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.

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:

3

733.  

(a) A licentiate shall not obstruct a patient in obtaining
4a prescription drug or device that has been legally prescribed or
5ordered for that patient. A violation of this section constitutes
6unprofessional conduct by the licentiate and shall subject the
7licentiate to disciplinary or administrative action by his or her
8licensing agency.

P3    1(b) Notwithstanding any other law, a licentiate shall dispense
2drugs and devices, as described in subdivision (a) of Section 4024,
3pursuant to a lawful order or prescription unless one of the
4following circumstances exists:

5(1) Based solely on the licentiate’s professional training and
6judgment, dispensing pursuant to the order or the prescription is
7contrary to law, or the licentiate determines that the prescribed
8drug or device would cause a harmful drug interaction or would
9otherwise adversely affect the patient’s medical condition.

10(2) The prescription drug or device is not in stock. If an order,
11other than an order described in Section 4019, or prescription
12cannot be dispensed because the drug or device is not in stock, the
13licentiate shall take one of the following actions:

14(A) Immediately notify the patient and arrange for the drug or
15device to be delivered to the site or directly to the patient in a
16timely manner.

17(B) Promptly transfer the prescription to another pharmacy
18known to stock the prescription drug or device that is near enough
19to the site from which the prescription or order is transferred, to
20ensure the patient has timely access to the drug or device.

21(C) Return the prescription to the patient and refer the patient.
22The licentiate shall make a reasonable effort to refer the patient to
23a pharmacy that stocks the prescription drug or device that is near
24enough to the referring site to ensure that the patient has timely
25access to the drug or device.

26(3) The licentiate refuses on ethical, moral, or religious grounds
27to dispense a drug or device pursuant to an order or prescription.
28A licentiate may decline to dispense a prescription drug or device
29 on this basis only if the licentiate has previously notified his or
30her employer, in writing, of the drug or class of drugs to which he
31or she objects, and the licentiate’s employer can, without creating
32undue hardship, provide a reasonable accommodation of the
33licentiate’s objection. The licentiate’s employer shall establish
34protocols that ensure that the patient has timely access to the
35prescribed drug or device despite the licentiate’s refusal to dispense
36the prescription or order. For purposes of this section, “reasonable
37accommodation” and “undue hardship” shall have the same
38meaning as applied to those terms pursuant to subdivision (l) of
39Section 12940 of the Government Code.

P4    1(c) For the purposes of this section, “prescription drug or device”
2has the same meaning as the definition in Section 4022.

3(d) This section applies to emergency contraception drug therapy
4and self-administered hormonal contraceptives described in Section
54052.3.

6(e) This section imposes no duty on a licentiate to dispense a
7drug or device pursuant to a prescription or order without payment
8for the drug or device, including payment directly by the patient
9or through a third-party payer accepted by the licentiate or payment
10of any required copayment by the patient.

11(f) The notice to consumers required by Section 4122 shall
12include a statement that describes patients’ rights relative to the
13requirements of this section.

14

SEC. 2.  

Section 4016.5 is added to the Business and Professions
15Code
, to read:

16

4016.5.  

“Advanced practice pharmacist” means a licensed
17pharmacist who has been recognized as an advanced practice
18pharmacist by the board, pursuant to Section 4210. A
19board-recognized advanced practice pharmacist is entitled to
20practice advanced practice pharmacy, as described in Section
214052.6, within or outside of a licensed pharmacy as authorized by
22this chapter.

23

SEC. 3.  

Section 4040 of the Business and Professions Code is
24amended to read:

25

4040.  

(a) “Prescription” means an oral, written, or electronic
26transmission order that is both of the following:

27(1) Given individually for the person or persons for whom
28ordered that includes all of the following:

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

30(B) The name and quantity of the drug or device prescribed and
31the directions for use.

32(C) The date of issue.

33(D) Either rubber stamped, typed, or printed by hand or typeset,
34the name, address, and telephone number of the prescriber, his or
35her license classification, and his or her federal registry number,
36if a controlled substance is prescribed.

37(E) A legible, clear notice of the condition or purpose for which
38the drug is being prescribed, if requested by the patient or patients.

39(F) If in writing, signed by the prescriber issuing the order, or
40the certified nurse-midwife, nurse practitioner, physician assistant,
P5    1or naturopathic doctor who issues a drug order pursuant to Section
22746.51, 2836.1, 3502.1, or 3640.5, respectively, or the pharmacist
3who issues a drug order pursuant to Section 4052.1, 4052.2, or
44052.6.

5(2) Issued by a physician, dentist, optometrist, podiatrist,
6veterinarian, or naturopathic doctor pursuant to Section 3640.7 or,
7if a drug order is issued pursuant to Section 2746.51, 2836.1,
83502.1, or 3460.5, by a certified nurse-midwife, nurse practitioner,
9physician assistant, or naturopathic doctor licensed in this state,
10or pursuant to Section 4052.1, 4052.2, or 4052.6 by a pharmacist
11licensed in this state.

12(b) Notwithstanding subdivision (a), a written order of the
13prescriber for a dangerous drug, except for any Schedule II
14controlled substance, that contains at least the name and signature
15of the prescriber, the name and address of the patient in a manner
16consistent with paragraph (2) of subdivision (a) of Section 11164
17of the Health and Safety Code, the name and quantity of the drug
18prescribed, directions for use, and the date of issue may be treated
19as a prescription by the dispensing pharmacist as long as any
20additional information required by subdivision (a) is readily
21retrievable in the pharmacy. In the event of a conflict between this
22subdivision and Section 11164 of the Health and Safety Code,
23Section 11164 of the Health and Safety Code shall prevail.

24(c) “Electronic transmission prescription” includes both image
25and data prescriptions. “Electronic image transmission
26prescription” means any prescription order for which a facsimile
27of the order is received by a pharmacy from a licensed prescriber.
28“Electronic data transmission prescription” means any prescription
29order, other than an electronic image transmission prescription,
30that is electronically transmitted from a licensed prescriber to a
31pharmacy.

32(d) The use of commonly used abbreviations shall not invalidate
33an otherwise valid prescription.

34(e) Nothing in the amendments made to this section (formerly
35Section 4036) at the 1969 Regular Session of the Legislature shall
36be construed as expanding or limiting the right that a chiropractor,
37while acting within the scope of his or her license, may have to
38prescribe a device.

39

SEC. 4.  

Section 4050 of the Business and Professions Code is
40amended to read:

P6    1

4050.  

(a) In recognition of and consistent with the decisions
2of the appellate courts of this state, the Legislature hereby declares
3the practice of pharmacy to be a profession.

4(b) Pharmacy practice is a dynamic, patient-oriented health
5service that applies a scientific body of knowledge to improve and
6promote patient health by means of appropriate drug use,
7drug-related therapy, and communication for clinical and
8consultative purposes. Pharmacy practice is continually evolving
9to include more sophisticated and comprehensive patient care
10activities.

11(c) The Legislature further declares that pharmacists are health
12care providers who have the authority to provide health care
13services.

14

SEC. 5.  

Section 4051 of the Business and Professions Code is
15amended to read:

16

4051.  

(a) Except as otherwise provided in this chapter, it is
17unlawful for any person to manufacture, compound, furnish, sell,
18or dispense a dangerous drug or dangerous device, or to dispense
19or compound a prescription pursuant to Section 4040 of a prescriber
20unless he or she is a pharmacist under this chapter.

21(b) Notwithstanding any other law, a pharmacist may authorize
22the initiation of a prescription, pursuant to Section 4052.1, 4052.2,
234052.3, or 4052.6, and otherwise provide clinical advice, services,
24information, or patient consultation, as set forth in this chapter, if
25all of the following conditions are met:

26(1) The clinical advice, services, information, or patient
27consultation is provided to a health care professional or to a patient.

28(2) The pharmacist has access to prescription, patient profile,
29or other relevant medical information for purposes of patient and
30clinical consultation and advice.

31(3) Access to the information described in paragraph (2) is
32secure from unauthorized access and use.

33

SEC. 6.  

Section 4052 of the Business and Professions Code is
34amended to read:

35

4052.  

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

36(1) Furnish a reasonable quantity of compounded drug product
37to a prescriber for office use by the prescriber.

38(2) Transmit a valid prescription to another pharmacist.

39(3) Administer drugs and biological products that have been
40ordered by a prescriber.

P7    1(4) Perform procedures or functions in a licensed health care
2facility as authorized by Section 4052.1.

3(5) Perform procedures or functions as part of the care provided
4by a health care facility, a licensed home health agency, a licensed
5clinic in which there is a physician oversight, a provider who
6contracts with a licensed health care service plan with regard to
7the care or services provided to the enrollees of that health care
8service plan, or a physician, as authorized by Section 4052.2.

9(6) Perform procedures or functions as authorized by Section
104052.6.

11(7) Manufacture, measure, fit to the patient, or sell and repair
12dangerous devices, or furnish instructions to the patient or the
13patient’s representative concerning the use of those devices.

14(8) Provide consultation, training, and education to patients
15 about drug therapy, disease management, and disease prevention.

16(9) Provide professional information, including clinical or
17pharmacological information, advice, or consultation to other
18health care professionals, and participate in multidisciplinary
19review of patient progress, including appropriate access to medical
20records.

21(10) Furnish thebegin delete followingend delete medicationsbegin insert described in
22subparagraph (A) in accordance subparagraph (B)end insert
:

23(A) begin insert(1)end insert Emergency contraception drug therapy and
24self-administered hormonal contraceptives, as authorized by
25Section 4052.3.

begin delete

26(B)

end delete

27begin insert(2)end insert Nicotine replacement products, as authorized by Section
284052.9.

begin delete

29(C)

end delete

30begin insert(3)end insert Prescription medications not requiring a diagnosis that are
31recommended by the federal Centers for Disease Control and
32Prevention for individuals traveling outside of the United States.

begin delete

33(D)

end delete

34begin insert(B)end insert The pharmacist shall notify the patient’s primary care
35provider of any drugs or devices furnished to the patientbegin insert, or enter
36the appropriate information in a patient record system shared with
37the primary care provider, as permitted by that primary care
38providerend insert
. If the patient does not have a primary care provider, the
39pharmacist shall provide the patient with a written record of the
P8    1drugs or devices furnished and advise the patient to consult a
2physician of the patient’s choice.

3(11) Administer immunizations pursuant to a protocol with a
4prescriber.

5(12) Order and interpret tests for the purpose of monitoring and
6managing the efficacy and toxicity of drug therapies. A pharmacist
7who orders and interprets tests pursuant to this paragraph shall
8ensure that the ordering of those tests is done in coordination with
9the patient’s primary care provider or diagnosing prescriber, as
10appropriate, including promptly transmitting written notification
11to the patient’s diagnosing prescriber or entering the appropriate
12information in a patient record system shared with the prescriber,
13when available and as permitted by that prescriber.

14(b) A pharmacist who is authorized to issue an order to initiate
15or adjust a controlled substance therapy pursuant to this section
16shall personally register with the federal Drug Enforcement
17Administration.

18(c) This section does not affect the applicable requirements of
19law relating to either of the following:

20(1) Maintaining the confidentiality of medical records.

21(2) The licensing of a health care facility.

22

SEC. 7.  

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

24

4052.3.  

(a) (1) Notwithstanding any other law, a pharmacist
25may furnish self-administered hormonal contraceptives in
26accordance with standardized procedures or protocols developed
27and approved by both the board and the Medical Board of
28California in consultation with the American Congress of
29Obstetricians and Gynecologists, the California Pharmacists
30Association, and other appropriate entities. The standardized
31procedure or protocol shall require that the patient use a
32self-screening tool that will identify patient risk factors for use of
33self-administered hormonal contraceptives, based on the current
34United States Medical Eligibility Criteria (USMEC) for
35Contraceptive Use developed by the federal Centers for Disease
36Control and Prevention, and that the pharmacist refer the patient
37to the patient’s primary care provider or, if the patient does not
38have a primary care provider, to nearby clinics, upon furnishing a
39self-administered hormonal contraceptive pursuant to this
P9    1subdivision, or if it is determined that use of a self-administered
2hormonal contraceptive is not recommended.

3(2) The board and the Medical Board of California are both
4authorized to ensure compliance with this subdivision, and each
5board is specifically charged with the enforcement of this
6subdivision with respect to its respective licensees. This subdivision
7does not expand the authority of a pharmacist to prescribe any
8prescription medication.

9(b) (1) Notwithstanding any other law, a pharmacist may furnish
10emergency contraception drug therapy in accordance with either
11of the following:

12(A) Standardized procedures or protocols developed by the
13pharmacist and an authorized prescriber who is acting within his
14or her scope of practice.

15(B) Standardized procedures or protocols developed and
16 approved by both the board and the Medical Board of California
17in consultation with the American Congress of Obstetricians and
18Gynecologists, the California Pharmacists Association, and other
19appropriate entities. The board and the Medical Board of California
20are both authorized to ensure compliance with this clause, and
21each board is specifically charged with the enforcement of this
22provision with respect to its respective licensees. This subdivision
23does not expand the authority of a pharmacist to prescribe any
24prescription medication.

25(2) Prior to performing a procedure authorized under this
26subdivision, a pharmacist shall complete a training program on
27emergency contraception that consists of at least one hour of
28approved continuing education on emergency contraception drug
29therapy.

30(3) A pharmacist, pharmacist’s employer, or pharmacist’s agent
31shall not directly charge a patient a separate consultation fee for
32emergency contraception drug therapy services initiated pursuant
33to this subdivision, but may charge an administrative fee not to
34exceed ten dollars ($10) above the retail cost of the drug. Upon an
35oral, telephonic, electronic, or written request from a patient or
36customer, a pharmacist or pharmacist’s employee shall disclose
37the total retail price that a consumer would pay for emergency
38contraception drug therapy. As used in this paragraph, total retail
39price includes providing the consumer with specific information
40regarding the price of the emergency contraception drugs and the
P10   1price of the administrative fee charged. This limitation is not
2intended to interfere with other contractually agreed-upon terms
3between a pharmacist, a pharmacist’s employer, or a pharmacist’s
4agent, and a health care service plan or insurer. Patients who are
5insured or covered and receive a pharmacy benefit that covers the
6cost of emergency contraception shall not be required to pay an
7administrative fee. These patients shall be required to pay
8copayments pursuant to the terms and conditions of their coverage.
9This paragraph shall become inoperative for dedicated emergency
10contraception drugs if these drugs are reclassified as
11over-the-counter products by the federal Food and Drug
12Administration.

13(4) A pharmacist shall not require a patient to provide
14individually identifiable medical information that is not specified
15in Section 1707.1 of Title 16 of the California Code of Regulations
16before initiating emergency contraception drug therapy pursuant
17to this subdivision.

18(c) For each emergency contraception drug therapy or
19self-administered hormonal contraception initiated pursuant to this
20section, the pharmacist shall provide the recipient of the drug with
21a standardized factsheet that includes, but is not limited to, the
22indications and contraindications for use of the drug, the
23appropriate method for using the drug, the need for medical
24followup, and other appropriate information. The board shall
25develop this form in consultation with the State Department of
26Public Health, the American Congress of Obstetricians and
27Gynecologists, the California Pharmacists Association, and other
28health care organizations. This section does not preclude the use
29of existing publications developed by nationally recognized
30medical organizations.

31

SEC. 8.  

Section 4052.6 is added to the Business and Professions
32Code
, to read:

33

4052.6.  

(a) A pharmacist recognized by the board as an
34advanced practice pharmacist may do all of the following:

35(1) Perform patient assessments.

36(2) Order and interpret drug therapy-related tests.

37(3) Refer patients to other health care providers.

38(4) Participate in the evaluation and management of diseases
39and health conditions in collaboration with other health care
40providers.

P11   1(5) Initiate, adjust, or discontinue drug therapy in the manner
2specified in paragraph (4) of subdivision (a) of Section 4052.2.

3(b) A pharmacist who adjusts or discontinues drug therapy shall
4promptly transmit written notification to the patient’s diagnosing
5prescriber or enter the appropriate information in a patient record
6system shared with the prescriber, as permitted by that prescriber.
7A pharmacist who initiates drug therapy shall promptly transmit
8written notification to, or enter the appropriate information into,
9a patient record system shared with the patient’s primary care
10provider or diagnosing provider, as permitted by that provider.

11(c) This section shall not interfere with a physician’s order to
12dispense a prescription drug as written, or other order of similar
13meaning.

14(d) Prior to initiating or adjusting a controlled substance therapy
15pursuant to this section, a pharmacist shall personally register with
16the federal Drug Enforcement Administration.

17(e) A pharmacist who orders and interprets tests pursuant to
18paragraph (2) of subdivision (a) shall ensure that the ordering of
19those tests is done in coordination with the patient’s primary care
20provider or diagnosing prescriber, as appropriate, including
21promptly transmitting written notification to the patient’s
22diagnosing prescriber or entering the appropriate information in a
23patient record system shared with the prescriber, when available
24and as permitted by that prescriber.

25

SEC. 9.  

Section 4052.8 is added to the Business and Professions
26Code
, to read:

27

4052.8.  

(a) In addition to the authority provided in paragraph
28(11) of subdivision (a) of Section 4052, a pharmacist may
29independently initiate and administer vaccines listed on the routine
30immunization schedules recommended by the federal Advisory
31Committee on Immunization Practices (ACIP), in compliance with
32individual ACIP vaccine recommendations, and published by the
33federal Centers for Disease Control and Prevention (CDC) for
34persons three years of age and older.

35(b) In order to initiate and administer an immunization described
36in subdivision (a), a pharmacist shall do all of the following:

37(1) Complete an immunization training program endorsed by
38the CDC or the Accreditation Council for Pharmacy Education
39that, at a minimum, includes hands-on injection technique, clinical
40evaluation of indications and contraindications of vaccines, and
P12   1the recognition and treatment of emergency reactions to vaccines,
2and shall maintain that training.

3(2) Be certified in basic life support.

4(3) Comply with all state and federal recordkeeping and
5reporting requirements, including providing documentation to the
6patient’s primary care provider and entering information in the
7appropriate immunization registry designated by the immunization
8branch of the State Department of Public Health.

9(c) A pharmacist administering immunizations pursuant to this
10section, or paragraph (11) of subdivision (a) of Section 4052, may
11also initiate and administer epinephrine or diphenhydramine by
12injection for the treatment of a severe allergic reaction.

13

SEC. 10.  

Section 4052.9 is added to the Business and
14Professions Code
, to read:

15

4052.9.  

(a) A pharmacist may furnish nicotine replacement
16products approved by the federal Food and Drug Administration
17for use by prescription only in accordance with standardized
18procedures and protocols developed and approved by both the
19board and the Medical Board of California in consultation with
20other appropriate entities and provide smoking cessation services
21if all of the following conditions are met:

22(1) The pharmacist maintains records of all prescription drugs
23and devices furnished for a period of at least three years for
24purposes of notifying other health care providers and monitoring
25the patient.

26(2) The pharmacist notifies the patient’s primary care provider
27of any drugs or devices furnished to the patientbegin insert, or enters the
28appropriate information in a patient record system shared with
29the primary care provider, as permitted by that primary care
30providerend insert
. If the patient does not have a primary care provider, the
31pharmacist provides the patient with a written record of the drugs
32or devices furnished and advises the patient to consult a physician
33of the patient’s choice.

34(3) The pharmacist is certified in smoking cessation therapy by
35an organization recognized by the board.

36(4) The pharmacist completes one hour of continuing education
37focused on smoking cessation therapy biennially.

38(b) The board and the Medical Board of California are both
39authorized to ensure compliance with this section, and each board
40is specifically charged with the enforcement of this section with
P13   1respect to their respective licensees. Nothing in this section shall
2be construed to expand the authority of a pharmacist to prescribe
3any other prescription medication.

4

SEC. 11.  

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

6

4060.  

A person shall not possess any controlled substance,
7except that furnished to a person upon the prescription of a
8physician, dentist, podiatrist, optometrist, veterinarian, or
9naturopathic doctor pursuant to Section 3640.7, or furnished
10pursuant to a drug order issued by a certified nurse-midwife
11pursuant to Section 2746.51, a nurse practitioner pursuant to
12Section 2836.1, a physician assistant pursuant to Section 3502.1,
13a naturopathic doctor pursuant to Section 3640.5, or a pharmacist
14pursuant to Section 4052.1, 4052.2, or 4052.6. This section does
15not apply to the possession of any controlled substance by a
16manufacturer, wholesaler, pharmacy, pharmacist, physician,
17podiatrist, dentist, optometrist, veterinarian, naturopathic doctor,
18certified nurse-midwife, nurse practitioner, or physician assistant,
19if in stock in containers correctly labeled with the name and address
20of the supplier or producer.

21This section does not authorize a certified nurse-midwife, a nurse
22practitioner, a physician assistant, or a naturopathic doctor, to order
23his or her own stock of dangerous drugs and devices.

24

SEC. 12.  

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

26

4076.  

(a) A pharmacist shall not dispense any prescription
27except in a container that meets the requirements of state and
28federal law and is correctly labeled with all of the following:

29(1) Except when the prescriber or the certified nurse-midwife
30who functions pursuant to a standardized procedure or protocol
31described in Section 2746.51, the nurse practitioner who functions
32pursuant to a standardized procedure described in Section 2836.1
33or protocol, the physician assistant who functions pursuant to
34Section 3502.1, the naturopathic doctor who functions pursuant
35to a standardized procedure or protocol described in Section
363640.5, or the pharmacist who functions pursuant to a policy,
37 procedure, or protocol pursuant to Section 4052.1, 4052.2, or
384052.6 orders otherwise, either the manufacturer’s trade name of
39the drug or the generic name and the name of the manufacturer.
40Commonly used abbreviations may be used. Preparations
P14   1containing two or more active ingredients may be identified by
2the manufacturer’s trade name or the commonly used name or the
3principal active ingredients.

4(2) The directions for the use of the drug.

5(3) The name of the patient or patients.

6(4) The name of the prescriber or, if applicable, the name of the
7certified nurse-midwife who functions pursuant to a standardized
8procedure or protocol described in Section 2746.51, the nurse
9practitioner who functions pursuant to a standardized procedure
10described in Section 2836.1 or protocol, the physician assistant
11who functions pursuant to Section 3502.1, the naturopathic doctor
12who functions pursuant to a standardized procedure or protocol
13described in Section 3640.5, or the pharmacist who functions
14pursuant to a policy, procedure, or protocol pursuant to Section
154052.1, 4052.2, or 4052.6.

16(5) The date of issue.

17(6) The name and address of the pharmacy, and prescription
18number or other means of identifying the prescription.

19(7) The strength of the drug or drugs dispensed.

20(8) The quantity of the drug or drugs dispensed.

21(9) The expiration date of the effectiveness of the drug
22dispensed.

23(10) The condition or purpose for which the drug was prescribed
24if the condition or purpose is indicated on the prescription.

25(11) (A) Commencing January 1, 2006, the physical description
26of the dispensed medication, including its color, shape, and any
27identification code that appears on the tablets or capsules, except
28as follows:

29(i) Prescriptions dispensed by a veterinarian.

30(ii) An exemption from the requirements of this paragraph shall
31be granted to a new drug for the first 120 days that the drug is on
32the market and for the 90 days during which the national reference
33file has no description on file.

34(iii) Dispensed medications for which no physical description
35exists in any commercially available database.

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

37(C) The information required by this paragraph may be printed
38on an auxiliary label that is affixed to the prescription container.

P15   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
12facility licensed pursuant to Section 1250 of the Health and Safety
13Code, it is not necessary to include on individual unit dose
14containers for a specific patient, the name of the certified
15nurse-midwife who functions pursuant to a standardized procedure
16or protocol described in Section 2746.51, the nurse practitioner
17who functions pursuant to a standardized procedure described in
18Section 2836.1 or protocol, the physician assistant who functions
19pursuant to Section 3502.1, the naturopathic doctor who functions
20pursuant to a standardized procedure or protocol described in
21Section 3640.5, or the pharmacist who functions pursuant to a
22policy, procedure, or protocol pursuant to Section 4052.1, 4052.2,
23or 4052.6.

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
33 practice.

34

SEC. 13.  

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

36

4111.  

(a) Except as otherwise provided in subdivision (b), (d),
37or (e), the board shall not issue or renew a license to conduct a
38pharmacy to any of the following:

39(1) A person or persons authorized to prescribe or write a
40prescription, as specified in Section 4040, in the State of California.

P16   1(2) A person or persons with whom a person or persons specified
2in paragraph (1) shares a community or other financial interest in
3the permit sought.

4(3) Any corporation that is controlled by, or in which 10 percent
5or more of the stock is owned by a person or persons prohibited
6from pharmacy ownership by paragraph (1) or (2).

7(b) Subdivision (a) shall not preclude the issuance of a permit
8for an inpatient hospital pharmacy to the owner of the hospital in
9which it is located.

10(c) The board may require any information the board deems is
11reasonably necessary for the enforcement of this section.

12(d) Subdivision (a) shall not preclude the issuance of a new or
13renewal license for a pharmacy to be owned or owned and operated
14by a person licensed on or before August 1, 1981, under the
15Knox-Keene Health Care Service Plan Act of 1975 (Chapter 2.2
16(commencing with Section 1340) of Division 2 of the Health and
17Safety Code) and qualified on or before August 1, 1981, under
18subsection (d) of Section 1310 of Title XIII of the federal Public
19Health Service Act, as amended, whose ownership includes persons
20defined pursuant to paragraphs (1) and (2) of subdivision (a).

21(e) Subdivision (a) shall not preclude the issuance of a new or
22renewal license for a pharmacy to be owned or owned and operated
23by a pharmacist authorized to issue a drug order pursuant to Section
244052.1, 4052.2, or 4052.6.

25

SEC. 14.  

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

27

4174.  

Notwithstanding any other law, a pharmacist may
28dispense drugs or devices upon the drug order of a nurse
29practitioner functioning pursuant to Section 2836.1 or a certified
30nurse-midwife functioning pursuant to Section 2746.51, a drug
31order of a physician assistant functioning pursuant to Section
323502.1 or a naturopathic doctor functioning pursuant to Section
333640.5, or the order of a pharmacist acting under Section 4052.1,
344052.2, 4052.3, or 4052.6.

35

SEC. 15.  

Section 4210 is added to the Business and Professions
36Code
, to read:

37

4210.  

(a) A person who seeks recognition as an advanced
38practice pharmacist shall meet all of the following requirements:

39(1) Hold an active license to practice pharmacy issued pursuant
40to this chapter that is in good standing.

P17   1(2) Satisfy any two of the following criteria:

2(A) Earn certification in a relevant area of practice, including,
3but not limited to, ambulatory care, critical care,begin insert geriatric
4pharmacy,end insert
nuclear pharmacy, nutrition support pharmacy, oncology
5 pharmacy, pediatric pharmacy, pharmacotherapy, or psychiatric
6pharmacy, from an organization recognized by the Accreditation
7Council for Pharmacy Education or another entity recognized by
8the board.

9(B) Complete a postgraduate residency through an accredited
10postgraduate institution where at least 50 percent of the experience
11includes the provision of direct patient care services with
12interdisciplinary teams.

13(C) Have provided clinical services to patients for at least one
14year under a collaborative practice agreement or protocol with a
15physician, advanced practice pharmacist, pharmacist practicing
16collaborative drug therapy management, or health system.

17(3) File an application with the board for recognition as an
18advanced practice pharmacist.

19(4) Pay the applicable fee to the board.

20(b) An advanced practice pharmacist recognition issued pursuant
21to this section shall be valid for two years, coterminous with the
22certificate holder’s license to practice pharmacy.

23(c) The board shall adopt regulations establishing the means of
24documenting completion of the requirements in this section.

25(d) The board shall, by regulation, set the fee for the issuance
26and renewal of advanced practice pharmacist recognition at the
27reasonable cost of regulating advanced practice pharmacists
28pursuant to this chapter. The fee shall not exceed three hundred
29dollars ($300).

30

SEC. 16.  

Section 4233 is added to the Business and Professions
31Code
, to read:

32

4233.  

A pharmacist who is recognized as an advanced practice
33pharmacist shall complete 10 hours of continuing education each
34renewal cycle in addition to the requirements of Section 4231. The
35subject matter shall be in one or more areas of practice relevant to
36the pharmacist’s clinical practice.

37

SEC. 17.  

No reimbursement is required by this act pursuant to
38Section 6 of Article XIII B of the California Constitution because
39the only costs that may be incurred by a local agency or school
40district will be incurred because this act creates a new crime or
P18   1infraction, eliminates a crime or infraction, or changes the penalty
2for a crime or infraction, within the meaning of Section 17556 of
3the Government Code, or changes the definition of a crime within
4the meaning of Section 6 of Article XIII B of the California
5Constitution.



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