Amended in Assembly September 6, 2013

Amended in Assembly September 3, 2013

Amended in Assembly August 19, 2013

Amended in Assembly August 5, 2013

Amended in Senate May 28, 2013

Amended in Senate April 24, 2013

Amended in Senate April 1, 2013

Senate BillNo. 493


Introduced by Senator Hernandez

February 21, 2013


An act to amend Sections 733, 4040, 4050, 4051, 4052, 4052.3, 4060, 4076, 4111, and 4174 of, and to add Sections 4016.5, 4052.6, 4052.8, 4052.9, 4210, and 4233 to, the Business and Professions Code, relating to pharmacy.

LEGISLATIVE COUNSEL’S DIGEST

SB 493, as amended, Hernandez. Pharmacy practice.

The Pharmacy Law provides for the licensing and regulation of pharmacists by the California State Board of Pharmacy in the Department of Consumer Affairs. The law specifies the functions pharmacists are authorized to perform, including to administer, orally or topically, drugs and biologicals pursuant to a prescriber’s order, and to administer immunizations pursuant to a protocol with a prescriber. Pharmacists may also furnish emergency contraception drug therapy pursuant to standardized procedures if they have completed a training program. A violation of the Pharmacy Law is a crime.

This bill, instead, would authorize a pharmacist to administer drugs and biological products that have been ordered by a prescriber. The bill would authorize pharmacists to perform other functions, including, among other things, to furnish self-administered hormonal contraceptives, nicotine replacement products, and prescription medications not requiring a diagnosis that are recommended for international travelers, as specified. Additionally, the bill would authorize pharmacists to order and interpret tests for the purpose of monitoring and managing the efficacy and toxicity of drug therapies, and to independently initiate and administer routine vaccinations, as specified. This bill also would establish board recognition for an advanced practice pharmacist, as defined, would specify the criteria for that recognition, and would specify additional functions that may be performed by an advanced practice pharmacist, including, among other things, performing patient assessments, and certain other functions, as specified. The bill would authorize the board, by regulation, to set the fee for the issuance and renewal of advanced practice pharmacist recognition at the reasonable cost of regulating advanced practice pharmacists pursuant to these provisions, not to exceed $300.

Because a violation of these provisions would be a crime, the bill would impose a state-mandated local program.

The bill would make other conforming and technical changes.

begin insert

This bill would incorporate additional changes in Section 4076 of the Business and Professions Code proposed by SB 205, that would become operative only if SB 205 and this bill are both chaptered and become effective on or before January 1, 2014, and this bill is chaptered last.

end insert

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    1

SECTION 1.  

Section 733 of the Business and Professions Code
2 is amended to read:

P3    1

733.  

(a) A licentiate shall not obstruct a patient in obtaining
2a prescription drug or device that has been legally prescribed or
3ordered for that patient. A violation of this section constitutes
4unprofessional conduct by the licentiate and shall subject the
5licentiate to disciplinary or administrative action by his or her
6licensing agency.

7(b) Notwithstanding any other law, a licentiate shall dispense
8drugs and devices, as described in subdivision (a) of Section 4024,
9pursuant to a lawful order or prescription unless one of the
10following circumstances exists:

11(1) Based solely on the licentiate’s professional training and
12judgment, dispensing pursuant to the order or the prescription is
13contrary to law, or the licentiate determines that the prescribed
14drug or device would cause a harmful drug interaction or would
15otherwise adversely affect the patient’s medical condition.

16(2) The prescription drug or device is not in stock. If an order,
17other than an order described in Section 4019, or prescription
18cannot be dispensed because the drug or device is not in stock, the
19licentiate shall take one of the following actions:

20(A) Immediately notify the patient and arrange for the drug or
21device to be delivered to the site or directly to the patient in a
22timely manner.

23(B) Promptly transfer the prescription to another pharmacy
24known to stock the prescription drug or device that is near enough
25to the site from which the prescription or order is transferred, to
26ensure the patient has timely access to the drug or device.

27(C) Return the prescription to the patient and refer the patient.
28The licentiate shall make a reasonable effort to refer the patient to
29a pharmacy that stocks the prescription drug or device that is near
30enough to the referring site to ensure that the patient has timely
31access to the drug or device.

32(3) The licentiate refuses on ethical, moral, or religious grounds
33to dispense a drug or device pursuant to an order or prescription.
34A licentiate may decline to dispense a prescription drug or device
35 on this basis only if the licentiate has previously notified his or
36her employer, in writing, of the drug or class of drugs to which he
37or she objects, and the licentiate’s employer can, without creating
38undue hardship, provide a reasonable accommodation of the
39licentiate’s objection. The licentiate’s employer shall establish
40protocols that ensure that the patient has timely access to the
P4    1prescribed drug or device despite the licentiate’s refusal to dispense
2the prescription or order. For purposes of this section, “reasonable
3accommodation” and “undue hardship” shall have the same
4meaning as applied to those terms pursuant to subdivision (l) of
5Section 12940 of the Government Code.

6(c) For the purposes of this section, “prescription drug or device”
7has the same meaning as the definition in Section 4022.

8(d) This section applies to emergency contraception drug therapy
9and self-administered hormonal contraceptives described in Section
104052.3.

11(e) This section imposes no duty on a licentiate to dispense a
12drug or device pursuant to a prescription or order without payment
13for the drug or device, including payment directly by the patient
14or through a third-party payer accepted by the licentiate or payment
15of any required copayment by the patient.

16(f) The notice to consumers required by Section 4122 shall
17include a statement that describes patients’ rights relative to the
18requirements of this section.

19

SEC. 2.  

Section 4016.5 is added to the Business and Professions
20Code
, to read:

21

4016.5.  

“Advanced practice pharmacist” means a licensed
22pharmacist who has been recognized as an advanced practice
23pharmacist by the board, pursuant to Section 4210. A
24board-recognized advanced practice pharmacist is entitled to
25practice advanced practice pharmacy, as described in Section
264052.6, within or outside of a licensed pharmacy as authorized by
27this chapter.

28

SEC. 3.  

Section 4040 of the Business and Professions Code is
29amended to read:

30

4040.  

(a) “Prescription” means an oral, written, or electronic
31transmission order that is both of the following:

32(1) Given individually for the person or persons for whom
33ordered that includes all of the following:

34(A) The name or names and address of the patient or patients.

35(B) The name and quantity of the drug or device prescribed and
36the directions for use.

37(C) The date of issue.

38(D) Either rubber stamped, typed, or printed by hand or typeset,
39the name, address, and telephone number of the prescriber, his or
P5    1her license classification, and his or her federal registry number,
2if a controlled substance is prescribed.

3(E) A legible, clear notice of the condition or purpose for which
4the drug is being prescribed, if requested by the patient or patients.

5(F) If in writing, signed by the prescriber issuing the order, or
6the certified nurse-midwife, nurse practitioner, physician assistant,
7or naturopathic doctor who issues a drug order pursuant to Section
82746.51, 2836.1, 3502.1, or 3640.5, respectively, or the pharmacist
9who issues a drug order pursuant to Section 4052.1, 4052.2, or
104052.6.

11(2) Issued by a physician, dentist, optometrist, podiatrist,
12veterinarian, or naturopathic doctor pursuant to Section 3640.7 or,
13if a drug order is issued pursuant to Section 2746.51, 2836.1,
143502.1, or 3460.5, by a certified nurse-midwife, nurse practitioner,
15physician assistant, or naturopathic doctor licensed in this state,
16or pursuant to Section 4052.1, 4052.2, or 4052.6 by a pharmacist
17licensed in this state.

18(b) Notwithstanding subdivision (a), a written order of the
19prescriber for a dangerous drug, except for any Schedule II
20controlled substance, that contains at least the name and signature
21of the prescriber, the name and address of the patient in a manner
22consistent with paragraph (2) of subdivision (a) of Section 11164
23of the Health and Safety Code, the name and quantity of the drug
24prescribed, directions for use, and the date of issue may be treated
25as a prescription by the dispensing pharmacist as long as any
26additional information required by subdivision (a) is readily
27retrievable in the pharmacy. In the event of a conflict between this
28subdivision and Section 11164 of the Health and Safety Code,
29Section 11164 of the Health and Safety Code shall prevail.

30(c) “Electronic transmission prescription” includes both image
31and data prescriptions. “Electronic image transmission
32prescription” means any prescription order for which a facsimile
33of the order is received by a pharmacy from a licensed prescriber.
34“Electronic data transmission prescription” means any prescription
35order, other than an electronic image transmission prescription,
36that is electronically transmitted from a licensed prescriber to a
37pharmacy.

38(d) The use of commonly used abbreviations shall not invalidate
39an otherwise valid prescription.

P6    1(e) Nothing in the amendments made to this section (formerly
2Section 4036) at the 1969 Regular Session of the Legislature shall
3be construed as expanding or limiting the right that a chiropractor,
4while acting within the scope of his or her license, may have to
5prescribe a device.

6

SEC. 4.  

Section 4050 of the Business and Professions Code is
7amended to read:

8

4050.  

(a) In recognition of and consistent with the decisions
9of the appellate courts of this state, the Legislature hereby declares
10the practice of pharmacy to be a profession.

11(b) Pharmacy practice is a dynamic, patient-oriented health
12service that applies a scientific body of knowledge to improve and
13promote patient health by means of appropriate drug use,
14drug-related therapy, and communication for clinical and
15consultative purposes. Pharmacy practice is continually evolving
16to include more sophisticated and comprehensive patient care
17activities.

18(c) The Legislature further declares that pharmacists are health
19care providers who have the authority to provide health care
20services.

21

SEC. 5.  

Section 4051 of the Business and Professions Code is
22amended to read:

23

4051.  

(a) Except as otherwise provided in this chapter, it is
24unlawful for any person to manufacture, compound, furnish, sell,
25or dispense a dangerous drug or dangerous device, or to dispense
26or compound a prescription pursuant to Section 4040 of a prescriber
27unless he or she is a pharmacist under this chapter.

28(b) Notwithstanding any other law, a pharmacist may authorize
29the initiation of a prescription, pursuant to Section 4052.1, 4052.2,
304052.3, or 4052.6, and otherwise provide clinical advice, services,
31information, or patient consultation, as set forth in this chapter, if
32all of the following conditions are met:

33(1) The clinical advice, services, information, or patient
34consultation is provided to a health care professional or to a patient.

35(2) The pharmacist has access to prescription, patient profile,
36or other relevant medical information for purposes of patient and
37clinical consultation and advice.

38(3) Access to the information described in paragraph (2) is
39secure from unauthorized access and use.

P7    1

SEC. 6.  

Section 4052 of the Business and Professions Code is
2amended to read:

3

4052.  

(a) Notwithstanding any other law, a pharmacist may:

4(1) Furnish a reasonable quantity of compounded drug product
5to a prescriber for office use by the prescriber.

6(2) Transmit a valid prescription to another pharmacist.

7(3) Administer drugs and biological products that have been
8ordered by a prescriber.

9(4) Perform procedures or functions in a licensed health care
10facility as authorized by Section 4052.1.

11(5) Perform procedures or functions as part of the care provided
12by a health care facility, a licensed home health agency, a licensed
13clinic in which there is a physician oversight, a provider who
14contracts with a licensed health care service plan with regard to
15the care or services provided to the enrollees of that health care
16service plan, or a physician, as authorized by Section 4052.2.

17(6) Perform procedures or functions as authorized by Section
184052.6.

19(7) Manufacture, measure, fit to the patient, or sell and repair
20dangerous devices, or furnish instructions to the patient or the
21patient’s representative concerning the use of those devices.

22(8) Provide consultation, training, and education to patients
23 about drug therapy, disease management, and disease prevention.

24(9) Provide professional information, including clinical or
25pharmacological information, advice, or consultation to other
26health care professionals, and participate in multidisciplinary
27review of patient progress, including appropriate access to medical
28records.

29(10) Furnish the medications described in subparagraph (A) in
30accordancebegin insert withend insert subparagraph (B):

31(A) (1) Emergency contraception drug therapy and
32self-administered hormonal contraceptives, as authorized by
33Section 4052.3.

34(2) Nicotine replacement products, as authorized by Section
354052.9.

36(3) Prescription medications not requiring a diagnosis that are
37recommended by the federal Centers for Disease Control and
38Prevention for individuals traveling outside of the United States.

39(B) The pharmacist shall notify the patient’s primary care
40provider of any drugs or devices furnished to the patient, or enter
P8    1the appropriate information in a patient record system shared with
2the primary care provider, as permitted by that primary care
3provider. If the patient does not have a primary care provider, the
4pharmacist shall provide the patient with a written record of the
5drugs or devices furnished and advise the patient to consult a
6physician of the patient’s choice.

7(11) Administer immunizations pursuant to a protocol with a
8prescriber.

9(12) Order and interpret tests for the purpose of monitoring and
10managing the efficacy and toxicity of drug therapies. A pharmacist
11who orders and interprets tests pursuant to this paragraph shall
12ensure that the ordering of those tests is done in coordination with
13the patient’s primary care provider or diagnosing prescriber, as
14appropriate, including promptly transmitting written notification
15to the patient’s diagnosing prescriber or entering the appropriate
16information in a patient record system shared with the prescriber,
17when available and as permitted by that prescriber.

18(b) A pharmacist who is authorized to issue an order to initiate
19or adjust a controlled substance therapy pursuant to this section
20shall personally register with the federal Drug Enforcement
21Administration.

22(c) This section does not affect the applicable requirements of
23law relating to either of the following:

24(1) Maintaining the confidentiality of medical records.

25(2) The licensing of a health care facility.

26

SEC. 7.  

Section 4052.3 of the Business and Professions Code
27 is amended to read:

28

4052.3.  

(a) (1) Notwithstanding any other law, a pharmacist
29may furnish self-administered hormonal contraceptives in
30accordance with standardized procedures or protocols developed
31and approved by both the board and the Medical Board of
32California in consultation with the American Congress of
33Obstetricians and Gynecologists, the California Pharmacists
34Association, and other appropriate entities. The standardized
35procedure or protocol shall require that the patient use a
36self-screening tool that will identify patient risk factors for use of
37self-administered hormonal contraceptives, based on the current
38United States Medical Eligibility Criteria (USMEC) for
39Contraceptive Use developed by the federal Centers for Disease
40Control and Prevention, and that the pharmacist refer the patient
P9    1to the patient’s primary care provider or, if the patient does not
2have a primary care provider, to nearby clinics, upon furnishing a
3self-administered hormonal contraceptive pursuant to this
4subdivision, or if it is determined that use of a self-administered
5hormonal contraceptive is not recommended.

6(2) The board and the Medical Board of California are both
7authorized to ensure compliance with this subdivision, and each
8board is specifically charged with the enforcement of this
9subdivision with respect to its respective licensees. This subdivision
10does not expand the authority of a pharmacist to prescribe any
11prescription medication.

12(b) (1) Notwithstanding any other law, a pharmacist may furnish
13emergency contraception drug therapy in accordance with either
14of the following:

15(A) Standardized procedures or protocols developed by the
16pharmacist and an authorized prescriber who is acting within his
17or her scope of practice.

18(B) Standardized procedures or protocols developed and
19 approved by both the board and the Medical Board of California
20in consultation with the American Congress of Obstetricians and
21Gynecologists, the California Pharmacists Association, and other
22appropriate entities. The board and the Medical Board of California
23are both authorized to ensure compliance with this clause, and
24each board is specifically charged with the enforcement of this
25provision with respect to its respective licensees. This subdivision
26does not expand the authority of a pharmacist to prescribe any
27prescription medication.

28(2) Prior to performing a procedure authorized under this
29subdivision, a pharmacist shall complete a training program on
30emergency contraception that consists of at least one hour of
31approved continuing education on emergency contraception drug
32therapy.

33(3) A pharmacist, pharmacist’s employer, or pharmacist’s agent
34shall not directly charge a patient a separate consultation fee for
35emergency contraception drug therapy services initiated pursuant
36to this subdivision, but may charge an administrative fee not to
37exceed ten dollars ($10) above the retail cost of the drug. Upon an
38oral, telephonic, electronic, or written request from a patient or
39customer, a pharmacist or pharmacist’s employee shall disclose
40the total retail price that a consumer would pay for emergency
P10   1contraception drug therapy. As used in this paragraph, total retail
2price includes providing the consumer with specific information
3regarding the price of the emergency contraception drugs and the
4price of the administrative fee charged. This limitation is not
5intended to interfere with other contractually agreed-upon terms
6between a pharmacist, a pharmacist’s employer, or a pharmacist’s
7agent, and a health care service plan or insurer. Patients who are
8insured or covered and receive a pharmacy benefit that covers the
9cost of emergency contraception shall not be required to pay an
10administrative fee. These patients shall be required to pay
11copayments pursuant to the terms and conditions of their coverage.
12This paragraph shall become inoperative for dedicated emergency
13contraception drugs if these drugs are reclassified as
14over-the-counter products by the federal Food and Drug
15Administration.

16(4) A pharmacist shall not require a patient to provide
17individually identifiable medical information that is not specified
18in Section 1707.1 of Title 16 of the California Code of Regulations
19before initiating emergency contraception drug therapy pursuant
20to this subdivision.

21(c) For each emergency contraception drug therapy or
22self-administered hormonal contraception initiated pursuant to this
23section, the pharmacist shall provide the recipient of the drug with
24a standardized factsheet that includes, but is not limited to, the
25indications and contraindications for use of the drug, the
26appropriate method for using the drug, the need for medical
27followup, and other appropriate information. The board shall
28develop this form in consultation with the State Department of
29Public Health, the American Congress of Obstetricians and
30Gynecologists, the California Pharmacists Association, and other
31health care organizations. This section does not preclude the use
32of existing publications developed by nationally recognized
33medical organizations.

34

SEC. 8.  

Section 4052.6 is added to the Business and Professions
35Code
, to read:

36

4052.6.  

(a) A pharmacist recognized by the board as an
37advanced practice pharmacist may do all of the following:

38(1) Perform patient assessments.

39(2) Order and interpret drug therapy-related tests.

40(3) Refer patients to other health care providers.

P11   1(4) Participate in the evaluation and management of diseases
2and health conditions in collaboration with other health care
3providers.

4(5) Initiate, adjust, or discontinue drug therapy in the manner
5specified in paragraph (4) of subdivision (a) of Section 4052.2.

6(b) A pharmacist who adjusts or discontinues drug therapy shall
7promptly transmit written notification to the patient’s diagnosing
8prescriber or enter the appropriate information in a patient record
9system shared with the prescriber, as permitted by that prescriber.
10A pharmacist who initiates drug therapy shall promptly transmit
11written notification to, or enter the appropriate information into,
12a patient record system shared with the patient’s primary care
13provider or diagnosing provider, as permitted by that provider.

14(c) This section shall not interfere with a physician’s order to
15dispense a prescription drug as written, or other order of similar
16meaning.

17(d) Prior to initiating or adjusting a controlled substance therapy
18pursuant to this section, a pharmacist shall personally register with
19the federal Drug Enforcement Administration.

20(e) A pharmacist who orders and interprets tests pursuant to
21paragraph (2) of subdivision (a) shall ensure that the ordering of
22those tests is done in coordination with the patient’s primary care
23provider or diagnosing prescriber, as appropriate, including
24promptly transmitting written notification to the patient’s
25diagnosing prescriber or entering the appropriate information in a
26patient record system shared with the prescriber, when available
27and as permitted by that prescriber.

28

SEC. 9.  

Section 4052.8 is added to the Business and Professions
29Code
, to read:

30

4052.8.  

(a) In addition to the authority provided in paragraph
31(11) of subdivision (a) of Section 4052, a pharmacist may
32independently initiate and administer vaccines listed on the routine
33immunization schedules recommended by the federal Advisory
34Committee on Immunization Practices (ACIP), in compliance with
35individual ACIP vaccine recommendations, and published by the
36federal Centers for Disease Control and Prevention (CDC) for
37persons three years of age and older.

38(b) In order to initiate and administer an immunization described
39in subdivision (a), a pharmacist shall do all of the following:

P12   1(1) Complete an immunization training program endorsed by
2the CDC or the Accreditation Council for Pharmacy Education
3that, at a minimum, includes hands-on injection technique, clinical
4evaluation of indications and contraindications of vaccines, and
5the recognition and treatment of emergency reactions to vaccines,
6and shall maintain that training.

7(2) Be certified in basic life support.

8(3) Comply with all state and federal recordkeeping and
9reporting requirements, including providing documentation to the
10patient’s primary care provider and entering information in the
11appropriate immunization registry designated by the immunization
12branch of the State Department of Public Health.

13(c) A pharmacist administering immunizations pursuant to this
14section, or paragraph (11) of subdivision (a) of Section 4052, may
15also initiate and administer epinephrine or diphenhydramine by
16injection for the treatment of a severe allergic reaction.

17

SEC. 10.  

Section 4052.9 is added to the Business and
18Professions Code
, to read:

19

4052.9.  

(a) A pharmacist may furnish nicotine replacement
20products approved by the federal Food and Drug Administration
21for use by prescription only in accordance with standardized
22procedures and protocols developed and approved by both the
23board and the Medical Board of California in consultation with
24other appropriate entities and provide smoking cessation services
25if all of the following conditions are met:

26(1) The pharmacist maintains records of all prescription drugs
27and devices furnished for a period of at least three years for
28purposes of notifying other health care providers and monitoring
29the patient.

30(2) The pharmacist notifies the patient’s primary care provider
31of any drugs or devices furnished to the patient, or enters the
32appropriate information in a patient record system shared with the
33primary care provider, as permitted by that primary care provider.
34If the patient does not have a primary care provider, the pharmacist
35provides the patient with a written record of the drugs or devices
36furnished and advises the patient to consult a physician of the
37patient’s choice.

38(3) The pharmacist is certified in smoking cessation therapy by
39an organization recognized by the board.

P13   1(4) The pharmacist completes one hour of continuing education
2focused on smoking cessation therapy biennially.

3(b) The board and the Medical Board of California are both
4authorized to ensure compliance with this section, and each board
5is specifically charged with the enforcement of this section with
6respect to their respective licensees. Nothing in this section shall
7be construed to expand the authority of a pharmacist to prescribe
8any other prescription medication.

9

SEC. 11.  

Section 4060 of the Business and Professions Code
10 is amended to read:

11

4060.  

A person shall not possess any controlled substance,
12except that furnished to a person upon the prescription of a
13physician, dentist, podiatrist, optometrist, veterinarian, or
14naturopathic doctor pursuant to Section 3640.7, or furnished
15pursuant to a drug order issued by a certified nurse-midwife
16pursuant to Section 2746.51, a nurse practitioner pursuant to
17Section 2836.1, a physician assistant pursuant to Section 3502.1,
18a naturopathic doctor pursuant to Section 3640.5, or a pharmacist
19pursuant to Section 4052.1, 4052.2, or 4052.6. This section does
20not apply to the possession of any controlled substance by a
21manufacturer, wholesaler, pharmacy, pharmacist, physician,
22podiatrist, dentist, optometrist, veterinarian, naturopathic doctor,
23certified nurse-midwife, nurse practitioner, or physician assistant,
24if in stock in containers correctly labeled with the name and address
25of the supplier or producer.

26This section does not authorize a certified nurse-midwife, a nurse
27practitioner, a physician assistant, or a naturopathic doctor, to order
28his or her own stock of dangerous drugs and devices.

29

SEC. 12.  

Section 4076 of the Business and Professions Code
30 is amended to read:

31

4076.  

(a) A pharmacist shall not dispense any prescription
32except in a container that meets the requirements of state and
33federal law and is correctly labeled with all of the following:

34(1) Except when the prescriber or the certified nurse-midwife
35who functions pursuant to a standardized procedure or protocol
36described in Section 2746.51, the nurse practitioner who functions
37pursuant to a standardized procedure described in Section 2836.1
38or protocol, the physician assistant who functions pursuant to
39Section 3502.1, the naturopathic doctor who functions pursuant
40to a standardized procedure or protocol described in Section
P14   13640.5, or the pharmacist who functions pursuant to a policy,
2 procedure, or protocol pursuant to Section 4052.1, 4052.2, or
34052.6 orders otherwise, either the manufacturer’s trade name of
4the drug or the generic name and the name of the manufacturer.
5Commonly used abbreviations may be used. Preparations
6containing two or more active ingredients may be identified by
7the manufacturer’s trade name or the commonly used name or the
8principal active ingredients.

9(2) The directions for the use of the drug.

10(3) The name of the patient or patients.

11(4) The name of the prescriber or, if applicable, the name of the
12certified nurse-midwife who functions pursuant to a standardized
13procedure or protocol described in Section 2746.51, the nurse
14practitioner who functions pursuant to a standardized procedure
15described in Section 2836.1 or protocol, the physician assistant
16who functions pursuant to Section 3502.1, the naturopathic doctor
17who functions pursuant to a standardized procedure or protocol
18described in Section 3640.5, or the pharmacist who functions
19pursuant to a policy, procedure, or protocol pursuant to Section
204052.1, 4052.2, or 4052.6.

21(5) The date of issue.

22(6) The name and address of the pharmacy, and prescription
23number or other means of identifying the prescription.

24(7) The strength of the drug or drugs dispensed.

25(8) The quantity of the drug or drugs dispensed.

26(9) The expiration date of the effectiveness of the drug
27dispensed.

28(10) The condition or purpose for which the drug was prescribed
29if the condition or purpose is indicated on the prescription.

30(11) (A) Commencing January 1, 2006, the physical description
31of the dispensed medication, including its color, shape, and any
32identification code that appears on the tablets or capsules, except
33as follows:

34(i) Prescriptions dispensed by a veterinarian.

35(ii) An exemption from the requirements of this paragraph shall
36be granted to a new drug for the first 120 days that the drug is on
37the market and for the 90 days during which the national reference
38file has no description on file.

39(iii) Dispensed medications for which no physical description
40exists in any commercially available database.

P15   1(B) This paragraph applies to outpatient pharmacies only.

2(C) The information required by this paragraph may be printed
3on an auxiliary label that is affixed to the prescription container.

4(D) This paragraph shall not become operative if the board,
5prior to January 1, 2006, adopts regulations that mandate the same
6labeling requirements set forth in this paragraph.

7(b) If a pharmacist dispenses a prescribed drug by means of a
8unit dose medication system, as defined by administrative
9regulation, for a patient in a skilled nursing, intermediate care, or
10other health care facility, the requirements of this section will be
11satisfied if the unit dose medication system contains the
12aforementioned information or the information is otherwise readily
13available at the time of drug administration.

14(c) If a pharmacist dispenses a dangerous drug or device in a
15facility licensed pursuant to Section 1250 of the Health and Safety
16Code, it is not necessary to include on individual unit dose
17containers for a specific patient, the name of the certified
18nurse-midwife who functions pursuant to a standardized procedure
19or protocol described in Section 2746.51, the nurse practitioner
20who functions pursuant to a standardized procedure described in
21Section 2836.1 or protocol, the physician assistant who functions
22pursuant to Section 3502.1, the naturopathic doctor who functions
23pursuant to a standardized procedure or protocol described in
24Section 3640.5, or the pharmacist who functions pursuant to a
25policy, procedure, or protocol pursuant to Section 4052.1, 4052.2,
26or 4052.6.

27(d) If a pharmacist dispenses a prescription drug for use in a
28facility licensed pursuant to Section 1250 of the Health and Safety
29Code, it is not necessary to include the information required in
30paragraph (11) of subdivision (a) when the prescription drug is
31administered to a patient by a person licensed under the Medical
32Practice Act (Chapter 5 (commencing with Section 2000)), the
33Nursing Practice Act (Chapter 6 (commencing with Section 2700)),
34or the Vocational Nursing Practice Act (Chapter 6.5 (commencing
35with Section 2840)), who is acting within his or her scope of
36 practice.

37begin insert

begin insertSEC. 12.5.end insert  

end insert

begin insertSection 4076 of the end insertbegin insertBusiness and Professions Codeend insert
38begin insert is amended to read:end insert

P16   1

4076.  

(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) Exceptbegin delete whereend deletebegin insert whenend insert the prescriber or the certified
5nurse-midwife who functions pursuant to a standardized procedure
6or protocol described in Section 2746.51, the nurse practitioner
7who functions pursuant to a standardized procedure described in
8Section 2836.1 or protocol, the physician assistant who functions
9pursuant to Section 3502.1, the naturopathic doctor who functions
10pursuant to a standardized procedure or protocol described in
11Section 3640.5, or the pharmacist who functions pursuant to a
12policy, procedure, or protocol pursuant tobegin delete eitherend delete Sectionbegin delete 4052.1
13orend delete
begin insert 4052.1,end insert 4052.2begin insert, or 4052.6end insert orders otherwise, either the
14manufacturer’s trade name of the drug or the generic name and
15the name of the manufacturer. Commonly used abbreviations may
16be used. Preparations containing two or more active ingredients
17may be identified by the manufacturer’s trade name or the
18commonly used name or the principal active ingredients.

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
25described 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 tobegin delete eitherend delete
30 Sectionbegin delete 4052.1 orend deletebegin insert 4052.1,end insert 4052.2begin insert, or 4052.6end insert.

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.

P17   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) If a pharmacist dispenses a prescribed drug by means of a
19unit dose medication system, as defined by administrative
20regulation, for a patient in a skilled nursing, intermediate care, or
21other health care facility, the requirements of this section will be
22satisfied if the unit dose medication system contains the
23aforementioned information or the information is otherwise readily
24available at the time of drug administration.

25(c) If a pharmacist dispenses a dangerous drug or device in a
26begin delete facility licensed pursuant toend deletebegin insert health facility, as defined inend insert Section
271250 of the Health and Safety Code, it is not necessary to include
28on individual unit dose containers for a specific patient, the name
29of the certified nurse-midwife who functions pursuant to a
30standardized procedure or protocol described in Section 2746.51,
31the nurse practitioner who functions pursuant to a standardized
32procedure described in Section 2836.1 or protocol, the physician
33assistant who functions pursuant to Section 3502.1, the naturopathic
34doctor who functions pursuant to a standardized procedure or
35protocol described in Section 3640.5, or the pharmacist who
36functions pursuant to a policy, procedure, or protocol pursuant to
37begin delete eitherend delete Sectionbegin delete 4052.1 orend deletebegin insert 4052.1,end insert 4052.2begin insert, or 4052.6end insert.

38(d) If a pharmacist dispenses a prescription drug for use in a
39facility licensed pursuant to Section 1250 of the Health and Safety
40Code, it is not necessary to include the information required in
P18   1paragraph (11) of subdivision (a) when the prescription drug is
2administered to a patient by a person licensed under the Medical
3Practice Act (Chapter 5 (commencing with Section 2000)), the
4Nursing Practice Act (Chapter 6 (commencing with Section 2700)),
5or the Vocational Nursing Practice Act (Chapter 6.5 (commencing
6with Section 2840)), who is acting within his or her scope of
7practice.

begin insert

8(e) This section shall remain in effect only until January 1, 2016,
9and as of that date is repealed, unless a later enacted statute, that
10is enacted before January 1, 2016, deletes or extends that date.

end insert
11begin insert

begin insertSEC. 12.end insertbegin insert7.end insert  

end insert

begin insertSection 4076 is added to the end insertbegin insertBusiness and
12Professions Code
end insert
begin insert, to read:end insert

begin insert
13

begin insert4076.end insert  

(a) A pharmacist shall not dispense any prescription
14except in a container that meets the requirements of state and
15federal law and is correctly labeled with all of the following:

16(1) Except when the prescriber or the certified nurse-midwife
17who functions pursuant to a standardized procedure or protocol
18described in Section 2746.51, the nurse practitioner who functions
19pursuant to a standardized procedure described in Section 2836.1
20or protocol, the physician assistant who functions pursuant to
21Section 3502.1, the naturopathic doctor who functions pursuant
22to a standardized procedure or protocol described in Section
233640.5, or the pharmacist who functions pursuant to a policy,
24procedure, or protocol pursuant to Section 4052.1, 4052.2, or
254052.6 orders otherwise, either the manufacturer’s trade name of
26the drug or the generic name and the name of the manufacturer.
27Commonly used abbreviations may be used. Preparations
28containing two or more active ingredients may be identified by the
29manufacturer’s trade name or the commonly used name or the
30principal active ingredients.

31(2) The directions for the use of the drug.

32(3) The name of the patient or patients.

33(4) The name of the prescriber or, if applicable, the name of
34the certified nurse-midwife who functions pursuant to a
35standardized procedure or protocol described in Section 2746.51,
36the nurse practitioner who functions pursuant to a standardized
37procedure described in Section 2836.1 or protocol, the physician
38assistant who functions pursuant to Section 3502.1, the
39naturopathic doctor who functions pursuant to a standardized
40 procedure or protocol described in Section 3640.5, or the
P19   1pharmacist who functions pursuant to a policy, procedure, or
2protocol pursuant to Section 4052.1, 4052.2, or 4052.6.

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 dispensed.

9(10) The condition or purpose for which the drug was prescribed
10if the condition or purpose is indicated on the prescription.

11(11) (A) Commencing January 1, 2006, the physical description
12of the dispensed medication, including its color, shape, and any
13identification code that appears on the tablets or capsules, except
14as follows:

15(i) Prescriptions dispensed by a veterinarian.

16(ii) An exemption from the requirements of this paragraph shall
17be granted to a new drug for the first 120 days that the drug is on
18the market and for the 90 days during which the national reference
19file has no description on file.

20(iii) Dispensed medications for which no physical description
21exists in any commercially available database.

22(B) This paragraph applies to outpatient pharmacies only.

23(C) The information required by this paragraph may be printed
24on an auxiliary label that is affixed to the prescription container.

25(D) This paragraph shall not become operative if the board,
26prior to January 1, 2006, adopts regulations that mandate the
27same labeling requirements set forth in this paragraph.

28(b) The information required by paragraphs (1), (2), (3), (7),
29and (10) of subdivision (a) shall be printed in at least a 12-point
30typeface.

31(c) If a pharmacist dispenses a prescribed drug by means of a
32unit dose medication system, as defined by administrative
33regulation, for a patient in a skilled nursing, intermediate care,
34or other health care facility, the requirements of this section will
35be satisfied if the unit dose medication system contains the
36 aforementioned information or the information is otherwise readily
37available at the time of drug administration.

38(d) If a pharmacist dispenses a dangerous drug or device in a
39health facility, as defined in Section 1250 of the Health and Safety
40Code, it is not necessary to include on individual unit dose
P20   1containers for a specific patient, the name of the certified
2nurse-midwife who functions pursuant to a standardized procedure
3or protocol described in Section 2746.51, the nurse practitioner
4who functions pursuant to a standardized procedure described in
5Section 2836.1 or protocol, the physician assistant who functions
6pursuant to Section 3502.1, the naturopathic doctor who functions
7pursuant to a standardized procedure or protocol described in
8Section 3640.5, or the pharmacist who functions pursuant to a
9policy, procedure, or protocol pursuant to Section 4052.1, 4052.2,
10or 4052.6.

11(e) If a pharmacist dispenses a prescription drug for use in a
12facility licensed pursuant to Section 1250 of the Health and Safety
13Code, it is not necessary to include the information required in
14paragraph (11) of subdivision (a) when the prescription drug is
15administered to a patient by a person licensed under the Medical
16Practice Act (Chapter 5 (commencing with Section 2000)), the
17Nursing Practice Act (Chapter 6 (commencing with Section 2700)),
18or the Vocational Nursing Practice Act (Chapter 6.5 (commencing
19with Section 2840)), who is acting within his or her scope of
20practice.

21(f) This section shall become operative on January 1, 2016.

end insert
22

SEC. 13.  

Section 4111 of the Business and Professions Code
23 is amended to read:

24

4111.  

(a) Except as otherwise provided in subdivision (b), (d),
25or (e), the board shall not issue or renew a license to conduct a
26pharmacy to any of the following:

27(1) A person or persons authorized to prescribe or write a
28prescription, as specified in Section 4040, in the State of California.

29(2) A person or persons with whom a person or persons specified
30in paragraph (1) shares a community or other financial interest in
31the permit sought.

32(3) Any corporation that is controlled by, or in which 10 percent
33or more of the stock is owned by a person or persons prohibited
34from pharmacy ownership by paragraph (1) or (2).

35(b) Subdivision (a) shall not preclude the issuance of a permit
36for an inpatient hospital pharmacy to the owner of the hospital in
37which it is located.

38(c) The board may require any information the board deems is
39reasonably necessary for the enforcement of this section.

P21   1(d) Subdivision (a) shall not preclude the issuance of a new or
2renewal license for a pharmacy to be owned or owned and operated
3by a person licensed on or before August 1, 1981, under the
4Knox-Keene Health Care Service Plan Act of 1975 (Chapter 2.2
5(commencing with Section 1340) of Division 2 of the Health and
6Safety Code) and qualified on or before August 1, 1981, under
7subsection (d) of Section 1310 of Title XIII of the federal Public
8Health Service Act, as amended, whose ownership includes persons
9defined pursuant to paragraphs (1) and (2) of subdivision (a).

10(e) Subdivision (a) shall not preclude the issuance of a new or
11renewal license for a pharmacy to be owned or owned and operated
12by a pharmacist authorized to issue a drug order pursuant to Section
134052.1, 4052.2, or 4052.6.

14

SEC. 14.  

Section 4174 of the Business and Professions Code
15 is amended to read:

16

4174.  

Notwithstanding any other law, a pharmacist may
17dispense drugs or devices upon the drug order of a nurse
18practitioner functioning pursuant to Section 2836.1 or a certified
19nurse-midwife functioning pursuant to Section 2746.51, a drug
20order of a physician assistant functioning pursuant to Section
213502.1 or a naturopathic doctor functioning pursuant to Section
223640.5, or the order of a pharmacist acting under Section 4052.1,
234052.2, 4052.3, or 4052.6.

24

SEC. 15.  

Section 4210 is added to the Business and Professions
25Code
, to read:

26

4210.  

(a) A person who seeks recognition as an advanced
27practice pharmacist shall meet all of the following requirements:

28(1) Hold an active license to practice pharmacy issued pursuant
29to this chapter that is in good standing.

30(2) Satisfy any two of the following criteria:

31(A) Earn certification in a relevant area of practice, including,
32but not limited to, ambulatory care, critical care, geriatric
33pharmacy, nuclear pharmacy, nutrition support pharmacy, oncology
34 pharmacy, pediatric pharmacy, pharmacotherapy, or psychiatric
35pharmacy, from an organization recognized by the Accreditation
36Council for Pharmacy Education or another entity recognized by
37the board.

38(B) Complete a postgraduate residency through an accredited
39postgraduate institution where at least 50 percent of the experience
P22   1includes the provision of direct patient care services with
2interdisciplinary teams.

3(C) Have provided clinical services to patients for at least one
4year under a collaborative practice agreement or protocol with a
5physician, advanced practice pharmacist, pharmacist practicing
6collaborative drug therapy management, or health system.

7(3) File an application with the board for recognition as an
8advanced practice pharmacist.

9(4) Pay the applicable fee to the board.

10(b) An advanced practice pharmacist recognition issued pursuant
11to this section shall be valid for two years, coterminous with the
12certificate holder’s license to practice pharmacy.

13(c) The board shall adopt regulations establishing the means of
14documenting completion of the requirements in this section.

15(d) The board shall, by regulation, set the fee for the issuance
16and renewal of advanced practice pharmacist recognition at the
17reasonable cost of regulating advanced practice pharmacists
18pursuant to this chapter. The fee shall not exceed three hundred
19dollars ($300).

20

SEC. 16.  

Section 4233 is added to the Business and Professions
21Code
, to read:

22

4233.  

A pharmacist who is recognized as an advanced practice
23pharmacist shall complete 10 hours of continuing education each
24renewal cycle in addition to the requirements of Section 4231. The
25subject matter shall be in one or more areas of practice relevant to
26the pharmacist’s clinical practice.

27begin insert

begin insertSEC. 17.end insert  

end insert
begin insert

Sections 12.5 and 12.7 of this bill incorporate
28amendments to Section 4076 of the Business and Professions Code
29proposed by both this bill and Senate Bill 205. They shall only
30become operative if (1) both bills are enacted and become effective
31on or before January 1, 2014, (2) each bill amends Section 4076
32of the Business and Professions Code, and (3) this bill is enacted
33after Senate Bill 205, in which case Section 12 of this bill shall
34not become operative.

end insert
35

begin deleteSEC. 17.end delete
36begin insert SEC. 18.end insert  

No reimbursement is required by this act pursuant
37to Section 6 of Article XIII B of the California Constitution because
38the only costs that may be incurred by a local agency or school
39district will be incurred because this act creates a new crime or
40infraction, eliminates a crime or infraction, or changes the penalty
P23   1for a crime or infraction, within the meaning of Section 17556 of
2the Government Code, or changes the definition of a crime within
3the meaning of Section 6 of Article XIII B of the California
4Constitution.



O

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