Amended in Senate September 1, 2015

Amended in Senate July 8, 2015

Amended in Senate June 9, 2015

Amended in Assembly April 28, 2015

Amended in Assembly April 6, 2015

California Legislature—2015–16 Regular Session

Assembly BillNo. 1073


Introduced by Assembly Member Ting

February 27, 2015


An act to amendbegin delete Sectionend deletebegin insert Sections 4076 andend insert 4199 of, and to add Section 4076.6 to, the Business and Professions Code, relating to pharmacy.

LEGISLATIVE COUNSEL’S DIGEST

AB 1073, as amended, Ting. Pharmacy: prescription drug labels.

The Pharmacy Law provides for the licensure and regulation of pharmacists by the California State Board of Pharmacy. That law requiresbegin insert a pharmacist to dispense a prescription in a container that, among other things, is correctly labeled with the directions for use of the drug, and requiresend insert the board to promulgate regulations that require, on or before January 1, 2011, a standardized, patient-centered, prescription drug label on all prescription medicine dispensed to patients in California. Existing regulations of the board implement that requirement, establishing standardized directions for use to be used when applicable, and requiring that the board publish on its Internet Web site translation of those directions for use into at least 5 languages other than English. A violation of that law is a crime.

This bill would require abegin insert pharmacist to use professional judgment in determining the content of the directions for use of a prescription. The bill would also require aend insert dispenser, excluding a veterinarian, upon the request of a patient or patient’s representative, to provide translated directions for use as prescribed. The bill would authorize a dispenser to use translations made available by the board pursuant to those existing regulations. The bill would make a dispenser responsible for the accuracy of English-language directions for use provided to the patient. By imposing new requirements on dispensers, the violation of which would be a crime, this bill would impose a state-mandated local program.

The Pharmacy Law also provides for the licensure and regulation of veterinary food-animal drug retailers by the board. That law subjects to specific prescription drug labeling requirements any veterinary food-animal drug dispensed pursuant to a prescription from a licensed veterinarian for food-producing animals from a veterinary food-animal drug retailer pursuant to that law.

This bill would also subject any veterinary food-animal drug so dispensed to the above drug labeling requirements relating to standardized directions for use.

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:

P2    1begin insert

begin insertSECTION 1.end insert  

end insert

begin insertSection 4076 of the end insertbegin insertBusiness and Professions
2Code
end insert
begin insert is amended to read:end insert

3

4076.  

(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
P3    1pursuant to a standardized procedure described in Section 2836.1
2or protocol, the physician assistant who functions pursuant to
3Section 3502.1, the naturopathic doctor who functions pursuant
4to a standardized procedure or protocol described in Section
53640.5, or the pharmacist who functions pursuant to a policy,
6procedure, or protocol pursuant to Section 4052.1, 4052.2, or
74052.6 orders otherwise, either the manufacturer’s trade name of
8the drug or the generic name and the name of the manufacturer.
9Commonly used abbreviations may be used. Preparations
10containing two or more active ingredients may be identified by
11the manufacturer’s trade name or the commonly used name or the
12principal active ingredients.

13(2) The directions for the use of the drug.

14(3) The name of the patient or patients.

15(4) The name of the prescriber or, if applicable, the name of the
16certified nurse-midwife who functions pursuant to a standardized
17procedure or protocol described in Section 2746.51, the nurse
18practitioner who functions pursuant to a standardized procedure
19described in Section 2836.1 or protocol, the physician assistant
20who functions pursuant to Section 3502.1, the naturopathic doctor
21who functions pursuant to a standardized procedure or protocol
22described in Section 3640.5, or the pharmacist who functions
23pursuant to a policy, procedure, or protocol pursuant to Section
244052.1, 4052.2, or 4052.6.

25(5) The date of issue.

26(6) The name and address of the pharmacy, and prescription
27number or other means of identifying the prescription.

28(7) The strength of the drug or drugs dispensed.

29(8) The quantity of the drug or drugs dispensed.

30(9) The expiration date of the effectiveness of the drug
31dispensed.

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
P4    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 same
10labeling requirements set forth in this paragraph.

11(b) If a pharmacist dispenses a prescribed drug by means of a
12unit dose medication system, as defined by administrative
13regulation, for a patient in a skilled nursing, intermediate care, or
14other health care facility, the requirements of this section will be
15satisfied if the unit dose medication system contains the
16aforementioned information or the information is otherwise readily
17available at the time of drug administration.

18(c) If a pharmacist dispenses a dangerous drug or device in a
19facility licensed pursuant to Section 1250 of the Health and Safety
20Code, it is not necessary to include on individual unit dose
21containers for a specific patient, the name of the certified
22nurse-midwife who functions pursuant to a standardized procedure
23or protocol described in Section 2746.51, the nurse practitioner
24who functions pursuant to a standardized procedure described in
25Section 2836.1 or protocol, the physician assistant who functions
26pursuant to Section 3502.1, the naturopathic doctor who functions
27pursuant to a standardized procedure or protocol described in
28Section 3640.5, or the pharmacist who functions pursuant to a
29policy, procedure, or protocol pursuant to Section 4052.1, 4052.2,
30or 4052.6.

31(d) If a pharmacist dispenses a prescription drug for use in a
32facility licensed pursuant to Section 1250 of the Health and Safety
33Code, it is not necessary to include the information required in
34 paragraph (11) of subdivision (a) when the prescription drug is
35administered to a patient by a person licensed under the Medical
36Practice Act (Chapter 5 (commencing with Section 2000)), the
37Nursing Practice Act (Chapter 6 (commencing with Section 2700)),
38or the Vocational Nursing Practice Act (Chapter 6.5 (commencing
39with Section 2840)), who is acting within his or her scope of
40practice.

begin insert

P5    1(e) A pharmacist shall use professional judgment in determining
2the content of the directions for use.

end insert
3

begin deleteSECTION 1.end delete
4begin insertSEC. 2.end insert  

Section 4076.6 is added to the Business and Professions
5Code
, to read:

6

4076.6.  

(a) Upon the request of a patient or patient’s
7representative, a dispenser shall provide translated directions for
8use, which shall be printed on the prescription container, label, or
9on a supplemental document.begin insert If translated directions for use appear
10on a prescription container or label, the English-language version
11of the directions for use shall also appear on the container or
12label, whenever possible, and may appear on other areas of the
13label outside the patient-centered area. When it is not possible for
14the English-language directions for use to appear on the container
15or label, it shall be provided on a supplemental document.end insert

16(b) A dispenser may use translations made available by the
17board pursuant to subdivision (b) of Section 1707.5 of Title 16 of
18the California Code of Regulations to comply with this section.

19(c) A dispenser shall not be required to provide translated
20directions for use beyond the languages that the board has made
21available or beyond the directions that the board has made available
22in translated form.

23(d) begin deleteNothing end deletebegin insertA dispenser may provide his or her own translated
24directions for use to comply with the requirements of this section,
25and nothing end insert
in this section shall be construed to prohibit a dispenser
26from providing translated directions for use in languages beyond
27those that the board has made available or beyond the directions
28that the board has made available in translated form.

29(e) A dispenser shall be responsible for the accuracy of the
30English-language directions for use provided to the patient.begin insert This
31section shall not affect a dispenser’s existing responsibility to
32correctly label a prescription pursuant to Section 4076.end insert

33(f) For purposes of this section, a dispenser does not include a
34veterinarian.

35

begin deleteSEC. 2.end delete
36begin insertSEC. 3.end insert  

Section 4199 of the Business and Professions Code is
37amended to read:

38

4199.  

(a) Any veterinary food-animal drug dispensed pursuant
39to a prescription from a licensed veterinarian for food producing
40animals from a veterinary food-animal drug retailer pursuant to
P6    1this chapter is subject to the labeling requirements of Sections
24076, 4076.6, and 4077.

3(b) All prescriptions filled by a veterinary food-animal drug
4retailer shall be kept on file and maintained for at least three years
5in accordance with Section 4333.

6

begin deleteSEC. 3.end delete
7begin insertSEC. 4.end insert  

No reimbursement is required by this act pursuant to
8Section 6 of Article XIII B of the California Constitution because
9the only costs that may be incurred by a local agency or school
10district will be incurred because this act creates a new crime or
11infraction, eliminates a crime or infraction, or changes the penalty
12for a crime or infraction, within the meaning of Section 17556 of
13the Government Code, or changes the definition of a crime within
14the meaning of Section 6 of Article XIII B of the California
15Constitution.



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