AB 1073, as amended, Ting. Pharmacy: prescription drug labels.
The Pharmacy Law provides for the licensure and regulation of pharmacists by the California State Board of Pharmacy. That law requires the board to promulgate regulations that require, on or before January 1, 2011, a standardized, patient-centered, prescription drug label on all prescription medicine dispensed to patients in California. Existing regulations of the board implement that requirement. A violation of that law is a crime.
This bill would require a dispenser, in his or her professional judgment, to use a standardized direction for use on the label of the prescription container from a list in existing regulations. The bill would require the board to make available translations, in a minimum of 5 languages other than English, of those standardized directions for use and post the translated standardized directions for use on its
Internet Web site.begin insert This bill would require the board to allow a dispenser 180 days to implement changes to translated standardized directions as may be adopted by the board.end insert The bill would require a dispenser, upon request of a patient for a translated direction for use, to select the appropriate translated standardized direction for use, if available, and append it to the label on the patient’s prescription container or provide it on a supplemental document. The bill would authorize a dispenser to provide his or her own translatedbegin delete directionsend deletebegin insert directions, in any language other than English,end insert as an alternative tobegin insert the translations made
available by the board andend insert the above-described procedure. By imposing new requirements on dispensers, the violation of which would be a crime, this bill would impose a state-mandated local program.
The bill would exempt from civil liability a dispenser who complies with the requirement to select the appropriate translated standardized direction for use, if available, and append it to the label, for any error that results from the inability of the dispenser to understand a translated direction for use in a language other than English.
The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: yes.
The people of the State of California do enact as follows:
Section 4076.6 is added to the Business and
2Professions Code, to read:
(a) For all dangerous drugs dispensed to patients in
4this state, when applicable and in the professional judgment of the
5dispenser, a dispenser shall use a standardized direction for use
6on the label of the prescription container from the list in subdivision
7(a) of Section 1707.5 of Title 16 of the California Code of
8Regulations.
9(b) The board shall make available translations, in a minimum
10of five languages other than English, of the standardized directions
11for use that are listed in subdivision (a) of Section 1707.5 of Title
1216 of the California Code of Regulations. These translations shall
13be approved by qualified translators, as determined by the board.
14The board
shall post these translated standardized directions for
15use on its Internet Web site.begin insert The board shall allow a dispenser a
16period of 180 days from the date of adoption by the board of any
P3 1change to the translated standardized directions for use to
2implement that change.end insert
3(c) Upon the request of a patient for a translated direction for
4use, a dispenser shall select the appropriate translated standardized
5direction for use from those established in accordance with
6subdivision (b), if available, and append it to the label on the
7patient’s prescription container or provide it on a supplemental
8document. If a translated direction for use appears on a prescription
9container label, the English version of the direction shall also
10appear on thebegin delete label.end deletebegin insert
container.end insert The translated direction for use
11shall appear in the patient-centered area of the label in accordance
12with
subdivision (a) of Section 1707.5 of Title 16 of the California
13Code of Regulations. The English version may appear in an area
14of the label outside the patient-centered area.
15(d) A dispenser may provide his or her own translated directionsbegin insert,
16in any language other than English,end insert as an alternative to the
17begin insert translations made available by the board and theend insert procedure
18established in subdivisions (a) to (c), inclusive. The translated
19directions for use shall appear in the patient-centered area of the
20label in accordance with subdivision (a) of Section 1707.5 of Title
2116 of the California Code of Regulations or a supplemental
22document.begin insert
If a translated direction for use appears on a
23prescription container label, the English version of the direction
24shall also appear on the container.end insert The English version may appear
25in other areas of the label outside the patient-centered area.
Section 1714.20 is added to the Civil Code, 27immediately following Section 1714.2, to read:
begin insert(a)end insertbegin insert end insertA dispenser who complies with subdivision (c)
29of Section 4076.6 of the Business and Professions Code shall not
30be liable for civil damages for any error that results from the
31inability of the dispenser to understand a translated direction for
32use in a language other than English.
33(b) This section does not affect existing liability under this
34division for translated directions not approved by the California
35State Board of Pharmacy.
No reimbursement is required by this act pursuant to
37Section 6 of Article XIII B of the California Constitution because
38the only costs that may be incurred by a local agency or school
39district will be incurred because this act creates a new crime or
40infraction, eliminates a crime or infraction, or changes the penalty
P4 1for a crime or infraction, within the meaning of Section 17556 of
2the Government Code, or changes the definition of a crime within
3the meaning of Section 6 of Article XIII B of the California
4Constitution.
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