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.

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

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

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

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

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

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

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

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

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

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

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

  (A) Chapter 67, Utah Medical Practice Act;

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

  (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.

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

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

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

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

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

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

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

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

  (a) can withstand repeated use;

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

  (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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

  (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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

  (44) "Patient's agent" means a:

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

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

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

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

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

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

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

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

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

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

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

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

  (52) "Refill" means to fill again.

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

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

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

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

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

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

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

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

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

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

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

  (64) "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 hereby adopted and incorporated by reference.

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

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

  (a) intracompany sales or transfers;

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

  (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.