Utah Admin. Code 156-17b-102

Current through Bulletin 2024-12, June 15, 2024

Section R156-17b-102 - Definitions

The following definitions supplement the statutory definitions in Title 58, Chapter 1, Division of Professional Licensing Act, and Title 58, Chapter 17b, Pharmacy Practice Act:

(1) "Accredited by" means that, on the day the applicant for licensure completed the program, the program was:

(a) accredited; or

(b) in candidate status.

(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 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) "Area of need" as used in Subsection 58-17b-612(1)(b)(i) means:

(a) a remote-rural hospital, as defined in Section 26-21-13.6;

(b) a county of the fourth, fifth, or sixth class, as classified in Section 17-50-501; or

(c) any area where a demonstration of need is approved by the Division in collaboration with the Board, based on any factors affecting the access of persons in that area to pharmacy resources.

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

(6) "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, as defined in Section 1504 of the Internal Revenue Code, if the pharmaceutical wholesaler:

(a) has a written agreement currently in effect with the manufacturer evidencing the ongoing relationship; and

(b) is listed on the manufacturer's current list of authorized distributors of record.

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

(8) "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 with the same common ownership and control.

(9) "Clinic" as used in Subsection 58-17b-625(3)(b) means a Class B pharmacy as defined in Subsection 58-17b-102(11), or a facility that provides outpatient health care services whose primary practice includes the therapeutic use of drugs related to a specific patient for:

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

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

(c) arresting or slowing a disease process.

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

(11) "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 21 CFR 203 (2021).

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

(13) "Compounding," as defined in Subsection 58-17b-102(18), in accordance with 21 U.S.C. 353a(e) Pharmacy Compounding, does not include:

(a) mixing, reconstituting, or other such acts that are performed in accordance with directions in approved labeling provided by the product's manufacturer and other manufacturer directions consistent with that labeling; or

(b) the addition of flavoring agents to conventionally manufactured and commercially prepared available liquid medications, if the flavoring agents:

(i) are therapeutically inert; and

(ii) do not exceed 5% of a preparation's total volume.

(14) "Consulting pharmacist" means a licensed pharmacist who provides consultation on an aspect of a pharmaceutical administration facility under Section R156-17b-614c.

(15) "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.

(16) "Counterfeit prescription drug" has the meaning given that term in 21 USC 321(g)(2).

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

(18) "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.

(19) "Designated representative" or "DR" means an individual supervising the licensed facility in accordance with Subsections R156-17b-615(4) and (5).

(20) "Device" means a prescription device as defined in 21 CFR 801.109 (2021).

(21) "DMP" means a dispensing medical practitioner licensed under Title 58, Chapter 17b, Part 8, Dispensing Medical Practitioner and Dispensing Medical Practitioner Clinic Pharmacy.

(22) "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(12);

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

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

(23) "DMPIC" means a dispensing-medical-practitioner-in-charge licensed under Title 58, Chapter 17b, Part 8, Dispensing Medical Practitioner and Dispensing Medical Practitioner Clinic Pharmacy who is designated by a dispensing medical practitioner clinic pharmacy to be responsible for activities of the pharmacy.

(24) "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.

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

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

(27) "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.

(28) "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.

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

(30) "ExCPT" means the Exam for the Certification of Pharmacy Technicians.

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

(32) "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.

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

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

(35) "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.

(36) "Legend drug" or "prescription drug" means a drug or device that has been determined to be unsafe for self-medication or one 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".

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

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

(39)

(a) "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.

(b) A manufacturer's exclusive distributor shall be licensed as a pharmaceutical wholesaler and be an "authorized distributor of record" to be considered part of the normal distribution channel.

(40) "Medical supplies" means items for medical use that are:

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

(b) disposable or semi-disposable and non-reusable.

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

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

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

(44) "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.

(45) "Normal distribution channel" means a chain of custody for a prescription drug that goes directly, by drop shipment as defined in Subsection (24), 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 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 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 to dispense or administer such drug for use by a patient.

(46) "Other health care facilities" means an entity as defined in Subsection R432-1-3(55).

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

(48) "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 (45)(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 another medical facility that provides health care services.

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

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

(51) "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.

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

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

(54) "PTCB" means the Pharmacy Technician Certification Board.

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

(56) "Refill" means to fill again.

(57) "Remote dispensing pharmacist-in-charge" or "RDPIC" means the PIC of a remote dispensing pharmacy. The RDPIC shall be the PIC of the remote dispensing pharmacy's supervising pharmacy.

(58) "Remote dispensing pharmacy" means a Class A or Class B pharmacy located in Utah that serves as the originating site where a patient receiving services through a telepharmacy system is physically located and the practice of telepharmacy occurs, pursuant to Section R156-17b-614g.

(59) "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.

(60) "Research facility" means a facility where research takes place that has policies and procedures describing such research.

(61) "Responsible party" means the identity of the supervisor or director or the Class E pharmacy under Section R156-17b-617a.

(62) "Reverse distributor" means a person or company that retrieves unusable or outdated drugs from a pharmacy by removing those drugs from stock and destroying them.

(63) "Self-administered hormonal contraceptive" means the same as defined in Subsection 26-64-102(9).

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

(65) "Supervising pharmacy" means the Class A or Class B pharmacy responsible for overseeing the operation of a remote dispensing pharmacy, and whose PIC is the RDPIC for the remote dispensing pharmacy, pursuant to Section R156-17b-614g.

(66) "Supervisor" means a licensed pharmacist or DMP in good standing with the Division.

(67) "Telepharmacy system" means a telecommunications and information technologies system that monitors the preparation and dispensing of prescription drugs and provides for related drug review and HIPAA-compliant patient counseling services using:

(a) asynchronous store and forward transfer as defined in Subsection 26-60-102(1);

(b) synchronous interaction as defined in Subsection 26-60-102(7); or

(c) still image capture.

(68) "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.

(69) "Unauthorized personnel" means a person not participating in the operational processes of the pharmacy who in some way would interrupt the natural flow of pharmaceutical care.

(70) "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.

(71) "Unprofessional conduct," as defined in Title 58, Chapter 1, Division of Professional Licensing Act, and Title 58, Chapter 17b, Pharmacy Practice Act, is further defined, in accordance with Subsection 58-1-203(1)(e), in Section R156-17b-502.

(72) The "Utah Hormonal Contraceptive Self-screening Risk Assessment Questionnaire," adopted September 18, 2018, by the Division in collaboration with the Utah State Board of Pharmacy and Physicians Licensing Board, which is incorporated by reference, is the self-screening risk assessment questionnaire approved by the Division pursuant to Section 26-64-106.

(73) "USP-NF" means the United States Pharmacopeia-National Formulary (USP 41-NF 36), either First Supplement, dated August 1, 2018, or Second Supplement, dated December 1, 2018, which is incorporated by reference.

(74) "Vaccine Administration Protocol" means the Vaccine Administration Protocol: Standing Order to Administer Immunizations and Emergency Medications, adopted September 24, 2020, by the Division in collaboration with the Board and Utah Physicians Licensing Board, which is incorporated by reference.

(75) "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.

(76) "Wholesale distribution" means the same as 21 CFR 203.3(cc) (2021).

Utah Admin. Code R156-17b-102

Amended by Utah State Bulletin Number 2015-6, effective 2/24/2015

Amended by Utah State Bulletin Number 2015-24, effective 12/1/2015

Amended by Utah State Bulletin Number 2016-10, effective 4/21/2016

Amended by Utah State Bulletin Number 2017-2, effective 12/22/2016

Amended by Utah State Bulletin Number 2018-1, effective 12/12/2017

Amended by Utah State Bulletin Number 2019-2, effective 12/27/2018

Amended by Utah State Bulletin Number 2019-24, effective 11/25/2019

Amended by Utah State Bulletin Number 2020-22, effective 11/10/2020

Amended by Utah State Bulletin Number 2022-03, effective 1/27/2022

Amended by Utah State Bulletin Number 2023-02, effective 1/5/2023