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 requires every prescription, as defined, to include 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 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-pointbegin delete sans serifend delete
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
31pursuant to a policy, procedure, or protocol pursuant to either
32Section 4052.1 or 4052.2.
33(5) The date of issue.
34(6) The name and address of the pharmacy, and prescription
35number or other means of identifying the prescription.
P3 1(7) The strength of the drug or drugs dispensed.
2(8) The quantity of the drug or drugs dispensed.
3(9) The expiration date of the
effectiveness of the drug
4dispensed.
5(10) The condition or purpose for which the drug was prescribed
6if the condition or purpose is indicated on the prescription.
7(11) (A) Commencing January 1, 2006, the physical description
8of the dispensed medication, including its color, shape, and any
9identification code that appears on the tablets or capsules, except
10as follows:
11(i) Prescriptions dispensed by a veterinarian.
12(ii) An exemption from the requirements of this paragraph shall
13be granted to a new drug for the first 120 days that the drug is on
14the market and for the 90 days during which the national reference
15file has no description on
file.
16(iii) Dispensed medications for which no physical description
17exists in any commercially available database.
18(B) This paragraph applies to outpatient pharmacies only.
19(C) The information required by this paragraph may be printed
20on an auxiliary label that is affixed to the prescription container.
21(D) This paragraph shall not become operative if the board,
22prior to January 1, 2006, adopts regulations that mandate the same
23labeling requirements set forth in this paragraph.
24(b) The information required by paragraphs (1), (2), (3), (7),
25and (10) of subdivision (a) shall be printed in at least a 12-point
26begin delete sans serifend delete
typeface.
27(c) If a pharmacist dispenses a prescribed drug by means of a
28unit dose medication system, as defined by administrative
29regulation, for a patient in a skilled nursing, intermediate care, or
30other health care facility, the requirements of this section will be
31satisfied if the unit dose medication system contains the
32aforementioned information or the information is otherwise readily
33available at the time of drug administration.
34(d) If a pharmacist dispenses a dangerous drug or device in a
35health facility, as defined in Section 1250 of the Health and Safety
36Code, it is not necessary to include on individual unit dose
37containers for a specific patient, the name of the certified
38nurse-midwife who functions pursuant to a standardized procedure
39or
protocol described in Section 2746.51, the nurse practitioner
40who functions pursuant to a standardized procedure described in
P4 1Section 2836.1 or protocol, the physician assistant who functions
2pursuant to Section 3502.1, the naturopathic doctor who functions
3pursuant to a standardized procedure or protocol described in
4Section 3640.5, or the pharmacist who functions pursuant to a
5policy, procedure, or protocol pursuant to either Section 4052.1
6or 4052.2.
7(e) If a pharmacist dispenses a prescription drug for use in a
8facility licensed pursuant to Section 1250 of the Health and Safety
9Code, it is not necessary to include the information required in
10paragraph (11) of subdivision (a) when the prescription drug is
11administered to a patient by a person licensed under the Medical
12Practice Act (Chapter 5 (commencing with Section 2000)), the
13Nursing
Practice Act (Chapter 6 (commencing with Section 2700)),
14or the Vocational Nursing Practice Act (Chapter 6.5 (commencing
15with Section 2840)), who is acting within his or her scope of
16practice.
No reimbursement is required by this act pursuant to
18Section 6 of Article XIII B of the California Constitution because
19the only costs that may be incurred by a local agency or school
20district will be incurred because this act creates a new crime or
21infraction, eliminates a crime or infraction, or changes the penalty
22for a crime or infraction, within the meaning of Section 17556 of
23the Government Code, or changes the definition of a crime within
24the meaning of Section 6 of Article XIII B of the California
25Constitution.
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