BILL ANALYSIS �
SB 205
Page 1
SENATE THIRD READING
SB 205 (Corbett)
As Amended August 19, 2013
Majority vote
SENATE VOTE :23-9
HEALTH 12-6 BUSINESS & PROFESSIONS
9-3
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|Ayes:|Pan, Ammiano, Atkins, |Ayes:|Bonilla, Bocanegra, |
| |Bonta, Chesbro, Gomez, | |Campos, Dickinson, |
| |Roger Hern�ndez, | |Eggman, Gordon, Holden, |
| |Gonzalez, Mitchell, | |Mullin, Ting |
| |Nazarian, | | |
| |V. Manuel P�rez, | | |
| |Wieckowski | | |
| | | | |
|-----+--------------------------+-----+--------------------------|
|Nays:|Logue, Maienschein, |Nays:|Jones, Maienschein, Wilk |
| |Mansoor, Nestande, | | |
| |Wagner, Wilk | | |
| | | | |
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APPROPRIATIONS 12-5
--------------------------------
|Ayes:|Gatto, Bocanegra, |
| |Bradford, |
| |Ian Calderon, Campos, |
| |Eggman, Gomez, Hall, |
| |Holden, Pan, Quirk, Weber |
| | |
|-----+--------------------------|
|Nays:|Harkey, Bigelow, |
| |Donnelly, Linder, Wagner |
| | |
--------------------------------
SUMMARY : Deletes and recasts existing law on labeling
requirements for prescription containers; and, requires,
beginning January 1, 2016, the following information currently
required to be included on the label of a prescription
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container, to be printed in 12-point sans serif typeface: 1)
the manufacturer's trade or generic name of the drug and the
name of the manufacturer, as specified; 2) directions for the
use of the drug; 3) name of the patient or patients; 4) strength
of the drug or drugs dispensed; and, 5) the condition or purpose
for which the drug was prescribed if the condition or purpose is
indicated on the prescription. Makes other technical and
clarifying changes.
EXISTING LAW :
1)Provides for the practice of pharmacy and the licensing and
regulation of pharmacies and pharmacists by the Board of
Pharmacy (Board) within the Department of Consumer Affairs.
2)Specifies certain requirements regarding the dispensing and
furnishing of dangerous drugs and devices and prohibits a
person from furnishing any dangerous drug or device except as
prescribed by a physician, dentist, podiatrist, optometrist,
or veterinarian.
3)Requires that each prescription dispensed by a pharmacist must
be in a container meeting state and federal specifications and
correctly labeled, as specified, including:
a) Unless otherwise ordered by the prescriber, the
manufacturer's trade name of the drug or the generic name
and the name of the manufacturer, as specified;
b) The directions for the use of the drug;
c) The name of the patient or patients;
d) The name of the prescriber, as specified;
e) The date of issue;
f) The name and address of the pharmacy and prescription
number or other means of identifying the prescription;
g) The strength of the drug or drugs dispensed;
h) The quantity of the drug or drugs dispensed;
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i) The expiration date of the effectiveness of the drug
dispensed;
j) The condition or purpose for which the drug was
prescribed if the condition or purpose is indicated on the
prescription; and,
aa) The physical description of the dispensed medication,
including its color, shape, and any identification code
that appears on the tablets or capsules.
EXISTING REGULATIONS :
1)Requires labels on drug containers dispensed to patients in
California to conform to the following format:
a) Each of the following must be clustered into one area of
the label that comprises at least 50% of the label and be
printed in at least 10-point sans serif typeface, or, if
requested by the consumer, at least a 12-point typeface,
and listed in the following order:
i) Name of the patient;
ii) Name of the drug and strength of the drug;
iii) Directions for the use of the drug; and,
iv) The condition or purpose for which the drug was
prescribed if the condition or purpose is indicated on
the prescription.
b) Requires for added emphasis, the label to highlight in
bold typeface or color, or use blank space to set off the
items listed in 1) a) above.
c) Requires the remaining elements that are required to be
printed on a label, as well as any other items of
information appearing on the label or the container, to be
printed so as not to interfere with the legibility or
emphasis of the primary elements specified in 1) a) above.
2)Requires the Board to collect and publish on its Web site
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examples of labels conforming to these requirements to aid
pharmacies in label design and compliance.
3)Requires a pharmacy to have policies and procedures in place
to help patients with limited or no English proficiency
understand the information on the label as specified in 1) a)
above in the patient's language. Requires the pharmacy's
policies and procedures to be specified in writing and to
include, at a minimum, the selected means to identify the
patient's language and to provide interpretive services in the
patient's language. Requires the pharmacy, at a minimum, to
provide interpretive services in the patient's language, if
interpretive services in such language are available, during
all hours that the pharmacy is open, either in person by
pharmacy staff or by use of a third-party interpretive service
available by telephone at or adjacent to the pharmacy counter.
FISCAL EFFECT : According to the Assembly Appropriations
Committee, negligible state fiscal effect.
COMMENTS : According to the author, "seniors are having
difficulty reading the small print on their prescription labels
and, for those who take multiple medications, their inability to
read the label puts them in serious danger." The author states
that among adults 65 years of age or older, 40% take five to
nine medications and 18% take 10 or more medications and that
taking these incorrectly or mixed with other medications can
cause adverse drug events that can lead to injury and death.
The author also notes that The New England Journal of Medicine
estimates that between 2007 and 2009, there were more than
260,000 emergency room visits for adverse drug events in the
United States by adults 65 years of age or older. Of those,
almost 100,000 required emergency hospitalizations, and nearly
two-thirds of those hospitalizations were due to unintentional
overdoses. The author points out that making prescription
medical container labels easier for patients to read is a simple
way to help avoid dosing or medication errors due to a patient's
inability to read the label.
Analysis Prepared by : Rosielyn Pulmano / HEALTH / (916)
319-2097
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FN: 0001836