy intern or pharmacy technician beyond the individual's scope of competency, abilities or education:
initial offense: $100 - $500
subsequent offense(s): $200 - $1,000
(56) Practicing or attempting to practice as a pharmacist, pharmacy intern or pharmacy technician beyond the scope of licensure:
initial offense: $100 - $500
subsequent offense(s): $200 - $1,000
(57) Verbally, physically or mentally abusing or exploiting any person through conduct connected with the licensee's practice:
initial offense: $100 - $1,000
subsequent offense(s): $500 - $2,000
(58) Failure to comply with the pharmacist-in-charge standards:
initial offense: $500 - $2,000
subsequent offense(s) $2,000 - $10,000
(59) Failure to resolve identified drug therapy management problems:
initial offense: $500 - $2,500
subsequent offense: $5,000 - $10,000
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) abandoning a pharmacy or leaving prescription drugs accessible to the public;
(9) failing to wear a name tag or badge while working in any pharmaceutical facility;
(10) failing to identify licensure classification when communicating by any means;
(11) the practice of pharmacy with an inappropriate pharmacist to pharmacy intern ratio established by Subsection R156-17b-306(4)(b) or pharmacist to pharmacy technician ratio as established by Subsection R156-17b-601(3);
(12) allowing any unauthorized persons in the pharmacy;
(13) failing to offer to counsel any person receiving a prescription medication;
(14) failing to pay an administrative fine that has been assessed in the time designated by the Division;
(15) failing to comply with the pharmacist-in-charge standards as established in Section R156-17b-603; and
(16) failing to take appropriate steps to avoid or resolve identified drug therapy management problems as referenced in Subsection R156-17b-611(3).
R156-17b-601. Operating Standards - Pharmacy Technician - Scope of Practice.
In accordance with Subsection 58-17b-102(56), the scope of practice of a 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 non-prescription drugs and dietary supplements under the direction of the supervising pharmacist as referenced in Subsection R156-17b-304(3)(ix);
(k) accepting new prescription drug orders telephonically or electronically submitted for a pharmacist to review; and
(l) additional tasks not requiring the judgment of a pharmacist.
(2) The pharmacy technician shall not receive new verbal prescriptions or medication orders, clarify prescriptions or medication orders nor perform drug utilization reviews.
(3) The licensed pharmacist on duty can, at his discretion, provide on-site supervision up to three pharmacy technicians, who are actually on duty at any one time, and only one of the three technicians can be unlicensed.
R156-17b-602. Operating Standards - Pharmacy Intern - Scope of Practice.
A pharmacy intern may provide all pharmaceutical care services provided the services are supervised by a preceptor that meets the criteria established in Subsections 58-17b-102(54) and R156-17b-306(4).
R156-17b-603. Operating Standards - Pharmacist-in-charge.
The pharmacist-in-charge shall have responsibility for, at a minimum, the following:
(1) assuring that pharmacists and pharmacy interns are dispensing drugs or devices, including:
(a) packaging, preparation, compounding and labeling; and
(b) ensuring that drugs are dispensed safely and accurately as prescribed;
(2) assuring that pharmacy personnel deliver drugs to the patient or the patient's agent, including ensuring that drugs are delivered safely and accurately as prescribed;
(3) assuring that a pharmacist, pharmacy intern or pharmacy technician communicates to the patient or the patient's agent information about the prescription drug or device or non-prescription products;
(4) assuring that a pharmacist or pharmacy intern communicates to the patient or the patient's agent, at their request, information concerning any prescription drugs dispensed to the patient by the pharmacist or pharmacy intern;
(5) assuring that a reasonable effort is made to obtain, record and maintain patient medication records;
(6) education and training of pharmacy technicians;
(7) establishment of policies for procurement of prescription drugs and devices and other products dispensed from the pharmacy;
(8) disposal and distribution of drugs from the pharmacy;
(9) bulk compounding of drugs;
(10) storage of all materials, including drugs, chemicals and biologicals;
(11) maintaining records of all transactions of the pharmacy necessary to maintain accurate control over and accountability for all pharmaceutical materials required by applicable state and federal laws and regulations;
(12) establishment and maintenance of effective controls against theft or diversion of prescription drugs and records for such drugs;
(13) if records are kept on a data processing system, the maintenance of records stored in that system shall be in compliance with pharmacy requirements;
(14) legal operation of the pharmacy including meeting all inspection and other requirements of all state and federal laws, rules and regulations governing the practice of pharmacy;
(15) assuring that any automated pharmacy system is in good working order and accurately dispenses the correct strength, dosage form and quantity of the drug prescribed while maintaining appropriate record keeping and security safeguards;
(16) implementing an ongoing quality assurance program that monitors performance of the automated pharmacy system, which is evidenced by written policies and procedures developed for pharmaceutical care; and
(17) assuring that all relevant information is submitted to the Controlled Substance Database in the appropriate format and in a timely manner.
R156-17b-604. Operating Standards - Closing a Pharmacy.
At least 14 days prior to the closing of a pharmacy, the pharmacist-in-charge shall comply with the following:
(1) If the pharmacy is registered to possess controlled substances, send a written notification to the appropriate regional office of the Drug Enforcement Administration (DEA) containing the following information:
(a) the name, address and DEA registration number of the pharmacy;
(b) the anticipated date of closing;
(c) the name, address and DEA registration number of the pharmacy acquiring the controlled substances; and
(d) the date on which the transfer of controlled substances will occur.
(2) If the pharmacy dispenses prescription drug orders, post a closing notice sign in a conspicuous place in the front of the prescription department and at all public entrance doors to the pharmacy. Such closing notice shall contain the following information:
(a) the date of closing; and
(b) the name, address and telephone number of the pharmacy acquiring the prescription drug orders, including refill information and patient medication records of the pharmacy.
(3) On the date of closing, the pharmacist-in-charge shall remove all prescription drugs from the pharmacy by one or a combination of the following methods:
(a) return prescription drugs to manufacturer or supplier for credit or disposal; or
(b) transfer, sell or give away prescription drugs to a person who is legally entitled to possess drugs, such as a hospital or another pharmacy.
(4) If the pharmacy dispenses prescription drug orders:
(a) transfer the prescription drug order files, including refill information and patient medication records, to a licensed pharmacy within a reasonable distance of the closing pharmacy; and
(b) move all signs or notify the landlord or owner of the property that it is unlawful to use the word "pharmacy", or any other word or combination of words of the same or similar meaning, or any graphic representation that would mislead or tend to mislead the public that a pharmacy is located at this address.
(5) Within 10 days of the closing of the pharmacy, the pharmacist-in-charge shall forward to the Division a written notice of the closing that includes the following information:
(a) the actual date of closing;
(b) the license issued to the pharmacy;
(c) a statement attesting:
(i) that an inventory as specified in Subsection R156-17b-605(6) has been conducted; and
(ii) the manner in which the legend drugs and controlled substances possessed by the pharmacy were transferred or disposed;
(d) if the pharmacy dispenses prescription drug orders, the name and address of the pharmacy to which the prescription drug orders, including refill information and patient medication records, were transferred.
(6) If the pharmacy is registered to possess controlled substances, a letter must be sent to the appropriate DEA regional office explaining that the pharmacy has closed. The letter shall include the following items:
(a) DEA registration certificate;
(b) all unused DEA order forms (Form 222) with the word "VOID" written on the face of each order form; and
(c) copy #2 of any DEA order forms (Form 222) used to transfer Schedule II controlled substances from the closed pharmacy.
(7) If the pharmacy is closed suddenly due to fire, destruction, natural disaster, death, property seizure, eviction, bankruptcy or other emergency circumstances and the pharmacist-in-charge cannot provide notification 14 days prior to the closing, the pharmacist-in-charge shall comply with the provisions of Subsection (1) as far in advance of the closing as allowed by the circumstances.
(8) If the pharmacist-in-charge is not available to comply with the requirements of this section, the owner or legal representative shall be responsible for compliance with the provisions of this section.
R156-17b-605. Operating Standards - Inventory Requirements.
(1) General requirements for inventory of a pharmacy shall include the following:
(a) the pharmacist-in-charge 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 must 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 typewritten or printed form and include all stocks of legend drugs and 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 must be promptly transcribed;
(e) the inventory may be taken either as of the opening of the business or the close of business on the inventory date;
(f) the person taking the inventory and the pharmacist-in-charge 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 pharmacist-in-charge 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 court or measure all Scheduled III, IV or V controlled substances and legend drugs, unless the container holds more than 1,000 tablets or capsules in which case an exact count of the contents must 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 which shall be listed separately from the inventory of the legend drugs; and
(j) if the pharmacy maintains a perpetual inventory of any of the drugs required to be inventoried, the perpetual inventory shall be reconciled on the date of the inventory.
(2) Requirement for taking the initial inventory shall include the following:
(a) all pharmacies having any stock of legend drugs or controlled substances shall take an inventory on the opening day of business. Such inventory shall include all stock of legend drugs and controlled substances including any out-of-date drugs and drugs in automated pharmacy systems;
(b) in the event a pharmacy commences business with none of the drugs specified in paragraph (2)(a) of this section on hand, the pharmacy shall record this fact as the initial inventory; and
(c) the initial inventory shall serve as the pharmacy's inventory until the next completed inventory as specified in Subsection (3) of this section.
(3) Requirement for annual inventory shall be 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.
(4) 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 Scheduled I and II controlled substances shall require the use of official DEA order forms (Form 222).
(5) Requirement for taking inventory when closing a pharmacy includes the pharmacist-in-charge, 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.
(6) Requirements specific to taking inventory in a Class B pharmacy shall include the following:
(a) all Class B pharmacies shall maintain a perpetual inventory of all Schedule II controlled substances which shall e reconciled according to facility policy; and
(b) the inventory of the institution shall be maintained in the pharmacy; if an inventory is conducted in other departments within the institution, the inventory shall be listed separately as follows:
(i) the inventory of drugs on hand in the pharmacy shall be listed separately from the inventory of drugs on hand in the other areas of the institution; and
(ii) the inventory of the drugs on hand in all other departments shall be identified by department.
R156-17b-606. Operating Standards - Approved Preceptor.
In accordance with Subsection 58-17b-601(1), the operating standard for a pharmacist acting as a preceptor includes:
(1) supervising more than one intern; however, a preceptor may supervise only one intern actually on duty in the practice of pharmacy at any one time;
(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-607. Operating Standards - Supportive Personnel.
(1) In accordance with Subsection 58-17b-102(66)(a), supportive personnel may assist in any tasks not related to drug preparation or processing including:
(a) stock ordering and restocking;
(b) cashiering;
(c) billing;
(d) filing;
(e) receiving a written prescription and delivering it to the pharmacist, pharmacy intern or pharmacy technician;
(f) housekeeping; and
(g) delivering a pre-filled prescription to a patient.
(2) Supportive personnel shall not enter information into a patient profile or accept verbal refill information.
(3) In accordance with Subsection 58-17b-102(66)(b), the supervision of supportive personnel is defined as follows:
(a) all supportive personnel shall be under the supervision of a licensed pharmacist; and
(b) the licensed pharmacist shall be present in the area where the person being supervised is performing services and shall be immediately available to assist the person being supervised in the services being performed.
(4) In accordance with Subsection 58-17b-601(1), a pharmacist, pharmacy intern or pharmacy technician whose license has been revoked or is suspended shall not be allowed to provide any support services in a pharmacy.
R156-17b-608. Reserved.
Reserved.
R156-17b-609. Operating Standards - Medication Profile System.
In accordance with Subsections 58-17b-601(1) and 58-17b-604(1), the following operating standards shall apply with respect to medication profile systems:
(1) Patient profiles, once established, shall be maintained by a pharmacist in a pharmacy dispensing to patients on a recurring basis for a minimum of one year from the date of the most recent prescription filled or refilled; except that a hospital pharmacy may delete the patient profile for an inpatient upon discharge if a record of prescriptions is maintained as a part of the hospital record.
(2) Information to be included in the profile shall be determined by a responsible pharmacist at the pharmaceutical facility but shall include as a minimum:
(a) full name of the patient, address, telephone number, date of birth or age and gender;
(b) patient history where significant, including known allergies and drug reactions, and a comprehensive list of medications and relevant devices;
(c) a list of all prescription drugs obtained by the patient at the pharmacy including:
(i) name of prescription drug;
(ii) strength of prescription drug;
(iii) quantity dispensed;
(iv) date of filling or refilling;
(v) charge for the prescription drug as dispensed to the patient; and
(d) any additional comments relevant to the patient's drug use.
(3) Patient medication profile information shall be recorded by a pharmacist, pharmacy intern or pharmacy technician.
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) Based upon the pharmacist's or pharmacy intern's professional judgments, 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.
(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) Only a pharmacist or pharmacy intern may verbally provide drug information 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) 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.
R156-17b-611. Operating Standards - Drug Therapy Management.
(1) In accordance with Subsections 58-17b-102(17) and 58-17b-601(1), decisions involving drug therapy management shall be made in the best interest of the patient. Drug therapy management may include:
(a) implementing, modifying and managing drug therapy according to the terms of the Collaborative Pharmacy Practice Agreement;
(b) collecting and reviewing patient histories;
(c) obtaining and checking vital signs, including pulse, temperature, blood pressure and respiration;
(d) ordering and evaluating the results of laboratory tests directly applicable to the drug therapy, when performed in accordance with approved protocols applicable to the practice setting; and
(e) such other patient care services as may be allowed by rule.
(2) For the purpose of promoting therapeutic appropriateness, a pharmacist shall at the time of dispensing a prescription, or a prescription drug order, review the patient's medication record. Such review shall at a minimum identify clinically significant conditions, situations or items, such as:
(a) inappropriate drug utilization;
(b) therapeutic duplication;
(c) drug-disease contraindications;
(d) drug-drug interactions;
(e) incorrect drug dosage or duration of drug treatment;
(f) drug-allergy interactions; and
(g) clinical abuse or misuse.
(3) Upon identifying any clinically significant conditions, situations or items listed in Subsection (2) above, the pharmacist shall take appropriate steps to avoid or resolve the problem including consultation with the prescribing practitioner.
R156-17b-612. Operating Standards - Prescriptions.
In accordance with Subsection 58-17b-601(1), the following shall apply to prescriptions:
(1) Prescription order shall be handled according to the rules of the Federal Drug Enforcement Administration.
(2) A prescription issued by an authorized licensed practitioner, if verbally communicated by an agent of that practitioner upon that practitioner's specific instruction and authorization, may be accepted by a pharmacist or pharmacy intern.
(3) A prescription issued by a licensed prescribing practitioner, if electronically communicated by an agent of that practitioner, upon that practitioner's specific instruction and authorization, may be accepted by a pharmacist, pharmacy intern and pharmacy technician.
(4) In accordance with Section 58-17b-609, prescription files, including refill information, shall be maintained for a minimum of five years by either a manual filing of written prescriptions or by an immediately retrievable electronic record.
(5) Prescriptions having a remaining authorization for refill may be transferred by the pharmacist at the pharmacy holding the prescription to a pharmacist at another pharmacy upon the authorization of the patient to whom the prescription was issued. The transferring pharmacist and receiving pharmacist shall act diligently to ensure that the total number of authorized refills is not exceeded.
(6) Prescriptions for terminal patients in licensed hospices, home health agencies or nursing homes may be partially filled if the patient has a medical diagnosis documenting a terminal illness and may not need the full prescription amount.
(7) Refills may be dispensed only in accordance with the prescriber's authorization as indicated on the original prescription drug order;
(8) If there are no refill instructions on the original prescription drug order, or if all refills authorized on the original prescription drug order have been dispensed, authorization from the prescribing practitioner must be obtained prior to dispensing any refills.
(9) Refills of prescription drug orders for legend drugs may not be refilled after one year from the date of issuance of the original prescription drug order without obtaining authorization from the prescribing practitioner prior to dispensing any additional quantities of the drug.
(10) Refills of prescription drug orders for controlled substances shall be done in accordance with Subsection 58-37-6(7)(f).
(11) A pharmacist may exercise his professional judgment in refilling a prescription drug order for a drug, other than a controlled substance listed in Schedule II, without the authorization of the prescribing practitioner, provided:
(a) failure to refill the prescription might result in an interruption of a therapeutic regimen or create patient suffering;
(b) either:
(i) a natural or manmade disaster has occurred which prohibits the pharmacist from being able to contact the practitioner; or
(ii) the pharmacist is unable to contact the practitioner after a reasonable effort, the effort should be documented and said documentation should be available to the Division;
(c) the quantity of prescription drug dispensed does not exceed a 72-hour supply;
(d) the pharmacist informs the patient or the patient's agent at the time of dispensing that the refill is being provided without such authorization and that authorization of the practitioner is required for future refills;
(e) the pharmacist informs the practitioner of the emergency refill at the earliest reasonable time;
(f) the pharmacist maintains a record of the emergency refill containing the information required to be maintained on a prescription as specified in this subsection; and
(g) the pharmacist affixes a label to the dispensing container as specified in Section 58-17b-602.
(12) If the prescription was originally filled at another pharmacy, the pharmacist may exercise his professional judgment in refilling the prescription provided:
(a) the patient has the prescription container label, receipt or other documentation from the other pharmacy which contains the essential information;
(b) after a reasonable effort, the pharmacist is unable to contact the other pharmacy to transfer the remaining prescription refills or there are no refills remaining on the prescription;
(c) the pharmacist, in his professional judgment, determines that such a request for an emergency refill is appropriate and meets the requirements of (a) and (b) of this subsection; and
(d) the pharmacist complies with the requirements of Subsections (11)(c) through (g) of this section.
(13) The transfer of original prescription drug order information for legend drugs and Schedule III through V controlled substances is permissible between pharmacies on a one time basis only for the valid remaining refills except as described in Subsection R156-17b-613(9).
(a) the transfer shall be communicated directly between pharmacists or pharmacy interns or as authorized under Subsection R156-17b-613(9):
(b) both the original and the transferred prescription drug orders shall be maintained for a period of five years from the date of the last refill;
(c) the pharmacist or pharmacy intern transferring the prescription drug order shall void the prescription electronically or write void on the face of the invalidated prescription manually;
(d) the pharmacist or pharmacy intern receiving the transferred prescription drug order shall:
(i) indicate on the prescription record that the prescription was transferred electronically or manually; and
(ii) record on the transferred prescription drug order the following information:
(A) original date of issuance and date of dispensing or receipt, if different from date of issuance;
(B) original prescription number and the number of refills authorized on the original prescription drug order;
(C) number of valid refills remaining and the date of last refill, if applicable;
(D) the name, address and, if a controlled substance, the DEA registration number of the pharmacy to which such prescription is transferred; and
(E) the name of the pharmacist or pharmacy intern transferring the prescription drug order information;
(e) the data processing system shall have a mechanism to prohibit the transfer or refilling of controlled substance prescription drug orders which have been previously transferred; and
(f) a pharmacist or pharmacy intern may not refuse to transfer original prescription information to another pharmacist or pharmacy intern who is acting on behalf of a patient and who is making a request for this information as specified in Subsections (12) and (13) of this section.
R156-17b-613. Operating Standards - Issuing Prescription Orders by Electronic Means.
In accordance with Subsections 58-17b-102(3) and 58-17b-601(1), prescription orders may be issued by electronic means of communication according to the following:
(1) Prescription orders for Schedule II - V controlled substances received by electronic means of communication shall be handled according to Title 58, Chapter 37, Utah Controlled Substances Act and R156-37, Utah Controlled Substances Act Rules.
(2) Prescription orders for non-controlled substances received by electronic means of communication may be dispensed by a pharmacist or pharmacy intern only if all of the following conditions are satisfied:
(a) all electronically transmitted prescription orders shall include the following:
(i) all information that is required to be contained in a prescription order pursuant to Section 58-17b-602;
(ii) the time and date of the transmission, and if a facsimile transmission, the electronically encoded date, time and fax number of the sender; and
(iii) the name of the pharmacy intended to receive the transmission;
(b) the prescription order shall be transmitted under the direct supervision of the prescribing practitioner or his designated agent;
(c) the pharmacist shall exercise professional judgment regarding the accuracy and authenticity of the transmitted prescription. Practitioners or their agents transmitting medication orders using electronic equipment are to provide voice verification when requested by the pharmacist receiving the medication order. The pharmacist is responsible for assuring that each electronically transferred prescription order is valid and shall authenticate a prescription order issued by a prescribing practitioner which has been transmitted to the dispensing pharmacy before filling it, whenever there is a question;
(d) a practitioner may authorize an agent to electronically transmit a prescription provided that the identifying information of the transmitting agent is included on the transmission. The practitioner's electronic signature, or other secure method of validation, shall be provided with the electronic prescription; and
(e) an electronically transmitted prescription order that meets the requirements above shall be deemed to be the original prescription.
(3) This section does not apply to the use of electronic equipment to transmit prescription orders within inpatient medical facilities.
(4) No agreement between a prescribing practitioner and a pharmacy shall require that prescription orders be transmitted by electronic means from the prescribing practitioner to that pharmacy only.
(5) The pharmacist shall retain a printed copy of an electronic prescription, or a record of an electronic prescription that is readily retrievable and printable, for a minimum of five years. The printed copy shall be of non-fading legibility.
(6) Wholesalers, distributors, manufacturers, pharmacists and pharmacies shall not supply electronic equipment to any prescriber for transmitting prescription orders.
(7) An electronically transmitted prescription order shall be transmitted to the pharmacy of the patient's choice.
(8) Prescription orders electronically transmitted to the pharmacy by the patient shall not be filled or dispensed.
(9) A prescription order for a legend drug or controlled substance in Schedule III through V may be transferred up to the maximum refills permitted by law with the prescriber's authorization by electronic transmission providing the pharmacies share a real-time, on-line database provided that:
(a) information required to be on the transferred prescription has the same information as described in Subsection R156-17b-6012(17)(b) and (i) through (v); and
(b) pharmacists, pharmacy interns or pharmacy technicians electronically accessing the same prescription drug order records may electronically transfer prescription information if the data processing system has a mechanism to send a message to the transferring pharmacy containing the following information:
(i) the fact that the prescription drug order was transferred;
(ii) the unique identification number of the prescription drug order transferred;
(iii) the name of the pharmacy to which it was transferred; and
(iv) the date and time of the transfer.
R156-17b-614. Operating Standards - Operating Standards, Class A and B Pharmacy.
(1) In accordance with Subsection 58-17b-601(1), standards for the operations for a Class A and Class B pharmacy include:
(a) shall be well lighted, well ventilated, clean and sanitary;
(b) the dispensing area, if any, shall have a sink with hold and cold culinary water separate and apart from any restroom facilities. This does not apply to clean room 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 devices 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 permit detection of entry at all times when the facility is closed.
(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 extensive 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) must follow USP-NF Chapter 795, compounding of non-sterile preparations;
(b) may compound in anticipation of receiving prescriptions in very limited amounts;
(c) bulk active ingredients must be component of FDA approved drugs listed in the approved drug products prepared by the Center for Drug Evaluation and Research of the FDA;
(d) compounding using drugs that are not part of a FDA approved drug listed in the approved drug products prepared by the Center for Drug Evaluation and Research of the FDA requires an investigational new drug application (IND). The IND approval shall be kept in the pharmacy for five years for inspection;
(e) 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;
(f) 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) expiration 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;
(g) 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) expiration 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;
(h) the expiration 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", 13th Edition, 2004;
(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 expiration dates shall be documented; and
(i) 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 Rules of the Division of Occupational and Professional Licensing;
(c) Title 58, Chapter 17b, Pharmacy Practice Act;
(d) R156-17b, Utah Pharmacy Practice Act Rules;
(e) Title 58, Chapter 37, Utah Controlled Substances Act;
(f) R156-37, Utah Controlled Substances Act Rules;
(g) Code of Federal Regulations (CFR) 21, Food and Drugs, Part 1300 to end or equivalent such as the USP DI Drug Reference Guides;
(h) current FDA Approved Drug Products (orange book); and
(i) 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 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 must 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) must be available to the Division whenever necessary.
(12) Pharmacists or other responsible individuals shall verify that the suppliers' invoices of legend drugs, including controlled substances, are listed on the invoices and were actually received by clearly recording their initials and the actual date of receipt of the controlled substances.
(13) The pharmacy facility must maintain a record of suppliers' credit memos for controlled substances and legend drugs.
(14) A copy of inventories required under Section R156-17b-605 must be made available to the Division when requested.
(15) The pharmacy facility must maintain hard copy reports of surrender or destruction of controlled substances and legend drugs submitted to appropriate state or federal agencies.
R156-17b-614a. Operating Standards - Class B pharmacy designated as a Branch Pharmacy.
In accordance with Subsections 58-17b-102(7) and 58-1-301(3), the qualifications for designation as a branch pharmacy include the following:
(1) The Division, in collaboration with the Board, shall approve the location of each branch pharmacy. The following shall be considered in granting such designation:
(a) the distance between or from nearby alternative pharmacies and all other factors affecting access of persons in the area to alternative pharmacy resources;
(b) the availability at the location of qualified persons to staff the pharmacy, including the physician, physician assistant or advanced practice registered nurse;
(c) the availability and willingness of a parent pharmacy and supervising pharmacist to assume responsibility for the branch pharmacy;
(d) the availability of satisfactory physical facilities in which the branch pharmacy may operate; and
(e) the totality of conditions and circumstances which surround the request for designation.
(2) A branch pharmacy shall be licensed as a pharmacy branch of an existing Class A or B pharmacy licensed by the Division.
(3) The application for designation of a branch pharmacy shall be submitted by the licensed parent pharmacy seeking such designation. In the event that more than one licensed pharmacy makes application for designation of a branch pharmacy location at a previously undesignated location, the Division in collaboration with the Board shall review all applications for designation of the branch pharmacy and, if the location is approved, shall approve for licensure the applicant determined best able to serve the public interest as identified in Subsection (1).
(4) The application shall include the following:
(a) complete identifying information concerning the applying parent pharmacy;
(b) complete identifying information concerning the designated supervising pharmacist employed at the parent pharmacy;
(c) address and description of the facility in which the branch pharmacy is to be located;
(d) specific formulary to be stocked indicating with respect to each prescription drug, the name, the dosage strength and dosage units in which the drug will be prepackaged;
(e) complete identifying information concerning each person located at the branch pharmacy who will dispense prescription drugs in accordance with the approved protocol; and
(f) protocols under which the branch pharmacy will operate and its relationship with the parent pharmacy to include the following:
(i) the conditions under which prescription drugs will be stored, used and accounted for;
(ii) the method by which the drugs will be transported from parent pharmacy to the branch pharmacy and accounted for by the branch pharmacy; and
(iii) a description of how records will be kept with respect to:
(A) formulary;
(B) changes in formulary;
(C) record of drugs sent by the parent pharmacy;
(D) record of drugs received by the branch pharmacy;
(E) record of drugs dispensed;
(F) periodic inventories; and
(G) any other record contributing to an effective audit trail with respect to prescription drugs provided to the branch pharmacy.
R156-17b-614b. Operating Standards - Class B - Sterile Pharmaceuticals.
In accordance with Subsection 58-17b-601(1), the USP-NF Chapter 797, Compounding for Sterile Preparations, shall apply to all pharmacies preparing sterile pharmaceuticals.
R156-17b-614c. Operating Standards - Class B - Pharmaceutical Administration Facility.
In accordance with Subsections 58-17b-102(44) and 58-17b-601(1), the following applies with respect to prescription drugs which are held, stored or otherwise under the control of a pharmaceutical administration facility for administration to patients:
(1) The licensed pharmacist shall provide consultation on all aspects of pharmacy services in the facility; establish a system of records of receipt and disposition of all controlled substances in sufficient detail to enable an accurate reconciliation; and determine that drug records are in order and that an account of all controlled substances is maintained and periodically reconciled.
(2) Authorized destruction of all prescription drugs shall be witnessed by the medical or nursing director or a designated physician or registered nurse employed in the facility and the supervising pharmacist and must be in compliance with DEA regulations.
(3) Prescriptions for patients in the facility can be verbally requested by a licensed prescribing practitioner and may be entered as the prescribing practitioner's order; but the practitioner must personally sign the order in the facility record within 72 hours if a Schedule II controlled substance and within 30 days if any other prescription drug. The prescribing practitioner's verbal order may be copied and forwarded to a pharmacy for dispensing and may serve as the pharmacy's record of the prescription order.
(4) Prescriptions for controlled substances for patients in Class B pharmaceutical administration facilities shall be dispensed according to Title 58, Chapter 37, Utah Controlled Substances Act, and R156-37, Utah Controlled Substances Act Rules.
(5) Requirements for emergency drug kits shall include:
(a) an emergency drug kit may be used by pharmaceutical administration facilities. The emergency drug kit shall be considered to be a physical extension of the pharmacy supplying the emergency drug kit and shall at all times remain under the ownership of that pharmacy;
(b) the contents and quantity of drugs and supplies in the emergency drug kit shall be determined by the Medical Director or Director of Nursing of the pharmaceutical administration facility and the pharmacist-in-charge of the pharmacy;
(c) a copy of the approved list of contents shall be conspicuously posted on or near the kit;
(d) the emergency kit shall be used only for bona fide emergencies and only when medications cannot be obtained from a pharmacy in a timely manner;
(e) records documenting the receipt and removal of drugs in the emergency kit shall be maintained by the facility and the pharmacy;
(f) the pharmacy shall be responsible for ensuring proper storage, security and accountability of the emergency kit and shall ensure that:
(i) the emergency kit is stored in a locked area and is locked itself; and
(ii) emergency kit drugs are accessible only to licensed physicians, physician assistants and nurses employed by the facility;
(g) the contents of the emergency kit, the approved list of contents and all related records shall be made freely available and open for inspection to appropriate representatives of the Division and the Utah Department of Health.
R156-17b-614d. Operating Standards - Class B - Nuclear Pharmacy.
In accordance with Subsections 58-17b-303(4)(d) and 58-17b-601(1), the operating standards for a Class B pharmacy designated as a nuclear pharmacy shall have the following:
(1) A nuclear pharmacy shall have the following:
(a) have applied for or possess a current Utah Radioactive Materials License; and
(b) adequate space and equipment commensurate with the scope of services required and provided.
(2) Nuclear pharmacies shall only dispense radiopharmaceuticals that comply with acceptable standards of quality assurance.
(3) Nuclear pharmacies shall maintain a library commensurate with the level of radiopharmaceutical service to be provided.
(4) A licensed Utah pharmacist shall be immediately available on the premises at all times when the facility is open or available to engage in the practice of pharmacy.
(5) In addition to Utah licensure, the pharmacist shall be currently certified by the Board of Pharmaceutical Specialties in Nuclear Pharmacy or have equivalent classroom and laboratory training and experience as required by the Utah Radiation Control Rules.
(6) This rule does not prohibit:
(a) a licensed pharmacy intern or technician from acting under the direct supervision of an approved preceptor who meets the requirements to supervise a nuclear pharmacy; or
(b) a Utah Radioactive Materials license from possessing and using radiopharmaceuticals for medical use.
(7) A hospital nuclear medicine department or an office of a physician/surgeon, osteopathic physician/surgeon, veterinarian, pediatric physician or dentist that has a current Utah Radioactive Materials License does not require licensure as a Class B pharmacy.
R156-17b-615. Operating Standards - Class C Pharmacy - Pharmaceutical Wholesaler/Distributor and Pharmaceutical Manufacturer in Utah.
In accordance with Subsections 58-17b-102(48) 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) A separate license shall be obtained for each separate location engaged in the distribution or manufacturing of prescription drugs.
(2) The licensee need not be under the supervision of a licensed pharmacist, but shall be under the supervision of a responsible officer or management employee.
(3) 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.
(4) 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 or prescription drug precursors 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.
(5) Each facility shall provide the storage of prescription drugs and prescription drug precursors 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 or prescription drug precursor, 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 or prescription drug precursors 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.
(6) Each facility shall ensure that:
(a) upon receipt, each outside shipping container containing prescription drugs or prescription drug precursors shall be visibly examined for identity and to prevent the acceptance of prescription drugs or prescription drug precursors that are contaminated, reveal damage to the containers or are otherwise unfit for distribution; and
(b) each outgoing shipment shall be carefully inspected for identity of the prescription drug products and to ensure that there is no delivery of prescription drugs that have been damaged in storage or held under improper conditions.
(7) Each facility shall ensure that:
(a) prescription drugs or prescription drug precursors 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 or prescription drug precursors until they are appropriately destroyed or returned to their supplier;
(b) 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; and
(c) 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.
(8) 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.
(9) 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; and
(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 two years after disposition of the product.
(10) 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.
(11) 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 authorize 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.
(12) 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.
(13) 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.
R156-17b-616. Operating Standards - Class D Pharmacy - Non-Residence 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-614(1) through (4);
(b) a copy of the pharmacist's license for the pharmacist-in-charge; and
(c) a copy of the most recent state inspection showing the status of compliance with the laws and regulations for physical facility, records and operations.
(2) Any Internet pharmacy located in another state but providing drugs to citizens of Utah must meet VIPPS standards as outlined by NABP. Any Internet pharmacy located within the state and providing services to Utah citizens shall be licensed as a Class A pharmacy.
R156-17b-617. Operating Standards - Class E pharmacy.
(1) In accordance with Section 58-17b-302 and Subsection 58-17b-601(1), the operating standards for a Class E pharmacy shall include a written pharmacy care protocol which includes:
(a) the identity of the supervisor or director;
(b) a detailed plan of care;
(c) identity of the drugs that will be purchased, stored, used and accounted for; and
(d) identity of any licensed healthcare provider associated with operation.
R156-17b-617a. Operating Standards - Class E - Animal Euthanasia Agency.
In accordance with Section 58-17b-302 and Subsection 58-17b-601(1), the operating standards for a Class E pharmacy operating as an animal euthanasia agency concerning the use of prescription drugs shall include:
(1) A veterinarian licensed in Utah shall supervise the use of prescription drugs used for animal euthanasia.
(2) The veterinarian shall be responsible for:
(a) identifying each euthanasia drug for which authorization is requested;
(b) identifying the location where euthanasia drugs and records will be maintained;
(c) identifying each person to be authorized to purchase, possess or administer euthanasia drugs;
(d) describing the training program for each person authorized to purchase, possess or administer euthanasia drugs as well as attesting to be responsible for that training; and
(e) maintaining euthanasia drug records.
R156-17b-617b. Operating Standards - Class E - Pharmaceutical Dog Trainer.
In accordance with Section 58-17b-302 and Subsections 58-17b-601(1), the operating standards for a Class E pharmacy operating as a pharmaceutical dog trainer shall require an affiliation with a law enforcement official from a Utah law enforcement agency who is responsible for the purchase, storage and use of the authorized prescription drugs.
R156-17b-618. Operating Standards - Third Party Payors.
Reserved.
R156-17b-619. Operating Standards - Automated Pharmacy System.
In accordance with Section 58-17b-621, automated pharmacy systems can be utilized in licensed pharmacies, remote locations under the jurisdiction of the Division and licensed health care facilities where legally permissible and shall comply with the following provisions:
(1) Documentation as to type of equipment, serial numbers, content, policies and procedures and location shall be maintained on site in the pharmacy for review upon request of the Division. Such documentation shall include, but is not limited to:
(a) name and address of the pharmacy or licensed health care facility where the automated pharmacy system is being used;
(b) manufacturer's name and model;
(c) description of how the device is used;
(d) quality assurance procedures to determine continued appropriate use of the automated device; and
(e) policies and procedures for system operation, safety, security, accuracy, patient confidentiality, access and malfunction.
(2) Automated pharmacy systems should be used only in settings where there is an established program of pharmaceutical care that ensures that before dispensing, or removal from an automated storage and distribution device, a pharmacist reviews all prescription or medication orders unless a licensed independent practitioner controls the ordering, preparation and administration of the medication; or in urgent situations when the resulting delay would harm the patient including situations in which the patient experiences a sudden change in clinical status.
(3) All policies and procedures must be maintained in the pharmacy responsible for the system and, if the system is not located within the facility where the pharmacy is located, at the location where the system is being used.
(4) Automated pharmacy systems shall have:
(a) adequate security systems and procedures to:
(i) prevent unauthorized access;
(ii) comply with federal and state regulations; and
(iii) prevent the illegal use or disclosure of protected health information.
(5) Records and electronic data kept by automated pharmacy systems shall meet the following requirements:
(a) all events involving the contents of the automated pharmacy system must be recorded electronically;
(b) records must be maintained by the pharmacy for a period of five years and must be readily available to the Division. Such records shall include:
(i) identity of system accessed;
(ii) identify of the individual accessing the system;
(iii) type of transaction;
(iv) name, strength, dosage form and quantity of the drug accessed;
(v) name of the patient for whom the drug was ordered; and
(vi) such additional information as the pharmacist-in-charge may deem necessary.
(6) Access to and limits on access to the automated pharmacy system must be defined by policy and procedures and must comply with state and federal regulations.
(7) The pharmacist-in-charge or pharmacist designee shall have the sole responsibility to:
(a) assign, discontinue or change access to the system;
(b) ensure that access to the medications comply with state and federal regulations; and
(c) ensure that the automated pharmacy system is filled and stocked accurately and in accordance with established written policies and procedures.
(8) The filling and stocking of all medications in the automated pharmacy system shall be accomplished by qualified licensed healthcare personnel under the supervision of a licensed pharmacist.
(9) A record of medications filled and stocked into an automated pharmacy system shall be maintained for a period of five years and shall include the identification of the persons filling, stocking and checking for accuracy.
(10) All containers of medications stored in the automated pharmacy system shall be packaged and labeled in accordance with federal and state laws and regulations.
(11) All aspects of handling controlled substances shall meet the requirements of all state and federal laws and regulations.
(12) The automated pharmacy system shall provide a mechanism for securing and accounting for medications removed from and subsequently returned to the automated pharmacy system, all in accordance with existing state and federal law. Written policies and procedures shall address situations in which medications removed from the system remain unused and must be secured and accounted for.
(13) The automated pharmacy system shall provide a mechanism for securing and accounting for wasted medications or discarded medications in accordance with existing state and federal law. Written policies and procedures shall address situations in which medications removed from the system are wasted or discarded and must be secured.
R156-17b-620. Operating Standards - Pharmacist Administration - Training.
(1) In accordance with Subsection 58-17b-502(9), appropriate training for the administration of a prescription drug includes:
(a) current Basic Life Support (BLS) certification; and
(b) successful completion of a training program which includes at a minimum:
(i) didactic and practical training for administering injectable drugs;
(ii) the current Advisory Committee on Immunization Practices (ACIP) of the United States Center for Disease Control and Prevention guidelines for the administration of immunizations; and
(iii) the management of an anaphylactic reaction.
(2) Sources for the appropriate training include:
(a) ACPE approved programs; and
(b) curriculum-based programs from an ACPE accredited college of pharmacy, state or local health department programs and other board recognized providers.
KEY: pharmacists, licensing, pharmacies
2005
Document Information
- Effective Date:
- 1/4/2005
- Publication Date:
- 12/01/2004
- Filed Date:
- 11/04/2004
- Agencies:
- Commerce,Occupational and Professional Licensing
- Rulemaking Authority:
Sections 58-17b-101 and 58-37-1; and Subsections 58-17b-601(1), 58-1-106(1)(a) and 58-1-202(1)(a)
- Authorized By:
- J. Craig Jackson, Director
- DAR File No.:
- 27529
- Related Chapter/Rule NO.: (1)
- R156-17b. Pharmacy Practice Act Rules.