SB 205, as amended, Corbett. Prescription drugs: labeling.
The Pharmacy Law provides for the licensure and regulation of pharmacists by the California State Board of Pharmacy. Existing lawbegin delete requires everyend deletebegin insert defines aend insert prescriptionbegin delete, as defined, to includeend deletebegin insert as includingend insert 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 billbegin insert, beginning January 1, 2016,end insert 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.
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 of the Business and Professions
2Code is amended to read:
(a) A pharmacist shall not dispense any prescription
4except in a container that meets the requirements of state and
5federal law and is correctly labeled with all of the following:
6(1) Except where the prescriber or the certified nurse-midwife
7who functions pursuant to a standardized procedure or protocol
8described in Section 2746.51, the nurse practitioner who functions
9pursuant to a standardized procedure described in Section 2836.1
10or protocol, the physician assistant who functions pursuant to
11Section 3502.1, the naturopathic doctor who functions pursuant
12to a standardized procedure or protocol described in Section
133640.5, or the pharmacist who functions pursuant to a policy,
14procedure,
or protocol pursuant to either Section 4052.1 or 4052.2
15orders otherwise, either the manufacturer’s trade name of the drug
16or the generic name and the name of the manufacturer. Commonly
17used abbreviations may be used. Preparations containing two or
18more active ingredients may be identified by the manufacturer’s
19trade name or the commonly used name or the principal active
20ingredients.
21(2) The directions for the use of the drug.
22(3) The name of the patient or patients.
23(4) The name of the prescriber or, if applicable, the name of the
24certified nurse-midwife who functions pursuant to a standardized
25procedure or protocol described in Section 2746.51, the nurse
26practitioner who functions pursuant to a standardized procedure
27described
in Section 2836.1 or protocol, the physician assistant
28who functions pursuant to Section 3502.1, the naturopathic doctor
29who functions pursuant to a standardized procedure or protocol
30described in Section 3640.5, or the pharmacist who functions
P3 1pursuant to a policy, procedure, or protocol pursuant to either
2Section 4052.1 or 4052.2.
3(5) The date of issue.
4(6) The name and address of the pharmacy, and prescription
5number or other means of identifying the prescription.
6(7) The strength of the drug or drugs dispensed.
7(8) The quantity of the drug or drugs dispensed.
8(9) The expiration date of the
effectiveness of the drug
9dispensed.
10(10) The condition or purpose for which the drug was prescribed
11if the condition or purpose is indicated on the prescription.
12(11) (A) Commencing January 1, 2006, the physical description
13of the dispensed medication, including its color, shape, and any
14identification code that appears on the tablets or capsules, except
15as follows:
16(i) Prescriptions dispensed by a veterinarian.
17(ii) An exemption from the requirements of this paragraph shall
18be granted to a new drug for the first 120 days that the drug is on
19the market and for the 90 days during which the national reference
20file has no description on
file.
21(iii) Dispensed medications for which no physical description
22exists in any commercially available database.
23(B) This paragraph applies to outpatient pharmacies only.
24(C) The information required by this paragraph may be printed
25on an auxiliary label that is affixed to the prescription container.
26(D) This paragraph shall not become operative if the board,
27prior to January 1, 2006, adopts regulations that mandate the same
28labeling requirements set forth in this paragraph.
29(b) The information required by paragraphs (1), (2), (3), (7),
30and (10) of subdivision (a) shall be printed in at least a 12-point
31
typeface.
32(c) If a pharmacist dispenses a prescribed drug by means of a
33unit dose medication system, as defined by administrative
34regulation, for a patient in a skilled nursing, intermediate care, or
35other health care facility, the requirements of this section will be
36satisfied if the unit dose medication system contains the
37aforementioned information or the information is otherwise readily
38available at the time of drug administration.
39(d) If a pharmacist dispenses a dangerous drug or device in a
40health facility, as defined in Section 1250 of the Health and Safety
P4 1Code, it is not necessary to include on individual unit dose
2containers for a specific patient, the name of the certified
3nurse-midwife who functions pursuant to a standardized procedure
4or protocol
described in Section 2746.51, the nurse practitioner
5who functions pursuant to a standardized procedure described in
6Section 2836.1 or protocol, the physician assistant who functions
7pursuant to Section 3502.1, the naturopathic doctor who functions
8pursuant to a standardized procedure or protocol described in
9Section 3640.5, or the pharmacist who functions pursuant to a
10policy, procedure, or protocol pursuant to either Section 4052.1
11or 4052.2.
12(e) If a pharmacist dispenses a prescription drug for use in a
13facility licensed pursuant to Section 1250 of the Health and Safety
14Code, it is not necessary to include the information required in
15paragraph (11) of subdivision (a) when the prescription drug is
16administered to a patient by a person licensed under the Medical
17Practice Act (Chapter 5 (commencing with Section 2000)), the
18Nursing
Practice Act (Chapter 6 (commencing with Section 2700)),
19or the Vocational Nursing Practice Act (Chapter 6.5 (commencing
20with Section 2840)), who is acting within his or her scope of
21practice.
begin insertSection 4076 of the end insertbegin insertBusiness and Professions
23Codeend insertbegin insert is amended to read:end insert
(a) A pharmacist shall not dispense any prescription
25except in a container that meets the requirements of state and
26federal law and is correctly labeled with all of the following:
27(1) Exceptbegin delete whereend deletebegin insert whenend insert the prescriber or the certified
28nurse-midwife who functions pursuant to a standardized procedure
29or protocol described in Section 2746.51, the nurse practitioner
30who functions pursuant to a standardized procedure described in
31Section 2836.1 or protocol, the physician assistant who functions
32pursuant to Section 3502.1, the naturopathic doctor who functions
33pursuant to a
standardized procedure or protocol described in
34Section 3640.5, or the pharmacist who functions pursuant to a
35policy, procedure, or protocol pursuant to either Section 4052.1
36or 4052.2 orders otherwise, either the manufacturer’s trade name
37of the drug or the generic name and the name of the manufacturer.
38Commonly used abbreviations may be used. Preparations
39containing two or more active ingredients may be identified by
P5 1the manufacturer’s trade name or the commonly used name or the
2principal active ingredients.
3(2) The directions for the use of the drug.
4(3) The name of the patient or patients.
5(4) The name of the prescriber or, if applicable, the name of the
6certified nurse-midwife who functions pursuant to a standardized
7procedure or protocol described in Section 2746.51, the nurse
8practitioner who functions
pursuant to a standardized procedure
9described in Section 2836.1 or protocol, the physician assistant
10who functions pursuant to Section 3502.1, the naturopathic doctor
11who functions pursuant to a standardized procedure or protocol
12described in Section 3640.5, or the pharmacist who functions
13pursuant to a policy, procedure, or protocol pursuant to either
14Section 4052.1 or 4052.2.
15(5) The date of issue.
16(6) The name and address of the pharmacy, and prescription
17number or other means of identifying the prescription.
18(7) The strength of the drug or drugs dispensed.
19(8) The quantity of the drug or drugs dispensed.
20(9) The expiration date of the effectiveness of the drug
21dispensed.
22(10) The condition or purpose for which the drug was prescribed
23if the condition or purpose is indicated on the prescription.
24(11) (A) Commencing January 1, 2006, the physical description
25of the dispensed medication, including its color, shape, and any
26identification code that appears on the tablets or capsules, except
27as follows:
28(i) Prescriptions dispensed by a veterinarian.
29(ii) An exemption from the requirements of this paragraph shall
30be granted to a new drug for the first 120 days that the drug is on
31the market and for the 90 days during which the national reference
32file has no description on file.
33(iii) Dispensed medications for which no physical description
34
exists in any commercially available database.
35(B) This paragraph applies to outpatient pharmacies only.
36(C) The information required by this paragraph may be printed
37on an auxiliary label that is affixed to the prescription container.
38(D) This paragraph shall not become operative if the board,
39prior to January 1, 2006, adopts regulations that mandate the same
40labeling requirements set forth in this paragraph.
P6 1(b) If a pharmacist dispenses a prescribed drug by means of a
2unit dose medication system, as defined by administrative
3regulation, for a patient in a skilled nursing, intermediate care, or
4other health care facility, the requirements of this section will be
5satisfied if the unit dose medication system contains the
6aforementioned information or
the information is otherwise readily
7available at the time of drug administration.
8(c) If a pharmacist dispenses a dangerous drug or device in a
9begin delete facility licensed pursuant toend deletebegin insert health facility, as defined inend insert Section
101250 of the Health and Safety Code, it is not necessary to include
11on individual unit dose containers for a specific patient, the name
12of the certified nurse-midwife who functions pursuant to a
13standardized procedure or protocol described in Section 2746.51,
14the nurse practitioner who functions pursuant to a standardized
15procedure described in Section 2836.1 or protocol, the physician
16assistant who functions pursuant to Section 3502.1, the naturopathic
17doctor who functions pursuant to a standardized procedure or
18protocol described in Section
3640.5, or the pharmacist who
19functions pursuant to a policy, procedure, or protocol pursuant to
20either Section 4052.1 or 4052.2.
21(d) If a pharmacist dispenses a prescription drug for use in a
22facility licensed pursuant to Section 1250 of the Health and Safety
23Code, it is not necessary to include the information required in
24paragraph (11) of subdivision (a) when the prescription drug is
25administered to a patient by a person licensed under the Medical
26Practice Act (Chapter 5 (commencing with Section 2000)), the
27Nursing Practice Act (Chapter 6 (commencing with Section 2700)),
28or the Vocational Nursing Practice Act (Chapter 6.5 (commencing
29with Section 2840)), who is acting within his or her scope of
30practice.
31(e) This section shall remain in effect only until January 1, 2016,
32and as of
that date is repealed, unless a later enacted statute, that
33is enacted before January 1, 2016, deletes or extends that date.
begin insertSection 4076 is added to the end insertbegin insertBusiness and Professions
35Codeend insertbegin insert, to read:end insert
(a) A pharmacist shall not dispense any prescription
37except in a container that meets the requirements of state and
38federal law and is correctly labeled with all of the following:
39(1) Except when the prescriber or the certified nurse-midwife
40who functions pursuant to a standardized procedure or protocol
P7 1described in Section 2746.51, the nurse practitioner who functions
2pursuant to a standardized procedure described in Section 2836.1
3or protocol, the physician assistant who functions pursuant to
4Section 3502.1, the naturopathic doctor who functions pursuant
5to a standardized procedure or protocol described in Section
63640.5, or the pharmacist who functions pursuant to a policy,
7procedure, or protocol pursuant to either Section 4052.1 or 4052.2
8orders otherwise,
either the manufacturer’s trade name of the drug
9or the generic name and the name of the manufacturer. Commonly
10used abbreviations may be used. Preparations containing two or
11more active ingredients may be identified by the manufacturer’s
12trade name or the commonly used name or the principal active
13ingredients.
14(2) The directions for the use of the drug.
15(3) The name of the patient or patients.
16(4) The name of the prescriber or, if applicable, the name of
17the certified nurse-midwife who functions pursuant to a
18standardized procedure or protocol described in Section 2746.51,
19the nurse practitioner who functions pursuant to a standardized
20procedure described in Section 2836.1 or protocol, the physician
21assistant who functions pursuant to Section 3502.1, the
22naturopathic doctor who functions pursuant to a standardized
23
procedure or protocol described in Section 3640.5, or the
24pharmacist who functions pursuant to a policy, procedure, or
25protocol pursuant to either Section 4052.1 or 4052.2.
26(5) The date of issue.
27(6) The name and address of the pharmacy, and prescription
28number or other means of identifying the prescription.
29(7) The strength of the drug or drugs dispensed.
30(8) The quantity of the drug or drugs dispensed.
31(9) The expiration date of the effectiveness of the drug dispensed.
32(10) The condition or purpose for which the drug was prescribed
33if the condition or purpose is indicated on the prescription.
34(11) (A) Commencing January 1, 2006, the physical description
35of the dispensed medication, including its color, shape, and any
36identification code that appears on the tablets or capsules, except
37as follows:
38(i) Prescriptions dispensed by a veterinarian.
39(ii) An exemption from the requirements of this paragraph shall
40be granted to a new drug for the first 120 days that the drug is on
P8 1the market and for the 90 days during which the national reference
2file has no description on file.
3(iii) Dispensed medications for which no physical description
4exists in any commercially available database.
5(B) This paragraph applies to outpatient pharmacies only.
6(C) The information required by this paragraph may be printed
7on an auxiliary label that is affixed to the prescription container.
8(D) This paragraph shall not become operative if the board,
9prior to January 1, 2006, adopts regulations that mandate the
10same labeling requirements set forth in this paragraph.
11(b) The information required by paragraphs (1), (2), (3), (7),
12and (10) of subdivision (a) shall be printed in at least a 12-point
13typeface.
14(c) If a pharmacist dispenses a prescribed drug by means of a
15unit dose medication system, as defined by administrative
16regulation, for a patient in a skilled nursing, intermediate care,
17or other health care facility, the requirements of this section will
18be satisfied if the unit dose medication system contains the
19
aforementioned information or the information is otherwise readily
20available at the time of drug administration.
21(d) If a pharmacist dispenses a dangerous drug or device in a
22health facility, as defined in Section 1250 of the Health and Safety
23Code, it is not necessary to include on individual unit dose
24containers for a specific patient, the name of the certified
25nurse-midwife who functions pursuant to a standardized procedure
26or protocol described in Section 2746.51, the nurse practitioner
27who functions pursuant to a standardized procedure described in
28Section 2836.1 or protocol, the physician assistant who functions
29pursuant to Section 3502.1, the naturopathic doctor who functions
30pursuant to a standardized procedure or protocol described in
31Section 3640.5, or the pharmacist who functions pursuant to a
32policy, procedure, or protocol pursuant to either Section 4052.1
33or 4052.2.
34(e) If a pharmacist dispenses a prescription drug for use in a
35facility licensed pursuant to Section 1250 of the Health and Safety
36Code, it is not necessary to include the information required in
37paragraph (11) of subdivision (a) when the prescription drug is
38administered to a patient by a person licensed under the Medical
39Practice Act (Chapter 5 (commencing with Section 2000)), the
40Nursing Practice Act (Chapter 6 (commencing with Section 2700)),
P9 1or the Vocational Nursing Practice Act (Chapter 6.5 (commencing
2with Section 2840)), who is acting within his or her scope of
3practice.
4(f) This section shall become operative on January 1, 2016.
No reimbursement is required by this act pursuant to
7Section 6 of Article XIII B of the California Constitution because
8the only costs that may be incurred by a local agency or school
9district will be incurred because this act creates a new crime or
10infraction, eliminates a crime or infraction, or changes the penalty
11for a crime or infraction, within the meaning of Section 17556 of
12the Government Code, or changes the definition of a crime within
13the meaning of Section 6 of Article XIII B of the California
14Constitution.
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