ENGROSSED SUBSTITUTE HOUSE BILL 1852
State of Washington 67th Legislature 2022 Regular Session
By House Health Care & Wellness (originally sponsored by
Representatives Thai, Cody, Gregerson, Macri, Santos, Slatter,
Valdez, Pollet, and Riccelli)
READ FIRST TIME 02/02/22.
1 AN ACT Relating to language requirements for prescription drug
2 labels; amending RCW 18.64.390; and adding a new section to chapter
3 18.64 RCW.
4 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF WASHINGTON:
5 NEW SECTION. Sec. 1. A new section is added to chapter 18.64
6 RCW to read as follows:
7 (1) By July 1, 2024, the commission shall adopt rules
8 establishing the requirements for the translation of prescription
9 drug labels and prescription information.
10 (a) At a minimum, the rules must require:
11 (i) The translation of the directions for use and any auxiliary
12 warnings that would otherwise be included on the prescription drug
13 label;
14 (ii) The translated version and English language version of the
15 directions for use appear on the prescription container or label; and
16 (iii) A pharmacy or nonresident pharmacy provide the translated
17 directions for use, auxiliary warnings, and any other information
18 required by the commission in rules if the language is one selected
19 by the commission upon the request of a patient, patient's
20 representative, or prescriber.
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1 (b) Rules adopted under this section must establish the
2 following:
3 (i) The languages for which translation is required;
4 (ii) The elements of a prescription drug label or other
5 information, such as information sheets or side effects, that must be
6 translated;
7 (iii) The pharmacies and settings that the translation
8 requirements apply to;
9 (iv) The process for procuring or providing the translations;
10 (v) When a pharmacy or nonresident pharmacy must provide the
11 translated prescription information; and
12 (vi) Any signage that a pharmacy must post to notify consumers of
13 the availability of translated prescription information.
14 (2) When adopting rules establishing the languages for which
15 translation is required, the commission shall choose at least 15
16 languages and aim to provide translations in all languages spoken by
17 at least five percent of the state population or 1,000 people in
18 Washington with limited English proficiency and must:
19 (a) Consult with the Washington state office of equity and the
20 governor's interagency council on health disparities;
21 (b) Consider the percent of the population in Washington that
22 speaks the language, that population's access to health care, and
23 principles of equity; and
24 (c) At least every five years, reassess, update, and increase the
25 number of languages as needed based upon the factors listed in this
26 subsection.
27 (3) The commission may contract with a state or nonstate entity
28 to implement and administer this section.
29 (4) Nothing in this section shall be construed to prohibit a
30 pharmacy or nonresident pharmacy from providing translated directions
31 for use, auxiliary warnings, side effects, or other prescription
32 information beyond the languages selected by the commission or to a
33 greater extent than required by the commission.
34 (5) A pharmacy, nonresident pharmacy, or pharmacist may not be
35 held liable for good faith reliance on translated prescription
36 information provided by or through a third party in compliance with
37 the rules adopted by the commission in subsection (1) of this section
38 if the pharmacy, nonresident pharmacy, or pharmacist contracted with
39 the third party in good faith, and the pharmacy, nonresident
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1 pharmacy, or pharmacist was not negligent with regard to the alleged
2 misconduct of the third party.
3 (6) The commission shall provide pharmacies and nonresident
4 pharmacies a minimum of 120 days from the date rules are adopted
5 under subsection (1) of this section to comply with the rules.
6 (7) This section applies only to outpatient prescriptions
7 dispensed for home use that are intended for human use.
8 (8) This section does not apply to:
9 (a) Prepackaged emergency medications as provided in RCW
10 70.41.480; and
11 (b) Opioid overdose reversal medication distributed pursuant to
12 RCW 70.41.485 and 71.24.594.
13 (9) By July 1, 2024, the commission shall adopt rules
14 establishing other accessibility requirements for individuals who are
15 blind, low vision, or otherwise print disabled for prescription drug
16 labels and prescription information.
17 (10) The commission may adopt any rules necessary to implement
18 and administer this section.
19 (11) By July 1, 2023, the commission shall report to the relevant
20 policy and fiscal committees of the legislature on the rule-making
21 progress, including the selection of languages and the process for
22 procuring or providing the translations.
23 (12) For purposes of this section, an "auxiliary warning" or
24 "advisory label" is a cautionary warning label added onto a dispensed
25 prescription drug label by a pharmacist in addition to the required
26 prescription drug label to provide extra information to the patient
27 on the safe administration, use, and storage of the prescription.
28 Sec. 2. RCW 18.64.390 and 2013 c 19 s 23 are each amended to
29 read as follows:
30 (1) The commission may deny, revoke, or suspend a nonresident
31 pharmacy license or impose a fine not to exceed ((one thousand
32 dollars)) $1,000 per violation for failure to comply with any
33 requirement of RCW 18.64.350 through 18.64.400 and section 1 of this
34 act.
35 (2) The commission may deny, revoke, or suspend a nonresident
36 pharmacy license or impose a fine not to exceed ((one thousand
37 dollars)) $1,000 per violation for conduct that causes serious bodily
38 or psychological injury to a resident of this state if the secretary
39 has referred the matter to the regulatory or licensing agency in the
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1 state in which the pharmacy is located and that regulatory or
2 licensing agency fails to initiate an investigation within ((forty-
3 five)) 45 days of the referral under this subsection or fails to make
4 a determination on the referral.
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Statutes affected: Substitute Bill: 18.64.390
Engrossed Substitute: 18.64.390