S.B. 88 Enrolled

1

PHARMACY PRACTICE ACT AMENDMENTS
2 2010 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor: Curtis S. Bramble
5 House Sponsor: Rebecca D. Lockhart
6
7 LONG TITLE
8 General Description:
9 This bill amends the Pharmacy Practice Act.
10 Highlighted Provisions:
11 This bill:
12 . amends provisions related to exemptions from licensure;
13 . defines terms;
14 . exempts prescribing physicians from licensure under the Pharmacy Practice Act
15 when a physician dispenses a cosmetic drug or injectable weight loss drug to the
16 physician's patient; and
17 . requires certain drug labeling and record keeping standards for the dispensing
18 physician.
19 Monies Appropriated in this Bill:
20 None
21 Other Special Clauses:
22 None
23 Utah Code Sections Affected:
24 AMENDS:
25 58-17b-309, as last amended by Laws of Utah 2005, Chapter 71
26
27 Be it enacted by the Legislature of the state of Utah:
28 Section 1. Section 58-17b-309 is amended to read:
29 58-17b-309. Exemptions from licensure.

30 (1) For purposes of this section:
31 (a) "Cosmetic drug":
32 (i) means a prescription drug that is:
33 (A) for the purpose of promoting attractiveness or altering the appearance of an
34 individual; and
35 (B) listed as a cosmetic drug subject to the exemption under this section by the
36 division by administrative rule; and
37 (ii) does not include a prescription drug that is:
38 (A) a controlled substance;
39 (B) compounded by the physician; or
40 (C) prescribed or used for the patient for the purpose of diagnosing, curing, mitigating,
41 treating, or preventing a disease.
42 (b) "Injectable weight loss drug":
43 (i) means an injectable prescription drug:
44 (A) prescribed to promote weight loss; and
45 (B) listed as an injectable prescription drug subject to exemption under this section by
46 the division by administrative rule; and
47 (ii) does not include a prescription drug that is a controlled substance.
48 (c) "Physician" means an individual licensed under either Chapter 67, Utah Medical
49 Practice Act, or Chapter 68, Utah Osteopathic Medical Practice Act.
50 [(1)] (2) In addition to the exemptions from licensure in Section 58-1-307 , the
51 following individuals may engage in the acts or practices described in this Subsection [(1)] (2)
52 without being licensed under this chapter:
53 (a) a person selling or providing contact lenses in accordance with Section
54 58-16a-801 ; [and]
55 (b) an individual engaging in the practice of pharmacy technician under the direct
56 personal supervision of a pharmacist while making satisfactory progress in an approved
57 program as defined in division rule[.]; and

58 (c) a physician who prescribes and dispenses a cosmetic drug or an injectable weight
59 loss drug to the physician's patient in accordance with Subsection (4).
60 [(2)] (3) In accordance with Subsection 58-1-303 (1)(a), an individual exempt under
61 Subsection [(1)] (2)(b) must take all examinations as required by division rule following
62 completion of an approved curriculum of education, within the required time frame. This
63 exemption expires immediately upon notification of a failing score of an examination, and the
64 individual may not continue working as a pharmacy technician even under direct supervision.
65 (4) A physician is exempt from licensing under the provisions of Subsection (2)(c) if
66 the physician:
67 (a) (i) writes a prescription for a cosmetic drug or injectable weight loss drug; and
68 (ii) informs the patient:
69 (A) that the prescription may be filled at a pharmacy or dispensed in the physician's
70 office;
71 (B) of the directions for appropriate use of the drug;
72 (C) of potential side-effects to the use of the drug; and
73 (D) how to contact the physician if the patient has questions or concerns regarding the
74 drug;
75 (b) dispenses a cosmetic drug or injectable weight loss drug only to the physician's
76 patients; and
77 (c) follows labeling, record keeping, patient counseling, and storage requirements
78 established by administrative rule adopted by the division in consultation with the boards
79 listed in Subsection (5)(a).
80 (5) (a) The division, in consultation with the board under this chapter, the Physician
81 Licensing Board, and the Osteopathic Physician Licensing Board, shall adopt administrative
82 rules pursuant to Title 63G, Chapter 3, Utah Administrative Rulemaking Act to designate:
83 (i) the prescription drugs that may be dispensed as a cosmetic drug or weight loss drug
84 under this section; and
85 (ii) the requirements under Subsection (4)(c).

86 (b) When making a determination under Subsection (1)(a), the division and boards
87 listed in Subsection (5)(a), may consider any federal Food and Drug Administration
88 indications or approval associated with a drug when adopting a rule to designate a prescription
89 drug that may be dispensed under this section.
90 (c) The division may inspect the office of a physician who is dispensing under the
91 provisions of this section, in order to determine whether the physician is in compliance with
92 the provisions of this section. If a physician chooses to dispense under the provisions of this
93 section, the physician consents to the jurisdiction of the division to inspect the physician's
94 office and determine if the provisions of this section are being met by the physician.
95 (d) If a physician violates a provision of this section the physician may be subject to
96 discipline under:
97 (i) this chapter; and
98 (ii) (A) Chapter 67, Utah Medical Practice Act; or
99 (B) Chapter 68, Utah Osteopathic Medical Practice Act.
100 (6) This section does not restrict or limit the scope of practice of an optometrist or
101 optometric physician licensed under Chapter 16a, Utah Optometry Practice Act.