Utah Admin. Code 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
26B-2-213;
(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 if:
(a) the
manufacturer and pharmaceutical wholesaler is part of an affiliated group, as
defined by Section 1504 of the Internal Revenue Code;
or
(b) the pharmaceutical
wholesaler has a written agreement currently in effect with the manufacturer
evidencing the ongoing relationship and is listed 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 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 to the term "counterfeit drug" in
21 USC
321(g)(2) as applied to
prescription drugs.
(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, Utah 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(14);
(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:
(a)
(i) a
manufacturer or the manufacturer's:
(A)
co-licensed product partner;
(B)
third party logistics provider; or
(C) exclusive distributor; or
(ii) an authorized distributor of
record that purchased the product directly from the manufacturer or an entity
listed in Subsection (24)(a)(i);
(b)
(i) the
pharmaceutical wholesale distributor takes title to but not physical possession
of the prescription drug;
(ii) the
pharmaceutical wholesale distributor invoices the pharmacy, pharmacy warehouse,
or other person authorized by law to dispense or administer the drug;
and
(iii) the pharmacy, pharmacy
warehouse, or other person authorized by law to dispense or administer the drug
receives delivery of the prescription drug directly from an entity listed in
Subsection (24)(a).
(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
USC 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) "Managerial control" means the ability,
regardless of title, to directly manage the finances, strategic initiatives,
and personnel of a pharmacy or pharmaceutical facility, including:
(a) taking on debt obligations;
(b) distributing profits;
(c) determining fees and costs charged for
products or services offered by the pharmacy or pharmaceutical
facility;
(d) hiring, firing, or
promoting any personnel, including the PIC; or
(e) changing the location or name of the
pharmacy or pharmaceutical facility.
(39) "Maintenance medications" means
medications the patient takes on an ongoing basis.
(40)
(a)
"Manufacturer's exclusive distributor" means an entity that:
(i) contracts with a manufacturer to provide
or coordinate warehousing, distribution, or other services on behalf of a
manufacturer; and
(ii) takes title
to that manufacturer's prescription drug, but does not have general
responsibility to direct the drug's sale or disposition.
(b) To be considered part of the normal
distribution channel, a manufacturer's exclusive distributor shall be:
(i) licensed as a pharmaceutical wholesaler;
and
(ii) an authorized distributor
of record.
(41)
"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.
(42) "MPJE" means the Multistate
Jurisprudence Examination.
(43)
"NABP" means the National Association of Boards of Pharmacy.
(44) "NAPLEX" means North American Pharmacy
Licensing Examination.
(45)
"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.
(46) "Normal distribution
channel" means a chain of custody for a prescription drug sent:
(a)
(i)
directly from the manufacturer;
(ii) by drop-shipment;
(iii) via intracompany transfer from the
manufacturer; or
(iv) from the
manufacturer's:
(A) co-licensed
partner;
(B) third party logistics
provider; or
(C) exclusive
distributor;
(b) to:
(i)
a pharmacy or other designated persons authorized to dispense or administer
prescription drugs to a patient;
(ii) a chain pharmacy warehouse that performs
intracompany sales or transfers of such drugs to a group of pharmacies under
common ownership and control;
(iii)
a cooperative pharmacy warehouse to a pharmacy that is a member of the pharmacy
buying cooperative or GPO to a patient;
(iv) 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;
(v) 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
(vi) 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.
(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)
"Pharmacy facility" means the same as "Pharmaceutical facility" defined in
Subsection
58-17b-102(46).
(51) "PIC," as used in this rule, means the
pharmacist-in-charge.
(52)
"Prepackaged" or "Prepackaging" means transferring a drug, manually or by use
of an automated pharmacy system, from a manufacturer's or distributor's
original container to another container before 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.
(53) "Prescription files"
means hard copy and electronic prescriptions that includes pharmacist or
technician notes, or information written or attached that is pertinent to the
prescription.
(54) "Professional
entry degree," as used in Subsection
58-17b-303(1)(e),
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).
(55) "PTCB" means the
Pharmacy Technician Certification Board.
(56) "Qualified continuing education," as
used in this rule, means continuing education that meets the standards set
forth in Section R156-17b-309.
(57) "Qualifying Ownership Change" means any
transaction or series of transactions that results in a change in the ownership
and managerial control of a pharmaceutical facility, but does not include
changes in ownership:
(a) caused by changes in
stockholders in publicly listed corporations whose stock is publicly
traded;
(b) that do not result in a
change in managerial control, including changes in the type of corporate entity
under which the pharmaceutical facility is held;
(c) constituting less than 50% of the total
ownership of the pharmaceutical facility; or
(d) of a parent entity holding an equitable
interest in a pharmaceutical facility as a subsidiary, if the equitable
interest constitutes less than 50% of the total ownership interest of the
pharmaceutical facility.
(58) "Refill" means to fill again.
(59) "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.
(60) "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.
(61) "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.
(62) "Research facility" means a facility
where research takes place that has policies and procedures describing such
research.
(63) "Responsible party"
means the identity of the supervisor or director or the Class E pharmacy under
Section R156-17b-617a.
(64) "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.
(65) "Self-administered hormonal
contraceptive" means the same as defined in Subsection
26B-4-501(22).
(66) "Sterile products preparation facility"
means any facility, or portion of the facility, that compounds sterile products
using aseptic technique.
(67)
"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.
(68) "Supervisor" means a licensed pharmacist
or DMP in good standing with the Division.
(69) "Telepharmacy system" means any
telecommunication or information technology system, or combination of systems,
that monitors the preparation and dispensing of prescription drugs and provides
for related drug review and HIPAA-compliant patient counseling
services.
(70) "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.
(71) "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.
(72) "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.
(73) "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 Subsection
58-1-203(1)(e)
and Section R156-17b-502.
(74) 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.
(75) "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.
(76)
"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.
(77) "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.
(78) "Wholesale distribution" means the same
as 21 CFR
203.3(cc)
(2021).
Notes
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