DAR File No. 42225

Commerce, Occupational and Professional Licensing

Rule R156-17b

Pharmacy Practice Act Rule

Notice of Proposed Rule

(Amendment)

DAR File No.: 42225
Filed: 10/16/2017 12:35:17 PM

RULE ANALYSIS

Purpose of the rule or reason for the change:

Multiple bills passed by the Legislature during the 2017 General Session amended the Pharmacy Practice Act, and required the Division of Occupational and Professional Licensing (Division) to make rules to implement the changes in consultation with the Utah State Board of Pharmacy. The Division is filing these proposed new rules to accomplish this mandate. S.B. 246 (2017) created a requirement that certain Utah-licensed nonresident pharmacies have to submit an inspection as a prerequisite for licensure and renewal, created an exclusion from certain labeling requirements under certain conditions, and permits certain pharmacists to administer some long-acting injectable drugs intramuscularly under certain conditions. H.B. 61 (2017) requires the Division to draft rules in relationship to the new law that allows a hospital pharmacy to dispense a limited supply of a prescription drug to a discharged patient, under certain circumstances, when the patient's regular retail pharmacy is not available. H.B. 146 (2017) requires that the partial filling of a Schedule II controlled substance prescription for certain patients must be made in accordance with federal law and rules made by the Division. Two additional amendments are also included in the proposed rule filing: 1) updating the reference in Subsection R156-17b-102(61) to the most current version of United States Pharmacopeia-National Formulary; and 2) modifying Section R156-17b-303b to allow the Division, in collaboration with the Pharmacy Board, the discretion to credit up to 500 hours of substantially related experience towards pharmacy internship standards.

Summary of the rule or change:

Subsection R156-17b-102(8) is added to define "clinic" as used in Subsection 58-17b-625(3)(b). Subsection R156-17b-102(11) is added to define "community pharmacy" as used in Subsection 58-17b-625(3)(b). Subsection R156-17b-102(33) is added to define "long-term care facility" as used in Section 58-17b-610.7. Subsection R156-17b-102 (61) is modified to update the reference to the United States Pharmacopeia-National Formulary. Section R156-17b-303 is modified to allow the Division, in collaboration with the Pharmacy Board, the discretion to credit up to 500 hours of substantially related experience towards pharmacy internship standards required for licensure as a pharmacist. Section R156-17b-610.6 is added to establish the guidelines for a hospital pharmacy to dispense to an individual, who is no longer a patient, on the day that the individual is discharged from the hospital setting. Section R156-17b-610.7 is added to establish that a pharmacy that partially fills a schedule II controlled substance shall specify by prescription number for each partial fill the date, quantity supplied, and quantity remaining of the prescription partially filled. In Section R156-17b-620, the proposed amendments to this section clarify a PIC (pharmacist-in-charge) or pharmacist designee's responsibilities regarding user access to an automated pharmacy system and its medications. Section R156-17b-621a is added to establish the training requirements for a pharmacist's administration of long-acting injectables intramuscularly.

Statutory or constitutional authorization for this rule:

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

This rule or change incorporates by reference the following material:

• Updates United States Pharmacopeia-National Formulary (USP 40-NF 35) and First Supplement, dated August 1, 2017 and Second Supplement, dated December 1, 2017, published by United States Pharmacoepeia, 2017

Anticipated cost or savings to:

the state budget:

The Division will incur a minimal cost of approximately $75 to reprint the rule once the filing is made effective. The Division also incurs a yearly cost of $908 to maintain the subscription to the updated United States Pharmacopeia-National Formulary which are incorporated by reference in the rule. Because the primary focus of these proposed rule changes, as they affect the Division, is to implement S.B. 246 (2017), H.B. 61 (2017) and H.B. 146 (2017), the additional costs or savings to the Division were included in the Legislature's consideration of these bills. A copy of these fiscal analyses are available from the Utah State Legislature's website at https://le.utah.gov/~2017/bills/static/SB0246.html, https://le.utah.gov/~2017/bills/static/HB0061.html, and https://le.utah.gov/~2017/bills/static/HB0146.html.

local governments:

There are no anticipated costs or savings to local governments created by the proposed rule changes, because the proposed amendments apply only to licensees under Title 58, Chapter 17b, and to owners, managers, and users of pharmacies and hospitals. Local governments will also not be indirectly impacted because none of the amendments create a situation requiring services from any local government. As a result, the Division estimates that there will be no fiscal impact on local governments.

small businesses:

There are no anticipated costs or savings created by the proposed rule changes related to small businesses beyond those created by the underlying legislation. The primary focus of the proposed rule changes is to implement S.B. 246 (2017), H.B. 61 (2017), and H.B. 146 (2017), and the costs or savings to small business were included in the Legislature?s consideration of the bills. A copy of these analyses are available from the Utah State Legislature's website at https://le.utah.gov/~2017/bills/static/SB0246.html, https://le.utah.gov/~2017/bills/static/HB0061.html, and https://le.utah.gov/~2017/bills/static/HB0146.html

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

Some savings to individual applicants for licensure as a pharmacist may result from the proposed amendments to Section R156-17b-303b, which allow the Division, in collaboration with the Pharmacy Board, to credit up to 500 hours of substantially related experience towards an individual's pharmacy internship standards. It is estimated that this simplification of the licensure application process could shorten the time period for some individuals to obtain a license and begin practicing. However, the exact amount of time savings and resultant cost savings is impossible to measure because it will vary significantly from individual to individual depending on circumstances. No additional costs or savings are anticipated to other persons from the remaining proposed rule changes, which are only updates or clarification of existing practice, or which implement S.B. 246 (2017), H.B. 61 (2017), and H.B. 146 (2017). Any additional costs or savings to other persons result from the underlying legislation, and were included in the Legislature?s consideration of the bills. A copy of these analyses are available from the Utah State Legislature's website at https://le.utah.gov/~2017/bills/static/SB0246.html, https://le.utah.gov/~2017/bills/static/HB0061.html,and https://le.utah.gov/~2017/bills/static/HB0146.html.

Compliance costs for affected persons:

There are no anticipated costs created by the proposed rule changes for affected persons, beyond those created by the underlying legislation, which were included in the Legislature's consideration of the bills. Copies of the analyses for S.B. 246 (2017), H.B. 61 (2017) and H.B. 146 (2017) are available from the Utah State Legislature website at https://le.utah.gov/~2017/bills/static/SB0246.html, https://le.utah.gov/~2017/bills/static/HB0061.html,and https://le.utah.gov/~2017/bills/static/HB0146.html.

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

Three bills passed by the Legislature during the 2017 General Session amended the Pharmacy Practice Act and require amendment of the Pharmacy Practice Act Rule. S.B. 246 (2017) permits certain pharmacies to administer some long-acting injectable drugs intramuscularly under certain conditions and requires training to those administering the injectable drugs. H.B. 61 (2017) requires the Division to draft rules to allow a hospital pharmacy to dispense a limited supply of a prescription drug to a discharged patient under circumstances when the patient's regular retail pharmacy is not available, and H.B. 146 (2017) requires that the partial filling of a Schedule II controlled substance prescription for certain patients must be made in accordance with federal law and rules made by the Division. In addition, Subsection R156-17b-102(61) is amended to update the reference in the rule to the current version of the United States Pharmacopeia-National Formulary and Section R156-17b-303 is amended to allow the Division, in collaboration with the Pharmacy Board, the discretion to credit up to 500 hours of substantially related experience towards pharmacy internship standards. Beyond the fiscal analysis included in the Legislature's consideration of the three referenced bills, there is no additional fiscal impact to businesses. Further, there is no fiscal impact with regard to the two described rule changes that were not mandated by the legislative action.

Francine A. Giani, Executive Director

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

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

Direct questions regarding this rule to:

• Larry Marx at the above address, by phone at 801-530-6254, by FAX at 801-530-6511, or by Internet E-mail at [email protected]
• Jennifer Zaelit at the above address, by phone at 801-530-7632, by FAX at , or by Internet E-mail at [email protected]

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

12/01/2017

This rule may become effective on:

12/08/2017

Authorized by:

Mark Steinagel, Director

R156. Commerce, Occupational and Professional Licensing.

R156-17b. Pharmacy Practice Act Rule.

R156-17b-102. Definitions.

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

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

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

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

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

(3) "Analytical laboratory":

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

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

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

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

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

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

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

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

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

(c) arresting or slowing a disease process.

([8]9) "Co-licensed partner" means a person that has the right to engage in the manufacturing or marketing of a co-licensed product.

([9]10) "Co-licensed product" means a device or prescription drug for which two or more persons have the right to engage in the manufacturing, marketing, or both consistent with FDA's implementation of the Prescription Drug Marketing Act as applicable.

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

([10]12) "Cooperative pharmacy warehouse" means a physical location for drugs that acts as a central warehouse and is owned, operated or affiliated with a group purchasing organization (GPO) or pharmacy buying cooperative and distributes those drugs exclusively to its members.

([11]13) "Counterfeit prescription drug" has the meaning given that term in 21 USC 321(g)(2), including any amendments thereto.

([12]14) "Counterfeiting" means engaging in activities that create a counterfeit prescription drug.

([13]15) "Dispense", as defined in Subsection 58-17b-102(22), does not include transferring medications for a patient from a legally dispensed prescription for that particular patient into a daily or weekly drug container to facilitate the patient taking the correct medication.

([14]16) "Device" means an instrument, apparatus, implement, machine, contrivance, implant, or other similar or related article, including any component part or accessory, which is required under Federal law to bear the label, "Caution: Federal or State law requires dispensing by or on the order of a physician."

([15]17) "DMP" means a dispensing medical practitioner licensed under Section 58-17b, Part 8.

([16]18) "DMP designee" means an individual, acting under the direction of a DMP, who:

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

(A) Chapter 67, Utah Medical Practice Act;

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

(C) Chapter 70a, Physician Assistant Act;

(D) Chapter 31b, Nurse Practice Act;

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

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

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

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

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

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

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

([18]20) "Drop shipment" means the sale of a prescription drug to a pharmaceutical wholesaler by the manufacturer of the drug; by the manufacturer's co-licensed product partner, third party logistics provider, or exclusive distributor; or by an authorized distributor of record that purchased the product directly from the manufacturer or from one of these entities; whereby:

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

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

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

([19]21) "Drug therapy management" means the review of a drug therapy regimen of a patient by one or more pharmacists for the purpose of evaluating and rendering advice to one or more practitioners regarding adjustment of the regimen.

([20]22) "Drugs", as used in this rule, means drugs or devices.

([21]23) "Durable medical equipment" or "DME" means equipment that:

(a) can withstand repeated use;

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

(c) generally is not useful to a person in the absence of an illness or injury;

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

(e) may include devices and medical supplies.

([22]24) "Entities under common administrative control" means an entity holds the power, actual as well as legal to influence the management, direction, or functioning of a business or organization.

([23]25) "Entities under common ownership" means entity assets are held indivisibly rather than in the names of individual members.

([24]26) "ExCPT", as used in this rule, means the Exam for the Certification of Pharmacy Technicians.

([25]27) "FDA" means the United States Food and Drug Administration and any successor agency.

([26]28) "FDA-approved" means the federal Food, Drug, and Cosmetic Act, 21 U.S.C.A. Section 301 et seq. and regulations promulgated thereunder permit the subject drug or device to be lawfully manufactured, marketed, distributed, and sold.

([27]29) "High-risk, medium-risk, and low-risk drugs" refers to the risk to a patient's health from compounding sterile preparations, as referred to in USP-NF Chapter 797, for details of determining risk level.

([28]30) "Hospice facility pharmacy" means a pharmacy that supplies drugs to patients in a licensed healthcare facility for terminal patients.

([29]31) "Hospital clinic pharmacy" means a pharmacy that is located in an outpatient treatment area where a pharmacist or pharmacy intern is compounding, admixing, or dispensing prescription drugs, and where:

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

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

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

([30]32) "Legend drug" or "prescription drug" means any drug or device that has been determined to be unsafe for self-medication or any drug or device that bears or is required to bear the legend:

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

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

(c) "Rx only".

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

([31]34) "Maintenance medications" means medications the patient takes on an ongoing basis.

([32]35) "Manufacturer's exclusive distributor" means an entity that contracts with a manufacturer to provide or coordinate warehousing, distribution, or other services on behalf of a manufacturer and who takes title to that manufacturer's prescription drug, but who does not have general responsibility to direct the drug's sale or disposition. Such manufacturer's exclusive distributor shall be licensed as a pharmaceutical wholesaler under this chapter and be an "authorized distributor of record" to be considered part of the "normal distribution channel".

([33]36) "Medical supplies" means items for medical use that are suitable for use in a health care facility or in the home and that are disposable or semi-disposable and are non-reusable.

([34]37) "MPJE" means the Multistate Jurisprudence Examination.

([35]38) "NABP" means the National Association of Boards of Pharmacy.

([36]39) "NAPLEX" means North American Pharmacy Licensing Examination.

([37]40) "Non drug or device handling central prescription processing pharmacy" means a central prescription processing pharmacy that does not engage in compounding, packaging, labeling, dispensing, or administering of drugs or devices.

([38]41) "Normal distribution channel" means a chain of custody for a prescription drug that goes directly, by drop shipment as defined in Subsection (19), or via intracompany transfer from a manufacturer; or from the manufacturer's co-licensed partner, third-party logistics provider, or the exclusive distributor to:

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

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

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

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

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

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

([39]42) "Other health care facilities" means any entity as defined in Utah Code Subsection 26-21-2(13)(a) or Utah Administrative Code R432-1-3(55).

([40]43) "Parenteral" means a method of drug delivery injected into body tissues but not via the gastrointestinal tract.

([41]44) "Patient's agent" means a:

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

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

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

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

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

([42]45) "Pedigree" means a document or electronic file containing information that records each distribution of any given prescription drug.

([43]46) "PIC", as used in this rule, means the pharmacist-in-charge.

([44]47) "Prepackaged" or "Prepackaging" means the act of transferring a drug, manually or by use of an automated pharmacy system, from a manufacturer's or distributor's original container to another container in advance of receiving a prescription drug order or for a patient's immediate need for dispensing by a pharmacy or practitioner authorized to dispense in the establishment where the prepackaging occurred.

([45]48) "Prescription files" means all hard-copy and electronic prescriptions that includes pharmacist notes or technician notes, clarifications or information written or attached that is pertinent to the prescription.

([46]49) "PTCB" means the Pharmacy Technician Certification Board.

([47]50) "Qualified continuing education", as used in this rule, means continuing education that meets the standards set forth in Section R156-17b-309.

([48]51) "Refill" means to fill again.

([49]52) "Repackage" means repackaging or otherwise changing the container, wrapper, or labeling to further the distribution of a prescription drug, excluding that completed by the pharmacist or DMP responsible for dispensing the product to a patient.

([50]53) "Research facility" means a facility where research takes place that has policies and procedures describing such research.

([51]54) "Reverse distributor" means a person or company that retrieves unusable or outdated drugs from a pharmacy for the purpose of removing those drugs from stock and destroying them.

([52]55) "Sterile products preparation facility" means any facility, or portion of the facility, that compounds sterile products using aseptic technique.

([53]56) "Supervisor" means a licensed pharmacist or DMP in good standing with the Division.

([54]57) "Third party logistics provider" means anyone who contracts with a prescription drug manufacturer to provide or coordinate warehousing, distribution, or other similar services on behalf of a manufacturer, but does not take title to the prescription drug or have any authoritative control over the prescription drug's sale.

([55]58) "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.

([56]59) "Unit dose" means the ordered amount of a drug in a dosage form prepared for a one-time administration to an individual and indicates the name, strength, lot number and beyond use date for the drug.

([57]60) "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.

([58]61) "USP-NF" means the United States Pharmacopeia-National Formulary (USP [39]40-NF [34]35), [2016 edition, which is official from May 1, 2016 through Supplement 2, dated December 1, 2016]either First Supplement, dated August 1, 2017, or Second Supplement, dated December 1, 2017, which is hereby adopted and incorporated by reference.

([59]62) "Wholesaler" means a wholesale distributor who supplies or distributes drugs or medical devices that are restricted by federal law to sales based on the order of a physician to a person other than the consumer or patient.

([60]63) "Wholesale distribution" means the distribution of drugs to persons other than consumers or patients, but does not include:

(a) intracompany sales or transfers;

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

(c) the sale, purchase, or trade of a drug pursuant to a prescription;

(d) the distribution of drug samples;

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

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

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

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

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

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

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

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

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

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

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

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

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

([v]e) Required experiences shall:

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

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

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

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

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

(i[x]) No credit will be awarded for didactic experience.

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

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

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

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

 

R156-17b-610.6. Hospital Pharmacy Dispensing Prescription Drugs to Patients at Discharge to Meet a Patient's Immediate Needs.

In accordance with Section 58-17b-610.6, the guidelines for a hospital pharmacy to dispense to an individual who is no longer a patient, on the day discharged from the hospital setting, are established in this section.

(1) The prescription drug shall be dispensed:

(a) during regular inpatient hospital pharmacy hours, by a pharmacist; or

(b) outside of regular inpatient hospital pharmacy hours, by the prescribing practitioner using an appropriately labeled pre-packaged drug.

(2) Labeling for a prescription under Section 58-17b-610.6 shall at a minimum include:

(a) prescribing practitioner's name, facility name, and telephone number;

(b) patient's name;

(c) name and strength of medication;

(d) date given;

(e) instructions for use; and

(f) beyond use date.

(3) Applicable data of controlled substances dispensed shall be reported to the Utah Controlled Substance Database.

 

R156-17b-610.7. Partial Filling of a Schedule II Controlled Substance Prescription.

In accordance with Section 58-17b-610.7, a pharmacy that partially fills a prescription for a Schedule II controlled substance shall specify by prescription number for each partial fill the:

(a) date;

(b) quantity supplied; and

(c) quantity remaining of the prescription partially filled.

 

R156-17b-620. 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:

(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;

(b) written policies and procedures in place prior to installation to ensure safety, accuracy, security, training of personnel, and patient confidentiality and to define access and limits to access to equipment and medications.

(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 PIC 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 PIC or pharmacist designee shall have the [sole ]responsibility to ensure that:

(a) user access to the system is assign ed, discontinue d or change d according to employment status and credentials[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-621a. Operating Standards - Pharmacist Administration of a Long-acting Injectable Drug Therapy - Training.

In accordance with Subsections 58-17b-502(9) and 58-17b-625(2):

(1) Training for a pharmacist to administer long-acting injectables intramuscularly shall include successful completion of:

(a) current Basic Life Support (BLS) certification; and

(b) a training program for administering long-acting injectables intramuscularly that is provided by an ACPE accredited provider.

(2) An individual who engages in the administration of long-acting injectables intramuscularly shall:

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

(b) for each renewal cycle after the initial training, successfully complete a minimum of two hours of continuing education related to long-acting injectables.

 

KEY: pharmacists, licensing, pharmacies

Date of Enactment or Last Substantive Amendment: [December 22, 2016]2017

Notice of Continuation: January 5, 2015

Authorizing, and Implemented or Interpreted Law: 58-17b-101; 58-17b-601(1); 58-37-1; 58-1-106(1)(a); 58-1-202(1)(a)