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 abegin delete dispenserend deletebegin insert dispenser, in his or her professional judgment,end insert 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. 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 translated directions as an alternative to 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, whenbegin delete applicable, end deletebegin insert applicable and in the professional
5judgment of the dispenser, end inserta dispenser shall use a standardized
6direction for use on the label of the prescription container from
7the list in subdivision (a) of Section 1707.5 of Title 16 of the
8California Code of Regulations.
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.
16(c) Upon the request of a patient for a translated direction for
17use, a dispenser shall select the appropriate translated standardized
18direction for use from those established in accordance with
19subdivision (b), if available, and append it to the label on the
20patient’s prescription container or provide it on a supplemental
P3 1document. If a translated direction for use appears on a prescription
2container label, the English version of the direction shall also
3appear on the label. The translated direction for use shall appear
4in the patient-centered area of the label in accordance with
5
subdivision (a) of Section 1707.5 of Title 16 of the California Code
6of Regulations. The English version may appear in an area of the
7label outside the patient-centered area.
8(d) A dispenser may provide his or her own translated directions
9as an alternative to the procedure established in subdivisions (a)
10to (c), inclusive. The translated directions for use shall appear in
11the patient-centered area of the label in accordance with subdivision
12(a) of Section 1707.5 of Title 16 of the California Code of
13Regulations or a supplemental document. The English version may
14appear in other areas of the label outside the patient-centered area.
Section 1714.20 is added to the Civil Code, 16immediately following Section 1714.2, to read:
A dispenser who complies with subdivision (c) of
18Section 4076.6 of the Business and Professions Code shall not be
19liable for civil damages for any error that results from the inability
20of the dispenser to understand a translated direction for use in a
21language other than English.
No reimbursement is required by this act pursuant to
23Section 6 of Article XIII B of the California Constitution because
24the only costs that may be incurred by a local agency or school
25district will be incurred because this act creates a new crime or
26infraction, eliminates a crime or infraction, or changes the penalty
27for a crime or infraction, within the meaning of Section 17556 of
28the Government Code, or changes the definition of a crime within
29the meaning of Section 6 of Article XIII B of the California
30Constitution.
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