Bill Text: CA SB205 | 2013-2014 | Regular Session | Enrolled
Bill Title: Prescription drugs: labeling.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Vetoed) 2014-02-27 - Consideration of Governor's veto stricken from file. [SB205 Detail]
Download: California-2013-SB205-Enrolled.html
BILL NUMBER: SB 205 ENROLLED
BILL TEXT
PASSED THE SENATE SEPTEMBER 11, 2013
PASSED THE ASSEMBLY SEPTEMBER 10, 2013
AMENDED IN ASSEMBLY SEPTEMBER 6, 2013
AMENDED IN ASSEMBLY AUGUST 19, 2013
AMENDED IN ASSEMBLY JULY 1, 2013
AMENDED IN SENATE APRIL 24, 2013
INTRODUCED BY Senator Corbett
FEBRUARY 8, 2013
An act to amend, repeal, and add Section 4076 of the Business and
Professions Code, relating to pharmacy.
LEGISLATIVE COUNSEL'S DIGEST
SB 205, Corbett. Prescription drugs: labeling.
The Pharmacy Law provides for the licensure and regulation of
pharmacists by the California State Board of Pharmacy. Existing law
defines a prescription as including a legible, clear notice of the
condition or purpose for which the drug is prescribed, if requested
by the patient. Existing law prohibits a pharmacist from dispensing
any prescription unless it is in a specified container that is
correctly labeled to include, among other information, the condition
or purpose for which the drug was prescribed if the condition or
purpose is indicated on the prescription. A violation of the Pharmacy
Law is a crime.
This bill, beginning January 1, 2016, would require certain
portions of the required information on the prescription label,
including the name of the patient or patients, to be printed in at
least a 12-point typeface. Because a violation of this requirement
would be a crime, the bill would impose a state-mandated local
program.
This bill would incorporate additional changes in Section 4076 of
the Business and Professions Code proposed by SB 493, that would
become operative only if SB 493 and this bill are both chaptered and
become effective on or before January 1, 2014, and this bill is
chaptered last.
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.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 4076 of the Business and Professions Code is
amended to read:
4076. (a) A pharmacist shall not dispense any prescription except
in a container that meets the requirements of state and federal law
and is correctly labeled with all of the following:
(1) Except when the prescriber or the certified nurse-midwife who
functions pursuant to a standardized procedure or protocol described
in Section 2746.51, the nurse practitioner who functions pursuant to
a standardized procedure described in Section 2836.1 or protocol, the
physician assistant who functions pursuant to Section 3502.1, the
naturopathic doctor who functions pursuant to a standardized
procedure or protocol described in Section 3640.5, or the pharmacist
who functions pursuant to a policy, procedure, or protocol pursuant
to either Section 4052.1 or 4052.2 orders otherwise, either the
manufacturer's trade name of the drug or the generic name and the
name of the manufacturer. Commonly used abbreviations may be used.
Preparations containing two or more active ingredients may be
identified by the manufacturer's trade name or the commonly used name
or the principal active ingredients.
(2) The directions for the use of the drug.
(3) The name of the patient or patients.
(4) The name of the prescriber or, if applicable, the name of the
certified nurse-midwife who functions pursuant to a standardized
procedure or protocol described in Section 2746.51, the nurse
practitioner who functions pursuant to a standardized procedure
described in Section 2836.1 or protocol, the physician assistant who
functions pursuant to Section 3502.1, the naturopathic doctor who
functions pursuant to a standardized procedure or protocol described
in Section 3640.5, or the pharmacist who functions pursuant to a
policy, procedure, or protocol pursuant to either Section 4052.1 or
4052.2.
(5) The date of issue.
(6) The name and address of the pharmacy, and prescription number
or other means of identifying the prescription.
(7) The strength of the drug or drugs dispensed.
(8) The quantity of the drug or drugs dispensed.
(9) The expiration date of the effectiveness of the drug
dispensed.
(10) The condition or purpose for which the drug was prescribed if
the condition or purpose is indicated on the prescription.
(11) (A) Commencing January 1, 2006, the physical description of
the dispensed medication, including its color, shape, and any
identification code that appears on the tablets or capsules, except
as follows:
(i) Prescriptions dispensed by a veterinarian.
(ii) An exemption from the requirements of this paragraph shall be
granted to a new drug for the first 120 days that the drug is on the
market and for the 90 days during which the national reference file
has no description on file.
(iii) Dispensed medications for which no physical description
exists in any commercially available database.
(B) This paragraph applies to outpatient pharmacies only.
(C) The information required by this paragraph may be printed on
an auxiliary label that is affixed to the prescription container.
(D) This paragraph shall not become operative if the board, prior
to January 1, 2006, adopts regulations that mandate the same labeling
requirements set forth in this paragraph.
(b) If a pharmacist dispenses a prescribed drug by means of a unit
dose medication system, as defined by administrative regulation, for
a patient in a skilled nursing, intermediate care, or other health
care facility, the requirements of this section will be satisfied if
the unit dose medication system contains the aforementioned
information or the information is otherwise readily available at the
time of drug administration.
(c) If a pharmacist dispenses a dangerous drug or device in a
health facility, as defined in Section 1250 of the Health and Safety
Code, it is not necessary to include on individual unit dose
containers for a specific patient, the name of the certified
nurse-midwife who functions pursuant to a standardized procedure or
protocol described in Section 2746.51, the nurse practitioner who
functions pursuant to a standardized procedure described in Section
2836.1 or protocol, the physician assistant who functions pursuant to
Section 3502.1, the naturopathic doctor who functions pursuant to a
standardized procedure or protocol described in Section 3640.5, or
the pharmacist who functions pursuant to a policy, procedure, or
protocol pursuant to either Section 4052.1 or 4052.2.
(d) If a pharmacist dispenses a prescription drug for use in a
facility licensed pursuant to Section 1250 of the Health and Safety
Code, it is not necessary to include the information required in
paragraph (11) of subdivision (a) when the prescription drug is
administered to a patient by a person licensed under the Medical
Practice Act (Chapter 5 (commencing with Section 2000)), the Nursing
Practice Act (Chapter 6 (commencing with Section 2700)), or the
Vocational Nursing Practice Act (Chapter 6.5 (commencing with Section
2840)), who is acting within his or her scope of practice.
(e) This section shall remain in effect only until January 1,
2016, and as of that date is repealed, unless a later enacted
statute, that is enacted before January 1, 2016, deletes or extends
that date.
SEC. 1.5. Section 4076 of the Business and Professions Code is
amended to read:
4076. (a) A pharmacist shall not dispense any prescription except
in a container that meets the requirements of state and federal law
and is correctly labeled with all of the following:
(1) Except when the prescriber or the certified nurse-midwife who
functions pursuant to a standardized procedure or protocol described
in Section 2746.51, the nurse practitioner who functions pursuant to
a standardized procedure described in Section 2836.1 or protocol, the
physician assistant who functions pursuant to Section 3502.1, the
naturopathic doctor who functions pursuant to a standardized
procedure or protocol described in Section 3640.5, or the pharmacist
who functions pursuant to a policy, procedure, or protocol pursuant
to Section 4052.1, 4052.2, or 4052.6 orders otherwise, either the
manufacturer's trade name of the drug or the generic name and the
name of the manufacturer. Commonly used abbreviations may be used.
Preparations containing two or more active ingredients may be
identified by the manufacturer's trade name or the commonly used name
or the principal active ingredients.
(2) The directions for the use of the drug.
(3) The name of the patient or patients.
(4) The name of the prescriber or, if applicable, the name of the
certified nurse-midwife who functions pursuant to a standardized
procedure or protocol described in Section 2746.51, the nurse
practitioner who functions pursuant to a standardized procedure
described in Section 2836.1 or protocol, the physician assistant who
functions pursuant to Section 3502.1, the naturopathic doctor who
functions pursuant to a standardized procedure or protocol described
in Section 3640.5, or the pharmacist who functions pursuant to a
policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or
4052.6.
(5) The date of issue.
(6) The name and address of the pharmacy, and prescription number
or other means of identifying the prescription.
(7) The strength of the drug or drugs dispensed.
(8) The quantity of the drug or drugs dispensed.
(9) The expiration date of the effectiveness of the drug
dispensed.
(10) The condition or purpose for which the drug was prescribed if
the condition or purpose is indicated on the prescription.
(11) (A) Commencing January 1, 2006, the physical description of
the dispensed medication, including its color, shape, and any
identification code that appears on the tablets or capsules, except
as follows:
(i) Prescriptions dispensed by a veterinarian.
(ii) An exemption from the requirements of this paragraph shall be
granted to a new drug for the first 120 days that the drug is on the
market and for the 90 days during which the national reference file
has no description on file.
(iii) Dispensed medications for which no physical description
exists in any commercially available database.
(B) This paragraph applies to outpatient pharmacies only.
(C) The information required by this paragraph may be printed on
an auxiliary label that is affixed to the prescription container.
(D) This paragraph shall not become operative if the board, prior
to January 1, 2006, adopts regulations that mandate the same labeling
requirements set forth in this paragraph.
(b) If a pharmacist dispenses a prescribed drug by means of a unit
dose medication system, as defined by administrative regulation, for
a patient in a skilled nursing, intermediate care, or other health
care facility, the requirements of this section will be satisfied if
the unit dose medication system contains the aforementioned
information or the information is otherwise readily available at the
time of drug administration.
(c) If a pharmacist dispenses a dangerous drug or device in a
health facility, as defined in Section 1250 of the Health and Safety
Code, it is not necessary to include on individual unit dose
containers for a specific patient, the name of the certified
nurse-midwife who functions pursuant to a standardized procedure or
protocol described in Section 2746.51, the nurse practitioner who
functions pursuant to a standardized procedure described in Section
2836.1 or protocol, the physician assistant who functions pursuant to
Section 3502.1, the naturopathic doctor who functions pursuant to a
standardized procedure or protocol described in Section 3640.5, or
the pharmacist who functions pursuant to a policy, procedure, or
protocol pursuant to Section 4052.1, 4052.2, or 4052.6.
(d) If a pharmacist dispenses a prescription drug for use in a
facility licensed pursuant to Section 1250 of the Health and Safety
Code, it is not necessary to include the information required in
paragraph (11) of subdivision (a) when the prescription drug is
administered to a patient by a person licensed under the Medical
Practice Act (Chapter 5 (commencing with Section 2000)), the Nursing
Practice Act (Chapter 6 (commencing with Section 2700)), or the
Vocational Nursing Practice Act (Chapter 6.5 (commencing with Section
2840)), who is acting within his or her scope of practice.
(e) This section shall remain in effect only until January 1,
2016, and as of that date is repealed, unless a later enacted
statute, that is enacted before January 1, 2016, deletes or extends
that date.
SEC. 2. Section 4076 is added to the Business and Professions
Code, to read:
4076. (a) A pharmacist shall not dispense any prescription except
in a container that meets the requirements of state and federal law
and is correctly labeled with all of the following:
(1) Except when the prescriber or the certified nurse-midwife who
functions pursuant to a standardized procedure or protocol described
in Section 2746.51, the nurse practitioner who functions pursuant to
a standardized procedure described in Section 2836.1 or protocol, the
physician assistant who functions pursuant to Section 3502.1, the
naturopathic doctor who functions pursuant to a standardized
procedure or protocol described in Section 3640.5, or the pharmacist
who functions pursuant to a policy, procedure, or protocol pursuant
to either Section 4052.1 or 4052.2 orders otherwise, either the
manufacturer's trade name of the drug or the generic name and the
name of the manufacturer. Commonly used abbreviations may be used.
Preparations containing two or more active ingredients may be
identified by the manufacturer's trade name or the commonly used name
or the principal active ingredients.
(2) The directions for the use of the drug.
(3) The name of the patient or patients.
(4) The name of the prescriber or, if applicable, the name of the
certified nurse-midwife who functions pursuant to a standardized
procedure or protocol described in Section 2746.51, the nurse
practitioner who functions pursuant to a standardized procedure
described in Section 2836.1 or protocol, the physician assistant who
functions pursuant to Section 3502.1, the naturopathic doctor who
functions pursuant to a standardized procedure or protocol described
in Section 3640.5, or the pharmacist who functions pursuant to a
policy, procedure, or protocol pursuant to either Section 4052.1 or
4052.2.
(5) The date of issue.
(6) The name and address of the pharmacy, and prescription number
or other means of identifying the prescription.
(7) The strength of the drug or drugs dispensed.
(8) The quantity of the drug or drugs dispensed.
(9) The expiration date of the effectiveness of the drug
dispensed.
(10) The condition or purpose for which the drug was prescribed if
the condition or purpose is indicated on the prescription.
(11) (A) Commencing January 1, 2006, the physical description of
the dispensed medication, including its color, shape, and any
identification code that appears on the tablets or capsules, except
as follows:
(i) Prescriptions dispensed by a veterinarian.
(ii) An exemption from the requirements of this paragraph shall be
granted to a new drug for the first 120 days that the drug is on the
market and for the 90 days during which the national reference file
has no description on file.
(iii) Dispensed medications for which no physical description
exists in any commercially available database.
(B) This paragraph applies to outpatient pharmacies only.
(C) The information required by this paragraph may be printed on
an auxiliary label that is affixed to the prescription container.
(D) This paragraph shall not become operative if the board, prior
to January 1, 2006, adopts regulations that mandate the same labeling
requirements set forth in this paragraph.
(b) The information required by paragraphs (1), (2), (3), (7), and
(10) of subdivision (a) shall be printed in at least a 12-point
typeface.
(c) If a pharmacist dispenses a prescribed drug by means of a unit
dose medication system, as defined by administrative regulation, for
a patient in a skilled nursing, intermediate care, or other health
care facility, the requirements of this section will be satisfied if
the unit dose medication system contains the aforementioned
information or the information is otherwise readily available at the
time of drug administration.
(d) If a pharmacist dispenses a dangerous drug or device in a
health facility, as defined in Section 1250 of the Health and Safety
Code, it is not necessary to include on individual unit dose
containers for a specific patient, the name of the certified
nurse-midwife who functions pursuant to a standardized procedure or
protocol described in Section 2746.51, the nurse practitioner who
functions pursuant to a standardized procedure described in Section
2836.1 or protocol, the physician assistant who functions pursuant to
Section 3502.1, the naturopathic doctor who functions pursuant to a
standardized procedure or protocol described in Section 3640.5, or
the pharmacist who functions pursuant to a policy, procedure, or
protocol pursuant to either Section 4052.1 or 4052.2.
(e) If a pharmacist dispenses a prescription drug for use in a
facility licensed pursuant to Section 1250 of the Health and Safety
Code, it is not necessary to include the information required in
paragraph (11) of subdivision (a) when the prescription drug is
administered to a patient by a person licensed under the Medical
Practice Act (Chapter 5 (commencing with Section 2000)), the Nursing
Practice Act (Chapter 6 (commencing with Section 2700)), or the
Vocational Nursing Practice Act (Chapter 6.5 (commencing with Section
2840)), who is acting within his or her scope of practice.
(f) This section shall become operative on January 1, 2016.
SEC. 2.5. Section 4076 is added to the Business and Professions
Code, to read:
4076. (a) A pharmacist shall not dispense any prescription except
in a container that meets the requirements of state and federal law
and is correctly labeled with all of the following:
(1) Except when the prescriber or the certified nurse-midwife who
functions pursuant to a standardized procedure or protocol described
in Section 2746.51, the nurse practitioner who functions pursuant to
a standardized procedure described in Section 2836.1 or protocol, the
physician assistant who functions pursuant to Section 3502.1, the
naturopathic doctor who functions pursuant to a standardized
procedure or protocol described in Section 3640.5, or the pharmacist
who functions pursuant to a policy, procedure, or protocol pursuant
to Section 4052.1, 4052.2, or 4052.6 orders otherwise, either the
manufacturer's trade name of the drug or the generic name and the
name of the manufacturer. Commonly used abbreviations may be used.
Preparations containing two or more active ingredients may be
identified by the manufacturer's trade name or the commonly used name
or the principal active ingredients.
(2) The directions for the use of the drug.
(3) The name of the patient or patients.
(4) The name of the prescriber or, if applicable, the name of the
certified nurse-midwife who functions pursuant to a standardized
procedure or protocol described in Section 2746.51, the nurse
practitioner who functions pursuant to a standardized procedure
described in Section 2836.1 or protocol, the physician assistant who
functions pursuant to Section 3502.1, the naturopathic doctor who
functions pursuant to a standardized procedure or protocol described
in Section 3640.5, or the pharmacist who functions pursuant to a
policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or
4052.6.
(5) The date of issue.
(6) The name and address of the pharmacy, and prescription number
or other means of identifying the prescription.
(7) The strength of the drug or drugs dispensed.
(8) The quantity of the drug or drugs dispensed.
(9) The expiration date of the effectiveness of the drug
dispensed.
(10) The condition or purpose for which the drug was prescribed if
the condition or purpose is indicated on the prescription.
(11) (A) Commencing January 1, 2006, the physical description of
the dispensed medication, including its color, shape, and any
identification code that appears on the tablets or capsules, except
as follows:
(i) Prescriptions dispensed by a veterinarian.
(ii) An exemption from the requirements of this paragraph shall be
granted to a new drug for the first 120 days that the drug is on the
market and for the 90 days during which the national reference file
has no description on file.
(iii) Dispensed medications for which no physical description
exists in any commercially available database.
(B) This paragraph applies to outpatient pharmacies only.
(C) The information required by this paragraph may be printed on
an auxiliary label that is affixed to the prescription container.
(D) This paragraph shall not become operative if the board, prior
to January 1, 2006, adopts regulations that mandate the same labeling
requirements set forth in this paragraph.
(b) The information required by paragraphs (1), (2), (3), (7), and
(10) of subdivision (a) shall be printed in at least a 12-point
typeface.
(c) If a pharmacist dispenses a prescribed drug by means of a unit
dose medication system, as defined by administrative regulation, for
a patient in a skilled nursing, intermediate care, or other health
care facility, the requirements of this section will be satisfied if
the unit dose medication system contains the aforementioned
information or the information is otherwise readily available at the
time of drug administration.
(d) If a pharmacist dispenses a dangerous drug or device in a
health facility, as defined in Section 1250 of the Health and Safety
Code, it is not necessary to include on individual unit dose
containers for a specific patient, the name of the certified
nurse-midwife who functions pursuant to a standardized procedure or
protocol described in Section 2746.51, the nurse practitioner who
functions pursuant to a standardized procedure described in Section
2836.1 or protocol, the physician assistant who functions pursuant to
Section 3502.1, the naturopathic doctor who functions pursuant to a
standardized procedure or protocol described in Section 3640.5, or
the pharmacist who functions pursuant to a policy, procedure, or
protocol pursuant to Section 4052.1, 4052.2, or 4052.6.
(e) If a pharmacist dispenses a prescription drug for use in a
facility licensed pursuant to Section 1250 of the Health and Safety
Code, it is not necessary to include the information required in
paragraph (11) of subdivision (a) when the prescription drug is
administered to a patient by a person licensed under the Medical
Practice Act (Chapter 5 (commencing with Section 2000)), the Nursing
Practice Act (Chapter 6 (commencing with Section 2700)), or the
Vocational Nursing Practice Act (Chapter 6.5 (commencing with Section
2840)), who is acting within his or her scope of practice.
(f) This section shall become operative on January 1, 2016.
SEC. 3. Sections 1.5 and 2.5 of this bill incorporate amendments
to Section 4076 of the Business and Professions Code proposed by both
this bill and Senate Bill 493. They shall only become operative if
(1) both bills are enacted and become effective on or before January
1, 2014, (2) each bill amends Section 4076 of the Business and
Professions Code, and (3) this bill is enacted after Senate Bill 493,
in which case Sections 1 and 2 of this bill shall not become
operative.
SEC. 4. No reimbursement is required by this act pursuant to
Section 6 of Article XIII B of the California Constitution because
the only costs that may be incurred by a local agency or school
district will be incurred because this act creates a new crime or
infraction, eliminates a crime or infraction, or changes the penalty
for a crime or infraction, within the meaning of Section 17556 of the
Government Code, or changes the definition of a crime within the
meaning of Section 6 of Article XIII B of the California
Constitution.
