Compounding: means the preparation, mixing, assembling, packaging, or labeling of a limited quantity drug, sterile product, or device:
(i)
as the result of a practitioner's prescription order or initiative based on the practitioner, patient, or pharmacist relationship in the course of professional practice;
(ii)
for the purpose of, or as an incident to, research, teaching, or chemical analysis and not for sale or dispensing; or
(iii)
in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns. See Utah Code 58-17b-102
Drug: means :
(i)
a substance recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them, intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals;
(ii)
a substance that is required by any applicable federal or state law or rule to be dispensed by prescription only or is restricted to administration by practitioners only;
(iii)
a substance other than food intended to affect the structure or any function of the body of humans or other animals; and
(iv)
substances intended for use as a component of any substance specified in Subsections (26)(a)(i), (ii), (iii), and (iv). See Utah Code 58-17b-102
Jurisdiction: (1) The legal authority of a court to hear and decide a case. Concurrent jurisdiction exists when two courts have simultaneous responsibility for the same case. (2) The geographic area over which the court has authority to decide cases.
Pharmacy: means any place where:
(a)
drugs are dispensed;
(b)
pharmaceutical care is provided;
(c)
drugs are processed or handled for eventual use by a patient; or
(d)
drugs are used for the purpose of analysis or research. See Utah Code 58-17b-102
Pharmacy manager: means :
(a)
a pharmacist-in-charge;
(b)
a licensed pharmacist designated by a licensed pharmacy to consult on the pharmacy's administration;
(c)
an individual who manages the facility in which a licensed pharmacy is located;
(d)
an individual who oversees the operations of a licensed pharmacy;
(e)
an immediate supervisor of an individual described in Subsections (54)(a) through (d); or
(f)
another operations or site manager of a licensed pharmacy. See Utah Code 58-17b-102
State: when applied to the different parts of the United States, includes a state, district, or territory of the United States. See Utah Code 68-3-12.5
(a)
submit a written application in the form prescribed by the division;
(b)
pay a fee as determined by the department under Section 63J-1-504;
(c)
satisfy the division that the applicant, and each owner, officer, or manager of the applicant have not engaged in any act, practice, or omission, which when considered with the duties and responsibilities of a licensee under this section indicates there is cause to believe that issuing a license to the applicant is inconsistent with the interest of the public’s health, safety, or welfare;
(d)
demonstrate the licensee’s operations will be in accordance with all federal, state, and local laws relating to the type of activity engaged in by the licensee, including regulations of the Federal Drug Enforcement Administration and Food and Drug Administration;
for each pharmacy manager, submit fingerprint cards and consent to a fingerprint background check in accordance with Section 58-17b-307; and
(g)
acknowledge the division’s authority to inspect the licensee’s business premises pursuant to Section 58-17b-103.
(2)
Each applicant applying for a class D license shall:
(a)
submit a written application in the form prescribed by the division;
(b)
pay a fee as determined by the department under Section 63J-1-504;
(c)
present to the division verification of licensure in the state where physically located and verification that such license is in good standing;
(d)
satisfy the division that the applicant and each of the applicant’s pharmacy managers has not engaged in any act, practice, or omission, which when considered with the duties and responsibilities of a licensee under this section, indicates there is cause to believe that issuing a license to the applicant is inconsistent with the interest of the public’s health, safety, or welfare;
(e)
for each pharmacy manager, submit fingerprint cards and consent to a fingerprint background check in accordance with Section 58-17b-307;
(f)
provide a statement of the scope of pharmacy services that will be provided and a detailed description of the protocol as described by rule by which pharmacy care will be provided, including any collaborative practice arrangements with other health care practitioners;
(g)
sign an affidavit attesting that any healthcare practitioners employed by the applicant and physically located in Utah have the appropriate license issued by the division and in good standing;
(h)
sign an affidavit attesting that the applicant will abide by the pharmacy laws and regulations of the jurisdiction in which the pharmacy is located; and
(i)
if an applicant engages in compounding, submit the most recent inspection report:
(i)
conducted within two years before the application for licensure; and
(ii)
(A)
conducted as part of the National Association of Boards of Pharmacy Verified Pharmacy Program; or
(B)
performed by the state licensing agency of the state in which the applicant is a resident and in accordance with the National Association of Boards of Pharmacy multistate inspection blueprint program.
(3)
Each license issued under this section shall be issued for a single, specific address, and is not transferable or assignable.
