58-17b-309 - Exemptions from licensure.
58-17b-309. Exemptions from licensure.
(1) For purposes of this section:
(a) "Cosmetic drug":
(i) means a prescription drug that is:
(A) for the purpose of promoting attractiveness or altering the appearance of anindividual; and
(B) listed as a cosmetic drug subject to the exemption under this section by the divisionby administrative rule; and
(ii) does not include a prescription drug that is:
(A) a controlled substance;
(B) compounded by the physician; or
(C) prescribed or used for the patient for the purpose of diagnosing, curing, mitigating,treating, or preventing a disease.
(b) "Injectable weight loss drug":
(i) means an injectable prescription drug:
(A) prescribed to promote weight loss; and
(B) listed as an injectable prescription drug subject to exemption under this section bythe division by administrative rule; and
(ii) does not include a prescription drug that is a controlled substance.
(c) "Physician" means an individual licensed under either Chapter 67, Utah MedicalPractice Act, or Chapter 68, Utah Osteopathic Medical Practice Act.
(2) In addition to the exemptions from licensure in Section 58-1-307, the followingindividuals may engage in the acts or practices described in this Subsection (2) without beinglicensed under this chapter:
(a) a person selling or providing contact lenses in accordance with Section 58-16a-801;
(b) an individual engaging in the practice of pharmacy technician under the directpersonal supervision of a pharmacist while making satisfactory progress in an approved programas defined in division rule; and
(c) a physician who prescribes and dispenses a cosmetic drug or an injectable weight lossdrug to the physician's patient in accordance with Subsection (4).
(3) In accordance with Subsection 58-1-303(1)(a), an individual exempt underSubsection (2)(b) must take all examinations as required by division rule following completionof an approved curriculum of education, within the required time frame. This exemption expiresimmediately upon notification of a failing score of an examination, and the individual may notcontinue working as a pharmacy technician even under direct supervision.
(4) A physician is exempt from licensing under the provisions of Subsection (2)(c) if thephysician:
(a) (i) writes a prescription for a cosmetic drug or injectable weight loss drug; and
(ii) informs the patient:
(A) that the prescription may be filled at a pharmacy or dispensed in the physician'soffice;
(B) of the directions for appropriate use of the drug;
(C) of potential side-effects to the use of the drug; and
(D) how to contact the physician if the patient has questions or concerns regarding thedrug;
(b) dispenses a cosmetic drug or injectable weight loss drug only to the physician'spatients; and
(c) follows labeling, record keeping, patient counseling, and storage requirementsestablished by administrative rule adopted by the division in consultation with the boards listedin Subsection (5)(a).
(5) (a) The division, in consultation with the board under this chapter, the PhysicianLicensing Board, and the Osteopathic Physician Licensing Board, shall adopt administrative rulespursuant to Title 63G, Chapter 3, Utah Administrative Rulemaking Act to designate:
(i) the prescription drugs that may be dispensed as a cosmetic drug or weight loss drugunder this section; and
(ii) the requirements under Subsection (4)(c).
(b) When making a determination under Subsection (1)(a), the division and boards listedin Subsection (5)(a), may consider any federal Food and Drug Administration indications orapproval associated with a drug when adopting a rule to designate a prescription drug that may bedispensed under this section.
(c) The division may inspect the office of a physician who is dispensing under theprovisions of this section, in order to determine whether the physician is in compliance with theprovisions of this section. If a physician chooses to dispense under the provisions of this section,the physician consents to the jurisdiction of the division to inspect the physician's office anddetermine if the provisions of this section are being met by the physician.
(d) If a physician violates a provision of this section the physician may be subject todiscipline under:
(i) this chapter; and
(ii) (A) Chapter 67, Utah Medical Practice Act; or
(B) Chapter 68, Utah Osteopathic Medical Practice Act.
(6) This section does not restrict or limit the scope of practice of an optometrist oroptometric physician licensed under Chapter 16a, Utah Optometry Practice Act.
Amended by Chapter 213, 2010 General Session