BILL ANALYSIS �
Senate Appropriations Committee Fiscal Summary
Senator Kevin de Le�n, Chair
SB 204 (Corbett) - Prescription drugs: labeling.
Amended: April 24, 2013 Policy Vote: B&P 7-2
Urgency: No Mandate: Yes
Hearing Date: May 6, 2013 Consultant: Brendan McCarthy
This bill does not meet the criteria for referral to the
Suspense File.
Bill Summary: SB 204 would require pharmacists to use specific
translations developed by the Board of Pharmacy, when providing
translated directions for the use of prescription drugs. For
translations into other languages not provided by the Board of
Pharmacy, pharmacists would be required to use certified
translation services.
Fiscal Impact: Potential one-time costs of about $75,000 to
adopt regulations by the Board of Pharmacy (Pharmacy Board
Contingent Fund). See below.
Background: Under current law and regulation, pharmacists are
required to follow certain standards when labeling prescription
medications. Information required to be on the label includes
the drug name, dosage, directions, the prescriber, the
dispensing pharmacy, and other information. As part of the
development of the regulations for prescription drug labels, the
Board of Pharmacy adopted a set of standard directions for
patients. The Board also worked with an outside foundation to
develop standard translations of those directions into five
languages.
Current practice for pharmacies that have non-English speaking
patients varies. Some pharmacies use bilingual staff to
communicate with patients while others make use of commercial,
phone-based translation services to provide directions to
patients and answer questions.
Proposed Law: SB 204 would require pharmacists to use specific
translations developed by the Board of Pharmacy, when providing
translated directions for the use of prescription drugs.
SB 204 (Corbett)
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For translations into other languages not provided by the Board
of Pharmacy, pharmacists would be required to use certified
translation services.
The bill would become operative on January 1, 2016.
Related Legislation: SB 205 (Corbett) would require information
on a prescription drug label to be in at least 12-point font.
That bill will be heard in this committee.
Staff Comments: As part of the current regulations on the
labeling of prescription drugs, the Board of Pharmacy adopted
certain standard directions for use. The Board also worked with
a foundation to have those directions translated into Spanish,
Chinese, Vietnamese, Korean and Russian and posted those
translations on its website. The regulation does not require
pharmacies to use those translations.
The Board indicates that it will not have to change the existing
regulations on labeling if this bill were enacted.
The bill requires pharmacists to use certified translation
services when translating directions into other languages.
Because the bill does not define what constitutes a certified
translation service, the Board may have to adopt a new
regulation providing clarity to pharmacies on what constitutes a
certified translation service.
The only mandated costs imposed on local agencies from the bill
relate to crimes and infractions, which are not reimbursable
under the California Constitution.