H.B. 440

1

DRUG PRODUCT EQUIVALENT AMENDMENTS
2 2007 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor: Eric K. Hutchings
5 Senate Sponsor: ____________
6
7 LONG TITLE
8 General Description:
9 This bill amends Pharmacy Practice Act provisions governing the substitution of a drug
10 product equivalent for a drug specified in a prescription order.
11 Highlighted Provisions:
12 This bill:
13 . amends the Pharmacy Practice Act;
14 . expands general drug substitution provisions to apply to any type of substitution;
15 . deletes duplicative language restating the definition of "drug product equivalent," a
16 term defined elsewhere in the Pharmacy Practice Act;
17 . except as specified, prohibits substitution of a drug product equivalent for a drug
18 prescribed to treat or prevent seizures without the prescribing practitioner's
19 authorization;
20 . deletes duplicative language permitting a pharmacist or pharmacy intern to
21 substitute a drug product equivalent for another drug without the prescribing
22 practitioner's authorization;
23 . makes clarifying changes; and
24 . makes technical corrections.
25 Monies Appropriated in this Bill:
26 None
27 Other Special Clauses:

28 None
29 Utah Code Sections Affected:
30 AMENDS:
31 58-17b-605, as enacted by Chapter 280, Laws of Utah 2004
32
33 Be it enacted by the Legislature of the state of Utah:
34 Section 1. Section 58-17b-605 is amended to read:
35 58-17b-605. Drug product equivalents.
36 (1) A pharmacist or pharmacy intern dispensing a prescription order for a specific drug
37 [by brand or proprietary name] may substitute another drug [product equivalent] for the
38 prescribed drug only if:
39 (a) the purchaser specifically requests or consents to the substitution [of a drug product
40 equivalent];
41 (b) the [substituted] substitute drug is a drug product equivalent [is] of the [same
42 generic type and is designated the therapeutic equivalent in the approved drug products with
43 therapeutic equivalence evaluations prepared by the Center for Drug Evaluation and Research
44 of the Federal Food and Drug Administration] prescribed drug;
45 (c) the [substituted] drug product equivalent is permitted to move in interstate
46 commerce;
47 (d) the pharmacist or pharmacy intern counsels the patient on the use and the expected
48 response to the [prescribed] dispensed drug, whether a substitute or not, and the substitution is
49 not otherwise prohibited by this chapter;
50 (e) the prescribing practitioner has not indicated that [an equivalent] a drug product [is]
51 equivalent may not [to] be substituted for the drug, as provided in Subsection [(5)] (4); [and]
52 (f) if the prescribed drug has been prescribed in this instance to treat or prevent
53 seizures, the pharmacist or pharmacy intern obtains the authorization of the prescribing
54 practitioner, unless:
55 (i) the drug product equivalent will be paid for, either in whole or in part, by the
56 Department of Health; and
57 (ii) (A) the drug product equivalent is a generic drug; and
58 (B) a Department of Health pharmacist has not overridden, pursuant to Subsection

59 58-17b-606 (5), the generic mandate provision of Subsection 58-17b-606 (4) and determined
60 that use of a nongeneric drug would result in a financial benefit to the state; or
61 (iii) in accordance with Subsection 58-17b-606 (4), the prescribing practitioner has
62 demonstrated to the Department of Health a medical necessity for dispensing the drug product
63 equivalent; and
64 [(f)] (g) the substitution is not otherwise prohibited by law.
65 (2) (a) Each out-of-state mail service pharmacy dispensing a [substituted] drug product
66 equivalent as a substitute for another drug into this state shall notify the patient of the
67 substitution either by telephone or in writing.
68 (b) Each out-of-state mail service pharmacy shall comply with the requirements of this
69 chapter with respect to [drugs which may be] a drug product equivalent substituted for another
70 drug, including labeling [and], record keeping[, when dispensing substituted drug products],
71 and in accordance with Subsection (1)(f), prescribing practitioner authorization.
72 [(3) Pharmacists or pharmacy interns may not substitute without the prescriber's
73 authorization on trade name drug product prescriptions unless the product is currently
74 categorized in the approved drug products with therapeutic equivalence evaluations prepared
75 by the Center for Drug Evaluation and Research of the Federal Food and Drug Administration
76 as a drug product considered to be therapeutically equivalent to another drug product.]
77 [(4)] (3) A pharmacist or pharmacy intern who dispenses a prescription with a drug
78 product equivalent under this section assumes no greater liability than would be incurred had
79 the pharmacist or pharmacy intern dispensed the prescription with the drug product prescribed.
80 [(5)] (4) (a) If, in the opinion of the prescribing practitioner, it is in the best interest of
81 the patient that [an equivalent] a drug product equivalent not be substituted for another drug,
82 the practitioner may indicate a prohibition on substitution either by writing "dispense as
83 written" or may sign in the appropriate space where two lines have been preprinted on a
84 prescription order and captioned "dispense as written" or "substitution permitted".
85 (b) If the prescription is communicated orally by the prescribing practitioner to the
86 pharmacist or pharmacy intern, the practitioner shall indicate the prohibition on substitution
87 and that indication shall be noted in writing by the pharmacist or pharmacy intern with the
88 name of the practitioner and the words "orally by" and the initials of the pharmacist or
89 pharmacy [practitioner] intern written after it.

90 [(6)] (5) The substitution, if any, shall be communicated to the purchaser. The
91 container shall be labeled with the name of the drug product equivalent dispensed and the
92 pharmacist, pharmacy intern, or pharmacy technician shall indicate on the file copy of the
93 prescription both the name of the prescribed drug and the name of the drug product equivalent
94 dispensed in its place.
95 [(7)] (6) Failure of a licensed medical practitioner to specify that no substitution is
96 authorized does not constitute evidence of negligence.




Legislative Review Note
as of 2-6-07 10:46 AM

Office of Legislative Research and General Counsel