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 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.
begin insertThis 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.
end insertThe 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 when 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,
14
procedure, 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
P3 1who functions pursuant to Section 3502.1, the naturopathic doctor
2who functions pursuant to a standardized procedure or protocol
3described in Section 3640.5, or the pharmacist who functions
4pursuant to a policy, procedure, or protocol pursuant to either
5Section 4052.1 or 4052.2.
6(5) The date of issue.
7(6) The name and address of the pharmacy, and prescription
8number or other means of identifying the prescription.
9(7) The strength of the drug or drugs dispensed.
10(8) The quantity of the drug or drugs dispensed.
11(9) The
expiration date of the effectiveness of the drug
12dispensed.
13(10) The condition or purpose for which the drug was prescribed
14if the condition or purpose is indicated on the prescription.
15(11) (A) Commencing January 1, 2006, the physical description
16of the dispensed medication, including its color, shape, and any
17identification code that appears on the tablets or capsules, except
18as follows:
19(i) Prescriptions dispensed by a veterinarian.
20(ii) An exemption from the requirements of this paragraph shall
21be granted to a new drug for the first 120 days that the drug is on
22the market and for the 90 days during which the national reference
23file
has no description on file.
24(iii) Dispensed medications for which no physical description
25
exists in any commercially available database.
26(B) This paragraph applies to outpatient pharmacies only.
27(C) The information required by this paragraph may be printed
28on an auxiliary label that is affixed to the prescription container.
29(D) This paragraph shall not become operative if the board,
30prior to January 1, 2006, adopts regulations that mandate the same
31labeling requirements set forth in this paragraph.
32(b) 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(c) 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(d) 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.
22(e) This section shall remain in effect only until January 1, 2016,
23and
as of that date is repealed, unless a later enacted statute, that
24is enacted before January 1, 2016, deletes or extends that date.
begin insertSection 4076 of the end insertbegin insertBusiness and Professions Codeend insert
26begin insert is amended to read:end insert
(a) A pharmacist shall not dispense any prescription
28except in a container that meets the requirements of state and
29federal law and is correctly labeled with all of the following:
30(1) Exceptbegin delete whereend deletebegin insert whenend insert the prescriber or the certified
31nurse-midwife who functions pursuant to a standardized procedure
32or protocol described in Section 2746.51, the nurse practitioner
33who functions pursuant to a standardized procedure described in
34Section 2836.1 or protocol, the physician assistant who functions
35pursuant to Section 3502.1, the naturopathic doctor who functions
36pursuant to a
standardized procedure or protocol described in
37Section 3640.5, or the pharmacist who functions pursuant to a
38policy, procedure, or protocol pursuant tobegin delete eitherend delete Sectionbegin delete 4052.1 begin insert 4052.1,end insert 4052.2begin insert, or 4052.6end insert orders otherwise, either the
39orend delete
40manufacturer’s trade name of the drug or the generic name and
P5 1the name of the manufacturer. Commonly used abbreviations may
2be used. Preparations containing two or more active ingredients
3may be identified by the manufacturer’s trade name or the
4commonly used name or the principal active ingredients.
5(2) The directions for the use of the drug.
6(3) The name of the patient or patients.
7(4) The name of the prescriber or, if applicable, the name of the
8certified nurse-midwife who functions pursuant to a standardized
9procedure or protocol described in Section 2746.51, the nurse
10practitioner who functions pursuant to a standardized procedure
11described in Section 2836.1 or protocol, the physician assistant
12who functions pursuant to Section 3502.1, the naturopathic doctor
13who functions pursuant to a standardized procedure or protocol
14described in Section 3640.5, or the pharmacist who functions
15pursuant to a policy, procedure, or protocol pursuant tobegin delete eitherend delete
16 Sectionbegin delete 4052.1 orend deletebegin insert
4052.1,end insert 4052.2begin insert, or 4052.6end insert.
17(5) The date of issue.
18(6) The name and address of the pharmacy, and prescription
19number or other means of identifying the prescription.
20(7) The strength of the drug or drugs dispensed.
21(8) The quantity of the drug or drugs dispensed.
22(9) The expiration date of the effectiveness of the drug
23dispensed.
24(10) The condition or purpose for which the drug was prescribed
25if the condition or purpose is indicated on the prescription.
26(11) (A) Commencing January 1, 2006, the physical description
27of the dispensed medication, including its color, shape, and any
28identification code that appears on the tablets or capsules, except
29as follows:
30(i) Prescriptions dispensed by a veterinarian.
31(ii) An exemption from the requirements of this paragraph shall
32be granted to a new drug for the first 120 days that the drug is on
33the market and for the 90 days during which the national reference
34file has no description on file.
35(iii) Dispensed medications for which no physical description
36exists in any commercially available database.
37(B) This paragraph applies to outpatient pharmacies only.
38(C) The information required by this paragraph may be printed
39on an auxiliary label that is affixed to the prescription container.
P6 1(D) This paragraph shall not become operative if the board,
2prior to January 1, 2006, adopts regulations that mandate the same
3labeling requirements set forth in this paragraph.
4(b) If a pharmacist dispenses a prescribed drug by means of a
5unit dose medication system, as defined by administrative
6regulation, for a patient in a skilled nursing, intermediate care, or
7other health care facility, the requirements of this section will be
8satisfied if the unit dose medication system contains the
9aforementioned information or the information is otherwise readily
10available at the time of drug administration.
11(c) If a pharmacist
dispenses a dangerous drug or device in a
12begin delete facility licensed pursuant toend deletebegin insert health facility, as defined inend insert Section
131250 of the Health and Safety Code, it is not necessary to include
14on individual unit dose containers for a specific patient, the name
15of the certified nurse-midwife who functions pursuant to a
16standardized procedure or protocol described in Section 2746.51,
17the nurse practitioner who functions pursuant to a standardized
18procedure described in Section 2836.1 or protocol, the physician
19assistant who functions pursuant to Section 3502.1, the naturopathic
20doctor who functions pursuant to a standardized procedure or
21protocol described in Section 3640.5, or the pharmacist who
22functions pursuant to a policy, procedure, or protocol pursuant to
23begin delete eitherend delete
Sectionbegin delete 4052.1 orend deletebegin insert 4052.1,end insert 4052.2begin insert, or 4052.6end insert.
24(d) If a pharmacist dispenses a prescription drug for use in a
25facility licensed pursuant to Section 1250 of the Health and Safety
26Code, it is not necessary to include the information required in
27paragraph (11) of subdivision (a) when the prescription drug is
28administered to a patient by a person licensed under the Medical
29Practice Act (Chapter 5 (commencing with Section 2000)), the
30Nursing Practice Act (Chapter 6 (commencing with Section 2700)),
31or the Vocational Nursing Practice Act (Chapter 6.5 (commencing
32with Section 2840)), who is acting within his or her scope of
33practice.
34(e) This section shall remain in effect only until January 1, 2016,
35and as of that date is repealed, unless a later enacted statute, that
36is enacted before January 1, 2016, deletes or extends that date.
Section 4076 is added to the Business and Professions
38Code, to read:
(a) A pharmacist shall not dispense any prescription
2except in a container that meets the requirements of state and
3federal law and is correctly labeled with all of the following:
4(1) Except when the prescriber or the certified nurse-midwife
5who functions pursuant to a standardized procedure or protocol
6described in Section 2746.51, the nurse practitioner who functions
7pursuant to a standardized procedure described in Section 2836.1
8or protocol, the physician assistant who functions pursuant to
9Section 3502.1, the naturopathic doctor who functions pursuant
10to a standardized procedure or protocol described in Section
113640.5, or the pharmacist who functions pursuant to a policy,
12procedure,
or protocol pursuant to either Section 4052.1 or 4052.2
13orders otherwise, either the manufacturer’s trade name of the drug
14or the generic name and the name of the manufacturer. Commonly
15used abbreviations may be used. Preparations containing two or
16more active ingredients may be identified by the manufacturer’s
17trade name or the commonly used name or the principal active
18ingredients.
19(2) The directions for the use of the drug.
20(3) The name of the patient or patients.
21(4) The name of the prescriber or, if applicable, the name of the
22certified nurse-midwife who functions pursuant to a standardized
23procedure or protocol described in Section 2746.51, the nurse
24practitioner who functions pursuant to a standardized procedure
25
described in Section 2836.1 or protocol, the physician assistant
26who functions pursuant to Section 3502.1, the naturopathic doctor
27who functions pursuant to a standardized
procedure or protocol
28described in Section 3640.5, or the pharmacist who functions
29pursuant to a policy, procedure, or protocol pursuant to either
30Section 4052.1 or 4052.2.
31(5) The date of issue.
32(6) The name and address of the pharmacy, and prescription
33number or other means of identifying the prescription.
34(7) The strength of the drug or drugs dispensed.
35(8) The quantity of the drug or drugs dispensed.
36(9) The expiration date of the effectiveness of the drug
37dispensed.
38(10) The condition or purpose for which the drug was prescribed
39if
the condition or purpose is indicated on the prescription.
P8 1(11) (A) Commencing January 1, 2006, the physical description
2of the dispensed medication, including its color, shape, and any
3identification code that appears on the tablets or capsules, except
4as follows:
5(i) Prescriptions dispensed by a veterinarian.
6(ii) An exemption from the requirements of this paragraph shall
7be granted to a new drug for the first 120 days that the drug is on
8the market and for the 90 days during which the national reference
9file has no description on file.
10(iii) Dispensed medications for which no physical description
11exists in any commercially available
database.
12(B) This paragraph applies to outpatient pharmacies only.
13(C) The information required by this paragraph may be printed
14on an auxiliary label that is affixed to the prescription container.
15(D) This paragraph shall not become operative if the board,
16prior to January 1, 2006, adopts regulations that mandate the same
17labeling requirements set forth in this paragraph.
18(b) The information required by paragraphs (1), (2), (3), (7),
19and (10) of subdivision (a) shall be printed in at least a 12-point
20typeface.
21(c) If a pharmacist dispenses a prescribed drug by means of a
22unit dose medication system, as
defined by administrative
23regulation, for a patient in a skilled nursing, intermediate care, or
24other health care facility, the requirements of this section will be
25satisfied if the unit dose medication system contains the
26
aforementioned information or the information is otherwise readily
27available at the time of drug administration.
28(d) If a pharmacist dispenses a dangerous drug or device in a
29health facility, as defined in Section 1250 of the Health and Safety
30Code, it is not necessary to include on individual unit dose
31containers for a specific patient, the name of the certified
32nurse-midwife who functions pursuant to a standardized procedure
33or protocol described in Section 2746.51, the nurse practitioner
34who functions pursuant to a standardized procedure described in
35Section 2836.1 or protocol, the physician assistant who functions
36pursuant to Section 3502.1, the naturopathic doctor who functions
37pursuant to a standardized procedure or protocol described in
38Section 3640.5, or the pharmacist who functions pursuant to a
39policy, procedure,
or protocol pursuant to either Section 4052.1
40or 4052.2.
P9 1(e) If a pharmacist dispenses a prescription drug for use in a
2facility licensed pursuant to Section 1250 of the Health and Safety
3Code, it is not necessary to include the information required in
4paragraph (11) of subdivision (a) when the prescription drug is
5administered to a patient by a person licensed under the Medical
6Practice Act (Chapter 5 (commencing with Section 2000)), the
7Nursing Practice Act (Chapter 6 (commencing with Section 2700)),
8or the Vocational Nursing Practice Act (Chapter 6.5 (commencing
9with Section 2840)), who is acting within his or her scope of
10practice.
11(f) This section shall become operative on January 1, 2016.
begin insertSection 4076 is added to the end insertbegin insertBusiness and Professions
13Codeend insertbegin insert, to read:end insert
(a) A pharmacist shall not dispense any prescription
15except in a container that meets the requirements of state and
16federal law and is correctly labeled with all of the following:
17(1) Except when the prescriber or the certified nurse-midwife
18who functions pursuant to a standardized procedure or protocol
19described in Section 2746.51, the nurse practitioner who functions
20pursuant to a standardized procedure described in Section 2836.1
21or protocol, the physician assistant who functions pursuant to
22Section 3502.1, the naturopathic doctor who functions pursuant
23to a standardized procedure or protocol described in Section
243640.5, or the pharmacist who functions pursuant to a policy,
25procedure, or protocol pursuant to Section 4052.1, 4052.2, or
264052.6 orders otherwise,
either the manufacturer’s trade name of
27the drug or the generic name and the name of the manufacturer.
28Commonly used abbreviations may be used. Preparations
29containing two or more active ingredients may be identified by the
30manufacturer’s trade name or the commonly used name or the
31principal active ingredients.
32(2) The directions for the use of the drug.
33(3) The name of the patient or patients.
34(4) The name of the prescriber or, if applicable, the name of
35the certified nurse-midwife who functions pursuant to a
36standardized procedure or protocol described in Section 2746.51,
37the nurse practitioner who functions pursuant to a standardized
38procedure described in Section 2836.1 or protocol, the physician
39assistant who functions pursuant to Section 3502.1, the
40naturopathic doctor who functions pursuant to a standardized
P10 1
procedure or protocol described in Section 3640.5, or the
2pharmacist who functions pursuant to a policy, procedure, or
3protocol pursuant to Section 4052.1, 4052.2, or 4052.6.
4(5) The date of issue.
5(6) The name and address of the pharmacy, and prescription
6number or other means of identifying the prescription.
7(7) The strength of the drug or drugs dispensed.
8(8) The quantity of the drug or drugs dispensed.
9(9) The expiration date of the effectiveness of the drug dispensed.
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
28same labeling 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
31typeface.
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,
35or other health care facility, the requirements of this section will
36be satisfied if the unit dose medication system contains the
37
aforementioned 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
P11 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 Section 4052.1, 4052.2,
11or 4052.6.
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.
22(f) This section shall become operative on January 1, 2016.
Sections 1.5 and 2.5 of this bill incorporate
24amendments to Section 4076 of the Business and Professions Code
25proposed by both this bill and Senate Bill 493. They shall only
26become operative if (1) both bills are enacted and become effective
27on or before January 1, 2014, (2) each bill amends Section 4076
28of the Business and Professions Code, and (3) this bill is enacted
29after Senate Bill 493, in which case Sections 1 and 2 of this bill
30shall not become operative.
No reimbursement is required by this act pursuant to
33Section 6 of Article XIII B of the California Constitution because
34the only costs that may be incurred by a local agency or school
35district will be incurred because this act creates a new crime or
36infraction, eliminates a crime or infraction, or changes the penalty
37for a crime or infraction, within the meaning of Section 17556 of
38the Government Code, or changes the definition of a crime within
P12 1the meaning of Section 6 of Article XIII B of the California
2Constitution.
O
95